ISO 22000:2005

UNIT 10 CLAUSE-WISE INTERPRETATION

OF ISO 22000: 2005
Structure
10.0 Objectives
10.1 Introduction
10.2 Clause-wise Explanation of the Standard
10.2.1 Clause 1: Scope
10.2.2 Clause 2: Normative References
10 2.3 Clause 3: Terms and Definitions
10.2.4 Clause 4: Food Safety Management System
10.2.5 Clause 5: Management Responsibility
10.2.6 Clause 6: Resource Management
10.2.7 Clause 7: Planning and Realization of Safe Products
10.2.8 Clause 8: Validation, Verification and Improvement of the FSMS
10.3 Let Us Sum Up
10.4 Key Words
10.5 Answers to Check Your Progress Exercise
10.6 Suggested Reading

10.0 OBJECTIVES
After studying this unit, we shall be able to:
• state the requirements of each clause of ISO 22000: 2005;
• deduce the interrelationship between different clauses;
• explain the mandatory procedures required to be maintained; and
• specify the mandatory records required to be maintained.

10.1 INTRODUCTION
The ISO 22000:2005 is Food Safety Management System Standard which has
been designed and formulated to ensure safety in whole food chain. Its
requirements for any organisation in the food chain provide a framework of
internationally harmonized provisions for the global approach. The
interpretation of ISO 22000:2005 requirements such as scope, normative
references, terms and definitions, broad coverage of the system, management
responsibility, resource management, planning and realization of safe products
and validation, verification and improvement of the food safety management
system are manifested in different clauses with an aim of suitably deploying
the same in respective food safety related application area. Further, the
contents of each clause are broadly explained followed by detailed
interpretation of contents therein.

10.2 CLAUSE-WISE EXPLANATION OF THE

STANDARD
10.2.1 Clause 1: Scope
Broad coverage
Purpose, applicability and enabling effect
Contents and interpretation
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The Standard specifies requirements for a food safety management system. By Clause -wise
Interpretation of
applying the standard a food processor in the food chain demonstrate its ability ISO 22000:2005
to control food safety hazards in order to ensure that food is safe at the time of
human consumption.
It is applicable to all food processors, irrespective of size, which are involved
in any aspect of food chain and want to implement systems that consistently
provide safe products.
The standard specifies requirements to enable a food processor to:
1) Plan, implement, operate, maintain and update a food safety management
system aimed at providing products that, according to their intended use,
are safe for the consumer,
2) Demonstrate compliance with applicable statutory and regulatory food
safety requirements,
3) Evaluate and assess customer requirements and demonstrate conformity
with those mutually agreed customer requirements that relate to food
safety, in order to enhance customer satisfaction,
4) Effectively communicate food safety issues to their suppliers, customers
and relevant interested parties in the food chain,
5) It ensures that the food processor conforms to its stated food safety policy,
6) Demonstrate such conformity relevant interested parties, and
7) To seek certification or registration of its food safety management system
by an external food processor, or make a self-assessment or self
declaration of conformity to ISO 22000.

10.2.2 Clause 2: Normative References

Broad Coverage
The standards referenced in the main body.
Contents and interpretation
The standard to be referred is ISO 9001:2000 - Quality Management Systems -
Fundamentals and vocabulary. (ISO 9001:2000 has been superceded by ISO
9001:2005).

10.2.3 Clause 3: Terms and Definitions

Broad Coverage
The key terms associated with crucial food safety related concepts are
explained.
Contents and interpretation

Term Definition
Critical Step at which control can be applied and is essential to prevent or
Control Point eliminate food safety hazard or reduce it to acceptable limits.
(CCP)
Control Food safety action or activity that can be used to prevent or eliminate
Measure food safety hazard or reduce it to acceptable limit.
Correction Action to eliminate detected non-conformity. (in connection with this
standard, a correction relates to the handling of potentially unsafe
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ISO 22000:2005 Term Definition
products, and can therefore be made in conjunction with a corrective
action).
A correction may be for example reprocessing; further processing,
disposal for other use, specific labelling or discarding.

Corrective Action to eliminate the cause of a detected non-conformity or other

Action undesirable condition.

Critical Limit Criterion which separates acceptability from unacceptability.

End Product Product that will undergo no further processing or transformation by the
food processor.

Flow Diagram Schematic and systematic presentation of the sequence and interactions
of the steps of production.

Food Chain Sequences of stages and operations involved in the production,

processing, distribution, storage and handling of food and its ingredients,
from primary production to consumption. (e.g. farm to fork)

Food Safety Concept that food will not cause harm to the consumer when it is
prepared and/or consumed according to its intended use.

Food Safety Biological, chemical or physical agent in the food, or condition of food,
Hazard with a potential to cause an adverse health effect on the consumer.

Food Safety Overall intentions and direction of a food processor related to food safety
Policy (3.1) as formally expressed by Food processor.

