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FSSC 22000 vs 4 Audit Requirements Checklist


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ISO 22000:2005
4 Food safety management system
4.1 General requirements
4.1 – 01 Has the organisation established, documented and implemented an effective food safety
management system in accordance with the requirements of ISO 22000 standard?
4.1 – 02 Is the FSMS maintained and updated?
4.1 – 03 Is the scope of the FSMS defined?
4.1 – 04 Are the products or product categories, processes and production sites that are addressed by the
food safety management system specified by scope?
4.1 – 05 Are the food safety hazards that may be reasonably expected to occur in relation to products within
the scope of the system identified, evaluated and controlled in such a manner that the products of
the organisation do not, directly or indirectly, harm the consumer?
4.1 – 06 Are the appropriate information - regarding safety issues related to the products - communicated
throughout the food chain?
4.1 – 07 Are the information - concerning development, implementation and updating of the FSMS
throughout the organisation - communicated to the extent necessary to ensure the food safety
required by the ISO 22000 standard?
4.1 – 08 Does the organisation periodically evaluate FSMS (and update when necessary) to ensure that the
system reflects the organisation's activities and incorporates the most recent information on the food
safety hazards subject to control?
4.1 – 09 Has the organisation ensured control over the outsourced processes that may affect end product
conformity?
4.1 – 10 Is the control of such outsourced processes identified and documented within the FSMS?
4.2 4.2 Documentation requirements
4.2.1 4.2.1 General
Does the FSMS documentation include:
4.2.1 – 01 a) documented statements of a food safety policy and related objectives?
4.2.1 – 02 b) documented procedures and records required by ISO 22000 standard?
4.2.1 – 03 c) documents needed by the organisation to ensure the effective development,
implementation and updating of the food safety management system?
4.2.2 4.2.2 Control of documents
4.2.2 – 01 Are the documents - which are required by the food safety management system - controlled?

4.2.2 – 02 Do the established controls ensure that all proposed changes are reviewed prior to
implementation to determine their effects on food safety and their impact on the food safety
management system?
Does a documented procedure exist to define the controls needed:
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4.2.2 – 03 a) to approve documents for adequacy prior to issue?
4.2.2 – 04 b) to review and update as necessary and reapprove documents?
4.2.2 – 05 c) to ensure that changes and the current revision status of documents are identified?
4.2.2 – 06 d) to ensure that relevant versions of applicable documents are available at points of use?
4.2.2 – 07 e) to ensure that documents remain legible and readily identifiable?
4.2.2 – 08 f) to ensure that relevant documents of external origin are identified and their distribution
controlled?
4.2.2 – 09 g) to prevent the unintended use of obsolete documents, and to apply suitable identification
to them if they are retained for any purpose?
4.2.3 4.2.3 Control of records
4.2.3 – 01 Are required records established and maintained in order to provide evidence of conformity to
requirements and evidence of the effective operation of the food safety management system?
4.2.3 – 02 Do records remain legible, readily identifiable and retrievable?
4.2.3 – 03 Does a documented procedure exist in order to define the controls needed for the correction,
identification, storage, protection, retrieval, retention time and disposition of records?
5 Management responsibility
5.1 Management commitment
5.1 – 01 Is top management able to provide evidence of its commitment to the development and
implementation of the food safety management system?
Is top management able to provide evidence that the effectiveness of the food safety management
system is continually improved by:
5.1 – 02 a) showing food safety is supported by the business objectives of the organisation?
5.1 – 03 b) communicating to the organisation the importance of meeting the requirements of ISO
22000 standard, any relevant statutory and regulatory requirements, as well as customer
requirements relating to food safety?
5.1 – 04 c) establishing the food safety policy?
5.1 – 05 d) conducting management reviews, and
5.1 – 06 e) ensuring the availability of resources?
5.2 Food safety policy
5.2 – 01 Has top management defined, documented and communicated its food safety policy?
Does top management ensure that the food safety policy:
5.2 – 02 a) is appropriate to the role of the organisation in the food chain
5.2 – 03 b) conforms with both statutory and regulatory requirements and with mutually agreed food
safety requirements of customers,
5.2 – 04 c) is communicated, implemented and maintained at all levels of theorganisation,
5.2 – 05 d) is reviewed for continued suitability,
5.2 – 06 e) adequately addresses communication, and
5.2 – 07 f) is supported by measurable objectives.
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5.3 Food safety management system planning
Does top management ensure that:
5.3 – 01 a) the planning of the food safety management system is carried out to meet the
requirements in clause 4.1, as well as the objectives of the organisation that support food
safety?
5.3 – 02 b) the integrity of the food safety management system is maintained when changes to the
food safety management system are planned and implemented?
5.4 Responsibility and authority
5.4 – 01 Does top management ensure that the responsibilities, authorities are defined and communicated
within the organisation to ensure the effective operation and
maintenance of the food safety management system?
5.4 – 02 Is the responsibility assigned to all personnel to report the problems with the food safety
management to identified person(s)?
5.4 – 03 Are there designated personnel with defined responsibility and authority to initiate and record
actions?
5.5 Food safety team leader
5.5 – 0.1 Has top management appointed a food safety team leader who, irrespective of other responsibilities,
shall have responsibility and authority:
5.5 – 0.2 a) to manage a food safety team and organize its work?
5.5 – 0.3 b) to ensure relevant training and education of the food safety team member?
5.5 – 0.4 c) to ensure that the food safetymanagement system is established, implemented,
maintained and updated?
5.5 – 0.5 d) to report to the organisation's topmanagement on the effectiveness and suitability of the
food safety management system?.
5.6 Communication
5.6.1 External communication
Has the organisation established, implemented and maintained effective arrangements for
communicating with:
5.6.1 – 0.1 a) suppliers and contractors?
5.6.1 – 0.2 b) customers or consumers, in particular in relation to product information (including
instructions regarding intended use, specific storage requirements and, as appropriate, shelf
life), enquiries, contracts or order handling including amendments, and customer feedback
including customer complaints?

5.6.1 – 0.3 c) statutory and regulatory authorities?


5.6.1 – 0.4 d) other organisations that have an impact on, or will be affected by, the effectiveness or
updating of the food safety management system?
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5.6.1 - 05 Does such communication provide information on food safety aspects (especially to known food
safety hazards that need to be controlled by other organisations in the food chain) of the
organisation's products that may be relevant to other organisations in the food chain?
5.6.1 – 06 Are records of communications maintained?
5.6.1 – 07 Are the food safety requirements - from statutory and regulatory authorities and customers –
available?
5.6.1 – 08 Are there designated personnel with defined responsibility and authority to communicate externally
any information concerning food safety?
5.6.1 – 09 Is information obtained through external communication included as input to system updating and
management review?
5.6.2 Internal communication
5.6.2 –01 Has the organisation established, implemented and maintained effective arrangements for
communicating with personnel on issues having an impact on food safety?
5.6.2 –02 Has the organisation ensured that the food safety team is informed in a timely manner of changes,
including but not limited to the following:
a) products or new products;
b) raw materials, ingredients and services;
c) production systems and equipment;
d) production premises, location of equipment, surrounding environment;
e) cleaning and sanitation programmes;
f) packaging, storage and distribution systems;
g) personnel qualification levels and/or allocation of responsibilities and authorizations;
h) statutory and regulatory requirements;
i) knowledge regarding food safety hazards and control measures;
j) customer, sector and other requirements that the organisation observes;
k) relevant enquiries from external interested parties;
l) complaints indicating food safety hazards associated with the product;
m) other conditions that have an impact on food safety.

5.6.2 –03 Does the food safety team ensure that above mentioned information is included in the updating of
the food safety management system?
5.6.2 –04 Does top management ensure that relevant information is included as input to the management
review?
5.7 Emergency preparedness and response
5.7 – 01 Has top management established, implemented and maintained procedures to manage potential
emergency situations and accidents that can impact food safety and which are relevant to the role of
the organisation in the food chain?

