DELYN PACKAGING LIMITED

CAERPHILLY

QUALITY MANUAL
&
PROCEDURES

ISSUE 2 Page 1 of 6 April 2016

 INTRODUCTION
The Operations Director and Commercial Director will develop and implement
procedures and instructions which will ensure that the systems within the company
fully meet the requirements of the food and associated industries.

The Management Systems described herein are mandatory for orders to be executed
to the following Quality Standards B.R.C British Retail Consortium.

Copies of this manual are controlled and the holder’s names are recorded in the
Quality Manual Controlled copy Register held by the Manufacturing Director.

RECORD OF AMENDMENTS

Section Reference Change Implemented Date

Manual review Updated to reflect current system Feb 2010

Manual review Manual subject to total document Feb 2010

And procedures review following
Move to new factory and system
Changes

Manual review Manual updated subject to Internal May 2014

Audit Systems.

Manual review Suppliers statement has now been changed from Feb 15
Being reviewed from yearly to every Three Years

Manual review New Procedure Added Blades/Sharps April 2016

Control

Manual review New Procedure Added Production Inspection Feb 2017

Light Boxes
Manual review New Procedure Added Metal Detection June 2017
Issue 2 Page 2 of 6 February 2010

QM 1 Company Background

The company was founded in 2003 by four experienced members of the

Packaging Industry and specialises in thermoformed plastic packaging systems.
Production is generated off a range of modern vacuum and pressure forming
machines.

The company has adopted an environmental policy of reclaiming and recycling

its primary polymers and constantly seeks to utilise environmentally acceptable
materials.

Products manufactured by the company are supplied mainly to the following

industries;

 Food and Food Services

 Pharmaceutical

 Medical

 Personal Care

 Toiletries

 Electronics

This Quality Manual defines the Quality System of Delyn Packaging Limited and
its commitment to Quality Assurance for all its products and services.

Each element of the Company’s operation had been identified and the principals
of control for each element are described in this manual.

Detailed instructions to personnel on the operation of the Quality System are

provided by Quality Assurance Procedures and working instructions referred to
in the Quality Procedures manual.

This manual will be reviewed annually by the Manufacturing Director and any
revisions that are necessary will be incorporated and recorded.
ISSUE 2 Page 3 of 6 February 2010

QM1.1

QUALITY POLICY STATEMENT

It is the policy of Delyn Packaging Limited to supply all the company’s

customers with products and services that fulfil all their requirements.

Delyn Packaging Limited will strive to ensure that customer satisfaction is

achieved with product manufactured right first time and delivered on time.

Products and services will be provided competitively and profitably.

The company’s management will take all necessary measures to ensure that the
Quality Policy and Objectives are understood, implemented and maintained by
all personnel.

The Management team will establish methods to continually review and improve
the systems and to review the Quality Policy to ensure the aims are met.

Mike Keenor January 2012

Operations Director.
ISSUE3 Page 4 of 6 January 2012
QM 1.4

MANAGEMENT RESPONSIBILITY

ORGANISATION

The Management organisational structure of the company is presented as an

organogram to demonstrate the various functions and identify the levels of
responsibility and authority.

The company has appointed a representative for Quality Assurance holding the
responsibility for the Company’s Quality Management System.

Each employee is aware of their responsibility to ensure the company’s policy for
Quality Assurance is maintained.

CHAIRMAN

The Quality Policy Statement of the company is issued and authorised by the
company chairman.

MANUFACTURING DIRECTOR

The Manufacturing Director is responsible for all aspects of the production

operation as follows;
 Manufacturing services.
 Maintenance and the upkeep of the building.
 Production planning.
 Design and sample manufacture.
 Warehousing
 Upkeep and maintenance of machinery plant and equipment.
 Quality Assurance System.
 Hygiene Policy and System.
 Coordinating the Health & Safety activity within the company.

SENIOR OPERATOR

The Senior Operator is responsible for the production and services areas on a
shift by shift basis.

CUSTOMER SERVICES MANAGER

The Customer Services Manager is responsible for ensuring that all orders and
contracts placed with the company are fully understood and processed on time to
meet the customer’s contract and for ensuring that customer orders are
despatched as required.

ISSUE 2 Page 5 of 6 February 2010

COMMERCIAL DIRECTOR

The Commercial Director is responsible for coordinating the administration

functions of the business and the customer order processing system. Maintaining
a new product estimating system and processing customer inquiries.

The Commercial Director is also responsible for seeking out and identifying
potential new business to expand the company’s product base.

SALES DIRECTOR

The Sales Director is responsible for servicing and monitoring customer orders
and requirements and for identifying new areas and opportunities of business
and for developing these activities.

Financial Manager

The Financial Manager is responsible for all aspects of Finance within the
company.