Monitoring Conducting a planned sequence of observations or measurements to

assess whether the control measures are operating as intended.

OPRP PRP as identified by the Hazard analysis as essential in order to control

(Operational the likelihood of introducing food safety hazards, contamination or
Prerequisite proliferation to the products or the processing environment.
Program)
PRP Basic conditions and activities that are necessary to maintain a hygienic
(Prerequisite environment throughout the food chain suitable for the production,
Program) handling and provision of safe end products and safe food for human
consumption.

Updating Immediate and/or planned activity to ensure application of most recent

information.

Validation Obtaining evidence that the control measures managed by the HACCP
plan and by the OPRPs are capable of being effective.

Verification Confirmation, through the objective evidence, that specified requirements

have been fulfilled.

10.2.4 Clause 4: Food Safety Management System

Broad coverage: General requirements including system documentation.
Contents and Interpretation
A. General Requirements
The food processor is required to establish, document, implement and maintain
an effective food safety management system and update it when necessary.
The food processor is required to define the scope. The scope is required to
specify the relevant products or product categories, processes and production
sites.
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The food processor is required to: Clause -wise
Interpretation of
• Identify, evaluate and control the associated food safety hazards in such a ISO 22000:2005
manner that the products of the food processor do not, directly or
indirectly, harm the consumer.
• Internally and externally communicate information concerning
development, implementation and updating of the food safety management
system.
• Periodically evaluate and update the food safety management system.
• Control the outsourced processes (if any).
B. Documentation Requirements
(i) General
The FSMS documentation is required to include:
• Food safety policy and related objectives.
• Required procedures and records.
• Other documents to ensure effective development, implementation and
updating of the FSMS.
(ii) Control of documents
FSMS documents are required to be controlled.
The controls is required to ensure that all proposed changes are reviewed prior
to implementation.
A documented procedure is required to be established to define the controls
needed for:
• Approval and re-approval of documents,
• Identification of changes in current documents,
• Availability at point of use,
• Legibility of documents,
• Control over documents of external origin, and
• Prevention of unintended use of obsolete documents.
(iii) Control of Records
A documented procedure is required to be established to define the controls
needed for the identification, storage, protection, retrieval, retention time and
disposition of records.

10.2.5 Clause 5: Management Responsibility

Broad Coverage
• Management commitment
• Food safety policy
• FSMS planning
• Role definition
• Food safety team leader
• Communication

41
ISO 22000:2005 • Emergency preparedness and response
• Management review
Contents and interpretation
A. Management Commitment
Food processor is required to provide evidence of its commitment to FSMS
and continually improve its effectiveness through supportive business
objectives
• Communicating the importance of meeting requirements of standard,
customer, government and regulations,
• Establishing food safety policy,
• Conducting management reviews, and
• Ensuring the availability of resources.
B. Food Safety Policy
Food processor is required to define, document and communicate its food
safety policy and ensure that the food safety policy:
• Is appropriate to the role of the food processor.
• Conforms to requirements of standard, customer, government and
regulations.
• Is communicated, implemented and maintained at all levels.
• Is reviewed for continual suitability.
• Adequately addresses communication.
• Is supported by measurable objectives.
C. Food Safety Management System Planning
Food processor is required to ensure that:
• Planning of the FSMS is carried out.
• The integrity of FSMS is maintained.
D. Responsibility and Authority
Food processor is required to ensure that roles are properly defined and
communicated. Designated personnel are required to have responsibility and
authority to initiate and record actions.
E. Food Safety Team Leader
Food processor is required to appoint a food safety team leader.
• to manage and train the food safety team,
• to ensure that the FSMS is established, implemented, maintained and
updated,
• to report on the effectiveness and suitability of FSMS, and
• to interface with external parties on FSMS.
F. Communication
(i) External Communication
The food processor is required to establish, implement and maintain effective
arrangements for communicating with:
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• Suppliers and contractors, Clause -wise
Interpretation of
• Customers or consumers, ISO 22000:2005

• Statutory and regulatory authorities, and

• Others having an impact on/of FSMS.
Designated personnel are required to have defined responsibility and authority
to communicate.
(ii) Internal Communication
The food processor is required to establish, implement and maintain effective
arrangements for communicating with internal personnel.
In order to maintain effectiveness of FSMS, the food processor is required to
ensure that the food safety team is informed in a timely manner of changes,
including but not limiting to the following:
• raw materials, ingredients, products and services,
• production premises, systems and equipment,
• cleaning and sanitation programs,
• packaging, storage and distribution systems,
• personnel qualification, responsibilities and authorities,
• statutory and regulatory requirements,
• knowledge regarding hazards and control measures,
• customer, sector and other applicable requirements,
• enquiries from external interested parties,
• complaints indicating hazards associated with the product, and
• other conditions that have an impact on food safety.
The food safety team is required to ensure that this information is used to
update FSMS.
G. Emergency preparedness and response
Food processor is required to establish, implement and maintain procedures to
manage emergency situations that can impact food safety.
H. Management Review
(i) General
Food processor is required to review FSMS at planned intervals to ensure its
continuing suitability, adequacy, effectiveness and maintain records.
(ii) Review Input
The input data for management review is required to include:
• Follow-up actions from previous management reviews,
• Analysis of results of verification activities,
• Changing circumstances that can affect food safety,
• Emergency situations, accidents and withdrawals,
• Review of results of system updating activities,
• Review of internal and external communication activities, and
• External audits or inspections.
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ISO 22000:2005 (iii) Review Output
Output from the management review is required to include decisions and
actions related to:
• assurance of food safety,
• improvement of the effectiveness of the FSMS,
• resource needs, and
• revisions of food safety policy and related objectives.

