Packaging Issue 6 - Interpretation Guideline (English)

ISSUE 6
Guideline
MATERIALS
PACKAGING
Interpretation
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Packaging Materials
Issue 6
INTERPRETATION GUIDELINE
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INTERPRETATION
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ISSUE 6
Liability
BRCGS1 publishes information and expresses opinions in good faith, but accepts no liability for any error or omission
in any such information or opinion, including any information or opinion contained in this publication.
Whilst BRCGS has endeavoured to ensure that the information in this publication is accurate, it shall not be liable
for any damages (including without limitation damages for pure economic loss or loss of business or loss of profits
or depletion of goodwill or otherwise in each case, whether direct, indirect or consequential) or any claims for
consequential compensation whatsoever (howsoever caused) arising in contract, tort (including negligence or breach
of statutory duty), misrepresentation, restitution or otherwise, in connection with this publication or any information
contained in it, or from any action or decision taken as a result of reading this publication or any such information.
All warranties, conditions and other terms implied by statute or common law are, to the fullest extent permitted by
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law, excluded.
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Nothing excludes or limits the liability of BRCGS for death or personal injury caused by its negligence, for fraud or
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fraudulent misrepresentation or for any matter which it would be illegal for it to exclude or attempt to exclude
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liability for.
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The Global Standard for Packaging Materials Issue 6: Interpretation Guideline and the terms of the disclaimer set
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out above shall be construed in accordance with English law and shall be subject to the non-exclusive jurisdiction
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of the English Courts.

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Copyright
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© 2019 BRCGS
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All rights reserved. No part of this publication may be transmitted or reproduced in any form (including
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photocopying or storage in any medium by electronic means) without the written permission of the copyright owner.
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Application for permission should be addressed to the Operations Director of Global Standards at BRCGS
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(contact details below). Full acknowledgement of the author and source must be given.
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The contents of this publication cannot be reproduced for the purposes of training or any other commercial activity.
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No part of this publication may be translated without the written permission of the copyright owner.
Warning: Any unauthorised act in relation to a copyright work may result in both a civil claim for damages and
criminal prosecution.
For more information about BRCGS, contact:
BRCGS
Second Floor
7 Harp Lane
London EC3R 6DP
Tel: +44 (0) 20 3931 8150

Email: enquiries@brcgs.com
Website: www.brcgs.com
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BRCGS is a trading name of BRC Trading Ltd.
PACKAGING MATERIALS
ISSUE 6
Contents
Part I – Explaining certification
Introduction 2
BRCGS certification 2
First steps to gaining certification 3
What to expect on the audit day(s) 4
Explanation of terms 5
Further guidance 8
Part II – Guidance on the requirements
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1 Senior management commitment 11
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2 Hazard and risk management 27
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3 Product safety and quality management 37
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4 Site standards 74
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5 Product and process control 104

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6 Personnel 132
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7 Requirements for traded products 150

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Glossary
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PACKAGING MATERIALS
ISSUE 6
Part I
Part I
Explaining
certification
Introduction 2
BRCGS certification 2
Why is certification required? 2
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First steps to gaining certification 3 , 2 er ipa
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Self-audit or gap analysis 3
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Who undertakes certification audits? 3

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Cost of audits 3
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When can the audit be undertaken? 4

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Part II
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What to expect on the audit day(s) 4

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Unannounced audits 5
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Explanation of terms
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Statements of intent 5
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Fundamental requirements 5
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‘Shall’ versus ‘may’ 6

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Risk assessment 6
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Appropriate 6
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Documented procedures 7
Validation 7
Verification 7
Monitoring 7
Annual frequency 7
Further guidance 8
Key to colour-coding of requirements 8
Glossary
PACKAGING MATERIALS
ISSUE 6
Part I
Explaining certification
Introduction
Welcome to the interpretation guideline for the sixth issue of the Global Standard for Packaging Materials (hereafter
referred to as the Standard). The interpretation guideline is designed to provide an accompaniment to Issue 6 of the
Standard and should be read in conjunction with the Standard. The full details of the certification process and
protocol are contained within the Standard.
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This document helps in the understanding of each requirement of the Standard and identifies methods of
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compliance. Examples are given to explain the type of documents, procedures and level of detail that would be
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required by a certification auditor.
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The contents of the guideline are designed to help interpret the Standard across all industry sectors; however, the
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exact requirements for any particular product, process or site will be specific to that industry and situation. Users of
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the guideline are therefore cautioned not to rely solely on the information provided here, but also to reconfirm
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needs on a product-by-product basis. Both legislative and voluntary safety requirements change frequently,
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highlighting the need for regular checks of precise requirements.

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While adherence to the guideline does not specifically form part of the requirement to achieve certification to the
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Standard (i.e. they do not form part of the audit requirements), companies will need to demonstrate that they have
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taken account of the topics addressed within this guideline. Examples are given as points to consider but should
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always be used in the correct context relevant to the business. Practices should be able to withstand challenge by an
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auditor and be in line with good industry practices.

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Achieving a particular requirement is based on evidence collected and observations made during the audit, and on
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the procedures expected within that industry sector. The level of non-conformity assigned by an auditor against a
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requirement of the Standard is an objective judgement with respect to severity and risk, and is based on the
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evidence seen during the audit and independently verified by the certification body management.
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BRCGS certification
Why is certification required?
Certification to the Standard was developed to establish a common standard for product safety and quality
management, allowing brand owners to demonstrate control and satisfy legal responsibility for products and
consumer safety, as well as reducing audit duplication for manufacturers. The Standard has become a benchmark for
best practice and is recognised worldwide by brand owners and manufacturers in the supply chain, with several
thousand packaging materials manufacturers now certificated to the Standard. The Standard has been developed for
manufacturers of packaging; however, certification throughout the supply chain is available through other Global
Standards:
•• Global Standard for Food Safety

•• Global Standard for Storage and Distribution
•• Global Standard for Consumer Products
•• Global Standard for Agents and Brokers.
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ISSUE 6
Part I
First steps to gaining certification
Self-audit or gap analysis
Once the decision has been made by the company to pursue certification to the Standard, the requirements need to
be understood. The site needs to be assessed with regard to its current status, and areas that need to be improved
must be identified. This may, for example, relate to the structure of buildings, equipment requirements, the design of
processes or the documentation and implementation of procedures. The company needs to establish an action plan.
Relevant staff need to understand what is expected. Training courses or further information are available and may
be useful.
A gap analysis or self-audit will need to be conducted. This could be undertaken in house – for example,
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incorporated into the company’s internal audit process. However, it may require external resources in the form
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of consultancy expertise, or a pre-assessment may be undertaken by the company’s chosen certification body.
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External consultants meeting the requirements of BRCGS can be located on the BRCGS training website
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(https://www.brcgs.com/training/events).
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Once the company has reviewed the gaps between the requirements and its current practices, the company’s senior
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management needs to establish a plan to ensure that work is undertaken to fulfil the requirements. This could
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include, for example, updating of policies and procedures, training of staff, capital expenditure for equipment and
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Part II
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maintenance of the building.

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Who undertakes certification audits?

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BRCGS does not undertake the audits itself. BRCGS is the Standard owner, documenting the requirements on behalf
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of stakeholders and controlling the operation of the certification scheme. The Standard is written by a committee of
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international representatives, coordinated by BRCGS, including retailers, packaging industry representatives and
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certification bodies. The BRCGS team then controls how audits are undertaken through the specification of the
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audit protocol and supporting rules and regulations for certification bodies undertaking the certification audits.
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Monitoring of certification bodies is undertaken through independent accreditation – for example, by the United
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Kingdom Accreditation Service (UKAS) or the American National Standards Institute (ANSI), operating to
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internationally recognised protocols – and by the BRCGS team.

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Therefore, a BRCGS-approved certification body needs to be selected by the company. There is a worldwide choice
of such bodies; a list can be found at www.brcgsdirectory.com. Certification bodies need to be appropriately qualified
to undertake the audit and conform to the company’s and its customers’ requirements.
Cost of audits
Audit costs vary and are set by the individual certification bodies. They may include the expenses of the auditor
(e.g. travel). Typically, the audit consists upward of 1.5 days on site, depending on factors such as company size (in
terms of staff numbers and size of site), the complexity of the manufacturing process, communication difficulties
(e.g. language) and difficulties during the audit. A full list of factors is given in the Standard. In addition, time is
needed to write up the report – typically 0.5–1 day. As with most purchases, the cost should be clearly stated and
Glossary
agreed between the company and the certification body prior to entering into the contract.
It should be noted that certification is a continual process, and it is a feature of the scheme that the certification
body has the option to visit a certificated company at any stage of certification to ensure that certification principles
are being upheld. This may arise through the receipt of further information, such as a complaint from a customer of
the site, and a charge may be made for any subsequent visits or investigations.
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A service fee is payable directly to BRCGS through the certification body for every audit undertaken.
The company also needs to consider investment costs that may be incurred to ensure the company is operating to
the standards required by the Global Standard, including site standards, training and procedural costs.
When can the audit be undertaken?

The company and the chosen certification body should agree a mutually convenient date for audits and re-audits to
ensure that the company retains ongoing certification. (For certificated sites this may be yearly or 6-monthly,
depending on the grade attained.) The company may wish to choose a date when:
•• products that need to be included within the scope of the certificate are being manufactured
•• personnel to be involved in the audit process are available.
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Ongoing announced re-audit dates need to be considered since the re-audit date will fall between 11 and 12 months
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from the original audit date (or 5 to 6 months from the original audit date if a Grade C or D is obtained, where
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re-audit is required after 6 months). Ensure the time of year is suitable for your company in years to come.
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What to expect on the audit day(s)

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The auditor/certification body shall have confirmed to the company the time of arrival on site and may have provided
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an outline of the plan of the audit schedule. The duration of the audit, although planned in advance, will depend on
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the activities on the day, but it may be shortened by a well-organised site and information provided in advance as
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requested by the certification body.

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The auditor will start with an opening meeting, which all the relevant company personnel (including the most senior
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production or operations manager on site) need to attend, to outline how the audit will be undertaken. This will
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enable agreement and organisation in terms of:

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•• documents that need to be provided

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•• rooms that need to be provided (e.g. consider where records are stored and how they can be supplied to the
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•• logistics to ensure that equipment, such as protective clothing, is provided.
The auditor is likely to require background details on the company and the process before any site tour, and may
therefore look through a number of documents, including:
•• company quality policies

•• organisation structure
•• hazard analysis and risk assessment (HARA).
Auditors will ask the company to carry out a traceability test while the auditor is on site, so it may be beneficial to
start this process as soon as practical to allow collation of documents.
The auditor will need to see the manufacturing process in operation around the site, checking and challenging the
operation of the company’s procedures. The auditor will check policies, procedures and records for objective
evidence that requirements are being met, and will ask for specific details and speak to a variety of staff. After the
audit, the auditor will require some quiet time to write up evidence and collate details of non-conformities, in
preparation for the closing meeting with the company, where the audit is summed up and details of the findings,
including non-conformities, are given.
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Part I
Unannounced audits
The option to undertake the unannounced audit scheme provides companies with an opportunity to demonstrate
their confidence in their systems and procedures, to the extent that they are willing to subject these to unannounced
scrutiny. Companies may thereby gain a competitive advantage with their customers, who are given an opportunity to
review suppliers’ risk ratings. Customers may view suppliers in the unannounced audit scheme more favourably,
depending on performance, and they may reduce the frequency of their own customer audits as a result.
The unannounced audit scheme is voluntary and the decision to participate in the scheme rests with the certificated
company. To opt into the scheme, companies must notify their certification body of their intention within the first
3 months following a qualifying audit; after this period only the announced scheme will be available.
The grading criteria will be as for the normal audit. Successful completion of the audit will result in the awarding of
certification Grade AA+, A+, B+, C+ or D+, where the plus symbol indicates an unannounced audit, and this grade
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will appear on the certificate. This certificate will supersede the existing certificate.
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While it may be accepted that the company would need to ensure that arrangements such as facilities to undertake
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meetings and review documentation are made available at short notice, an unannounced audit should not affect the
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logistics of how an audit is undertaken, and should be approached in the same way by both the auditor and the
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company. The company should consider the requirements for contingency plans in the event of documents, such as
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personnel records, being kept in locked cupboards and the nominated key holder being off-site (e.g. through the
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Part II
provision of spare keys).
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Issue 6 of the Standard provides an unannounced audit option. Full details of the unannounced audit scheme can be
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found in Part III, section 3 of the Standard.

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Explanation of terms
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Within the Standard there are some specific terms and language used and a good starting point for interpreting the
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Standard is to be familiar with these terms and their context. A full glossary of these terms is given in the Appendix.
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Statements of intent
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Each main section or subsection of the requirements in the Standard begins with a statement of intent (SOI).
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This sets out the expected outcome of compliance with the requirements of that section. This forms part of the
audit and all companies must comply with the statements of intent.
Below the statements of intent in the tables are more specific and detailed requirements (clauses) that, if applied
appropriately, will help to achieve the stated objective of the requirement. All of the requirements and statements
of intent shall form part of the audit and must be complied with in order for a certificate to be issued.
Fundamental requirements
The Standard contains certain requirements that have been designated as ‘fundamental’. These are marked with the
Glossary
word ‘Fundamental’ and denoted by the following symbol . These requirements relate to systems that are crucial
to the establishment and operation of an effective quality and safety operation. The requirements deemed
fundamental are:
•• Senior management commitment and continual improvement (1.1)

•• Hazard analysis and risk assessment (2.2)
•• Specifications (3.4)
•• Internal audits (3.5)
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•• Corrective and preventive action (3.6)

•• Traceability (3.11)
•• Housekeeping and cleaning (4.8)
•• Process control (5.4)
•• Training and competence: raw materials handling, preparation, processing, packing and storage areas (6.1).
Fundamental requirements apply to those controls that cannot be implemented quickly prior to an audit
(e.g. management commitment, internal audits) and where the output of their implementation can be assessed.
They are designed to ensure that the quality system will be effective between certification dates.
A lack of focus on a fundamental requirement may result in certification not being granted.
‘Shall’ versus ‘may’
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The style of the Standard is generally one of guidance, to allow companies to ensure that all aspects of control have
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been considered, so that thorough and comprehensive policies and procedures may be developed. In some
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instances, the Standard requires that criteria must be included within a policy or procedure, and this is generally
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covered by the term ‘shall’. If any of the points included are not covered adequately, a non-conformity will result.
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However, there are also a number of clauses that provide examples or guidelines, generally preceded by the words
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‘may include’ or ‘should’. This information is provided as guidance for incorporation in company policies and
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procedures. It is the responsibility of the company to ensure that the auditor is satisfied that the system in place is
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appropriate.
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Clause 3.7.4 shows an example of both usages:

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‘The site shall have an up-to-date list or database of approved suppliers. This may be on paper (hard copy) or it may
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be controlled on an electronic system.’

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Risk assessment
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A number of clauses within the Standard refer to risk assessments being the basis for developing appropriate control
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procedures, such as establishing a frequency for monitoring a control point. Risk assessment is defined as using
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judgement to identify hazards and determine their impact on product safety, legality or quality, and designing an
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appropriate control or procedure to minimise the risk of problems occurring.

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These clauses require the site to conduct risk assessments and to carry out any activities that mitigate the hazards
identified. During the course of the certification audit, the auditor will require evidence of these risk assessments.
For example, they may take the form of documents that identify the hazard, the risk of it occurring and the options
for control; alternatively, this information may be incorporated within established procedures. Risk assessments
do not need to be long, complicated documents; they must, however, demonstrate which aspects have been
assessed and, where further action has not been carried out, some description of the justification for not doing
so will be required.
The principle is to demonstrate that any potential hazards have been considered by the company, and that the
controls applied are justified and will stand up to robust challenge by any auditor. In many cases, industry best
practice, where known and available, will meet this requirement.
Appropriate
A number of clauses within the Standard refer to the need to fulfil requirements ‘where appropriate’. ‘Appropriate’
is defined as suitable for a particular condition or occasion, and requirements shall be met where it is an industry
requirement or justified to do so.
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PACKAGING MATERIALS
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Part I
A number of the requirements specify appropriate timescales, appropriate personnel etc. , and thus contain a level of
judgement. They are designed to provide a degree of flexibility to ensure the operation of policies or procedures
that are right for the organisation.
Documented procedures
In many instances, the Standard specifically states that requirements shall be satisfied by documented procedures;
in others, this is implied as the company needs to demonstrate that systems are in place. Any policies and
documents must be written in sufficient detail to satisfy their purpose and must reflect the activities that happen
in practice.
Validation
Validation is defined as obtaining evidence that a control measure (or combination of measures), if properly
implemented, is capable of controlling a hazard to a specified outcome. Validation activity is completed before
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the controls are introduced or when changes are expected (e.g. new products, new processes or new equipment).
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Validation might include:
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•• document and data review – previous test results, industry data, codes of practice and legislation may all contain
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useful information
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•• experiments/testing – consider tests on the product or factory environment that will demonstrate control
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(worst‑case-scenario tests, final product tests etc.)

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Part II
•• challenge studies – for example, challenging vision systems to determine whether physical contaminants can be
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detected at the appropriate detection level.

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Verification
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Verification is defined as obtaining evidence, on a predetermined and ongoing basis, that a control is operating within
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the correct parameters. Verification requires the application of methods, procedures, tests or evaluations, in addition to
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monitoring, to determine whether the control measure is operating as intended. Verification activities may include:
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•• audits – both internal and third party

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•• review of records (e.g. records of the monitoring of temperatures and times, or other records completed during
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•• corrective action review

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•• test results – depending on the control being verified, these might include final products, raw materials etc.
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Monitoring
Monitoring is defined as conducting a planned sequence of observations or measurements to assess whether a
control measure is within acceptable limits (e.g. temperature checks, test weights etc.).
Annual frequency
Many requirements in the Standard refer to an annual frequency for the completion of, for example, internal audits
or specific tasks. The aim of this specification is to ensure that certain tasks are completed within the minimum of a
12-month period (e.g. that the test of the system is completed every 12 months). There is a difference of 23 months
Glossary
between a test being carried out each January, and a test occurring in January one year, and December in the
subsequent year.
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PACKAGING MATERIALS
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Further guidance
Further guidance is available from the BRCGS website, where each Standard has its own set of pages, the BRCGS
bookshop, and BRCGS Participate, the online service. This guidance includes sector-specific guidelines, such as
those for the Glass Container Manufacturers’ Guideline.
Key to colour-coding of requirements

Requirements assessed as part of the audit of good manufacturing practice (GMP)
Requirements assessed as part of the audit of records, systems and documentation

(‘desk‑top’ audit)
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Requirements assessed as part of the GMP and ‘desk-top’ audits
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PACKAGING MATERIALS
ISSUE 6
Part I
Part II
Guidance on the
requirements
1 Senior management
commitment 11
1.1 Senior management commitment and continual
improvement 11
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1.2 Management review 20
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1.3 Organisational structure, responsibilities and
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management authority 24
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2 Hazard and risk management 27

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2.1 Hazard and risk management team 27

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Part II
2.2 Hazard analysis and risk assessment 29
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3 Product safety and quality

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management 37
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3.1 Product safety and quality management system 37

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3.2 Document control 39

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3.4 Specifications 42
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3.5 Internal audits 46

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3.6 Corrective and preventive action 49

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3.7 Supplier approval and performance monitoring 53

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3.8 Product authenticity, claims and chain of custody 59

3.9 Management of subcontracted activities and
outsourced processes 61
3.10 Management of suppliers of services 64
3.11 Traceability 65
3.12 Complaint-handling 68
3.13 Management of product withdrawals, incidents
and product recalls 70
Glossary
4 Site standards 74
4.1 External standards 74
4.2 Building fabric and interiors: raw materials
handling, preparation, processing, packing and
storage areas 77
4.3 Utilities 80
4.4 Site security and product defence 82
4.5 Layout, product flow and segregation 84
4.6 Equipment 86
4.7 Maintenance 88
4.8 Housekeeping and cleaning 91
4.9 Product contamination control 94
4.10 Waste and waste disposal 97
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4.11 Pest management 100
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5 Product and process control
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104
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5.1 Product development 104

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5.2 Graphic design and artwork control 107

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5.3 Packaging print control 111

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5.4 Process control 114

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monitoring devices 118
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5.8 Incoming goods 125

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5.9 Storage of all materials and intermediate and

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5.10 Dispatch and transport 129

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6 Personnel
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132
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6.1 Training and competence: raw materials handling,

preparation, processing, packing and storage areas 132
6.2 Personal hygiene: raw materials handling,
preparation, processing, packing and storage areas 136
6.3 Staff facilities 139
6.4 Medical screening 144
6.5 Protective clothing 146
7 Requirements for traded

products 150
7.1 Approval and performance monitoring of
manufacturers/packers of traded packaging
products 150
7.2 Specifications 153
7.3 Product inspection and laboratory testing 155
7.4 Product legality 157
7.5 Traceability 158
PACKAGING MATERIALS
ISSUE 6
Part I
Part II
Guidance on the requirements
1 Senior management commitment
1.1 Senior management commitment and continual improvement
Fundamental
The site’s senior management shall demonstrate that they are fully committed to the
implementation of requirements of the Global Standard for Packaging Materials.
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Interpretation
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This clause is a fundamental requirement. The Standard places a high priority on the demonstration of senior
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management commitment and it will be assessed by the auditor throughout the site audit. Such commitment may be
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demonstrated by the implementation of a well-thought-out company policy that is communicated and implemented
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throughout the organisation and supported by the provision of adequate resources and support systems.
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Part II
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Without commitment from the senior management, who have the authority to allocate budget and resources and set
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site policies, it is not possible to properly implement the requirements of the Standard. Although a department
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manager or quality manager may be able to implement elements of the Standard on their own initiative, many of the
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requirements need support from different parts of the site and demand commitment at the highest level.
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The requirement encompasses a need to effect continual improvement as product quality and safety expectations
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At the opening meeting, no senior management representatives are available. The quality manager informs the
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auditor that the senior managers are on vacation and have left the quality manager to deputise. The auditor notes
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that no senior managers have been consistently present at any management review meetings for the past year.
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The senior managers evidently do not understand the importance of their commitment, both in attendance of the
audit, and in management review.
The auditor will raise a non-conformity for lack of senior management commitment.
Example
Throughout the audit the auditor identifies a number of non-conformities across a range of requirements, which
implies that the senior management are not committed to the Standard. For example, cleaning standards are poor
because of the lack of equipment and time allowed for cleaning operations; the internal audit is behind schedule
because of insufficient auditors; the building fabrication is in a poor state with no commitment to upkeep; and
Glossary
actions arising from pest control recommendations are not being completed.
Senior management evidently do not support the commitment to the Standard’s requirements. The auditor will
raise a non-conformity for lack of senior management commitment.
brcgs.com 11
PACKAGING MATERIALS
ISSUE 6
Clause Requirements
1.1.1 The site shall have a documented policy which states the site’s intention to meet its
obligation to produce safe and legally compliant products to the specified quality and
confirms its responsibility to its customers. This shall be:
•• signed by the person with overall responsibility for the site
•• communicated to all staff.
Interpretation Product safety and quality management policy

A policy statement should clearly state the aims of the site, establish the commitment of
the senior management, and enable all staff to work together towards the common goal
of producing safe and legal products that meet customer requirements. This statement
establishes the commitment of the company’s senior management and outlines how they
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are going to achieve consistent product safety, quality and legality. The statement should
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be a summary – it need not be more than half a page.
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The policy statement should be signed by the most senior manager at the site, such as the
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managing director, plant manager or site manager, and dated to establish its relevance.
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It should be reviewed regularly to ensure that it is still applicable. Even if it doesn’t require
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altering, evidence must be available to show that amendment has been considered. The
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Standard does not define the frequency of review but ideally this would take place annually,
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perhaps as part of the management review meeting. An auditor could be concerned if the
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statement is reviewed less frequently and may ask for a reason for the interval chosen.
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All sites should be committed to the production of safe and legal products, and the policy
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statement is the most effective way of demonstrating this. All sites are required to provide
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evidence that they are committed to the processes of review and continual improvement
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and be able to communicate the policy to all relevant staff. Regular review of the policy by
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the senior management team would ensure that this happens.

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This requirement also defines what must be included in the policy statement. Auditors need to
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check that all aspects are included. It should state the objectives of the company, including
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specific reference to how the company intends to meet its responsibilities for the production
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of safe and legal products to a specified quality that meet customer requirements; it should
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also emphasise the company’s commitment to continual improvement.
1.1.2 The site’s senior management shall define and maintain a clear and effective plan for the
development and continual improvement of a product safety and quality culture. This shall
include:
•• defined activities involving all sections of the site that have an impact on product safety
and quality
•• a description of how the activities will be undertaken and measured, and the intended
timescales
•• a review of the effectiveness of completed and ongoing activities.
Clause effective from 1 February 2021.
Interpretation Product safety and quality culture

All companies have a culture. This requirement is focused on the site recognising it and
taking steps to ensure it is aligned with its objectives to deliver safe products to the
required quality.
Changing or improving culture can be challenging. It relies not just on measurables and
specifics but an ethos and values felt by people at all levels of the company. The size and
12 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
complexity (or simplicity) of the site should not be a barrier to a successful culture. Good
culture is also expressed through the ease of movement of information between different
levels of the company. A proactive, positive culture within a company can make all the
difference in the effectiveness of the product safety and quality plan and its consistent
implementation. The culture must be adopted by senior management and ‘felt’ throughout
the organisation, so that all aspects of the business are informed and involved.
The company is required to develop and implement a clear plan or programme for developing
and improving its product safety and quality culture. Such a plan would be based on the nature
of the organisation and depend on its size and the overall aims it has identified as important.
Typical indicators for an organisational culture include:
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•• people – staff retention, levels of staff engagement
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•• process – levels of non-conforming product or customer returns
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•• purpose – empowerment, investment in training
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•• proactivity – senior management engagement at all levels of the business,
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communication throughout the organisation.

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The objectives of the plan do not need to be achieved within a year. A strategic plan could,
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Part II
for example, cover 5 years, with activities designed to measure or establish the status of the
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current culture, implement changes and assess improvements (or where improvement was
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not evident, a review of why). Some aspects of the plan may occur more frequently than
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others and the tools, metrics and measures for monitoring the plan should be demonstrable.
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A wide range of activities could be incorporated into the plan, some of which the company
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may already be conducting. For example:

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•• a staff survey focusing on values and culture

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•• training review and staff development

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•• effective communication strategies

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•• activities to maintain product safety standards.

The auditor will expect to find evidence of a plan with objectives, and evidence of the site
completing the activities in its action plan. This will be determined through interviews and
by reviewing objective evidence of the steps taken.
Interviews may be conducted across all levels of personnel by the auditor. They will be
expected to find an awareness of product safety and quality culture, how individuals can
impact on it, and the company’s objectives.
Organisational culture is expressed throughout the Standard where successful
implementation has been achieved; for example, in communication (1.3.2), corrective and
Glossary
preventive action (3.6), and training and competence (6.1). The auditor will be looking for
evidence of the culture objectives in the other relevant parts of the audit, to ensure that
the site is developing and implementing its own plans.
BRCGS operates a module in product safety culture excellence which sites can elect to
add to their BRCGS audit. It will publish a guideline on product safety culture which may
be purchased from the BRCGS bookshop (www.brcgsbookshop.com) or viewed online at
BRCGS Participate (www.brcgsparticipate.com).
brcgs.com 13
PACKAGING MATERIALS
ISSUE 6
Clause Requirements
Example Strategic plan for a product safety and quality culture
A large company is creating a product safety and quality culture plan. Senior management
have recognised that product quality is a continual concern; each week, up to 35% of total
dispatched product is returned by their customers.
The company discovers through root cause analysis that the reasons for the returns are
spread across the organisation; therefore it establishes a multidisciplinary team with
representatives from management, supervision and the shop floor to look in depth at the
contributing factors.
Products are returned mainly because of physical contamination and non-conforming
product, and poor staff engagement, training and competence are found to be the cause.
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As a result, several customers have ceased trading with the company, and other
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customers have imposed strict conditions regarding hygiene and inspection of product
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prior to dispatch. The team returned an action plan that had the commitment of all levels
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of the plant.
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The site’s plan starts out quite simply by stating its intention to reduce physical
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contamination of product. Senior management conduct anonymous surveys to try to

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understand the feelings of staff about hygiene and the correct use of protective clothing.
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Following these surveys, the company identifies that staff do not understand how their
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actions impact on the business, and how poor hygiene leads to subsequent product returns.
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It also discovers that staff do not feel recognised by the management team for good work.
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The company decides to implement the plan, which includes hygiene training,
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communications and staff recognition programmes as follows:

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•• Enhanced hygiene training – beyond the simple induction training to an understanding

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of the hygiene rules and involvement in risk assessment to determine the correct use of
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protective clothing across the site.

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boards. Updates are used to communicate production, incidences of non-conforming

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product, customer complaints and their corrective actions, and improvements in product
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quality. They also focus on company strategy and product safety objectives.
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•• A clear feedback process – to initiate communication ‘up’ to management, so that

communication is not just seen as management ‘telling’ staff.
•• Recognition – instigation of initiatives such as ‘employee of the month’ as a reward for
successful improvements.
1.1.3 The site’s senior management shall establish clear objectives to maintain and improve the
quality, safety and legality of products manufactured, in accordance with the site’s product
safety and quality policy and this Standard. These objectives shall be:
•• documented and include targets or clear measures of success
•• clearly communicated to relevant staff
•• monitored, and the results reported at a suitable predetermined frequency to the site’s
senior management.
14 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
Interpretation Setting objectives and targets
Senior management must set objectives concerning product safety and quality which help
to achieve the stated policy. The objectives must be communicated so that the relevant
staff, i.e. those whose roles can affect product safety or quality, understand what is required
from them. The setting of these objectives also helps the allocation of suitable budgets
and resources. Auditors will look for evidence that the objectives are in place and have
been communicated to staff.
Good objectives are usually:
•• specific – clear and directly related to the site’s aims or goals for product safety and quality
•• measurable – so that the site can assess progress
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•• achievable – targets that stretch the company are acceptable but it is important that they
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are realistic and that sufficient resources will be available
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•• relevant – designed to maintain and improve product safety and quality
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•• time-bound – either long term (e.g. throughout the period of certification) or shorter term
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(e.g. within the next 3 months); however, the timescales or deadlines should be clear to
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enable the site to review progress and, if necessary, amend activities.

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There are many examples of objectives that could be included. For example, reductions in:
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Part II
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•• customer complaints
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•• customer rejections or returns.

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In each of these examples it would be necessary for the site to consider how to make the
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objective specific and measurable; for example, 10% fewer customer complaints to be
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achieved by year end.

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To facilitate continual improvement, the company’s senior management need to analyse

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the data from the discussions and formulate new objectives and targets regarding the
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safety, quality and legality of its products. The auditor will expect to see documented
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objectives with target results, often expressed as key performance indicators (KPIs).
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Evidence is vital for the auditor to witness that both continual development activities take
place and that there are suitable routes of communication for the identified actions.
Although feedback loops are not specified in the Standard, they may benefit the company
by helping to demonstrate that actions have been verified and signed off as completed
within the nominated timescales, in line with clause 1.2.3.
Independent sites or facilities that are part of a large group with company-wide objectives
can adopt the company-wide objectives, but are required to ‘own’ the objectives and carry
out the implementation, monitoring, review etc. at site level.
Glossary
brcgs.com 15
PACKAGING MATERIALS
ISSUE 6
Clause Requirements
1.1.4 The company’s senior management shall provide the human and financial resources
required for the production of safe packaging material, to the required quality, and in
compliance with the requirements of this Standard.
Interpretation Provision of resources

Sites must have sufficient financial and human resources to be able to maintain the product
safety and quality systems and produce safe packaging materials to the required quality in
order to achieve certification.
This clause will be assessed by the auditor on a number of aspects witnessed during the
visit. Questions about resources might include:
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•• audits, tests etc. and adherence to schedule
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•• availability of necessary information, such as subscription to information sources
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•• budget availability for training on quality or safety issues
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•• risk assessments and expertise availability
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•• equipment essential for product safety being adequately repaired, serviced or calibrated.
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Without the appropriate resources and skills, it is unlikely that the company could meet
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the requirements of the Standard. Where external consultants are used as the main source
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of technical knowledge, it is essential that the company can demonstrate that a consultant
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is readily available and that there is no compromise on product safety and legality. The site
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must be able to show that the day-to-day responsibilities for the implementation of the
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Standard are under the control of the site.

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rectifying identified issues and ongoing maintenance or training programmes.

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Although a review of resources forms part of the management review process (clause 1.2.2),
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it should not be restricted to a single annual discussion if there is a need to make changes
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As well as looking at the minutes of the management review meeting, auditors will also
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look at the type, number and root cause of non-conformities identified at the audit, as the
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ability of the site to correct these will partly demonstrate that the appropriate resources
and skills are available.
The auditor will examine the provision of resources during the site tour and desk-top audit.
The auditor will expect the site to demonstrate that it is adequately resourcing its product
safety and quality activities, which may include capital expenditure (e.g. for repairs or new
equipment), maintaining adequate levels of staff and staff training.
1.1.5 The company’s senior management shall have a system in place to ensure that the site is
kept informed of and reviews:
•• scientific and technical developments
•• industry codes of practice
•• all relevant legislation applicable in the country of manufacture and, where known, the
country where the product will be used.
Products shall meet the minimum legal requirements in the country of manufacture and of
use where known.
16 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
Interpretation Information system
The company must be able to demonstrate that it maintains up-to-date knowledge of
relevant legislation, scientific and technical developments, and industry codes of practice.
For example:
•• membership of a trade association and receipt of its newsletters
•• subscription to a service provider supplying legal updates
•• help from local enforcement offices
•• regular reviews of identified websites covering legislation and standards.
The company must show that it can readily access, either directly or through a third party,
legislation relating to their packaging materials in the country, state or territory where they
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are manufactured (as a minimum) and, where known, the country, state or territory where
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the materials are used.
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The auditor will be looking for evidence of systematic checking for relevant information
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and for a process to ensure that the information is translated into action as necessary.
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1.1.6 The site shall have a genuine, original hard copy or electronic version of the current
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Standard and be aware of any changes to the Standard or protocol that are published on
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Part II
the BRCGS website.
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Interpretation Site shall have a copy of the Standard

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The aim of this requirement is to ensure the site has easy access to all the relevant
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requirements needed for compliance and certification to the Standard. The site is therefore
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required to have an official copy of the Standard available in either paper or electronic
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form. A copy of the Standard in PDF format is available as a free download from the BRCGS
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bookshop, and a subscription to BRCGS Participate provides an online version of the

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Standard (and access to all BRCGS publications) and therefore also meets this requirement.
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In addition, during the lifetime of the Standard, the BRCGS technical advisory committee
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(TAC) may be asked to:

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•• review the wording of a requirement in the Standard or audit protocol

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•• provide an interpretation for a requirement

•• give clarification on how different industry sectors use a requirement
•• rule on the grading of a non-conformity against a clause.
Published TAC opinions are defined as position statements. Position statements are
binding on the way that the audit and certification process are carried out and are
considered to be an extension to the Standard. Sites must therefore be aware of any
published position statements and, where necessary, ensure the information is translated
into action. Position statements are published on the BRCGS website and electronically
communicated to both sites and certification bodies.
Glossary
brcgs.com 17
PACKAGING MATERIALS
ISSUE 6
Clause Requirements
1.1.7 Where the site is certificated to the Standard, it shall ensure that recertification audits
occur on or before the audit due date indicated on the certificate.
Interpretation Scheduling of recertification audits

The audit due date is indicated on both the audit report and the certificate issued to all
certificated sites, and responsibility for scheduling the next audit rests with the site.
The scheduling of certification audits needs to ensure that certification does not lapse
between assessments; this would result in a major non-conformity.
The audit can take place up to 28 calendar days prior to, but not after, the audit due date.
The timescales for corrective actions and the certification process will be taken into
account when making arrangements for an audit. A dialogue with the chosen certification
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body should take place to ensure any issues with maintaining compliance with the audit
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due date are identified. However, it is ultimately the company’s responsibility to ensure a
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It is recognised that there may be specific circumstances where certification cannot be

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renewed within the certification cycle. The Standard states these circumstances in Part III,
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section 2.8.2. Circumstances that would not result in the awarding of a major
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non‑conformity are where the company is:

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•• situated in a specific country or an area within a specific country where there is

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government advice to not visit and there is no suitable local auditor

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•• within a statutory exclusion zone

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•• in an area that has suffered a natural or unnatural disaster, rendering the site unable to
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produce or the auditor unable to visit

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•• affected by conditions that do not allow access to the site or restrict travel (e.g. heavy snow)
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•• not in production across the whole site due to rebuilding or renovations works.
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Lack of personnel availability is not an acceptable reason for adjusting recertification audit
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ensure the smooth operation of the site, including the provision of adequate cover for
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absence with assigned managerial deputies. Similarly, the undertaking of building work
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when the site is in production is not an acceptable reason, since product integrity must be
ensured in all circumstances.
It is not a justifiable reason to delay audits when sites are not in full production; however,
audits must be undertaken while products are being manufactured.
Where certification is not a customer requirement and the certificate has lapsed for more
than 6 months, re-entry to the BRCGS certification scheme will be considered as a new
application and this clause will not apply.
Where a site has opted into the unannounced audit scheme, it becomes the responsibility
of the certification body to ensure that this requirement is met.
Example A site’s audit is late by one week. The site states that the company’s general manager, who
is the senior management representative on the hazard and risk management team, is
unavailable to attend the site for personal reasons.
This is not an acceptable reason for delaying the audit as there should be a competent
deputy in place to take over when the general manager is not available. A non-conformity
will be raised.
18 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
Example A glass factory with one furnace is about to undertake its scheduled furnace rebuild, which
takes place every 10–12 years. During this time, no production will take place but the audit
due date falls in the middle of the 3-month rebuild period.
Audits can only be undertaken when the factory is in production. As the factory has
stopped production completely, this is an acceptable justification for audit delay. Note that
if this was one of several furnaces on site and production continued, the audit should go
ahead as per the audit schedule.
1.1.8 The most senior production or operations manager on site shall participate in the opening
and closing meetings of the audit for certification to the Standard.
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Relevant departmental managers or their deputies shall be available as required during the
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audit.
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Interpretation Senior management attendance at the audit
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The most senior production or operations managers on site (i.e. those who are responsible
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for the hands-on, daily running of the site) must participate in person in at least the
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opening and closing meetings of the audit.

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Part II
It may be the case that the most senior operations managers within the company are
D te ate
absent on the day of the audit (possibly if it is an unannounced audit or because of other
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commitments); however, there must always be a nominated deputy available (clause 1.3.1).
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The objective is to ensure that non-conformities are effectively understood and agreed;
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therefore this site representative will need to be sufficiently senior to make decisions
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regarding any non-conformities and the corrective action to be taken.

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1.1.9 The site’s senior management shall ensure that the root causes of any non-conformities
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identified at the previous audit against the Standard have been effectively addressed to
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prevent recurrence.
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Interpretation Effective closure of non-conformities

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Non-conformities identified in previous certification audits must have been fully rectified
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and these will be checked during the current audit.

Many sites have found it useful to retain copies of records and documents implicated by
non-conformities with the audit records. This allows quick and easy reference to the
specific document while reviewing, investigating and correcting the non-conformity.
(The original copy of the document should, of course, be returned to the appropriate
location in the site’s quality system.)
An important aspect of this requirement is the need to ensure that the non-conformity
does not recur. This should be achieved by the accurate identification of the cause(s) of
the non-conformity (the root cause) and the introduction of effective preventive action.
Glossary
BRCGS has published a guideline to understanding root cause analysis and preventive
action which explains some of the techniques available for identifying the cause of
non-conformities and preventing them from recurring. The guideline may be purchased
from the BRCGS bookshop (www.brcgsbookshop.com) or viewed online at BRCGS
Participate (www.brcgsparticipate.com).
If effective preventive action has not been introduced, a non-conformity may be raised
against this clause at the next audit in addition to a non-conformity against the clause that
has the recurring issue.
brcgs.com 19
PACKAGING MATERIALS
ISSUE 6
Clause Requirements
1.1.10 The BRCGS logo and references to certification status shall be used only in accordance
with the conditions of use detailed in the audit protocol section (Part III, section 5.6).
Interpretation Use of the BRCGS logo

Sites that have gained certification against any of the Global Standards are entitled to
demonstrate their pride in the achievement and use the BRCGS certification logo for
marketing purposes. This means the logo can be used on websites, letter headers, business
cards etc.
However, the BRCGS logo is not a product certification mark, so it (or words stating that
the product was produced in a BRCGS-certificated site) cannot be used on product
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packaging. The rules around logo use are detailed in the protocol of the Standard and
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further guidance is available from BRCGS.
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Where an auditor finds packaging with any BRCGS logo or wording during an audit, they
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will raise a non-conformity.
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1.2 Management review

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The site’s senior management shall ensure that a management review is undertaken to ensure that the product
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safety and quality management system is both fully implemented and effective, and that opportunities for
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Interpretation
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Establishing an effective product safety and quality management system is crucial in order to meet the requirements
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of the Standard. However, the site’s management should regularly review the system in order to ensure that it
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remains effective and relevant throughout the company and that the BRCGS audit has the highest possibility of
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success.
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Senior management should take responsibility for the review process. This may involve scheduling meetings,
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chairing of meetings, reviewing the resultant minutes and action points, or collating data and action points where
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they are covered by a number of departmental meetings. Splitting agenda points across several meetings is
acceptable, as long as all agenda points are covered in each annual period.
The process should be documented, with agendas and meeting minutes available to the auditor.
20 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
1.2.1 Management review meetings attended by the site’s senior management shall be
undertaken at appropriate scheduled intervals (at a minimum annually) to review the site’s
performance against the Standard and the objectives set out in clause 1.1.3.
Interpretation Review schedule

Senior management are considered to be managers who have the authority to make
decisions on product safety objectives and/or the provision of adequate human and
financial resources. The management team would usually include the site manager and
those managers responsible for production, technical operations, purchasing, engineering
and human resources. For large, multi-site organisations the management review meeting
may include head office representatives, but this decision should be driven by the senior
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management on site.
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Such participation will ensure that all identified actions are allocated to appropriate
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individuals, together with achievable timescales. Minutes of meetings will provide evidence
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of senior management involvement. The objective is to identify areas for improvement and
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continually strive for a more efficient and effective product safety and quality system.
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The Standard requires that the review takes place annually, i.e. within a 12-month period,
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Part II
although other shorter time periods are acceptable. The frequency of review meetings
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typically reflects the organisation, its activities, size and the complexity of its operations.
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Example An auditor reviews the management review minutes and observes that although customer
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complaints were on the agenda, only the figures and future targets were mentioned.
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The site representative explains that a monthly customer services meeting takes place
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with the customer services manager and that this forms part of the review process.
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The auditor then reviews the minutes from the customer services meetings and observes
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that all the functions of the review process have been met (complaints, feedback and
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progress against targets are reviewed) and that the customer services manager reports the
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outcome of these meetings to the formal management review meeting.

