How can we help?

ISO 22000

The professional inspection solution

You can conduct this checklist for free on the Checkbuster platform. You can use a lap-top, PC or the free inspection App

4.1 General requirements food safety management system

  • 4.1 – 01 The organization has established, documented and implemented an effective food safety management system in accordance with the requirements of ISO 22000 standard.
  • 4.1 – 02 The food safety management system is maintained and updated.
  • 4.1 – 03 The scope of the food safety management system is defined.
  • 4.1 – 04 The products or product categories, processes and production sites that are addressed by the food safety management system are specified by scope.
  • 4.1 – 05 Food safety hazards that may be reasonably expected to occur in relation to products within the scope of the system identified, are evaluated and controlled in such a manner that the products of theorganization do not, directly or indirectly, harm the consumer.
  • 4.1 – 06 The appropriate information – regarding safety issues related to the products – are communicated throughout the food chain.
  • 4.1 – 08 The information – concerning development, implementation and updating of the food safety management system throughout the organization – are communicated to the extent necessary to ensure the food safety required by the ISO 22000 standard.
  • 4.1 – 09 The organization periodically evaluates FSMS (and update when necessary) to ensure that the system reflects the organization’s activities and incorporates the most recent information on the food safety hazards subject to control.
  • 4.1 – 10 The organization has ensured control over the outsourced processes that may affect end product conformity.
  • 4.1 – 11 The control of such outsourced processes is identified and documented within the FSMS.

4.2.1 General documentation requirements

  • 4.2.1 – 01 The FSMS documentation does include documented statements of a food safety policy and related objectives.
  • 4.2.1 – 02 The FSMS documentation does include documented procedures and records required by ISO 22000 standard.
  • 4.2.1 – 03 The FSMS documentation does include documents needed by the organization to ensure the effective development, implementation and updating of the food safety management system.

4.2.2 Control of documents

  • 4.2.2 – 01 The documents – which are required by the food safety management system – are controlled.
  • 4.2.2 – 02 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.
  • 4.2.2 – 03 A documented procedure exists to define the controls needed to approve documents for adequacy prior to issue.
  • 4.2.2 – 04 A documented procedure exists to define the controls needed to review and update as necessary and reapprove documents.
  • 4.2.2 – 05 A documented procedure exists to define the controls needed to ensure that changes and the current revision status of documents are identified.
  • 4.2.2 – 06 A documented procedure exists to define the controls needed to ensure that relevant versions of applicable documents are available at points of use.
  • 4.2.2 – 07 A documented procedure exists to define the controls needed to ensure that documents remain legible and readily identifiable.
  • 4.2.2 – 08 A documented procedure exists to define the controls needed to ensure that relevant documents of external origin are identified and their distribution controlled.
  • 4.2.2 – 09 A documented procedure exists to define the controls needed 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 Control of records

  • 4.2.3 – 01 Required records are 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 Records remain legible, readily identifiable and retrievable.
  • 4.2.3 – 03 A documented procedure exists in order to define the controls needed for the correction, identification, storage, protection, retrieval, retention time and disposition of records.

5.1 Management commitment

  • 5.1 – 01 Top management is able to provide evidence of its commitment to the development and implementation of the food safety management system.
  • 5.1 – 02 Top management is able to provide evidence that the effectiveness of the food safety management system is continually improved by showing food safety is supported by the business objectives of the organization.
  • 5.1 – 03 Top management is able to provide evidence that the effectiveness of the food safety management system is continually improved by communicating to the organization 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 Top management is able to provide evidence that the effectiveness of the food safety management system is continually improved by establishing the food safety policy.
  • 5.1 – 05 Top management is able to provide evidence that the effectiveness of the food safety management system is continually improved by conducting management reviews.
  • 5.1 – 06 Top management is able to provide evidence that the effectiveness of the food safety management system is continually improved by ensuring the availability of resources.

5.2 Food safety policy

  • 5.2 – 01 Top management has defined, documented and communicated its food safety policy.
  • 5.2 – 02 Top management ensures that the food safety policy is appropriate to the role of the organization in the food chain.
  • 5.2 – 03 Top management ensures that the food safety policy conforms with both statutory and regulatory requirements and with mutually agreed food safety requirements of customers.
  • 5.2 – 04 Top management ensures that the food safety policy is communicated, implemented and maintained at all levels of the organization.
  • 5.2 – 05 Top management ensures that the food safety policy is reviewed for continued suitability.
  • 5.2 – 06 Top management ensures that the food safety policy adequately addresses communication.
  • 5.2 – 07 Top management ensures that the food safety policy is supported by measurable objectives.