ISSUE 2 Page 6 of 6 February 2010

Who’s who and what they do.
DELYN PACKAGING LIMITED

CAERPHILLY

PROCEDURES MANUAL
 PROCEDURES MANUAL

CONTENT

TITLE ISSUE No. of Pages DATE

Management review 2 1 Feb 10

Employee Training & Development 2 2 Feb 10

Contract Review 2 2 Feb 10

Purchasing 2 2 Feb 10

Sample & Tool Development 2 3 Feb 10

Process Control 2 7 Feb 10

Plant Maintenance 2 2 Feb 10

Corrective Actions 2 5 Feb 10

Calibration 2 2 Feb 10

Documentation Control 2 2 Feb 10

Control of Records 2 3 Feb 10

Internal Audit Procedure 1 1 April 14

Blade/Sharps Control 2 1 April 16

Inspection Light Boxes 1 1 Feb 17

Metal Detection 1 2 June 17

Nut Control 1 1 March 18

Graph
MANAGEMENT REVIEW

1.0 OBJECTIVE

To ensure that Senior Management review the effectiveness of the Management

Systems on an ongoing basis by monitoring and reviewing the performance of key
indicators.

2.0 RESPONSIBILITIES

2.1 The Manufacturing Director and the Commercial Director will be responsible for
co-ordinating any review of the systems. The reviews will take place a minimum
of every twelve months or sooner.

2.2 The Manufacturing Director will be responsible for monitoring the progress and
effectiveness of the required actions and for producing any new procedures or
amending existing procedures.

3.0 METHOD

3.1 A review team consisting of the Manufacturing Director, Commercial Director,

and Senior Operator will be established to gather the required information.

3.2 The information gathered will include;

 The level of customer complaints.
 The proportion of deliveries made on time.
 Customer vendor ratings.
 The level of scrap.
 Technological changes and improvements.
 Audit results internal and external.
 Changes to the company structure and personnel responsibility.
 Changes to the customer / National Standards to be addressed
affecting the Quality System.
 Supplier performance.
 Health & Safety & Hygiene Performance ratings.

3.3 The review team will review the data and establish the overall compliance and
effectiveness of the system against the Company’s Policies.

3.4 Minutes will be issued and a programme of improvement developed specifying

responsibility and target date for its effective implementation.

3.5 The Manufacturing Director will monitor the progress and effectiveness of the
required actions and provide assistance as and when required.

ISSUE 2 PAGE 1 OF 1 February 2010

EMPLOYEE TRAINING AND DEVELOPMENT

1.0 OBJECTIVES

1.1 To ensure that all employees receive the correct training related to their job
description and their terms and conditions of employment.

2.0 RESPONSIBILITIES

2.1 Induction and ongoing training will be the responsibility of the Manufacturing
Director or Supervisor to whom the new employee will report.

3.0 METHOD

3.2 Induction will be carried out on the first day of employment or as near the first
day as possible.
3.2 The Manufacturing Director or nominated Supervisor will carry out the induction.

3.3 Each area of the company will be visited and explained to the new employee.

3.4 The employee will be given copies of the company rules.

3.5 On completion of the induction programme the new employee will be required to
confirm the Induction Training has been completed and to sign a confirmation
form.

3.6 The Manufacturing Director in conjunction with the employee will identify any
skill shortages and prepare a training plan. A training matrix will be completed to
show the competence levels reached.

3.7 The plan will identify what training each employee has received and will also
indicate future needs. The Manufacturing Director will review the plan at least
once a year during an appraisal of the employee and will agree any further training
require.

3.8 Training may be carried out on site or external training may be used. The
Manufacturing Director will maintain the employee’s training file to reflect any
qualifications gained or achievements made.

3.9 Records of the training requirements, plans, achievement and copies of any
Certificates will be held in the employee’s personnel file.

3.10 Any temporary / agency employees must undergo induction. The Manufacturing
Director or responsible supervisor will use the ‘Temporary Agency Induction
Form’.

ISSUE 12 PAGE 1 OF 1 February 2010

CONTRACT REVIEW
1.0 OBJECTIVE

1.1 To ensure that all contracts / orders placed with Delyn Packaging Limited are
reviewed to ensure the company can fulfil al contractual requirements.

1.2 Any outstanding issues will be resolved before the company undertakes
commencement of the order.

2.0 RESPONSIBILITIES

2.1 The Customer Services Manager is responsible for ensuring that all contracts /
orders placed upon the company are reviewed.

3.0 METHOD

3.1 All contracts / orders received by Delyn Packaging Limited must be passed to the
Sales Office for the attention of the Customer Services Manager.

3.2 The Sales Office will review each contract / order within 24 hours of receipt.

3.3 The review will cover the date, the account number, delivery address, part
number, (this also includes the checking the issue/modification level) the part
description, material type, quantity, the delivery date and price. Each section must
be reviewed to ensure that all the customers requirements are known and
understood.

3.4 If there are any concerns or problems the Customer Services Manager must ensure
that are resolved before proceeding with the order.

3.5 Once the order is accepted the order is filed and entered into the production plan.

3.6 An Order Acknowledgement will then be sent to the customer.

3.7 If there are any queries they will be dealt with by the Customer Services Manager.

3.8 A blanket order is reviewed when first received into the Sales Office. Verbal Call
Offs must always be confirmed in writing.

ISSUE 2 PAGE 1 OF 1 February 2010

PURCHASING

1.0 OBJECTIVE
1.1 To ensure materials and services are purchased in a controlled manner from
approved suppliers and sources where possible.

2.0 RESPONSIBILITIES

2.1All purchased goods and services must proceed with an order number.

2.2 The Customer Services Manager is responsible for co ordinating and controlling
the purchasing function.

3.0 METHOD

3.1A request to purchase materials or services will be raised and an order number
provided from the purchase order register. The order must be initialled by the
person raising the order.