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This is satisfactory.
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1.2.2 The review process shall include the evaluation of:

•• previous management review documents, action plans and timeframes
•• the results of internal, second-party and third-party audits
•• any customer performance indicators, complaints and feedback
•• the effectiveness of the hazard and risk management (HARM) system
•• the impact of any applicable legislative and certification scheme changes
•• any incidents, corrective actions, out-of-specification results and non-conforming
materials
•• resource requirements
Glossary
•• any objectives that have not been met, to understand the underlying reasons.
This information shall be used when setting future objectives and to facilitate
continual improvement
•• the effectiveness of the product defence and product fraud prevention plans.
brcgs.com 21
PACKAGING MATERIALS
ISSUE 6
Clause Requirements
Interpretation Review process
Management review should be a specific meeting, or a series of meetings, with a defined
agenda, and the Standard specifies agenda items that shall be included; however, other
relevant subjects can be added. Topics discussed during other events, such as a short
mention of safety matters in a weekly management meeting, do not constitute a review.
Where management review topics are discussed outside of the formal management review
meeting, the minutes and actions of the discussions, where relevant, should also be
included to ensure that all aspects are covered by the management team.
Note that this clause gives a list of aspects that must be covered as a minimum, and the
auditor will check this list as part of the audit. All the bulleted points should be addressed;
it is unacceptable to omit any. Information provided to the meeting must be available to
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the auditor, along with the meeting minutes.
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The auditor will be looking for evidence that sufficient information has been provided for
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each agenda item to allow an informed discussion to take place leading to appropriate
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action plans. This may be demonstrated through a review of the inputs to the meeting,
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minutes of the discussion of the items and, where necessary, agreed action plans. For
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example, to demonstrate that the senior management have reviewed the HARM system,
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the minutes should contain a general summary of the HARM review (clause 2.2.12) and a
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record of the outcomes of the HARM meeting (provided as inputs to the senior
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management meeting). Any actions requested during the senior management meeting
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should have been recorded as outputs.

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The product safety and quality system and the requirements of the Standard should have
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been reviewed as part of the internal audit programme throughout the preceding year.
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Individual issues should have been identified and acted upon at the time and, where
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necessary, escalated to the management team. Second- or third-party audits include

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customer audits, regulatory authority visits etc.

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With regard to any customer performance indicators, complaints and feedback, the
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company’s senior management need to analyse this data and formulate action plans for
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continual improvement. The objective here is to ensure that sites don’t focus solely on the
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financial impacts but assess the detail and specific data associated with the complaints.
Embedding this approach in the organisational culture ensures that senior management
fully understand the challenges and opportunities for their organisation.
The meeting shall review performance against the objectives for product safety and quality
(clause 1.1.3) and an output will be the establishment of new or amended targets and
objectives for the following year. This should be clearly documented within the minutes of
the meeting.
Where the site has not met its objectives, the senior management need to understand why.
The outcome of the review would not be preventive action but a plan for continual
improvement, allowing the site to refine its future targets based on empirical data.
The outcomes from the review meeting must be communicated to the relevant staff to
ensure implementation. It should be evident to the auditor how this has been achieved
(e.g. cascaded through staff briefings or posted on noticeboards).
22 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
Example Customer complaints have been identified as a key area for improvement at a site
producing reels of PET for thermoformed food trays. The company has collated its data on
customer complaints, returns and feedback for the last 12 months, analysed the data to
identify the trends, and has set targets for improvement. The key areas for improvement
have been communicated to the production and dispatch areas of the site, and plans have
been established for reducing out-of-specification and mislabelled goods. Relevant new
procedures have been documented and implemented. The site has seen a decrease in
customer returns.
The site has demonstrated that it has collated data and then used it effectively by setting
targets which have resulted in improvement.
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1.2.3 The meeting shall be documented and used to revise the objectives. The decisions and
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actions agreed within the review process shall be effectively communicated to appropriate
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staff, and actions implemented within agreed timescales. t 2 es tic
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Interpretation Documentation
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Evidence is vital for the auditor to witness that, in addition to facilitating the route of
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communication for identified actions, management have ensured that the required activity
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Part II
does then take place. They must be able to demonstrate that actions have been verified and
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signed off as completed within the nominated timescales.

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1.2.4 The site shall have a demonstrable system in place which enables product safety, legality,
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integrity and quality issues to be brought to the attention of a designated manager.

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The system shall allow for the resolution of issues requiring immediate action.
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Interpretation Product safety alerts

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The auditor requires evidence that a system is in place to ensure that any factors with the
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potential to adversely affect product safety, legality or quality are reported to the
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designated manager. This system may involve a standard agenda item for a regular meeting
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(e.g. daily or weekly production meetings, but at least quarterly) or another established and
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clearly understood communication channel (e.g. an email alert). Whichever system is

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chosen, there should also be a suitable follow-up process to ensure that any necessary
remedial actions have been reviewed for relevancy and any required measures
implemented.
This review can form part of the management review activity.
Where a product safety or quality hazard is identified by a staff member, the reporting
function and subsequent activity should be sufficiently rapid to mitigate any product safety
or quality risks.
A transfer of information from an employee to the designated manager regarding unsafe or
out-of-specification product or raw materials is an example of good product safety and
Glossary
quality culture. If employees feel supported and empowered to identify and report issues
and make positive changes, this will typically be reflected in how they feel about the
organisation and the ongoing product safety and quality culture.
brcgs.com 23
PACKAGING MATERIALS
ISSUE 6
Clause Requirements
Further guidance Developing effective management review meetings
Attendees
In addition to the senior management team, the meeting may also include representatives of
any departments responsible for specific activities or actions to be discussed at the meeting.
Agenda
The Standard identifies specific agenda items that need to be included in the meeting, as
per clause 1.2.2. It is important that sufficient information is presented to the meeting to
enable a full discussion and, where appropriate, actions to be agreed.
Frequency of the meetings
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At a minimum meetings should be once a year, i.e. annual. The site needs to set the
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frequency and timing of the meetings to maximise input and ensure that actions are timely.
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For example, a management meeting shortly after an external audit allows any
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non‑conformities to be included in the discussion and relevant corrective actions to
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be agreed.
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All sites should have a predefined schedule so all participants are aware, in advance, of
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when the meetings will take place.

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Documenting the meeting

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The auditor will be checking that the review meeting documents have been produced and
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circulated, that there are minutes of the discussion, and that there are agreed action plans.
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For example, one of the outputs from the meeting should be a review of performance against
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the defined objectives and the establishment of new or amended targets and objectives for
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the following year. This should be documented within the minutes of the meeting.
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Completing actions
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Timescales should be attributed to all actions. It should be evident that actions are
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meeting records, or assessment of actions could be added to the internal audit programme.
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1.3 Organisational structure, responsibilities and management authority
The company shall have a clear organisational structure and lines of communication to enable effective
management of product safety, legality, regulatory compliance and quality.
Interpretation
The objective is to ensure that staff are clear who has responsibility for all aspects of the product safety and quality
system and that the responsible person has the knowledge and ability to fulfil the role.
If an organisation is well structured with clear roles, reporting lines and responsibilities, it is much simpler to
communicate with staff and manage the site, and identify any gaps in responsibilities. This requirement applies to
any type of site, whether small or large, and whether making simple or complex products. The same principle always
applies, even though the actual structures needed may be more complex in some cases.
The auditor will be looking for evidence that personnel at all levels in the company are aware of the company
structure and comfort in using those communication channels is indicative of a well-functioning culture.
24 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
1.3.1 The site shall have a current organisation chart demonstrating the management structure
and reporting channels of the company.
The responsibilities for the management of activities which ensure product safety, quality
and legality shall be clearly allocated and understood by the managers responsible. It shall
be clearly documented who deputises in the absence of the responsible person.
Interpretation Organisation chart and assignment of responsibilities

There is a requirement for an organisation chart, clearly indicating reporting lines for all
managers on the site and, where applicable, relationships to the company head office roles.
The chart would normally be expected to show a position or job title and may also include
the named person occupying that position. Where the chart shows job titles only, other
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documents must indicate the person occupying each position.
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The Standard specifies a chart, so text describing the organisation will not be sufficient.
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The chart must be up to date and accurate, and it needs to be dated.
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The chart or associated documentation needs to clearly indicate the responsibilities of

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each relevant member of staff associated with the management of product safety, legality
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or quality. Examples include technical managers, quality assurance employees, managers

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Part II
accountable for overseeing production and cleaning activities (i.e. those responsible for
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ensuring the correct standards are maintained), any laboratory employees, and product
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development teams.
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conforming products, process deviations, finished product release, document control and
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customer complaints. It is usual for specific responsibilities to be defined within the job
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descriptions of key employees, especially for management and supervisors; however, they
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may instead be described within site procedures, e.g. responsibility for decisions on
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corrective action may be incorporated into the site’s corrective action procedure.
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key staff member. Deputies would usually be identified on the organisational chart and/or
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in job descriptions, but documentation could also be in the form of an additional table.
The responsibility may be assigned to either a more senior or more junior person, as long
as the deputy has the knowledge and ability to adequately cover for the absent person.
Deputies may be appointed for the whole role or particular responsibilities may be
deputised to different people, as long as this is clearly defined.
The auditor will be looking for both documented responsibilities and evidence that the
responsible person is able to fulfil the role. Clause 6.1.4 requires the company to review the
competencies of employees and ensure that any necessary training, mentoring or
experience is provided.
Glossary
brcgs.com 25
PACKAGING MATERIALS
ISSUE 6
Clause Requirements
1.3.2 The site’s senior management shall ensure that all employees are aware of their
responsibilities. Where documented work instructions exist for activities undertaken, the
relevant employees shall have access to these and be able to demonstrate that work is
carried out in accordance with the instructions.
Interpretation General work instructions

The objective of this clause is to ensure that employees, including temporary and agency
staff, are able to work effectively and ensure that product safety and quality are maintained.
This will usually be established by the auditor discussing job roles with the employees
themselves during the audit.
A description of general work duties, which are documented and communicated, must be
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available for all staff with activities relating to product safety, legality and quality. This may
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be achieved either through general work instructions or by being included in job
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descriptions. There is no requirement for a detailed job description; however, staff should
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19
be aware of their particular responsibilities. The detailed instructions on how to carry out
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specific tasks should be recorded in work instructions. These documents contain the
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practical details of how to carry out tasks in a form easily understood by the member of
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staff. They can be pictorial, diagrammatic or in text format.

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Many procedures, such as those for methods of work, housekeeping and site systems,
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can contribute to the assurance of safe products and should, therefore, be detailed.

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Where the role or an activity that makes up part of the role covers a product safety or
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quality issue described within a procedure, e.g. a critical control point (CCP) or prerequisite
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programme, the staff member must understand what is expected of them and be able to
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access the relevant procedure.

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26 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
2 Hazard and risk management
2.1 Hazard and risk management team
A multidisciplinary hazard and risk management team shall be in place to develop and manage the hazard and
risk management system and to ensure that the system is fully implemented and evaluated for its effectiveness.
Interpretation
The Standard identifies a well-planned hazard and risk analysis as the building block for a successful product safety
and quality management system. The analysis and subsequent management system need to be systematic, thorough,
fully implemented and maintained.
The purpose of these requirements is to create a plan to mitigate product safety hazards. The specific terminology used
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in the Standard, such as ‘prerequisites’ and ‘critical control points’ (CCPs), is intended to reflect the global terminology
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used to describe expectations. Sites are not required to use the specific terminology in the Standard; alternatives are
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acceptable providing it is evident that all the requirements have been fully met. For example, if the site has an
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established and effective HACCP plan, there is no need to rename or refer to it as a HARA plan. However, sites are
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advised to avoid having multiple plans with different terminology as this is administratively complex and unnecessary.
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It is vital that sites assess hazards to product quality, no matter how minor the potential quality issue might be. Any
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Part II
deviation from customer specification should be regarded as a potential quality issue and non-conforming product.
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Assessing the potential quality hazards at this point allows for any quality system prerequisite programmes as set
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out in sections 4 and 5 to be validated, while establishing any special measures (or quality control points) which
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need to be taken as part of the site’s comprehensive product safety and quality management system.
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Clause Requirements
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2.1.1 The hazard analysis and risk assessment shall be developed, reviewed and managed by a
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multidisciplinary team that includes those responsible for quality, technical, engineering/
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maintenance, production operations and other relevant functions.

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In the event that the site does not have the appropriate expertise in house, external
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expertise may be used to analyse any hazards and the risk of them occurring, and/or
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develop and review the hazard and risk management system. However, the day-to-day
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management of the system shall remain the responsibility of the site.
Interpretation The hazard analysis and risk assessment (HARA) team

In order to ensure a comprehensive hazard and risk management system is established and
maintained, it needs to be managed by a nominated HARA team with the relevant training,
skills and experience.
The number of team members needs to be appropriate to the size and structure of the
company and to the site’s risk category, as the team should include representatives of each
department with responsibility for adherence to the Standard. There will always be more
Glossary
than one person, because one person does not constitute a team.
The team needs to know the types of operation that are carried out within the company
and the hazards that these operations may present to the product. A summary of the roles
of team members within the company should be documented, and membership of the
team needs to be reviewed regularly – for example, when job responsibilities change or
personnel leave or join the company. Responsibility for reviewing the documentation and
championing these principles on a day-to-day basis within the production environment
should be allocated to a member of the HARA team.
brcgs.com 27
PACKAGING MATERIALS
ISSUE 6
Clause Requirements
Where external expertise has been used in developing the hazard and risk management plan,
the site must demonstrate ownership of the requirements identified. This is best evidenced
by an employee being the team leader and not a member of the external resource.
It is essential that senior management show commitment to the hazard and risk
management system and the HARA team, and this is most effectively demonstrated by:
•• the presence of senior management on the HARA team
•• policy statements referring to the hazard and risk management system
•• evidence within the management review of discussions pertaining to the hazard and risk
management system.
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2.1.2 The multidisciplinary team shall have a designated team leader who shall be suitably
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trained and able to demonstrate competence and experience of hazard and risk analysis.
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Interpretation HARA team leader
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An effective HARA team leader is able to demonstrate competency in hazard and risk
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management (through the quality of the plan) and be qualified, most probably through
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HACCP-based training. Documented evidence of their qualification needs to be given

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(e.g. through successful completion of an industry-recognised training course).

D te ate
Where there is no suitably qualified member of the senior management team, the team may
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be guided by an appropriately qualified external consultant or member of staff who is not

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in the senior management team; however, in the case of an external consultant, the
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day-to-day management of the team should rest with the site.

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Training courses in HACCP and effective hazard analysis and risk assessment for packaging
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are available from the BRCGS Academy and its network of approved training partners (ATPs).
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2.1.3 The team shall be able to demonstrate competence in hazard and risk analysis principles
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and be kept up to date with factory changes and customer requirements as they occur.
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Interpretation The hazard and risk analysis team training and updating
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Training records need to demonstrate that adequate training has been given to all team
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members. This may be achieved through either an external course or internal training.
The auditor will be looking for evidence that the team have a mechanism by which they
are notified of any changes in the factory, or changes required by the customer, in order to
adjust any measures taken (prerequisite programmes, CCPs, QCPs) and maintain an
effective risk mitigation system.
28 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
2.2 Hazard analysis and risk assessment
Fundamental
A documented hazard analysis and risk assessment (HARA) shall be in place to ensure that all
hazards to product safety and legality are identified and appropriate controls established.
Interpretation
These requirements have been deemed fundamental, as an effective hazard analysis and risk assessment is essential
to the operation of a site if it is to conform to the Standard. Without proper control of the manufacturing process,
safe products that are fit for purpose cannot be consistently achieved. The hazard analysis and risk assessment
outlined in the Standard is based on HACCP principles with the addition of a 13th step of reviewing the system on
at least an annual basis to ensure it remains systematic, thorough and fully implemented. It is recognised that other
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HARA processes, such as FMEA (failure modes and effects analysis) and SWIFT (structured what-if technique),
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may be equally suitable and these should also be acceptable to the auditor.
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For non-direct food (or other non-hygiene-sensitive) contact materials, prerequisite programmes will manage the
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likely types of hazard that may be presented to the packaging material, and hazards more closely associated with
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hygiene for food and microbiological contamination will not be relevant. Therefore, the intention here is to ensure
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that the prerequisite programmes manage all the potential hazards and safety requirements, and that control
Fr 9. tps
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Part II
measures will be put in place to manage any further issues.
D te ate
Packaging manufacturing sites may identify a very low number of CCPs, if any, and this is typical for packaging,
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but the hazard and risk management plan must be demonstrably comprehensive and robust.
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Clause Requirements
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2.2.1 The scope of the hazard analysis and risk assessment shall be clearly defined and
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documented and shall cover all products and processes included within the intended
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scope of certification.
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Interpretation Scope of the hazard analysis and risk assessment

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All products that are manufactured on site and the processes associated with them should
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be included in the scope. Auditors may be interested in why certain products in production
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have been excluded from the HARA scope or are not adequately described in it.
The HARA scope is not simply a product description and this will not satisfy the scope of
the BRCGS audit. The HARA scope should describe all the products and processes to be
included within the study.
Where multiple types or variants of products are manufactured, the site may group them by
similar properties or characteristics of process. Grouping should be clear and consistent and
the site should be able to demonstrate that variations within groups have been assessed.
Alternatively, the system may be split into modules that cover specific process steps,
producing a mix-and-match structure for the plan of any specific product. Where the
Glossary
modular mix-and-match approach is used, sites should assess any hazards that may occur
where modules meet but do not address an intermediate step, such as transporting a
product from one area to another.
brcgs.com 29
PACKAGING MATERIALS
ISSUE 6
Clause Requirements
Example A site produces three-piece steel cans for use with food. Its main process is forming and
flanging the can bodies and seaming the maker’s end to the body. The scope of their hazard
and risk management system is set around this process. During the audit, the auditor
discovers the site also manufactures the maker’s end of the can in a side building where
stamping equipment is installed. The site representative states that this part of the
operation was disregarded because it was in a different building.
The site gains a non-conformity as the stamping process is not in the scope of the hazard
and risk management system but has not been excluded from the scope of the audit and
certificate.
In this example, the scope of the hazard analysis and risk assessment will need to include
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two clearly defined products: can ends and can bodies with the maker’s end seamed on.
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As these are produced by different processes that take place in different buildings on the
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site, management may well find that they are best addressed as two separate hazard and
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risk analyses, which is entirely acceptable.
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2.2.2 The HARA team shall maintain awareness of and take into account:
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•• historical, known and foreseeable product safety hazards associated with specific
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processes and raw materials

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•• intended use of the product (where known)

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•• known likely product defects that affect safety

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•• relevant codes of practice or recognised guidelines

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•• legislative requirements.
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Interpretation Information systems

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The Standard emphasises the importance of the requirement to collate, maintain and
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deploy background information concerning legal requirements and product safety and
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industry practices for both the regions of manufacture and, where known, intended sale.
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Up-to-date information must be taken into account when preparing the plan. There are
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many sources of information, particularly on the internet, and these should be referenced
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in the plan and be recoverable or available on request. A listing of legislation or codes of

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practice referenced will be helpful.

This requirement’s listing of aspects to be taken into account is not comprehensive,
and the site should make particular effort to consider any industry-specific sources of
information. Similarly, the site should be considering historical and known hazards around
product safety. Subsequent clauses will focus on product quality hazards with equal weight
as for product safety.
The auditor will be looking for systematic checks for new information, and evidence that
the information is understood, recorded and translated into action where necessary.
2.2.3 A full description of the product, product group and process shall be developed, which
includes all relevant information on product safety and integrity. As a guide this shall
include:
•• composition (e.g. raw materials, inks, varnishes, coatings and other print chemicals)
•• origin of raw materials, including use of recycled materials
•• intended use of the packaging materials and defined restrictions on use; for example,
direct contact with food or other hygiene-sensitive products, or the physical or chemical
conditions.
30 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
Interpretation Product descriptions
A full description of the product, product group and process, including its foreseeable
use and final market, is required to ensure that all aspects of product safety, quality and
integrity have been considered. For example, without considering the intended use of the
product, the site may fail to recognise some specific piece of legislation associated with its
use in particular markets.
The foreseeable use is important as this means the site can use risk assessment to
determine the likely product safety and integrity hazards (including the level of packaging
required, i.e. primary, secondary or tertiary) in the later clauses of this section. For example,
sites manufacturing materials intended for direct contact with food will have greater
concern over microbiological contamination than a site manufacturing corrugated board
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intended for use as secondary and tertiary packaging.
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Example The hazard and risk management team in a general carton factory groups its products by
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the intended use (e.g. cartons used in direct contact with food; ones used for food but not
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in direct contact with the product; and cartons intended for the packaging of non-foods).
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The team asserts that the different applications for the cartons introduce different risks or
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Part II
levels of risk. Critical among these risks may be migration of mineral oils from the recycled
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content of board that will be in direct contact with food.

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2.2.4 The process flow diagram prepared for each product, product group and process shall set
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out each process step from the receipt of raw materials, through manufacture and storage,
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to dispatch to the customer. As a guide this shall include, where applicable:

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•• receipt and approval of artwork and specification

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•• receipt and preparation of raw materials such as additives, inks and adhesives
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•• each manufacturing process step

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•• in-line testing or measuring equipment

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•• the use of rework and post-consumer recycled materials

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•• any subcontracted processes

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•• customer returns.
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Interpretation Process flow diagram

An accurate process flow diagram will show all the process steps, including inputs
and outputs, that are carried out in order for the site to manufacture its products.
The construction of the diagram will depend on the type of approach used in clause 2.2.1,
but the interaction between each process step must be clearly identified.
The list provided in the clause is not exhaustive or mandatory, and a site should document
the points that are relevant to its process.
Glossary
brcgs.com 31
PACKAGING MATERIALS
ISSUE 6
Clause Requirements
2.2.5 The accuracy of the process flow diagram shall be verified by the HARA team at least once
per year and following any significant incidents or process changes.
Interpretation Verification of the process flow diagram

The flow diagram created for clause 2.2.4 should be verified as accurate whenever there is
a review of the plan; it should be dated. The HARA team should take part in a physical
walk-through of the process within the relevant areas and validate the documented
process flow.
Where changes in the factory or other important elements have occurred (clauses 2.1.3 and
2.2.2), the site is expected to reflect this in the process flow diagram within a reasonable
amount of time and have taken any steps to identify and mitigate any product safety
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hazards. This is because any change, no matter how small, can detrimentally impact the
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site’s product safety and quality management system.
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The auditor will challenge the flow diagram as they walk around the site, and will expect to
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see the details of each process step, including seemingly minor steps such as the transport
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of materials from one process step to another.

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Example The HARA team at the steel can factory has developed a process flow diagram for the four
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main product types it produces and considers each of the points set out in the Standard.
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The diagram includes warehousing, as it stores finished product stock for certain customers.
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The team verifies the process flow diagram by walking around the site and identifies any
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areas that may have been omitted. It notes on this occasion that the finished cans have
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layer pads added at the bottom and top of the pallet load before it is stretch-wrapped for
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storage or distribution and therefore includes this in the flow diagram for the relevant
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products. It also notes that some cans are sorted at a subcontractor rather than on site and
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this is added to the flow diagram.

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2.2.6 The HARA team shall identify and record all potential product safety hazards that are
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reasonably expected to occur at each step in relation to the product and process.
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The hazards considered shall include, where relevant:

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•• microbiological hazards
•• chemical contamination (e.g. taint, odour, allergen, component transfer from inks,
varnishes and glues)
•• potential for unintended migration of substances from the packaging material into food
or other hygiene-sensitive products
•• foreign objects
•• potential problems arising from the use of recycled materials
•• foreseeable misuse by the consumer
•• defects critical to consumer safety
•• hazards that may have an impact on the functional integrity and performance of the final
product in use
•• potential for malicious intervention
•• potential for raw material fraud.
32 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
Interpretation Identification of potential hazards
The site needs to identify product safety hazards that may be introduced if production is
not adequately controlled. These hazards include:
•• contamination from poor personal hygiene
•• contamination from machinery, buildings, other products etc.
•• poor control of equipment settings
•• malfunctioning equipment
•• use of incorrect parameters
•• potential for mixing different types of materials; for example, materials with or without
recycled content
•• use of unsuitable raw materials; for example, inks or varnishes that are incompatible with
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food on printed packaging materials
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•• potential allergens or sources of contamination (by migration).
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The site must be aware that any change to processes, procedures or building structure may
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affect which hazards are presented. It must include these in the plan, and should establish
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the sources of these hazards, whether perceived or actual.

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BRCGS has an effective hazard analysis and risk assessment course for manufacturers of
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Part II
packaging and packaging materials, available from the BRCGS Academy and global network
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of approved training partners (ATPs).

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Example The hazard and risk management team recognise that all the hazards identified are
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controlled by the prerequisite programme (as laid out in sections 4–6 of the Standard),
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apart from the potential for mixing finished product in the warehouse. This will therefore
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require specific control and monitoring.

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2.2.7 The HARA team shall identify control measures necessary to prevent, eliminate or reduce
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each product safety hazard to acceptable levels.

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Where control is through prerequisite programmes as set out in sections 3, 4 and 6, these
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shall be reviewed to ensure they adequately control the risk identified and, where
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Interpretation Identify control measures for product safety hazards

Control measures required to reduce or eliminate the identified product safety hazards
must be established. Any hazard that cannot be eliminated must have control measures
designed to reduce it to an acceptable level of occurrence. The acceptable hazard level
should be justified by, for example, using industry guidelines.
Failure to implement a recognised improvement may result in a non-conformity against this
requirement or the relevant requirement by which the hazard should have been controlled.
Glossary
Example The HARA team establishes a procedure to manage the different specifications of finished
products by introducing new pallet labelling and acceptance procedures into the
warehouse. Pallets are visually checked for identification at entry into the warehouse.
brcgs.com 33
PACKAGING MATERIALS
ISSUE 6
Clause Requirements
2.2.8 For each hazard that requires control, other than by an existing prerequisite programme,
the control points shall be reviewed to identify those that are critical. This process shall
include an assessment of the risk level for each hazard based on the likelihood of the
occurrence and the severity of the outcome.
Critical control points (CCPs) shall be those control points that are required to prevent,
eliminate or reduce a product safety hazard to acceptable levels. Where a control point is
not classified as critical and control may be achieved through a prerequisite programme,
a programme shall be developed that is sufficiently specified to effectively control the
identified hazard(s).
Interpretation Establish critical control points
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For the product safety hazard, each control measure needs to be reviewed to highlight
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those that are critical (by using the criteria associated with the chosen analysis – typically
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severity and potential frequency). Records must be available showing how this has been
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conducted and how decisions have been reached.
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Further process steps that are not under the control of the site must not be taken for
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granted; any such activities must be fully documented.

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Example Labelling of the pallet of finished goods has been identified as a CCP as it is not possible
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for a later step to remove the hazard (i.e. using the wrong specification). If the filler fills the
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wrong container because the products have been erroneously labelled, the error may not
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be identified until the product is in the food supply chain, which could pose a risk to
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product safety.
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For each CCP, the appropriate critical limits shall be defined in order to identify clearly
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whether the process is in or out of control. Critical limits shall be measurable, where
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possible, and the rationale for their establishment clearly documented. Relevant legislation
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and codes of practice shall be taken into account when establishing the limits.
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Interpretation Establish critical limits

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All identified CCPs must have defined critical limits. Criteria in packaging often include
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dimensional measurements, printing errors and performance-related faults such as leaks.

Details on how critical limits have been reached need to be referenced and may include
consideration of production trials and industry best practice.
Example The critical limit set in place is for each pallet to have two labels, with the coding on each
being scannable. Each pallet must leave the line with two labels and each pallet must be
checked for the presence of the two labels before being admitted to the warehouse.
34 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
2.2.10 For each CCP, a monitoring system shall be defined in order to ensure compliance with
critical limits. Records of the monitoring shall be maintained. Documented procedures
relating to the monitoring of critical controls shall be included in internal audits against the
Standard (see clause 3.5).
Interpretation Monitor CCPs

Each CCP needs to be monitored to ensure that the established limits are not exceeded.
This can be achieved by observing or measuring the CCP at scheduled intervals.
Monitoring needs to be able to detect any variation that might result in limits being broken
if no remedial action is taken. In order for a variation not to constitute a risk, monitoring
must be at a frequency that ensures any necessary remedial action can be taken in
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sufficient time.
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2.2.11 , 2 er ipa
The corrective action that shall be taken when monitored results indicate a failure to meet
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the control limit for CCPs shall be established and documented. This shall include the
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procedures for quarantining and evaluating potentially out-of-specification products to

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ensure they are not released until their safety, quality and legality can be established.
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Part II
Interpretation Establish appropriate corrective actions
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A procedure needs to be established, detailing the actions to be taken and by whom, where
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monitoring indicates that limits have been exceeded or may be exceeded if no remedial
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action is taken. The procedure may include quarantine, disposal, alternative processing,
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increased monitoring etc. Any product that has passed through the process and may have
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exceeded the limits needs to be included. The documentation for this procedure must
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undertake these actions and make decisions, and must also include verification of actions.
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Any deviation from product specification should be regarded as non-conforming product.

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The implications may not be as grave as a product safety risk, but the consequences are
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down‑time at the packer/filler.

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Example Pallets of finished materials that have no pallet labels are quarantined and subsequently
checked for specification before applying the requisite two labels. Those identified with
one pallet label have label details verified and additional labels issued. The team leaders
are informed about pallets identified in this way and corrective action is undertaken,
depending on the cause of the issue. The number of mislabelled pallets is documented at
the end of each shift and becomes a KPI for each team.
The site determines that checking each finished pallet is performed at the appropriate
interval, and that extra ad hoc checks are also carried out by the team leader.
Glossary
brcgs.com 35
PACKAGING MATERIALS
ISSUE 6
Clause Requirements
2.2.12 A review of the hazard and risk management system and prerequisite programmes shall be
carried out at least once per year and following any significant incidents or when any
process changes.
The review shall include a verification that the hazard analysis and risk assessment plan is
effective. It shall also include any:
•• process changes
•• product composition changes
•• complaints
•• product failures and finished product recalls from consumers (including system tests)
•• product withdrawals
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•• results of internal audits of prerequisite programmes
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•• results from external and third-party audits
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•• new developments in the industry associated with materials, process or product.
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Interpretation Review of the hazard and risk management system

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The hazard and risk management system needs to be reviewed on a regular basis.
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The review must include, but is not limited to:

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•• changes in products, processing methods and equipment

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•• new product design and development

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•• instances where a non-conformity has been found, or where there have been changes in
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the operation of the hazard and risk management plan.

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Changes that may affect product safety, such as those listed in the Standard, need to be
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evaluated in the context of the plan before they are introduced, and the plan amended as
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necessary. This may be achieved through documenting a procedure that lists the activities
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or changes that will trigger a hazard and risk management plan review, but this must be
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backed by evidence that it has actually been carried out.

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36 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
3 Product safety and quality management
Interpretation
A well-controlled, systematic and documented management system forms the basis for the controls necessary to
produce safe packaging materials that meet customer specifications and to ensure that the staff are well trained and
informed. The management system requirements are very similar to a number of other quality management system
(QMS) standards.
This is the section of the Standard that has most overlap with generic QMS standards such as ISO 9001.
Most sector-specific schemes contain a part about management systems; this is because good systems allow
for well‑controlled management, which in turn helps to deliver consistent, controlled performance in any field,
enabling problems to be properly investigated and improvements to be made.
A site that has a well-functioning, documented QMS should be able to meet the requirements of this section
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without a great deal of extra effort or resource, since the Standard is not generally prescriptive about how
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requirements are met. It will therefore not be necessary to replace any existing programme or have a different
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system in place to conform to this Standard. Sites should compare their system against the requirements of the
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Standard and address any gaps that exist.
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If the system used has not been set up specifically to meet the requirements of the Standard, it may be helpful to
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the auditor and make the audit quicker and more efficient (and therefore more cost-effective) if the company is able
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Part II
to provide a short summary tabulating how the documentation for the two schemes interacts (e.g. by providing a
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document index).
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QMS standards. Sites should contact their certification bodies directly for more information.
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3.1 Product safety and quality management system

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The site’s processes and procedures to meet the requirements of this Standard shall be documented to allow
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consistent application, facilitate training, and support due diligence in the production of a safe and legal product.
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Interpretation
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Policies, procedures and work instructions covering the requirements of the Standard must be in place, easily
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retrievable and available where needed. These documents must be collated into a quality manual which forms the
reference point for all documents that are included in the product safety and quality system.
There is no requirement for the quality manual to be numbered in accordance with the numbering system used in
the Standard.
Clause Requirements
3.1.1 The site’s documented policies, procedures, working methods and practices shall be
collated in a navigable and readily accessible system, with consideration being given to
translation into appropriate languages.
Glossary
Where the site is part of a company governed by a head office, the interaction between the
site’s system and that of other sites and the head office should be documented.
All policies and procedures necessary for the operation of the site being assessed must be
available at the site.
brcgs.com 37
PACKAGING MATERIALS
ISSUE 6
Clause Requirements
Interpretation Product safety and quality manual
The objective of this requirement is to ensure that up-to-date policies and procedures are
accessible at relevant times and in the most appropriate format for the relevant user of the
system. For example, the incident management procedure should be available through an
internet link or on a disk that is accessible away from the site to ensure its availability
should the site or parts of the site become inaccessible because of an incident. Where
multiple copies of documents or manuals exist, they need to be adequately controlled,
including those in electronic form.
It is useful if the quality manual includes an overview of how the company’s policies and
procedures are arranged.
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Note that the requirement refers to appropriate languages. In some areas, the composition
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of the workforce may mean that multiple languages are in use at the site. To avoid
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misunderstandings that may lead to product safety or quality management issues, the site
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should establish whether translation of any particular policies or procedures is required.
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It may, however, not be necessary to translate all of the policies. The auditor will be looking
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for evidence that the company has a good understanding of any specific language
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requirements within their organisation and the need to translate.

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Example A site has a documented product safety and quality manual. It comprises a series of parts
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which address different aspects of the product safety and quality management system.
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It includes parts on hazard and risk management, quality, operating procedures and training.
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Some of the documentation is accessible through the site’s intranet, and the site is
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uploading new versions of the documents for access around the site.
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The site has a robust manual that can be easily used through its index, and only the
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electronic copies are regarded as controlled.

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The auditor finds this acceptable.

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3.1.2
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The system shall be fully implemented, reviewed at appropriate planned intervals and
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improved where necessary.

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Interpretation Implementation and review of the product safety and quality management system
The auditor will not only need to see that the site has established procedures for the
manufacture of safe and legal products to the required quality but that those procedures
are fully implemented. Evidence of this will become apparent during the site tour and
interviews with staff, so it is important that documented procedures are understood by
those using them. The procedures in the manual will be evaluated against the actual
practices on the site, with the expectation that they are followed correctly.
It is the nature of business that organisations will change and evolve through time and it
is essential that the manual remains relevant to the nature of the organisation and the
products it produces. Planned reviews of the documentation are required, and it is
advisable that any change to the site, such as equipment or processing, is followed by
policy and procedure validation, ensuring that the documented policies and procedures
are up to date.
38 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
3.2 Document control
An effective document control system shall ensure that only the correct versions of documents, including
recording forms, are available and in use.
Interpretation
Documentation may be produced and stored in several different ways, including electronic copies, databases,
intranet systems, photographs, diagrams etc. Records must be permanent (or at least have a defined lifetime) and
therefore adequate storage or back-up systems will be necessary.
Clause Requirements
3.2.1 The company shall have a documented procedure to manage documents which form part
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of the product safety and quality management system. This shall include:
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••
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a list of all controlled documents indicating the latest version number
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•• the method for the identification and authorisation of controlled documents
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•• a record of the reason for any changes or amendments to the documents

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•• the system for the replacement of existing documents when these are updated.
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Interpretation Documentation requirements

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In order to be useful, documents must be available where and when they are needed, and
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controlled so there can be no confusion when a new version of a document is created.

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Out-of-date documents must be rescinded promptly and effectively. Alterations made by

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writing unauthorised notes on printed copies of documents are not permissible.

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The method the company uses to control documents should itself be documented as a
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procedure so that any member of staff producing documents understands the system and
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operates in the same way. This clause states the minimum that is required in order to retain
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adequate control. Where a site has determined additional requirements, these should be
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listed in the procedure. It should also be clear when a document is not controlled.
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A register is a good place to start as it allows the site to list documents of all types and to
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identify any duplication or omissions with regard to the site’s requirements and ongoing
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compliance with the Standard.

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The most appropriate methodology for identification and authorisation of documents is for the
site to determine, but simplicity is key to an easily navigable system. Documents will typically
be identified by a unique reference, version number and issue date, plus author or responsible
department, and each page should be numbered and state the total number of pages.
Where procedures change, it is often useful to understand how that has come about and
why, particularly over time and where personnel, equipment and sites change through the
needs of the business. The history of a document need not be kept with the current
version, but a change log is commonly used to trace the history, retaining visibility.
Glossary
The site will also need to ensure that where documents change there is a method for
rescinding previous versions, which avoids their inappropriate or unintended use.
During the audit, the auditor will examine documentation and will expect to see that any
records, documents or other recording systems are in the correct version. This is as
applicable to the desk-top portion of the audit as the site tour, so it is essential that work
instructions, recording forms, bills of material, job bags etc. currently in use are carrying the
appropriate version number. The auditor may also check that the operators understand the
access path to key instructions stored within an electronic system.
brcgs.com 39
PACKAGING MATERIALS
ISSUE 6
Clause Requirements
Note that the system for document control extends to the issuing of external documents
such as copies of standards (including the Standard), customer specifications and legal
information.
Example The label printer supplying a toiletries company has a paper-based document management
system which is stored in the quality manager’s office. On the printing press, an
unauthorised photocopy of a work instruction is found to be in use. When checking the
documentation, it is apparent that the work instruction on the press is the wrong version,
it having been superseded a month ago.
The auditor issues a non-conformity, as an unauthorised copy of an out-of-date work
instruction was found to be in use.
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Example A site’s work instructions are only available in the quality manager’s office and are
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inaccessible during a night shift at a company manufacturing thermoformed trays. The work
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instructions are required as new staff have been employed who are still under supervision
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and induction training.

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The auditor raises a non-conformity, as documents are not readily accessible to relevant
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employees.
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3.2.2 Where documents and records are in electronic form these shall be:
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•• stored securely (e.g. with authorised access, control of amendments, or

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password‑protected)
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•• backed up to prevent loss or malicious intervention.

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Interpretation Electronic document protection

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The Standard recognises that documented systems are commonly managed on computers
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and this is perfectly acceptable; there is no need for paper (‘hard’) copies to be maintained
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in order to evidence the system.

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However, electronics are vulnerable in different ways from hard copies of documentation
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or records and the site is required to ensure that the integrity and safety of their
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management systems are maintained. This may be achieved through restricting access for
the amendment of documents to specific job roles (thus preventing unauthorised users
from making any changes that could compromise the system).
Suitable protection also refers to the possibility of failure of computer equipment or power
sources. Sufficient measures must be taken to ensure that breakdown of one part of the
system does not result in loss or damage to a site’s valuable documentation.
40 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
3.3 Record-keeping
The site shall maintain genuine records to demonstrate the effective control of product safety, legality and quality.
Interpretation
Records are documented information that provide evidence about past events – particularly events that concern
product safety, quality and legality. They provide information to act upon and data to help with continual
improvements. There should be a clear understanding of why records are to be kept and what purpose the
information will serve. Records must therefore be maintained in an appropriate way to ensure they demonstrate
control of systems and operations.
Clause Requirements
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3.3.1
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Records shall be legible, appropriately authorised, retained in good condition, and
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retrievable.
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Interpretation General record-keeping requirements
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In order to be useful, records must be legible and genuine. It is also essential that they are
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signed, dated and authorised so that the person making the record can be identified and
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consulted as necessary.
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Part II
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Records relating to the safety, legality or quality of the products must be kept securely and
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in good condition so that they can be consulted when needed.

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Example A site retains records of training for all its full- and part-time permanent staff and retains
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records for the duration of the employee’s employment plus 3 years. An auditor asks for
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the training records of a member of staff who was in the hazard and risk management team
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at the previous audit but has since left the company. The site is unable to locate them.
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The auditor will raise a non-conformity. The site has a procedure, but it is not evident that
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it has been adequately followed and records have not been properly retained.
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3.3.2 Any alterations to records shall be authorised and justification for the alteration shall be
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recorded.
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Interpretation Alterations to records

There will always be occasions when mistakes are made and records need to be amended.
Such amendments must be clear and identified; for example, by simply crossing out a
result, recording the correct one and initialling the change. If appropriate, a brief reason for
the change can be included. The use of pencil (which can be erased) and correction fluid
(which obscures the original) should not be considered as acceptable for amendments to
records. Records which record results electronically, whether by manual or automatic
processes, should have suitable systems to prevent unauthorised changes.
3.3.3 The company’s senior management shall ensure that documented procedures are
Glossary
established and implemented for the organisation, review, maintenance, storage and
retrieval of all records relating to product safety, legality, regulatory compliance and quality.
Interpretation Record-keeping procedures

Senior management are responsible for the procedures relating to the overall control of
records in all aspects. They must ensure that the data is properly collected, used, stored,
reviewed and maintained. It is important that there is a mechanism to ensure that the
records are complete, accurate and in good condition before they are filed.
brcgs.com 41
PACKAGING MATERIALS
ISSUE 6
Clause Requirements
Example A site manufacturing PET bottles for the toiletries industry maintains specifications for its
standard products on the internal specifications system. The system is restricted to
authorised personnel and does not allow any amendments to be made unless the inputter
states a reason for the amendment. Any amendments are monitored by the technical
manager and incomplete comments by the inputter are rejected.
The auditor is satisfied that procedures are in place and records are maintained appropriately.
3.3.4 The site shall document its period of retention for records which relate to the usable life of
the packaging and the products it is designed to contain, and shall respect any customer
requirements.
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Interpretation Period of retention
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The retention period (i.e. the length of time for which a record needs to be kept) depends
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on a number of criteria:
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•• legal requirements in the country/regions of sale: some countries have minimum periods,
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especially related to product liability laws

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•• customer requirements: some customers demand a minimum period

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•• product lifetime: this is a reasonable approach but may be difficult to determine in

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practice. An estimation of the reasonable lifespan of a product should be part of a risk

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assessment.
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The site management will be required to demonstrate that they have determined the
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appropriate retention periods for their products, as these may differ where there are
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multiple product lines, and that they adhere to their retention procedure.
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3.4 Specifications
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Appropriate specifications shall exist for raw materials, intermediate and finished products, and for
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any product or service which could affect the safety, quality or legality of the finished product and
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customer requirements.
Interpretation
This clause has been deemed fundamental as the requirements within it pertain to the safety and legality of the
product’s manufacture.
The company must be assured of the quality of the products purchased. This includes any raw materials or services
that can have an impact on product safety and quality (e.g. water, cleaning chemicals, pest control, cleaning and
distribution services). Specifications for in-house intermediate products (work in progress) should be developed
where they need to be checked at a later stage in the process, and where they have an impact on product safety,
legality and quality.
A finished product specification must exist for all products covered under the certification scope, to ensure that
required legislation and customer expectations are achieved.
42 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
3.4.1 Specifications shall be suitably detailed, accurate and compliant with relevant product
safety and legislative requirements. They may be in the form of a printed or electronic
document, or part of an online specification system.
Interpretation Specifications
The correct materials and components are essential to the safety and quality of the
product. If items are not clearly specified or bought on well-defined specifications, it is
likely that they will be unsuitable for the purpose. The supplier cannot be responsible for
supplying the wrong grade of material if it has not been correctly specified.
Specifications for raw materials and finished products need to be provided and adequately
detailed. They must include the parameters that are critical not only to the quality of the
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product (judged by performance or physical characteristics) but also to its safety and
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legality. Specifications for cleaning chemicals must include components, usage instructions
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Specifications for services need to be adequately detailed to allow the company to

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understand and agree the service parameters they are purchasing.