5.8 Management review


5.8.1 General
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5.8.1 – 01 Does top management review the organisation’s food safety management system, at planned
intervals, to ensure its continuing suitability, adequacy and effectiveness ?
5.8.1 - 02 Does this review include assessing opportunities for improvement and the need for changes to the
food safety management system, including the food safety policy?
5.8.1 - 03 Are records from management reviews maintained?
5.8.2 Review input
Does the input to management review include information about:
5.8.2 – 01 a) follow-up actions from previous management reviews?
5.8.2 – 02 b) analysis of results of verification activities?
5.8.2 – 03 c) changing circumstances that can affect food safety?,
5.8.2 – 04 d) emergency situations, accidents and withdrawals?
5.8.2 – 05 e) reviewing results of system-updating activities?
5.8.2 – 06 f) review of communication activities, including customer feed-back?
5.8.2 – 07 g) external audits or inspections?
5.8.2 – 08 Are the data presented in a manner that enables top management to relate the information to stated
objectives of the food safety management system?
5.8.3 Review output
Does the output from the management review include any decisions and actions related to
5.8.3 – 01 a) assurance of food safety?
5.8.3 – 02 b) improvement of the effectiveness of the food safety management system?
5.8.3 – 03 c) resource needs?
5.8.3 – 04 d) revisions of the organisation's food safety policy and related objectives?
6 Resource management
6.1 Provision of resources
6.1 – 01 Does the organisation provide adequate resources for the establishment, implementation,
maintenance and updating of the food safety management system?
6.2 Human resources
6.2.1 General
6.2.1 – 01 Are the food safety team and the other personnel carrying out activities having an impact on food
safety, competent on the basis of appropriate education, training, skills and experience?
6.2.1 – 02 Are there available records of agreement or contracts defining the responsibility and authority of
external experts, where the assistance of external experts is required for the development,
implementation, operation or assessment of the food safety management system?

6.2.2 Competence, awareness and training


Does the organisation:
6.2.2 – 01 a) identify the necessary competencies for personnel whose activities have an impact on
food safety?
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6.2.2 – 02 b) provide training or take other action to ensure personnel have the necessary
competencies?
6.2.2 – 03 c) ensure that personnel responsible for monitoring, corrections and corrective actions of
the food safety management system are trained?
6.2.2 – 04 d) evaluate the implementation and the effectiveness of the actions taken in a), b) and c)?
6.2.2 – 05 e) ensure that the personnel are aware of the relevance and importance of their individual
activities in contributing to foodsafety,
6.2.2 – 06 f) ensure that the requirement for effective communication is understood by all personnel
whose activities have an impact on food safety?
6.2.2 – 07 g) maintain appropriate records of training and actions described in b) and c)?
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6.3 Infrastructure
6.3 – 01 Does the organisation provide the resources for the establishment and maintenance of the
infrastructure needed to implement the requirements of ISO 22000 standard?
6.4 Work environment
6.4 – 01 Does the organisation provide the resources for the establishment, management and maintenance
of the work environment needed to implement the requirements of ISO 22000 standard?
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7 Planning and realization of safe products
7.1 General
7.1 – 01 Does the organisation plan and develop the processes needed for the realization of safe products?

7.1 – 02 Does the organisation implement, operate and ensure the effectiveness of the planned activities and
any changes to those activities.
7.2 Prerequisite programmes (PRPs)
Has the organisation established, implemented and maintained PRP(s) to assist in controlling
7.2.1 – 01 a) the likelihood of introducing food safety hazards to the product through the work
environment?
7.2.1 – 02 b) biological, chemical and physical contamination of the product(s), including cross
contamination between products?
7.2.1 – 03 c) food safety hazard levels in the product and product processing environment?.
Are the PRP(s):
7.2.2 – 01 a) appropriate to the organisational needs with regard to food safety?
7.2.2 – 02 b) appropriate to the size and type of the operation and the nature of the products being
manufactured and/or handled?
7.2.2 – 03 c) implemented across the entire production system, either as programmes applicable in
general or as programmes applicable to a particular product or operational line?
7.2.2 – 04 d) approved by the food safety team.
7.2.2 – 05 Does the organisation identify statutory and regulatory requirements related to the above?
7.2.3 – 01 Does the organisation consider and utilize appropriate information, when selecting and/or
establishing PRP(s)?
7.2.3 – 02 Does the organisation consider the following (when establishing PRP(s)):
a) construction and lay-out of buildings and associated utilities;
b) lay-out of premises, including workspace and employee facilities;
c) supplies of air, water, energy and other utilities;
d) supporting services, including waste and sewage disposal;
e) the suitability of equipment and its accessibility for cleaning, maintenance and preventative
maintenance;
f) management of purchased materials (e.g. raw materials, ingredients, chemicals and packaging),
supplies (e.g. water, air, steam and ice), disposals (e.g. waste and sewage) and handling of
products (e.g. storage and transportation);
g) measures for the prevention of cross contamination;
h) cleaning and sanitizing;
i) pest control;
j) personnel hygiene;
k) other aspects as appropriate.
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7.2.3 – 03 Is verification of PRP(s) planned?
7.2.3 – 04 Are PRP(s) modified as necessary?
7.2.3 – 05 Are records of verifications and modifications maintained?
7.2.3 – 06 Do documents specify how activities included in the PRP(s) are managed?
7.3 Preliminary steps to enable hazard analysis
7.3.1 General
7.3.1 – 01 Are all relevant information - needed to conduct the hazard analysis - collected, maintained,
updated and documented?
7.3.1 – 02 Are the records related to hazard analysis maintained?
7.3.2 Food safety team
7.3.2 – 01 Has a food safety team been appointed?
7.3.2 – 02 Do the members of the food safety team provide a combination of multi-disciplinary knowledge and
experience in developing and implementing the food safety management system?
7.3.2 – 03 Are records - that demonstrate that the food safety team has the required knowledge and
experience - maintained?
7.3.3 Product characteristics
7.3.3.1 Raw material, ingredients and product- contacted material
Are all raw materials, ingredients and product-contact materials described in documents to the
extent needed to conduct the hazard analysis, including the following, as appropriate:
7.3.3.1- 01 a) biological, chemical and physical characteristics;
7.3.3.1- 02 b) composition of formulated ingredients, including additives and processing aids;
7.3.3.1- 03 c) origin;
7.3.3.1- 04 d) method of production;
7.3.3.1- 05 e) packaging and delivery methods;
7.3.3.1- 06 f) storage conditions and shelf life;
7.3.3.1- 07 g) preparation and/or handling before use or processing;
7.3.3.1- 08 h) food safety-related acceptance criteria or specifications of purchased materials and
ingredients appropriate to their intended uses.
7.3.3.1- 09 Does the organisation identify statutory and regulatory food safety requirements related to the raw
materials, ingredients and product-contact materials?
7.3.3.1- 10 Are the descriptions kept up-to-date including, when required?
7.3.3.2 Characteristics of end products
Are the characteristics of end products described in documents to the extent needed to conduct the
hazard analysis, including information on the following, as appropriate:
7.3.3.2- 01 a) product name or similar identification;
7.3.3.2- 02 b) composition;
7.3.3.2- 03 c) biological, chemical and physical characteristics relevant for food safety;
7.3.3.2- 04 d) intended shelf life and storage conditions;
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7.3.3.2- 05 e) packaging
7.3.3.2- 06 f) labeling relating to food safety and/or instructions for handling, preparation and usage
7.3.3.2- 07 g) method(s) of distribution.
7.3.3.2- 08 Does the organisation identify statutory and regulatory food safety requirements related to the
characteristics of end products?
7.3.3.2- 09 Are the descriptions kept up-to-date including, when required?
7.3.4 Intended use
7.3.4 – 01 Are the intended use, the reasonably expected handling of the end product, and any unintended but
reasonably expected mishandling and misuse of the end product considered and described in
documents to the extent needed to conduct the hazard analysis?
7.3.4 – 02 Are groups of users and, where appropriate, groups of consumers identified for each product, and
consumer groups known to be especially vulnerable to specific food safety hazards considered?

7.3.4 - 03 Are the descriptions kept up-to-date including, when required?