10.2.6 Clause 6: Resource Management

Broad Coverage
• Provision of competent human resources,
• Provision of necessary infrastructure, and
• Provision of required work environment.
Contents and interpretation
A. Provision of Resources
The food processor is required to provide adequate resources for establishing,
implementing, maintaining and updating FSMS.
B. Human Resources
(i) General
The food safety team and other relevant personnel are required to have
appropriate education, training, skills and experience.
(ii) Competency, awareness and training
The food processor is required to:
a) identify the competencies of relevant personnel,
b) ensure that the personnel have necessary competence,
c) evaluate the implementation and effectiveness of training,
d) ensure that the personnel are aware of the relevance and importance of
their activities including effective communication, and
e) maintain records of training and other actions.
(iii) Infrastructure
The food processor is required to provide infrastructure needed to implement
the standard.
(iv) Work Environment
The food processor is required to provide work environment needed to
implement the standard.

10.2.7 Clause 7: Planning and Realization of Safe Products

Broad Coverage
• Prerequisite program
• Pre steps to Hazard Analysis
• Hazard Analysis
• OPRP
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• Establishment of HACCP plan Clause -wise
Interpretation of
• Updating PRP and HACCP plan ISO 22000:2005

• Verification
• Traceability
• Control of non-conforming product
Contents and interpretation: General
The food processor is required to plan and develop the processes needed for
realization of the safe products.
A. Prerequisite programs (PRPs)
(i) The food processor is required to establish, implement and maintain PRPs
for controlling.
• Likelihood of introducing hazards to the products.
• Biological, chemical and physical contamination of products.
• Hazard levels in the product and processing environment.
(ii) The PRPs are required:
• to be appropriate to food safety needs,
• to be appropriate to the size and type of the operation and the nature
of the products,
• to be implemented across the entire production system, and
• to be approved by the food safety team.
The food processor is required to identify statutory and regulatory
requirements related to above.
(iii) When selecting and/or establishing PRPs, the food processor is required to
consider and utilize appropriate information (e.g. Statutory and regulatory
requirements, customer requirements, recognized guidelines, Codex
Alimentarius Commission (Codex) principles and codes of practices,
national and international or sector standards). The food processor is
required to consider following while establishing these programs:
• Construction and lay-out of buildings and associated utilities,
• Lay-out of premises, including workspace and employee facilities,
• Supplies of air, water, energy and other utilities,
• Supporting services, including waste and sewage disposal,
• The suitability of equipment and its accessibility for cleaning,
maintenance and preventive maintenance,
• Management of purchased materials, supplies (e.g. water, steam, ice
etc.), disposals (e.g. waste and sewage) and handling of product (e.g.
storage and transportation),
• Measures for prevention of cross contamination,
• Cleaning and sanitization,
• Pest control,
• Personnel hygiene, and
• Other aspects as appropriate.
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ISO 22000:2005 Verification of PRPs is required to be planned and PRPs are required to be
modified as necessary. Records of verifications and modifications are required
to be maintained. Documents should specify how activities included in the
PRPs are managed.
B. Preliminary steps to enable Hazard Analysis
General
Information needed to conduct hazard analysis is required to be collected,
maintained, updated and documented. Records are required to be maintained.
(i) Food Safety Team
A food safety team is required to be appointed.
The food safety team is required to have a combination of multi-disciplinary
knowledge and experience in developing and implementing the FSMS.
(ii) Product Characteristics
a) Raw Materials, ingredients and product-contact materials
All raw materials, ingredients and product-contact materials are required to be
described in revise it to conduct the hazard analysis, including the following,
as appropriate:
• biological, chemical and physical characteristics;
• composition of formulated ingredients, including additives and processing