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The company shall seek formal agreement of specifications with relevant parties where
Part II
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required by the customer. Where specifications are not formally agreed, then the company
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shall be able to demonstrate that it has taken steps to put an agreement in place.
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Interpretation Agreement of specifications

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The company must ensure that the specification meets customer requirements. The site is
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obliged to ask the customer to confirm that the specification for the product is what it
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wishes to purchase and that it is satisfied with any safety or legal requirements. If possible,
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both the customer and the producer should agree the specification. Customers may not
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wish to do this, but in the Standard the onus is on the manufacturer to attempt to get
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agreement and to be able to show that the attempt has been made.
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In some geographical regions it may be legally required for a senior member of staff from
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the customer to formally agree the specification by signing it, but this is not a requirement
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in the Standard.
Example A company produces a detailed specification for its products and the regulations that will
be taken into account. This document is referenced, signed, dated and sent to the
customer. Once an order has been agreed, the company sends the customer a purchase
order which references the specification and requires the customer to sign and date the
order before any work is started.
An auditor would find this procedure satisfactory.
Example The customer places several repeat orders. For each one, the same process is followed.
Glossary
After 6 months the specification is reviewed and modified, owing to a change in raw
material. A new reference specification is produced and agreed with the customer;
subsequent orders reference this new specification.
An auditor would find this procedure satisfactory.
brcgs.com 43
PACKAGING MATERIALS
ISSUE 6
Clause Requirements
Example The customer places several repeat orders. For each one, the same process is followed.
After 6 months the specification is reviewed and modified, owing to a change in raw
material. A new reference specification is created; however, the site does not let the
customer know that the specification number has changed; subsequent orders reference
the old (obsolete) specification reference.
An auditor would raise a non-conformity as the site has not informed the customer that
the specification has changed.
3.4.3 Where packaging for food or other hygiene-sensitive products is produced, a statement of
compliance shall be maintained which enables users of the packaging to ensure
compatibility between the packaging and the product with which it may be in contact.
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The statement of compliance shall be compiled and authorised by a suitably competent
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person. It shall contain as a minimum:
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•• the nature of the materials used in the manufacture of the packaging
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•• confirmation that the packaging meets relevant legal requirements

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•• details of any post-consumer recycled materials.

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The statement shall identify:

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•• its date of issue and, where appropriate, its expiry date

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•• any limitations of use of the product, and

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•• the usable life of the packaging (where relevant).

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Interpretation The statement of compliance

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The statement of compliance is designed to replace/support the level of information

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transferred between companies rather than relying on a migration test certificate or a

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simple statement that the materials comply with EU regulations. It goes beyond the
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certificate of compliance, which indicates that the materials are suitable for food
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contact use.
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The statement of compliance is a legal requirement within Europe. It is specific to all

materials and articles in contact with food (not only packaging) traded within the EU.
For example, if a food importer brings in pre-packed foods from outside the EU, then the
packaging materials must have a declaration of compliance in case of challenge.
Within the EU, plastics materials are subject to a specific regulation which lists more
requirements regarding the content of the statement of compliance.
The statement of compliance is required to have stated limitations on use. This refers to
the materials as well as to the statement. The declaration may state that the materials have
limitations on contact with certain foodstuffs or within temperature tolerances, but it may
also state that the declaration itself is valid for a period that is related to its issue date, or
another factor such as a batch code.
A generic statement of compliance is acceptable for groups of products where the raw
material and typical applications are the same for all products.
44 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
Example The supplier of plastic film for use in packaging breakfast cereals completes a statement
of compliance for all its products which contains the following information:
•• name and address of the manufacturer
•• date of issue or version of the declaration
•• product name/function, including the brand or trade name of the material where
appropriate
•• confirmation that the composition of the product complies with the requirements in the
country of manufacture and use, where known
•• information about substances that were used and for which legal limits or specifications
exist in order to enable the downstream processor or the party responsible for the first
placing on the market to adhere to these limitations (e.g. regarding specific migration
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limits or recycled content).
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The statement of compliance is specific to each product type and a procedure for the
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review of these statements is in place. Each declaration also contains a statement
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pertaining to the limitations on use (i.e. that the information contained in it is subject to
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change for further batches of the material and should only be used for the batch
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purchased, when purchasing from stock).

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Part II
An auditor would find that this supplier is complying with the clause requirements.
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3.4.4 The presence of a manufacturer’s trademarks or logo on packaging materials shall, where
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appropriate, be formally agreed between the relevant parties.

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Interpretation Trademarked materials

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specific design or construction of the packaging itself. While this is unusual, where it occurs
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the manufacturer must take steps to agree the presence of the trademark on the packaging
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or packaging material.
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3.4.5 A specification review process shall be operated where the product composition or
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characteristics change or at an appropriate predetermined interval. Reviews and changes

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shall be documented and communicated to the customer, where required.

Any changes to existing agreements or contracts shall be agreed, documented and
communicated to appropriate departments.
Interpretation Review of specification

It is expected that reviews will take place whenever any changes to product composition
(e.g. changes in lamination structure, formulation etc.), process or design occur, and at
regular intervals, determined according to the nature and risk of the material, as this may
affect the functionality of the product and ultimately the customer use. Any changes in
specification must be agreed with the customer and formally agreed, where possible.
Glossary
brcgs.com 45
PACKAGING MATERIALS
ISSUE 6
3.5 Internal audits
Fundamental
The company shall be able to demonstrate that it verifies the effective application of the
requirements of the Standard and any applicable module through internal audits.
Interpretation
Internal audits are a fundamental requirement within the Standard because an effectively implemented internal audit
programme, with useful reports and a functional non-conformity procedure, is essential for the site to understand its
level of compliance with the Standard. The importance of the internal audit programme cannot be underestimated.
As well as ensuring that the management system is functioning and working as expected, an internal audit provides
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evidence that the site is committed to its safety, legality and quality goals. It is also key in demonstrating continued
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compliance with the requirements of the Standard, and will be regarded by management as being critical to the
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company’s operation.
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BRCGS has a separate best-practice guideline, ‘Internal Audit’, which may be useful for those requiring more
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information.
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Clause Requirements
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3.5.1 There shall be a scheduled programme of internal audits.

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The frequency at which each activity is audited shall be established in relation to the risks
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associated with the activity and previous audit performance. All processes shall be audited
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at least annually.
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The internal audit programme shall be fully implemented and effective.

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Interpretation Internal audit frequency

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The frequency of the audits should be based on risk – for example, the severity of
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consequences if the system, or compliance with it, is inadequate, and the potential for
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changes that would affect these control systems. Frequency may also be influenced by
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known issues within the company, best practice or customer requirements.

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The audit process itself may instigate a more frequent audit if results from the previous
audit infer that the system is inadequate or not complying.
The Standard requires that sites use a risk assessment to determine their internal audit
programme, with every aspect audited at least once a year, including the requirements of
any additional modules. A risk-based approach should mean that certain aspects are
audited more frequently which will result in non-conformities being notified more often to
senior management. There needs to be a mechanism to manage this where management
review meetings occur less frequently than the outputs of internal audits.
3.5.2 As a minimum, the scope of the internal audit programme shall include the:
•• HARA or product safety and quality plan, including the activities to implement it
(e.g. supplier approval, corrective actions and verification)
•• prerequisite programmes (e.g. hygiene, pest control)
•• product defence and product fraud prevention plans
•• procedures implemented to achieve the Standard and modules.
Each internal audit within the programme shall have a defined scope and consider a specific
activity or section of the HARA or product safety plan.
46 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
Interpretation Scheduling
The scope of internal audits needs to be relevant to the site’s aims and objectives, of which
achieving or maintaining certification to the Standard and any relevant additional modules
should be one. Therefore, the site’s internal audit programme should cover all of the
aspects addressed by the Standard and its modules.
The Standard requires audits to be scheduled and the scope defined for all aspects.
This may be done on a departmental basis or be process-based. If the company is carrying
out internal audits for more than one standard (e.g. ISO 9001), similar audits may be
combined providing the audit adequately covers the requirements of the Standard.
This ensures that aspects of the Standard do not get missed or glossed over and that, over
a 12-month period, all areas are covered, including:
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•• every aspect of the product safety and quality management system
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•• policies
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•• documentation
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•• hygiene
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•• production.
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Part II
3.5.3 Internal audits shall be carried out by appropriately trained and competent auditors.
D te ate
Auditors shall be independent from the process or activity being audited to ensure
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impartiality (i.e. they must not audit their own work).

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Interpretation Competency of internal auditors

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Effective auditing is a skill and auditors need to be trained to ensure they are carrying out
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this function effectively. Training must include auditing skills as well as relevant technical
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knowledge, such as hazard and risk management. Technical knowledge of the process is not
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always essential but will sometimes be required. Internal auditors need to be able to show
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via training records that they have received formal training on internal auditing, either by
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attendance on an external course or training within the company. They will also need to
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Auditors must be sufficiently independent of the area being audited. This principle is to
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ensure that the audit is rigorous, thorough and not influenced by the work that may need to
be carried out to implement corrections and improvements. Auditors must not be biased or
influenced and must never audit their own work, otherwise the audit will not be viewed as
objective. The use of external auditors may need to be considered if there is insufficient
internal resource.
For very small sites with a limited budget, the key is allocating responsibility for carrying
out the audit, so it is likely that two people who do different tasks and who cover for each
other occasionally are able to audit each other’s tasks (i.e. one person who does not usually
do the task can audit the other person’s task).
Glossary
brcgs.com 47
PACKAGING MATERIALS
ISSUE 6
Clause Requirements
Example A site has a programme of internal audits covering all aspects of the product safety and
quality management system which is carried out by the QA team. The programme includes
both process areas and systems, with audits carried out each month, allowing the whole
system to be covered in a year. Audits are well documented, with both positive and
negative comments being recorded. Any non-conformities identified are reported to the
section manager and reviewed at quarterly meetings. The audits are carried out by internal
personnel who have been trained in internal auditing by an external body and are
independent of the areas being audited.
The auditor is satisfied that the audit programme is comprehensive and carried out by
suitably trained personnel.
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3.5.4 Internal audit reports shall identify conformity as well as non-conformity.
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Results shall be notified to the personnel responsible for the process/activity audited. Root
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cause analysis shall be used to determine appropriate corrective actions and a designated
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manager shall be responsible for the implementation.

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Interpretation Internal audit reporting

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The purpose of detailing both the conformity and non-conformity found during an audit
D te ate
is to demonstrate that all aspects have been considered by the auditors. Recording only a
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non-conformity may give an incomplete picture of the activity in the department.

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Reports from internal audits should be written in sufficient detail for anyone who reads
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them (and who is not involved the audit) to gain a good understanding of the desired
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outcome of the aspect being audited. Results of the audits should be notified to the
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relevant supervisory staff either via operational or review meetings or by an update at the
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end of the audit combined with documentation such as a memo or copy of the audit
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report. Corrective actions and timescales should then be agreed; responsibility for the
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corrective actions could be demonstrated by being recorded on the audit record sheet.
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An appropriate timescale for the implementation of corrective actions sets an expectation

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which can be reviewed against the actual result achieved. Where non-conformities have
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been identified, corrective action shall be verified as having been completed effectively.
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Good practice would be to ensure that a nominated member of staff with the appropriate
authority checks that the action has been taken within the agreed timescale, and that it has
sufficiently rectified the problem to prevent a recurrence. This should not be the person
responsible for completion of the actions, and ideally should be the original auditor.
It is essential that audits and follow-up actions are clearly and completely recorded.
If matters are not recorded, it is not possible for an auditor to verify that the work has
been done, nor can the site refer back to issues at a later date.
Example An internal audit report is supplied to the relevant section manager after an internal audit.
The report identifies only non-conformities and the section manager is able to put
corrective actions in place to close the issue. This activity is monitored through the
quarterly meetings.
The auditor is satisfied that the internal audit process is in place and effective, but raises a
non-conformity as compliance with the requirements has not been recorded on the audit
report and there is no record of conformity.
48 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
3.5.5 For sites manufacturing materials intended to be in contact with food or other hygiene-
sensitive products, in addition to the internal audit programme, there shall be a separate
programme of documented inspections to ensure that the factory environment and
processing equipment are maintained in a suitable condition. At a minimum, these
inspections shall include:
•• hygiene inspections to assess cleaning and housekeeping performance
•• inspections to identify any risks to the product from the building or equipment.
The frequency of these inspections shall be based on risk.
Interpretation Hygiene and fabrication-based inspections
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The Standard requires a programme of documented inspections to ensure that the factory
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environment and processing equipment are maintained in suitable condition. These
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inspections are different from the internal audit programme specified in clauses 3.5.1 to
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3.5.4, which examines practices against documented procedures. These hygiene and
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fabrication-based inspections assess standards of cleaning, equipment, building fabrication

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and personal hygiene to ensure that high standards are maintained and a safe, hygienic
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production environment is in place. For example, completion of a foreign-body audit can

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Part II
identify and control potential foreign bodies before they have the opportunity to
D te ate
contaminate a product. The frequency of the inspections should be based on risk.

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The site shall be able to demonstrate that it uses the information from failures in its systems and
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processes to take any necessary corrective and preventive actions.

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Interpretation
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The objective is to ensure there are clear procedures to deal with problems that have the potential to affect product
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safety, legality or quality, ensuring that the finished product and consumer safety are not compromised. This must
include immediate actions and an analysis of the overall issues so that long-term preventive actions may be put
in place.
Clause Requirements
3.6.1 The site shall have a procedure for the completion of root cause analysis and corrective
actions and to determine preventive actions. As a minimum, root cause analysis shall be
used to implement ongoing improvements and to prevent recurrence of non-conformities
in the event of:
Glossary
•• an analysis of non-conformities for trends which shows that there has been a significant
increase in a type of non-conformity
•• a non-conformity which places the safety, legality, integrity or quality of a product at risk
(including withdrawals)
•• the results of internal, second- or third-party audits
•• failure of in-line testing equipment
•• any incidents.
brcgs.com 49
PACKAGING MATERIALS
ISSUE 6
Clause Requirements
Interpretation Root cause analysis
When errors occur, such as those listed in the requirement, the site should prevent
recurrence of these errors using root cause analysis. This is not a generally prescribed set
of actions or activities, but comprises a set of tools that can be deployed where required to
determine the true cause of an error.
Root cause analysis should include:
•• a set of parameters that will initiate the use of an appropriate tool (i.e. the site must
define when the analysis will be completed if it is not already prescribed by the Standard)
•• who is trained and/or authorised to complete the analysis
•• the methods that the site will use to conduct the analysis
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•• the records which detail the analysis and any subsequent preventive actions
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•• the methods for the verification of the completed actions.
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non-conforming products before a significant number of those failures is recorded. This
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tolerance should be consistent with industry standards and norms, which the auditor will
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be familiar with.
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The auditor will expect to see a documented procedure that includes this information,
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as well as evidence of any root cause analysis and preventive action that the site has
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carried out.
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3.6.2 The site shall evaluate the effectiveness of root cause analyses, and of any corrective and
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preventive actions.
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Interpretation Monitoring of corrective and preventive action

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the resultant preventive actions are indeed effective in preventing recurrence of the issue.
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Results should be monitored for evidence of the impact of preventive actions, and
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verification and validation used where necessary to establish that actions taken to rectify
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the issue are appropriate and sufficient.

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The auditor will examine the same data sources as the site to determine compliance with
this clause, as well as discussing the steps taken with production and storage or
warehousing personnel during the site tour.
50 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
Further guidance Root cause analysis
An important part of an effective corrective action process is the identification of the root
or underlying cause of the non-conformity and the implementation of suitable action to
prevent recurrence. Root cause analysis is a process of conducting an investigation into an
identified problem to allow the investigators to understand the fundamental cause and put
it right. While there are a number of techniques for undertaking root cause analysis, one of
the most common and simplest to use is the ‘five whys’ technique. The technique is based
on repeatedly digging deeper into the cause of a problem by asking ‘Why …?’ to get to the
root of the issue. Usually, the root cause becomes evident after five steps, but this is not
fixed and further investigation should be completed where required.
Do all non-conformities need correction?
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All non-conformities generated by or occurring at a site need to be subjected to corrective
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action. This may include non-conformities or problems identified by:
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•• employees, particularly those in production areas who are in a prime location to raise the
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alarm if any product, raw material or process is outside predefined limits

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•• internal audits
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•• third-party audits (including the site’s BRCGS audit)

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Part II
•• management review activities
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•• product testing (including product inspection, quality assurance checks or laboratory

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testing)
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•• monitoring of production processes (e.g. CCP monitoring)

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•• information from regulatory authorities (e.g. product testing or site visits).

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Documentation and records

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Two types of documentation are required:

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•• A corrective action procedure that details the process for handling non-conformities.
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—— identification of the competent and authorised individual(s) responsible for

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investigating the non-conformity and deciding the appropriate response

—— activities that must be completed as part of the process, including deciding actions,
setting timescales for the completion of actions, assigning responsibility for actions to
specific individuals, verifying the completion of actions, completing root cause
analysis, and carrying out preventive action.
•• Records of each non-conformity and subsequent action taken, including:
—— details of the non-conformity, when it occurred and how it was identified
—— details of the actions taken
—— dates when the actions were completed
Glossary
—— verification that the actions were completed and effective

—— root cause analysis and preventive action.
brcgs.com 51
PACKAGING MATERIALS
ISSUE 6
Clause Requirements
Example The five whys technique
An operator is instructed to perform a simple action, ‘Select raw material A’. However, the
operator inadvertently uses raw material B instead. The immediate reaction would probably
be that this was operator error. Although this may be accurate, it does not establish the
reason why the error occurred or prevent it from happening in the future. Using the five
whys technique, the root cause analysis should ask and answer a series of questions:
•• Why did the operator make the error? The operator was unfamiliar with the procedure.
•• Why was an operator who was unfamiliar with the procedure asked to complete it?
He had been trained but there was no supervision or sign-off of the training to confirm
it was satisfactory.
•• Why was the training not satisfactory? The two raw materials looked identical.
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•• Why weren’t the raw materials clearly labelled? The labels had been removed during
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cleaning and not replaced.
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•• Why weren’t the labels replaced? The cleaning staff did not consider the significance of
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the delay or the potential for an error.
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•• Why were the raw material containers being used if they had not been labelled correctly
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for manufacture? Checking the labels did not form part of anyone’s duties.
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The conclusion of a root cause analysis should be to identify what should be changed to
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prevent recurrence of the error. In this example, the conclusion might be to:
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•• update the training procedure

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•• introduce a training sign-off procedure to ensure training is understood

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•• replace labels – if practical, with ones that cannot be removed. Where labels must be
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removed occasionally, ensure that post-maintenance line checks include a check of

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•• ensure that an individual (e.g. the production manager) is authorised and responsible for
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post-cleaning line sign-off

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•• ensure that cleaning staff fully understand and are trained in the need to return labelling
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(and all equipment) to a fully operational state.

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Now that the root cause analysis has been completed, it is easy to see how this incident
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occurred. The causes were:

•• an incomplete training procedure
•• a faulty cleaning process
•• lack of post-cleaning check procedures.
The next step of the process is for the site to identify and implement suitable preventive
action to ensure the problem does not occur again (where a non-conformity has multiple
causes it is important that the preventive action addresses all of these). For example:
•• update the training procedure to ensure sign-off (and possibly a supervision step)
•• replace raw material labels, ideally with ones that cannot be removed
•• if labels must occasionally be removed, ensure that post-cleaning line checks include a
signage check
•• ensure an individual is authorised and responsible for post-cleaning line sign-off
•• ensure cleaners fully understand and are trained in the need to return labelling (and all
equipment) in a fully operational state.
Quick tips •• Train employees in any new requirements resulting from corrective and preventive action.
•• Ensure root cause analysis is completed so that effective preventive controls can be
established.
52 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
3.7 Supplier approval and performance monitoring
The company shall operate effective procedures for the approval and monitoring of its suppliers.
Interpretation
This clause sets out the requirements for companies to effectively control the purchase of anything that could
affect product safety, legality or quality. This includes not only raw materials but also components, subcontracted
work and possibly instruments, if they could result in unsafe products being produced. It is essential that potential
suppliers are evaluated.
Clause Requirements
3.7.1 The site shall have a documented supplier approval procedure and continual assessment
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programme in place, based upon risk analysis and defined performance criteria. These shall
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apply to the suppliers of:
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•• materials
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•• outsourced (subcontracted) production.

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The procedure shall ensure that the materials and services procured conform to defined
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requirements where there is a potential impact to product safety, quality or legality.

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Part II
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Interpretation Documented supplier approval procedure

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It is essential that sites work with reliable suppliers and that they know the basis on which
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they have been chosen. Every supplier of goods or services that could affect the safety,
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quality and legality of the final product needs to be formally evaluated using risk
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assessment to ensure that it is able to reliably deliver the specified products. Suppliers
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must not only be able to supply to specification but also maintain adequate systems such
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as traceability, facilitating their own activity.

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The approval of new and existing suppliers may include considerations of risk according to the:
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•• nature of the product or service provided and the known hazards associated with it
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•• nature of the use of the product or service

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•• breadth of use of the product or service within the company or its products
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•• nature of the supplier and historical experience with the supplier

•• customer’s or legislative requirements.
As an example, suppliers of raw materials and their control systems (where the safety and
integrity of the raw material are critical to the safety, quality and legality of the final
product) must be assessed robustly to ensure compliance with requirements. Where
approval depends on a combination of criteria, the site must clearly define which ones are
to be met according to the risk associated with the product being supplied.
This requirement also applies to purchased services, such as laundry, maintenance of
equipment, pest control, waste removal and transport services, where documentation for
Glossary
approval is required.
Ink kitchens, common in sites with print operations, are typically subcontracted (and operated
by the ink supplier) and as such are subject to supplier approval. The auditor will examine the
ink kitchen as part of the site tour, and inspect those procedures that affect product safety
and quality, including traceability. Traceability of inks is addressed in clause 3.11.
The Standard does not specify the required frequency of supplier assessment, but it should
be based on risk, ensuring that the ongoing approval of those raw material suppliers who are
most crucial to the safety and legality of the product are monitored on a more regular basis.
brcgs.com 53
PACKAGING MATERIALS
ISSUE 6
Clause Requirements
3.7.2 The approval procedure shall be based on risk and include either one or a combination of:
•• a valid certification to the applicable Global Standard or GFSI-benchmarked standard.
The scope of the certification shall include the raw materials purchased, and the site shall
validate any BRCGS certificates using the BRCGS Directory.
•• supplier audits, with a scope to include product safety, traceability, HARA review and
good manufacturing practices, undertaken by an experienced and demonstrably
competent product safety auditor. Where the supplier audit is completed by a second or
third party, the company shall be able to:
—— demonstrate the competency of the auditor
—— confirm that the scope of the audit includes product safety, traceability, HARA review
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and good manufacturing practices
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—— obtain and review a copy of the full audit report
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•• where a valid risk-based justification is provided, a satisfactorily completed supplier

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questionnaire may be used for initial approval. The questionnaire shall have a scope that
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includes product safety, traceability, HARA review and good manufacturing practices, and
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it shall have been reviewed and verified by a demonstrably competent person.

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Interpretation Acceptable methods of supplier approval

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All suppliers must be evaluated for their ability to meet the specifications of the materials
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or service they are supplying, and requirements for safety, quality and legality. The precise
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methods of approval are not prescribed and may vary depending on the items to be
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purchased and the level of risk, as well as the experience of working with the site.
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Whichever method is used, a documented procedure is required. This should set out the
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procedures to be used, whether a risk assessment has been conducted, the records to be
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kept, the criteria for approval or non-approval, and how exceptions may be handled.
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The acceptable methods of supplier approval will depend on the raw material and the
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risks associated with it and will include one or more of the following activities:
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•• certification to the relevant BRCGS scheme, such as the Global Standards for
Packaging Materials; Storage and Distribution; Agents and Brokers; or another of the
GFSI‑benchmarked schemes. The site must confirm the validity of the certification.
This will include confirmation of the certification status (e.g. this can be confirmed
on an independent database; for Global Standards it can be confirmed at
www.brcgsdirectory.com). Photocopies of certificates are not recommended and on
their own are not considered suitable validation of certification status. During the
BRCGS audit, the site may be asked to demonstrate its validation process by:
—— confirming that the certification remains up to date (e.g. by receiving confirmation
of successful completion of the recertification processes or by recording certificate
expiry dates and completing checks for ongoing certification)
—— ensuring that the raw materials are within the scope of the certification.
54 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
•• a supplier audit covering at a minimum product safety, traceability, hazard and risk
analysis, and good manufacturing processes. Such an audit must be completed by an
appropriately experienced and competent auditor (i.e. someone who has completed
training in auditing techniques, has experience of auditing, and has knowledge of the
product or processes being audited). Non-conformities should be addressed (e.g. in an
agreed action plan with timescales) unless they are critical to product safety or legality,
in which case supply may not be permitted until the non-conformities have been
satisfactorily addressed. If the raw material supplier is independently audited to another
standard that is not GFSI-benchmarked, this may be acceptable as an alternative to the
site completing its own audit of the supplier providing that:
—— the scope of the audit meets the requirements of the Standard (i.e. at a minimum
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product safety, product quality, traceability, hazard and risk analysis review and good
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manufacturing practices)
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—— the site has a copy of the full audit report (not just a certificate)
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—— the supplier can demonstrate the competence of the auditor.
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•• the completion of a supplier questionnaire (with a focus on product safety and quality)
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where a risk assessment has indicated that a supplier is low risk (e.g. because of a history
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Part II
of trading with the site or the nature of the raw materials traded). If a supplier
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questionnaire is the only mechanism used to assess a supplier (i.e. there are no additional
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activities such as supplier audits) then it is important that the questionnaire (and replies
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from the supplier) contains all the relevant information to allow the site to confidently
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make a decision on approval.

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The auditor will expect to see, and will challenge, risk assessments.
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Approval and the associated risk assessments must be up to date. The site should therefore
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consider reviewing the assessment whenever there is a significant change (e.g. new suppliers,
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Example A site manufactures polypropylene (PP) tubs for ice cream. No documented supplier
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approval process is available although three suppliers are approved to supply PP on the
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basis that two have current ISO 9000 certification and one is certificated to the Global
Standard for Packaging Materials.
The auditor is satisfied that the basis for approval is satisfactory but raises a
non‑conformity as no documented supplier approval procedure is in place.
3.7.3 There shall be a documented process for ongoing supplier performance review, based on
risk and defined performance criteria. The process shall be fully implemented.
Where approval is based on questionnaires, these shall be reissued at agreed intervals
based on risk, and suppliers shall be required to notify the site of any significant changes
Glossary
in the interim, including any change in certification status.

Records of ongoing supplier assessment and any necessary actions shall be maintained
and reviewed.
brcgs.com 55
PACKAGING MATERIALS
ISSUE 6
Clause Requirements
Interpretation Ongoing monitoring
Although it is important to know how and why suppliers are approved, it is also vital to
ensure that ongoing approval is justified. The site is free to determine how it confers
continuing approval on its suppliers, but it is important that the site uses a risk-based
approach.
The defined performance criteria can be determined by the site and should depend on
the supplier’s performance. As a guide, this may include:
•• the risks associated with the raw material or supplier
•• incidences of contamination or non-conforming raw materials
•• quality of material supplied.
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The frequency of ongoing approval is also important, and this is left to the site to
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determine. However, where approval is based on supplier questionnaires, these must be
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reissued at least every 3 years.
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The company should maintain records of criteria on which supplier approval has been
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based in order to demonstrate that supplier approval is adequately controlled and that
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there is continuing compliance with the requirements.

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3.7.4 The site shall have an up-to-date list or database of approved suppliers. This may be on
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paper (hard copy) or it may be controlled on an electronic system.

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The list or relevant components of the database shall be readily available to the
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relevant staff.
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Interpretation Approved suppliers list

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The company must also maintain an up-to-date list of approved suppliers based on the
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outcome of the supplier approval process. This list can either be in hard copy (i.e. paper)
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or electronic format (such as an approval database). It is expected that all purchased raw
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materials will be from the suppliers on the list unless it is a purchase by exception.
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The auditor may refer to the list to facilitate the effective sampling of supplier approval
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records.
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The list (or relevant sections of it) should be available where goods are taken in, and be
accessible to anyone who needs it at the points at which it should be used. This is likely
to include purchasing where this activity is carried out at the site (i.e. not at a corporate
facility).
3.7.5 The company shall ensure that its suppliers of raw materials have an effective traceability
system. Where a supplier has been approved based on a questionnaire instead of
certification or audit, verification of the supplier’s traceability system shall be carried out
on first approval and then at least every 3 years. This may be achieved by a traceability test.
56 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
Interpretation Supply chain traceability
It is important for the integrity of products that appropriate traceability systems operate
throughout the supply chain. Therefore sites must ensure that their raw material suppliers
have suitable traceability systems in operation. This assurance can be obtained from
certification, auditing or by directly testing traceability. Examples of acceptable traceability
include:
•• the raw material supplier is certificated to a GFSI-benchmarked standard. Assessment
of traceability systems forms part of these audits and therefore no additional action is
required to comply with the requirements of this clause; however, a communication
mechanism should be in place, such that if the raw material supplier were no longer
certificated, the site would be made aware of this change
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•• the raw material supplier is audited by the site and the audit includes an assessment of
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the traceability systems. This would comply with the requirement as traceability has been
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assessed. The audit should be repeated at least every 3 years
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•• verification of a supplier’s traceability system where approval has been based solely on
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a questionnaire with no additional testing. This verification could include, for example:
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—— a test of the raw material supplier’s traceability. For example, as part of the site’s
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Part II
traceability test, a relevant raw material is highlighted. The batch details are forwarded
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to the supplier to enable them to complete the traceability test for the specific batch
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of raw materials and send the relevant records back to the site
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—— a worked example from the raw material supplier, which clearly explains the
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traceability process
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—— a detailed description of the traceability system provided by the raw material supplier.
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Information received during the traceability verification should be incorporated into the
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supplier approval process.

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Traceability verification is a requirement for each raw material supplier. Therefore any
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traceability test (because the supplier approval is based solely on a questionnaire) should
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be designed to test the raw material supplier’s systems and not to trace every single
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material they produce. Where a site purchases multiple ingredients from the same raw
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material supplier, it is not a requirement to complete a traceability test for every single
material purchased; only to complete the traceability test for each supplier from which
ingredients are purchased.
The frequency of the traceability verification should link to the supplier approval
programme; that is, the traceability is verified on first approval of the supplier, and then at
least every 3 years. It is good practice to phase these verifications over the 3-year period
rather than trying to complete them for all sites at once.
During the BRCGS audit the auditor will not undertake a test of raw material suppliers’
traceability systems but they will review the site’s processes and the information received
Glossary
from its raw material suppliers.

Issues arise with raw materials from time to time so it is beneficial to consider the
monitoring of any materials that may need further transparency within the supply chain.
This ensures that the site is proactive, not reactive, potentially mitigating the risk of future
concerns about raw materials.
brcgs.com 57
PACKAGING MATERIALS
ISSUE 6
Clause Requirements
3.7.6 Where raw materials are purchased from companies that are not the manufacturer or
packer (e.g. purchased from an agent, broker or wholesaler), the site shall know the identity
of the last manufacturer or packer.
Information to enable the approval of the manufacturer or packer shall be obtained from
the agent/broker or directly from the supplier, unless the agent/broker is certificated to the
relevant Global Standard (e.g. Global Standard for Agents and Brokers) or a relevant
standard benchmarked by GFSI.
Interpretation Purchasing from agents and brokers

Potential product safety risks need to be understood for all raw materials, including those
that have been purchased through an agent or broker.
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The purpose of this clause is to ensure that, where a site has purchased a raw material from
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an agent or broker, or a wholesaler (i.e. not the manufacturer or packer), the site has
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sufficient information to ensure traceability and to enable the approval of the last
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processor of the raw material. This information can be provided directly by the
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manufacturer, processor or packer, or alternatively through the agent or broker.

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Where the agent or broker is certificated to the Global Standard for Agents and Brokers, the
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wholesale module of the Global Standard for Storage and Distribution, or the relevant traded
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products/goods scope in the Global Standard for Packaging Materials, the requirement to
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approve the processor or packer is not applicable, as the requirements of these Standards
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ensure that effective systems for supplier approval and traceability are in place. However, the
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site will still be expected to know the identity of the processor or packer.
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3.7.7 The procedures shall define how exceptions are handled; for example, the use of products
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or services where an audit or monitoring has not been undertaken. Assessment (on a batch
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or delivery basis) may take the form of:

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•• certificate of analysis
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•• statement of compliance.
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Interpretation Exceptions to the supplier approval procedure

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The Standard recognises that in some cases the company may need to use suppliers who
are not approved according to the normal procedures and that this is normal practice
within the packaging industry. Valid reasons for the use of a non-approved supplier include
cases where the product purchased is an ad hoc or irregularly purchased material or
additive, or where extraordinary circumstances prevent supply by an approved supplier.
Where purchase from a non-approved supplier takes place, the auditor would be looking
for evidence that a procedure is in place to ensure that the materials delivered are to
requirements.
Example A laminate film manufacturer is unable to secure supply of PE film from its approved
supplier because of a regional strike. An alternative, unapproved supplier is able to supply
the film at short notice and supplies a declaration of compliance and documented proof of
compliance with relevant plastics migration legislation prior to the delivery of the first batch.
The auditor is satisfied that the site has used appropriate measures as detailed in its
procedure to ensure product safety and quality.
58 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
Example A manufacturer of spirally wound paperboard tubes for the whisky gifting industry buys in
caps and bases from an approved supplier. During the peak season it receives an increased
order from one customer, but its supplier is unable to meet the demand. It sources caps
and bases from a BRCGS-certificated supplier in China and accepts certification as the
basis for approval.
The auditor accepts that the third-party audited certificate ensures that the supplier is
operating in a manner compatible with that of the audited site.
3.8 Product authenticity, claims and chain of custody
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Systems shall be in place to minimise the risk of purchasing fraudulent raw materials for packaging and to ensure
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that all product descriptions and claims are legal, accurate and verified.
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Interpretation
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The objectives of this section are to ensure that the site has assessed its raw materials and supply chain for
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Fr 9. tps
vulnerability to fraudulent activities (such as dilution and substitution) and that the site has appropriate controls
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Part II
in place to minimise the risk of purchasing fraudulent or adulterated raw materials. The site should ensure that any
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claims relating to raw materials used in products can be substantiated.

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Clause Requirements
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3.8.1 The company shall have processes in place to access information on historical and
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developing threats to the supply chain which may present a risk of substitution of raw
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materials (i.e. fraudulent raw materials). Such information may, for example, come from:
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•• trade associations
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•• government sources
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•• private resource centres.

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Interpretation Obtaining information

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Information relating to the substitution of raw materials constantly changes as new threats
are identified and existing ones are managed. The objective of this clause is to ensure that
sites remain up to date with emerging issues and are able to adapt their systems to protect
their products against new and existing threats.
The company must be able to demonstrate that it maintains up-to-date knowledge of
relevant scientific and technical developments, emerging issues and known threats relating
to the raw materials it purchases and the potential for fraud in the supply chain.
Mechanisms to achieve this may include:
•• membership of a trade association which provides this type of information to its members
Glossary
•• help from government officials or local enforcement officers

•• subscription to a service provider supplying this type of information.
The auditor will look for evidence of systematic checking and the process for ensuring the
information is translated into action as necessary. Information may be obtained and
collated as part of the provision of technical knowledge (clause 1.1.5) or as a separate
exercise, providing it is clear that relevant information is being obtained.
brcgs.com 59
PACKAGING MATERIALS
ISSUE 6
Clause Requirements
3.8.2 A documented vulnerability assessment shall be carried out on all raw materials or groups
of raw materials to assess the potential risk of substitution. This shall take into account:
•• historical evidence of substitution
•• economic factors which may make substitution more attractive
•• ease of access to raw materials through the supply chain
•• sophistication of routine and upstream testing to identify substitution
•• nature of the raw material.
The output from this assessment shall be a documented vulnerability assessment plan.
This plan shall be kept under review to reflect changing economic circumstances and
market intelligence which may alter the potential risks. It shall be formally reviewed
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annually.
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Interpretation Vulnerability assessment , 2 er ipa
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A vulnerability assessment is a search for potential weaknesses in the supply chain in order
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to prevent fraud (such as the substitution of raw materials before they arrive at the site).
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It is a specialised form of risk assessment. The aim of the assessment is not to assess the
Fr 9. tps
potential for fraud at the site, but to examine the supply chain for potential concerns or
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weaknesses, thereby identifying those raw materials that are at particular risk of substitution,
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so that appropriate controls can be put in place (clause 3.8.3). The vulnerability assessment
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will need to consider information relating to each raw material in order to assess the
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potential for fraud. Where a site purchases a number of similar raw materials, it may be
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possible to consider these as a group rather than considering each raw material individually,
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providing the risks are similar.

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The nature of the raw material may change the potential for product fraud. For example,
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when a site is purchasing granular material, the potential for fraud/substitution may
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increase because the addition of substituted granular material is less visible.

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The Standard does not define the exact process that the site must follow when completing
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the vulnerability assessment; however, it is likely to incorporate the following steps:

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•• draw up a list of raw materials (or groups of raw materials) and the controls (e.g. product
testing, traceability systems or supply chain audits) that are already in operation
•• consider the information obtained from clause 3.8.1 for each raw material
•• complete a risk assessment on the vulnerability of each raw material.
The output of the vulnerability assessment should be a ranking or scoring of the materials
to identify those which need additional controls.
It is important that the vulnerability assessment remains up to date and it must be
reviewed at least annually or when there is a significant change to the raw material. As a
guide, a review may be triggered by the following, although this is not an exhaustive list:
•• a change in the country of origin or the supplier of raw materials
•• a change in the financial situation of raw material suppliers or countries of origin
•• a change in cost of raw materials, either upwards or downwards
•• a change in the supply chain, logistics and delivery of materials
•• a change in material availability
•• emergence of a new risk (e.g. known substitution of a raw material)
•• developments in scientific information associated with materials, process or product
•• information received as part of supplier approval (e.g. clause 3.7.2) which highlights new
or evolving risks.
60 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
3.8.3 Where raw materials are identified as being at particular risk of substitution, the
vulnerability assessment plan shall include appropriate assurance and/or testing processes
to mitigate the identified risk(s).
Interpretation Output from the vulnerability assessment

Where raw materials are identified as being of particular risk of substitution, appropriate
assurance controls need to be in place to ensure that only genuine materials are purchased.
Depending on the perceived risk, assurance controls may include:
•• certificates of analysis from raw material suppliers
•• raw material testing
•• supply chain audits
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•• use of tamper evidence or seals on incoming raw materials
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•• enhanced supplier approval checks
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•• mass balance exercises at the raw material supplier t 2 es tic
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•• changes to the supply chain (e.g. a change of supplier or a move to a shorter supply chain).
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Where a site wishes to make claims relating to product composition (such as the Forest
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Stewardship Council (FSC), Programme for the Endorsement of Forest Certification (PEFC)
Fr 9. tps
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Part II
or recycled content), the site is responsible for maintaining the evidence to support
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those claims.
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3.9 Management of subcontracted activities and outsourced processes

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Where any process steps in the manufacture of the packaging material are outsourced to a third party, or the
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process is wholly subcontracted to another site, this shall be managed to ensure it does not compromise the
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quality, safety or legality of the product.

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Interpretation
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What constitutes a subcontractor is defined in the glossary of the Standard. Within the packaging industry
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subcontractors are typically used to carry out specific processes or activities that are not in the normal range of the
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company being audited. Although complete subcontracting of a job cannot be considered within the scope of the
Standard, subcontracted processes (e.g. foil blocking on a printed carton where the cartons are returned to site before
dispatch to the customer) can be considered within scope, providing the supplier approval procedures (set out in
clause 3.7) are met and the site has included the subcontracting activity in its hazard and risk management plan.
Example
A site that prints labels for the whisky and spirits industry subcontracts part of the production for a label with a
special finish to a specialist label printer. The approval and use of the subcontractor meets the requirements set out
in the Standard. The site also subcontracts the whole production of booklets and leaflets which go into the
presentation boxes, buying these from the supplier as finished products for which it provides artwork and a
Glossary
specification. The development of the items meets the requirements set out in clauses 3.10 and 5.1. The site then
repacks these into sets with the appropriate labels for the manufacturer of the whisky.
Where items are bought as finished products and the certificated site conducts no production activity on the actual
item, the approval of the supplier must meet the requirements set out in clause 3.7.
brcgs.com 61
PACKAGING MATERIALS
ISSUE 6
Clause Requirements
3.9.1 The company shall be able to demonstrate that, where any part of the production is
outsourced and undertaken off-site, this has been declared to the customer or brand owner
and, where required, approval has been granted.
Interpretation Use of subcontractors

Subcontracting part of a job allows packaging suppliers to offer flexibility to their
customers. However, the company must ensure that customers are advised of
subcontracted activities within the job, are aware of the status of the subcontractor with
regard to certification, and are satisfied that the company is managing the subcontractor
effectively.
The purpose of this requirement is to ensure that the customer is able to make an informed
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decision on its supply of goods and is not misled into believing it is buying products from
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one supplier when the items are, in fact, supplied partially from another source.
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Example The gluing of windows into a carton for confectionery is subcontracted to a third party by a
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carton printer because its own gluing machine has broken down. The site does not notify
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the customer that it is using a subcontractor for this task. It also does not know the
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subcontractor’s status with respect to the Standard, despite having approved the supplier
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by receipt of a questionnaire.
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The auditor raises a non-conformity as the requirement to notify the customer has not
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been met.
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3.9.2 Where any processes are subcontracted or outsourced, including artwork or pre-press
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activity, the risks to the quality and safety of the product shall form part of the hazard and
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risk analysis and the company’s evaluation of the system shall be held on record.
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Interpretation Hazard and risk analysis and subcontracted processes

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process within the hazard analysis and risk assessment. Depending on the method used
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for its hazard and risk management system, the company may include the subcontracted
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activities as modules, taking account of any unique characteristics a job may have to ensure
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that no risk is presented to the materials. The requirement is to assess the risks to the
quality or safety of the product and to communicate these risks so that measures can be
put in place to effectively manage any hazards.
The company should also take into consideration the risks that may be involved in the
transport of the materials to ensure that this poses no risk of contamination. Adequate
protection and packaging should be in place, for example, and the company needs to put
appropriate checks in place upon receipt of the materials to ensure they meet the specified
requirements.
This element of the hazard and risk analysis must also be documented, and all associated
records (such as audit reports or supplier approval documentation) must be present and
available.
62 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
Example A company manufacturing cartons includes the subcontracting of any activity in its hazard
and risk management system and manages all potential hazards surrounding subcontracted
work by auditing the company and agreeing a specification. Its inbound goods procedure
means that all work received from subcontractors is checked for cleanliness and quality.
The documented results of the inbound goods checks confirm that the procedure is fully
in place and effective.
The auditor has viewed the documented hazard and risk management plan and is satisfied
that the site has put adequate measures in place to manage the potential hazards from
subcontracted activity.
3.9.3 Clear specifications shall be agreed for all work outsourced or subcontracted.
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Interpretation Specifications
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Where subcontractors are used, the company becomes a customer. As such, clear
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specifications should be in place to ensure that both parties have similar expectations of
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the outcome of the work being carried out.

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The specifications set in place should be in line with the requirements set out in clause 3.4.
Fr 9. tps
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Part II
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3.9.4 Where any process steps in the manufacture of the packaging materials are subcontracted
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or outsourced, final release of the product shall remain the responsibility of the site.
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Controls shall be in place for checks on finished work to ensure product safety and quality
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meets specification prior to dispatch to the final customer.

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Interpretation Dispatch of product after outsourced or subcontracted processes

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The company is responsible for ensuring that the finished product meets the quality
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standards agreed with its customer. Any subcontracted work must meet these standards
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and be subject to monitoring to ensure it does not compromise the safety, quality or
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legality of the product.