3.2 All Purchase Orders are numbered sequentially and must contain the following
data;
 Name and address of supplier
 Quantity
 Description of goods
 Price and delivery date

3.3 The company will develop a list of approved suppliers.

3.4 Purchase orders must be signed and approved by a Director or the Customer
Services Manager.

3.5 All goods / materials will be delivered to the Goods In area and a Goods
Received Note will accompany ALL deliveries. The warehouse person must
check ( a physical and visual check )that the goods agree with the delivery note,
then sign the carbon copy and pass it directly to the Customer Services Manager.

ISSUE;2 PAGE 1 OF 2 February 2010

PURCHASING

3.6 The purchase order is raised in the sales office and a number is issued by the sales
office manager. An entry is recorded in the Purchase Order Book.

3.7
APPROVAL OF SUPPLIERS
The approval of suppliers meets one of the following criteria;
a) Company approved to a nationally approved standard.
b) Based on historical knowledge.
c) Approved and assessed via visiting the suppliers premises.
d) Due to HACCP being reviewed subject to our policy moving forward we have
now changed our suppliers self audit from every year to every three years.

3.8
The Sales Office Manager will maintain a list of approved suppliers.

3.9
The Manufacturing Director and the Sales Office Manager will review the status
of all suppliers every three years. The review will be base on performance, cost,
delivery, and service plus a review of specifications to meet current legislation.

ISSUE 2 PAGE 2 OF 2 February 2010

SAMPLE AND TOOLING DEVELOPMENT

1.0 OBJECTIVE

1.1 The aim of this procedure is to ensure that all new products are developed
in a logical and systematic manner that will enable us to meet our customers
expectations.

2.0 RESPONSIBILITIES
2.1 The Manufacturing Director is responsible for the development of new designs
and patterns and the purchasing of all new tooling.
2.2 The Sales Director is responsible for obtaining Customer approval for samples.

3.0 METHOD
3.1 The Sales Director and customer will discuss a new or potentially new product.
The Sales Director will fill in a form ‘E1’.
The Enquiry form ‘E1’ contains the following;
 Customer name, delivery address of samples, description, number
required.
 Details of the samples, material type, gauge, date required.
 Information relating to tray design, dimensions, manufacturing process.
 Customer process requirements, a sketch of the product as required.
3.2 The E1 form is passed to the Commercial Director for costing and economical
assessment. No price will be given unless the product is part of a standard product
range.
3.3 Once complete the form E1, the estimate, is logged in the quotation log and
passed to the Sales Director who will agree the price with the customer.

3.4 A sample may be requested and the Sales Director will request the Manufacturing
Director to provide a sample at an agreed date. The Manufacturing Director will
Co-ordinate with the Pattern Maker to produce the sample.

3.5 The Pattern Maker will produce the required number of samples and send them to
the Manufacturing Director for first off approval.

3.6 The Manufacturing Director will obtain approval from the customer in writing and
the written approval will be filed in the Customer File.

3.7 Tooling expenditure will be agreed between the Manufacturing Director and the
Commercial Director and both Directors will APPROVE the expenditure by
signing the form E1 held in the Customer File.

3.8 The Manufacturing Director and the Commercial Director will agree the method
of recovering the cost of the tooling.
3.9 The Manufacturing Director will place an order with the toolmaker to
manufacture the tool.

ISSUE 2 PAGE 1 OF 2 February 2010

3.10 The Manufacturing Director will raise and fill in a Product Specification Sheet.
This details the relevant information, material, tooling, product quality, etc, to
Enable the part to be manufactured. No changes can be made to the Product
Specification sheet unless authorised by the Manufacturing Director.

3.11 The final Product Specification Sheet is approved and signed off by the
Manufacturing Director.

3.12 A copy of the Product Specification Sheet will be available on the production
machine during the complete running of production.

3.13 During the first run a Master Sample will be obtained and approved by the
Manufacturing Director. The sample will be used as an aid to production.
3.14 At the start of each new part run, a Packing Specification is developed for each
part by the Manufacturing Director. The specification details how the part is
packed. eg; quantity and product configuration. A copy of the Packing
Specification will be held in the Customer File.

ISSUE 2 PAGE 2 OF 2 February 2010

PROCESS CONTROL

1.0 OBJECTIVE

1.1 To ensure that the manufacturing process within the company is planned and
controlled to meet Customer Requirements. Instructions and documentation will
be raised to control and plan all aspects of the manufacturing cycle.

1.3 To ensure that all materials used within the company, in particular those for food
Contact use are manufactured from approved sources, and are safe for their
intended use. Materials will be traceable back to source.

2.0 RESPONSIBILITIES

2.1 All employees are responsible for ensuring that that the status of materials and
components is known and displayed throughout the manufacturing cycle from
Goods Inwards to Dispatch.
2.2 All Operators are for placing a hold on all suspect work for the attention of the
Manufacturing Director. All suspect work must be segregated from approved
product.

2.3 The Manufacturing Director will be responsible for ensuring that any customer
returns are quarantined and identified pending disposal instructions.

3.0 METHOD
3.1 PLANNING
The Sales Office Manager or the Manufacturing Director will raise a works order
For each job to be manufactured. Each order will detail the customers
Requirements. Each order will be allocated manufacturing capacity against a
Manufacturing cost centre.