aids;
• origin;
• method of production;
• packaging and delivery methods;
• storage conditions and shelf life;
• preparation and/or handling before use or processing; and
• food safety-related acceptance criteria or specifications of purchased
materials and ingredients appropriate to their intended uses.
The food processor is required to identify statutory and regulatory food safety
requirements related to the above.
b) Characteristics of end products
The characteristics of end products is required to be described in documents
including information on the following:
• product name or similar identification;
• composition;
• biological, chemical and physical characteristics relevant for food safety;
• intended shelf life and storage conditions;
• packaging;
• labelling relating to food safety and/or instructions for handling;
• preparation and usage; and
• method of distribution.
The food processor is required to identify statutory and regulatory food safety
requirements related to the above.
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c) Intended use Clause -wise
Interpretation of
The intended use, the reasonably expected handling of the end product, and ISO 22000:2005
any unintended but reasonably expected mishandling and misuse of the end
product is required to be considered and is required to be described in
documents.
Groups of users and, where appropriate, groups of consumers is required to be
identified for each product, and consumer groups known to be especially
vulnerable to specific food safety hazards is required to be considered.
d) Flow diagrams, process steps and control measures
(i) Flow diagrams are required to be prepared for the products or process
categories covered by the food safety management system. Flow diagrams
is required to provide a basis for evaluating the possible occurrence,
increase or introduction of food safety hazards. Flow diagrams is required
to include the following:
• sequence and interaction of all steps in the operation;
• any outsourced processes and subcontracted work;
• where raw materials ingredients and intermediate products enter the
flow, are released or removed, and
• where reworking and recycling take place.
The food safety team is required to verify the accuracy of the flow
diagrams by on-site checking. Verified flow diagrams is required to be
maintained as records.
(ii) Description of process steps and control measures
The existing control measures, process parameters and/or the rigorousness
with which they are applied, or procedures that may influence food safety, is
required to be described. External requirements (e.g. from regulatory
authorities of customers) that may impact the choice and the rigorousness of
the control measures is also required to be described.
C. Hazard Analysis
(i) General
The food safety team is required to conduct a hazard analysis to determine
which hazards need to be controlled, the degree of control required to ensure
food safety, and which combination of control measures is required.
(ii) Hazard identification and determination of acceptable levels
A. All food safety hazards that are reasonably expected to occur in relation to
the type of product, type of process an actual processing facilities is
required to be identified and recorded. The identification is required to be
based on:
• the preliminary information and data collected;
• experience;
• external information including, epidemiological and other historical
data; and
• information from the food chain on food safety hazards that may be of
relevance for the safety of the end products, intermediate products and
the food at consumption.
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ISO 22000:2005 The step(s) (from raw materials, processing and distribution) at which each
food safety hazard may be introduced is required to be indicated.
B. When identifying the hazards, consideration is required to be given to:
• the steps preceding and following the specified operation,
• the process equipment, utilities/services and surroundings, and
• the preceding and following links in the food chain.
C. For each of the food safety hazards identified, the acceptable level of the
food safety hazard in the end product is required to be determined
whenever possible. The determined level is required to take into account
established statutory and regulatory requirements, customer food safety
requirements, the intended use by the customer and other relevant data.
The justification for, and the result of the determination is required to be
recorded.