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3.9.5 The company shall ensure that any subcontracted or outsourced processors have an
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effective traceability system. Where a supplier has been approved based on a questionnaire
instead of certification or audit, verification of the supplier’s traceability system shall be
carried out on first approval and then at least once every 3 years. This may be achieved by a
traceability test.
Glossary
brcgs.com 63
PACKAGING MATERIALS
ISSUE 6
Clause Requirements
Interpretation Traceability in subcontracted or outsourced processes
This clause applies to products listed within the scope of a site’s certification but which
include a process step that is outsourced to another company or site. Examples include
products where a component product or intermediate is:
•• partially processed at another location before being returned to the site for further work
or packing – this typically happens when there is a need for specialist equipment
•• sent to a country with a lower-cost economy for a very labour-intensive part of the process.
The scope of the audit report and any certificate will reflect the activities undertaken only
at the site where the audit was undertaken. Where a product is entirely manufactured at a
separate site (i.e. where co-manufacturing occurs), it will not be covered by these
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requirements as the expectation is that each individual site will be certificated.
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There must be documented mechanisms to ensure traceability is maintained throughout
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all subcontracted or outsourced processes. Records relating to the traceability of individual
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batches of processed product must be available.
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3.10 Management of suppliers of services

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The company shall be able to demonstrate that, where services are outsourced, any risks presented to product
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safety, quality or legality have been evaluated to ensure effective controls are in place.
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Interpretation
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Where clause 3.9 specifically refers to management of subcontracted processes, this set of requirements refers to
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the services that the site may subcontract to a specialist provider. Some or all of the services listed in clause 3.10.1
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may be subcontracted, but the auditor will be looking for evidence of risk-based controls to minimise the risk to
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product safety, quality and legality.

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Clause Requirements
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3.10.1 There shall be a documented procedure for the approval and monitoring of suppliers of
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services. Such services shall include, but are not limited to:
•• pest control
•• laundry services
•• transport and distribution
•• storage and dispatch
•• sorting or rework
•• laboratory services
•• calibration services
•• waste management
•• product safety and quality consultants to the site.
Providers of utilities such as water, electricity or gas may be excluded on the basis of risk.
This approval and monitoring process shall be risk-based and take into consideration:
•• risk to the safety and quality of products
•• compliance with any specific legal requirements
•• potential risks to the security of the product (i.e. risks identified in the vulnerability and
product defence assessments).
64 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
Interpretation Managing suppliers of services
The basis on which a site (or company) approves the suppliers of its services must be
documented and detail the ongoing monitoring of these suppliers to ensure compliance
with the site’s requirements.
Where utilities are provided by state or nationalised services, the site may deem that
the controls in place are sufficient where a risk analysis demonstrates this; however,
water when used as a raw material may be subject to further risk assessment (e.g. in
paper‑making).
3.10.2 Contracts or formal agreements shall exist with the suppliers of services which clearly
define service expectations and ensure potential risks associated with the service have
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been addressed.
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Interpretation Formal agreements
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Services provided to the site must have a documented agreement, just as any other
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subcontracted activity. This may be as simple as a service level agreement, or it may detail
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visits, specific services etc. The auditor will expect the site to understand what it needs
Fr 9. tps
from the service providers and that it has a basis against which it can monitor the providers
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Part II
for ongoing approval.
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Service providers who are on site will need to receive appropriate training to ensure that
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they complete their activities in a way that will not negatively impact the safety, quality or
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legality of the products being manufactured (clause 6.1.2).

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3.11 Traceability
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Fundamental
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The site shall be able to trace and follow all raw materials through processing (including
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subcontracted processes) to the distribution of the finished product (packaging material) to the
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customer and vice versa.

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Interpretation
This is a fundamental requirement because it is vital that materials can be traced in order to take appropriate action.
There are two aspects to consider:
•• tracing back to suppliers’ raw materials and components that are used on site to produce the products
•• tracing finished products forward to the initial customers (i.e. retailers or wholesalers who have purchased the
items). In some cases, it will be a legal or customer requirement that products can be traced further.
This is often summarised as one step forward and one step back.
Glossary
It is worth remembering that a good traceability system usually makes sound business sense and prevents or limits
the scope of unnecessary recalls or withdrawals of product. BRCGS publishes a best-practice guideline, ‘Traceability’,
which gives more detail for those requiring further information. It includes examples of methods to be used and
case studies.
brcgs.com 65
PACKAGING MATERIALS
ISSUE 6
Clause Requirements
3.11.1 The site shall have a documented traceability procedure and system that can trace and
follow all raw materials from the supplier through all stages of processing (including
subcontracted processes) and distribution of the finished product, and vice versa.
Where continuous processes are used, or raw materials are in bulk silos, traceability shall
be achieved to the best practical level of accuracy.
Interpretation Traceability system

As well as being a legislative requirement in some industries, traceability is a risk
management tool that allows businesses to withdraw or recall products that have been
identified as unsafe.
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A company must maintain systems and procedures that facilitate identifying from whom
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raw materials have been obtained and to which customers finished product has been
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supplied. The system must ensure that products supplied to customers are adequately
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labelled or identified to enable traceability, and traceability details need to be provided to
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relevant parties in sufficient detail and in a timely manner.

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The glass industry has guidelines set by FEVE (the European Container Glass Federation)
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which describe the limitations on traceability in glass through the volume of materials
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used, the nature of the process and the use of cullet (generally post-consumer recycled
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material). BRCGS accepts these limitations on the glass industry.

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Inks can be difficult to maintain with regards to traceability. Batches are often blends of
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other inks and can be used and re-used over several different dates and batch codes,
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rendering original compositional data potentially meaningless. The site should, however,
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bear ‘one step forward, one step back’ in mind when considering traceability for inks.
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The site should know from where the inks have originated, and the typical blends that are
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used. Ink kitchens should have procedures for recording new batches that are introduced
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together, and where composite batches (those produced in the ink kitchen to obtain a
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specific colour or viscosity) are combined. However, as with bulk materials in silos,
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traceability to the best practical level of accuracy is acceptable.

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3.11.2 Identification of raw materials, intermediate products, finished products, non-conforming

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products and quarantined goods shall be adequate to ensure traceability.
Interpretation Identification of raw materials

It is vital that traceability is maintained throughout the production process, and special
effort may be required where products are stored as intermediate products, either as part
of a process, or to build up stock for further processing.
3.11.3 For traceability, an appropriate system shall be in place to ensure that the customer can
identify a product or production lot number for the product.
Where coding is applied, this shall be checked for legibility and accuracy against
production records.
66 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
Interpretation Customer identification of production lot
The user of the packaging should be able to identify batches of the product, and where
possible details should be visible on the product. This is often achieved through date-
coding the batch or lot using blind debossing, inkjet printing or labelling. Where this is not
practical, batches of product should be traceable through, for example, batch-coded labels
fixed to shipping containers, reels of material and/or pallets. Corresponding codes should
be printed on dispatch documents.
Labelling or any other type of identification-marking should be applied at the line or point
of manufacture upon completion.
Example A two-piece can manufacturer uses a computerised system to trace raw materials from
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suppliers through processes (including approximation for silo storage) to packing and
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dispatch. The inputting of data is driven by the bill of materials, and finished product batch
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codes are applied to the underside of each can in transparent ink before dispatch to the filler.
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The site has demonstrated a system is in place and has executed traceability for silos to an
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appropriate level.
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Fr 9. tps
3.11.4
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The traceability procedure and system shall be tested at a predetermined frequency, at
Part II
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least annually, and the results shall be retained and easily retrieved for inspection.
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Traceability of all materials shall be achievable in a timely manner.

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Interpretation Traceability system testing

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The traceability system needs to be tested at least annually in its entirety. This may be
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completed as part of a real product recall or withdrawal scenario if this has occurred, since
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the objective is to test the system and identify areas for improvement rather than supply
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records or a ‘test’ for its own sake. The system should provide traceability both forwards and
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backwards and should therefore be tested in both directions. For example, a raw material
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could be selected and traced forward to show in which finished product it had been used.
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A finished product could also be selected and traced backward to show all the raw materials
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that had been used to produce it. The tests should include identifying which customers had
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received the finished product and which suppliers had provided the raw materials.
The tests might also include quantity detail so that a quantity check or mass balance may
be undertaken in any traceability test or recall scenario to account for all materials. This is
defined as a reconciliation of the amount of incoming raw materials against the amount
used in the resulting finished products, taking into account process waste and rework.
This sort of test might only be considered where there is particular risk to the consumer, as
quantity checks may take a lot of time and resource to complete successfully. The principle
is to ensure that the traceability system is effective; mass balance is a key measure of this
workability and may highlight areas for improvement throughout the process.
Glossary
Where recycled materials are used, it is acceptable to start from when they have been
accumulated in some way or part reprocessed. The purpose is to establish the source of the
material, not to its molecular level, but so that any other materials that may be affected can
also be traced, in case of any major incidents affecting the safety, quality or legality of the
finished packaging materials and subsequently the products that are packed into it.
The auditor will typically conduct a traceability test during the BRCGS certification audit.
Retrieval of records to complete the test should be achievable in the duration of the audit,
i.e. before the auditor leaves.
brcgs.com 67
PACKAGING MATERIALS
ISSUE 6
Clause Requirements
Customers may have additional requirements for traceability to be completed in a shorter
time, sometimes as little as 30 minutes, in order to ensure that their incident management
plans operate as efficiently as possible; this is important when product safety is under
question. This doesn’t necessarily indicate that packaging materials are or could be at fault;
rather it is a test of the quality of the information received from their suppliers, which is
crucial to the effectiveness of their own systems. Where customer-specific requirements
are in place, the site should consider incorporating them into their systems to ensure that
those customer needs can be met.
3.11.5 Where rework or any reworking operation is performed or outsourced or subcontracted

activities are carried out, traceability shall be maintained.
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Interpretation Traceability in outsourced or subcontracted processes
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Products handled by and manipulated by subcontractors, or in need of re-inspection, may
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either be returned to the production area for additional quality checks or sent to a specialist
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contractor to be worked. Traceability will need to be maintained throughout these processes

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so the site will need to ensure that the organisations have traceability systems.
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3.11.6 Traceability of test data and samples to production lots shall be maintained.
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Interpretation Sample traceability

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Where testing is carried out off-line, it is essential that the site is able to identify the
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production batches or lots from which the testing samples have originated. This ensures
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that results are linked to the correct batch and assists the site in validating its ongoing
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product quality results.

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3.12 Complaint-handling
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Customer complaints relating to product hygiene, safety or quality shall be handled effectively and the
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information used to reduce complaint levels.

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Interpretation
In some ways complaint-handling is very similar to dealing with non-conformities. The site needs to ensure that
complaints are effectively captured and recorded. Depending on the nature of the business, it is likely that
complaints will be received from a wide range of sources and delivered to a number of people; for example,
comments made to sales people during business development meetings or product returns from unsatisfactory
deliveries. Whatever the source, the site needs a system to capture and collate the information.
Many sites will record product safety and quality complaints along with a much wider range of issues. This is quite
acceptable provided that quality and safety issues can be identified and are routed to an appropriate person for
investigation in a timely manner.
Complaints are an important source of information concerning business performance and customer satisfaction.
It is important that this information can be recorded accurately and that it is not hidden or lost because people are
worried about the implication of reporting negative comments. Complaints should be seen as opportunities for
improvement.
Ultimately the desired outcome of managing complaints from customers, conducting analysis and determining the
root cause is to reduce the overall number of complaints received. Sites that work with their customers to identify
complaints (real and potential) or opportunities for process improvements will see benefits through cost-savings,
improved resource efficiency and a demonstrable commitment to continual improvement.
68 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
3.12.1 All complaints shall be recorded and investigated (including root cause analysis) and the
results of the investigation documented.
Actions appropriate to the seriousness and frequency of the problems identified shall be
carried out promptly and effectively by appropriately trained staff.
Interpretation Documentation and investigation of complaints

The company needs to identify routes of communication for complaints to ensure that they
are effectively captured in an appropriate manner. Staff should be able to identify when a
complaint is made and ensure that the origin and content of the complaint are documented.
A documented complaints procedure, including use of a standardised complaint form, may
be useful. All complaints must be captured to a central control point to ensure they are
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adequately assessed and investigated and the results of this investigation documented.
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The clause also requires that appropriate actions are carried out by suitably trained staff.
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Sites would be expected to note the frequency of problems and review the recurrence of
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similar issues, taking action to investigate the causes (and not just deal with issues on an
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ad hoc basis as they occur).

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Corrective action plans must be clearly documented, giving details of the investigation and
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Part II
actions taken to prevent a recurrence.
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Example A company has a procedure for logging complaints and a simple form on its intranet site where
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all employees can record information. It is part of every employee’s initial training to have the
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system explained to them. Each section manager is responsible for reviewing the input to the
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system on a monthly basis and a customer services manager has overall responsibility for
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reviewing the complaints and following them up with any necessary actions. When complaints
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concern safety, quality or legality, they are coded so that the quality manager also receives the
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complaint immediately and can review the urgency of any action to be taken.
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An auditor reviews the complaints on the intranet system and selects one example.
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He follows the trail of the complaint to ensure that all parties have carried out the required
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actions and that the correct information has been logged. During this investigation, he
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takes the opportunity to question employees about the system and finds it to be well
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understood and used. He is satisfied with the process.
3.12.2 Complaint data shall be analysed to identify significant trends. Where there has been an
increase or repetition of a complaint type, root cause analysis shall be used to implement
ongoing improvements to product safety, legality and quality, and to avoid recurrence.
This analysis shall be made available to relevant staff.
Interpretation Analysis of data

It is a requirement of the Standard that complaint data is analysed and used to drive
continual improvement. This is good practice in all industry sectors. A summary of this data,
Glossary
any obvious trends and the effectiveness of any corrective actions taken as a result should
be part of the annual management review.
Sites should consider the quality of their complaint investigations, particularly where the data is
a key input to trending and root cause analysis. Tools such as the Ishikawa (fishbone) diagram or
the ‘five whys’ technique should be used to facilitate an effective root cause analysis.
brcgs.com 69
PACKAGING MATERIALS
ISSUE 6
3.13 Management of product withdrawals, incidents and product recalls
The site shall have a documented procedure and systems in place to effectively manage any product
withdrawals, returns from customers, incidents or product recalls in order to ensure that all potential risks to the
hygiene, quality, safety or legality of products and the final consumer are controlled.
Interpretation
The Standard recognises that the most common activity within this clause for packaging manufacturers will be
product withdrawals (or returns), defined in the glossary as materials withdrawn from customers but not the final
consumer. This may occur in many scenarios, commonly associated with excess delivery volumes, a manufacturing
defect, or a requirement for rework of delivered packaging materials.
Typically, it is only the brand owner or retailer that is in a position to initiate a product recall, which is a more
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significant return of product from the consumer or retail supply chain. This clause is arranged to reflect this hierarchy
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of activity, but also states that the site needs to support any product recall activity by its customers where it is
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required to do so.
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Clause Requirements
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3.13.1 A product withdrawal procedure shall be documented and include as a minimum:

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•• identification of the key personnel involved in assessing potential product withdrawals or

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returns, with their responsibilities clearly defined

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•• a communications plan including methods of informing customers

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•• root cause analysis and corrective action to implement appropriate improvements as

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required.
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Interpretation Product withdrawal procedure

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A documented product withdrawal procedure is required, and the Standard contains

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specific requirements that must be included to help ensure that an effective system is
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Bearing in mind that a withdrawal may be initiated at any time, the information kept must
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include office hours and out-of-hours contact details, and these must be kept up to date
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by periodic verification. The procedure must also include details of how products are
withdrawn, including what corrective action needs to be taken and how any disruption to
manufacturing capacity is to be dealt with. Some of this activity may be risk-based (e.g. a
manufacturing defect that affects an entire day’s production will require more attention
than the return of an additional portion of product).
Root cause analysis and corrective actions
Where a product withdrawal has taken place, it is essential that the site looks at what has
happened and attempts to avoid recurrence. The site is required to use root cause analysis
and this may be applied on a case-by-case basis, or grouped where a number of withdrawals
have occurred for the same reason. Results of the analysis should be fed back through the
company and the relevant processes and procedures should be amended so that
appropriate corrective action can be implemented.
70 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
3.13.2 The withdrawal procedure shall be capable of being operated at any time and will take into
account notification to the supply chain, stock return, logistics for recovery, storage of
recovered product, and disposal.
Interpretation Operation of the product withdrawal procedure

An assessment needs to be made to establish whether the product withdrawal procedures
are appropriate and capable of being operated at any time. Key personnel should have
access to the procedures at all times. The procedures need to take into account stock
reconciliation (in the company’s control), logistics, recovery, storage and disposal protocols.
The procedures must be regularly reviewed (e.g. annually) to ensure that they remain
accurate and appropriate.
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3.13.3 The company shall provide written guidance and training for relevant staff regarding the
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type of event that would constitute an incident.
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Incidents may include:
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•• disruption to normal production processes

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•• disruption to key services such as water, energy, transport, refrigeration processes, staff
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availability and communications
Part II
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Where products which have been released from the site could be affected by an incident,
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the need to withdraw products and, where appropriate, advise customers to withdraw
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and/or recall products shall be considered.

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Interpretation Documented incident management procedure

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Incidents are events that may result in the production of unsafe, illegal or non-conforming
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product and risks to consumer safety. An emergency situation may occur as a result of a
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sudden, unforeseen crisis that requires immediate action, such as fire or a power shortage.
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The effectiveness of any incident management system relies on communication. Therefore,

staff need to be given clear written guidance both on the types of event that would
constitute an incident or emergency situation and on the reporting system required to
ensure communication is accurate, fast and effective. Systems must be in place and used to
ensure that information is collated and quickly assessed by staff who understand its
significance.
3.13.4 The company shall determine and document the activity required to effectively manage an
incident to prevent release of product where hygiene, safety or quality may have been
Glossary
affected.
Interpretation Managing an incident

The requirement here is straightforward. The site must effectively manage an incident;
but what constitutes an incident must first be established on the basis of risk assessment.
An example of good practice would be to quarantine all goods until they can be positively
released, when it can be confirmed that no contamination or potential injury to the safety,
integrity or legality of the product has occurred.
brcgs.com 71
PACKAGING MATERIALS
ISSUE 6
Clause Requirements
3.13.5 A procedure to manage product recalls initiated by the brand owner or specifier shall be
documented and include as a minimum:
•• identification of the key personnel involved in assessing potential recalls, together with
clearly defined responsibilities
•• a communications plan that includes methods of informing customers and (where
necessary) regulatory bodies in a timely manner.
Interpretation Procedure for recall by brand owner/specifier

This clause contains specific points to help ensure that an effective recall system is
designed that includes communication with key contacts, both internal and external.
Bearing in mind that a recall may be initiated by a brand owner or retailer at any time, the
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recall system shall include office hours and out-of-hours contact details. These details
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must be kept up to date by periodic verification.
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The recall procedure must also include what corrective action should be taken, how any
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disruption to manufacturing capacity should be dealt with, and how to instigate a root
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cause analysis.
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3.13.6
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Where a site’s products are involved in a product recall, the site shall assist with provision
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of information (such as traceability) as required.

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Interpretation Assistance in product recalls

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manufacturer’s products are involved in a product recall, the manufacturer should provide
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any information to the customer that is relevant. This may be mainly traceability information,
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or technical support in identifying the cause of the issue that prompted the recall.
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The product withdrawal procedure shall be tested, at least annually, in a way that ensures
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activities.
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The results of the test, and of any actual withdrawals, shall be used to review the procedure
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and implement improvements as necessary.
72 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
Interpretation Testing of the product withdrawal procedure
It is expected that the withdrawal procedure will be tested at least annually. The aims of
this are to:
•• demonstrate that the system does or does not work
•• highlight gaps and where the system requires improvement
•• demonstrate how quickly the required information can be collated and thereby
appropriate corrective action taken (e.g. by materials being isolated and quarantined)
•• act as a training exercise for personnel to ensure clear roles and responsibilities are
undertaken in the event of a real withdrawal situation.
The test of the withdrawal procedure must include verification of the decision-making
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process, traceability of raw materials through to finished product, verification of contact
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details and timings of key activities. Records need to be kept of tests of the withdrawal
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procedure and must include a comment on the result of the test and any action points for
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improvement.
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Ideally, the test should involve all aspects of the supply chain, including delivery to final
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customers on the ‘one step forward, one step back’ principle.

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Part II
Example A site manufacturing aseptic cartons demonstrated its product withdrawal procedure
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8 weeks prior to the audit when a customer returned stock where the printing on the pack,
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including allergen warnings, was fading. The site was able to establish that the incident
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required a product withdrawal and set in place its withdrawal procedure, alerting the
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relevant personnel to the incident. The documented procedure was procured and the
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requirements followed, led by the designated manager.

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The company withdrew all of the packaging materials in the related batches and traced the
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cause of the issue to a failed UV lamp on one piece of printing equipment, which had
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resulted in inadequate ink curing. The company established that the ink used on the
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cartons was a new batch but that the chemical composition of the ink did not differ from
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During the attempt to withdraw any other affected printed packaging materials, the
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company discovered that it was unable to trace which equipment had been used to
manufacture one item of packaging. It was, however, able to put in place additional
procedures to enable it to manage any potential for cross-contamination, as low-migration
inks are used in some products.
Using a ‘mass balance’ exercise, the company was able to establish that the ink in question
had not been used on any other materials.
The failed lamp was replaced immediately and the company initiated a review of the
maintenance schedule for each piece of equipment, ensuring that any changes in the
maintenance schedule were reflected in the hazard and risk management plan.
Glossary
The site has demonstrated that the incident management and product withdrawal
procedure is operable and the actual event constitutes a testing of the system.
Documentation of the event shows that the appropriate steps and measures were taken
and improvements were made where required.
brcgs.com 73
PACKAGING MATERIALS
ISSUE 6
4 Site standards
Interpretation
This part of the Standard is one of the most straightforward. It requires that the manufacturing facility is fit for
purpose, both externally and internally, and requires that operations are conducted in an orderly fashion so as not to
jeopardise the safety or quality of the product.
4.1 External standards
The site shall be of suitable size and construction, in a suitable location, and maintained to an appropriate
standard to reduce the risk of contamination and facilitate the production of safe and legal products.
Interpretation
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For many products, the external conditions around a site will have no effect, but there are some situations where the
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external conditions can have a substantial effect on the products being manufactured. It is important to ensure that
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the grounds around the manufacturing site are finished and maintained to minimise the risk of contamination to the
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product.
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Clause Requirements
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4.1.1 Consideration shall be given to local activities and the site environment, which may have
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an adverse impact on the safety or quality of the finished product or raw materials, and
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measures shall be taken to prevent contamination. Where measures have been put in place
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to protect the site, they shall be regularly reviewed to ensure they continue to be effective
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(e.g. flood controls).

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Interpretation Local activities and measures to prevent contamination

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This clause requires a site to consider its external environment. Points to consider could
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include:
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•• derelict buildings, rubbish dumps, building sites, overgrown vegetation and wasteland,
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which could present potential harbouring of pests

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•• adjacent watercourses at risk of flooding

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•• neighbouring companies and the nature of their business

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•• standing water.
In many cases there will be no concerns, but if measures have to be taken, the site must
demonstrate that it checks these measures and ensures that they remain adequate.
This may require the addition of specific points on regular audit schedules.
Example A site is located on a large light industrial estate where there are green fields to the north
and a river tributary to the south that leads to a major river 1 kilometre away. Investigations
show there is no historical data to suggest that the river has flooded far enough to affect
the site. There are no local activities that would affect production on the site.
The auditor would be satisfied that the site has assessed the risk correctly.
4.1.2 The external areas shall be maintained in good order. Any grassed or planted areas
surrounding buildings shall be regularly tended and well maintained. External traffic routes
under site control shall be suitably surfaced to avoid contamination of the product.
74 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
Interpretation External areas maintained in good order
This clause is rather subjective, but its purpose is to ensure that the products are protected
from the risk of contamination, and made safely to the quality required.
External areas should be generally tidy with storage of excess waste or other debris
avoided. External areas should not be a dumping ground for old equipment and unwanted
materials, which may become potential harbourage for pests. Where production and
storage areas are surrounded by grassed or planted areas, there shall be a vegetation-free
zone around the buildings.
Good practice would be to have a clear zone, free of vegetation, around the external walls
of buildings. It is worth considering that appearances, even for auditors, can be important,
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and an untidy, unkempt exterior may lead the auditor to question the site’s commitment to
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quality and safety – even if such matters do not directly affect the products.
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Some issues to think about when considering this requirement include:
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•• piles of rubbish or disused equipment that could harbour pests

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•• stagnant water, which may be a breeding ground for insects, or create an unpleasant odour.
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Roadways under the control of the site should be maintained to minimise the risk of product
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Part II
contamination by, for example, mud or dust. Roads may have a variety of surfaces and no
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particular requirements are defined in the Standard. Other factors (such as the weather) can
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affect the situation and similar problems could arise from shared or public roads that are
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outside the site’s control. It may be necessary to have extra measures, such as additional
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protective packaging, cleaning grates on vehicle entrances or wash-down facilities for trucks.
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The principle is to ensure that products are not placed at risk of contamination through the
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inappropriate surfacing of routes where products are transferred.

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In some cases the state of the road may have no bearing on the products. In this situation
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there is no need for any action, but the site should have assessed the condition of the road
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4.1.3 The building fabric shall be maintained to minimise potential for pest entry, ingress of
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water and other contaminants. External silos, pipework or other access points for the
product and/or raw materials shall be appropriately sealed and secured. Where possible, a
clean and unobstructed area shall be provided along the external walls of the buildings
used for production and/or storage.
Interpretation Building fabric maintained in good order

The building should be maintained sufficiently so as not to increase the risk of unsafe products.
Items such as broken windows, damaged walls and peeling paint can pose a risk of physical
contamination. The use of unsuitable building materials may make cleaning or product handling
difficult. Damage to roofs or doors can allow products to deteriorate in storage or allow the
Glossary
entry of pests. There are many other examples where a badly maintained building may impair
the ability of the site to manufacture products that are free from contamination.
Where damage to the building is identified, it should be recorded and scheduled for
correction. Risk assessment can be used to prioritise corrective actions, and damage that
can cause immediate potential hazards to the product must be corrected promptly.
brcgs.com 75
PACKAGING MATERIALS
ISSUE 6
Clause Requirements
Site personnel should be vigilant to the appearance of damage over time. This is often
difficult as people become accustomed to their surroundings, but many non-conformities
arise on the site tour because of the presence of gaps around doors, or where walls or
floors are found to be in poor condition. This doesn’t mean that the site has to undertake
an extensive renovation in order to meet the Standard, but if the site is in a poor state then
it is unlikely to meet some of the specific requirements.
This clause is one where several minor non-conformities of the same type may escalate to
produce a major non-conformity. For example, one broken or cracked window is likely to be
considered as a minor issue, but if a number of windows are damaged and broken, this shows
a more systemic failure to address the issue and a major non-conformity would result.
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Example The perimeter of a large site is fenced and gated, with CCTV covering the two secure
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designated entrances. The condition of the site is checked as part of the monthly GMP audit.
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During an audit cracked windows are identified in several areas of the site. The site
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representative states that he did not think the breakages posed a risk to the product so he
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had not bothered to repair the cracks.

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The site has failed to establish whether the broken windows pose a risk to products from
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ingress of water or pest entry. The auditor raises a non-conformity and considers whether
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to elevate it to a major non-conformity due to the repeated occurrence around the site.
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4.1.4 Where natural external drainage is inadequate, additional drainage shall be installed. Drains
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shall be properly protected to prevent entry of pests.

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Interpretation Drainage
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Drainage should be adequate to deal with normal quantities of rainfall without long-term
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pooling of water in areas likely to be relevant to the safety or quality of the product.
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Any site with a history of flooding should take measures to rectify this or to ensure an
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action plan exists to protect products if the situation occurs. If natural drainage is
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4.1.5 Where external storage of raw materials is necessary, these shall be protected in order to
minimise the risk of contamination.
Interpretation External storage of raw materials

One of the greatest risks of contamination from foreign bodies or by cross-contamination
comes from the storage of materials; where storage is external, the company must take
steps to protect it.
There is a risk of contamination from weather, pests, physical damage and direct sunlight
when raw materials are stored externally. Materials must be adequately protected by outer
packaging or covered.
76 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
4.2 Building fabric and interiors: raw materials handling, preparation, processing, packing and
storage areas
The internal site, buildings and facilities shall be suitable for the intended purpose and shall be designed,
constructed, maintained and monitored to effectively control the risk of product contamination.
Interpretation
Buildings used to manufacture and store product should be adequately constructed to allow products to be made
safely and to the quality required. As a guide, the auditor will review the importance that the site places on providing
adequate levels of lighting for each process being carried out. For example, far higher levels of lighting will be
required in areas where printing is carried out, compared with in a warehouse.
A site needs to consider which factors may affect its products and whether it has taken reasonable steps to avoid or
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control the risks from these factors, particularly with regard to appropriate cleaning measures. In order to maintain a
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good level of tidiness and cleanliness in production areas, sites may choose to pursue a 5S approach. This method
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describes how to organise working spaces for efficiency and effectiveness by identifying and storing the items used,
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maintaining the area and items, and sustaining the new order.
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The 5S are:
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•• Sort Remove unnecessary materials and sort those that are required to aid the working process
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Part II
•• Set in order Arrange materials required in order to smooth the workflow
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•• Shine Clean the work area and maintain cleanliness to keep it safe and easy to work in
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•• Standardise Implement standardised practices to facilitate consistency

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•• Sustain Maintain the system and use internal audits to monitor effectiveness of the system.
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Clause Requirements
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4.2.1 Walls, floors, ceilings and pipework shall be maintained in good condition and shall
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Interpretation Walls, floors, ceilings and pipework

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The walls in areas where there is handling of raw materials or preparing, processing,
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packaging or storing of product must be kept in a sound condition, be easy to clean and,
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where necessary, to disinfect. For example, walls must have a smooth, impervious finish
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with sealed and cleanable surfaces, be in a good state of repair and be free from flaking
paint. Ledges should be kept to a minimum or designed with a slope to avoid dust
collection. Vulnerable wall surfaces or corners, for example where vehicles pass in close
proximity, should be protected from damage (e.g. with metal plating or barriers).
4.2.2 Where suspended ceilings exist, they shall be constructed, finished and maintained to
prevent the risk of product contamination, and accessible for cleaning and inspection for
pests unless the void is fully sealed.
Interpretation Suspended ceilings

Glossary
Where suspended ceilings are used, access must be available for pest control purposes,
even if the roof void is not normally used. Air-conditioning equipment can often be
located in roof voids, and access will be required for pest control inspections, cleaning and
maintenance.
brcgs.com 77
PACKAGING MATERIALS
ISSUE 6
Clause Requirements
Example During the audit of a site manufacturing paper products, including fresh-cake discs and
paper plates, the auditor observes that the walls are well constructed and in good
condition, the floors are constructed of coated concrete, which is in a generally good
condition, and the ceilings are intact and free from excessive dust or grease.
A suspended ceiling is observed in the warehousing facility, which is entirely sealed and
has been in place for 9 years with no incidents. The site states that it is part of the monthly
GMP audit to check the ceiling for any evidence of pest ingress. Should any evidence be
found then the ceiling will be unsealed and included in the pest control programme.
The site has taken into consideration the potential for the suspended ceiling to provide
harbourage for pests and has a procedure in place to manage it.
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4.2.3 All internal drain openings shall be suitably protected against the entry of pests and
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designed to minimise odour.
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Interpretation Internal drainage

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Drainage must be designed and maintained to ensure that product contamination risks are
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minimised. Drainage systems should not constitute a potential risk to product and should
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prevent entry of pests or odour.

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The auditor should be able to confirm a lack of pest activity in the area and see records
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demonstrating that no pest activity has been present. There should not be any odour or
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any build-up of waste that could cause blockage.

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4.2.4 Where they constitute a risk to product, and based on the likelihood and risk of
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contamination, windows and roof glazing shall be protected against breakage.

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Interpretation Glass windows

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Where a broken window would pose a risk to product, an example of a suitable precaution
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is the use of adhesive plastic sheeting. This can be fixed to the glass in order to minimise its
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spread in the event of breakage.

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Example An auditor identifies that a site does not have protective screens in place on windows in
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the production hall, which is located away from the production line. The site representative
explains that the risk assessment did not determine that the windows posed a risk to the
product; glass and brittle plastic are regularly monitored and a breakage procedure is in
place and understood by the site’s employees.
The auditor views the risk assessment documentation and accepts that the site has taken
adequate consideration of the windows.
4.2.5 Where they constitute a risk to product, and based on the likelihood and risk of non-
production glass contamination, all bulbs and strip lights, including those on flying-insect
control devices, shall be adequately protected.
Interpretation Protection of glass lighting units

The hazards from physical contamination in packaging, particularly in food packaging,
usually surround the risk of consumption of sharp objects; therefore the focus in this
clause is mainly on glass and brittle plastics. The company needs to identify any likely
source of this type of physical contamination (based on risk assessment) and either
eliminate the hazard or reduce it to an acceptable level and monitor the glass at a
predetermined frequency to establish whether any breakage has occurred.
78 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
The Standard recognises that some glass may be in areas that are particularly susceptible to
physical contamination (e.g. where open containers are handled beneath unprotected glass
light bulbs) but that the risk of breakage is low because no equipment in the site’s facility
can be raised to such a height as to pose a risk. For this reason, the use of risk assessment is
vital. A site may still choose to replace or protect such lighting with shatterproof covers or
sleeves in order to ‘future-proof’ the facility.
4.2.6 Where elevated walkways are adjacent to or pass over production lines, based on risk they
shall be:
•• designed to prevent contamination of products and production lines
•• easy to clean
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•• correctly maintained.
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Interpretation Consideration of walkways
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Where walkways are located above or adjacent to product lines they should be assessed as
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to whether they might be a source of contamination to the product. Walkways should be:
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•• constructed of a solid base and sides (rather than open grid/perforated material) to make
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it less likely that material from footwear could fall off the walkway and onto the product
Part II
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or production lines below

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•• cleaned using minimal amounts of water to reduce the likelihood of splashing onto
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materials below
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•• included in the programme of documented inspections of the factory environment (see

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clause 3.5.5) to facilitate prompt corrective action in the event of a problem.

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Suitable and sufficient lighting shall be provided to ensure a safe working environment,
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correct operation of processes, effective inspection of the product and cleaning.

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Adequate lighting must be provided to allow:

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•• staff to be able to monitor quality and defects in the product, particularly where fine
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detail work such as printing is carried out

•• the correct operation of processes
•• effective cleaning
•• a safe working environment.
All areas need to be considered; for example, storage areas with poor lighting may hinder
effective cleaning or inspection.
As a guide, the auditor will want to understand the importance the site places on lighting
that is crucial to the production process and at the very least be reassured that eye strain
is avoided.
Glossary
4.2.8 Suitable and sufficient ventilation shall be provided.
Interpretation Ventilation
Adequate ventilation needs to be provided. Extraction/air conditioning may be necessary
where very dusty operations are carried out, fumes are generated, conditions are hotter, or
there is the potential for condensation build-up during processes that require a drier
atmosphere. Risk assessment should determine what type of environmental conditions
need to be established in particular areas of the site.
brcgs.com 79
PACKAGING MATERIALS
ISSUE 6
4.3 Utilities
All utilities to and within the production and storage areas shall be designed, constructed, maintained and monitored
to effectively control the risk of product contamination.
Interpretation
The provision of utilities (i.e. power, water and gases) to production and storage areas needs to be considered to
ensure they do not constitute a contamination risk to product.
Clause Requirements
4.3.1 All water used in the processing of the products or equipment cleaning shall be potable or
suitably treated to prevent contamination.
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Interpretation Water use
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This clause refers to water which is used in processing but not regarded as a raw material.
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Water used in paper manufacture and processing, for example, is not relevant to this clause
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as it forms part of the finished product.

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Water needs to be provided in sufficient quantities (e.g. for cleaning operations), pose no
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contamination risk (e.g. be potable) and conform to relevant legislation either by being
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suitably treated or drawn from the mains.

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The auditor should be able to see evidence that the water which is in contact with
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processing equipment or packaging materials has been verified as potable on the basis of
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a risk assessment. Where the use of potable water is not possible or appropriate, the
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treatment of the water prior to use should be effective in removing any sources of
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potential contamination (which may be physical, chemical or microbiological).

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Water used by sites, but which does not come into contact with the packaging material as
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part of the manufacturing process. should be suitable for the task. It does not need to be
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potable or treated unless there is a risk of it coming into contact with the material (e.g. during
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tool changes). In this instance, the water should be either suitably treated or potable.
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Example An injection-moulding facility uses water inside the tools to control the temperature
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throughout the processing cycle. The water does not come into contact with the face of the
tool or the packaging during normal processing. The engineer notes that during tool changes
some water may come into contact with the face of the tools as they are being changed,
and highlights this during the development of the hazard and risk management plan.
The company decides to manage this risk by:
•• cleaning the tooling and ensuring it is free from water after any maintenance
•• operating a documented start-up procedure to run the tooling a number of times until
good product is produced.
80 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
4.3.2 Based on risk assessment, the microbiological and chemical quality of water, steam, ice, air,
compressed air or other gases which come into direct contact with packaging shall be
regularly monitored. These shall present no risk to product safety or quality and shall
comply with relevant legal regulations.
Interpretation Microbiological and chemical qualities of water, air and other gases
The frequency of analysis of water needs to be based on risk (including historical
information), consideration of the source, the treatments given to the water, and its usage.
The chemical and microbiological analysis of water will be expected to confirm compliance
with national legislation and be completed at least annually; it may be provided by the
water supplier. Samples of water should be taken at the point of use, as this is the point at
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which potential contamination could reach the packaging material.
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Where used, ice must be formed from water to a similar standard as in clause 4.3.1 and be
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included in the sampling plan. Equipment used for the provision of water, ice, steam, air and
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compressed air needs to be appropriately specified, and the process for their production
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must not pose a risk to product.

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Compressed air should be treated as suitable for food contact, with filtration to remove
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Part II
contaminants and the use of food grade oils where oil filters are used to remove moisture.
D te ate
The Standard recognises that for non-food sites that are not hygiene-sensitive, the
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microbiological or chemical quality of the utilities can bear no implications for their
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materials. However, should the hazard and risk management system highlight some
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potential risks then measures should be taken to minimise or eliminate them.

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Example A company that prints self-adhesive labels does not use any compressed air or water that
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comes into direct contact with the product. ‘Dry’ methods of cleaning are carried out on
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equipment. Water is sourced from the local mains supply and is used only for services.
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The auditor reviews the risk assessment documentation and accepts that there is negligible
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risk of contamination to the product from water and compressed air.

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Example A company manufactures blow-moulded plastic bottles and carries out 100% in-line
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pressure testing for leaks.

The company uses compressed air to form the bottles and in the pressure testing
afterwards. The compressed air will need to conform with food contact legislation and be
regularly monitored; the compressors must be subject to service agreements.
In a large factory there may be a number of compressors used in different parts of the
process, and an auditor must be assured that the compressed air used in all of them
conforms with the relevant legislation, and the compressors are regularly serviced.
Glossary
brcgs.com 81
PACKAGING MATERIALS
ISSUE 6
4.4 Site security and product defence
A product defence plan shall be in place to ensure that there are systems to protect products, premises and
brands from malicious actions while under the control of the site.
Interpretation
Access to sites should be controlled in order to prevent any accidental or malicious damage to the product or
materials, forming a product defence plan. The objective is to ensure that the safety of finished products is not
jeopardised through malicious actions or by the misunderstanding of unauthorised persons gaining access to the
site. Therefore procedures need to be in place to limit and control access.
Care should also be taken that the system for site security is maintained during shift work and any shut-down
periods, and that the plan is equally effective in peak production times when there are more people moving on to,
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around, and off the site.
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Clause Requirements
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4.4.1 The company shall undertake a documented risk assessment (threat assessment) of the
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security arrangements and potential risks to the products from any deliberate attempt to
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inflict contamination or damage. This threat assessment shall include both internal and
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external threats.
D te ate
The output from this assessment shall be a documented product defence plan.
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Areas shall be assessed according to risk; sensitive or restricted areas shall be defined,
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clearly marked, monitored and controlled.

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This plan shall be kept under review to reflect changing circumstances and external
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influences. It shall be formally reviewed at least annually.

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Interpretation Risk assessment of security

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Establishing the appropriate level and application of security systems on a site should be
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based on risk assessment. The management should understand that the purpose of this
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clause is to protect the final consumer, the site’s customers and the company from
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deliberate malicious intervention to the product. Each area may have a different need,
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depending on the hazards associated with contamination at that point.

For example, the storage areas for raw materials at a plastics converter may be at lower
risk from physical contamination than those containing finished products, because of
the process steps that will either eliminate or reduce the risk to an acceptable level.
The auditor should be able to identify that the risk assessment has been thorough and
that each identified risk has control measures in place.
New threats arise from time to time, and arise in areas not related to the packaging industry.
Sites might find it useful to be aware of threats arising in other industries and take note of
any relevance to their own facilities.
4.4.2 Measures shall be in place to ensure only authorised personnel have access to production
and storage areas, and access to the site by employees, contractors and visitors shall be
controlled.
A visitor reporting system shall be in place. Staff shall be trained in site security procedures
and encouraged to report unidentified or unknown visitors.
82 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
Interpretation Site access
Access to the site must be controlled and include a visitor reporting procedure. When visitors
or contractors come onto the site they should not be able to enter production areas without
first reporting to site representatives. They should be made aware of site rules, and issued
with protective clothing where required. Control may be achieved through the use of signage
and clear company procedures, including visitor identification.
To maintain site security, production and storage areas should have designated access
points, which are controlled to ensure entry only by authorised personnel. Each area of
the site needs to be assessed according to risk, defined, clearly marked, monitored and
controlled. For example, cleaning chemicals may need to be locked away when not in use.
Areas that are sensitive or need to have restricted access could be controlled through
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locked doors, with keys issued to nominated personnel or locks operated by key codes.
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Clear demarcation through doorways, signage and painted flooring may indicate those areas
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particularly sensitive or subject to restriction. These areas should be clearly identified on
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the site plan.

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This requirement may be met through induction training and refresher training as
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appropriate. It is essential that, in order to facilitate the security of the site and the integrity
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Part II
of the packaging materials, personnel should feel comfortable about approaching
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unidentified strangers on site, or referring unidentified visitors to security staff where

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personal safety may be compromised. Ensuring visitors wear visitor identification badges
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Contractors should be suitably qualified and supervised, where appropriate. Regardless

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designated as responsible for any contractors on site and should ensure that appropriate
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procedures are respected.

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Example Access to a site is regulated with a perimeter fence and staffed security gates through
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which employees, visitors and incoming goods travel. Employees and visitors use
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designated entrances and there is an entrance procedure for visitors who will enter
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production areas. Storage areas that require additional security are locked and accessible
only to authorised employees.
The site has established the appropriate level of security and is able to minimise the risk
of entry of unauthorised personnel.
4.4.3 External storage tanks, silos and any intake pipes with an external opening shall be
sufficiently secure to prevent unauthorised access.
Interpretation External storage

Openings should be covered and proofed to prevent ingress of pests and unauthorised
Glossary
entry. Particular care should be taken for pipes/entry points for cables, ventilation ducts
etc. that may no longer be in use or where building work is taking place.
brcgs.com 83
PACKAGING MATERIALS
ISSUE 6
4.5 Layout, product flow and segregation
The factory layout, flow of processes and movement of personnel shall be sufficient to prevent the risk of
product contamination and to comply with all relevant legislation.
Interpretation
The layout of a plant is essential to an efficient production process. The company must ensure that the design of the
process flow does not pose a risk of contamination to the product.
Clause Requirements
4.5.1 There shall be a current map or plan of the site which defines:
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•• access points for personnel
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•• travel routes for personnel, raw materials and intermediate or finished products
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••
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staff facilities
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•• routes for the removal of waste
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•• production and process flows

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•• storage areas.
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Interpretation Site plan

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A site diagram must be available, indicating the areas of the site and how personnel access
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and travel between these areas. The Standard specifies what is to be included on the site
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plan, but the site is free to add any other aspects that may be useful, such as the location of
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any external storage.