5.3 Food safety management system planning

  • 5.3 – 01 Top management ensures that the planning of the food safety management system is carried out to meet the requirements in clause ‘General requirements’, as well as the objectives of the organization that support food safety.
  • 5.3 – 02 Top management ensures 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 Top management ensures that the responsibilities, authorities are defined and communicated within the organization to ensure the effective operation and maintenance of the food safety management system.
  • 5.4 – 02 The responsibility is assigned to all personnel to report the problems with the food safety management to identified person(s).
  • 5.4 – 03 There are designated personnel with defined responsibility and authority to initiate and record actions.

5.5 Food safety team leader

  • 5.5 – 01 Top management appointed a food safety team leader who, irrespective of other responsibilities, shall have responsibility and authority.
  • 5.5 – 02 Top management has appointed a food safety team leader who, irrespective of other responsibilities, shall have responsibility and authority to ensure relevant training and education of the food safety team member.
  • 5.5 – 03 Top management has appointed a food safety team leader who, irrespective of other responsibilities, shall have responsibility and authority to ensure that the food safety management system is established, implemented, maintained and updated.
  • 5.5 – 04 Top management has appointed a food safety team leader who, irrespective of other responsibilities, shall have responsibility and authority to report to the organization’s top management on the effectiveness and suitability of the food safety management system.

5.6.1 External communication

  • 5.6.1 – 01 The organization has established, implemented and maintained effective arrangements for communicating with suppliers and contractors.
  • 5.6.1 – 02 The organization has established, implemented and maintained effective arrangements for communicating with 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 – 03 The organization has established, implemented and maintained effective arrangements for communicating with statutory and regulatory authorities.
  • 5.6.1 – 04 The organization has established, implemented and maintained effective arrangements for communicating with other organizations that have an impact on, or will be affected by, the effectiveness or updating of the food safety management system.
  • 5.6.1 – 05 Such communication provides information on food safety aspects (especially to known food safety hazards that need to be controlled by other organizations in the food chain) of the organization’s products that may be relevant to other organizations in the food chain.
  • 5.6.1 – 06 Records of communications are maintained.
  • 5.6.1 – 07 The food safety requirements – from statutory and regulatory authorities and customers – are available.
  • 5.6.1 – 08 There are designated personnel with defined responsibility and authority to communicate externally any information concerning food safety.
  • 5.6.1 – 09 Information obtained through external communication is included as input to system updating and management review.

5.6.2 Internal communication

  • 5.6.2 – 01 The organization has established, implemented and maintained effective arrangements for communicating with personnel on issues having an impact on food safety.
  • 5.6.2 – 02 a The organization ensured that the food safety team is informed in a timely manner of changes to products or new products.
  • 5.6.2 – 02 b The organization ensured that the food safety team is informed in a timely manner of changes to raw materials, ingredients and services.
  • 5.6.2 – 02 c The organization ensured that the food safety team is informed in a timely manner of changes to production systems and equipment.
  • 5.6.2 – 02 d The organization ensured that the food safety team is informed in a timely manner of changes to production premises, location of equipment, surrounding environment.
  • 5.6.2 – 02 e The organization ensured that the food safety team is informed in a timely manner of changes to cleaning and sanitation programmes.
  • 5.6.2 – 02 f The organization ensured that the food safety team is informed in a timely manner of changes to packaging, storage and distribution systems.
  • 5.6.2 – 02 g The organization ensured that the food safety team is informed in a timely manner of changes to personnel qualification levels and/or allocation of responsibilities and authorizations.
  • 5.6.2 – 02 h The organization ensured that the food safety team is informed in a timely manner of changes to statutory and regulatory requirements.
  • 5.6.2 – 02 i The organization ensured that the food safety team is informed in a timely manner of changes to knowledge regarding food safety hazards and control measures.
  • 5.6.2 – 02 j The organization ensured that the food safety team is informed in a timely manner of changes to customer, sector and other requirements that the organization observes.
  • 5.6.2 – 02 k The organization ensured that the food safety team is informed in a timely manner of changes to relevant enquiries from external interested parties.
  • 5.6.2 – 02 l The organization ensured that the food safety team is informed in a timely manner of changes to complaints indicating food safety hazards associated with the product.
  • 5.6.2 – 02 m The organization ensured that the food safety team is informed in a timely manner of changes to other conditions that have an impact on food safety.
  • 5.6.2 – 03 The food safety team ensures that above mentioned information is included in the updating of the food safety management system.
  • 5.6.2 – 04 Top management ensures that relevant information is included as input to the management review.

