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ISO 22000:2005
Quality Manual
QUALITY MANUAL
The manual describes how manufacturers will comply with the requirements of
the ISO 22000:2005 and HACCP (Hazard Analysis and Critical Control Point).
The manual also includes: Codes of Practice; Protocols; Recommended Systems.
The Manual is a living document and will be subject to continual improvement.
Introduction
The company developed and implemented a Quality Management System (QSM)
in order to document the companys best business practice, better satisfy the
requirements and expectations of its customers and improve the overall
management of the company.
This manual is used internally to guide the companys employees through the
various requirements of the ISO standard that must be met and maintained in
order to ensure customer satisfaction, continuous improvement and provide the
necessary instructions that create an empowered work force.
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ISO 22000 integrates the principles of the Hazard Analysis and Critical Control
Point (HACCP) system and application steps developed by the Codex
Alimentarius Commission. By means of auditable requirements, it combines the
HACCP plan with prerequisite programs. Hazard analysis is the key to an effective
food safety management system, since conducting a hazard analysis assists in
organizing the knowledge required to establish an effective combination of control
measures. ISO 22000 requires that all hazards that may be reasonably expected to
occur in the food chain, including hazards that may be associated with the type of
process and facilities used, are identified and assessed. Thus it provides the means
to determine and document why certain identified hazards need to be controlled
by a particular organization and why others need not.
1.1 Introduction
1.1.1 This Quality Management System is established and maintained in order to
define and provide an overview of the Quality Management System (QMS)
documented and implemented to ensure conformance with the industry standards.
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1.1.2 Further, this Quality System Manual is established and maintained to identify
the processes and define the interactions of these processes, and their
management, to satisfy specified requirements.
1.2 Application
1.2.1 This Quality Management System, including this Quality Systems Manual, all
interrelated procedures, work instructions, and associated forms and records is
applicable to management and personnel with assigned responsibilities having the
potential to affect product and/or service quality.
1.2.4 Exclusions: THE COMPANY does not herein claim or justify any exclusion
from the sub clauses of the standards.
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1.4.2 The staff will be notified of changes through the formal change control
process,
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The members of the Organization shall strictly adhere to the various FSMS
procedures and work instructions as supported by the policies outlined in this
manual.
Team leader of food safety has been appointed as Food safety team leader of
Organization. The Food Safety Team Leader is responsible for ensuring
compliance with the FSMS requirements stipulated in this manual. He is
authorized to ensure that the FSMS system is established, implemented and
maintained by THE COMPANY. Top Management shall give full support and co-
operation Food Safety Team Leader.
1.8 Organization
To ensure a formal organizational chart is maintained which clearly defines the
organizational structure of the company. This chart defines the reporting
structure, hierarchy levels of authority, basic responsibilities.
The Operating Procedures supporting this ISO 22000 Manual define individual
responsibilities in respect to authority, actions to be taken in the event of errors,
corrective action and any re-evaluation necessary to ensure our operations remain
in compliance with our policy and objectives, supported by detailed job function
descriptions.
1.8.1 Resources
To ensure adequate resources are provided for the performance of all operations,
coupled with trained resources in order to maintain our overall process capability
in the best interests of our customers.
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3.2 Responsibility
Director approves Front / Cover page of the ISO 22000 Manual. The control and
maintenance of this manual is the responsibility of Food Safety Team Leader who
is maintaining master list of manual. Also when any changes / amendment are
there, then the same page is approved by the Top Management before issue of
such changed / amended page to the concerned copyholder.
3.3 References
ISO 22000: 2005 Food Safety management system Requirements
Requirements for ISO 22000 based food safety system
Document History
Document Controller
Item Description
Who:
Role:
Telephone:
Email:
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THE COMPANY has defined the scope of the food safety management system in
chapter No. 01 to this Manual.
We have identified, evaluated and controlled the food safety hazards so that the
products (manufactured in THE COMPANY) do not, directly or indirectly, harm
the consumer.
4.1.1 QMS processes and sub-processes are defined in this Quality Manual and in
associated Quality System Procedures (QSPs) showing both their sequence and
interrelationships. QSPs further instruct on how to implement and apply them
throughout the organization.