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4.5.2 The process flow from intake to dispatch shall be arranged to minimise the risk of
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contamination or damage to the product.

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Interpretation Product process flow

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This clause is far more important in some industries than others. It is especially relevant
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when the product is likely to become contaminated or damaged by being placed in contact
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with other stages of production. Sites that do not operate continuous flow are particularly
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susceptible, where potential mixing may give rise to non-compliant products.

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The site may choose to use either risk assessment or the hazard and risk management
system to determine whether any hazards are present and, if so, whether existing controls
are sufficient to manage the risks.
4.5.3 Premises shall allow sufficient working space and storage capacity to enable all operations
to be carried out properly under safe and hygienic conditions.
Interpretation Work space

It is self-evident that if a site is too cramped, the quality of the operation is likely to suffer.
Auditors will wish to evaluate how close proximity, for example, is managed to prevent
cross-contamination.
It is essential that equipment is located with sufficient space to allow easy access for
operating, cleaning and maintenance.
84 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
4.5.4 Sorting or other activities involving the direct handling of the product shall take place in
areas that have, as a minimum, the same standards as production areas.
Interpretation Direct handling of product

Product may often be sorted or reworked for quality reasons where non-conforming
product has been identified. It is essential that the good standards maintained so far in raw
materials handling and production are not lost. The facility used to carry out the activity
should meet the requirements set out in sections 4 and 5.
4.5.5 Activities that could produce a contamination risk, such as the removal of outer packaging,
shall be carried out in a designated, segregated area.
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Interpretation Minimising contamination from external packaging
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To maintain the integrity of the areas used in raw material handling, preparation, processing
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and storage, it is imperative that any activity with the potential to introduce sources of
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contamination into those areas is prevented. Because external packaging is typically
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exposed to dust and dirt in the outside environment, it should be removed from the loads
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in a segregated area.
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Part II
4.5.6 If it is .necessary to allow access through production areas, designated walkways shall be
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provided that ensure there is adequate segregation from materials.

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Interpretation Designated walkways

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Where personnel are allowed to pass through one production area to access another, transit
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routes must be indicated to avoid potential contamination from personnel. For example,
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when moving through ‘goods in’ to get to the production area, employees need to walk along
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a clearly defined pathway that is painted in a different colour on the floor. There may also be
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a need for barriers at doorways to provide additional protection to the production areas.
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4.5.7 Where possible, all facilities shall be designed and positioned so that movement of
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Interpretation Location of facilities

Wherever possible, direct routes for staff transit and access should be in place to minimise
the potential for product contamination. Access to and through production areas needs to
be as simple as possible.
Glossary
brcgs.com 85
PACKAGING MATERIALS
ISSUE 6
4.6 Equipment
Equipment shall be suitably designed for the intended purpose and shall be maintained and used so as to
minimise the risk to product safety, legality and quality.
Interpretation
This clause is about ensuring that equipment is properly specified, installed and maintained, and that machinery that
is unfit for purpose does not continue to be used. The Standard details the levels of control necessary, and these will
depend on the type of production being carried out. The site should be able to demonstrate that the equipment in
use does not constitute a contamination risk to product, is fit for purpose and is used as intended.
Clause Requirements
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4.6.1 Production, storage and warehousing equipment shall be designed for the intended
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purpose and shall minimise the risk of contamination to the product. Lubrication points
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and application methods of any lubricant shall not be able to contaminate the product.
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Equipment shall be constructed of suitable materials and be designed to ensure it can be

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effectively cleaned and maintained.

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Interpretation Equipment design

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The commitment of senior management to the implementation of a good-quality

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management system and the requirements of the Standard may be demonstrated to some
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extent by the equipment in use. If it is of good quality, used in accordance with its intended
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purpose and maintained in line with the requirements set out in clause 4.7, it gives a strong
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indication to the auditor that the site is maintaining good operating conditions.
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An auditor might examine production control records to establish whether the equipment
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is capable of consistently producing products that meet specification.

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4.6.2 Newly installed equipment shall be properly specified before purchase. New equipment
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shall be tested and commissioned prior to use and a maintenance and cleaning programme
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established.
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Interpretation New equipment purchase and installation

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The intended use of the new equipment should be established before purchase to enable
appropriate specification of its design and fabrication. The ability to effectively clean and
perform maintenance works on the equipment should be considered (e.g. design for easy
maintenance). Equipment should be purchased on the basis that its specification fulfils the
needs of the operation.
Focus must be given to equipment that controls critical control points (CCPs).
Documentary evidence should be available to confirm commissioning and testing prior
to use (i.e. trials of operation and cleaning and appropriate instruction to staff).
Consistent safety and quality of production are ensured by maintaining equipment;
therefore it is essential that all new equipment has a proper maintenance programme
based on risk assessment. Documentary evidence of a suitable maintenance schedule
to ensure the efficient and effective operation of the equipment should be available.
The auditor will expect to see evidence of the risk assessment.
86 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
Example A site is considering the purchase of new equipment to automatically palletise and
stretch‑wrap its product at the end of the production lines. It approaches several potential
specialist suppliers with a specification for the machinery and two suppliers visit the site
to establish the layout and space available.
During the financial approval of the supplier, technical approval is also gained, in line with
clause 3.7.
Upon installation of the bespoke equipment, the cleaning and maintenance teams include
the equipment in their schedules, and the engineering and production teams test and
approve use of the equipment before it is used in production.
The company reviews its hazard analysis and risk assessment (HARA) system and
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establishes that the system needs modification.
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The auditor would be satisfied that the requirement had been met.
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4.6.3 Wooden equipment including desks, chairs, tables, etc. shall be properly sealed to enable
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effective cleaning. This equipment shall be kept clean, in good condition and free from
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splinters or other sources of physical contamination.

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Part II
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Interpretation Wooden equipment

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Everyday wear and tear means there is the need for a procedure to identify damaged items
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and minimise the potential for contamination. Procedures must detail how this control is to
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be effected and include regular checks to ensure wooden equipment is in good condition
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and clean.
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4.6.4 Notices on equipment shall be cleanable and secure.

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Interpretation Equipment notices

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Although it is common practice to post notices for the purpose of instruction, safety advice
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or cleaning onto large pieces of equipment, they should not be regarded as noticeboards.
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Where notices are required, they should be cleanable and secure to reduce the likelihood
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the notice is secured properly. However, care must be taken to ensure that notices remain
in a good condition.
Glossary
brcgs.com 87
PACKAGING MATERIALS
ISSUE 6
4.7 Maintenance
An effective maintenance programme shall be in operation for plant and equipment to prevent contamination
and reduce the potential for breakdowns.
Interpretation
To ensure that all equipment is suitably maintained and does not pose a contamination risk to product, it must be
controlled by a documented maintenance system. Planned maintenance may be completed internally or via
contracted services. Maintenance undertaken internally needs to be documented in the form of a plan, and records
maintained. For equipment that is maintained under external contracts, evidence of contractual agreements must be
available.
Clause Requirements
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4.7.1 A documented programme of maintenance shall be operated, covering all items of
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production equipment and plant critical to product safety, legality and quality, to prevent
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contamination and reduce the risk of breakdown.
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Interpretation Documented maintenance programme

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This documented programme should contain all items of production equipment, including
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large plant equipment such as palletisers. As packaging materials come into direct contact
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with these items, it is essential that any hazards from them are identified and entirely
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eliminated or mitigated and managed.

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Maintenance logs shall be maintained for all off-line testing equipment. This shall include,
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as a minimum:
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•• any adjustments
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•• the re-calibration date of any interventions.

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Interpretation Maintenance logs

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Any off-line testing equipment which is used to verify product safety, quality and
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legality needs to be adequately maintained to ensure the reliability of the test results.

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Records shall be held by the site to indicate any adjustments made (and by whom), the
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re‑calibration results, and any subsequent interventions.

Evidence needs to be retained to show that the products tested at any time using the
off-line testing equipment meet the product specifications.
4.7.3 In addition to any planned maintenance programme, where there is a risk of product
contamination by foreign bodies arising from equipment failure or damage, the equipment
shall be inspected at predetermined intervals, inspection results documented, and
appropriate action taken.
88 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
Interpretation Preventive maintenance programme
When one or more indicators show that equipment is going to fail or that its performance
is deteriorating, maintenance is performed. In this way the equipment is maintained at the
right time (i.e. not simply according to a schedule when it is working well), thereby
minimising down-time.
The auditor will expect to see an ongoing maintenance programme for all equipment on
site, with evidence of maintenance and activities undertaken in logs and potentially a
demonstrable benefit through fewer breakdowns or equipment failures (which may be
reflected in the site’s objectives). Tracking maintenance activities (both planned and
risk-based) and breakdowns allows the site to identify which items of equipment suffer
from a recurrence of breakdowns or require unplanned maintenance, highlighting
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opportunities for equipment replacement.
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Although this requirement states that a condition-based preventive maintenance
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programme must be in place for items of equipment that are critical to product safety,
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legality and quality, within the context of the Standard this should include all items of
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equipment included in the scope of the audit.

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Part II
Example An operative on a semi-automated platen die cutter at a carton printer fails to check the
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equipment as part of the condition-based maintenance programme and does not notice
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that the die has slipped by 3 mm because of a loose bolt on the platen. An allergen warning
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is partly obscured because of the slip, resulting in half the batch having to be destroyed
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and reprinted at the site’s cost.

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The cartons have to be destroyed because the loss of the allergen warning presents a risk
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to human health. If the equipment had been properly checked, the loose bolt could have
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been identified and repaired.

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The site may be awarded a non-conformity because the procedure was not properly
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followed.
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Maintenance work shall not place product safety, quality or legality at risk. Maintenance
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work shall be followed by a documented clearance procedure which records that

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contamination hazards have been removed and equipment cleared to resume production.
Interpretation Equipment checking prior to production

Documented procedures should ensure that, when maintenance activity occurs, the
activity itself does not place product safety, quality or legality at risk. This risk may be from
additional personnel, such as contractors, being in storage or productions areas; dust or
other contaminants being created during maintenance; or normal process flows being
disturbed to accommodate the maintenance activity.
It is common for packaging sites to use shut-down periods to carry out maintenance work,
Glossary
particularly on large pieces of equipment, but it is still essential to establish any hazards
that maintenance activity may cause by conducting appropriate risk assessments.
On occasions when equipment is subject to maintenance interventions, it may be
necessary to revalidate specified machine settings, particularly those that are used to
determine quality control points. Sites should consider this in their maintenance and
change management procedures, and assess under which circumstances revalidation may
be required, allowing time and resources to conduct the activity.
brcgs.com 89
PACKAGING MATERIALS
ISSUE 6
Clause Requirements
4.7.5 Tools and other maintenance equipment shall be cleared away after use and appropriately
stored.
Interpretation Maintenance tools

Tools or equipment used in maintenance must not be allowed to become sources of
potential contamination; procedures should be in place to ensure that non-production-
related equipment is removed from the production line or area, as appropriate.
Example In a food-contact or hygiene-sensitive product thermoforming company, a line engineer is

responsible for installing any change of tooling on the forming machine. Upon completion,
the engineer checks that all parts are fitted and working correctly; that the tooling is clean
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and free from grease and oil; and that the machine is clear, with all working tools removed.
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The engineer signs a clearance form to confirm that this action has been carried out.
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The form may be countersigned by the line supervisor or manager to confirm acceptance.
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The auditor would find this practice satisfactory.

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4.7.6 Temporary repairs/modifications using tape, cardboard etc. shall only be permitted in
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emergencies and where product contamination is not at risk. Such modifications shall be
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subject to a time limit and shall be recorded and scheduled for correction.
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Interpretation Temporary modifications

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Temporary modifications should be kept to a minimum and used only in emergencies when
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not making such a modification would pose a risk to the safety, integrity or legality of the
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product. Where such modifications have been made, a system must be in place to
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demonstrate that an appropriate responsible person has been notified, a record has been
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made, and a permanent repair has been scheduled.

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Good practice demands that repairs to any temporary modification are recorded to ensure
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that any repeated modification is recognised and a permanent modification made, where
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necessary.
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4.7.7 Engineering workshops shall be controlled to prevent transfer of engineering debris to

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production or storage areas (e.g. by provision of swarf mats).
Interpretation Engineering workshops

Swarf, also known as turnings, chips or filings, are shavings and chippings generated from
metal-working operations. Swarf mats assist in the removal of this from shoes.
Materials used for equipment and plant maintenance that pose a risk by direct or indirect
contact with product must be suitable for the product’s intended use. Lubricants of a
suitable grade for food contact must be used where there is potential for contamination
(for example, in those sites manufacturing packaging for use in direct contact with food)
and documentary evidence of this may be required.
Example A small manufacturer of thermoformed trays has a workshop in a room just off the
production floor for the purposes of cleaning and maintaining the tools used in production.
The workshop also repairs tools when they have become misaligned and damaged. There is a
limited amount of swarf generated, but there is a swarf mat at the door to ensure that no
metal shavings can come into contact with the packaging being manufactured.
The company has put adequate provision in place to minimise the risk of contamination,
even though the likelihood of swarf reaching the product may be minimal.
90 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
4.7.8 Contractors involved in maintenance or repair shall be suitably monitored by a staff
member who shall be responsible for their activities.
Interpretation Contractors on site

A large number of different contractors may visit a company and enter production areas to
carry out specialist tasks. Examples are engineers (to install or repair machines),
electricians, printing ink technologists, builders and consultants. It is important that these
personnel are aware of and comply with company requirements on hygiene and
contamination control.
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4.8 Housekeeping and cleaning
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Fundamental
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Housekeeping and cleaning systems shall be in place which ensure that appropriate standards of
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hygiene are maintained and that the risk of product contamination is minimised.
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Part II
Interpretation
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This clause has been deemed a fundamental clause because no matter what types of packaging material are being
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made, a clean, tidy site prevents unnecessary contamination and ensures that the work is carried out in an orderly
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fashion.
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Control of hygiene is generally achieved through schedules of cleaning and policies on housekeeping procedures
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based on risk assessment. The methods of cleaning themselves should not pose a risk of product contamination
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(e.g. from cleaning areas adjacent to unprotected raw materials or packaging materials). Any areas found to be of an
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inappropriate standard of hygiene may be raised as a minor non-conformity. Where multiple instances of minor
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non-conformities are given, a major non-conformity may be recorded. This would result in non-certification.
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The site should also determine the cleaning frequency for structures at a high level. This may be building structures
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such as frameworks for production equipment, brackets and struts, all of which are potential sources of physical
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contamination.
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Clause Requirements
4.8.1 Good standards of housekeeping shall be maintained, which shall include a condition-
based cleaning or ‘clean as you go’ policy.
Interpretation Good standards of housekeeping

While conducting the audit, the auditor should be able to see good overall standards of
housekeeping and cleanliness. For example:
•• floors – clear with no detritus or litter
Glossary
•• walls – clean and intact

•• equipment – clean and free from grease or dust.
It is recognised that some packaging manufacturing processes are much ‘dirtier’ than others
and that good standards of housekeeping may vary depending on the process; however, it
should be possible to maintain an area free from sources of physical and chemical
contamination.
brcgs.com 91
PACKAGING MATERIALS
ISSUE 6
Clause Requirements
4.8.2 Documented cleaning procedures shall be in place and maintained for buildings,
equipment and vehicles. Cleaning schedules and procedures shall include the following
information:
•• responsibility for cleaning
•• item/area to be cleaned
•• frequency of cleaning
•• method of cleaning
•• cleaning materials to be used
•• cleaning record and responsibility for verification.
The frequency and methods of cleaning shall be based on risk.
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The procedures shall be implemented to ensure that appropriate standards of cleaning are
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achieved.
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Interpretation Cleaning schedules and procedures
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Documented cleaning schedules must be in place. These should contain information on:
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•• the person or position responsible for cleaning

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•• the equipment or area to be cleaned

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•• frequency of cleaning, which may be established by risk assessment

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•• method of cleaning, with photo or diagrammatic instructions where required according

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to risk assessment
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•• materials to be used, which do not in themselves cause contamination – for example,

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manufactured packaging materials

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•• cleaning record with verification by the person or position deemed responsible – for
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example, visual inspection of the area by the cleaning supervisor, who signs off the
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record.
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4.8.3
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Cleaning chemicals shall be fit for purpose, suitably labelled, and used in accordance with
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manufacturers’ instructions. They shall be stored in a secured, designated location, in

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closed containers. Chemicals that are strongly scented or could give rise to taint and odour
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contamination shall not be used.

Cleaning equipment shall be kept in a suitable designated location.
Interpretation Controls for cleaning (and other) chemicals

Cleaning materials often contain potentially dangerous chemicals, and some may become
hazardous if mixed with other chemicals. This clause is included here because the primary
use of chemicals on many sites is for cleaning, but the requirement also applies to any
other chemicals used, such as pest control chemicals, weed killers and machine lubricants.
All chemicals on site shall be adequately labelled and securely stored to minimise the risk
of contamination of the product.
Cleaning chemicals should be selected to minimise the risk of tainting the product through
odour or other chemical contamination. Strongly scented chemicals should be avoided
(e.g. pine-scented disinfectant) because even if used in small quantities, odour can be
transferred and eventually taint the product inside the packaging.
4.8.4 Materials and equipment used for cleaning toilets shall be differentiated from those used
elsewhere, and physically segregated where necessary.
92 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
Interpretation Segregation of toilet cleaning materials
Materials used for the cleaning of toilets need to be segregated from other cleaning
materials to minimise the risk of microbiological cross-contamination.
4.8.5 Where appropriate, based on risk, a microbiological environmental monitoring programme shall
be in place to ensure that the cleaning operations are effective in minimising the risk of
contamination by microorganisms that would be detrimental to the products. The programme
shall consider the likelihood of the microorganisms’ survival on packaging materials and their use.
Where a programme is in place, this shall include:
•• sampling protocol
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•• identification of sample locations
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•• frequency of tests
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•• target organisms (e.g. pathogens, spoilage organisms and/or indicator organisms)
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•• test methods
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•• recording and evaluation of results.

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The programme and its associated procedures shall be documented.

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Part II
Interpretation Risk-based microbiological environmental monitoring
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The purpose of an environmental monitoring programme is to identify any potential

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microbiological risks so that they can be appropriately managed.

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An effective programme can, for example, be used to:

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•• confirm the effectiveness of cleaning and hygiene activities and identify any areas that
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require additional activity

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•• prevent product contamination by acting as an ‘early warning’ – identifying potential

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contamination from the site’s facilities before they affect products.

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As a minimum the environmental monitoring programme shall include:

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•• a sampling protocol – it is important that the sampling method does not inadvertently
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create false positives by allowing post-sampling contamination or false negatives by

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killing organisms in the sample before the test is completed. Sampling must be
appropriate for the target organism, test methods and locations to be sampled;
techniques may include swabs or air sampling
•• identification of suitable test locations, taking into account:
—— significance of the area or equipment
—— areas or parts of equipment that are difficult to clean and could harbour organisms
—— areas of the site or equipment that previously tested positive
•• frequency of tests, taking into account:
—— areas or equipment that may support microbial growth
Glossary
—— locations with previous positive results or an upward trend of results

•• target organisms – these may include specific organisms that could present a risk to the
product or environment (e.g. Listeria spp in wet environments or Enterobacteriaceae in
dry environments) or indicator organisms (e.g. total plate count)
•• test methods – rapid on-site and laboratory tests are available and sites should consider
which is most applicable
•• evaluation of results – the significance of the results and any actions required must be
considered.
brcgs.com 93
PACKAGING MATERIALS
ISSUE 6
4.9 Product contamination control
All practicable steps shall be taken to identify, eliminate, avoid or minimise the risk of foreign-body or chemical
contamination.
Interpretation
The company must identify the level of control that is required. There are various kinds of foreign-body detection
but this most usually applies to metal detectors or visual identification of foreign bodies. The BRCGS best-practice
guideline ‘Foreign Body Detection’ gives guidance for those unfamiliar with this topic.
The hazards from physical contamination in packaging, particularly in food packaging, usually surround the risk of
consumption of sharp objects, and therefore the focus is mainly on glass and brittle plastics. The company needs to:
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•• identify any likely source of this type of physical contamination (based on risk assessment)
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•• eliminate the hazard or reduce it to an acceptable level
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•• monitor potential contaminants on an appropriate predetermined basis.
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The auditor will expect to see a robust assessment of each potential source of contamination.
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4.9.1 Glass, brittle plastics, ceramics and similar materials control

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Clause Requirements
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4.9.1.1 There shall be no unnecessary non-production glass, ceramics or brittle plastic present,
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which may pose a foreseeable risk of contamination.

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Where non-production glass, ceramics or brittle plastics are required in production,

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packing or storage areas, and where there is a risk of product contamination, procedures for
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their handling shall be in place.

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Interpretation The use of unnecessary non-production glass and brittle plastic materials should be
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minimised in areas where breakage could contaminate the product. Bulbs and lighting
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should be protected and regularly monitored for damage. This may be part of a regular
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audit of the glass and brittle plastics register or through personnel training that encourages
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employees to identify breakages and notify them to a senior manager.

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Diligence must still be demonstrated where such glass or plastics are present in the
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production environment, and the Standard requires that where glass is present it should be
protected. Breakage procedures are also required.
4.9.1.2 Glass or brittle plastics (other than the product) that pose a potential product
contamination hazard shall be controlled and recorded on a register that includes, as a
minimum:
•• a list of items detailing location, number, type and condition
•• recorded checks of condition of items, carried out at a specified frequency that is based
on the level of risk to the product
•• details on cleaning or replacing items to minimise the potential for product
contamination.
Glass or brittle plastics not in the production or storage areas shall be included in the
register on the basis of risk.
94 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
Interpretation Glass and brittle plastics register
The auditor will expect to see a detailed register of glass and brittle plastics in areas of
the factory that pose a potential product contamination hazard and evidence of frequent
checks to ensure that damaged or broken items are recorded and scheduled for repair.
The register must be in sufficient detail to enable identification of items (but does not
need to individually list and number each one). For example, ‘Line 1, machine A, 12
overhead lighting tubes’ would suffice. The frequency of checks will be based on hazard
analysis and risk assessment (HARA).
Glass or brittle plastics not in the production or storage areas must be included in the
register on the basis of risk.
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The Standard recognises that some glass may be in areas that could be regarded as
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particularly susceptible to physical contamination (e.g. where open containers are beneath
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a row of unprotected glass light bulbs) but that the risk of breakage is low because no
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equipment on the site’s facility can be raised to such a height as to pose that risk. For this
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reason, the use of risk assessment is vital. A site may still choose to replace such light bulbs
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in order to ‘future-proof’ the facility (in case, for example, cherry-pickers that can reach the
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height are purchased).

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Part II
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Example The auditor notices a broken plastic protective screen on a production line during the
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site tour.
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The auditor finds that this has not been recorded on the last glass audit and issues a
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non-conformity against this clause.

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4.9.1.3 Where non-production glass or brittle plastic breakage occurs, a responsible person shall
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be placed in charge of the clean-up operation and shall ensure that no other area is
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allowed to become contaminated due to the breakage. Any product that has become
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All breakages shall be recorded in an incident report.

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Interpretation Glass or brittle plastic breakage policy

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There must be a documented policy that clearly defines the action to be taken and the
person or position responsible for cleaning up following a breakage. Details should be
recorded on an incident report together with action taken on any contaminated stock.
Example An auditor notices from the monthly glass audit that a side window in the warehouse was
broken a month ago. The auditor checks to see if the breakage procedure has been
followed and asks to see the incident report.
The report has been completed correctly, is signed off by the quality manager and confirms
that there was no risk of contamination as no product was located in the area at the time of
Glossary
the breakage.
The auditor would find this satisfactory as the procedure has been correctly followed.
brcgs.com 95
PACKAGING MATERIALS
ISSUE 6
4.9.2 Sharps and metal control

Interpretation
Sharps are items not from the packaging material itself, such as offcuts or shards of glass, but items that have been
introduced for the purpose of cutting or slitting materials.
Blades are very often used in the manufacture of packaging materials and explicit control of them is impractical and
unnecessary. A policy should still be in place regarding sharps, and snap-off blades are prohibited.
Clause Requirements
4.9.2.1 There shall be a documented policy for the controlled use and storage of sharp
implements, including knives, needles and wires, to prevent contamination.
The policy shall include control of these items into and out of the site.
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Interpretation Sharps control
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A documented policy must be in place and be part of contamination control training.
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As contamination by sharp materials can be critical to human health, it is essential that the
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risks associated with sharps are covered adequately and effectively in the policy document,
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and that personnel understand the potential impacts.

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The auditor will look for evidence of a working procedure for the control of sharp blades.
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This could involve the numbering of approved knives and recorded issue to production
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staff, a signed record of the issue and return of all blades, and an incident report to be
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completed for any lost blades. Blade control must be veriﬁed as part of the internal audits.
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4.9.2.2 Production equipment that incorporates blades or sharps shall be monitored. Blades or
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other sharp implements shall not be allowed to contaminate the product.

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Interpretation Blades or sharps incorporated in equipment

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Blades and/or cutting instruments that are part of manufacturing equipment need to
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be monitored to ensure they do not pose a risk to the product being produced.
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The monitoring of these could be incorporated into the start-up checks prior to

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operating machinery, or form part of a shift start and end check.

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Consideration should also be given to:

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•• storage of blades or sharps when not in use

•• storage and issue of replacement blades.
4.9.2.3 Snap-off blade knives shall not be used.
Interpretation Snap-off blades

Snap-off blades present an unacceptable hazard at an unacceptable level of risk. They are
not permitted in any certificated site.
4.9.2.4 Where open noticeboards are present in production, packing and storage areas, loose
fastenings, such as drawing pins and staples, shall not be used.
Interpretation Open noticeboard fixings

Sharp metal pins or staples could become a possible source of contamination for the
product. Noticeboards should be covered or use materials such as tape, Blu-Tack®,
plastic wallets or magnets.
Use of fixings within an enclosed secure noticeboard is acceptable.
96 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
4.9.3 Chemical and biological control
Interpretation
Where required, lubricants and adhesives should be of food grade and not pose a potential risk of microbiological
contamination. This may be achieved through good standards of housekeeping or through prevention of contact
between the material and the substance.
Clause Requirements
4.9.3.1 Processes shall be in place to manage the use, storage and handling of non-production
chemicals, to prevent chemical contamination. These shall include, as a minimum:
•• a list of approved chemicals for purchase
•• availability of material safety data sheets and specifications
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•• avoidance of strongly scented products
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•• the labelling and/or identification of containers of chemicals at all times
01 ve te.
•• designated storage area with access restricted to authorised personnel
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•• use by trained personnel only.
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Interpretation Chemical control

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Controls shall be in place to prevent chemical contamination. The requirement specifies

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what data is needed as a minimum so the auditor will expect to see a list of all chemicals
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Part II
used in the factory together with the data specified in this list.
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4.9.3.2
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Hazard and risk analysis shall be used to identify, control and manage any potential risks
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from microbiological contamination and any potential allergens.

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Interpretation Biological control

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The possibility of microbiological contamination, including allergens, coming into direct or

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indirect contact with the product should be included as part of the hazard and risk analysis.
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Appropriate controls shall be put in place where hazards have been identified.
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4.10 Waste and waste disposal

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Waste disposal shall be managed in accordance with legal requirements and to prevent accumulation, risk of
contamination and the attraction of pests.
Interpretation
Waste materials allowed to accumulate may be a source of product contamination, be a harbourage for pests,
become confused with satisfactory products or materials or otherwise present a risk of materials being misused.
Disposal of waste should comply with local legal requirements.
The site needs to establish by risk assessment the movement and flow of waste. For example, bins must be dedicated
to the material (or types of material) that can be disposed of in them, and the waste materials should not re-enter
Glossary
the production areas.
Clause Requirements
4.10.1 Where licensing is required by law for the removal of waste, it shall be removed by licensed
contractors and records of removal shall be maintained and available for audit.
brcgs.com 97
PACKAGING MATERIALS
ISSUE 6
Clause Requirements
Interpretation Waste-handling licensing
In some regions, legislation requires waste-handling organisations to be licensed in order
to ensure that the waste is disposed of appropriately and according to local regulations.
The site will be expected to demonstrate that, as part of the supplier approval process, the
waste disposal contractor has any required licensing and is complying with the conditions
of the licensing. Where no licensing is required, this requirement may be marked as not
applicable.
4.10.2 Process waste shall be managed to minimise release to the environment. This shall include,
but is not limited to, pellet, flake, powder, dust and offcuts.
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Interpretation Process waste management
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Waste materials, including those that are re-incorporated into production processes,
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must not be allowed to pose a risk of contamination to the finished product or to the
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19
environment. The clause states that this applies to pellet, flake, powder, dust and offcuts,
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which are typically associated with plastics conversion, but process waste from any industry
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should be considered.
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4.10.3 Suitable and sufficient refuse and waste containers shall be provided, which shall be
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emptied at appropriate frequencies and maintained in an adequately clean condition.

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Interpretation Waste and refuse containers

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This is a general requirement for a sufficient quantity of waste containers to be available,

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emptied regularly and maintained in a clean condition. The aim here is to ensure that the
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site is maintained in a clean condition and that waste or refuse cannot be introduced into
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the production stream. The site should monitor the use of waste and refuse bins to ensure
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that they are sited in the most appropriate positions.

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Where appropriate, waste shall be categorised according to legislative requirements based

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on the intended means of disposal (such as recycling), and sorted, segregated and collected
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in appropriate designated waste containers.

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Interpretation Categorisation and segregation of waste

There are a number of reasons why waste may need to be categorised and segregated.
Examples include:
•• disposal of toxic waste
•• disposal of highly flammable waste
•• recycling requirements.
In some cases, particularly those concerning toxic waste, disposal may only be carried out
by registered and licensed operators. If so, the site must demonstrate that appropriate
contractors were identified and evaluated through the site’s supplier approval scheme and
that appropriate records are maintained and include information such as:
•• identification of discarded material
•• quantity (volume, weight, number as appropriate)
•• type and number of containers
•• date and time of disposal
•• signature of the waste contractor (or responsible employee if in house).
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PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
Example During an audit of a factory printing paperboard swing tags for linens and towels, the
auditor sees that the bin for collecting the offcuts from the manually operated die cutter is
overflowing and waste is spilling out over the floor. Another operative is asked by the
production supervisor to empty the bin and the operative empties the paper offcuts into
an external bin clearly marked ‘plastic’. When asked, the operative claims that the waste
contractor ‘sorts all that out’. Upon viewing the waste disposal contract, it is clear that the
site is required to segregate the waste, and it is a legal requirement in the country of
manufacture to segregate paperboard waste for recycling.
The facility is required to consider refuse and waste containers, and may gain up to three
non-conformities as a result: the first, under clause 4.10.3 for the overflowing bin; the
second for failure of the site to adequately segregate and sort the waste under local legal
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requirements (clause 4.10.4); and an additional penalty may be imposed due to lack of
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training of the site personnel.
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4.10.5 Substandard trademarked materials shall be rendered unusable through a destructive
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process. All materials disposed of shall be recorded.

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Interpretation Disposal of trademarked materials

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Part II
In this clause, trademarked materials are those defined as having been marked with a
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distinctive sign or indicator used by an individual, business organisation or other legal

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entity to identify that the products or services to consumers with which the trademark
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appears originate from a unique source, and to distinguish its products or services from
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those of other entities. A trademark is typically formed from a name, word, phrase, logo,
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symbol, design or image, or a combination of these elements.

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Where packaging is deemed substandard to customer requirements, it may be necessary to

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counterfeited.
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This clause also applies to equipment that bears trademarks (such as printing plates or moulds
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used in decoration). The site should ensure that this equipment cannot be misused as this
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The auditor will expect to see evidence of the method of disposal, and that appropriate
methods have been used, depending on the nature of the equipment or materials requiring
disposal.
4.10.6 If substandard trademarked materials are transferred to a third party for destruction or
disposal, that third party shall be a specialist in appropriate waste disposal and shall provide
records of material destruction.
Interpretation Third-party disposal of trademarked materials

Requirements for the disposal of trademarked waste need to be defined within a contract
Glossary
with the provider and include records of destruction or disposal.
4.10.7 External storage of refuse shall be in designated areas and designed or maintained to
minimise the risk of pest harbourage.
Interpretation External storage of refuse

This clause requires that the containers are managed so they do not present any risk to the
product. Particular consideration must be given to the pest control implications of external
waste collection areas.
brcgs.com 99
PACKAGING MATERIALS
ISSUE 6
4.11 Pest management
In order to minimise the risk of infestation and risk to products, the whole site shall have an effective preventive
pest management programme in place and the resources available to respond immediately to any issues which
occur.
Interpretation
Most sites need some form of pest control to ensure that products are not damaged or contaminated. Control of
pests must be undertaken at a level commensurate with the needs of the site, based on the nature of identified
pests, raw materials, equipment, characteristics of finished products, processes, the site and its environment, as well
as the potential for future pest risks. There are many publications providing further detail on pest control, including
the BRCGS best-practice guideline ‘Pest Control’.
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Typically, the auditor will be looking for any evidence of pests during the site tour, but will also be examining
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documentation, reviewing records and interviewing site personnel to determine whether any evidence of pests or
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other infestations has been identified. Typically, a minor non-conformity would be raised during an audit where slight
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evidence of an infestation is found resulting from a casual intruder (e.g. instances of pest ingress of a single occasion
19
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or low numbers that have not been appropriately investigated and corrected).
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Where any established infestation (i.e. where large numbers of pests are breeding within the building or site over a
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period of time) is in evidence at the time of the audit, a major non-conformity will be raised. This implies a failure of
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the pest control and inspection measures and should be regarded as a loss of control and lack of maintenance.
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A critical non-conformity would be raised where the presence of an established infestation puts product or raw
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materials at risk of contamination.

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Clause Requirements
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4.11.1 A preventive pest management programme shall be maintained, covering all areas of the
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site under the site’s control.

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The site shall assess the suitability of its pest management programme to address variation
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in pest activity through different seasons, and consider any additional preventive activity
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required.
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The site shall document and implement any required additional activity.
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Interpretation Preventive pest control programme

An appropriate pest control programme, which is under the company’s control, must be in
operation across the whole of the site and cover all types of pest that are likely to affect
that type of production site in that location. Where instances of pest ingress (i.e. single
occasion of low numbers) occur, these need to be appropriately investigated and actioned,
but this will not be deemed to constitute loss of control.
However, where pest infestation (i.e. large numbers of pests breeding within the building or
site over a period of time) occurs, this will be regarded as a loss of control and lack of
maintenance of the pest control programme and will lead to a major non-conformity being
awarded where infestation is evident at the time of the audit.
Should the pest infestation occur between audits and control be regained prior to the
subsequent audit, the auditor will need to see evidence of the activities required in clauses
4.11.2 to 4.11.6, and evidence that the source or sources of pest infestation have been
identified and effectively controlled. Unsatisfactory evidence to the auditor may result in a
non-conformity.
100 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
4.11.2 The site shall either contract the services of a competent pest management organisation or
have appropriately trained staff for the regular inspection and treatment of the site in order
to deter and eradicate infestation. The frequency of inspections shall be determined by risk
assessment and documented. The risk assessment shall be reviewed whenever:
•• there are changes to the building or production processes which could have an impact
on the pest management programme
•• there has been a significant pest issue.
Where the services of a pest management contractor are employed, the service contract
shall be clearly defined and reflect the activities of the site.
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Interpretation External contract or internal trained staff
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Pest control is often subcontracted to external companies, which may need to be licensed
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or approved by the authorities. Where contractors are used, the signed contract must
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clearly define the scope and level of activity to be provided. If pest control is handled in
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house, responsible staff must have undergone formal training and have demonstrated their
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competence.
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Example A site has a contract in place with a local pest controller to cover internal and external pest
Part II
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control for insects and rodents. The contract states that there will be eight routine visits
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annually, with four biologist inspections and four electric fly-killer inspections. A site plan
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with a recent version number and date demonstrates the positions of the bait stations.
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The site representative states that the supplier has been approved in line with clause 3.10
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and the contract with the pest controller is reviewed annually.

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There is no evidence of pest infestation or ingress, but the pest control records show that a
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rat was sighted in the trailer yard 2 months previously.

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The site has effective and appropriate pest control in place and the details of contractor
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and contract coverage are clear.

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4.11.3 Where a site undertakes its own pest management, it shall be able to demonstrate that:
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•• pest management operations are undertaken by trained and competent staff with
sufficient knowledge to select appropriate pest control chemicals and proofing methods
and understand the limitations of use, relevant to the biology of the pests associated
with the site
•• staff undertaking pest management activities meet any legal requirements for training or
registration
•• sufficient resources are available to respond to any infestation issues
•• there is ready access to specialist technical knowledge when required
•• legislation governing the use of pest control products is understood and complied with
•• dedicated locked facilities are used for the storage of pesticides.
Glossary
Interpretation Site’s own pest management

Documented procedures and detailed records must be maintained (as per this clause and
clause 4.11.8) to ensure that staff carrying out pest control activities are adequately trained
and that all the requirements of this section are met.
brcgs.com 101
PACKAGING MATERIALS
ISSUE 6
Clause Requirements
4.11.4 Equipment such as bait stations, traps or electric fly-killing devices shall be appropriately
located and operational.
Interpretation Location of bait stations

Most nationally recognised pest control contractors will carry out a full hazard analysis and
risk assessment on a company and its manufacturing facilities to determine the best
locations for pest control equipment. This should be regularly reviewed in the light of any
reported pest activity.
4.11.5 Effective precautions shall be in place to prevent pests entering the premises. The building
shall be suitably proofed against the entry of all pests via doors, windows, ducts and cable
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entry points.
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This shall include measures to prevent birds and flying mammals from entering buildings or
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roosting above loading or unloading areas.
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Interpretation Pest proofing

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This clause states that the site must evaluate the potential ingress points of pests and
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suitably proof all points. The site also needs to ensure that the proofing remains effective.
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If a pest control contractor is used, it is most likely that they will assess potential ingress
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points and the effectiveness of proofing; if this is the case then their suggestions must be
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taken in line with clause 4.11.6.

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4.11.6 In the event of infestation, immediate action shall be taken to eliminate the hazard.
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Action shall be taken to identify, evaluate the potential for contamination or damage, and
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authorise the release of any product potentially affected.

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Interpretation Removal of infestation

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This clause is intended to ensure that the appropriate actions are taken if any infestation is
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discovered. The hazard should immediately be controlled and eradicated, and the cause
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investigated. It is likely that additional cleaning may be required. If a product has actually or
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potentially been contaminated, the site must evaluate the situation with regard to:
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•• safety – could contamination cause a health risk?

•• customer specification – are there any customer requirements?
•• cross-contamination – could other products be affected?
A responsible person is required to authorise the release of any such products.
Action may also include steps to protect other products and instigate inspection by the
pest control specialist. Any infestations and corrective actions taken must be recorded.
102 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
4.11.7 In the event of an infestation, and at appropriate intervals, the site shall request a catch
analysis from flying-insect control devices to help identify problem areas.
In the event of increase in activity, the site shall use risk assessment to determine the
activity required to eliminate the hazard.
Interpretation Catch analyses

The site should conduct periodic evaluation of pest control trapping devices to identify
any trends that may be emerging; these will indicate where action needs to be taken. As a
minimum, this catch analysis should be conducted annually and also in the event of an
infestation. It may also consider trends in bait takes and recommendations for proofing and
housekeeping. The catch analysis may either be prepared as a report or incorporated into
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the company management review.
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4.11.8 , 2 er ipa
Documented procedures and detailed records of pest activity, pest management
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inspections and recommendations shall be maintained. These shall include, as a minimum:
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•• an up-to-date, signed and authorised site plan identifying numbered pest control devices
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and their locations

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•• identification of the baits and/or monitoring devices on site

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Part II
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•• clearly defined responsibilities for the site management and the contractor
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•• details of pest control products used and instructions for their effective use
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•• detailed records of inspections, recommendations and of any pest infestation.

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It shall be the responsibility of the site to ensure that all the relevant recommendations
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made by the contractor or in-house expert are implemented in a timely manner and
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monitored for efficacy.

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those items set out in the requirement.

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Any recommendations made by the pest control contractor or in-house specialist must be
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reviewed and implemented within an appropriate timescale.

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4.11.9 Employees shall understand the signs of pest activity and be aware of the need to report
any evidence to a designated manager.
Interpretation Employee awareness

The Standard requires employees to understand the signs of pest activity and be aware
that, should they identify evidence of pests, they should notify someone who is able to act
on the information.
Note that in addition to signs of pest activity, personnel should also be aware of potential
Glossary
points of pest ingress, such as gaps or holes in doors or open doors, and where materials or
grassy areas next to buildings might camouflage these. It is vital that everyone on site is
involved in pest control (and other measures) to maintain the required hygiene level.
Consequently pest control should be included as part of basic staff hygiene training, in
particular the need to report any new signs of pest activity.
brcgs.com 103
PACKAGING MATERIALS
ISSUE 6
5 Product and process control

5.1 Product development
Documented product development or modification procedures shall be in place to ensure the production of
safe and legal products to defined quality parameters.
Interpretation
The company should have processes and procedures in place to ensure that the design of any new products, or
redevelopment of existing products, will result in the production of a safe and legal packaging material, with relevant
manufacturing controls in place throughout the process. Where product development is controlled wholly or partly
by a company’s head office or is in another location, these requirements will still be applicable and audited at the
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site, since records must be available detailing how the design and development process links to the manufacture of
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products. Therefore, the site should have access to documentation and records that support product development
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processes where these are held centrally or at another site.
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Clause Requirements
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5.1.1 Customer requirements relating to the design, development, specification, manufacture

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and distribution of the product shall be documented and agreed with the customer.
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This shall take into consideration process requirements and end use, where possible.
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Any critical-use parameters shall be identified and defined; for example, barrier
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requirements, maximum/minimum use temperature, machine running, use of recycled

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materials, and testing requirements (including migration, where relevant).

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Special attention shall be paid to any materials that are required or requested to be
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manufactured from recycled materials, to ensure that they are both appropriate and legal.
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Interpretation Establishing customer design requirements

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This may be quite demanding as it requires the packaging supplier to communicate with its
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customers to ensure that the most effective packaging solution is developed for the needs
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of the product and its supply chain.

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To facilitate the most effective product development process, potential issues can be
‘designed out’ by establishing customer design requirements that take into consideration
each step through which the packaging is likely to go in the production and supply chain to
the ultimate user. Elements that may be considered include:
•• final use of the packaging – for whom the product is designed and in which region it will
be sold (e.g. retail through supermarkets or through internet retailers)
•• other packaging components – a self-adhesive label for a PET jar will need the correct
type of adhesive; the recycled content composition of a carton for a cereal product will
influence the internal bag barrier requirements
•• the technical requirements of the packer/filler of the product – for example, where
corrugated cases are intended to be machine-erected, or batch-coding areas on printed
labels are to be left varnish-free
•• the nature of the product being packed – for example, frozen, chilled or ambient food,
non-food consumer product (such as chemicals or pharmaceuticals) or secondary
packaging for clothing
•• the nature of the supply chain for the packed product – for example, chilled, frozen or
ambient food; by road, rail or sea.
104 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
The above list is not comprehensive but each packaging material manufacturer should
establish with the customer, and any other relevant packaging material manufacturers,
what the critical information is for a specific product or product type, how to obtain it, and
how to communicate it effectively to the development team. This is good practice already
demonstrated by many packaging suppliers and essentially forms a hazard and risk
management plan for the finished product.
The term ‘recycled materials’ typically means post-consumer or post-industrial waste
recovered from another location. In-process recyclate includes in-process regrind, factory
rework and post-consumer or post-industrial waste. For example, a glass factory may use cullet
(broken glass waiting to be remelted) plus in-process recyclate from quality check rejects.
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5.1.2 The site shall clearly define and document when a production trial is required.
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The site shall determine the outputs and success criteria required from a production trial,
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and any changes and/or additions made to materials, processing characteristics or
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equipment as a result of the trial.