7.3.5 Flow diagrams, process steps and control measures
7.3.5.1 Flow diagrams
7.3.5.1- 01 Are flow diagrams prepared for the products or process categories covered by the food safety
management system?
7.3.5.1- 02 Do flow diagrams provide a basis for evaluating the possible occurrence, increase or introduction of
food safety hazards?
7.3.5.1- 03 Are flow diagrams clear, accurate and sufficiently detailed?
7.3.5.1- 04 Do flow diagrams, as appropriate, include the following:
a) the sequence and interaction of all steps in the operation;
b) any outsourced processes and subcontracted work;
c) where raw materials, ingredients and intermediate products enter the flow;
d) where reworking and recycling take place;
e) where end products, intermediate products, by- products and waste are released or removed.

7.3.5.1- 05 Does the food safety team verify the accuracy of the flow diagrams by on-site checking?
7.3.5.1- 06 Are verified flow diagrams maintained as records?
7.3.5.2 Description of process steps and control measures
7.3.5.2- 01 Are the existing control measures process parameters and/or the rigorousness with which they are
applied, or the procedures that may influence food safety, described to the extent needed to conduct
the hazard analysis?
7.3.5.2- 02 Are external requirements (e.g. regulatory authorities or customers) that my impact the choice or
rigorousness of the control measures described and updated?
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7.4 Hazard analysis
7.4.1 General
7.4.1 - 01 Does the food safety team 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?

7.4.2 Hazard identification and determination of acceptable levels


7.4.2.1- 01 Are all food safety hazards that are reasonably expected to occur in relation to the type of product,
type of process and actual processing facilities identified and recorded?
Is the identification based on
7.4.2.1- 02 a) the preliminary information and data collected in preliminary steps to enable hazard
analysis,
7.4.2.1- 03 b) experience,
7.4.2.1- 04 c) external information including, to the extent possible, epidemiological and other historical
data, and
7.4.2.1- 05 d) 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.
7.4.2.1- 06 Are the step(s) (from raw materials, processing and distribution) - at which each food safety hazard
may be introduced – indicated?
7.4.2.2- 01 When identifying the hazards, does the company consider the following:
a) the steps preceding and following the specified
operation,
b) the process equipment, utilities/services and surroundings, and
c) the preceding and following links in the food chain.
7.4.2.3- 01 Are the acceptable level of the food safety hazard in the end product determined (whenever
possible) for each of the food safety hazards identified?
7.4.2.3- 02 Does the determined level take into account established statutory and regulatory requirements,
customer food safety requirements, the intended use by the customer and other relevant data?
7.4.2.3- 03 Are the justification for, and the result of, the determination of the acceptable level of the food safety
hazard recorded?
7.4.3 Hazard assessment
7.4.3- 01 Is a hazard assessment conducted to determine, for each food safety 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?
7.4.3- 02 Is each food safety hazard evaluated according to the possible severity of adverse health effects
and the likelihood of their occurrence?
7.4.3- 03 Is the methodology used for hazard described?
7.4.3- 04 Are the results of the food safety hazard assessment recorded?
7.4.4 Selection and assessment of control measures
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7.4.4- 01 Is an appropriate combination of control measures selected (based on the hazard assessment),
which is capable of preventing, eliminating or reducing these food safety hazards to defined
acceptable levels?
7.4.4- 02 Is each of the selected control measures reviewed with respect to its effectiveness against the
identified food safety hazards?
7.4.4- 03 Is each selected control measure categorized as to whether it needs to be managed through
operational PRP(s) or by the HACCP plan, using a logical approach that includes assessments with
regard to the following:
a) its effect on identified food safety hazards relative to the strictness applied;
b) its feasibility for monitoring (e.g. ability to be monitored in a timely manner to enable immediate
corrective actions);
c) its place within the system relative to other control measures;
d) the likelihood of failure in the functioning of a control measure or significant processing variability;
e) the severity of the consequence(s) in the case of failure in its functioning;
f) whether the control measure is specifically established and applied to eliminate or significantly
reduce the level of hazard(s);
g) synergistic effects (i.e. interaction that occurs between two or more measures resulting in their
combined effect being higher than the sum of their individual effects).

7.4.4- 04 Are control measures - categorized as belonging to the HACCP plan – implemented?
7.4.4- 05 Are other control measures implemented as operational PRPs?
7.4.4- 06 Are the methodology and parameters - used for this categorization - described in documents?
7.4.4- 07 Are the results of the assessment recorded?
7.5 Establishing the operational prerequisite programmes (PRPs)
7.5- 01 Are the operational PRPs documented?
7.5- 02 Does the documentation for the operational PRPs include the following information for each
programme:
a) food safety hazard(s) to be controlled by the programme?
b) control measure(s)?
c) monitoring procedures that demonstrate that the operational PRPs are in place?
d) corrections and corrective actions to be taken if monitoring shows that the operational PRPs are
not in control ?
e) responsibilities and authorities?
f) record(s) of monitoring?
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7.6 Establishing the HACCP plan
7.6.1 HACCP plan
7.6.1- 01 Is the HACCP plan documented?
7.6.1- 02 Does the HACCP plan include the following information for each identified critical control point
(CCP):
a) food safety hazard(s) to be controlled at the CCP?
b) control measure(s)?
c) critical limit(s)?
d) monitoring procedure(s)?
e) corrections and corrective action(s) to be taken if critical limits are exceeded?
f) responsibilities and authorities?
g) record(s) of monitoring?

7.6.2 Identification of critical controlpoints


7.6.2- 01 Are CCP(s) identified for the control measures identified, for each hazard that is to be controlled by
the HACCP plan?
7.6.3 Determination of critical limits for CCP(s)
7.6.3- 01 Are critical limits determined for the monitoring established for each CCP?
7.6.3- 02 Are critical limits established on such way to ensure that the identified acceptable level of the food
safety hazard in the end product is not exceeded?
7.6.3- 03 Are critical limits measurable?
7.6.3- 04 Are the rationale for the chosen critical limits documented?
7.6.3- 05 Are critical limits - based on subjective data (such as visual inspection of product, process, handling,
etc.) - supported by instructions or specifications and/or education and training?
7.6.4 System for the monitoring of critical control points
7.6.4- 01 Is a monitoring system established for each CCP to demonstrate that the CCP is in control?
7.6.4- 02 Are all scheduled measurements or observations - relative to the critical limit(s) - included in the
monitoring system?
Does the monitoring system consist of relevant procedures, instructions and records that cover the
following:
7.6.4- 03 a) measurements or observations that provide results within an adequate time frame?
7.6.4- 04 b) monitoring devices used?
7.6.4- 05 c) applicable calibration methods?
7.6.4- 06 d) monitoring frequency?
7.6.4- 07 e) responsibility and authority related to monitoring and evaluation of monitoring results?
7.6.4- 08 f) record requirements and methods?
7.6.4- 09 Are the monitoring methods and frequency capable of determining when the critical limits have been
exceeded in time for the product to be isolated before it is used or consumed?
7.6.5 Actions when monitoring results exceed critical limits
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7.6.5- 01 Are planned corrections and corrective actions - to be taken when critical limits are exceeded -
specified in the HACCP plan?
Do the actions ensure that:
7.6.5- 02 a) the cause of nonconformity is identified?
7.6.5- 03 b) the parameter(s) controlled at the CCP is (are) brought back under control?
7.6.5- 04 c) recurrence is prevented?.
7.6.5- 05 Are documented procedures established and maintained for the appropriate handling of potentially
unsafe products to ensure that they are not released until they have been evaluated?
7.7 Updating of preliminary information and documents specifying the PRPs
and the HACCP plan
7.7- 01 Does the organisation update the following information in operational PRP(s) and/or the HACCP
plan, if necessary:
a) product characteristics?
b) intended use?
c) flow diagrams?
d) process steps?
e) control measures?

7.7- 02 Are the HACCP plan and the procedures and instructions specifying the PRP(s) amended, If
necessary?
7.8 Verification planning
7.8- 01 Does verification planning define the purpose, methods, frequencies and responsibilities for the
verification activities?
Do the verification activities confirm that
7.8- 02 a) the PRP(s) are implemented?
7.8- 03 b) input to the hazard analysis is continually updated?
7.8- 04 c) the operational PRP(s) and the elements within the HACCP plan are implemented and
effective,
7.8- 05 d) hazard levels are within identified acceptable levels?
7.8- 06 e) other procedures required by the organisation are implemented and effective?
7.8- 07 Is the output of verification planning in a form suitable for the organisation's method of operations?