(iii) Hazard Analysis

A hazard assessment is required to be conducted to determine, for each hazard
identified, whether its elimination or reduction to acceptable levels is essential
to the production of a safe food, and whether its control is needed to enable the
defined acceptable levels to be met.
Each hazard is required to be evaluated according to the possible severity of
adverse health effects and the likelihood of their occurrence. The methodology
used is required to be described, and the results of the hazard assessment is
required to be recorded.

(iv) Selection and assessment of control measures

Based on the hazard assessment an appropriate combination of control
measures is required to be selected. In this selection, each of the control
measures is required to be reviewed with respect to its effectiveness against the
identified hazards.
The control measures selected is required to be categorized as to whether they
need to be managed through operational PRP(s) or by the HACCP plan. The
selection and categorization is required to be carried out using a logical
approach that includes assessments with regard to the following:
a) its effect on identified hazards relative to the strictness applied;
b) its feasibility for monitoring;
c) its place within the system relative to other control measures;
d) the likelihood of failure and/or variability in its functioning;
e) the severity of the consequence(s) in the case of failure;
f) whether the control measure is specifically established and applied; and
g) synergistic effects (i.e. interaction that occurs between two or more
measures resulting in their combined effect being higher the sum of their
individual effects).
The methodology and parameters used for this categorization is required to be
described in documents, and the results of the assessment is required to be
recorded.
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D. Establishing the operational prerequisite programs (OPRPs) Clause -wise
Interpretation of
The operational PRPs is required to be documented and is required to include ISO 22000:2005
the following information for each program:
• hazards to be controlled by the program;
• control measures;
• monitoring procedures that demonstrate that OPRPs are implemented;
• corrections and corrective actions to be taken if monitoring shows that
OPRPs are not in control;
• responsibilities and authorities; and
• record of monitoring.
E. Establishing the HACCP plan
(i) HACCP plan
The HACCP plan is required to be documented and is required to include the
following information for each identified critical control point (CCP).
• food safety hazards to be controlled at the CCP;
• control measures;
• critical limits;
• corrections and corrective actions to be taken if monitoring shows that
OPRPs are not in control;
• responsibilities and authorities; and
• record of monitoring.
(ii) Identification of critical control points (CCPs)
For each hazard that is to be controlled by the HACCP plan, CCPs are
required to be identified for the control measures identified.
(iii) Determination of critical limits for critical control points
Critical limits is required to be determined for the monitoring established for
each CCP. Critical limits is required to be established to ensure that the
identified acceptable level of the food safety hazard in the end product is not
exceeded.
The rationale for the chosen critical limits is required to be documented.
Critical limits based on subjective data (such as visual inspection of product,
handling, etc.) is required to be supported by instructions or specifications
and/or education and training.
(iv) System for the monitoring of critical control points
A monitoring system is required to be established for each CCP to demonstrate
that the CCP is in control. The system is required to include all scheduled
measurements of observations relative to the critical limits.
The monitoring system is required to consist of relevant procedures,
instructions and records that cover the following:
• measurements or observations that provide results within an adequate
time frame;
• monitoring devices used;
• applicable calibration methods;
• monitoring frequency;
49
ISO 22000:2005 • responsibility and authority related to monitoring and evaluation of
monitoring results; and
• record requirements and methods.
The monitoring methods and frequency is required to be capable of
determining when the critical limits have been exceeded in time for the product
to be isolated before it is used or consumed.
(v) Actions when monitoring results exceed critical limits
Planned corrections and corrective actions to be taken when critical limits are
exceeded is required to be specified in the HACCP plan. The actions is
required to ensure that the cause of non-conformity is identified, that the
parameters controlled at the CCP are brought back under control, and that
recurrence is prevented.
Documented procedures is required to be established and maintained for the
appropriate handling of potentially unsafe products to ensure that they are not
released until they have been evaluated.
F. Updating of preliminary information and documents specifying the
PRPs and the HACCP plan
Following the establishment of OPRPs and/or the HACCP plan, the food
processor is required to update the following information:
• product characteristics;
• intended use,
• flow diagrams,
• process steps, and
• control measures.
The HACCP plan and the procedures and instructions specifying the PRPs are
required to be amended.
G. Verification planning
Verification planning is required to define the purpose, method, frequencies
and responsibilities. The verification activities are required to confirm that :
• the PRPs are implemented,
• input to the hazard analysis is continually updated,
• the OPRPs and the elements within the HACCP plan are implemented and
effective,
• hazard levels are within identified acceptable levels, and
• other procedures required by the food processor are implemented and
effective.
The output of the planning is required to be in a form suitable for the food
processor’s method of operations. Verification results are required to be
recorded and are required to be communicated to the food safety team.
Verification results is required to be provided to enable the analysis of the
results of the verification activities.
If system verification is based on testing of end product samples, and where
such test samples show non-conformity with the acceptable level of the hazard,
the affected lots of product is required to be handled as potentially unsafe.
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H. Traceability system Clause -wise
Interpretation of
The food processor is required to establish and apply a traceability system that ISO 22000:2005
enables the identification of product lots and their relation to batches of raw
materials, processing and delivery records. The traceability system is required
to be able to identify incoming material from the immediate suppliers and the
initial distribution route of the end product.
Traceability record is required to be maintained for a defined period for system
assessment to enable the handling of potentially unsafe products and in the
event of product withdrawal.
I. Control of Non-conformity
(i) Corrections
The food processor is required to ensure that when critical limits for CCPs are
exceeded or there is a loss of control of OPRPs, the products affected are
identified and controlled with regard to their use and release.
A documented procedure is required to be established and maintained defining:
• the identification and assessment of affected end products to their proper
handling; and
• a review of the corrections carried out.
Products manufactured under conditions where critical limits have been
exceeded are potentially unsafe products. Products manufactured under
conditions where OPRPs have not been conformed with is required to be
evaluated with respect to the causes of the non-conformity and to the
consequences thereof. The evaluation is required to be recorded.
(ii) Corrective Actions
Data derived from the monitoring of OPRPs and CCPs is required to be
evaluated by designated persons with sufficient knowledge and authority to
initiate corrective actions.
Corrective actions are required to be initiated when critical limits are exceeded
or when there is a lack of conformity with OPRPs.
The food processor is required to establish and maintain documented
procedures that specify appropriate actions to identify and eliminate the cause
of detected non-conformities, to prevent recurrence, and to bring the process of
system back into control after non-conformity is encountered. These actions
include:
• reviewing non-conformities (including customer complaints),
• reviewing trends in monitoring results that may indicate development
towards loss of control,
• determining the causes of non-conformities,
• evaluating the need for action to ensure that non-conformities do not recur,
• determining and implementing the actions needed,
• recording the results of corrective actions taken, and
• reviewing corrective actions taken to ensure that they are effective.
Corrective actions are required to be recorded.

