FSSC 22000 v

4.1 -
CHECKLIST
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:
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 the organisation,
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.
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 safety management system is established, implemented, maintained and updated?
5.5 0.5 d) to report to the organisation's top management 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?
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
5.8.1 01 Does top management review the organisations 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?
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
food safety,
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)?
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?
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.
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;
7.3.3.2- 05 e) packaging
7.3.3.2- 06 f) labelling 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?
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
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?
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 control points
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
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
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?
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.
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?
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?
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?
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?
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?
ISO/TS 22002-
1 - PRE-
REQUISITE
PROGRAMM
ES
4 Construction
and layout of
buildings
4.1 General Requirements
4.1- 01 Are buildings designed , constructed and maintained in a manner appropriate to the nature of food processing
operations to be carried out, the food safety hazards associated with those operations and the potential sources of
contamination from the plant environs?
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 tended/removed? Drainage for roads, yards and parking areas to
prevent standing water? Roads, yards and parking areas maintained?
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 washable/cleanable, as appropriate for the process or product hazard? Are
construction materials resistant to the cleaning system applied?
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 wet 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?
5.4- 02 Is equipment located to permit access for operation, cleaning and maintenance?
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 of people, plant and products? 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 potential contamination of
products?
5.6 -02 Have additional 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? Where specified, 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, secure (locked or otherwise access controlled) storage area provided for cleaning materials,
chemicals and other hazardous substances?
5.7 -07 If applicable, 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 process(es)?
6.2- 02 Are facilities for 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 (incl. culinary 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?
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?
Are measures taken to prevent non-potable water from refluxing into the potable system?
6.3 Boiler chemicals
6.3- 01 If used, are boiler chemicals approved food additives which meet relevant additive specifications OR 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- 02 Are boiler chemicals stored in a separate, secure (locked or otherwise access-controlled) 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 (natural or mechanical) provided 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
established 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 or raw to clean areas? Are specified air
pressure differentials maintained? Are systems accessible 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 (incl. those used for transporting, blowing or drying
materials, products or equipment) 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, where there is potential for the air to come into contact with the product, 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 (natural or artificial) allowing personnel to operate in a hygienic manner? The intensity of the
lighting should be appropriate to the nature of the operation.
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 identified, 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
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 (minimum daily)?
7.3- 03 Are there measures for the disfigurement or destruction of labelled materials, products or printed packaging designated
as waste, to ensure that trademarks cannot be reused?
7.3- 04 Is the removal and destruction of waste performed by an approved disposal contractor?
7.3- 05 Are waste 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 process 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
corrosion free?
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 (e.g. CIP, COP), use
of dedicated cleaning tools, removal or disassembly requirements and cleaning verification methods?
8.6 Preventive and corrective maintenance
8.6- 01 Is there a preventive maintenance programme in place?
8.6- 02 Does the preventive maintenance 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 safety? 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 verified to specified purchase requirements?
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 suppliers ability to meet quality and food safety expectations,
requirements and specifications?
9.2- 04 Does the process include description of how suppliers are assessed?
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 (airborne or from traffic patterns) 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 finished or ready to eat products?
10.2- 04 Is there structural segregation - physical barriers, walls or separate building, to control the risk of microbiological cross-
contamination?
10.2- 05 Are there access controls with requirements to change into required work gear, to control the risk of microbiological
cross-contamination?
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 potential 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 OR is rework,
containing allergens, used only through a process which is demonstrated to remove or destroy the allergenic material??
10.3- 04 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 physical 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?
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 cleaning and sanitising tasks specified?
11.3- 04 Is the cleaning/sanitising method and frequency specified?
11.3- 05 Are monitoring and verification arrangements for cleaning and sanitising programmes specified?
11.3- 06 Does cleaning and sanitising programmes specify post clean inspections?
11.3- 07 Does cleaning and sanitising programmes specify pre start-up inspections?
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? Incl. type, concentration, contact time and temperature of any
chemicals used.
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 to 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 Pest control programmes include a list of chemicals which are approved for use in specified areas of the
establishment?
12.3 Preventing access
12.3- 01 Are buildings maintained in good repair and are holes, drains and other potential pest access points sealed?
12.3- 02 Are external doors, windows or ventilation openings designed to minimise the potential for pest entry?
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 (e.g. burrows, undergrowth, stored items) removed?
12.4- 04 Where outside space is used for storage, are stored items protected from weather or pest damage (e.g. bird droppings)?
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? Is a
map of the detectors and traps 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 Are all personnel, visitors and contractors required to comply with the documented personal hygiene and behaviours
requirements?
13.2 Personnel hygiene facilities and toilets
13.2- 01 Are personnel hygiene facilities available?
13.2- 02 Are personnel hygiene facilities close to areas of need and are they clearly designated?
13.2- 03 Are there adequate numbers, locations and means of hygienically washing, drying and sanitising (where required)
hands?
13.2- 04 Are there non-hand operated sinks specifically for handwashing (separate from sinks for food use and equipment-
cleaning stations)?
13.2- 05 Is there an adequate number of toilets of appropriate hygienic design, each with hand washing, drying and sanitising
(where required) 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
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, storage and serving? Are the storage
 conditions, cooking and holding temperatures, and time limitations specified?
13.3- 03 Are employees storing and 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 work clothing
that is fit for purpose, clean and in good condition?
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 coverage to ensure that hair, perspiration, etc. cannot contaminate the product?