4.1.2 QMS documentation also defines criteria and methods required to ensure
that the operations and controls of the quality system processes are effective. This
includes assignment of responsibilities and allocation of resources for the process,
instructions on how to carry out (or operate) the process, and definition of
methods for monitoring and/or measuring the effectiveness of the process, where
applicable.
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Ref. Purchasing
Example:
QSP Category Document Description
Internal Audit
Control of Records
Management Review
Training
Purchasing
Product Identification and Traceability
Product Handling, Storage, Packaging, Preservation, & Delivery
Complaint Handling
Monitoring and Measurement of Product
Control of Nonconforming Materials
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4.2.3.1 THE COMPANY has established and maintains Document and Data
Control to define the controls needed to:
a) Define a standardized process for the development of new documents
required by the QMS [i.e., QSPs, WIs, and Forms]
b) Review and approved documents for adequacy prior to issue;
c) Review and up-date, as necessary, and re-approve documents;
d) To ensure that changes and the current revision status of documents are
identified;
e) To ensure that the relevant revisions of applicable documents are available
at the point of use;
f) To ensure that documents remain legible and readily identifiable;
g) To ensure that documents of external origin [documents such as industry
standards and guidance documents indispensable for the application of the TIOT
Quality Management System] are identified, their distribution is controlled,
and there is an internal process to ensure that the organizations quality
management system addresses all required elements of the most current
revision of these standards.
h) To prevent the unintended use of obsolete documents, and to apply
suitable identification to them if they are retained for any purpose.
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5.2.2 Product Customers: The goal of the QMS is stated in the Quality Policy to
meet and/or exceed our customers requirements We will accomplish this
objective by carefully listening to the voice of the customer through complaints
and customer satisfaction survey reports, and other means of feedback regarding
our products and services. We will routinely communicate with our customers, as
possible, to understand our customers stated and implied requirements. We will
establish and maintain processes that are reliable to ensure that products are
outsourced and/or manufactured in strict accordance with specifications and
drawings.
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It is the policy of THE COMPANY to meet and/or exceed our customer requirements by on-
time delivery of the highest quality of products, in strict compliance with safety and regulatory
requirements, while providing maximum value and superior customer service during and after the
sale of products.
5.3.1 Top Management shall annually review the Quality Policy for continued
appropriateness and suitability to the mission and objectives. This annual review
of the Quality Policy shall be documented in accordance with Management
Review of the Quality Management System.
5.3.2 The Quality Policy provides an overall framework for establishing specific
quality objectives, and provides direction for the goal of continual improvement.
5.3.3 Top Management shall ensure that the Quality Policy is known and
understood by all employees, is prominently displayed throughout the facility, and
is distributed to customers and other interested parties.
5.4 Planning
The resources needed to achieve the objectives are identified, discussed in the
management review meeting and planned. The resource planning is documented.
Top Management ensures that planning of the food safety management system is
carried out in line with ISO 22000:2005 requirements and objectives.
The quality planning includes
a) Processes of the Food safety management system
b) Resources needed
c) Requirements of safe food practices
d) Continual improvement
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Inputs into the process of establishing Quality Objectives may include relevant
findings from management reviews, current product results, customer satisfaction
ratings, customer complaints, and process monitoring results.
5.4.2.2 The Quality Assurance Manager is responsible for ensuring that the QMS
process required are implemented, and that the sequence and interaction of these
processes are identified. Processes are documented and controlled and monitored
through:
Quality System Procedures
Work Instructions, where specified
Flow Charts
Product Quality Planning
Records
5.4.2.4 Changes to the Quality Management System are planned and controlled in
accordance with Document and Data Control, and are reviewed for adequacy
before implementation.
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5.4.2. All staff members are responsible for reporting problems with food safety
management system to authorized person.
5.4.3. Personnel in THE COMPANY at various level are responsible and have the
authority within their defined areas of control for:
The quality of work carried out.
Initiating action to prevent the occurrence of product Non-Conformance.