7.8- 08 Are verification results recorded and communicated to the food safety team?
7.8- 09 Are verification results provided on a such way to enable the analysis of the results of the
verification activities?
7.8- 10 Are the affected lots of product handled as potentially unsafe, if system verification is based on
testing of end product samples, and where such test samples show lack of conformity with the
acceptable level of the food safety hazard?

7.9 Traceability system


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7.9- 01 Has the organisation established and does it apply a traceability system that enables the
identification of product lots and their relation to batches of raw materials, processing and delivery
records?
7.9 - 02 Is the traceability system able to identify incoming material from the immediate suppliers and the
initial distribution route of the end product?
7.9 - 03 Are traceability records maintained for a defined period for system assessment to enable the
handling of potentially unsafe products and in the event of product withdrawal?
7.9 - 04 Are records in accordance with statutory and regulatory requirements and customer requirements?

7.10 Control of nonconformity


7.10.1 Corrections
7.10.1- 01 Does the organisation ensure that when critical limits for CCP(s) are exceeded or there is a loss of
control of operational PRP(s), the end products affected are identified and controlled with regard to
their use and release?

Is a documented procedure established and maintained, defining the following:


7.10.1- 02 a) the identification and assessment of affected end products to determine their proper
handling?
7.10.1- 03 b) a review of the corrections carried out?
7.10.1- 04 Are potentially unsafe products - manufactured under conditions where critical limits have been
exceeded - handled in accordance with clause 7.10.3.?
7.10.1- 05 Are products - manufactured under conditions where operational PRP(s) have not been conformed
with - evaluated with respect to the cause(s) of the nonconformity and to the consequences thereof
in terms of food safety?
7.10.1- 06 Are these products, where necessary, handled in accordance with 7.10.3.?
7.10.1- 07 Is the evaluation recorded?
7.10.1- 08 Are all corrections approved by the responsible person(s), and recorded together with information
on the nature of the nonconformity, its cause(s) and consequence(s), including information needed
for traceability purposes related to the nonconforming lots.

7.10.2 Corrective actions


7.10.2- 01 Are data - derived from the monitoring of operational PRPs and CCPs - evaluated by designated
person(s) with sufficient knowledge and authority to initiate corrective actions?
7.10.2- 02 Are corrective actions initiated when critical limits are exceeded or when there is a lack of conformity
with operational PRP(s)?
7.10.2- 03 Has the organisation established and does it maintain documented procedures that specify
appropriate actions to identify and eliminate the cause of detected nonconformities, to prevent
recurrence, and to bring the process or system back into control after nonconformity is
encountered?

7.10.2- 04 Are corrective actions recorded?


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7.10.3 Handling of potentially unsafe products
7.10.3.1 General
7.10.3.1- 01 Does the organisation handle nonconforming products by taking action(s) to prevent the
nonconforming product from entering the food chain unless it is possible to ensure that
a) the food safety hazard(s) of concern has(ve) been reduced to the defined acceptable levels,
b) the food safety hazard(s) of concern will be reduced to identified acceptable levels prior to
entering into the food chain, or
c) the product still meets the defined acceptable level(s) of the food safety hazard(s) of concern
despite the nonconformity?

7.10.3.1- 02 Are all lots of product - that may have been affected by a nonconforming situation - held under
control of the organisation until they have been evaluated?
7.10.3.1- 03 Does the organisation notify relevant interested parties and initiate a withdrawal, if products that
have left the control of the organisation are subsequently determined to be unsafe?
7.10.3.1- 04 Are the controls and related responses and authorization for dealing with potentially unsafe products
documented?
7.10.3.2 Evaluation for release
7.10.3.2- 01 Is each lot of product affected by the nonconformity released as safe only when any of the following
conditions apply:
a) evidence other than the monitoring system demonstrates that the control measures have been
effective;
b) evidence shows that the combined effect of the control measures for that particular product
complies with the performance intended;
c) 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 hazard(s) concerned?

7.10.3.3 Disposition of nonconforming products


7.10.3.3- 01 Is the lot of product - which is not acceptable for release - handled (after evaluation) by one of the
following activities:
a) reprocessing or further processing within or outside the organisation to ensure that the food
safety hazard is eliminated or reduced to acceptable levels;
b) destruction and/or disposal as waste.handled (after evaluation) by one of the following activities:

7.10.4 Withdrawals
To enable and facilitate the complete and timely withdrawal of lots of end products which have been
identified as unsafe…
7.10.4- 01 a) Has top management appointed personnel having the authority to initiate a withdrawal
and personnel responsible for executing the withdrawal?
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7.10.4- 02 b) Has the organisation established and does it maintain a documented procedure for
1) notification to relevant interested parties (e.g. statutory and regulatory authorities,
customers and/or consumers),
2) handling of withdrawn products as well as affected lots of the products still in stock, and
3) the sequence of actions to be taken?

7.10.4- 03 Are withdrawn products 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?
7.10.4- 04 Are the cause, extent and result of a withdrawal recorded and reported to top management as input
to the management review?
7.10.4- 05 Does the organisation verify and record the effectiveness of the withdrawal programme through the
use of appropriate techniques (e.g. challenge testing, mock withdrawal or practice withdrawal)?

8 Validation, verification and improvement of the FSMS


8.1 General
8.1 – 01 Does the food safety team plan and implement the processes needed to validate control measures
and/or control measure combinations, and to verify and improve the food safety management
system?

8.2 Validation of control measure combinations


8.2- 01 Does the organisation validate (prior to implementation of control measures to be included in
operational PRP(s) and the HACCP plan and after any change therein) that
a) the selected control measures are capable of achieving the intended control of the food safety
hazard(s) for which they are designated?
b) the control measures are effective and capable of, in combination, ensuring control of the
identified food safety hazard(s) to obtain end products that meet the defined acceptable levels?

8.2- 02 Are the control measure and/or combinations thereof modified and re-assessed when the result of
the validation shows that one or both of the above elements cannot be confirmed?
8.3 Control of monitoring and measuring
8.3- 01 Are there evidences that the specified monitoring and measuring methods and equipment are
adequate to ensure the performance of the monitoring and measuring procedures?
Are the measuring equipment and methods used:
8.3- 02 a) calibrated or verified at specified intervals, or prior to use, against measurement
standards traceable to international or national measurement standards?
Is the basis used for calibration or verification recorded, where no
such standards exist?
8.3- 03 b) adjusted or re-adjusted as necessary?
8.3- 04 c) identified to enable the calibration status to be determined?
8.3- 05 d) safeguarded from adjustments that would invalidate the measurement results?
8.3- 06 e) protected from damage and deterioration?
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8.3- 07 Are records of the results of calibration and verification maintained?
8.3- 08 Does the organisation assess the validity of the previous measurement results when the equipment
or process is found not to conform to requirements?
8.3- 09 Does the organisation take action appropriate for the equipment and any product affected, If the
measuring equipment is nonconforming?
8.3- 10 Are records of such assessment and resulting actions maintained?
8.3- 11 Is the ability of computer software confirmed to satisfy the intended application when used in the
monitoring and measurement of specified requirements?
8.3- 12 Is the confirmation of computer software undertaken prior to initial use and reconfirmed as
necessary?
8.4 FSMS verification
8.4.1 Internal audit
8.4.1- 01 Does the organisation conduct internal audits at planned intervals to determine whether the food
safety management system:
a) conforms to the planned arrangements, to the food safety management system requirements
established by the organisation, and to the requirements of this International Standard?
b) is effectively implemented and updated?