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ISO 22000:2005 (iii) Handling of potentially unsafe products
General
The food processor is required to handle non-conforming products by taking
actions to prevent it from entering the food chain unless it is possible to ensure
that:
a) The food safety hazards of concern have been reduced to the defined
acceptable levels,
b) The food safety hazards of concern will be reduced to identified
acceptable levels prior to entering into the food chain, and
c) The product still meets the defined acceptable levels of the food safety
hazards of concern despite the non-conformity.
All lots of food product that may have been affected by a non-conforming
situation is required to be held under control of the food processor until they
have been evaluated.
If products that have left the control of the food processor are subsequently
determined to be unsafe, the food processor is required to notify relevant
interested parties and initiate a withdrawal. The withdrawal includes recall.
The controls and related responses and authorization for dealing with
potentially unsafe products is required to be documented.
Evaluation for Release
Each lot of product affected by the non-conformity is required to be released as
safe only when any of the following conditions apply:
• evidence other than the monitoring system demonstrates that the control
measures have been effective;
• evidence shows that the combined effect of the control measures for that
particular product complies with the performance intended (i.e. identified
acceptable levels as identified in accordance with); and
• the results of sampling analysis and/or other verification activities
demonstrate that the affected lot of product complies with the identified
acceptable levels for the food safety hazards concerned.
Disposition of non-conforming products
Following evaluation, if the lot of product is not acceptable for release it is
required to be handled by one of the following activities:
• reprocessing or further processing within or outside the food processing
area to ensure that the food safety hazard is eliminated or reduced to
acceptable levels; and
• destruction and/or disposal as waste.
(iv) Withdrawals
To enable and facilitate the complete and timely withdrawal of lots of end
products which have been identified as unsafe.
• Food processor is required to appoint personnel having the authority to
initiate a withdrawal and personnel responsible for executing the
withdrawal,
• The food processor is required to establish and maintain a documented
procedure for notification to relevant interested parties (e.g. statutory and
regulatory authorities, customers and/or consumers),
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• Handling of withdrawn products as well as affected lots of the products Clause -wise
Interpretation of
still in stock, and ISO 22000:2005
• The sequence of actions to be taken.
Withdrawn products is required to be secured or held under supervision until
they are destroyed, used for purposes other than originally intended,
determined to be safe for the same (or other) intended use, or reprocessed in a
manner to ensure they become safe.
The cause, extent and result of a withdrawal is required to be recorded and
reported as input to the management review.
The food processor is required to verify and record the effectiveness of the
withdrawal program through the use of appropriate techniques.

10.2.8 Clause 8: Validation, Verification and Improvement of

the FSMS
Broad coverage
• Validation of control measure combinations
• Monitoring and measurement
• FSMS verification
• Improvement
Contents and interpretation
General
The food safety team is required to plan and implement the processes needed
to validate control measures and/or control measure combinations, and
improve the food safety management system.
A. Validation of control measure combinations
Prior to implementation of control measures to be included in OPRPs and the
HACCP plan and after any change therein, the food processor is required to
validate that:
• the selected control measures are capable of achieving the intended control
of the food safety hazards for which they are designated, and
• the control measures are effective and capable of, in combination, ensuring
control of the identified food safety hazards to obtain end products that
meet the defined acceptable levels.
If the result of the validation shows that one or both of the above elements
cannot be confirmed, the control measure and/or combinations thereof is
required to be modified and re-assessed.
B. Control of monitoring and measuring
The food processor is required to provide evidence that the specified
monitoring and measuring methods and equipment are adequate to ensure the
performance of the monitoring and measuring procedures.
Where necessary to ensure valid results, the measuring equipment and methods
used:
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ISO 22000:2005 • are required to be calibrated or verified at specified intervals, or prior to
use, against measurement standards traceable to international or national
measurement standards; where no such standards exist, the basis used for
calibration or verification is required to be recorded,
• are required to be adjusted or re-adjusted as necessary,
• are required to be identified to enable to the calibration status to be
determined,
• are required to be safeguarded from adjustments that would invalidate the
measurement results, and
• are required to be protected from damage and deterioration.
Records of the results of calibration and verification is required to be
maintained.
In addition, the food processor is required to assess the validity of the previous
measurement results when the equipment or process is found not to conform to
requirements. If the measuring equipment is non-conforming, the food
processor is required to take appropriate action for the equipment and any
product affected. Records of such assessment and resulting actions is required
to be maintained.
When used in the monitoring and measurement of specified requirements, the
ability of computer software to satisfy the intended application is required to
be confirmed. This is required to be undertaken prior to initial use and is
required to be reconfirmed as necessary.
C. Food safety management system verification
Internal audit
The food processor is required to conduct internal audits at planned intervals to
determine whether the food safety management system:
• conforms to the planned arrangements, to the food safety management
system requirements established by the food processor, and to the
requirements of this international standard, and
• is effectively implemented and updated.
An audit program is required to be planned. The audit criteria, scope frequency
and methods are required to be defined. Selection of auditors and the conduct
of audits is required to ensure the objectivity and impartiality of the audit
process. Auditor is required not to audit their own work.
The management responsible for the area being audited is required to ensure
that actions are taken without undue delay to eliminate detected non-
conformities an their causes. Follow-up activities is required to include the
verification of the actions taken and the reporting of the verification results.
D. Analysis of results of verification activities
The food safety team is required to analyze the results of verification activities,
including the results of the internal audits and external audits. The analysis is
required to be carried out in order:
• to confirm that the overall performance of the system meets the planned
arrangements and the food safety management system requirements
established by the food processor,
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• to identify the need for updating or improving the FSMS, Clause -wise
Interpretation of
• to establish information for planning of the internal audit program , and ISO 22000:2005