Identifying and recording problems.
Requirements of safe food practices.
Initiating, recommending and providing solutions to problems.
To verify the effectiveness of the solutions.
Controlling further processing until all conditions are satisfactory.
The organization chart for our company, showing the interrelation of all the
personnel who manage, perform and verify the work ensuring quality, is given at
the end of this chapter.
5.4.4. Authority and responsibility for all the concerned persons is documented in
job description and communicated to them in order to facilitate effective Food
Safety Management System. Also copies of job description and specifications are
given to the concerned.
5.4.6. Interrelationship of all personnel who manage, perform and verify work
affecting product quality is identified in an Organizational Chart (see below).
5.4.7. All departments and functions in the company are responsible for
implementing, maintaining and improving the Quality Management System.
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5.6 Communication
5.6.1 External Communication
a) THE COMPANY ensures that sufficient information on issues
concerning food safety is available throughout the food chain.
b) THE COMPANY has established implemented and maintained effective
arrangements for communicating with Suppliers and Contractors,
Customers or Consumers, in relation to product information which
includes instruction regarding intended use, specific storage requirements,
shelf life, enquires, contracts order, amendments and customer feedback
including customer complaints, statutory and regulatory authorities, other
organization that have an impact on, or will be affected by, the
effectiveness or updating of the food safety management system.
c) Records are maintained for communication, which provide information on
food safety aspects of products.
d) Food safety requirements from statutory and regulatory authorities and
customers are available.
e) Top Management has defined responsibility and authority to communicate
externally any information concerning food safety. Information obtained
through external communication is included as input to system updating
and management review.
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It also includes any changes in our food safety system, Hazard analysis, HACCP
plans and results of monitoring of critical control points.
This review is carried out at least once a year by Top Management or their
nominee by holding Management Review Meetings, which are attended by Food
Safety Team Leader and all Top Management. It is the responsibility of the
Management Representative to prepare the agenda and minutes of management
review meeting covering:
Discussion held,
Action planned,
Target date of completion for planned actions.
Person responsible to complete planned actions
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Any kind of external experts are not required by THE COMPANY as of now, but
whenever needed for assistance of external experts records of agreement or
contracts defining the responsibility and authority are maintained.
6.2.1.2. THE COMPANY has established and maintains job descriptions for each
position affecting product quality, which identify appropriate education, skills,
experience and training for the position.
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obtained. Also during routine work due to change in area of work or any
other reason the training needs are identified and provided
c) Ensures that employees are trained, who are responsible for monitoring,
corrections and corrective actions of the food safety management system
d) Evaluates the effectiveness and implementation of the training provided as
per the established process approach
e) Ensures that employees are aware of the relevance and importance of their
activities and how they contribute to the achievement of the food safety.
f) Ensures the requirement for effectives communication is understood by all
personnel whose activities impacting on food safety
g) Maintains appropriate records for the education, experience, training and
qualification
Ref. Training
6.3 Infrastructure
THE COMPANY provides necessary resources for the establishment,
management and maintenance of the infrastructure needed to implement the
requirements in accordance with international standard.
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6.3.2. Top management is responsible to ensure that facilities are of suitable size,
construction, and location with adequate control systems to facilitate operations.
6.4.1. It is the responsibility of top management to determine and mange the work
environment needed to achieve conformity to product requirements, which
includes ensuring that the facility is maintained in a good state of repair,
organization, and cleanliness consistent with the product and manufacturing
requirements.
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7.2.3 THE COMPANY has considered following while establishing the PRPs
Construction and lay-out of buildings and associated utilities;
Lay-out premises, including workspace and employee facilities;
Supplies of air, water, energy and other utilities;
Supporting services, including waste and sewage disposal;
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7.4.2.2 For all identified food safety hazards we have determined the acceptable
level of the food safety hazard in the end product, which has considered the
established statutory and regulatory requirements and customer food safety
requirements, the intended use by the customer. Such records for determination
are maintained.
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Traceability records are maintained for a defined period for system assessment to
enable the handing of potentially unsafe products and in the event of products
withdrawal. Records on the end product lot identification are maintained
accordance with statutory and regulatory requirements and customer
requirements.