3.2 The customer name, part description, customer reference, order quantity, delivery
information and any special instructions are recorded on the production planning
board.

3.3 The Manufacturing Order is held in the Sales Office and a ‘T’ card system is
located on the planning board.

3.4 The Manufacturing Director will place an order for raw material with an approved
supplier.
3.5 GOODS INWARDS
The Storeman will check the condition of the delivery for any damage or
contamination. The Storeman will check the delivery quantity by referring to the
Purchase Order. All raw materials will be offloaded and placed in the materials
Storage area.
3.6 The delivery note will be signed and filed in the Sales Office in the delivery note
file.
ISSUE 2 PAGE 1 0F 5 February 2010
3.7 FORMING HALL
When required, the Operator will obtain the identified tooling and set up the
tooling in the machine. The Storeman will relocate the raw material from the
storage area into position behind the forming machine.

3.8 The Operator will remove the existing tooling from the forming machine and
return it to the tool store and locate the tooling in the tool racking area. The
Operator will collect the required tooling from the tool racking area and set the
Tooling into the forming machine.

3.9 The Operator will generate first off production samples and the Manufacturing
Director will assess the quality standard and confirm approval by signing the
Quality Forming in Process sheet.

3.10 When approved, the formed and cut parts are packed according to the
Packing Specification. The box is sealed and placed on a pallet. When full, the
pallet is taken to the warehouse.

3.11 The Manufacturing Director will organise printing sufficient box labels to cover
the required production volume. As each box is filled, a label is completed by the
Operator and attached to the outer carton.
3.12 During the production run, random checks are carried out on the quality of the
parts. The checks involve taking a representative sample from the machine,
without any interruptions or adjustments. The sample is visually assessed against
the ‘First Off’ sample and the results recorded on the Quality Forming in Process
audit sheet. The check sheet is signed, dated, and the time is noted for every
check.

3.13 The pallet stack is wrapped with shrink wrap and the pallet details are recorded
on the Daily Production sheet. The boxes on the pallet must be stacked evenly to
prevent the possibility of collapsing.

3.14 The pallet is then stored in the warehouse awaiting dispatch.

3.15 If during the production run a problem is encountered, the machine must be
stopped and the Manufacturing Director or Commercial Director informed.
All suspect product must be checked and sorted.

3.16 All skeletal waste and running rejects are placed in a waste container which is
located by each machine. Materials must not be mixed in the containers as this
will lead to contamination. Each material type will be granulated. When the
waste material container is full it is taken to the granulation area. The waste
container will be thoroughly cleaned out to remove any residue waste in the
bottom of the container.

ISSUE;2 PAGE 2OF 5 February 2010

3.17 When the production run is complete, the quality sheets and production sheet
are returned to the Sales Office for filing.

3.18 GRANULATING / RECYCLING MATERIAL

All skeletal waste and running waste are recycled. They are placed in the waste
Containers by each machine. When full, the container is taken to the
Granulating area for granulating.

3.19 The waste material is granulated into bulk bags. When full, the bags are
identified and moved to a storage area.

3.20 If during the production process a quality problem occurs, the Operator will
inform the Manufacturing Director and any suspect material will be
quarantined.
3.21 All quarantined material will be identified with QUARANTINED tape.

3.22 Any Customer returns will be identified with Quarantined tape when received
and moved to a designated area for investigation.

3.23 TRACEABILIY
The traceability of raw materials used in the factory is documented on the
Production Recording Sheet and archived for future reference.
3.24 HANDLING AND STORAGE
All materials and goods handled within the company shall be to safe working
systems and practices.

3.25 All personnel involved in handling and storing raw materials, in process
materials and finished parts will be trained to ensure that the system of work
prevents damage and deterioration to the materials and parts.

3.26 Raw materials will be stored in the designated storage area within the factory to
avoid the extremes of heat and sunlight.

3.27 Care will be taken to avoid contamination of raw material by water or other
liquids, ingress of dirt and dust and cross contamination with other materials.

3.28 The storeman is responsible for ensuring that old stock is used first to ensure the
stock is rotated.

3.29 Before use the pallet is checked for damage and the surface is checked to ensure
it is clean.

ISSUE 2 PAGE 3 OF 5 February 2010

3.30 Pallets of rollstock may be stacked on top of each other providing they are safe
and secure.

3.31 When required the storeman will remove the pallets of rollstock and place them
on the floor in the designated area behind each forming machine.
ISSUE 1 PAGE OF MARCH 2003
3.32 As required, each roll is unwrapped and the outer wrap discarded. The material is
fed through the machine and the machine set.

3.33 The company has a system for recycling waste material by granulating it and
returning the granulate to selected processors.

3.34 PACKAGING
The packaging of manufactured parts is outlined on the Packaging Specification
For each product.

3.35 In certain cases the customer will provide a Packaging Specification. In this
event, the requirement will be recognised at the Contract Review stage.

3.36 The sales office will transfer packing requirements onto the Quality Forming in
Process Sheet.

3.37 Carton Labels are produced as required for each production run. The labels
 contain provision for the following;
 Customer
 Description
 Material Description
 Part Number
 Customer Code
 Customer Order Number (If Required)
 Quantity Per Carton
 Carton Number
 Operator Number

3.38 Due to the nature of the basic materials, both raw materials and finished product
is not subject to shelf life restrictions. However, the conditions of warehouse
stock will be assessed on a regular basis.