• to provide evidence that any corrections and corrective actions that have
been taken are effective.
The results of the analysis and the resulting activities is required to be reported
as input to the management review.
E. Improvement
(i) Continual improvement
Food processor is required to ensure that the food processor continually
improves the effectiveness of the FSMS through the use of communication,
management review, internal audit, evaluation of individual verification
results, analysis of results of verification, validation of control measure
combinations, corrective actions and FSMS updating.
(ii) Updating the FSMS
Food processor is required to ensure that the FSMS is continually updated.
In order to achieve this, the food safety team is required to evaluate the FSMS
at planned intervals. The team is required to consider then whether it is
necessary to review the hazard analysis the established OPRPs and the HACCP
plan.
The evaluation and updating the activities is required to be based on:
• input from communication, external as well as internal.
• input from other information concerning the suitability, adequacy and
effectiveness of the FSMS.
• output from the analysis of results of verification activities.
• output from management review.
System updating activities is required to be recorded and reported, in an
appropriate manner, as an input to the management review.

Check Your Progress Exercise 1 "

Note: a) Use the space below for your answers.
b) Compare your answers with those given at the end of the unit.
1) List ten constituents of the food chain to which ISO 22000 is applicable?
…………………………………………………………………………….
…………………………………………………………………………….
…………………………………………………………………………….
…………………………………………………………………………….
2) List seven essential internal communication aspects?
…………………………………………………………………………….
…………………………………………………………………………….
…………………………………………………………………………….
…………………………………………………………………………….
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ISO 22000:2005 3) Give reference of clauses from standard for at least five review inputs for
conducting management review meeting?
…………………………………………………………………………….
…………………………………………………………………………….
…………………………………………………………………………….
…………………………………………………………………………….

…………………………………………………………………………….

4) Explain the similarity and difference between OPRP and HACCP plan?
…………………………………………………………………………….
…………………………………………………………………………….
…………………………………………………………………………….
…………………………………………………………………………….
…………………………………………………………………………….

5) Explain the main purpose of verification planning?

…………………………………………………………………………….
…………………………………………………………………………….
…………………………………………………………………………….
…………………………………………………………………………….
…………………………………………………………………………….

6) List the inputs essential for conducting activity for updating food safety
management system?
…………………………………………………………………………….
…………………………………………………………………………….
…………………………………………………………………………….
…………………………………………………………………………….
…………………………………………………………………………….

10.3 LET US SUM UP

ISO 22000: 2005 standard, which covers all Food safety related applicable
areas in an industry which is a part of supply chain. The standard harmonize its
structure with other management system standards like ISO 9001:2000 and
ISO 14001: 2004. The standard consists of eight clauses further divided into
thirty three sub-clauses. This structure follows PDCA approach in the
organisation and sequence of the clauses.
The intent of the clauses and the internal congruence between the clauses has
been explained. The contents cover mandatory documents including plans,
procedures and records. The overall focus is on prevention of hazards likely to
occur in the operation during food processing. Emphasis has been given on
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internal and external communication, emergency preparedness and response, Clause -wise
Interpretation of
classifying control measures according to the impact they have on the potential ISO 22000:2005
hazards.

10.4 KEY WORDS

Critical : Steps at which control can be applied and is essential to
Control prevent or eliminate food safety hazard or reduce it to
Point (CCP) acceptable limits.
Control : Food safety action or activity that can be used to prevent
Measure or eliminate food safety hazard or reduce it to acceptable
limit.
Corrective : Action to eliminate the cause/s of a detected non-
Action conformity or other undesirable condition.
Critical : Criterion which separates acceptability from unaccept-
Limit ability.
Food Safety : Biological, chemical or physical agent in the food, or
Hazard condition of food, with a potential to cause an adverse
health effect on the consumer.
Prerequisite : Basic conditions and activities that are necessary to
Programme maintain a hygienic environment throughout the food
(PRP) chain suitable for the production, handling and provision
of safe end products and safe food for human
consumption.