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Where appropriate, production trials shall be carried out and testing shall validate that
Fr 9. tps
manufacturing processes are capable of producing a safe and legal product to defined
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Part II
quality parameters. New products or product changes shall be subject to suitable
D te ate
evaluation to ensure that required safety and quality parameters can be achieved.
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Interpretation Production trials

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In both new or existing product development, there will be some situations where a
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production trial is definitely required and others where it is not so clear-cut. This
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requirement states that the site must define the circumstances where a trial is required.
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This may be by using a decision tree and risk assessment, or a set of scenarios where trials
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Production trials may be required for many reasons; for example, during the development
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of new products; as a result of a customer request; after a risk assessment; when process
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controls are revalidated; and to ensure that new techniques for production can be
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maintained. When production trials take place, whether of a whole or part process, the
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company should document the results that validate the capability of the manufacturing
processes to produce a safe and legal product against the proposed shelf life. This is to
ensure that all operating conditions under production within the factory environment are
considered prior to manufacture.
5.1.3 The company shall ensure that production is carried out using defined operating
conditions which result in safe and legal products to defined quality parameters.
Interpretation Defined operating conditions

For each product or product type the company must establish and document the operating
Glossary
conditions and the required production parameters. These may include, as appropriate,
running temperatures, dwell times, atmospheric conditions, running speeds and in-line
testing.
Such defined conditions may result in a process specification or a work instruction that sets
out the machine settings for automated processes. Manual or semi-automated processes may
be simpler, with descriptions of the process to be undertaken. The ultimate goal is that these
defined operating conditions, process specifications or work instructions result in packaging
materials of the required quality and safety being consistently produced.
brcgs.com 105
PACKAGING MATERIALS
ISSUE 6
Clause Requirements
5.1.4 Where required by the customer, a technical product specification shall be prepared and,
where possible, agreed with the customer or brand owner before the production process
begins.
Interpretation Product specification

It is essential that the details determined through the process set out in clause 5.1.1 are
captured effectively. A product specification should contain all the information relevant to
the production and supply of packaging. Although it is not always possible to formally
agree the specification with the customer, the company should be able to demonstrate
that an agreement process is in place.
Agreement of the specification may not require a document with a signature. Confirmation
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may also be by electronic means such as email or an electronic specifications system.
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5.1.5 , 2 er ipa
Samples as agreed with the specifier shall be retained for future reference.
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Interpretation Sample retention

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If customers require a sample to be kept, their instructions must be followed. If there is no

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customer requirement, the company may still choose to retain samples, or partial samples
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of larger items.
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5.1.6 A documented procedure shall be in place to address the transfer of customer

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specifications or requirements to the site’s own systems. This shall include (but is not
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limited to):
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•• validation of accuracy of data transferred

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•• how changes to customer specifications are updated and communicated

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•• how the agreed requirements for customer testing methods are met
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•• evaluation of how changes made to the customer specifications affect the technical
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Settings derived from successfully conducted production trials or equipment installations

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shall be transferred accurately to process control documentation.

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Interpretation Transfer of customer specifications or requirements

It is important that, after carrying out any development work, the final product specification
requirements agreed with the customer are transferred into the site’s own system of
working; for example, process control documentation.
Following a successful product development, the manufacturing specification, work
instruction and process settings should be formally documented into the site’s own
systems. It should be possible to see clearly how the process works in respect of
integrating the customer’s requirements into the site’s systems and how this is managed.
106 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
5.2 Graphic design and artwork control
Artwork and all pre-press processes conducted by the site shall be managed to ensure that loss of information
and variation from the customer’s specifications are eliminated.
Interpretation
It is common for sites that print or decorate their packaging materials to have in-house artwork creation and
reprographics facilities. Some sites will have comprehensive services while others will have simpler processes.
All activities relating to any decoration that is applied to packaging materials are subject to the requirements of this
clause. This includes print by any method, embossing, debossing, inkjet or engraving.
The focus of these requirements is to ensure that where a packaging manufacturer is responsible for anything that
will be applied to the material, all necessary steps are taken to ensure that the result meets the expectation and
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specification of the customer, and maintains product quality, safety and legality.
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The key is that the site is responsible for anything that it carries out on its own site but that it should also be aware
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of what happens elsewhere.
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Clause Requirements
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5.2.1 The site shall have a documented artwork management procedure covering the activities
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Part II
for which the site has responsibility. This may include, but is not limited to:
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•• collation of information to be included into artwork

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•• receipt of artwork files from the customer

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•• verification of completed artwork and approval by the customer.

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Interpretation Documented artwork management procedure

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The company is required to have a documented procedure which outlines all of the steps
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that take place on the site. Any artwork activity carried out by another organisation is out
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of scope, but it may be helpful for the site to have an understanding of those activities.
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Where the activity is carried out at another site belonging to the same company, the site
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must have visibility of those processes and procedures, and it must take responsibility for
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The requirement is not specific in what this procedure should contain, as there is no fixed
route for artwork creation. However, the first step in ensuring that the images and text that
will later appear on packaging are complete is to collate all the elements that will be
displayed. This includes print marks that may not appear on the final package once in use.
The procedure requires the final artwork to be verified and approved by the customer; this
refers to the artwork itself and not the final product. This may be in the form of digital or
‘wet’ proofing, depending on customer requirements. The purpose here is to ensure that
the customer has seen the artwork in its assembled form after the site has carried out its
processes to prepare the image for print.
Glossary
This requirement should be stated as non-applicable only where the packaging is not
decorated. Decoration includes inkjet codes applied to each individual packaging
component, and batch labelling or identification of pallets or bulk packs. This is to ensure
that the correct information is applied so that components and batches are traceable
throughout the supply chain.
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PACKAGING MATERIALS
ISSUE 6
Clause Requirements
5.2.2 A process shall be in place to seek formal acceptance and approval of final product
concepts and artworks by the specifier.
The outcome shall be documented.
Interpretation Approval process

In this requirement, final product concepts are the printed packaging material. This may be
in the form of a 3D rendering of a finished glass bottle, a press-proof of a printed film, a
mock-up of a carton board pack with artwork in position, or a ‘first-off’ from the initial
production run. Any output is acceptable as long as there is a demonstrable process by
which approval can be gained.
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The process of approval must be in place, even though in some instances it may not be
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possible to gain documented approval such as a signature from a customer. The site may
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insert conditions of acceptance into its terms and conditions of sale based on the order of
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the printed component, or accept emails acknowledging receipt of proofs or mock-ups as
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evidence of acceptance. It is vital, though, that whatever the outcome of the site seeking
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acceptance, the results are documented and retained.

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Example A site printing and converting carton board cereal boxes receives artwork files from its
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customer for a new product. It performs reprographics activity for colour separation and
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plate making and issues a digital proof for approval of text and positioning when the colour
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separation process is complete. The site also provides the customer with several samples
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of the container in the correct material but in different sizes and shapes from the site’s
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computer-aided design machine. The customer attends at the time of printing to conduct a
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press-pass and approves the packaging for press once the right colour match and
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registration have been achieved.

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For another customer’s promotional print for a ‘20% extra free’ flash on the front of the
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pack, the site simply provides a digital proof to the customer with a colour reference for
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the additional flash, and the customer’s order based on the artwork is evidence of
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acceptance of the proof.

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Both aspects of the site’s procedures are documented in its external customer approval
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process procedures.
In both instances, the site has a process to enable the customer’s acceptance of the
artwork and product concepts, and the auditor is satisfied that they meet the requirement.
5.2.3 Where appropriate, print trials shall be carried out and testing shall validate that the agreed
product quality and print standards can be consistently achieved.
108 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
Interpretation Print trials
As stated in clause 5.1.2, the site is required to determine when a production trial is
required. This also applies to printed and decorated packaging materials to ascertain that
the desired appearance is achievable on a consistent basis. The words ‘where appropriate’
mean that the site decides whether to carry out trials or not. However, the auditor will be
looking for evidence that the site has evaluated the risks associated with not carrying out
print trials.
Where the site is implementing a simple and straightforward change to printed media, such
as a colour change or slightly altered substrate composition, it may decide that a full print
trial is not required. Another example of a print trial not being required is at the start of
production where the customer is on site to approve the print once complete; a master is
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then created to which the site must adhere for the rest of production.
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Sites that decorate packaging without the use of a print process, such as glass bottles with
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embossed shoulder decorations, will not be able to produce full trials until moulds are
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available, which may not be until immediately before full production. In this instance there
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is no requirement for the site to run full trials. However, on the basis of risk, it is common
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for sites such as those manufacturing glass or polymer bottles to use ‘first-offs’ as the
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Part II
production trial and continue with full production only on the basis of acceptance of those
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first-off pieces.
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5.2.4 Printing equipment such as plates, silk screens, anilox rollers, cylinders and blankets shall
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be verified as being correct to specification and artwork version or agreed master prior to
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use, and fully traceable to the customer’s approved origination material.

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Interpretation Traceability of print equipment and reproduction media

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Traceability of all materials and media associated with a piece of packaging must be
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possible, as set out in clause 3.11. This requirement may be met through job codes that do
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not form part of the final packaging but are clearly visible on the plates and traceable to
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the approved artwork.

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The purpose of this clause is to ensure that all the information so carefully collated at the
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start of the process is reflected in the accurate printing of the component. It ultimately
aids the packaging user to avoid incidences of missing information, but does not implicate
the packaging printer where information has not been supplied. The packaging
manufacturer cannot be responsible for information that has not been supplied to it.
This traceability may refer to the process specification developed as part of compliance
with clause 5.1; the specification will list all the required print media to complete the job,
and the most recent artwork version approved by the customer.
As well as the evident benefits in aiding the site’s traceability system, the focus is twofold:
to avoid loss of information by unintentionally omitting a piece of print equipment; and to
Glossary
ensure that the correct print media are used, particularly where artwork may have changed.
The auditor will be looking for evidence that the site has a robust system by which all print
media on site can be related to a specific print job, and may use the vertical audit approach
to select a packaging component and then trace back to all the elements associated with it.
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PACKAGING MATERIALS
ISSUE 6
Clause Requirements
5.2.5 Customer-approved reference material, including artwork masters and colour standards
used during print runs, shall be controlled to ensure minimisation of degradation and shall
be returned to appropriate storage after use.
The site shall have a policy to address requirements for the renewal of approved masters,
as necessary.
Interpretation Maintenance of masters

When decorating packaging materials, it is good practice to have an approved master or set
of standards against which production can be assessed for accuracy. This requirement sets
out how these should be maintained in order to achieve a consistent result over time on
repeat print runs. As an example, if a colour standard is exposed to long periods of light,
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it may degrade through fading. Subsequent print runs may then suffer from colour
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differentiation and fail to meet the customer’s quality requirements.
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The auditor will expect to see that the site has considered the possibility of degradation of
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approved masters of any type and taken appropriate action to retain their integrity. This
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may be through a number of methods. The Standard is not specific, but the site should be
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clear on the method it uses to maintain quality throughout production runs and on
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subsequent print runs. The site must also have considered how to manage degradation of
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standards, perhaps by renewing samples and re-approving them according to the previous
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master (e.g. using spectrophotometer results to determine validity), or being able to

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demonstrate that no degradation has taken place during the storage of the master sample.
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Common colour standards include Pantone references, and these should be maintained
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and renewed at appropriate times, in accordance with good practice.

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5.2.6 The site shall have a documented procedure for managing changes to artwork and print
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specifications to manage obsolete artwork and printing materials.

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Interpretation Artwork change procedure

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The aim here is to avoid incidences of misprinting where artwork has been altered or
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updated, particularly where the alteration is subtle. It is good practice to allocate new job
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codes to packs where artwork has been adjusted to avoid misprinting or the use of
incorrect or out-of-date printing media. The requirements in clause 5.2.4 are linked to this
requirement and an effective traceability system will ensure that it is easy to identify
where artwork has changed and if incorrect print media are in use.
This requirement applies to all print media (including cutting dies, print blankets etc. that
have an impact on the final printed image), so sites that carry out only digital printing are
also affected.
5.2.7 Where artwork files and approved masters are in electronic form, these shall be suitably
protected to prevent loss or malicious intervention.
Interpretation Protection of artwork files

This requirement focuses on maintaining the integrity of the artwork and subsequent
printed image from any sort of damage, whether through digital file corruption, malicious
intervention or the impact of damage to digital networks.
The auditor will be looking for evidence that the site has a robust system to protect digital
files and also an effective back-up and recovery route.
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PACKAGING MATERIALS
ISSUE 6
Part I
5.3 Packaging print control
Where packaging materials are printed or decorated, documented procedures shall be in place to ensure that the
information is fully legible and correctly reproduced to customer specification and complies with any legal
requirements.
Interpretation
This clause may only be regarded as not applicable if no printing or decoration activity takes place on the site.
Print activity includes the printing of batch codes or any information that is applied to the packaging material,
such as in-mould labelling, as these are key to an effective traceability system.
The following clauses refer to all printed or decorated materials. The site must have systems in place to ensure that
printed information is legible and printed correctly, meeting the customer’s requirements and maintaining the
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quality, safety and legality of the product.
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Clause Requirements
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5.3.1 An assessment shall be carried out for the pre-press activity, print process and handling of
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printed packaging (product) to identify:

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•• risks of loss of essential information

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Part II
•• mixing of printed product.
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Controls shall be established and implemented to reduce the risks identified.

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Interpretation Hazard analysis and risk assessment for printed packaging materials
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All print activity should be included in the hazard analysis and risk assessment (clause 2.2).
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Depending on the approach taken by the company, the print activity may be added on to
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each process flow as a module, especially if not every packaging type is printed or decorated.
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Of particular concern is the risk of the packaging either not containing information that is
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essential (such as allergen or legal information) or being mixed up with other packaging
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that is similar but printed with different information (such as packaging for a product that
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contains an allergen with one that does not). The implications of such scenarios may have
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serious repercussions for consumers. When such risk is identified, the company must put in
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place procedures to eliminate or reduce the risk to an acceptable level.

Where changes are made to artwork or processes, this must be reflected in the HARA study.
A change to artwork, particularly for food contact materials, may result in additional hazards
where safety, legal or allergen information is displayed. Such changes may already be part of
the quality management system, but the auditor will need to see that the site has considered,
and continues to consider, any risks associated with the points in this requirement.
5.3.2 Printing plates, cylinders, cutting dies, print blankets and any other printing equipment
shall be appropriately stored to minimise damage.
Glossary
Interpretation Storage of printing plates

The aim of this clause is to prevent damage to the printing equipment that may either
render it unusable or remove part of the information on the plate, and to ensure that the
potential for malicious contamination or damage is minimised. This can be achieved by
introducing a signing-out system for plates related to the productions planned. Traceability
must be maintained as per the requirement in clause 5.2.4.
The requirement is non-applicable where no physical printing plates are used; for example,
where the only print that takes place on site is digital, or consists only of ink jetting of
batch codes, or similar.
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PACKAGING MATERIALS
ISSUE 6
Clause Requirements
5.3.3 Each print run shall be approved against the agreed standard (or master sample). This shall
be recorded.
Interpretation Approval of print run

To ensure consistency of print and that the legality of product are maintained, the site
must ensure that a procedure for the approval of print runs against the master sample is in
place. The master sample may be pre-supplied or an approved sample from the first print
run. It is essential that this approved sample is maintained in conditions that prevent its
degradation to ensure that future print runs are to specification and customer
requirements, as per the requirement in clause 5.2.5.
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5.3.4 A system shall be in place to detect and identify printing errors during the run and to sort
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these errors from the acceptable printed material.
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Interpretation Identification and removal of printing errors
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It is normal during start-up, and periodically throughout the run, to produce substandard
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materials that will not meet specification or customer requirements, particularly on longer
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runs of large-volume material. The nature of the printing process is such that colours may
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‘drop out’ or there may be tiny shifts in the registration of colours. The company must have
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a method by which to identify these materials so that they may immediately (or later)
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remove the non-conforming product for disposal. This requirement may be met by ‘tagging’
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the start and end of non-conforming product in a reel or stack of printed material and
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sorting later, or by 100% inspection of materials by an electronic vision system.

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5.3.5 Where composite print is used (a mixture of different designs printed together), a process
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shall be in place to ensure effective segregation of differing print variants.

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Interpretation Composite print

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Composite print is often used on smaller items of printed materials, such as labels, where
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the print run length justifies mixing variants of smaller numbers to fully use the printing
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equipment and minimise set-up and down times.

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Where composite print is used, the company needs to ensure that the potential for variants
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to be mixed up once they have been separated (e.g. through slitting for material that is on a
reel) is eliminated or minimised to an acceptable level. This is particularly important where
the material is to be used for foodstuffs that contain allergens; the company must
establish and verify operational controls, and determine how the procedures are to be
measured and checked.
5.3.6 Samples of printed packaging shall be retained together with production records for a
period of time to be agreed with the customer/specifier/brand owner.
Interpretation Printed packaging sample retention

This requires the company to agree any sort of retention of printed product samples with
its customers. Where no agreement is in place, this requirement can be marked as
non‑applicable, even if the site has its own retention policy for printed packaging.
112 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
5.3.7 Any unused printed product shall be accounted for and either disposed of or identified
and appropriately stored.
Interpretation Unused printed product

Unused printed product is that which meets specification but is in excess of customer
requirements. It is often referred to as ‘overs’ and the company must decide how this
printed material is to be handled. The customer may decide to purchase the excess
material or to request either its storage for future use or its disposal. Should it be stored
then the material must be identified. The auditor will expect to see evidence of a
procedure to handle excess materials being followed.
The reason for this focus is to minimise the risk of genuine printed packaging being used
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for counterfeit products. The way that excess material is handled will vary between
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customers and between jobs, depending on the nature of the packaging material and its
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Where the packaging material is disposed of, the site should take care to ensure that it is
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rendered unusable, as per the requirements of clause 4.10.5.

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5.3.8
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Lighting in print inspection cabinets and other means of print/colour checking shall be
Part II
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agreed with the customer or conform to accepted industry standards.

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Interpretation Light cabinets

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Light cabinets used for print checking should be calibrated where necessary, and the
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specific lighting conditions agreed with customers.

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Where no agreement is in place about what lighting should be used, the site should
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consider the best light by which to check print. In some instances, a manual or automatic
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spectrophotometer may be used instead of a lightbox. Print/colour checking should either

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be to the customer’s requirement (e.g. where a Pantone reference has been supplied) or to
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industry-standard colour properties regarding hue, brightness and saturation, depending on

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Example An auditor notices that the lightbox at the end of the press in a label printing house has a
pink light which the printer is using to check colour balance and appearance against an
approved sample. The auditor questions the printer, who replies that the light is unusual
but has been requested by the customer.
The requirement states that the customer may dictate the means of print and colour
checking, and an auditor would be satisfied that the printer had knowledge of why such a
bulb was to be used.
Glossary
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PACKAGING MATERIALS
ISSUE 6
5.4 Process control
Fundamental
Documented procedures, work instructions and process specifications shall be in place to ensure
effective quality assurance of operations throughout the process.
Interpretation
This is a fundamental requirement because without proper control of the manufacturing process, safe products that are
fit for purpose cannot be consistently achieved. There are various aspects to product safety: designing a product;
selecting materials that are capable of resulting in a safe, quality product; and ensuring that the manufacturing process
is controlled so that this is achieved on a consistent basis, thereby meeting the requirements of the customer.
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Clause Requirements
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5.4.1 The hazard and risk management team shall identify and record all potential product
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defects that are reasonably expected to occur at each step in relation to the product and
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process. The hazards considered shall include, where applicable:

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•• product quality defects

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•• defects that may have an impact on the functional integrity and performance of the final
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product in use
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•• defects which result in the production of products which are outside customer-specified
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quality parameters.
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Interpretation Identification of manufacturing process control points

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The purpose of assessing the whole manufacturing process through the hazard analysis
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prerequisite programmes, is to ensure that the site is aware of the potential for any aspect
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of the process to go out of control, and to have mitigating measures in place. It is tempting
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to think only about significant issues, such as those that might cause harm to human
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health; however, this requirement can and should be applied more broadly and in depth to
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ensure that any parameter that might produce an out-of-specification result is controlled,
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no matter how slight the impact and how infrequent the occurrence. This will ensure that
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appropriate quality is maintained.

The use of raw materials must be considered. Are they sufficiently controlled and validated
to ensure that, by using them, the quality required can be achieved? This may be through
the provision of certificates of analysis (CoA), or in-house/contracted testing of raw
materials. Consideration should also be given to the parameters of raw materials, such as
relative humidity and temperature.
When conducting a risk assessment, the site should first consider those factors that are
critical to product safety and quality, then the less frequent issues.
Example A site has determined that the even application of lacquer to the interior of an aluminium
drinks can is a manufacturing process control point related to quality. An uneven
application of lacquer could result in degradation of the interior wall of the can, leading to
an unacceptable change in the organoleptic characteristics of the beverage and the can’s
subsequent failure in the supply chain. The site has implemented a monitoring system to
ensure the lacquer layer is checked.
The auditor would be satisfied that the site has identified and recorded the potential
defects in its process.
114 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
5.4.2 A review of the manufacturing and, where applicable, printing process shall identify
manufacturing process control points that can prevent or limit the risk of producing
products with quality defects.
Interpretation Review of the manufacturing process

This clause is partly met through the requirements set out in clause 2.2. Proper execution
of the hazard analysis and risk assessment will ensure that the company is able to identify
all the points in its process that, although they may not be critical control points (CCPs),
still require controls with specific regard to quality. This is best demonstrated when the
hazard and risk analysis is effectively transferred into day-to-day operations.
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5.4.3 For each manufacturing process control point, machine settings or process limits shall be
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established and documented – the process specification.
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Interpretation Manufacturing process control points
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Processes must be adequately controlled and monitored to ensure that the final product is
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within speciﬁcation; to accomplish this it is essential that the machine settings and process
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limits are properly established and documented. The settings may be by product or product
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type, or be common to the process irrespective of the product being manufactured.

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Part II
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5.4.4
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Where equipment settings are critical to the safety or legality of the product, changes to
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the equipment settings shall only be completed by trained and authorised staff. Where
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Interpretation Equipment settings

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quality or legality shall be adjusted only by trained, competent and authorised staff, and
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controls should be in place to ensure this remains the case.

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5.4.5 A bill of materials and process specification (including manufacturing process control
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Interpretation Bill of materials and process specification availability

A bill of materials is simply a list of those items that will be used to manufacture or convert
a packaging material. It will typically list all raw materials, adhesives, inks, varnishes or other
materials that comprise the final piece of packaging. The process specification lists the
equipment and processes through which those raw materials will go.
Documented process specifications, procedures and work instructions must be available for
all key stages of the operation and must be readily available to staff in the area in which the
activity is undertaken. The documents must be sufficiently detailed to make certain that all
key process parameters are specified and controlled, thereby ensuring that the manufactured
product consistently meets the required standards of safety, legality and quality.
Glossary
Typically, these documents will cover:

•• all raw materials
•• process instructions
•• equipment process settings
•• process times and temperatures
•• batch coding
•• CCPs and any other manufacturing process control points that have been identified in
the hazard and risk analysis.
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PACKAGING MATERIALS
ISSUE 6
Clause Requirements
Manufacturing instructions and process specifications must correctly reflect customer
requirements, such as final product specifications.
Staff must be trained in the requisite processes and procedures relevant to their role
(clause 6.1).
5.4.6 Documented process checks shall be undertaken at start-up, following adjustments to

equipment and periodically during production, to ensure products are consistently
produced to the agreed quality specification.
Interpretation Documented process checking

Processes must be adequately controlled and monitored to ensure that the final product is
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within specification. These may include CCPs or prerequisite programmes addressing
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issues such as temperature, time, pressure and chemical properties.
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The site is required to have documented the validated settings for use in processes, then to
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record the actual key critical process settings.

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The site should ensure that it has physical records of critical quality parameters. These
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should not only permit control adjustment to previously validated tolerances/settings,

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but also allow for trends to be seen. Furthermore they offer clear records for root cause
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analysis when quality issues are detected.

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Monitoring must be carried out at suitable frequencies based on experience of the

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quality. The frequency of checks should be included on recording forms and/or in

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procedure documentation. Process checking throughout the duration of production is

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good practice and can avoid having to scrap large volumes of packaging materials due to
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A record of all monitoring activities must be maintained.

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Where processes are shown to have exceeded defined limits, corrective actions must be
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taken and this action must be recorded.

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5.4.7 A documented clearance procedure shall be in place to ensure that at start-up the line is
clear of all previous work and production documents.
Interpretation Line clearance procedure

Documented checks carried out on the production line before production commences will
ensure that systems are correctly set and running. Checks, as a guide, will include
confirmation that lines have been:
•• suitably cleaned
•• cleared of any raw materials, packaging or work instructions from previous production
runs.
Line checks are usually the responsibility of the line manager or supervisor. Evidence that
checks have been carried out (e.g. line checklists) and guidelines on the checks to
complete should be available.
116 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
5.4.8 In the event of changes to product composition, processing methods or equipment, the
site shall, where appropriate, re-establish process characteristics and validate product data
to ensure that product safety, legality and quality are achieved.
Interpretation Re-establishing process characteristics

From time to time, the material composition of a packaging material may be altered; for
example, to influence its physical or barrier properties or for the processing of the material
to become more energy-efficient. When this occurs, it is imperative that the company
establishes whether the controls in place are appropriate and, if not, re-establishes those
process characteristics. The auditor will expect to see records to demonstrate that
processes have been validated following such changes.
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5.4.9 The documented line clearance procedure shall include:
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•• the roles of persons involved in line clearance
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•• areas where materials can become trapped
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•• validation of the line clearance

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•• sign-off for continuing production.

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The line clearance procedure shall be fully implemented for each production run.
Part II
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Interpretation In addition to what needs to be included within the line clearance procedure, the site needs
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to determine what constitutes a production run. For a continuous process a line change may
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therefore the need for the clearance procedure should be determined and documented.
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brcgs.com 117
PACKAGING MATERIALS
ISSUE 6
5.5 Calibration and control of measuring and monitoring devices
The site shall be able to demonstrate that measuring and monitoring equipment is sufficiently accurate and
reliable to provide confidence in measurement results.
Interpretation
Equipment is required to be properly calibrated at an appropriate frequency and by suitably qualified employees.
It is easy to believe test results, but if the equipment being used to take the measurements is not properly calibrated
then this can lead to a false sense of security and potentially unsafe products being manufactured.
Clause Requirements
5.5.1 The site shall identify and control in-line and off-line measuring equipment used to
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monitor critical control points (where applicable) and product safety, quality and legality.
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This shall include, as a minimum:
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•• a documented list of equipment and its location
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•• an identification code and calibration due date

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•• prevention from adjustment by unauthorised staff

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•• protection from damage, deterioration and misuse.

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Interpretation Identification and control of measuring devices

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The site needs to identify measuring equipment, such as micrometers, spectrophotometers

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and gauges, that are used to monitor CCPs, process manufacturing control points, and
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product safety, quality and legality. As a minimum this equipment must be:
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•• documented in a list
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labelling the equipment with a reference and its calibration due date, but any method of
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•• protected against unauthorised adjustment (e.g. through the use of programme ID codes
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The auditor will be looking for evidence that controls are in place, and the site should
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expect to demonstrate that results from calibrated equipment are accurate and consistent,
and that the equipment is appropriately maintained.
5.5.2 All identified measuring equipment shall be checked and adjusted at a predetermined
frequency, based on risk analysis. This shall be carried out by trained staff to a defined
method to ensure accuracy within defined parameters. All results shall be documented.
Where possible, calibration shall be traceable to a recognised national or international
standard. Where a traceable calibration is not possible, the site shall demonstrate the basis
by which standardisation is carried out.
118 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
Interpretation Risk-based calibration checks
Measuring equipment should be accurate and checked on a regular basis by suitably
trained personnel and to predetermined levels of accuracy that are appropriate to the
element being measured. The site needs to establish the method by which the equipment
is verified for precision and accuracy. This should include:
•• how frequently equipment needs to be checked, based on a risk assessment (e.g. historical
reliability and nature of use)
•• by whom it needs to be checked (i.e. trained staff)
•• where possible, traceability to a recognised national or international standard (e.g. use of
a master calibration thermometer that has a valid test certificate traceable to a national
standard).
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Example A site manufacturing steel beverage cans has a vision system set up on its line to detect
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evidence of physical contamination in the cans. The equipment is calibrated to detect items
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at 0.05 mm but the tolerance for foreign bodies agreed with the customer is 0.02 mm.
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The site has not set the accuracy of the check according to the measurements required.
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The auditor will not be satisfied that the site has met this requirement and a
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Part II
non‑conformity may be raised.
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5.5.3 Corrective action and reporting procedures shall be established and documented in the
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event of the monitoring and testing procedure identifying any failure of product
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inspection, testing or measuring equipment. Any such failures shall be subject to an

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equipment.
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Interpretation Faulty measuring equipment

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Documented procedures must detail the action to be taken when equipment is found to
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be non-functioning or operating outside of specified limits. The documentation must

specify what will be done and by whom, and must include what will happen to products
that have been monitored by this equipment since the last successful check (e.g. to prevent
potentially non-conforming products from being used by customers).
Identification of malfunctioning equipment should be logged and checked immediately and,
if appropriate, at the management review. It is important that any product manufactured
during the period of deviation is assessed for integrity and positively released.
Records must be kept of the actions taken.
Glossary
Example An internal audit on the calibration of measuring devices finds that the calibration records
of a vision system (used to check print and detect physical contamination) on a production
line are not available as a result of a systems failure that may indicate a deeper root cause.
The responsible person is notified and a corrective and preventive action plan developed
to manage and resolve the issue. The whole outcome of the report is shared with senior
management, as often it is only senior management who are able to make the human or
financial resources required.
An auditor would find this satisfactory as long as the objective evidence for corrective
action is available and preventive measures are in place.
brcgs.com 119
PACKAGING MATERIALS
ISSUE 6
5.6 Product inspection, testing and measuring
The company shall undertake appropriate inspections and analyses that are critical to product safety, legality,
integrity and quality.
Interpretation
Whether product inspection and testing are conducted in house or externally, analyses that are critical to confirm
product safety, legality and quality must be undertaken using appropriate methods (e.g. industry-recognised).
Any on-site laboratory facilities must be operated in a way that ensures they themselves do not pose a risk of
product contamination.
Clause Requirements
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5.6.1 Quality checks shall be carried out to demonstrate that the finished product is within the
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tolerances laid down in the agreed product specification and conforms to any critical
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technical/legal requirements.
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The frequency of checks and sampling shall be in accordance with industry-accepted

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practice or customer requirements and based on risk analysis.

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The site shall define how samples used for checking in-process quality are disposed of.
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This may be by returning to stock, regrinding/recycling, or segregation and disposal.

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Interpretation Quality checking during production

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particularly where the production run is long. The frequency and types of check will be
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determined by product type, material, run length, customer requirements and complexity
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of operations. Checks may also need to be carried out where goods have been stored as
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work in progress before production processes commence, to ensure no loss of integrity of

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carried out.
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Example A printer manufacturing labels for toiletries regularly prints large-volume runs for a
supermarket own-brand shampoo. The equipment used is fitted with a camera that is able
to check 100% of the printed materials.
The auditor would be satisfied that the site had implemented quality checks to
demonstrate that the product is produced within the agreed tolerances.
5.6.2 Hazard and risk analysis principles shall be used to determine the need for in-line product
testing equipment to ensure product safety, quality and legality.
120 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
Interpretation In-line testing equipment
The parts of the process which need in-line testing equipment are established following
the assessment of potential hazards and required process control. In-line testing and
measuring may be needed on the product itself – for example, strength or thickness
measurements – or on the environmental conditions. In all cases the parameter to be
measured should be clearly defined, as should the acceptable tolerance, frequency of
measurement, measuring equipment and means of recording results.
The methods of testing should be considered. In some cases, this could mean challenge-
testing (i.e. creating defective items and putting them in the production line) on a regular
but random basis, while in others, 100% testing may be possible. In each case, calibration is
essential in line with the requirements of clause 5.5. Auditors are likely to ask to view some
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of these records, such as control charts filled in by operators or automated electronic
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records.
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Automatic systems can be very useful but, if they are to be relied upon, checks should
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be in place to ensure that they function correctly. This clause calls for routine testing.
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The auditor will wish to understand how the interval between checking was established
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Part II
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5.6.3 The accuracy of in-line equipment shall be specified (with permitted tolerances), having
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due regard to the product parameter being controlled.

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it cannot be reliably used for measurements of 150°C. Similarly, if a balance has been
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5.6.4 The company shall establish, document and implement procedures for the operation,
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routine monitoring and testing of all equipment used in product inspection, testing and
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measurement. This shall include:

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•• frequency and sensitivity of checks

•• authorisation of trained personnel to carry out specified tasks
•• documentation of test results.
Interpretation Operation, routine monitoring and testing of equipment

Risk assessment may be used to establish the frequency and sensitivity of checks in order
to comply with this requirement, and measures should be taken to ensure that no
unauthorised personnel are able to adjust equipment. Test results need to be documented
and the auditor may ask to see this documentation to verify that procedures are operating
Glossary
effectively.
Where automated vision systems are in use, they should be challenge-tested with
appropriate samples to ensure correct function. The site should have a programme of
testing, but the auditor should view a challenge test and assess the outcome.
The rationale for the testing methods developed by the site should be relative to the
parameters being examined and ensure that the system is capable of identifying the
required level of contaminant or deviation from specification.
brcgs.com 121
PACKAGING MATERIALS
ISSUE 6
Clause Requirements
Example A glass-container manufacturer has a series of testing stations at the cold end of the
operation where the critical characteristics of the bottle are checked. The bottle is
pressure-tested to ensure it remains intact under pressurisation (e.g. for carbonated
beverages). The station that tests this is challenge-tested using a modified sample to the
critical limits that have been identified in the hazard and risk management plan. The test is
conducted every 20 minutes and the results documented.
The auditor would be satisfied that the company has established the hazard adequately and
can verify the validity of the test result.
5.6.5 Routine off-line quality checks shall be carried out at appropriate stages in production to
demonstrate that the product is within the tolerances laid down in the agreed product
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specification.
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A system that includes off-line or randomised quality checks shall be in place to identify
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and remove non-conforming product from the production lot.
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Interpretation Off-line quality checks

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product is conforming to customer requirements. This may happen once during production,
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often shortly after the start of production, or it may occur at regular intervals during long
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production runs. This clause formalises the process and requires that the site has a system
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in place to remove any identified non-conforming product discovered as a result.

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5.6.6 In-line testing equipment critical to product quality or safety shall incorporate a system to
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identify non-conforming product for removal or divert it out of the product flow.
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Interpretation Removing non-conforming product

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Where in-line testing is in place and can identify non-conforming product, a system should
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for later removal or by ejecting it from the production line. For example, a glass-bottle line
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with a piece of scanning equipment able to identify whether wall thickness is too thin
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inspects each bottle and ejects non-conforming bottles that are to be returned to the
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furnace.
5.6.7 Test methods, analytical methods and customer-approved reference samples (where
required) shall be of the most recent version and be available in the laboratory or where
off-line testing is conducted. Samples shall be suitably stored to avoid degradation.
Interpretation Ensuring test result reliability

It is easy to believe test results, but if the equipment being used to take the measurements
is incorrect, this can lead to a false sense of security and unsafe products. It is crucial that
the company has an ongoing system in place to verify that its test results are reliable.
5.6.8 The test methods used by the site in both on-line and off-line testing shall be validated to
ensure their sensitivity, reproducibility and range, in addition to any other relevant criteria.
Where standardised tests are used, the site shall ensure prescribed methodologies are
followed.
Where testing shows out-of-specification results, a documented procedure for
investigating these results shall be established and followed to determine whether the
cause is non-conforming product or a testing failure.
122 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
Interpretation Out-of-specification samples shall be re-tested to demonstrate analytical error, not to
reverse a previous result. Wherever testing is carried out, acceptable or action limits should
be established so that the results can be interpreted.
5.6.9 Where automated inspection equipment (e.g. vision systems) is used to check print or
other material features, the site shall establish and implement procedures for the operation
and testing of the equipment to ensure that it is correctly set up and capable of alerting or
rejecting the packaging when it is out of specification.
As a minimum, testing of the equipment shall be completed at:
•• the start of the production run
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•• a frequency based on the site’s ability to identify, hold and prevent the release of any
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implicated materials should the equipment fail (e.g. during the production run or when
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changing batches of raw materials).
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The site shall establish and implement procedures in the event of a failure in the
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equipment (e.g. a documented and trained manual checking procedure).

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Part II
Interpretation Automated inspection equipment testing
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if the product does not meet the required parameters it is effectively removed from the
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production line. In order for the system to function correctly it must be set up and
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challenged with the appropriate test print/material. This should be tested as a minimum at
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the start and end of a run. Additional testing during the run should be completed to ensure
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that if the equipment fails, the product manufactured during the failure period can be
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satisfactorily quarantined.
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5.6.10 Where the company undertakes or subcontracts an analysis critical to product safety or
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legality, the laboratory or subcontractors shall have gained recognised laboratory

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for the test undertaken (General requirements for the competence of testing and
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calibration laboratories). Documented justification shall be available where accredited

methods are not undertaken.
The significance of the laboratory results shall be understood and acted upon accordingly.
Interpretation Laboratory accreditation

An accredited laboratory is one that has been audited by the appropriate national
accreditation service to check that it operates in accordance with ISO 17025. There are
other national accreditation schemes but these generally follow the same principles. If a
laboratory is working to an alternative scheme, this can be accepted provided it has been
audited by a competent and independent third party and can show that it follows the
Glossary
requirements of ISO 17025.

The review of laboratory results should be recorded, noting the name of the person
undertaking the review and a record of any actions taken.
brcgs.com 123
PACKAGING MATERIALS
ISSUE 6
5.7 Control of non-conforming product
The site shall ensure that out-of-specification product is clearly identified and effectively managed to prevent
unauthorised release.
Interpretation
It is vital that non-conforming products or materials cannot be mixed up with ‘good’ items. All non-conforming
product must be identified, segregated and investigated. Non-conforming materials include any items that do not
meet the stated specification.
All rejected or non-conforming product must be physically segregated from fit-for-purpose product. The procedure
should cover how non-conforming product will be labelled or identified, with what information, how it should be
held in any electronic inventory system, and who has the authority to release it. Periodic testing of any electronic
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inventory control system of quarantined product should be in place and documented.
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The intent here is that anything that is quarantined cannot be inadvertently shipped to the customer.
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Example
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The manufacturer of printed flexible tubes for use with toiletries such as shower gels and body lotions manufactures a
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batch of tubes that are 10 mm longer than the specification. The batch is quarantined, labelled as ‘quarantined work in
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progress’, and the production team establishes that it can rework the batch to the specified requirements. Meanwhile,
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the team evaluates the production process to establish the cause of the occurrence, using a root cause analysis tool.
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The site has demonstrated that it has a procedure to manage the out-of-specification goods and to determine the
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Clause Requirements
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5.7.1 Clear procedures for the control of out-of-specification or non-conforming materials shall
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be in place, documented and understood by all personnel. These shall include the effective
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identification and management of materials before a decision has been made on their final
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Interpretation Management of non-conforming product

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A documented system must be in place that is well understood by personnel on site and
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which manages the physical identification of non-conforming product – for example, by

tags or locating the items in a segregated area of the warehouse.
The site may have various options for dealing with the non-conforming product and, although
these may not be stated in the procedure (as methods of disposition will vary from site to site
and customer to customer), the site must be clear on how it is to be treated and the safeguards
that must be in place to ensure it does not become mixed with ‘good’ product. This may
require controls on when and how non-conforming product can be introduced back into the
product flow, if necessary, or how it is to be destroyed to prevent misuse in the supply chain.
5.7.2 Non-conforming materials shall be assessed and a decision taken to reject, accept by
concession, rework or put to alternative use. The decision and reasons shall be documented.
Interpretation Disposition of non-conforming product

Wherever non-conforming product arises, the site must be clear on how it manages it,
whatever its final destination. The site might use a decision tree to help determine how to
manage the materials (depending on the nature of the non-conformity), but often the user of
the packaging materials will have significant input. The user may decide that they can accept
the materials after some rework or reject them as simply not acceptable. In each scenario the
site is required to document the reason for the action taken, as well as the action itself.
124 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
5.8 Incoming goods
The site shall ensure that incoming goods are appropriately checked for contents, packaging integrity and
potential contamination.
Interpretation
When any materials are brought onto the site, the site should ensure that the materials themselves are as required
and do not pose a risk to the integrity of the site and its activities. This may simply involve an initial visual check of
materials before they are brought into storage, but a more in-depth process may sometimes be needed. This will be
determined by the type of material being manufactured and the risk significance of the material.
This set of requirements applies to raw materials, intermediate goods (perhaps returning from a subcontractor) and
finished goods (and also to traded goods where applicable).
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Clause Requirements
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5.8.1 The site shall document a raw materials and intermediate product intake procedure to
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ensure that incoming goods match purchase or product specifications. This may take the
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form of:
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•• purchase orders
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Part II
•• delivery notes.
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Interpretation Intake procedure

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a site will accept a delivery of any type and ensure that the goods arriving match the
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requirements of the site. Compliance with this set of requirements may also be partially
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demonstrated through supplier approval, particularly where an ongoing relationship with a

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supplier of a single raw material means that this process is much more straightforward.
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5.8.2 There shall be a procedure for the inspection of loads on arrival to ensure that products
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are free from pest infestation, contamination or damage and are in a satisfactory condition.
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Unloading areas for bulk deliveries shall be clearly identified and designed to prevent
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product mix-ups.
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Regarding raw materials, all complaints or defects identified by the site shall be recorded
and investigated (including root cause analysis) and the results of the investigation
documented.
Interpretation Inspection of loads on arrival

The acceptance of goods must be clearly understood by those involved in the intake
process. In addition to checking the accuracy of the order to ensure the correct materials,
grades and quantities have been delivered, specific checks shall be made of loads to ensure
incoming goods are free from pests, contamination or damage.
Glossary
There shall be clear instructions relating to the offloading of bulk materials to ensure the
correct intake point is selected.
There shall be clear instructions on who is authorised to accept and reject non-conforming
materials.
brcgs.com 125
PACKAGING MATERIALS
ISSUE 6
Clause Requirements
5.8.3 The site shall have a procedure for the acceptance of raw materials. This may include a
valid certificate of analysis (CoA) or testing.
All raw materials awaiting the results of in-house testing or verification of data shall be
held until released for use.
Interpretation Acceptance of raw materials

Goods-in acceptance procedures must be fully implemented and therefore intake
personnel are expected to know the site’s procedure and be familiar with any testing,
sampling requirements or required certificates. The procedure may, for example, take the
form of a product acceptance matrix identifying each material’s acceptance criteria and,
where applicable, the sampling frequency. Results of appropriate raw material checks must
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be maintained.
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Raw materials awaiting test results must be clearly identified as not being available for use
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until they have been cleared for release. This can be achieved via warehouse management
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systems where raw materials are hidden from available stock or by way of physical labelling
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of raw materials.
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Receipt documents and/or product identification shall facilitate correct stock rotation of
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goods in storage and, where appropriate, ensure materials are used in the correct order and
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within the prescribed shelf life.