3.39 DELIVERY
The despatch and delivery of finished product is controlled prior to and during
despatch.

ISSUE 2 PAGE 4 OF 5 February 2010

3.40 The Sales Office Manager will raise a Picking Note, which will tell the Despatch
area what pallets to despatch. The storeman will remove the pallets from the
warehouse. The condition of the pallets and the labelling are checked. All
despatches are recorded on the daily despatch sheet. If any boxes are damaged
and in need of reboxing then the storeman will attend to this prior to loading
the delivery vehicle.

3.41 The storeman signs the Picking Note and returns it to the Sales Office where a
Delivery Note is raised. The note states the following;
 Order Number
 Date
 Customer Order Number
 Consignee / Invoice Address
 Delivery Address
 Part Number
 Description
 Delivery Date
 Quantity

3.42 There are three copies of the delivery note. One copy is signed by the carrier and
is retained in the Sales Office. The other two copies are sent with the goods. The
second copy is signed by the customer and returned to the Sales Office
Manager. The third copy is retained by the customer.

3.43 The first and second copy of the delivery notes are collated and filed in the sales
 and can provide proof of delivery if required.

3.44 Where a carriers specific documentation is used then it is completed in

accordance with the carriers requirements.

ISSUE 2 PAGE 5 OF 5 February 2010

PLANT MAINTENANCE
1.0 OBJECTIVE

1.1 To ensure that where required, all plant and equipment in the company is within a
preventative maintenance programme.

1.2 The programme will be documented and outline all the necessary requirements.

2.0 RESPONSIBILITIES
2.1 The Manufacturing Director will be responsible for identifying the preventative
maintenance requirements for all the plant and equipment.

2.2 A documented schedule will be developed which will outline the requirements of
the system.

3.0 METHODS

3.1 The schedule will highlight what jobs and tasks are required daily, weekly and
monthly.

3.2 The Manufacturing Director will assign Operators to carry out tasks at the
prescribed intervals.

3.3 The Manufacturing Director will issue instructions and all the relevant
information to enable the preventative maintenance to be carried out.
3.4 As the tasks are completed the Manufacturing Director will sign off and date the
schedule sheets.

3.5 All the necessary data sheets and specification sheets are filed by the
Manufacturing Director.

3.6 When a new piece of equipment is purchased the Manufacturing Director will add
it to the Preventative Maintenance Programme.

3.7 A schedule will be drawn up for the equipment. The schedule will outline what is
required, any special equipment involved etc’. Reference will be made to any
specific manufacturers recommendations when developing the schedule.

3.8 All records relating to the preventative maintenance scheme will be held and filed
by the Manufacturing Director.

ISSUE 2 PAGE 1 OF 1 February 2010

CORRECTIVE ACTIONS

1.0 OBJECTIVES

1.1 To ensure that the company has in place a documented system of dealing with
corrective actions, that can be identified in response to customer complaints, in
house problems or supplier problems

1.2 To ensure that any non-conformity, be it raw material or manufactured product

is identified and controlled.

1.3 Any non conformity will be segregated from the main stream production process.

1.4 Records will be kept of non-conformities to allow management to investigate and

analyse any trends that will enable positive corrective action to be taken to
Eliminate or reduce the non-conformities.

1.5 All customer complaints will be recorded and thoroughly investigated and where
proven, short term and long term measures will be taken to prevent any
recurrences.

2.0 RESPONSIBILITIES
2.1 All Operators will be responsible for ensuring that all corrective actions are dealt
with in a professional manner.
2.2 The Manufacturing Director will ensure that when required, non-conformities
(rejects) are controlled and identified.

2.3 The Manufacturing Director will ensure that any customer complaints are
investigated. All customer returns will be identified and segregated from the
manufacturing process.

2.4 The disposition of any customer returns will be co-ordinated by the

Manufacturing Director.

3.0 METHOD
3.1 GOODS INWARDS
If a non-conformity is identified at goods inwards, the Storesperson will segregate
and isolate all the potential raw material involved.

3.2 The Storesperson will notify the Sales Office Manager who will notify the
Manufacturing Director and arrange for the disposition of the material.

ISSUE 2 PAGE 1 OF 4 February 2010

3.3 Each pallet or cage will be identified with Quarantine or Reject tape, displayed
prominently.

3.4 FORMING / CUTTING

All skeletal waste, set up and running scrap is placed in the scrap / regrind
container by the machine. As the container is filled it is removed to the grinding
area waiting recycling.

3.5 If during the run a problem is identified with the boxed work, the Manufacturing
Director will be notified. The Operator will identify any suspect batch and isolate
the parts with Quarantine Tape.

3.6 The Manufacturing Director will raise a Stock Release Sheet. The stock will be
released to the warehouse once cleared. Any reject parts will be recorded and the
shortfall made good.

3.7 If the stock has been transferred to the warehouse the Stores person will ensure
that all suspect is identified and quarantined. The stock must not be moved
without the Manufacturing Directors agreement.

3.8 The Stores person will raise a Stock Release Sheet and pass a copy to the Sales
Office Manager who will ensure that the stock records are adjusted.