13.4- 06 Is hair, beards and moustaches protected by restraints, if required by hazard analysis?
13.4- 07 Are gloves clean and in good condition? The use of latex gloves should be avoided where possible.
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 undergone medical examinations prior to employment in food contact operations (unless documented
hazard or medical assessment indicates otherwise)?
13.5- 02 Are additional medical examinations done at intervals determined by the organisation (unless documented hazard or
medical assessment indicates otherwise)?
13.6 Illness and injuries
13.5- 01 Are employees required to report the following conditions to management for possible exclusion from food-handling
areas - jaundice, diarrhoea, vomiting, fever, sore throat with fever, visibly infected skin lesions (boils, cuts or sores) 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? Are dressings brightly coloured and metal detectable where appropriate?
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?
13.7- 04 Are personnel required to refrain from sneezing or coughing over materials or products? Is spitting prohibited?
13.7- 05 Are personnel required to keep fingernails clean and trimmed?
13.8 Personal behaviour
13.8- 01 Is there a documented policy describing the behaviours required of personnel in processing, packaging and storage
areas?
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 stored 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 incorporated in a product 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 maintained list of key contacts in the event of a recall?
15.2- 02 Where products are withdrawn due to immediate health hazards, is the safety of products produced under that same
conditions evaluated? Is the need for public warnings considered?
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 specified stock rotation systems (FIFO/FEFO) observed?
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 given in relevant specifications?
16.3- 02 Do vehicles, conveyances, and containers provide protection against damage or contamination of 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?
FSSC
ADDITIONAL
REQUIREME
NTS
2.1.4.1
Management
of Services
2.1.4.1- 01 Do all provided services (incl. utilities, transport, maintenance, cleaning and outsourced activities) have specified
requirements which are regularly reviewed?
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 assessed and approved to show compliance with the specified requirements?
2.1.4.1- 05 Are these services monitored to assure the continued approval status of the service provider?
2.1.4.1- 06 Has the company implemented a system to assure that all analyses which are critical to the verification of food safety,
are done by a competent (e.g. ISO 17025 accredited) laboratory?
2.1.4.2
Product
Labelling
2.1.4.2- 01 Are the finished products labelled according to the applicable food regulations in the country of intended sale?
2.1.4.3 Food
Defence
Does the company have a documented, established and maintained procedure for a food defence threat assessment that:
2.1.4.3.1- 01 a) Identifies potential threats?
2.1.4.3.1- 02 b) Develops control measures?
2.1.4.3.1- 03 c) Prioritise the control measures against the threats?
2.1.4.3.1- 04 Does the company assess the susceptibility of its products to potential food defence acts?
2.1.4.3.2- 01 Did the company put appropriate control measures in place to reduce/eliminate the identified threats?
2.1.4.3.3- 01 Are all policies, procedures and records which are included in the Food Defence plan supported by the company's
FSMS for all its products?
2.1.4.3.3- 02 Does the Food Defence plan comply with applicable legislation?
2.1.4.4 Food
Fraud
Prevention
Does the company have a documented, established and maintained procedure for a food fraud vulnerability assessment
that:
2.1.4.4.1- 01 a) Identifies potential vulnerabilities
2.1.4.4.1- 02 b) Develops control measures?
2.1.4.4.1- 03 c) Prioritise the control measures against the vulnerabilities?
2.1.4.4.1- 04 Does the company assess the susceptibility of its products to potential food fraud acts?
2.1.4.4.2- 01 Did the company put appropriate control measures in place to reduce/eliminate the identified vulnerabilities?
2.1.4.4.3- 01 Are all policies, procedures and records which are included in the Food Fraud prevention plan supported by the
company's FSMS for all its products?
2.1.4.4.3- 02 Does the Food Fraud prevention plan comply with applicable legislation?
2.1.4.5 Logo
Use
2.1.4.5- 01 If the company is already certified to the FSSC 22000 scheme, does it use the logo in the prescribed manner?
2.1.4.6
Management
of Allergens
2.1.4.6.1- 01 Does the company have a documented allergen management procedure in place, incl.
2.1.4.6.1- 02 a) A risk assessment identifying potential allergen cross contamination?
2.1.4.6.1- 03 b) Control measures to reduce or eliminate the risk of cross contact?
2.1.4.6.1- 04 c) Validation and verification of the effective implementation of this procedure?
2.1.4.6.2- 01 Are all finished products that contain allergenic materials (intentionally or potentially) labelled according to the
allergen labelling regulations of the country manufacture and the country of destination?
2.1.4.7
Environmental
Monitoring
2.1.4.7- 01 Does the company have an environmental monitoring program in place to verify the effectiveness of the cleaning and
sanitation programmes, according to the verification requirements as described in ISO 22000?
2.1.4.8
Formulation of
products (Only
for pet food for
dogs and cats)
2.1.4.8.1- 01 Is compounded pet food for dogs and cats formulated in a manner that is consistent with the intended use?
2.1.4.8.1- 02 Are formulation procedures in place to manage the use of ingredients that contain nutrients that can have adverse
animal health impacts?
2.1.4.9
Management
of Natural
Resources (for
Animal
Production
only)
2.1.4.9-01 Does the company (animal farm) identify the risks it exposes from animal production to both animal and public health?
2.1.4.9-02 Does the company (animal farm) assess the hazards that expose these risks derived from on-farm used natural
resources?
2.1.4.9-03 Has the company (animal farm) put appropriate protective and control measures in place to protect public and animal
health?