10.5 ANSWERS TO CHECK YOUR PROGRESS "

EXERCISE
Your answer should include following points:
Check Your Progress Exercise 1
1) • Primary food processors
• Food manufacturer
• Secondary food manufacturer
• Wholesaler
• Retailer
• Producers of packaging material
• Transportation and storage operators
• Producers of equipment
• Producers of Fertilizers
• Producers of sanitizing agents
2) • Raw material, ingredients and products
• Production premises, production system, equipment, equipment
location
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ISO 22000:2005 • Cleaning and sanitation programs
• Packaging, storage and distribution systems
• Statutory and regulatory requirements
• Knowledge regarding food safety hazards and control measures
• Complaints indicating food safety hazards associated with the product
3) • Analysis of results of verification activities (Clause 8.2.3)
• Changing circumstances that can affect food safety (Clause 5.6.2)
• Emergency situations, accidents and withdrawals (Clause 5.7 & 7.10.4)
• Reviewing results of system updating activities (Clause 8.5.2)
• Review of communication activities, including customer feedback
(Clause 5.6.1)
4) Similarities:
• Both need to specify hazards they control and associated control
measures.
• Both need to be documented.
• Both require monitoring procedures.
• Records of monitoring of both need to be maintained.
• Responsibilities and authorities for both need to be specified.
Differences:
• Critical limits are required to be mentioned only in HACCP plan and
not in OPRP.
• For HACCP plan corrections and corrective actions need to be taken if
critical limits are exceeded whereas for OPRP they are to be taken if
monitoring shows that OPRPs are not in control.
• In case of OPRP, monitoring procedures need to demonstrate that
OPRPs are implemented.
5) • Confirming that PRPs are implemented.
• Confirming that input to hazard analysis is continually updated.
• Confirming that OPRPs and HACCP elements are implemented and
effective.
• Confirming that the hazard levels are within the identified acceptable
limits.
• Confirming that procedures required by the organisation are
implemented and effective.
6) • Confirming that PRPs are implemented.
• Input from internal and external communication
• Analysis of results of verification activities
• Result of management reviews
• Input information about suitability, adequacy and effectiveness of
FSMS.
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Multiple Choice Questions Clause -wise
Interpretation of
ISO 22000:2005
1) Food safety system audits are used to verify
a) the number of persons who wash their hands.
b) the extent to which audit criteria are fulfilled.
c) that all suppliers to the organisation have ISO 22000 certification.
d) all of the above.
e) none of the above.
2) A third party audit is
a) an internal audit.
b) an audit by the customer or client.
c) an audit by an independent organisation.
d) all of the above.
e) none of the above.
3) ISO 22000 includes:
a) health and safety requirements.
b) food safety planning.
c) food safety system costing.
d) all of the above.
e) none of the above.
4) Which of the following activities must be carried out by someone who
does not perform the activity being evaluated?
a) a hazard analysis.
b) a food inspection.
c) an internal audit.
d) all of the above.
e) none of the above.
5) A system based on the requirements of ISO 22000 aims to
a) meet regulatory requirements.
b) demonstrate an organisation’s ability to consistently supply safe food.
c) prevent cross contamination.
d) all of the above.
e) none of the above.
6) Data supporting the existence or verity of something is called:
a) objective evidence.
b) a deficiency.
c) a non-conformity report.
d) all of the above.
e) none of the above.
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ISO 22000:2005 7) What information is being sought during a third party audit of a food
safety system?
a) a list of non-conformities to ISO 22000.
b) objective evidence of conformity with ISO 22000.
c) a management commitment to public safety.
d) all of the above.
e) none of the above.
8) To act as an auditor of a food safety system a person has to
a) be registered as a certificated auditor.
b) have a detailed knowledge of the product or service of the organisation
to be audited.
c) be a food safety team member.
d) all of the above.
e) none of the above.
9) “Action or activity that can be used to prevent or eliminate a food safety
hazard” is called:
a) a critical control point.
b) corrective action.
c) a control measure.
d) all of the above.
e) none of the above.
10) The extent of documentation of the food safety system should be
determined by:
a) top management.
b) the requirements of ISO 22000.
c) the culture of the organisation.
d) all of the above.
e) none of the above.
Answers:
1) b 2) c 3) b 4) c 5) d 6) a 7) b 8) e 9) c 10) b

10.6 SUGGESTED READING

http://www.iso.org
http://www.codexalimentarius.net
Codex Alimentarius Food Hygiene Basic Texts, Food and Agricultural
Organisation of the United Nations, World Health Organisation, Rome, 2001.
ISO / TS 22004: Food System Management Systems - Guidance on the
application of ISO 22000: 2005.
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ISO 19011: 2002 - Guidelines for Quality and /or Environmental Management Clause -wise
Interpretation of
Systems Auditing. ISO 22000:2005

ISO 15161: 2001 - Guidelines on the Application of ISO 9001:2000 for the
Food and Drink Industry.
ISO 9000: 2005 - Quality Management Systems- Fundamentals and
Vocabulary.
CAC/RCP 1 - 1969 (Rev 4- 2003), Recommended International Code of
Practice- General Principles of Food Hygiene.

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