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Interpretation Stock, whether raw materials, intermediate products (items that are between processes) or
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finished products in storage, must be controlled to ensure that products are used in an
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appropriate order. Although raw materials for packaging rarely exceed their shelf life in a
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short amount of time, certain active materials for some applications may be most effective
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when ‘fresh’, and good practice generally demands a ‘first in, first out’ procedure.
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Receipt documents and/or product identification such as labelling will help facilitate
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5.8.5 The site shall have a system in place to validate all raw materials and intermediate products
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prior to their introduction to the process.
Interpretation Raw material and intermediate product validation

Sites shall have systems to ensure that raw materials and intermediate products have been
approved for use in processing. Approval can be achieved by acceptance confirmation of
the raw materials at the intake stage or by extracting details of the raw materials and
intermediate product identified either on the bill of materials or works order (or both).
Some sites may validate or test raw materials prior to use in processing.
The purpose is to ensure that the correct raw materials and intermediate products are used
to prevent a problem occurring further on in the process flow.
126 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
5.9 Storage of all materials and intermediate and finished products
The handling, management and storage of all materials and products shall minimise the risk of contamination or
malicious intervention, and protect product safety, quality and legality.
Interpretation
Products are at risk of contamination during storage and when they are being moved around a site or transported
off site. Off-site transport is often out of the control of the production site but, where the site has responsibility
for such transport, it must not introduce hazards and must take steps to remove any identified risks.
Clause Requirements
5.9.1 Procedures to maintain product safety and quality during storage shall be risk-based,
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understood by the relevant staff, and implemented accordingly. They shall include, as
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appropriate:
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•• instructions for the packing of finished product
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•• segregation of products where necessary to avoid cross-contamination (physical,

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microbiological or allergenic), mixing of sorts, or taint

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•• storage of product/materials off the floor and away from walls

Fr 9. tps
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Part II
•• specific handling or stacking requirements to prevent product damage.
D te ate
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Interpretation Storage of materials

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Risk assessment should determine the storage required on site for materials. It should take
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into account the product packaging and whether this minimises the risk of contamination
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and damage. As with clause 5.9.2, products should be identified and protected so neither
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can occur.
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Example A site converting paperboard purchases large reels of paperboard and because of their size
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and structure it stores these directly on the floor rather than on pallets. A risk assessment
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by the site determines that the outer wrapping and product from the base and top of the
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reels should be removed during set-up and during the converting/trimming process. This is
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deemed to be acceptable practice for the operation.

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The auditor will want to see evidence that the area where the large reels are stored is kept
in a hygienic condition. The floor area must be clean and free from debris to ensure that
there are no risks of contamination (e.g. pieces of wood that could pierce into the reels).
If the auditor is satisfied that the risk has been eliminated then this would be acceptable.
5.9.2 All materials, work in progress and finished product shall be properly identified and
protected during storage by appropriate packaging to protect them from contamination.
Interpretation Storage and identification of materials

A risk assessment will help to decide what level of protective packaging is required to
prevent physical, chemical or microbiological contamination of raw materials, work in
Glossary
progress and finished product. Packaging for the finished product may already be specified
by the customer, but the assessment will also determine whether the packaging is
appropriate for the purpose by examining any complaints of product contamination.
brcgs.com 127
PACKAGING MATERIALS
ISSUE 6
Clause Requirements
5.9.3 Storage, including off-site storage, shall be controlled to protect the product from
contamination, including taint or odour and malicious intervention. Where off-site storage
is used, the same site standards apply as for on-site storage.
Interpretation On-site and off-site storage facilities

The standards established for the storage of goods should be maintained throughout the
supply chain. The facilities should protect the product from contamination, including
through odour or taint.
Where storage is off-site but under the control of the company, the auditor needs to
observe the storage site in order for it to be part of the scope of the audit and certificate.
The site may opt to exclude such storage from the audit, in which case the exclusion
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should be clearly stated on the report and certificate.
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Should the site not meet the requirements as set out in the Standard a non-conformity
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must be raised.
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5.9.4 Finished or intermediate product storage shall meet customer requirements (with regard to
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first in, first out (FIFO) where applicable), with dispatch after positive release.
Fr 9. tps
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Where external storage of finished product is required, the product shall be suitably
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protected.
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Interpretation Sites must ensure that finished products or intermediate products are used/dispatched in
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date order.
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Where sites store finished products externally, consideration should be given to ensure
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that the products do not become contaminated; therefore they shall be adequately
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protected against damage or contamination.

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5.9.5 Packaging used for storage or dispatch of intermediate or finished products, such as pallets,
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shall be appropriately protected if stored outside and inspected for signs of damage or
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contamination prior to use.

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Interpretation Where sites store packaging (including pallets) externally, they should be protected from
contamination and weather damage. Prior to entry for use, such packaging should be
inspected for any sign of potential contamination or damage.
5.9.6 In order to prevent contamination, documented procedures shall be in place to

appropriately segregate raw materials, intermediate products and finished products.
Interpretation The focus of this clause is to ensure that raw materials, intermediate products and finished
goods are not mixed up, particularly where doing so may cause a hazard to product safety,
quality or legality. The auditor will need to see that the site has robust systems and
documented procedures in place to ensure that risks of mixing are mitigated.
128 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
5.9.7 The site shall ensure that hazardous chemicals are handled in such a way that risk to
product safety, quality and legality is minimised.
Interpretation Often, the safe handling of chemicals pertains only to mitigating the health and safety risks
for personnel. Here, the hazard concerns the packaging material being produced, on to
which taints could be transferred. Where chemicals including process chemicals, inks and
solvents are in use, care must be taken to ensure they are handled in a manner that
precludes their becoming injurious to human health if they were to come into contact with
packaging materials in concentrations that may be hazardous.
5.9.8 Material intended for recycling shall be appropriately protected against contamination
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hazards.
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Interpretation Protection of material intended for recycling
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Because materials intended for recycling often depend on being contamination-free, while
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being stored they should be offered the same protection as raw materials and intermediate
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and finished goods. They are not required to be kept indoors, but protection to the
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materials should be offered.

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Part II
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5.10 Dispatch and transport

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The dispatch and transport of raw materials and finished products shall be undertaken in a manner that
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minimises the risk of contamination or malicious intervention and maintains product safety, legality and quality.
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Interpretation
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The aim of this clause is to aid the user of packaging materials to reduce the risk of their physical, chemical and
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microbiological contamination by ensuring that, as such material leaves the site of manufacture, it is in a sound
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condition and suitable for use. This means that the product’s external packaging must be fit for purpose and able
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to keep it safe, clean and in a suitably hygienic condition until it reaches its destination.
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Customer complaints or feedback may be helpful here. If a customer has indicated any damage or issues with
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previous deliveries, this will help to develop more suitable packaging for future dispatches.
Clause Requirements
5.10.1 The company shall have procedures for the dispatch and transport of products, which shall
include:
•• any restrictions on the use of combined loads (e.g. where materials from other
companies are in the same transport)
•• requirements for the security of products during transit, particularly when vehicles are
parked and unattended away from a designated storage depot.
Glossary
Interpretation This clause requires the site to protect any products loaded onto vehicles from both
sources of contamination and possible malicious intervention. The site may communicate
its restrictions of use and security-in-transit requirements to all transport companies used
and obtain agreement that they will comply. Alternatively the site may request a copy of
the transport companies’ own procedures to ensure that the necessary controls are in
place before using them.
brcgs.com 129
PACKAGING MATERIALS
ISSUE 6
Clause Requirements
5.10.2 All products and materials shall be identified and either protected during distribution by
appropriate external packaging or transported under conditions to protect the product
from contamination. This shall include the risk of taint or odour and of malicious
intervention.
Interpretation Transportation of materials

Transportation and storage are often the weak link in the chain because the normal
controls that should protect the materials may not be in place. Therefore, it is essential to
ensure that goods are properly identified and protected before they leave the site, so the
company can show that it has taken reasonable steps to protect the materials from taint or
malicious intervention during transportation. Protective packaging may also help to
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ascertain whether there has been any malicious intervention.
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A risk assessment will assist in determining the required level of protective packaging.
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5.10.3 All pallets shall be checked. Damaged, contaminated or unacceptable pallets shall be
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discarded. Wooden pallets that come into direct contact with finished products or raw
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materials shall not be allowed to contaminate the product. Wooden pallets, if used, shall
Fr 9. tps
be sound, dry, clean and free from damage and contamination.

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Interpretation Wooden pallets

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This clause requires that all pallets used for finished products or raw materials are in a
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good condition. Poor-condition wooden pallets should be discarded because of the risk
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of product contamination.
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5.10.4 All company-owned or leased vehicles used for deliveries shall be included in the
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documented cleaning schedules and kept clean and in a condition that minimises the risk
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of product contamination.
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Interpretation Cleaning of company-owned vehicles

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Vehicles under the control of the company should be kept in a good condition, and an
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effective way to demonstrate this is to provide cleaning schedules and records.

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5.10.5 All delivery vehicles and shipping containers shall be subject to a documented hygiene
and odour checking procedure before loading.
Interpretation Hygiene checking procedures for delivery vehicles and shipping containers
A documented procedure must be in place which confirms that the vehicle or shipping
container to be used is clean and, where necessary, hygienic, thus preventing
contamination of the finished product.
Example During the factory inspection an auditor observes a delivery vehicle being loaded and asks
the employee what checks are carried out before loading. The employee states that he
checks that the products being loaded are secure and not damaged. He does not mention
the checking of the delivery vehicle.
Delivery vehicles and containers must be subject to a hygiene check before loading. In this
instance a non-conformity would be raised.
130 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
5.10.6 Where the company employs third-party contractors, there shall be a contract or agreed
terms and conditions. All the requirements specified in this section shall be clearly defined
in the contract or the company shall be certificated to the Global Standard for Storage and
Distribution.
Where this is not possible, with general carriers, the packaging shall be adequate to protect
the product against damage, contamination hazards, taint and odour.
Interpretation Third-party transport contractor agreements

Many packaging manufacturers do not have formal agreements with regular transport
companies, and instead use general carriers or express couriers, particularly where small
loads are dispatched on a regular basis. Where this is the case, the company needs to
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ensure that terms and conditions are in place. These are often met through the carrier’s
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terms and conditions, which are stated on carriage agreements or dispatch documentation.
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Sites producing direct food-contact or other hygiene-sensitive products should ensure
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that their regular transport contractors either meet the requirements set out in this section
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or are certificated to the Global Standard for Storage and Distribution.

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5.10.7
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Vehicle drivers shall comply with the site rules relevant to this Standard.
Part II
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Access to the site for third-party transport personnel shall be controlled and, where
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possible, facilities provided to negate the need to enter storage or production areas.
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Interpretation Vehicle drivers

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Where possible, facilities should be provided (see clauses 4.4.2 and 6.3.7) for third-party
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transport drivers. This requirement also applies to company-managed vehicle drivers, who
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should observe the same requirements as all staff.

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Glossary
brcgs.com 131
PACKAGING MATERIALS
ISSUE 6
6 Personnel
6.1 Training and competence: raw materials handling, preparation, processing, packing and
storage areas
Fundamental
The company shall ensure that all personnel performing work that affects product safety, legality
and quality are adequately trained, instructed and supervised commensurate with their activity and
that they are competent to undertake their job role.
Interpretation
People can be the most important component in ensuring the production of safe and legal products. They are also
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of major importance to the success or failure of an audit.
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In order to produce anything successfully, it is important that staff are competent, well trained and understand their
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duties. Auditors will expect sites to be able to show that staff meet these requirements, and they will interview and
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observe staff to assess the extent to which this requirement has been met.
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Auditors are likely to focus mainly on production, quality and technical staff, but others who could influence the
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products should also be considered – for example, dispatchers, cleaners and administrators taking orders. Temporary
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personnel must also be included, and where agencies are used for the provision of staff, all these requirements need to
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be adequately met and evidenced. This may include specifying company policies within any supply contract, obtaining
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evidence of staff training records from the agency prior to a staff member commencing work, and, for example, using a
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risk-based system to challenge the understanding of staff and ensure their competence in carrying out roles.
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Note that the requirements of this section apply to general duties as well as to specific job training. Basic
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understanding of a site’s procedures is as important as specialist knowledge. Misunderstanding the site procedures
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(for example, storing products in the wrong places, not using the correct tools, or not understanding the site
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requirements for hand-washing) may have a harmful effect on product safety, quality and legality.
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This is designated a fundamental requirement as effective training and robust competence are crucial to the
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implementation and maintenance of the requirements of the Standard.

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Clause Requirements
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6.1.1 All personnel, including temporary personnel and contractors, shall be appropriately
trained prior to commencing work and adequately supervised throughout the working
period. Induction training shall include the company hygiene rules.
Interpretation Initial training and supervision

To ensure that all relevant personnel adequately understand the role they are expected to
undertake while working within raw materials handling, preparation, processing, packing and
storage areas, the company needs to ensure that all employees, including temporary staff
and contractors, receive training to a level commensurate with their responsibility and the
type of work carried out. The following may be considered:
•• induction training for all staff, covering company policies on hygiene and quality
requirements, and the hazard and risk management system
•• training of the hazard and risk management team
•• training of those personnel involved with identified critical control points (CCPs) or
manufacturing process control points that are relevant to the areas in which they may work
•• training in areas that have an impact on product safety, such as cleaning, machine
operation, quality inspections and sampling
•• hygiene training (to be included in induction training).
132 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
All personnel, including temporary and agency staff, should be adequately supervised
throughout the working period, particularly with regard to the needs of temporary workers
and contractors. Good practice is for new starters to have additional supervision for a
defined period. This additional supervision can be reduced or removed at the end of the
period, following a review of the worker’s competency to fulfil the role.
6.1.2 Where personnel are engaged in activities relating to product safety, quality and legality,
relevant training and competency assessment shall be in place. This may include, but is not
limited to:
•• product inspection, testing and measuring
•• calibration
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•• printed packaging controls
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•• operatives at manufacturing process control points
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•• product defence.
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Interpretation Specific skill training

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Specific skill training should cover all tasks related to control points including all quality
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Part II
parameters that may create a safety issue. This is about broadening the focus solely from
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CCPs that could injure people to quality control points that prevent the creation of
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non-conforming products.
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To ensure that activities identified as CCPs within the hazard analysis and risk assessment
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are managed correctly, personnel involved in these activities must be appropriately trained
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in the procedures. This includes the operation of controls, monitoring activities and
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corrective actions. Clear, documented instructions must be available, detailing:

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•• how to carry out the tasks

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•• when the task is to be completed

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•• records to be maintained
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•• action to be taken in the event of a non-conforming result.

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A competency assessment must take place on completion of the training and at predefined
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intervals (e.g. during CCP internal audits). The assessment needs to:
•• confirm that the procedure is followed correctly
•• test knowledge of corrective actions
•• check completion of relevant training.
6.1.3 The site shall define and document how new or changed procedures, working methods and
practices related to product safety or quality are communicated to relevant personnel.
Interpretation It is important that when procedures, working instructions and practices are updated they
Glossary
are communicated effectively to the relevant personnel. Sites are required to document
how this is achieved; for example:
•• staff briefings on updated procedures, work instructions and practices with attendance
recorded
•• evidence within training records of the updated version of a procedure or work
instruction recorded
•• requesting that all relevant staff sign the updated procedure or work instruction and that
this is kept as a record of completion.
brcgs.com 133
PACKAGING MATERIALS
ISSUE 6
Clause Requirements
6.1.4 The company shall routinely review and document the competencies of all staff and
provide relevant training as appropriate. This may be in the form of training, refresher
training, coaching, mentoring or on-the-job experience.
Interpretation Ongoing competency

Initial training is essential, but the company must also ensure that its personnel
comprehend the training given and can demonstrate competency on a continuing basis.
This ongoing assessment may take place in many ways (e.g. through one-to-one appraisals,
team performance monitoring by line managers, review of results of internal audits or
record review). Where the need is identified, there must be appropriate refresher training,
coaching, mentoring or on-the-job experience to improve skills and understanding.
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Example An auditor is visiting a paper-carton factory and asks an operative what her duties are with
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regard to packing the cartons into outer boxes. The operative does not appear to
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understand and is not packing in the same way as operatives on other lines. The auditor
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seeks clarification from the supervisor and is told that the operative, whose first language is
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not used on the site, is new and has been sent by an agency as a temporary worker to help
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with a backlog of rework.

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The auditor raises a non-conformity. The site must have a way of ensuring that all workers
D te ate
are competent and clearly understand their job. In this case, some hands-on training,
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followed by a sign-off after the operative has demonstrated competence, would be

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appropriate.
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6.1.5 Records of training shall be available. These shall include:

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the name of the trainee and confirmation of attendance

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•• the date and duration of the training

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•• the title or course contents, as appropriate

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•• the training provider (external or internal provider).

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Where training is undertaken by agencies on behalf of the company, records of the training
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shall be available.
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Interpretation Training records

All evidence of training needs to be kept. It must include the name of the trainee and
confirmation of attendance, date and duration of the training, title or course contents, and
the name of the training provider. All this information may be included in the certificate of
attendance provided at an external or internal course. Alternatively, the course contents
(e.g. personnel induction booklet) may be kept and cross-referenced with a record of
training that states the attendee’s name, the course date(s) and the name of the trainer,
together with the name of any translator.
It is important to ensure that appropriate training records for any temporary staff or
external consultants, as well as workers recruited through agencies, are also available for
a visiting auditor to check.
134 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
6.1.6 The site shall put in place documented programmes covering the training needs of relevant
personnel. These shall include, as a minimum:
•• identifying the necessary competencies for specific roles
•• providing training or other action to ensure staff have the necessary competencies
•• reviewing the effectiveness of training and trainers
•• the delivery of training in the appropriate language of trainees.
Interpretation Documented training programme

The site is required to have a documented training programme where job role
competencies are identified, actions are undertaken to ensure that staff obtain these
competencies, and a review of the effectiveness of these actions is carried out.
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For example, a job training matrix could be used to list all job roles on site together
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with details of which procedures and work instructions are required for each role.
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Training must be delivered in an appropriate language for the trainee (e.g. by providing
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either written or oral translation where it is required). It is not a requirement for all
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documentation to be translated into every language of the workforce, but it is a

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requirement that all staff can understand the instructions necessary for their job.
Fr 9. tps
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Part II
Hygiene rules may be provided in written translations or in pictorial format, and CCP
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monitoring instructions may be translated into languages spoken by staff deployed in

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these areas.
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Training may be delivered by internal or external resource, but the company needs to retain
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overall control and ensure that the training has been effective. Assessment of the ability of
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staff to undertake their designated tasks can be achieved, for example, by testing their
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knowledge or by on-the-job appraisal.

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Example A factory operative is asked by the auditor about methods of adjusting a computer-
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controlled cutting machine. The operative doesn’t appear to know. When asked, the
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supervisor produces evidence that the operative was sent on an external course to learn
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about the machine. On further questioning, it appears that the operative did not
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understand the course, did not go back for the second day of instruction, and no evaluation
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questionnaires about the course were completed.

The operator could not demonstrate competence or adequate training and a non-
conformity would be raised.
Example The test laboratory in a factory has just bought a new piece of equipment, a micrometer,
to test material thickness. The laboratory supervisor used a similar machine several years
ago but others are not familiar with it. An in-house training session has been arranged with
the supplier, and all staff will complete the training before commissioning the new
equipment. The laboratory has also signed up to a correlation trial to ensure that its results
are reliable.
Glossary
This is a satisfactory way of addressing an issue when no-one on site has the required
competence to carry out training.
brcgs.com 135
PACKAGING MATERIALS
ISSUE 6
6.2 Personal hygiene: raw materials handling, preparation, processing, packing and storage areas
The site’s personal hygiene standards shall be developed to minimise the risk of product contamination from
personnel. These standards shall be appropriate to the products produced and be adopted by all personnel,
including agency-supplied staff, contractors and visitors to the production facility.
Interpretation
This set of requirements encompasses good manufacturing practices (GMP) and prerequisites for a hazard and risk
management plan. All personnel entering raw materials handling, preparation, processing, packing and storage areas
must adhere to the company’s personal hygiene rules, which must be written down following assessment of risk to
product in those areas.
This section is fairly prescriptive in its requirements. It is necessary not only to meet the requirements but also to
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monitor their implementation and take action on any lapses. The auditor will observe compliance with this
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requirement throughout the course of the audit and will expect to see that any policies drawn up by the company
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are adhered to by all staff at all times.
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Clause Requirements
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6.2.1 The requirements for personal hygiene at sites producing materials for direct contact with
Fr 9. tps
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food or other hygiene-sensitive products shall be documented and communicated to all

D te ate
personnel. These shall include, as a minimum, the following instructions:

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•• wrist bands, wrist-worn devices or watches shall not be worn

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•• jewellery including piercings shall not be worn on exposed parts of the body, with the
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exception of a plain wedding ring, wedding wristband or medical alert jewellery

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•• fingernails shall be kept short and clean and free from nail varnish
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•• false fingernails and nail art shall not be worn

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•• excessive perfume or aftershave shall not be worn.

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Requirements at sites producing materials that will not come into contact with food or
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hygiene-sensitive products shall be based on risk assessment.

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Compliance with the site’s requirements shall be checked routinely.

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Interpretation Documented hygiene policy

Where a site does not manufacture products for direct contact with food or other
hygiene‑sensitive products, a documented risk assessment is required to show the site
has considered the risk of product contamination from personnel.
Clear guidance must be given to all personnel on site regarding the hygiene requirements
and what can and cannot be worn in the relevant areas. The company may choose to
enforce requirements in addition to those stated in the Standard. Exceptions should be
minimal and not constitute a risk to the product (e.g. wristbands identifying a particular
medical condition may be worn where product safety and legality are not at risk).
Only plain wedding rings/wristbands (i.e. without any stones that may fall out) or
continuous-loop sleeper earrings (hoops) are permitted to be worn. The reason sleeper
earrings are permitted is because there is much less chance of the earring falling out and
contaminating the packaging. Where religious reasons prevent the removal of an item of
jewellery it must be covered and the site must complete a risk assessment to confirm how
this will be achieved (e.g. by being totally covered either by the wearer’s normal clothing or
by overalls).
136 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
The potential for broken, damaged or lost glasses and contact lenses to become a
foreign‑body hazard should be considered, as this could compromise product safety,
quality and legality. Watches are not permitted.
These requirements are applicable equally to all areas related to the production and
storage of raw materials, intermediate products and finished goods.
Example A company that manufactures dispensers (lotion pumps and aqueous sprays) employs a
member of staff who has non-removable facial piercings. These were permitted by a
previous quality manager as he had established by risk assessment that the piercings posed
no risk of contamination to the product.
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Under this requirement, the person’s jewellery would not be acceptable. No jewellery
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except as described could be acceptable and a non-conformity would be raised.
01 ve te.
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6.2.2
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Hand-washing shall be performed on entry to the production areas and at a frequency that
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19
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is appropriate to minimise the risk of product contamination.

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Interpretation Hand-washing
Fr 9. tps
When entering production areas, all personnel, including visitors, temporary staff and
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Part II
contractors, must wash their hands. Hand-washing is the single most effective method to
D te ate
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mitigate the risk of contaminants from hands.

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Additional hand-washing may be required through the course of time in the production
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area. Personnel should feel motivated to maintain clean hands and have sufficient
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awareness of the impact of poor hand hygiene on product to do so.

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If sites do not have hand-washing facilities at the entrance to the production areas, wash
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stations should be installed when other provisions for hand-washing are not adequate.
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If toilets are the only facilities for the cleaning of hands, the site must be able to
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demonstrate that they are suitably accessible to personnel and are therefore used by all
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staff. A small number of wash basins cannot be said to adequately serve hundreds of
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employees at the start of a work shift. Similarly, wash basins in toilets that are located away
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from the production area cannot be said to be suitably accessible.

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The site should risk-assess the frequency of hand-washing and provide the auditor with
evidence that the assessment has been completed and the results communicated to staff.
6.2.3 Personal items and belongings, including personal mobile phones, shall not be taken into
production areas without the permission of the management.
Interpretation Personal items

Good manufacturing practice doesn’t usually allow personal items to be taken into areas
related to the production of goods. However, some company policies allow certain
Glossary
personnel to use their personal mobile phones in production areas in lieu of

company‑issued equipment. This may be particularly relevant in large sites and where
communication is required throughout production runs.
The auditor would expect to see a documented procedure/instructions where this has
been permitted.
brcgs.com 137
PACKAGING MATERIALS
ISSUE 6
Clause Requirements
6.2.4 The site shall use risk assessment to determine the procedures and written instructions
necessary to control the use and storage of personal medicines in production and storage
areas, to minimise the risk of product contamination.
Interpretation Personal medicines

Personal medicines need to be controlled to ensure they do not constitute a risk to
product, and therefore the site will be expected to have documented procedures.
Where there is a need for staff to keep personal medicines with them (e.g. for asthma or
diabetes) and therefore to take medicines and equipment into production areas, suitable
control procedures must be in place. The format and packaging of the medicines
(e.g. glass vials or bottles) should be considered in order to minimise the risk of product
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contamination.
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Example An operative on a machine in a large corrugated paper factory suffers from asthma.
5
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The company has conducted a risk assessment to establish the risk of keeping his medicine
us s R ar
19
ug ht sp
(an inhaler) close to the machine in case of an asthma attack. The assessment concludes
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that the inhaler poses no risk and can be kept on the monitoring station.
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Fr 9. tps
This would be acceptable according to the requirements of the Standard.

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D te ate
6.2.5 Where visitors cannot comply with site hygiene rules, suitable control procedures shall be
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in place (e.g. non-handling of product, use of gloves).

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Interpretation Fingernails
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Long or false fingernails are a potential source of physical contamination because they may
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break off, and hence are not permitted; neither are varnished nails, nails displaying nail art
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or false nails. Fingernails should be kept clean, commensurate with the level of hygiene
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expected within the production and storage environment.

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Where visitors cannot comply with these rules, other controls such as limiting where they
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may enter, what they may touch and the use of gloves must be implemented to minimise
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the risk of contamination.

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The requirements must be communicated to all personnel (e.g. through induction training
for staff and sign-in procedures for visitors and contractors). Consideration must be given
to staff who are non-native speakers and appropriate methods of training (e.g. use of
translators) must be provided for them.
Compliance with this requirement must be checked regularly. This could be done by
incorporating checks into daily/weekly GMP audits, or through challenge/questioning of
personnel at regular intervals.
6.2.6 All cuts and grazes on exposed skin shall be covered by an appropriately coloured plaster
that is different from the product colour (preferably blue). These shall be site-issued and
monitored when people are involved in work with materials intended to come into direct
contact with food or other hygiene-sensitive products. Where appropriate, in addition to
the plaster, a finger stall or glove shall be worn.
138 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
Interpretation Cuts and grazes
Cuts and grazes on exposed areas of skin must be covered to prevent contamination of
product.
To minimise the potential for plasters (band aids) to contaminate the packaging material,
the wearing of such plasters shall be controlled by the site and covered by an issue
procedure (e.g. numbering the plasters and documenting in a log when and to whom they
were issued). This applies to sites producing packaging material that will come into direct
contact with food or other hygiene-sensitive products.
Plasters should be visually distinct, preferably blue (although a colour significantly
different from that of the packaging may also be used) and include a metal detectable strip
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so that further steps in the manufacturing chain may locate them if they become detached
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from the wearer.
01 ve te.
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5
Finger stalls (a sheath to protect the whole finger dressing, often available in blue plastic)
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19
or gloves shall also be worn in addition to the plaster where deemed necessary.
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Tattoos are typically classed as open wounds for 2 weeks post-ink and shall be covered.
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Fr 9. tps
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Part II
D te ate
6.3 Staff facilities

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Staff facilities shall be sufficient to accommodate the required number of personnel and shall be designed and
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operated to minimise the risk of product contamination. Such facilities shall be kept in a good and clean condition.
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Interpretation
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This clause focuses on staff facilities from the perspective of eliminating product contamination. There may be
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other requirements relating to the health, safety and well-being of staff, but these are not part of the scope of the
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Standard.
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Staff facilities should enable workers to adhere to company policies; for example, by having the correct storage of
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protective clothing and personal belongings to ensure product contamination risk is kept to a minimum. Adequate
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facilities must be provided to accommodate temporary as well as permanent staff.
Clause Requirements
6.3.1 Locker rooms shall be accessed without the need to enter production areas unless
appropriately segregated walkways are in place.
Interpretation Locker room location

The location and position of locker rooms should be considered to ensure product
integrity is not at risk from possible microbiological or chemical contamination caused by
employees or their food and personal effects.
Glossary
A risk assessment should establish whether adequate measures are in place to manage
potential food safety or hygiene hazards.
6.3.2 Lockers shall be provided for all personnel who work in raw material handling, processing,
preparation, packing and storage areas. Lockers shall be of sufficient size to accommodate
all reasonable personal items and any protective clothing required.
brcgs.com 139
PACKAGING MATERIALS
ISSUE 6
Clause Requirements
Interpretation Storage of personal items
In order to prevent personnel from bringing personal items into production and storage
areas (where they could become foreign objects), sufficient and suitably secure storage for
personal belongings must be provided. Procedures for the storage of bulky objects such as
motorbike leathers and helmets as well as smaller items such as jewellery and
confectionery should also be considered.
The Standard is not too prescriptive on this matter and solutions commensurate with the
size and complexity of the site are acceptable.
6.3.3 Site-issued protective clothing and personal clothing shall not be stored in the same
locker or shall be appropriately segregated based on risk within the locker.
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01 ve te.
Interpretation Segregation of protective and personal clothing
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It is essential that clean workwear is not contaminated by being placed next to outdoor
5
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19
clothing and other personal effects. Auditors may ask to view storage areas, the provisions
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for storage and the risk assessment that has determined the form that effective segregation
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takes.
Fr 9. tps
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Segregation is often achieved by:

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•• using a locker with a divider to separate work clothing from personal clothing
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•• enclosing protective clothing in a bag, such as a laundry bag, before use

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•• providing a separate area for hanging up work clothing or protective clothing.

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Where relevant, clean protective clothing may also need to be segregated from dirty
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protective clothing to prevent cross-contamination (e.g. through the provision of separate

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locker areas or a dedicated collection point for dirty laundry, as stated in clause 6.5.9).
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Example A small company printing labels has a locker room for its staff. This provides each member
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of staff with a single locker for personal belongings and personal clothing. Coat hooks are
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provided to store in-use protective clothing and a separate cupboard is used to store the
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site’s clean protective clothing.

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The auditor will be satisfied that a suitable and sufficient physical separation is in place.
6.3.4 Eating (including the eating of confectionery and chewing of gum or tobacco), drinking and
smoking shall not be allowed in locker and changing rooms.
Interpretation Eating, drinking and smoking in locker rooms

No food is permitted in storage, processing or production areas (as set out in clause 6.3.8),
but the locker or changing room may be regarded as an appropriate place for the clean and
hygienic storage of food brought from home, provided no risk is presented to the product
as a result.
However, eating, drinking and smoking are prohibited in these areas as the potential for
cross-contamination between production and non-production areas is generally regarded as
much greater, particularly where staff need to remove their protective clothing before breaks.
Staff are expected to demonstrate diligence in hand-washing before returning to storage,
processing and production areas. The site’s documented procedures should reinforce this.
All food and drink must be consumed in designated locations away from product handling,
production and storage areas. Where appropriate, designated outside areas can be provided
for staff to eat food; where provided, these must have measures in place to control waste.
140 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
6.3.5 Suitable and sufficient hand-washing facilities shall be available to enable cleaning of
hands before commencing work, after breaks, and as necessary during the course of work.
Such hand-washing facilities shall provide, as a minimum:
•• sufficient quantity of water at a suitable temperature to encourage hand-washing
•• unscented liquid soap or foam
•• adequate hand-drying facilities
•• advisory signs to prompt use (including signs in appropriate languages).
Where materials are handled that will be in direct contact with food or other
hygiene‑sensitive products, hand-washing facilities shall be sited at the entrance to
the production area.
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Interpretation Hand-washing facilities
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Hand-wash basins shall be dedicated for hand-washing. At sites where there is direct
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contact with food or other hygiene-sensitive products, the facilities must be located at the
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19
ug ht sp
entrance to the production area. They should contain, as a minimum:

, A Rig rcg
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•• appropriate instructions for use, considering the language needs of staff (e.g. including
Fr 9. tps
pictorial instructions)
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Part II
•• water in sufficient quantities and at a suitable temperature (comfortably warm is about
D te ate
45ºC or 113ºF)
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•• liquid or foam soap solution

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•• suitable hygienic hand-drying facilities (either single-use hand towels or suitably

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designed and located hand driers). Where single-use towels are used, consideration
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should be given to the location and design of appropriate bins.

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For sites not producing packaging materials for direct contact with food or other hygiene-
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sensitive products (where the hand-washing facilities are not available at each entrance
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but provided within toilets as the only means for hand-washing before re-entering
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production), the requirements listed above will apply to the toilet areas.
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6.3.6
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Toilets shall not open directly into storage, processing or production areas in order to
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prevent the risk of contamination to product. Toilets shall be provided with suitable and
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sufficient hand-washing facilities.
Interpretation Toilet facilities

Toilet facilities must not open directly into storage, processing, production or packing
areas and must be equipped to enable staff to maintain good hand-washing practice,
particularly where toilets contain the only facilities for the washing of hands. Where this
is the case, appropriate mechanisms should be in place to ensure effective hand-washing,
as set out in clause 6.3.5.
Example A small high-hygiene site providing labels for the food industry has limited space to install
Glossary
additional hand-washing facilities and the only ones for the site are located in the toilets.
The company has confirmed that its products do not come into direct contact with food
or hygiene-sensitive products, and the risk assessment concludes that there is limited risk
of contamination of the labels. The toilets are situated at the main entrance to the
production area.
The auditor will be satisfied that the facilities provided are sufficient for the level of risk
associated with the product.
brcgs.com 141
PACKAGING MATERIALS
ISSUE 6
Clause Requirements
6.3.7 Facilities for visitors and contractors shall enable compliance with the site’s hygiene policy.
Interpretation Visitor and contractor facilities

Whatever facilities have been provided for regular staff should also be available to visitors
and contractors to meet the site’s hygiene policies.
6.3.8 All food brought into manufacturing premises shall be stored in a clean and hygienic state.
No food shall be taken into storage, processing or production areas.
Interpretation Personal food storage

Suitable storage facilities must be provided for food brought onto the site by staff,
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enabling it to be stored in a hygienic manner. No food is allowed to be taken into storage,
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processing or production areas as it may constitute a risk to the product, and it must be
01 ve te.
adequately controlled when stored in other areas.
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In countries where refrigerators in the home are the norm, the provision of refrigerators in
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the workplace would be expected. They should be kept clean, maintained and operating at
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an appropriate temperature.
Fr 9. tps
Refrigerators for personal food storage must not be located in production or production-
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D te ate
related areas, nor in areas for the storage or processing of raw materials or finished product.
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Example During an audit in a high-hygiene site, an operative is observed removing a container of

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food from a refrigerator situated in the production area and taking it into the staff canteen
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facilities. The site representative states that the refrigerator is only for the use of staff and
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is located in the production area because the canteen manager does not want it located in
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the canteen.
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This is not acceptable. The Standard states that no food should enter the production area
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and a non-conformity will be raised.

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6.3.9 Eating (including the eating of confectionery and chewing of gum or tobacco), drinking and
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smoking shall not be allowed in the production or storage areas. If it is impractical for
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personnel to leave their work area, local controlled facilities (such as a fully walled area
with hand-washing facilities) shall be provided.
Interpretation Control of eating and drinking

Particular manufacturing techniques or environments necessitate larger production
facilities where, for example, leaving the area for short breaks is impractical. At sites
producing packaging materials for direct food contact or hygiene-sensitive products, all
food and drink must be consumed in designated places away from raw materials handling,
production, processing or storage areas. These places may be fully walled areas with the
appropriate facilities to ensure that the activity presents no risk of contamination to the
product under manufacture.
6.3.10 Drinking of water from purpose-made dispensers and/or by using disposable conical cups
or spill-proof lidded containers may be allowed, provided it is confined to a designated
area away from equipment.
142 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
Interpretation Water dispensers
In some industries it is necessary to permit the drinking of water by personnel in
production areas because of the nature and conditions in the production environment
(this does not necessarily represent poor manufacturing practice). Should water dispensers
be deemed necessary by the company, they should be positioned so that they present no
risk of contamination to the packaging material or the process.
Where larger drinking containers are used, the possibility of condensation and the
proximity of these containers to activity associated with the packaging materials should be
considered.
Example A large glass-container manufacturing site has three furnaces and operates 24 hours a day,
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365 days a year. The site permits food and drink to be consumed on the production floor at
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the hot end of the operation, in designated positions away from the forming and
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production equipment. The company has conducted a risk assessment to determine the
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position of the eating facilities, as it is not possible for personnel to leave the equipment
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for long breaks. Water dispensers are also positioned in the production area to allow
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personnel to remain hydrated in the hot environment.

Fr 9. tps
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Part II
This sort of activity is normal in the glass industry. The company has used risk assessment
D te ate
to determine the best position for the consumption of food and drink and the auditor
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should be satisfied that it meets the requirements of the Standard.

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6.3.11 Where smoking is allowed under national law, it shall only be permitted in designated
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controlled smoking areas which shall be isolated from production and storage areas and
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fitted with extraction equipment to the exterior of the building. Adequate arrangements for
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dealing with smokers’ waste shall also be provided at smoking facilities, both inside
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buildings and at external locations.

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The use of electronic cigarettes and associated materials shall not be permitted in locker
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rooms, nor in production or storage areas, and shall only be permitted in designated
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smoking areas.
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Interpretation Smoking areas

Facilities in line with national legislation must be provided for staff wishing to smoke.
These facilities must not be located within the packing or production areas, nor where
smoke could reach product or raw materials. Indoor facilities must have sufficient
extraction to the exterior of the building.
Procedures for the wearing of protective clothing and hand-washing must be in place
whenever staff enter or leave production and packing areas; therefore suitable facilities for
staff to remove their protective clothing before smoking and for washing their hands
afterwards must be provided. Signs must direct them to the hand-washing facilities.
Glossary
There must be sufficient and appropriately positioned facilities for the collection of waste
generated by those persons smoking.
Where electronic cigarettes (e-cigs) are permitted on site, instructions for use must comply
with national and local legislation. Electronic cigarettes must not be taken into storage,
processing or production areas.
brcgs.com 143
PACKAGING MATERIALS
ISSUE 6
6.4 Medical screening
Sites that manufacture packaging for direct contact with food or other hygiene-sensitive products shall ensure
that documented procedures are in place to ensure that health conditions likely to adversely affect product
safety are monitored and controlled.
Interpretation
To ensure that everyone who will come into contact with packaging materials intended for use in direct contact with
food or other hygiene-sensitive products during production and storage is not themselves a hazard, the company
should have procedures in place by which health conditions can be monitored and controlled.
Sites manufacturing packaging materials not intended to come into contact with food or other hygiene-sensitive
products should use risk assessment to determine whether the ill-health of employees, visitors or contractors is
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likely to adversely impact their products.
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Clause Requirements
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6.4.1 Where there is handling of materials intended for direct contact with food or other hygiene-
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sensitive products, the site shall make employees aware of the symptoms of infection,
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disease or condition which would prevent a person working. The site shall have a procedure
Fr 9. tps
for the notification by personnel, including temporary personnel, of any relevant infections,
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diseases or conditions with which they may have been in contact or be suffering from.
D te ate
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Employees, contractors and visitors suffering from any of the above shall be excluded from
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work involving the handling of direct food contact or other hygiene-sensitive product
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packaging for as long as the symptoms persist.

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Interpretation Notification of medical status

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The site must ensure that personnel do not constitute a risk to product by coming to work
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while either suffering from an infection or having the potential to contract an infection
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after being in contact with someone suffering from a specified illness. The company is
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expected to define the infections of concern, as advised by local legislation (e.g. from a list
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of communicable diseases).
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The company must have a policy for staff to notify their relevant manager of any potential
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for contracting these infections. The company may also consider the use of a return-to-
work medical questionnaire as being appropriate to the risk.
In some geographical areas, investigating the medical status of personnel is prohibited by law
and in such circumstances the company would be expected to facilitate the self-declaration
of medical status from personnel without discrimination. The site may first establish what
sorts of medical conditions pose a potential source of infection and which areas of the site
are most vulnerable to contamination by such infections. Appropriate measures must be
introduced, such as personal hygiene rules requiring staff to notify a manager if they are
carrying or have a condition which may result in transmission of the disease to the packaging.
The personnel do not need to declare what they may be suffering from or carrying.
Many routes may be used for this purpose: signage at entry points around the relevant
areas; availability of supervisory personnel; or nomination for work in areas deemed least
vulnerable to contamination from an infectious source.
It is possible that many companies producing packaging materials may declare their site as
not vulnerable to typical sources of infection, disease or medical conditions by a hazard
analysis and risk assessment, but this should not prevent the company from having a
procedure of notification of medical status by staff, as the nature of microbiological
contamination is not fixed and the effects may not be known.
144 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
6.4.2 Where permitted by law, visitors and contractors shall be required to fill in a health
questionnaire or otherwise confirm that they are not suffering from any symptoms which may
put product safety at risk, prior to being allowed into production, packing or storage areas.
Interpretation Notification of medical status of visitors and contractors

In many cases, this requirement is met through a health questionnaire at the designated
visitors’ point of entry on site, such as reception. This may either be a separate form or
make up part of the visitor’s identification badge.
It is essential that the information given on the questionnaire is taken note of and
appropriate action taken if the visitor is found to cause a hazard to product safety or quality.
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Example A site manufactures wide-mouth glass containers, such as jars for jam. It has established
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01 ve te.
the sorts of infection that may be critical to the safety and integrity of its packaging and
, 2 er ipa
includes training on the symptoms of these conditions for its staff during induction
5
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19
training and also on refresher courses. Signage is also present in locker and changing rooms
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to remind staff, who are requested to alert their team leaders if they are suffering from any
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of the symptoms identified.

Fr 9. tps
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The company has identified those conditions that present no risk to the product at, or prior
Part II
D te ate
to, the hot end of the glass factory, due to the high temperatures and production
.c ip icip
conditions involved. However, the cold end of the operation is subject to restrictions,
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particularly as two of the six finishing lines require staff to manually pack large specialist
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containers onto pallets.

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Visitors and new employees or agency staff are required to complete a health
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questionnaire before entering the production areas.

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The site has used risk assessment to establish the likely hazards to its packaging materials
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at different stages in the process and has taken steps to minimise or reduce the hazard
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occurring. The site has also equipped staff and visitors with the knowledge to determine
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whether they may present a risk to the packaging materials.