3.9 The Operator will co-ordinate any necessary re-boxing.

3.10 All rejects will be removed and scrapped by the Operator. The Manufacturing
Director will note the value of any rejects and notify the Sales Office Manager.

3.11 CUSTOMER RETURNS

All returns must be authorised by a Director who will sign a Customer Return
Note.
3.12 Upon the receipt of a signed Customer Return Note, the Sales Office Manager
 will organise the most cost effective means of transport.

3.13 Upon receipt at goods inwards, the returned goods will be checked by the
Stores person against the Customer Return Note.

3.14 The goods will be quarantined by the Storesperson.

3.15 The Customer Services Manager will be passed a copy of the Customer Returns
Note to allow for a credit note to be raised.

3.16 The Manufacturing Director will assess the rejects and decide what course of
action is necessary. eg; sort, scrap, reprocess, etc.

3.17 The aim is for the agreed action to be completed within four working days.
Once completed, all good parts will be returned to the warehouse and the Sales
Office Manager will be informed and re-adjust stock levels.
Issue 2 Page 2 OF 4 February 2010

3.18 RAISING A CONCERN;

The Sales Office Manager will record the complaint in the Master Concerns
File, Recording; company name, date, Reference number, and cause.

3.19 The Sales Office Manager will allocate each complaint a sequential number.
3.20 A blank Concern form will be raised and the following information recorded;
date raised, part No., Customer, description, contact name, telephone number of
contact.
3.21 A copy of the concern will be provided to the Sales Director.

3.22 The Manufacturing Director will liaise with the Sales Director to develop the
short term actions. An immediate response is required, especially if there is a
customer complaint. The response could include a visit to the customer by either
the Sales Director or the Manufacturing Director. All stock within the company
will be quarantined and the Manufacturing Director will organise a random
check to verify or refute the concern.

3.23 The response to a customer on short-term actions will be within three working
days.

3.24 If sorting is required, the Manufacturing Director will raise a Stock Disposition
sheet which will detail what rework is required. If a remake is required, the sales
office and manufacturing office will organise and give priority to materials and
machines to replace any condemned stock.

3.25 Having contained the immediate problem, the root cause and preventative
measures must be identified and developed to prevent a recurrence of the
problem.

3.26 The root cause of the problem may not be obvious and apparent, in which case
simple problem techniques can be employed.
3.27 Once identified, the root cause should be tested to ensure that it is the cause of
the problem. The preventative solution and implementation dates must be
developed and agreed.

3.28 When the problem has been solved and the solutions implemented successfully,
the Manufacturing Director will sign off, date and close the concern. A summary
of all concerns raised will be presented at the regular management meeting by
the Manufacturing Director for update and action. All concerns will be reviewed
for any trends or modifications to existing procedures or methods of work.

3.29 PRODUCT RECALL

In the unlikely event of any products having to be recalled from the
Market place, the Manufacturing Director will record the complaint in the
Master Complaint Register, recording the Company name, date, reject cause
and allocate a Concern Complaint Reference Number. A Concern / Complaint
Form is raised and filled in with all the relevant information.

ISSUE 2 PAGE 3 OF 4 February 2010

3.30 The Concern / Complaint will be circulated to all the Directors and Sales Office
Manager. The Manufacturing Director will liaise with the Customer
representative, normally the buyer, on the line of action to pursue.

3.31 The Manufacturing Director will quarantine all work in progress, stock etc at
Caerphilly, and organise an investigation into the stock. All customer stock will
be returned to Caerphilly for analysis and investigation.

3.32 Once the investigation is completed, the Manufacturing Director will report all
of the finding to the Management Team.

3.33 The findings of the report will be forwarded to the customer representative and
the disposition of all the involved stock decided and agreed between the
Manufacturing Director and the Customer.
ISSUE 2 PAGE 4 OF 4 February 20

CALIBRATION
1.0 OBJECIVE

1.1 To ensure that any test equipment, measuring instruments or gauges used within
the company that could have an effect on product quality are controlled and
calibrated.

1.2 All items of equipment will be uniquely identified and calibrated at a regular
frequency to confirm their accuracy and precision.

1.3 All calibrations will be traceable to a recognised national standard and will be
carried out by an approved source or test house.

2.0 RESPONSIBILITIES

2.1 The Manufacturing Director will be responsible for ensuring that where required
all test equipment, measuring instruments and gauges are uniquely identified and
calibrated to a recognised national standard.

2.2 All Operators will ensure that all calibrated equipment is use in the prescribed
manner and if broken or out of calibration, will notify the Manufacturing
Director.

3.0 METHOD

3.1 The Manufacturing Director will develop a list of all test equipment, measuring
instruments and gauges that could affect the quality of products manufactured by
the company.

3.2 Each piece of equipment will be given its own unique number, the number will
remain on file for the life of the equipment. Each piece of equipment, instrument
or gauge will have a label attached to indicate the calibration status and the due
 date. No piece of equipment is to be used if the label is missing. The
Manufacturing Director must be notified immediately.

3.3 The Manufacturing Director will draw up a calibration due date frequency
programme, which will outline when calibration is required. The Manufacturing
Director will liaise with Operators to ensure that any disruption is minimal.

3.4 Where required calibration such as weighing scales will be carried out on site by
the suppliers representative at a mutually agreed time.