8.4.1- 02 Is an audit programme planned, taking into consideration the importance of the processes and
areas to be audited, as well as any updating actions resulting from previous audits?
8.4.1- 03 Are the audit criteria, scope, frequency and methods defined?
8.4.1- 04 Do the selection of auditors and the conduct of audits ensure objectivity and impartiality of the audit
process?
8.4.1- 05 Is it ensured that auditors do not audit their own work?
8.4.1- 06 Are the responsibilities and requirements for planning and conducting audits, and for reporting
results and maintaining records defined in documented procedure?
8.4.1- 07 Does the management responsible for the area being audited ensure that actions are taken without
undue delay to eliminate detected nonconformities and their causes?
8.4.1- 08 Do follow-up activities include the verification of the actions taken and the reporting of verification
results?
8.4.2 Evaluation of individual verification results
8.4.2- 01 Does the food safety team systematically evaluate the individual results of planned verification?
8.4.2- 02 Does the organisation take action to achieve the required conformity, when verification does not
demonstrate conformity with the planned arrangements?
8.4.2- 03 Does action – taken for achieving the required conformity – include (but is not limited to), review of
a) existing procedures and communication channels?
b) the conclusions of the hazard analysis, the established operational PRP(s) and the HACCP plan?
c) the PRP(s)?
d) the effectiveness of human resource management and of training activities?
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8.4.3 Analysis of results of verification activities
8.4.3- 01 Does the food safety team analyse the results of verification activities, including the results of the
internal audits and external audits?
8.4.3- 02 Is the analysis carried out in order
a) to confirm that the overall performance of the system meets the planned arrangements and the
food safety management system requirements established by the organisation?
b) to identify the need for updating or improving the food safety management system?
c) to identify trends which indicate a higher incidence of potentially unsafe products?
d) to establish information for planning of the internal audit programme concerning the status and
importance of areas to be audited?
e) to provide evidence that any corrections and corrective actions that have been taken are
effective?

8.4.3- 03 Are the results of the analysis and the resulting activities recorded and reported, in an appropriate
manner, to top management as input to the management review?
8.4.3- 04 Are the results of the analysis and the resulting activities used as an input for updating the food
safety management system?
8.5 Improvement
8.5.1 Continual improvement
8.5.1-01 Does top management ensure that the organisation continually improves the effectiveness of the
food safety management system through the use of:
- communication,
- management review,
- internal audit,
- evaluation of individual verification results,
- analysis of results of verification activities,
- validation of control measure combinations,
- corrective actions and
- food safety management system updating?.

8.5.2 Updating the food safety management system


8.5.2- 01 Does top management ensure that the food safety management system is continually updated?
8.5.2- 02 Does the food safety team evaluate the food safety management system at planned intervals in
order to achieve that FSMS is continually updated?
8.5.2- 03 Does the team consider whether it is necessary to review the hazard analysis, the established
operational PRP(s) and the HACCP plan?
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8.5.2- 04 Are the evaluation and updating activities based on:
a) input from communication, external as well as internal?
b) input from other information concerning the suitability, adequacy and effectiveness of the food
safety management system?
c) output from the analysis of results of verification activities?
d) output from management review?

8.5.2- 05 Are system updating activities recorded and reported, in an appropriate manner, as input to the
management review?
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ISO/TS 22002-1 - PRE-REQUISITE PROGRAMMES


4 Construction and layout of buildings
4.1 General Requirements
4.1- 01 Are buildings designed , constructed and maintained in a manner appropriate for food processing
operations?
4.1- 02 Are buildings and facilities of durable construction which presents no hazard to the product?
4.2 Environment
4.2- 01 Is the production carried out in an area free of potentially harmful substances?
4.2- 02 Is the effectiveness of measures taken to protect against potential contaminants periodically
reviewed?
4.3 Locations of establishments
4.3- 01 Are site boundaries clearly defined?
4.3- 02 Is there access control to the site?
4.3- 03 Is the site maintained in good order, vegetation tendered/removed, drainage for roads, yards and
parking areas?
5 Layout of premises and workspace
5.1 General Requirements
5.1- 01 Are internal layouts designed, constructed and maintained to facilitate good hygiene and
manufacturing?
5.1- 02 Are movement patterns of materials, products and people and the layout of equipment designed to
protect against potential contamination?
5.2 Internal design, layout and traffic patterns
5.2- 01 Does the building provide adequate space with a logical flow of materials, products and personnel?
Is there physical separation of raw from processed areas?
5.2- 02 Are openings intended for transfer of materials designed to minimise entry of foreign matter and
pests?
5.3 Internal structures and fittings
5.3- 01 Are process area walls and floors cleanable? Are construction materials resistant to the cleaning
methods?
5.3- 02 Are wall floor junctions and corners designed to facilitate cleaning?
5.3- 03 Are floors designed to avoid stagnant water?
5.3- 04 Are floors sealed and drained in process areas? Are the drains trapped and covered?
5.3- 05 Are ceilings and overhead fixtures designed to minimise dirt build up and condensation?
5.3- 06 Are there insect screens on external opening windows, roof vents or fans?
5.3- 07 Are external opening doors screened or at least closed when not in use?
5.4 Location of equipment
5.4- 01 Is equipment designed so as to facilitate good hygiene practices and monitoring?
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5.4- 02 Is equipment located to permit access for operation, cleaning and maintenance.
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5.5 Laboratory facilities
5.5- 01 Are in-line and on-line test facilities controlled to minimise risk of contamination?
5.5- 02 Is the micro lab designed, located and operated so as to prevent contamination? Does it open
directly into the production area?
5.6 Temporary or mobile premises and vending machines
5.6 -01 Are temporary structures designed, located and constructed to avoid pest infestation and
contamination of products?
5.6 -02 Have hazards associated with temporary structures and vending machines been assessed and
controlled?
5.7 Storage of food, packaging materials, ingredients and non-food chemicals

5.7 -01 Are facilities used to store ingredients, packaging and products providing protection from dust,
condensation, drains, waste and other sources of contamination?
5.7 -02 Are storage areas dry and well ventilated? Is there monitoring and control of temperature and
humidity?
5.7 -03 Are storage areas designed or arranged to allow segregation of raw materials, work in progress and
finished products?
5.7 -04 Are materials and products stored off the floor with sufficient space between the material and the
walls to allow inspection and pest control activities to be carried out?
5.7 -05 Is the storage area designed to allow maintenance and cleaning , prevent contamination and
minimise deterioration?
5.7 -06 Is there a separate and secure storage area provided for cleaning materials, chemicals and other
hazardous substances?
5.7 -07 Are exceptions for bulk or agricultural crop materials documented in the FSMS?
6 Utilities - air, water, energy
6.1 General Requirements
6.1- 01 Are provision and distribution routes for utilities to and around processing and storage areas
designed to minimise product contamination risk?
6.1- 02 Is the quality of utilities monitored to minimise product contamination risk?
6.2 Water Supply
6.2- 01 Is the supply of potable water sufficient to meet the needs of the production purposes?
6.2- 02 Are storage, distribution and, where needed, temperature control of the water designed to meet
specified water quality requirements?
6.2- 03 Is water used as a product ingredient, including ice or steam, or in contact with products or product
surfaces meeting the specified quality and microbiological requirements relevant to the product?