7.9.1 THE COMPANY has established and maintains Product Identification and
Traceability to define the process for identifying product by suitable means
throughout all phases of product realization, from designthrough
acquisitionthrough manufacturingthrough storage and delivery.
7.9.2 Product Identification and Traceability defines the means implemented for
identifying inspection status of components and product throughout all stages
of product realization, indicating acceptance or rejection for further processing or
shipment, using either a stamp or inspection authority initials. The required
inspection status tags or markings are specified in Receiving Inspection; In-
Process Inspection; and Final Inspection.
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7.10.4 Withdrawals
a) Top management has appointed and authorized the food safety team
leader to initiating and executing withdrawals.
b) The organization has established and maintained a documented procedure
to inform to customers, consumers and statutory and regulatory
authorities. The sequences of action to be taken to handle withdrawn and
affected products are also documented in the procedure.
c) Record for the withdrawal are maintained and reported to the top
management as a basis of input to the management review.
d) The effectiveness of the withdrawal programme is verified and records are
maintained.
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If above control measures are not suitable then the same are modified and re
assessed as appropriate i.e. changes in control measures, raw material,
manufacturing technologies, end product characteristics and method of
distribution and / or indented use of end products.
8.3.2. Equipments are calibrated at regular intervals and the tolerances established
on the basis of stability, purpose and usage, thereby ensuring that it is capable of
getting the necessary accuracy and measurement requirements.
8.3.3. The salient features of the calibration system established and maintained are
as under:
a) Equipment used in our group of companies are selected based on
capability, accuracy and precision of the measurement required to be
made.
b) The instruments are calibrated and adjusted at regular intervals as per
schedules or prior to use and recorded. All the critical equipments get
calibrated against certified equipment having a known valid relationship to
nationally / internationally recognized standard by trained group of
companies personnel or by employing services of outside parties having
traceability with national / international standards. In the absence of
establishing such traceability, it is calibrated through some recognized
parties or as per established procedure.
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c) Procedures are established and details are given for calibration methods,
frequency, equipment identification system etc. The records of calibration
are maintained. Calibration status of the equipment is identified by stickers
/ tags / records to recall back when calibration is due.
8.3.4. In case any equipment is found out of calibration, the validity of previous
inspection shall be assessed and necessary corrective action is taken.
a) Test equipment are calibrated under suitable environmental conditions.
b) Equipment are handled in a manner to avoid damage and deterioration
during handling, maintenance and storage. Trained persons should handle
the equipment to ensure the validity of calibration. The measuring and
monitoring devices are safeguarded to eliminate the possibility of
invalidation of the calibration or is subjected to calibration before use.
c) New or repaired equipment and devices used for inspection are subjected
to an initial inspection for accuracy or are proven prior to release for use in
testing.
8.4.1.1. THE COMPANY has established and maintains Internal Audit, in order
to define the systems and assign responsibilities for conducting, documenting, and
reporting to management the results of internal audits at planned intervals to
determine whether the QMS is effectively implemented and maintained.
8.4.1.2. Internal Audit Schedule - Internal Audit defines how Internal audits are
scheduled to ensure that all elements of the QMS are audited annually by
personnel independent of those activities being audited, or directly supervised by
the activity subject to audit.
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8.4.1.3. Timely Response - Internal Audit defines the requirement for TIOT to
identify timely response times for addressing detected non-conformances.
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The results of the analysis and resulting activities are recorded and
reported to top management and used as an input for updating food safety
management system.
8.5 Improvement
8.5.1 Continual Improvement
The process is laid down for follow up of process for continual improvement of
the Food safety management system.
The continual improvement of food safety management system is facilitated
through the use of communication, management review, internal audit, evaluation
of individual verification results, and analysis of results of verification activities,
validation of control measure combinations, corrective action and food safety
management system updating.
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Note
Food Safety Team Leader directly reports to Top Management for effective
functioning of the system. They are given authority to execute the work for
installation of Food Safety Management System in their THE COMPANY and
reports directly to director.
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