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The auditor would find this satisfactory as the site has used risk assessment to identify the
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areas where staff and visitors may pose a risk.
6.4.3 Medical screening for sites producing materials that will not come into direct contact with
food or other hygiene-sensitive products shall be implemented on the basis of risk.
Interpretation Risk assessment

Sites producing materials intended for secondary or tertiary (transit) packaging should use
risk assessment to determine what screening or declarations are required in order to
mitigate any hazard to the product and, in turn, the consumer. Risks may be minimal, but
sites should also take note of any specific customer requirement which may be influenced
Glossary
by the method of filling or the facility the materials will be used in.
Example A site producing outer-case cartons for use by food manufacturing companies has
completed a risk assessment of the need for medical screening and has concluded that as
the products manufactured are for food products that have already been fully packaged
prior to their use, the site does not require medical screening of its staff or visitors/
contractors. The risk assessment has been documented.
The auditor would expect to review the risk assessment to ensure that the products
produced at the site are secondary/tertiary packaging before accepting this risk assessment.
brcgs.com 145
PACKAGING MATERIALS
ISSUE 6
6.5 Protective clothing
Appropriate protective clothing shall be worn in production and storage areas to minimise the risk of product
contamination.
Interpretation
Protective clothing includes uniforms, overalls, head coverings (such as hats and hairnets), shoes and boots, and
gloves. Clothing of a suitable design must be provided to staff, visitors and contractors by the company.
Protective clothing protects the product from contamination. This set of requirements utilises hazard and risk
analysis to determine whether a site needs to enforce the wearing of particular types of protective clothing.
Risk assessment establishes whether there are any additional hazards to the safety, integrity or legality of the
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packaging material from staff not wearing protective clothing. Where protective clothing is not required, the auditor
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will expect to see a robust risk assessment supporting such a stance while complying with any mandated specifics.
01 ve te.
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Note that this clothing does not refer to personal protective clothing that protects the employee from health and
5
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safety hazards. This set of clauses refers to clothing that protects the product from the worker.
us s R ar
19
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Clause Requirements
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6.5.1
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Hair coverings and/or beard snoods, where appropriate, shall be worn in production areas at
D te ate
sites manufacturing materials for direct contact with food or other hygiene-sensitive
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products.
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Hazard and risk principles shall be used to determine the need for any other protective
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clothing, including garments and footwear in areas handling raw materials, and in
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preparation, production and storage areas.

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Where risk assessment has determined that protective clothing is not required in a
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particular area, it shall be fully justified and not pose a contamination risk to the product.
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Interpretation Protective clothing and risk assessment

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Hair coverings for all staff in production areas are required at sites manufacturing materials
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intended for direct contact with food or other hygiene-sensitive products. The site should
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also establish rules for the wearing of beard snoods.

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The company is required to determine, based on risk assessment, the procedures for the
application and use of additional protective clothing. Should the company establish that only
minimal additional protective clothing is required in the production area, the auditor will
expect to see a robust risk assessment supporting such a stance. Additional protective items
may be needed if the risk assessment deems them necessary, such as coverings for arms.
The risk assessment should consider foreign-body and chemical contamination risks as
appropriate, as well as general good-practice principles, such as removal of protective
clothing before entering toilets or break rooms, or before smoking.
Any clothing that is provided as protection must not, in itself, present a contamination risk
to the products. Own clothes may be worn as long as they do not pose a risk to the product
and comply with protective clothing requirements.
146 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
Example A site manufacturing polypropylene tubs and lids for use with butters and margarines has
conducted a risk assessment to determine the need for protective clothing in addition to
hair coverings. It establishes the need for such clothing, which should not have pockets on
the upper-body garments or sewn-on buttons, in line with the requirements of its
customers who fill the containers. The site reaches this conclusion on the grounds that
there is a risk that hair, items in pockets or sewn-on buttons could enter the product and
may not be detected prior to filling.
The company has looked at its process and the processes of its customers in order to
establish the need for protective clothing.
Example A site that does not manufacture direct food contact or hygiene-sensitive packaging
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materials has determined that no protective clothing is required; however, the site rules
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state that staff can only wear their own clothing as long as it has no embellishments on the
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The auditor checks for evidence of adherence to this rule on the site tour and concludes
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that this rule is acceptable for this particular site.

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6.5.2
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The company shall use risk assessment to determine, document and communicate to all
Part II
D te ate
employees, including temporary personnel and contractors, the rules regarding the wearing
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of protective clothing in all situations, including:

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•• during the journey to work

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•• in raw materials handling, preparation, production and storage areas

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•• when away from the production environment (e.g. removal before entering toilets,
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canteen or smoking areas).

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Interpretation Wearing of protective clothing

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The site is required to use risk assessment to determine when any protective clothing must
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be removed in order to retain the integrity of that clothing and of the manufactured
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packaging material.
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Rules about the wearing of protective clothing must be documented and adequately
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communicated, understood and adhered to by employees. The auditor will be looking for
evidence that the site’s rules are part of the induction and refresher training, and that staff
comply with them when arriving on site, when using the canteen or smoking areas, and on
returning to work.
The Standard is not specific about the rules, recognising that each site will have its own
unique set of circumstances; the risk assessment approach will help to determine what
those rules should be.
6.5.3 Where protective clothing is required, appropriate clean protective clothing that cannot
Glossary
contaminate the product shall be worn. Sufficient sets of clothing appropriate to the
activities being carried out shall be provided.
Interpretation Provision of protective clothing

The company needs to consider the quantity of clothing that personnel may reasonably be
expected to maintain in an acceptable condition for work (e.g. to allow time for washing).
This clause may be stated as non-applicable where no need for reusable protective
clothing has been identified.
brcgs.com 147
PACKAGING MATERIALS
ISSUE 6
Clause Requirements
6.5.4 Protective clothing worn in production areas shall provide adequate coverage. Where there
is handling of materials intended for direct contact with food or other hygiene-sensitive
products, the clothing shall have no external pockets on the upper-body garments or
sewn-on buttons. Changes of such clothing shall be available at all times as required.
Interpretation Upper-body protective clothing

The company needs to consider the design of protective clothing and, where direct
food-contact or other hygiene-sensitive materials are handled, the clothing should not
have any external pockets or sewn-on buttons; this will reduce the potential for foreign-
body contamination through normal production activity.
This requirement applies to an employee’s own clothing as well as to company-supplied
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protective clothing.
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6.5.5 , 2 er ipa
Based on the assessment of risk to the product, suitable footwear shall be worn within the
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factory environment.
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Interpretation Footwear
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Fr 9. tps
The company must consider the requirement for particular types of footwear to be worn in
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production areas and must also provide footwear that can be kept clean where it is deemed
D te ate
necessary.
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6.5.6 If gloves are used they shall be replaced regularly, be distinctive, intact and not cause a
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contamination risk to the product.

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Interpretation Protective gloves

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The gloves themselves may present a risk of physical contamination; therefore it is

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essential that the company has sufficient control procedures in place, such as regular
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inspection and replacement of gloves, to ensure that they are intact and do not shed loose
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fibres. The company should consider the design of gloves and the need to be disposable;
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the gloves should be of food grade where appropriate, and of a visually distinct colour from
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the product (preferably blue).

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6.5.7 Protective clothing shall be kept clean and laundered. Laundering shall be carried out by
one of the following methods:
•• professional laundry service
•• in-house
•• controlled laundering facilities
•• home laundry.
Interpretation Laundering
The Standard specifies that protective clothing must be kept clean and laundered.
The clothing may be cleaned in a number of different ways: by contracting the services
of a specialised laundry; by laundering in house; or by the employee washing it at home.
The appropriate method should be determined using hazard and risk analysis, with
consideration given to the potential for physical, chemical or microbiological
contamination through each route.
Where a contracted laundry is used, it should be incorporated into the company’s
purchasing supplier approval programme.
148 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
Where protective clothing cannot be laundered (e.g. gloves, shoes and aprons), the site
should use risk assessment to determine whether the clothing presents any risk to the
product; worn or dirty clothing should be replaced as necessary.
6.5.8 Where home laundry is permitted, the site shall ensure that:
•• employees have received written instructions regarding the laundering process to be
used and these shall be reinforced as part of an induction or other in-house training
programme
•• employees shall be provided with a bag or other suitable means to safely transport
washed garments from home to the workplace
•• there shall be a defined process within the site for monitoring the effectiveness of the
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system
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•• there shall be a procedure and system for dealing with any case where employees are
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unable to perform home laundry effectively, either through lack of diligence or
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19
inadequate facilities.
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Interpretation Home laundry

Fr 9. tps
Home laundering may be the simplest option for many companies; however, this needs to
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Part II
be controlled by written instructions to employees that include how garments are to be
D te ate
washed (temperature, detergent, specifying items not to be washed together, and drying
.c ip icip
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instructions). Staff must be provided with a suitable means to safely transport garments
pa tic rt
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from home to the workplace (sealable plastic bags or similar).

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There must be a defined responsibility within the company for monitoring the effectiveness
tro gh rom
of the system. This is typically achieved by visual inspection. There must also be a procedure
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and system for effectively dealing with any cases where employees are unable to do the
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laundry themselves, through either lack of diligence or absence of facilities. This system must
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be capable of being brought into immediate effect once a problem has been identified.
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6.5.9 Clean and dirty clothing shall be segregated and controlled to prevent cross-
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contamination.
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Interpretation Segregation of clean and dirty clothing

Because of the potential for cross-contamination, clean protective clothing must be
segregated from dirty protective clothing (e.g. through provision of separate locker areas,
as per clause 6.3.3).
6.5.10 Disposable protective clothing, if used, shall be subject to adequate control to avoid
product contamination.
Interpretation Disposable clothing

Where disposable protective clothing is used, the company needs to consider how it will
Glossary
be disposed of. This requirement may be met by placing labelled bins at every entrance/
exit where personnel can discard used items. Further disposal of the items must also be
considered to ensure that they do not contaminate new items, and that they are
appropriately removed from the site.
brcgs.com 149
PACKAGING MATERIALS
ISSUE 6
7 Requirements for traded products

Interpretation
Where a site purchases and sells packaging products that would normally fall within the scope of the Standard and
are stored at the site’s facilities, but which are not manufactured, further processed or packed at the site being
audited, the site’s management of these products shall be covered by the requirements in this section.
All the relevant requirements from sections 1 to 6 must also be fulfilled in addition to the requirements outlined in
this section.
7.1 Approval and performance monitoring of manufacturers/packers of traded packaging products
The company shall operate procedures for approval of the last manufacturer or packer of packaging products
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which are traded to ensure that traded packaging products are safe, legal and manufactured in accordance with
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any defined product specifications.
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Interpretation
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All traded packaging materials brought onto the site must be sourced from approved suppliers who are regularly
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monitored for their performance. The risk assessment should focus more on those products and suppliers that
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Fr 9. tps
present a greater risk (in terms of safety, legality and quality).

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D te ate
Clause Requirements
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7.1.1
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The company shall have a documented supplier approval procedure which identifies the
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process for initial and ongoing approval of suppliers and the manufacturer/processor of
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each product traded. The requirements shall be based on the results of a risk assessment
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which shall include consideration of:

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•• the nature of the product and associated risks

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•• customer-specific requirements
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•• legislative requirements in the country of sale or importation of the product

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•• the brand identity of the products (i.e. customer own brand or branded product).
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Interpretation Supplier approval and monitoring system: risk assessment

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For easier management, sites could choose to integrate the approval process for their
suppliers of traded products with that of their raw materials suppliers, or organise the
suppliers of traded products as a separate workstream.
All suppliers of traded products must be evaluated on the basis of a risk assessment for
their ability to meet the specifications of the products they are supplying to the
certificated site; in particular, the requirements for safety, quality and legality. For example,
the assessment should consider:
•• known hazards associated with the product provided (e.g. microbiological, chemical or
foreign-body risks). Access to reference information and an awareness of emerging issues
are essential to ensure all known risks are assessed
•• customer or legislative requirements (e.g. suppliers may be specified by customers, but
this does not negate the need for risk assessment). Legislation in the country of expected
sale should be considered
•• geographic origins (products from particular countries may carry a greater risk because of
environmental conditions, more relaxed local legal requirements or a less developed
product safety culture)
150 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
•• the potential for fraudulent activity or product defence issues in the supply chain
(e.g. undeclared additions, dilution or substitution of the raw material or a component
of it). The outcome of this activity must also be considered when assessing the
requirements for supplier approval and monitoring procedures.
7.1.2 The company shall have a procedure for the initial and ongoing approval of the
manufacturers of products. This approval procedure shall be based on risk and include
either one or a combination of:
•• a valid certification to the applicable Global Standard or other GFSI-benchmarked
standard. The scope of the certification shall include the products purchased
•• supplier audits, with a scope to include product safety, traceability, hazard and risk
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management systems review and good manufacturing practices, undertaken by an
9 d. co
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experienced and demonstrably competent product safety and quality management
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auditor. Where this supplier audit is completed by a second or third party, the company
t 2 es tic
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shall be able to:
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—— demonstrate the competency of the auditor

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—— confirm that the scope of the audit includes product safety, traceability, HARA review
Fr 9. tps
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Part II
and good manufacturing practices
D te ate
—— obtain and review a copy of the full audit report.

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By exception, and only where a valid risk-based justification is provided, initial and ongoing
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approval may be based on:

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•• a historical trading relationship supported by documented evidence of performance

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reviews demonstrating satisfactory performance

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•• a manufacturing site questionnaire which has been reviewed and verified by a

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demonstrably competent person

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•• a specific customer requirement to supply product from a manufacturer where liability is

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with the customer.

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Interpretation Supplier approval and monitoring system: approval procedure

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The company must document its procedure for supplier approval and monitoring. This needs
Su
to include the methods of approval, frequency of monitoring, staff responsibilities and how
the process will be managed.
Approval will be dependent on the product and the risks associated with it and will include
one or more of the following activities:
•• certification to the relevant BRCGS scheme (Packaging, Storage and Distribution, or
Agents and Brokers) or a GFSI-benchmarked scheme. The site must confirm the validity
of the certification. This will include:
—— confirmation of the certification status (this could be confirmed on an independent
Glossary
database; for Global Standards it can be confirmed at www.brcgsdirectory.com).

Photocopies of certificates are not recommended and on their own are not considered
suitable validation of certification status.
During the BRCGS audit the site may be asked to demonstrate its validation process.
—— confirmation that the certification remains up to date (e.g. by receiving confirmation of
successful completion of the recertification process or by recording certificate expiry
dates and completing checks for ongoing certification)
—— confirmation that the raw materials are within the scope of the certification.
brcgs.com 151
PACKAGING MATERIALS
ISSUE 6
Clause Requirements
•• a successful site audit which, at a minimum, covers product safety, traceability, hazard and
risk analysis, and good manufacturing processes. This audit must be completed by an
appropriately experienced and competent auditor (i.e. someone who has completed
training in auditing techniques, has experience of auditing, and has knowledge of the
product, ingredient or processes being audited).
Non-conformities should be addressed (e.g. in an agreed action with timescales) unless
they are critical to product safety or legality, in which case supply should not be permitted
until non-conformities have been satisfactorily addressed. If the supplier is audited to a
standard that is not GFSI-benchmarked, this may be acceptable providing that:
—— the scope of the audit meets the requirements of the Standard
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—— the site has a copy of the full audit report, not just a certificate
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—— the site can demonstrate the competence of the auditor.
01 ve te.
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Where the risk assessment (completed as part of this clause) indicates that a supplier is
t 2 es tic
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19
low risk (because of the history of trading with the site, the nature of the products traded
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etc.), the completion of a supplier questionnaire with a focus on food safety and quality
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may be sufficient. If a supplier questionnaire is the only mechanism used to assess a

Fr 9. tps
supplier (i.e. there are no additional activities such as supplier audits), then it is important
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that the questionnaire (and the replies from the supplier) contains all the relevant
D te ate
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information to allow the site to confidently make a decision on approval.

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The auditor will expect to see, and will challenge, any risk assessments that determine that
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suppliers have been deemed to be low risk.

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7.1.3 Records shall be maintained of the manufacturer’s or packer’s approval process, including
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audit reports or verified certificates confirming the product safety status of the
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manufacturing/packing sites supplying the products traded. There shall be a process of

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review, and records of follow-up of any issues identified at the manufacturing/packing sites
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with the potential to affect packaging products traded by the company.

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Interpretation Records of approval

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The site is required to maintain records of the approval process along with the evidence
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used to approve that supplier.

Approval and associated risk assessments must be up to date and the site should therefore
review the supplier assessment whenever there is an issue at the manufacturing site.
7.1.4 There shall be a documented process for the ongoing review of manufacturers or packers,
based on risk and using defined performance criteria, which shall include:
•• complaints
•• results of any product tests
•• regulatory warnings/alerts
•• customer rejections or feedback.
The process shall be fully implemented.
152 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
Interpretation Ongoing monitoring
As much as it is important to know how and why suppliers are approved, it is also vital to
ensure that ongoing approval is justified. The site is free to determine how it confers
continuing approval on its suppliers, but it must ensure that the supplier’s performance is
matching its own food safety objectives.
The defined performance criteria can be determined by the site and these may include:
•• punctuality of deliveries against planned delivery times
•• incidences of contamination
•• quality of material supplied.
Frequency of ongoing approval is also left for the site to determine. The site should be
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able to demonstrate to the auditor that the monitoring it uses is appropriate, justified and
01 ve te.
risk-based. Examples of different types of monitoring will be required.
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7.2 Specifications
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Specifications or information to meet legal requirements and assist customers in the safe usage of the product
Part II
D te ate
shall be maintained and available to customers.

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Interpretation
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A finished product specification must exist for all traded packaging materials to ensure that legislation requirements
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and customer expectations are met.

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Clause Requirements
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7.2.1 Specifications shall be available for all products. These shall either be in the agreed format
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as supplied by the customer or, where this is not specified, include key data to meet legal
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requirements and assist the customer in the safe usage of the product.
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Specifications may be in the form of a printed or electronic document, or part of an online

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specification system.
Interpretation Product specifications

Specifications for all products must be provided and adequately detailed. They must
include the defined data for all parameters critical to the safety, legality and quality of the
product. The specifications may be in the format provided by the supplier or in the
company’s own format, as long as the information controlling the product’s safety, quality
and legality are clearly defined.
7.2.2 The company shall seek formal agreement of the specifications with relevant parties.
Glossary
Where specifications are not formally agreed, the company shall be able to demonstrate
that it has taken steps to put an agreement in place.
Interpretation Formal agreement of specifications

Customer-branded finished product specifications must be formally agreed and, wherever
possible, signed by both parties. However, where signature or approval is not formally
available, proof that specifications have been issued (such as an email request for formal
acknowledgement or specifications) is required. In this situation the site must be able to
demonstrate it is following a formal process agreed with its suppliers.
brcgs.com 153
PACKAGING MATERIALS
ISSUE 6
Clause Requirements
7.2.3 Companies shall operate demonstrable processes to ensure that any customer-specified
requirements are met. This may be by inclusion of customer requirements within buying
specifications or by undertaking further work on the purchased product to meet the
customer’s specification (e.g. sorting or grading of product).
Interpretation Customer requirements

Many customers have specific requirements relating to product safety, quality and legality
and the site needs to ensure that it is aware of and understands them (e.g. by retaining
copies of relevant customer’s policy documents or service level agreements).
The site must also have a mechanism for ensuring that these requirements are met.
For example, by communicating with the relevant suppliers of products, by incorporating
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the information in specifications, or by recording minutes of review meetings in which the
9 d. co
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requirements are agreed with the supplier.
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Occasionally the site may arrange for additional work to be completed on the product
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19
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before it is sent to the customer. Good practice is to ensure that any changes to the
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requirements are communicated and agreed in a timely manner.

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Fr 9. tps
7.2.4
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Specifications shall be reviewed whenever products/packaging or suppliers change or at

D te ate
least every 3 years. The date of review and the approval of any changes shall be recorded.
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Interpretation Review of specifications

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Specifications must be reviewed whenever changes occur to the product, process or

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composition.
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Where no known changes have occurred, the specifications should be reviewed at least
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every 3 years, or more frequently if required, to ensure they remain completely up to date
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and accurate. Evidence that a review has been completed needs to be available and this
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should be achieved by the addition of a signature and date to the specification or by the
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use of a matrix showing specifications and the latest review date and reviewer.
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The control of the amendment and approval of specifications should be laid down in a
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documented procedure. The procedure should also detail who can approve the
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amendments.
Some sites, companies or customers use cloud-based services which are able to notify the
user when there has been a change to the data. In this case the site should have a
mechanism to review the specification/change to understand whether there is any impact
on the product.
154 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
7.3 Product inspection and laboratory testing
The site shall operate processes to ensure that the products received comply with buying specifications and that
the supplied product is in accordance with any customer specification.
Interpretation
The company needs to identify and schedule critical inspections and analyses for its traded products. These may
include:
•• identification of known product safety risks associated with the product type
•• assessment of legal requirements, particularly those associated with the country of intended sale (where known)
•• assurance of product integrity (e.g. where a genuine risk of adulteration, substitution or fraud has been identified
during a vulnerability assessment)
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•• inspection of quality attributes (e.g. where these form part of a specification agreed with the customer).
9 d. co
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The frequency and types of inspection and analysis are not prescribed by the Standard but should be risk-based and
, 2 er ipa
5
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specific to the type of products.
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ug ht sp
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Clause Requirements
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Fr 9. tps
7.3.1 The site shall use risk assessment where product sampling or testing is required to verify
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Part II
that the products are in accordance with buying specifications and meet legal and safety
D te ate
requirements.
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Where verification is based on sampling, the sample rate and assessment process shall be
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risk-based.
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Records of the results of assessments or analysis shall be maintained.

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Interpretation Product tests

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The company needs to have a documented schedule of product sampling or assurance

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tests which are carried out on the products.

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The objective of product tests is to ensure that products are manufactured to specification
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and in compliance with safety and legislative requirements. The frequency and type of
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product tests should be based on risk and on any particular customer requirements.
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They may, for example, include:

•• quality tests (e.g. size and shape, colour or performance characteristics)
•• safety tests (e.g. chemical or microbiological, or tests to confirm legality)
•• customer-specific requirements based on the specification or the customer’s contract
with the company.
The site should be able to explain and justify the basis for the frequency of tests with
reference to historical or scientific information as appropriate.
Good practice is for the test method and specifications to be documented. Where the
Glossary
results of a test are not quantitative, colour standards or reference samples must be used
to provide a reference point for the test results (i.e. to define pass/fail criteria).
Where tests are completed on site, the location of the testing should be considered;
for example, laboratory facilities will need appropriate siting and controls.
brcgs.com 155
PACKAGING MATERIALS
ISSUE 6
Clause Requirements
7.3.2 Where verification of conformity is provided by the supplier (e.g. certificates of conformity or
analysis), the company shall use risk assessment to determine whether periodic independent
product analysis may be required to ensure confidence in the information provided.
Interpretation Verification of conformity

The company must be able to demonstrate that each product meets the legal requirements
for its use.
Products are often traded with supporting evidence provided by the supplier; for example,
in the form of a certificate of analysis or certificate of conformity relating to the specific batch
or lot of product supplied. Where these are used, they must be supported by procedures to
substantiate the reliability of the information using independent product analysis.
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The frequency of this periodic assessment should be based on risk assessment that considers
01 ve te.
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the likelihood of an error occurring and the potential consequences if the error occurred.
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19
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7.3.3 Where claims are made about the products being handled, including the provenance, chain
, A Rig rcg
of custody or assured status of a product, supporting information shall be available from

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the supplier or independently to verify the claim.

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Interpretation Status verification of products

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The types of claim covered by this clause relate to the provenance of products that
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•• specific product characteristics, such as mineral oil or BPA-free

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•• assurance claims, e.g. Forest Stewardship Council (FSC) or Programme for the
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Endorsement of Forest Certification (PEFC).

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products of the supplier on a database. Reliance solely on a declaration from a supplier will
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not be sufficient.
Such claims are limited in the packaging industry, but specific customer requirements may
indicate that evidence of compliance with this clause should be available.
7.3.4 Where the company undertakes or subcontracts analyses which are critical to product
safety or legality, the laboratory or subcontractors shall have gained recognised laboratory
accreditation or operate in accordance with the requirements and principles of ISO 17025.
Documented justification shall be available where non-accredited test methods are used.
Interpretation Analyses critical to safety and legality

This clause applies to tests which are critical to product safety or legality. Results from
such tests must be credible and may be called upon in a court of law.
The company needs to identify which tests are critical to product safety or legality, such as
compliance with label claims/declarations and tests for contamination (e.g. mineral oils).
Note that while the laboratory itself may have accreditation, the actual test methods must
also be accredited. Any method of analysis that is not accredited needs justification as to
why it was used (e.g. it may be a method for which no accreditation is yet available).
156 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
Where critical tests are carried out by non-accredited laboratories (either contracted or
on-site laboratories), there must be suitable documentary assurances that the laboratory is
working to the requirements and principles of ISO 17025. This must include confirmation
of the laboratory’s procedures to meet the following general principles:
•• staff competency and documented training
•• documented test methodology based on accepted standards
•• equipment that is fit for purpose and appropriately calibrated
•• a documented quality assurance programme, including paired testing, ring testing etc.
•• completion of internal audits of the laboratory’s operation.
7.3.5 Test and inspection results shall be retained and reviewed to identify trends. Appropriate
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Interpretation Reviewing test results
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Systems of recording and review must be formalised and include evidence of actions taken
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charts of test results provides a good method of identifying trends and anomalous results.
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7.4 Product legality

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The company shall have processes in place to ensure that the products traded comply with the legal
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requirements in the country of sale where known.

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7.4.1 The company shall have documented processes to verify the legality of products which are
traded. These shall include, as applicable:
•• labelling information
•• compliance with relevant legal compositional requirements
•• compliance with quantity or volume requirements.
Where such responsibilities are undertaken by the customer, this shall be clearly stated in
contracts.
Interpretation Legal compliance

Glossary
Products traded must meet all the legal requirements for the intended country of use.
The site must therefore have processes to ensure it remains up to date with requirements
(such as labelling in that country) and that these requirements are met and fulfilled.
As a minimum the Standard requires labelling, composition and quantity or volume
requirements as applicable depending on the product being considered.
Where labelling is not controlled by the company but is the responsibility of the customer, this
shall be clearly stated in contracts. Good practice is to ensure that all the relevant information
is transferred to the customer and that any changes are communicated in a timely manner.
brcgs.com 157
PACKAGING MATERIALS
ISSUE 6
7.5 Traceability
The company shall be able to trace all product lots back to the last manufacturer and forward to the customer of
the company.
Interpretation
In keeping with the traceability requirements for manufactured and processed products, sites that trade packaging
materials are required to maintain traceability, allowing its customers and authorities to withdraw or recall products
that have been identified as unsafe.
The system must ensure that products supplied to customers are adequately labelled or identified to facilitate
traceability.
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Traceability details need to be retained in a format that allows access in a timely manner.
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Clause Requirements
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7.5.1 The site shall maintain a traceability system for all batches of product which identify the
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last manufacturer or packer of the product. Records shall also be maintained to identify the
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recipient of each batch of product from the company.

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Interpretation Identification of product

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Products may be identified by physical labelling or through the use of computerised

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bar-coding systems or radio-frequency identification (RFID). The level of traceability must

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be able to identify the supplier of the product and to whom it is supplied (i.e. one step
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forward and one step back). This will enable the product to be identified if a particular
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batch needs to be recalled.

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of products) should be considered. For example, if batches or lots of product are broken
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down into smaller consignments for individual customers, is all the necessary information
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available to the customer (i.e. was there any additional information on the original outer
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packaging that the customer would need to ensure traceability, and can the site confidently
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Strict controls on identification, traceability and segregation are also required to preserve
the integrity of any claims made. Where logos are used that make specific claims about
production systems (e.g. scheme assurance), full traceability and validations must be
demonstrated.
7.5.2 The company shall test the traceability system at least annually to ensure that traceability
can be determined back to the last manufacturer and forward to the recipient of the
product from the company. This shall include identification of the movement of the
product through the chain from the manufacturer to receipt by the company (e.g. each
movement and intermediate place of storage).
158 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
Clause Requirements
Interpretation Tests of the traceability system
The site’s traceability system for traded products must be tested at least annually.
Traceability testing may be completed as part of a real product recall or withdrawal
scenario if one has occurred, since the objective is to test the system and identify areas for
improvement, rather than supply records of a ‘test’ for its own sake.
The system must provide traceability ‘forwards’ and ‘backwards’; therefore, the system
should be tested in both directions. For example, a product could be selected and traced
forward to show to whom it was dispatched.
Further information on the content of the BRCGS audit, including the vertical audit, can be
obtained from the BRCGS guide to auditing techniques. The guide may be purchased from
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the BRCGS bookshop (www.brcgsbookshop.com) or viewed online at BRCGS Participate
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Interpretation Traceability results

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The test of traceability should be timed and full traceability would be expected to be
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achieved within 4 hours, unless information is required from external parties, such as
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suppliers. This is to reflect the need for rapid traceability in the event of a recall. Where
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traceability takes longer than 4 hours, the areas where the retrieval of information is slow
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The tests must also include a reconciliation of quantities (sometimes referred to as a

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usage of a full batch of product. This helps to ensure that the traceability systems are
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•• Select a batch code of a particular specific product.

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•• Identify the quantity of product received under that batch code.

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•• Identify the customers purchasing that product and the amounts each received of the
specific batch.
•• Calculate the quantity of any unused part of the batch in the warehouse.
•• Reconcile the quantity received against the amounts sold plus any residual unused stock.
Glossary
brcgs.com 159
PACKAGING MATERIALS
ISSUE 6
Glossary
accreditation The procedure by which an authoritative body gives formal recognition of the
competence of a certification body to provide certification services against a specified
standard.
agent A company that facilitates trade between a site or company and its raw material or
packaging suppliers or its customers through the provision of services, but does not at
any point own or take title to the goods.
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allergen A known component which causes physiological reactions due to an immunological
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response.
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announced audit An audit where the company agrees the scheduled audit day in advance with the
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certification body.
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artwork The elements that constitute a mechanical drawing, supplied as type, proofs and
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illustrations.
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audit A systematic examination to measure compliance of practices with a predetermined

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system, and whether the system is implemented effectively and is suitable to achieve
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objectives, carried out by certified bodies.

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auditor A person possessing the appropriate competence and skills to carry out an audit.
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batch A discrete quantity of products made using the same operation and raw materials
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(alternative term is ‘lot’).

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brand owner The owner of a brand logo or name who places the said logo or name onto retail
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branded product Products bearing the logo, copyright or address of a company that is not a retailer.
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broker A company which purchases or ‘takes title to’ products for resale to businesses
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(e.g. manufacturers, retailers or food service companies) but not to the ultimate
consumer.
calibration A set of operations that establish, under specified conditions, the relationship between
values of quantities indicated by a measuring instrument or measuring system, or values
represented by a material measure or reference material, and the corresponding values
realised by standards.
certificate suspension Revocation of certification for a given period, pending remedial action on the part of
the company.
certificate withdrawal Where certification is revoked. Certification may only be regained following successful
completion of the full audit process.
certification The procedure by which an accredited certification body, based on an audit and
assessment of a company’s competence, provides written assurance that a company
conforms to a standard’s requirements.
certification body Provider of certification services, accredited to do so by an authoritative body and
registered with BRCGS.
160 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
clause A specific requirement or statement of intent that a site must comply with in order to
achieve certification.
company The entity with legal ownership of the site which is being audited against a Global
Standard.
competence Demonstrable ability to apply skill, knowledge and understanding of a task or subject to
achieve intended results.
compliance Meeting the regulatory or customer requirements concerning product safety, legality
and quality.
consumer The end-user of the finished product, commodity or service.
consumer product Non-food products normally bought or supplied to wholesale and private consumers
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for personal, business or household use, and included within the scope of the Global
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Standard for Consumer Products.
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contamination Introduction or occurrence of an unwanted organism, taint or substance to packaging,

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food or the food environment. Contamination includes physical, chemical, biological

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and allergen contamination.

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contract packer A company that packages the final product into consumer packaging.
Part II
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contractor or supplier A person or organisation providing services or materials.

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control To manage the conditions of an operation to maintain compliance with established

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criteria, and/or the state wherein correct procedures are being followed and criteria are
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being met.
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control measure Any action or activity that can be used to prevent or eliminate a product safety hazard
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controlled document A document which is identifiable and for which revisions and removal from use can be
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correction Action to eliminate the cause of a detected non-conformity.

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critical control point (CCP) A step at which control can be applied and is essential to prevent or eliminate a food or
product safety hazard or reduce it to an acceptable level.
cross-docking Material is unloaded at distribution premises, and handled, but not formally put away
into storage. This may be a staging area where inbound materials are sorted,
consolidated and temporarily stored until the outbound shipment is complete and
ready to ship.
customer A business or person to whom a service or product has been provided, either as a
finished product or as a component part of the finished product.
Glossary
customer focus A structured approach to determining and addressing the needs of an organisation to
which the company supplies products and which may be measured by the use of
performance indicators.
decoration An addition, adornment or embellishment applied to a material; may contain legally
required text.
dispatch The point at which the product leaves the factory site or is no longer the responsibility
of the company.
brcgs.com 161
PACKAGING MATERIALS
ISSUE 6
distribution The transportation of goods within any container (goods on the move) by road, rail, air
or ship.
exclusion Not included in the scope of the audit: this can be a physical area of the certificated
site or a product category.
flow diagram A systematic representation of the sequence of steps or operations used in the
production or manufacture of a particular item.
food safety Assurance that food will not cause harm to the consumer when it is prepared and/or
eaten according to its intended use.
functional barrier A material that prevents harm to human health by stopping or retarding the passage of
atmospheric gases, water vapour or volatile flavours and aromas that can cause
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unacceptable changes in the composition of food and its organoleptic characteristics.
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consumer product.
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fundamental requirement A requirement of the Standard that relates to a system which must be well established,
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to the system will have serious repercussions on the integrity or safety of the product
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supplied.
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Global Food Safety Managed by the Consumer Goods Forum, a project to harmonise and benchmark
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good hygiene practice The combination of process, personnel and/or service control procedures intended to
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ensure that products and/or services consistently achieve appropriate levels of hygiene.
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good manufacturing Implemented procedures and practices undertaken using best-practice principles.
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practice (GMP)
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hazard An agent of any type with the potential to cause harm (usually biological, chemical,
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hazard analysis and risk A system that identifies, evaluates and controls hazards which are significant for
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hygiene-sensitive product A product intended for human consumption or that comes into contact with the body;
for example, by application to the skin.
importer A company facilitating the movement of products across an international border.
Usually the first recipient of the products in that country.
incident An event that has occurred that may result in the production or supply of unsafe, illegal
or non-conforming products.
initial audit The BRCGS audit at a company/site which is not in possession of a valid BRCGS
certificate. This may be the first audit at a site or a subsequent audit of a site whose
certification has lapsed.
integrity (packaging) Once a packaging container has been filled and sealed, its integrity is based upon its
ability to contain, protect and preserve the contained product during its intended use.
internal audit General process of audit, for all the activities of the company. Conducted by or on
behalf of the company for internal purposes.
job description A list of the responsibilities for a given position at a company.
162 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
key staff Those staff whose activities affect the safety, legality and quality of the finished
product.
legality In compliance with the law in the place of production and in the countries where the
product is intended to be sold.
lot See definition of ‘batch’.
manufacturer A company that produces product from raw materials and/or components and supplies
product to a customer.
master sample See definition of ‘reference sample’.
may Indicates a requirement or text which provides guidance but is not mandatory for
compliance with the Standard.
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monitoring A planned sequence of observations or measurements of defined control parameters
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to assess whether predefined limits are being met.
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non-applicable Any specific requirement that refers to an activity which does not occur on a site.
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non-conformity The non-fulfilment of a specified product safety, legal or quality requirement or a

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specified system requirement.

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outer packaging Packaging which is visible when the product is released from the site. For example, a
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cardboard box could be considered as outer packaging even if wrapped in clear film.
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outsourced (subcontracted) Where an intermediate production process or step in the manufacture of a product is
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processing completed at another company or site.

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performance indicators Summaries of quantified data that provide information on the level of compliance
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against agreed targets (e.g. customer complaints, product incidents, laboratory data).
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positive release Ensuring a product or material is of an acceptable standard prior to release for use.
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potable water Water being safe to drink, free from pollutants and harmful organisms and conforming
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premises A physical building or place owned by the company and audited as part of a site.
prerequisite The basic environmental and operational conditions in a packaging materials site that
are necessary for the production of safe packaging materials. These conditions provide
the necessary control of generic hazards required for good manufacturing and hygienic
practice and shall be taken into full consideration within the hazard and risk
management system.
preventive action Action to eliminate the fundamental, underlying cause (root cause) of a detected
non-conformity and prevent recurrence.
Glossary
primary packaging That packaging which constitutes the unit of sale, used and disposed of by the
consumer (e.g. bottle, closure and label).
print/printing Decoration of a pack by any print process, such as litho, flexo, gravure, tampo, screen,
digital etc.
procedure Agreed method of carrying out an activity or process which is implemented and
documented in the form of detailed instructions or a process description (e.g. a
flowchart).
brcgs.com 163
PACKAGING MATERIALS
ISSUE 6
product recall Any measures aimed at achieving the return of an unfit product from customers and
final consumers.
product safety culture The attitudes, values and/or beliefs which are prevalent at the site, relating to the
importance of product safety and the confidence in the product safety systems,
processes and procedures used by the site.
product withdrawal Any measures aimed at achieving the return of out-of-specification or unfit products
from customers, but not from final consumers.
protective clothing Clothing designed to protect the product from potential contamination by the wearer.
provenance The origin or the source of raw materials.
quality Meeting the customer’s specification and expectation.
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quality assurance A system for ensuring a desired level of quality in the development, production or
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delivery of products and services.
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quality control A system for establishing and maintaining a desired level of quality in a product
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through planning, use of proper equipment, continued inspection and corrective action,
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as required.
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quantity check/mass A reconciliation of the amount of incoming raw material against the amount used in
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balance the resulting finished products, also taking into account process waste and rework.
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quarantine The status given to any material or product set aside while awaiting confirmation of its
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raw material Any base material or semi-finished material used by the organisation for the
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manufacture of a product.
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recognised laboratory Laboratory accreditation schemes that have gained national and international
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users of the Standard (e.g. ISO/IEC 17025 or equivalents).

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recycled Material that has been reprocessed from recovered (reclaimed) material, including
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or a component for incorporation into goods or services.

reference sample Agreed product or components for referral by the manufacturer for production.
regrind Excess materials or reject containers that are ground into a raw material before being
returned to production. Typically this is an in-house process.
regulatory A law, rule or other order prescribed by an authority that has been designed to regulate
conduct or conformity to regulatory requirements.
requirement Those statements comprising a clause with which compliance will allow sites to be
certificated.
retail brand A trademark, logo, copyright or address of a retailer.
retailer A business selling products to the public by retail.
retailer-branded products Products bearing a retailer’s logo, copyright, address or ingredients used to
manufacture products within a retailer’s premises. Retailer-branded products are
legally regarded as the responsibility of the retailer.
164 brcgs.com
PACKAGING MATERIALS
ISSUE 6
Part I
retained production sample Representative product or components taken from a production run and securely held
for future reference.
risk The likelihood of occurrence of harm from a hazard.
risk analysis A process consisting of three components: risk assessment, risk management and risk
communication.
risk assessment The identification, evaluation and estimation of the levels of risk involved in a process
to determine an appropriate control process.
root cause The underlying cause of a problem which, if adequately addressed, will prevent a
recurrence of that problem.
sampling plan A documented plan defining the number of samples to be selected, the acceptance or
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rejection criteria, and the statistical confidence of the result.
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schedule A tabulated statement giving details of actions and/or timings.
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secondary packaging Packaging that is used to collate and transport sales units to the retail environment
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(e.g. corrugated case).
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senior management Those with strategic/high-level operational responsibility for the company and the
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capability to authorise the financial or human resources necessary for the
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implementation of the Standard.

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shall Signifies a requirement to comply with the contents of the clause.

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should Signifies that compliance with the contents of the clause or requirement is expected
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or desired.
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site A unit of a company; the entity which is audited and which is the subject of the audit
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report and certificate.

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specification An explicit or detailed description of a material, product or service.

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specifier A company or person requesting the product or service.

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subcontractor A firm, company or individual carrying out a process step on intermediate products on
behalf of the site being certificated to the Standard. See also outsourced
(subcontracted) processing.
supplier The person, firm, company or other entity to which a site’s purchase order to supply is
addressed.
suspension Where certification is revoked for a given period, pending remedial action on the part
of the company.
Glossary
traceability Ability to trace and follow raw materials, components and products, through all stages
of receipt, production, processing and distribution both forwards and backwards.
traded goods Goods not manufactured or part-processed on site but bought in and sold on.
trend An identified pattern of results.
unannounced audit An audit undertaken on a date unknown to the company in advance.
brcgs.com 165
PACKAGING MATERIALS
ISSUE 6
user The person or organisation who requests information from the company regarding
certification.
utilities Commodities or services, such as electricity or water, that are provided by a public
body.
validation Obtaining evidence through the provision of objective evidence that a control or
measure, if properly implemented, is capable of delivering the specified outcome.
vehicle Any device used for the conveyance of product that is capable of being moved upon
highways, waterways or airways. Vehicles can be motorised (e.g. a lorry) or
non‑motorised (e.g. container or rail truck).
verification The application of methods, procedures, tests and other evaluations, in addition to
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monitoring, to determine whether a control or measure is or has been operating as
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where appropriate In relation to a requirement of the Standard, it means that the company will assess the
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need for the requirement and, where applicable, put in place systems, processes,
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procedures or equipment to meet the requirement. The company shall be mindful of

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legal requirements, best-practice standards, good manufacturing practice and industry

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guidance, and any other information relating to the manufacture of safe and legal
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product.
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work in progress/work in Partially manufactured products, intermediates or materials waiting for completion of
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BRCGS To learn more about the BRCGS certification

Floor 2 programme please visit brcgs.com
7 Harp Lane
London EC3R 6DP To learn more about the BRCGS online
subscription service please visit brcgsparticipate.com
T: +44 (0)20 3931 8150 To purchase printed copies or PDFs from its full range
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Packaging Issue 6 - Interpretation Guideline (English)

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Packaging Issue 6 - Interpretation Guideline (English)

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ISSUE 6

of the English Courts.

For more information about BRCGS, contact:

Tel: +44 (0) 20 3931 8150

Part II – Guidance on the requirements

5 Product and process control 104

7 Requirements for traded products 150

Who undertakes certification audits? 3

When can the audit be undertaken? 4

What to expect on the audit day(s) 4

‘Shall’ versus ‘may’ 6

highlighting the need for regular checks of precise requirements.

auditor and be in line with good industry practices.

•• Global Standard for Food Safety

maintenance of the building.

Who undertakes certification audits?

internationally recognised protocols – and by the BRCGS team.

When can the audit be undertaken?

What to expect on the audit day(s)

requested by the certification body.

enable agreement and organisation in terms of:

•• staff who need to be available to discuss specific aspects

•• documents that need to be provided

•• logistics to ensure that equipment, such as protective clothing, is provided.

•• company quality policies

found in Part III, section 3 of the Standard.

•• Senior management commitment and continual improvement (1.1)

•• Corrective and preventive action (3.6)

‘Shall’ versus ‘may’

Clause 3.7.4 shows an example of both usages:

be controlled on an electronic system.’

appropriate control or procedure to minimise the risk of problems occurring.

(worst‑case-scenario tests, final product tests etc.)

detected at the appropriate detection level.

•• audits – both internal and third party

•• corrective action review

Key to colour-coding of requirements

Requirements assessed as part of the audit of records, systems and documentation

2 Hazard and risk management 27

2.1 Hazard and risk management team 27

3 Product safety and quality

3.1 Product safety and quality management system 37

3.2 Document control 39

3.5 Internal audits 46

3.6 Corrective and preventive action 49

3.7 Supplier approval and performance monitoring 53

3.8 Product authenticity, claims and chain of custody 59

5.1 Product development 104

5.2 Graphic design and artwork control 107

5.3 Packaging print control 111

5.4 Process control 114

5.5 Calibration and control of measuring and

5.6 Product inspection, testing and measuring 120

5.7 Control of non-conforming product 124

5.8 Incoming goods 125

5.9 Storage of all materials and intermediate and

5.10 Dispatch and transport 129

6.1 Training and competence: raw materials handling,

7 Requirements for traded

rise steadily and legal requirements become more complex.

does not appear.

Interpretation Product safety and quality management policy

the senior management team would ensure that this happens.

also emphasise the company’s commitment to continual improvement.