6.2- 04 Is water for cleaning or applications where there is a risk of indirect product contact meeting
specified quality and microbiological requirements relevant to the application?
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6.2- 05 Where water supplies are chlorinated, are there checks to ensure that the residual chlorine level at
the point of use remain within limits given in relevant specifications?
6.2- 06 Does non-potable water have a separate supply system that is labelled and not connected to the
potable water system?
6.3 Boiler chemicals
6.3- 01 Are the boiler chemicals approved food additives which meet relevant additive specifications?
6.3- 02 Are boiler chemicals additives which have been approved by the relevant regulatory authority as
safe for use in water intended for human consumption?
6.3- 03 Are boiler chemicals stored in a separate, secure area when not in immediate use?
6.4 Air quality and ventilation
6.4- 01 Has the organisation established requirements for filtration, humidity and microbiology of air used as
an ingredient or for direct product contact?
6.4- 02 Are there control and monitoring where temperature and/or humidity are deemed critical?
6.4- 03 Is there ventilation to remove excess or unwanted steam, dust and odours, and to facilitate drying
after wet cleaning?
6.4- 04 Is room air supply quality controlled to minimise risk from airborne microbiological contamination?
Are there protocols for air quality monitoring and control where products which support the growth or
survival of microorganisms are exposed?
6.4- 05 Are ventilation systems designed so as to avoid air flow from contaminated/raw to clean areas? Are
specified air pressure differentials maintained? Are systems accesible for cleaning, filter changing
and maintenance?
6.4- 06 Are exterior air intake ports examined periodically for physical integrity?
6.5 Compressed air and other gases
6.5- 01 Are compressed air, carbon dioxide, nitrogen and other gas systems used in manufacturing and/or
filling constructed and maintained so as to prevent contamination?
6.5- 02 Are gases intended for direct or incidental product contact acquired from a source approved for food
contact use and filtered to remove dust, oil and water?
6.5- 03 Is the oil used for compressors food grade?
6.5- 04 Are specifications for filtration, humidity and the microbiology of the air/gases specified?
6.6 Lighting
6.6- 01 Is the lighting provided allowing personnel to operate in a hygienic manner?
6.6- 02 Are light fixtures protected to ensure that materials, product or equipment are not contaminated in
the case of breakages?
7 Waste disposal
7.1 General Requirements
7.1- 01 Are there systems in place to ensure that waste materials are identiified, collected, removed and
disposed of in a manner which prevents contamination of products or production areas?
7.2 Containers for waste and inedible or hazardous substances
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7.2- 01 Are the containers clearly identified for their intended purpose?
7.2- 02 Are they located in a designated area?
7.2- 03 Are they constructed of impervious material which can be easily cleaned and sanitised?
7.2- 04 Are they closed when not in immediate use?
7.2- 05 Are they locked where the waste may pose a risk to the product?
7.3 Waste management and removal
7.3- 01 Is there a provision for the segregation, storage and removal of waste?
7.3- 02 Are there measures to prevent accumulation of waste in the food handling and storage areas? Are
the removal frequencies managed to avoid accumulations?
7.3- 03 Are there measures for labelled materials, products or printed packaging to be designated as waste
to ensure that trademarks cannot be reused? Is the removal and destruction performed by an
approved disposal contractor? Are the destruction records maintained?
7.3- 04 Is the removal and destruction performed by an approved disposal contractor?
7.3- 05 Are the destruction records maintained?
7.4 Drains and drainage
7.4- 01 Are the drains designed, constructed and located so as to avoid the risk of contamination of
materials or products? Do the drains have the capacity sufficient to remove expected flow loads?
Are drains designed to not pass over processing lines?
7.4- 02 Is the drainage direction designed in a manner that avoids flow from a contaminated to a clean
area?
8 Equipment suitability, cleaning and maintenance
8.1 General Requirements
8.1- 01 Is food contact equipment designed and constructed to facilitate cleaning, disinfection and
maintenance? Are food contact surfaces designed so as to not affect, or be affected by, the intended
product or the cleaning system?
8.1- 02 Is food contact equipment constructed of durable materials able to resist repeated cleaning?
8.2 Hygienic design
8.2- 01 Does equipment meet established principles of hygienic design?
8.2- 02 Does equipment have smooth, accessible, cleanable surfaces and is it self draining in wet areas?

8.2- 03 Is equipment made of materials compatible with intended products and cleaning or flushing agents?

8.2- 04 Is the framework of the equipment not penetrated by holes or nuts and bolts?
8.2- 05 Is the piping and ductwork cleanable and without dead ends?
8.2- 06 Is the equipment designed to minimise contact between the operator's hands and the products?
8.3 Product contact surfaces
8.3- 01 Are product contact surfaces constructed from materials designed for food use? Are they
impermeable and rust or corrossion free?
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8.4 Temperature control and monitoring equipment
8.4- 01 Is the equipment used for thermal processes able to meet the temperature gradient and holding
conditions given in relevant product specifications?
8.4- 02 Does the equipment provide for the monitoring and control of temperature?
8.5 Cleaning plant, utensils and equipment
8.5- 01 Are wet and dry cleaning programmes documented to ensure that all plant, utensils and equipment
are cleaned at defined frequencies?
8.5- 02 Do the cleaning programmes specify what is to be cleaned, the responsibility, method of cleaning,
use of dedicated cleaning tools, removal or disassembly requirements and cleaning verification
methods?

8.6 Preventive and corrective maintenannce


8.6- 01 Is there a preventive maintenance programme in place?
8.6- 02 Does the preventive maintenannce programme include all devices used to monitor and/or control
food safety hazards?
8.6- 03 Is corrective maintenance conducted so as to prevent the risk of contamination on production on
adjoining lines or equipment?
8.6- 04 Is priority given to maintenance requests which impact food safety?
8.6- 05 Are temporary fixes performed in a way that does not compromise product risk? Is a request for
replacement by a permanent repair included in the maintenance schedule?
8.6- 06 Are lubricants and heat transfer fluids food grade in cases where there is a risk of direct or indirect
contact with the product?
8.6- 07 Does the procedure for releasing maintained equipment back to production include clean up,
sanitising and inspection?
8.6- 08 Do local area PRP requirements apply to maintenance areas and maintenance activities in process
areas? Are maintenance personnel trained in the product hazards associated with their activities?

9 Management of purchased materials


9.1 General Requirements
9.1- 01 Is the purchasing of materials which impact food safety controlled to ensure that the suppliers used
have the capability to meet the specified requirements?
9.1- 02 Is the conformance of incoming materials specified and are purchase requirements verified?
9.2 Selection and management of Suppliers
9.2- 01 Is there a defined process for the selection, approval and monitoring of suppliers?
9.2- 02 Is the process used justified by hazard assessment, including the potential risk to the final product?
9.2- 03 Does the above process include the assessment of the supplier’s ability to meet quality and food
safety expectations, requirements and specifications?
9.2- 04 Does the process include description of how suppliers are assessed?
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9.2- 05 Does the process include monitoring the performance of the supplier to assure continued approval
status?
9.3 Incoming material requirements (raw/ingredients/packaging)
9.3- 01 Are delivery vehicles checked prior to, and during, unloading to verify that the quality and safety of
the material has been maintained during transit?
9.3- 02 Are materials inspected, tested or covered by COA to verify conformity with specified requirements
prior to acceptance or use?
9.3- 03 Is the method of verification documented?
9.3- 04 Are materials which do not conform to relevant specifications handled under a documented
procedure which ensures they are prevented from unintended use?
9.3- 05 Are access points to bulk material receiving lines identified, capped and locked?
9.3- 06 Does discharge into bulk material receiving systems take place only after approval and verification
of the material received?
10 Measures for prevention of cross-contamination
10.1 General Requirements
10.1- 01 Are there programmes in place to prevent, control and detect contamination? Do these include
measures to prevent physical, allergen and microbiological contamination?
10.2 Microbiological cross-contamination
10.2- 01 Have areas of potential microbiological cross-contamination been identified, and has a segregation
plan been implemented?
10.2- 02 Has a hazard assessment been carried out to determine potential contamination sources,
susceptibility of the product and control measures suitable for these areas?
10.2- 03 Is there a separation of raw from ready to eat products
10.2- 04 Is there structural segregation - physical barriers, walls or separate building?
10.2- 05 Are there access controls with requirements to change into required work gear?
10.2- 06 Have traffic patterns or equipment segregation, people, materials, equipment and tools been
assessed as potential sources of contamination?
10.2- 07 Have air pressure differentials been assessed as potential contamination sources?
10.3 Allergen management
10.3- 01 Have all allergens present in the product, either by design or by manufacturing cross contact been
declared? Is the declaration on the consumer product label and on the label or accompanying
documentation for products intended for further processing?
10.3- 02 Are products protected from unintended allergen cross contact by cleaning and line change over
practices and/or product sequencing?
10.3- 03 Is rework containing allergens only limited to products which contain the same allergens by design?