ISSUE 2 PAGE 1 OF 2 February 2010

3.5 The Manufacturing Director will establish from the manufacturers

recommendations and historical information and data the type and frequency of
calibration required. Each part will have its own history record file, the file will
contain the following information;

 Part Number
 Part Description
 Location
 Calibration Frequency
 Calibration History, Records & Acceptance Criteria
 Name of Calibration Source

3.6 No equipment within the calibration system will be used unless covered by a
valid certificate of conformity. The Manufacturing Director will hold all the
Calibration Certificates in the Master History record file.

3.7 If any piece of equipment or measuring instrument within the calibration system
is broken, the Manufacturing Director must be notified immediately. If measuring
equipment is found to be outside the calibration limits after checking, the
Manufacturing Director will notify the Sales Director and collectively they will
decide whether any product or material is to be recalled or scrapped. The
Manufacturing Director will raise a Concern Sheet outlining the actions.

3.8 The Manufacturing Director prior to accepting the equipment or instrument back
into the calibration system will assess each Certificate of Conformity. Every
Certificate will be signed and dated by the Manufacturing Director and approved
as acceptable.

3.9 If during future developments and improvements it is recognised that measuring

equipment or instrumentation will be required, provision must be made to ensure
that the accuracy and precision of all such equipment is established and known.
The measurement capability of any such equipment or instrumentation will be
established and recorded.

3.10 All information pertinent to the calibration system, history record files, and
certificates of conformity, will be held centrally by the Manufacturing Director.
As required, all such records will be archived and stored in a suitable
environment to prevent deterioration and allow easy retrieval by the
Manufacturing Director.
ISSUE 2 PAGE 2 OF 2 February 2010

DOCUMENTATION CONTROL

1.0 OBJECTIVE

1.1 To provide a method by which documentation used by the company for qualitative
aspects will be controlled.

1.2 All controlled documentation will be identified within the company. The
procedure will ensure that only current issues of documentation are used within
the company.

2.0 RESPOSIBILITIES

2.1 The Manufacturing Director will maintain a list of all documents used within the
Quality System and will ensure that quality documents generated within the
company are controlled.

2.2 The Manufacturing Director must approve any new documentation that may have
an effect on the Quality System prior to use.

3.0 METHOD

3.1 QUALITY MANUAL

All copies of the Quality Manual will be issued by the authority of the Company
Chairman. The Manufacturing Director will be responsible for issuing all copies
of the Quality Manual.

3.2 All internal copies of the Quality Manual will be over stamped with the word
‘CONTROLLED COPY’ on each page. Copies of the Quality Manual may be
given to customers at the discretion of the Chairman. These will not be controlled
and will be over stamped with ‘UNCONTROLLED COPY’. The company
accepts no liability for updating uncontrolled copies of the manual or for ensuring
the accuracy of their contents.

3.3 QUALITY PROCEDURES

All quality procedures will be prepared by the Manufacturing Director.

3.3 PRODUCT SPECIFICATIONS

The specifications outline the process method, tooling process and any other
information required to manufacture the part and is generated by the
Manufacturing Director. The specefication sheet is filed with the tooling layout
sheet held in the Manufacturing Office.
ISSUE 2 PAGE 1 OF 2 February 2010

3.4 PACKING SPECIFICATIONS

The specification is prepared during the first production run of a new part. The
Manufacturing Director is responsible to for maintaining and updating the
specifications. Any changes to the specification must be notified to the
Manufacturing Director.

3.5 PURCHASE ORDERS

All orders will be raised and controlled by the Customer Services Manager.

3.6 CONTRACT REVIEW

All contract review sheets will be raised and controlled under the Procedure for
Contract Review by the Customer Services Manager.
3.7 STANDARDS
Any external standards ie; British Standards, will be controlled by the
Manufacturing Director and the Commercial Director will develop a list. All
external standards will be stamped with ‘CONTROLLED’ and will be initialled
and dated by the Manufacturing Director. The Manufacturing Director will be
responsible for updating the and issuing the standards.

3.8 FORMS
A master document folder will be held by the Commercial Director. The master
will contain the latest level of form in use within the Quality System. The
Commercial Director will be responsible for ensuring the master document folder
is up to date.

3.9 MACHINE SETTING SHEETS

The production department will be responsible for maintaining the set and run
parameters for all thermoforming machines. This will include written setting
sheets and computer discs.

3.10 COMPUTER DATA

Accounts related information is stored by the cost accountant at the end of each
session.

3.11As computer data expands within the company, policies and procedures will be
developed.
ISSUE 2 PAGE 2 OF 2 February 2010

CONTROL OF RECORDS
1.0 OBJECTIVE

1.1 To provide a method by which records used by the company for qualitative
aspects will be listed, stored and controlled. All quality related records will be
retained for a period of five years or longer if agreed contractually with the
customer.

2.0 RESPONSIBILITIES

2.1 The Manufacturing Director will ensure that all quality records generated within
the company for qualitative aspects will be listed, stored and controlled.
All quality related records will be retained for a period of five years or longer if
agreed contractually with the customer.

2.2 The Manufacturing Director is responsible for ensuring that the latest issue level
of documentation is in use within the factory and any obsolete documentation is
removed.

3.0 METHOD

3.1 PREPARATION OF QUALITY PROCEDURES

identified, the Manufacturing Director will co-ordinate and compile the
procedure. Each procedure will be given a reference number commencing at
issue 1. A amended procedures will take the next sequential issue number for
that particular document.