10.3- 04 Is rework containing allergens only limited to products which contain the same allergens through a
process which is demonstrated to remove or destroy the allergenic material?
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10.3- 05 Have food handlers received specific training in allergen awareness and associated manufacturing
practices?
10.4 Physical contamination
10.4- 01 Where brittle materials are used, are there periodic inspection requirements and defined procedures
in case of breakage?
10.4- 02 Are glass breakage records being maintained?
10.4- 03 Has a hazard assessment to prevent, control or detect potential contamination been conducted and
have prevention or control measures been put in place?
11 Cleaning and sanitising
11.1 General Requirements
11.1- 01 Are there established cleaning and sanitising programmes to ensure that the food-processing
equipment and environment are maintained in a hygienic condition?
11.1- 02 Are the programmes monitored for continued suitability and effectiveness?
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11.2 Cleaning and sanitising agents and tools
11.2- 01 Are facilities and equipment maintained in a condition which facilitates wet or dry cleaning and/or
sanitation?
11.2- 02 Are cleaning and sanitising agents and chemicals clearly identified, food grade, stored separately
and used only in accordance with the manufacturer's instructions?
11.2- 03 Are tools and equipment of hygienic design and are they maintained in a condition which does not
present a potential source of extraneous matter?
11.3 Cleaning and sanitising programmes
11.3- 01 Have cleaning and sanitation programmes been established and validated by the organisation to
ensure that all parts of the establishment and equipment are cleaned and/or sanitised to a defined
schedule, including the cleaning of cleaning equipment?
11.3- 02 Are areas, items of equipment and utensils to be cleaned and/or sanitised specified in the
programmes?
11.3- 03 Are responsibilities for the tasks specified?
11.3- 04 Is the cleaning/sanitising method and frequency specified?
11.3- 05 Are monitoring and verification arrangements specified?
11.3- 06 Are post clean inspections specified?
11.3- 07 Are pre start-up inspections specified?
11.4 Cleaning in place (CIP) systems
11.4- 01 Are CIP systems separated from active product lines?
11.4- 02 Are parameters for CIP systems defined and monitored?
11.5 Monitoring sanitation and effectiveness
11.5- 01 Are cleaning and sanitation programmes monitored at frequencies specified by the organisation to
ensure their continuing suitability and effectiveness?
12 Pest control
12.1 General Requirements
12.1- 01 Are there hygiene, cleaning, incoming materials inspection and monitoring procedures that are
implemented to avoid creating an environment conducive for pest activity?
12.2 Pest control programmes
12.2- 01 Is there a nominated person to manage pest control activities and/or deal with expert contractors?

12.2- 02 Are there documented pest management programmes that identify target pests, and address plans,
methods, schedules, control procedures and, where necessary, training requirements?
12.2- 03 Do the programmes include a list of approved chemicals?
12.3 Preventing access
12.3- 01 Are buildings maintained in good repair and are holes, drains and other potential pest access points
sealed?
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12.3- 02 Are external doors, windows or ventilation openings designed to minimise the potentialfor pest
entry?
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12.4 Harbourage and infestations
12.4- 01 Are storage practices designed to minimise the availability of food and water to pests?
12.4- 02 Are infested materials handled in a way that prevents contamination of other materials, products or
the establishment?
12.4- 03 Are potential pest harbourages removed?
12.4- 04 Where outside space is used for storage, are stored items protected from weather or pest damage?

12.5 Monitoring and detection


12.5- 01 Do pest monitoring programmes include the placing of detectors and traps in key locations to
identify pest activity? Are maps of the detectors maintained? Are detectors and traps designed and
located so as to prevent potential contamination of materials, products or facilities?
12.5- 02 Are detectors and traps of robust, tamper resistant construction? Are they appropriate for the target
pest?
12.5- 03 Are detectors and traps inspected at a frequency intended to identify new pest activity. Are results of
inspections analysed to identify trends?
12.6 Eradication
12.6- 01 Are eradication measures put in place immediately after evidence of infestation is reported?
12.6- 02 Is pesticide use and application restricted to trained operatives and controlled to avoid product
safety hazards?
12.6- 03 Are records of pesticide use that show the type, quantity and concentrations used maintained? Do
they show where and how the pesticide is applied, and the target pest?
13 Personnel hygiene and employee facilities
13.1- 01 Are the requirements for personal hygiene and behaviours proportional to the hazard posed to the
process area or product established and documented?
13.1- 02 Do all personnel, visitors and contractors comply with the documented requirements?
13.2 Personnel hygiene facilities and toilets
13.2- 01 Are personnel hygiene facilities available?
13.2- 02 Are they close to areas of need and are they clearly designated?
13.2- 03 Are there adequate handwahing, drying and sanitising stations?
13.2- 04 Are there non-hand operated sinks specifically for handwashing?
13.2- 05 Is there an adequate number of toilets of appropriate hygienic design with hand washing and
sanitising facilities?
13.2- 06 No employee hygiene facilities that opens directly onto production, packing or storage areas?
13.2- 07 Are there adequate changing facilities for personnel?
13.2- 08 Are changing facilities sited to enable food handlers to move to production areas without
compromising the cleanliness of their workwear?
13.3 Staff canteens and designated eating areas
Company:
FSSC 22000 vs 4 Audit Requirements Checklist
Audit Date:

Clause No. Description Score Auditor's Comments


13.3- 01 Are canteens and designated areas for food storage and consumption situated so that the potential
for cross contamination is minimised?
13.3- 02 Are canteens managed to ensure hygienic storage of ingredients, preparation and serving? Are the
storage conditions, cooking and holding temperatures, and time limitations specified?
13.3- 03 Are employees consuming their own food in designated areas only?
13.4 Workwear and protective clothing
13.4- 01 Do persons who work in, or enter into areas where exposed products and/or materials are handled
have appropriate and in condition clothing?
13.4- 02 Is clothing mandated for food protection or hygiene purposes solely used for that purpose?
13.4- 03 Is workwear free of buttons, outside pockets above waist level?
13.4- 04 Is workwear laundered to standards and at appropriate intervals?
13.4- 05 Does workwear provide adequate covering?
13.4- 06 Is hair, beards and moustaches protected by restraints if required?
13.4- 07 Are gloves clean and in good condition?
13.4- 08 Are shoes used in processing areas fully enclosed and made from non-absorbent materials?
13.4- 09 Is PPE designed to prevent product contamination and maintained in hygienic condition?
13.5 Health status
13.5- 01 Have employees undergoone medical examinations prior to employment in food contact
operations?
13.5- 02 Are additional medical examinations done at intervals determined by the organisation?
13.6 Illness and injuries
13.5- 01 Are employees required to report the following conditions to management?: jaundice, diarrhoea,
vomiting, fever, sore throat with fever, visibly infected skin lesions and discharges from the ear, eye
or nose
13.5- 02 Are people known or suspected to be infected with diseases or illnesses transmissible through food
prevented from handling food or food contact materials?
13.5- 03 Are wounds covered with specified dressings in food handling areas? Are lost dressings reported
immediately to supervisors?
13.7 Personal cleanliness
13.7- 01 Are personnel in food production areas required to wash and where required sanitise hands before
starting any food handling activities?
13.7- 02 Are personnel in food production areas required to wash and where required sanitise hands
immediately after using the toilet or blowing the nose?
13.7- 03 Are personnel in food production areas required to wash and where required sanitise hands
immediately after handling any potentially contaminated material?
13.8 Personal behaviour
13.8- 01 Is there a documented policy describing the behaviours required of personnel in processing,
packaging and storage areas?
Company:
FSSC 22000 vs 4 Audit Requirements Checklist
Audit Date:

Clause No. Description Score Auditor's Comments


Does the policy at least cover the following:
13.8- 02 Permissibility of smoking, eating, chewing in designated areas only?
13.8- 03 Control measures to minimize hazards presented by permitted jewellery, such as that worn by
personnel in processing and storage areas, taking into account religious, ethnic, medical and
cultural imperatives;
13.8- 04 Permissibility of personal items, such as smoking materials and medicines, in designated
areas only;
13.8- 05 Prohibition of the use of nail polish, false nails and false eyelashes;
13.8- 06 Prohibition of carrying of writing implements behind the ears;
13.8- 07 Maintenance of personal lockers so that they are kept free from rubbish and soiled clothing;
13.8- 08 Prohibition of storage of product contact tools and equipment in personal lockers.
14 Rework
14.1 General Requirements
14.1- 01 Is rework stored, handled and used in such a way that product safety, quality, traceability and
regulatory compliance are maintained?
14.2 Storage, Identification and Traceability of Rework
14.2- 01 Is rework protected from exposure to microbiological, chemical or extraneous matter contamination?