All pages of the procedure will be identified with a title and the procedure
reference number(QP)

3.2 The procedure will be drafted in a rough form in the following format;

 TITLE ;Brief description of the procedure.

 OBJECTIVE ;A brief outline of the procedure.
 RESPONSIBILITY;Outline who is responsible for following the
procedure.
 METHOD ;outline and describe what the procedure will achieve
and how it is achieved.
3.3 The rough draft procedure will be presented to the Board Of Directors for
discussion. Once agreed and finalised, the Manufacturing Director will organise
the final completion of the procedure.

3.4 The Manufacturing Director will approve and date the procedure.
3.5
ISSUE 2 PAGE 1 OF 3 February 2010

3.6 The procedure will be issued, the Manufacturing Director will sign the acceptance
slip and insert the new document into the appropriate position in the procedure
manual file. The obsolete document will be removed and destroyed.

3.7 The Manufacturing Director will be responsible for ensuring that the procedure or
amendment is explained fully to the Operators and that it is implemented.

3.8 The Manufacturing Director will enter details of the issue on the record of issues
and revisions in the master file.

3.9 Each recipient who will be responsible for its security and updating will keep all
issued copies of the Quality Procedure in a suitably identified folder.

3.10 The Manufacturing Director will ensure a copy of all obsolete or amended
procedures are filed and archived for future reference.

3.11 The Manufacturing Director will file any raw material certificates of conformity.

3.12 As the file becomes full, or approximately every twelve months, the
Manufacturing Director will collect together the files. They will be indexed and
filed by supplier and removed to the central archive file for boxing and storing.

3.13 All contract review sheets will be attached to the customer order and filed in
the
Sales Office by customer / part number.

3.14 As required, the Manufacturing Director will help the Customer Services
Manager to remove any obsolete files.

3.15 The files will be boxed in customer and date order. Each box will be
identified as
to its contents and stored in the central archive file.

3.16 All other sales office information, correspondence, sample approval will be
treated as aforementioned.

3.17 The Manufacturing Director / Commercial Director hold records and

correspondence related to raw material including material specifications. The are
held by supplier/ material type. As necessary, the files will be cleared.

3.18 The files will be boxed, the outside of the box will be identified as to its
contents. The box will be removed to the central quality file.

3.19 The Manufacturing Director will hold all the files relative to calibration
records, audit results and customer complaints/concerns management reviews
customer supplied product. Each subject will have ita own file and record
information.
ISSUE 2 PAGE 2 OF 3 February 2010

3.20 The Manufacturing Director will clear the files as required. The files will be
boxed and identified on the outside. All boxes will be stored in the central
archive file.

3.21 Information and files relating to the accounts department are held and
archived
in the accounts area. The works order copies are held in a file. The returned
delivery notes from the customer and the invoice payments are held in separate
files.

3.22 All purchase orders are filed by supplier along with any correspondence.

3.23 As required, the customer services manager will organise the removal and
archiving of the files. They will be secured and boxed by type, customer,
supplier and date.

3.24 All archived files must be stored to prevent any ingress from dust and
contamination. They should be boxed and sealed. I f boxes are are stored on
each other, they should not collapse and must be stacked correctly and evenly.
All boxes should be clearly identified as to their contents.

3.25 The contents of all record boxes should be logical. They should be in
sequence,
Alphabetically, or numerically.

3.26 The Manufacturing Director controls all plant maintenance records. They will
be
kept for twelve months before disposal.
ISSUE 2 PAGE 3 OF 3 February 2010

Internal Audits

4.0 OBJECTIVE

To look for areas of improvement and best practice and to make sure that what is
going on in practice is in line with policies, processes and procedures. Also the
purpose of the internal audit programme is to plan a number of audits, as well as to
identify and provide the necessary resources to conduct them.

5.0 RESPONSIBILITIES

2.1 The Operations Director and the Quality Assurance Co-ordinator will be
responsible for Planning Audits, Conducting Audits, Reporting Results and
Maintaining Records.

2.2 The Operations Director and Quality Assurance Co-ordinator will work together
by carrying out Audits to look for areas for improvement and best practice. The
Quality Assurance Co-ordinator will also be responsible for monitoring the progress
and effectiveness of the required actions or amending existing procedures.

6.0 METHOD

3.1 An annual Audit plan will be revised to address the requirements needed to
improve the company’s operating systems and procedures.

3.2 The Audits will be completed within a month from start date with all non-
conformances completed.

3.3 Audits will be carried out Formal, Planned, Organised and Assessed. They will be
conducted in an impartial and Objective manner following an agreed scope.

3.4 All the facts and evidence will be gathered to determine the degree to which
requirements are being met.

3.5 All non-conformities will be listed as Critical, Major, Minor and the Auditor will
share some positive comments in there reports to encourage improved of
conformance.

3.6 Any Critical and Major non-conformities are to be passed on to the Operations
Director who will determine the corrective actions needed, in order for them to be
signed off.
3.7 All prior audits will be filed in the completed Audit files to be considered the
status and importance of the areas to be audited i.e. some areas may require greater
attention than others depending on how important they are to the business.

ISSUE 1 PAGE 1 OF 1 April 2014