14.2- 02 Are segregation requirements for rework (e.g. allergen) documented and met?
14.2- 03 Is rework clearly identified and/or labelled to allow traceability? Are traceability records for rework
maintained?
14.2- 04 Is there rework classification or is the reason for rework designation recorded? (e.g. product name,
production date, shift, line of origin, shelf-life)
14.3 Rework Usage
14.3- 01 Where rework is incoporated as an "in-process" step, is the acceptable quantity, type and conditions
of rework specified? Is the process step and method of addition, including any necessary pre-
processing stages defined?
14.3- 02 Where rework activities involve removing a product from filled or wrapped packages, are controls
put in place to ensure the removal and segregation of packaging materials and to avoid
contamination of the product with extraneous matter?

15 Product Recall Procedures


15.1 General Requirements
15.1- 01 Are there systems in place to ensure that products failing to meet requirements are identified,
located and removed from all necessary points of the supply chain.
15.2 Product Recall Requirements
15.2- 01 Is there a list of key contacts in the event of a recall maintained?
15.2- 02 Where products are withdrawn due to immediate health hazards, is the safety of products produced
under that same conditions evaluated? Is a need for public warnings considered?
Company:
FSSC 22000 vs 4 Audit Requirements Checklist
Audit Date:

Clause No. Description Score Auditor's Comments


16 Warehousing
16.1 General Requirements
16.1- 01 Are materials and products stored in clean, dry, well-ventilated spaces protected from dust,
condensation, fumes, odours or other sources of contamination.
16.2 Warehousing requirements
16.2- 01 Are there effective control of warehousing temperature, humidity and other environmental conditions
provided where required by product or storage specifications?
16.2- 02 Where products are stacked, are there measures in place to protect the lower layers.
16.2- 03 Are waste materials and chemicals (cleaning products, lubricants, and pesticides) stored
separately?
16.2- 04 Is there a separate area or other means of segregation for non-conforming materials.
16.2- 05 Are there specified stock rotation systems (FIFO/FEFO)?
16.2- 06 Are gasoline or diesel powered forklift trucks prohibited from the food ingredient or product areas.

16.3 Vehicles, conveyances, and containers


16.3- 01 Are vehicles, conveyances, and containers maintained in a state of repair, cleanliness and condition
consistent with requirements givent in relevant specifications?
16.3- 02 Do vehicles, conveyances, and containers provide protection against damage or contaminationof
the product? Is the control of temperature and humidity applied and recorded where required by the
organisation?
16.3- 03 Where the same vehicles, conveyances, and containers are used for food and non-food products,
are they cleaned between loads?
16.3- 04 Are bulk containers dedicated to food use or specified materials only?
17 Product Information and consumer awareness
17- 01 Is information presented to consumers in a way that enables them to understand its importance and
make informed choices?
18 Food Defence, biovigilance, and bioterrorism
18.1 General Requirements
18.1- 01 Has the establishment conducted an assessment of hazards posed by potential acts of sabotage,
vandalism or terrorism and are there proportional protective measures in place?
18.2 Access controls
18.2- 01 Have potentially sensitive areas within the establishment been identified, mapped and subjected to
access control?
18.2- 02 Where feasible, is access physically restricted by use of locks, electronic card key or alternative
systems?
Company:
FSSC 22000 vs 4 Audit Requirements Checklist
Audit Date:

Clause No. Description Score Auditor's Comments

FSSC ADDITIONAL REQUIREMENTS


2.1.4.1 Management of Services
2.1.4.1- 01 Do all provided services (incl. utilities, transport, maintenance and outsourced activities) have
specified requirements?
2.1.4.1- 02 Are all services described in documents to the extent needed to conduct hazard analysis?
2.1.4.1- 03 Are these services managed in conformance with the sector PRPs?
2.1.4.1- 04 Are these services monitored?
2.1.4.2 Supervision of Personnel
2.1.4.2- 01 Are personnel effectively supervised in the correct application of the food safety principles and
practices correspoinding to their activity?
2.1.4.3 Management of Supplied Materials
2.1.4.3-01 Does all input (supplied materials) which may have an impact of food safety specified requirements?

2.1.4.3-02 Are these supplied materials described in documents to the extent needed to conduct hazard
analysis?
2.1.4.3-03 Do all supplied materials comply with applicable regulatory requirements (e.g. control of prohibited
substances)?
2.1.4.3-04 Does the company have an implemented system to assure that analysis (according to ISO 17025 or
equivalent) of all input critical to the verfication of product safety is done?
2.1.4.4 Management of Natural Resources (for Animal Production only)
2.1.4.4-01 Does the company (animal farm) identify the risks it exposes from animal production to both animal
and public health?
2.1.4.4-02 Does the company (animal farm) assess the hazards that expose these risks derived from on-farm
used natural resources?
2.1.4.4-03 Has the company (animal farm) put appropriate protective and control measures in place to protect
public and animal health?
2.1.4.5 Food Defence
Does the company have a documented, established and maintained procedure for a food defence
threat assessment that:
2.1.4.5.1- 01 a) Identifies potential threats?
2.1.4.5.1- 02 b) Develops preventative measures?
2.1.4.5.1- 03 c) Prioritise the preventative measures against the threats?
2.1.4.5.1- 04 Does the company assess the susceptibility of its products to potential acts of sabotage, vandalism
and terrorism?
2.1.4.5.2- 01 Have the company put in place appropriate preventaibe measures to protect consumer health?
2.1.4.5.2- 02 Are these measures controlled within the scope of the FSMS?
2.1.4.5.2- 03 Are these measures in compliance with applicable legistlation?
Company:
FSSC 22000 vs 4 Audit Requirements Checklist
Audit Date:

Clause No. Description Score Auditor's Comments


2.1.4.5.3- 01 Is the food defense procedure reviewed after each actual or potential failure of a preventative
measure or at least annually?
Company:
FSSC 22000 vs 4 Audit Requirements Checklist
Audit Date:

Clause No. Description Score Auditor's Comments


2.1.4.6 Food Fraud Prevention
Does the company have a documented, established and maintained procedure for a food fraud
vulnerability assessment that:
2.1.4.6.1- 01 a) Identifies potential vulnerabilities?
2.1.4.6.1- 02 b) Develops preventative measures?
2.1.4.6.1- 03 c) Prioritise the preventative measures against the vulnerabilities?
2.1.4.6.1- 04 Does the company assess the susceptibility of its products to potential acts of food fraud?
2.1.4.5.2- 01 Have the company put in place appropriate preventative measures to protect consumer health?
2.1.4.5.2- 02 Are these measures controlled within the scope of the FSMS?
2.1.4.5.2- 03 Are these measures in compliance with applicable legistlation?
2.1.4.6.3- 01 Is the food fraud prevention procedure reviewed after each actual or potential failure of a
preventative measure or at least annually?
2.1.4.7 Formulation of products (Only for pet food for dogs and cats)
2.1.4.7.1- 01 Are compounded pet food for dogs and cats formulated in a manner that is consistent with the
intended use?
2.1.4.7.1- 02 Are formulation procedures in place to manage the use of ingredients that contain nutrients that can
have adverse animal health impacts?
2.1.4.8 Management of Allergens
2.1.4.8.1- 01 Does the company have a documented allergen management procedure in place, incl
2.1.4.8.1- 02 a) A risk assessment identifying potential allergen cross contaminaiton?
2.1.4.8.1- 03 b) Controls to reduce or elimnate the risk of cross contact?
2.1.4.8.1- 04 c) Validation and verification of the effective implementation of this procedure?
2.1.4.8.2- 01 Are alll finished products that contain allergenic materials (intentionally or potentially) labeled
according to the allergen labelling regulations of the country of destination?
2.1.4.9 Product Labelling
2.1.4.9- 01 Are the finished products labelled according to the applicable food regulations in the country of
intended sale?
2.1.4.10 Environmental Monitoring
2.1.4.10- 01 Does the company have an environmental monitoring program in place to validate and verify the
microbiological hygiene of the site demonstrating the effectiveness of the cleaning and sanitation
programmes?

2.1.4.11 Logo Use


2.1.4.11- 01 If the company is already certified to the FSSC 22000 scheme, does it use the logo in the prescribed
manner?