5.7 Emergency preparedness and response

  • 5.7 – 01 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 organization in the food chain.

5.8.1 General management review

  • 5.8.1 – 01 Top management reviews the organization’s food safety management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness.
  • 5.8.1 – 02 This review does 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 Records from management reviews are maintained.

5.8.2 Input management review

  • 5.8.2 – 01 The input to management review does include information about follow-up actions from previous management reviews.
  • 5.8.2 – 02 The input to management review does include information about analysis of results of verification activities.
  • 5.8.2 – 03 The input to management review does include information about changing circumstances that can affect food safety.
  • 5.8.2 – 04 The input to management review does include information about emergency situations, accidents and withdrawals.
  • 5.8.2 – 05 The input to management review does include information about reviewing results of system-updating activities.
  • 5.8.2 – 06 The input to management review does include information about review of communication activities, including customer feed-back.
  • 5.8.2 – 07 The input to management review does include information about external audits or inspections.
  • 5.8.2 – 08 The data are presented in a manner that enables top management to relate the information to stated objectives of the food safety management system.

5.8.3 Output management review

  • 5.8.3 – 01 The output from the management review does include any decisions and actions related to assurance of food safety.
  • 5.8.3 – 02 The output from the management review does include any decisions and actions related to improvement of the effectiveness of the food safety management system.
  • 5.8.3 – 03 The output from the management review does include any decisions and actions related to resource needs.
  • 5.8.3 – 04 The output from the management review does include any decisions and actions related to revisions of the organization’s food safety policy and related objectives.

6.1 Provision of resources

  • 6.1 – 01 The organization provides adequate resources for the establishment, implementation, maintenance and updating of the food safety management system.

6.2.1 General human resources

  • 6.2.1 – 01 The food safety team and the other personnel carrying out activities are having an impact on food safety, competent on the basis of appropriate education, training, skills and experience.
  • 6.2.2 – 02 There are 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

  • 6.2.2 – 01 a) The organization does identify the necessary competencies for personnel whose activities have an impact on food safety.
  • 6.2.2 – 02 b) The organization does provide training or take other action to ensure personnel have the necessary competencies.
  • 6.2.2 – 03 c) The organization does ensure that personnel responsible for monitoring, corrections and corrective actions of the food safety management system are trained.
  • 6.2.2 – 04 The organization does evaluate the implementation and the effectiveness of the actions taken in a), b) and c).
  • 6.2.2 – 05 The organization does ensure that the personnel are aware of the relevance and importance of their individual activities in contributing to food safety.
  • 6.2.2 – 06 The organization does ensure that the requirement for effective communication is understood by all personnel whose activities have an impact on food safety.
  • 6.2.2 – 07 The organization does maintain appropriate records of training and actions described in b) and c).

6.3 Infrastructure

  • 6.3 – 01 The organization provides 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 The organization provides the resources for the establishment, management and maintenance of the work environment needed to implement the requirements of ISO 22000 standard.

7.1 General planning and realization of safe products

  • 7.1 – 01 The organization does plan and develop the processes needed for the realization of safe products.
  • 7.1 – 02 The organization does implement, operate and ensure the effectiveness of the planned activities and any changes to those activities.

7.2 Prerequisite programmes (PRPs)

  • 7.2.1 – 01 The organization has established, implemented and maintained PRP(s) to assist in controlling the likelihood of introducing food safety hazards to the product through the work environment.
  • 7.2.1 – 02 The organization has established, implemented and maintained PRP(s) to assist in controlling biological, chemical and physical contamination of the product(s), including cross contamination between products.
  • 7.2.1 – 03 The organization has established, implemented and maintained PRP(s) to assist in controlling food safety hazard levels in the product and product processing environment.
  • 7.2.2 – 01 The PRP(s) are appropriate to the organizational needs with regard to food safety.
  • 7.2.2 – 02 The PRP(s) are appropriate to the size and type of the operation and the nature of the products being manufactured and/or handled.
  • 7.2.2 – 03 The PRP(s) are 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 The PRP(s) are approved by the food safety team.
  • 7.2.2 – 05 The organization does identify statutory and regulatory requirements related to the above.
  • 7.2.3 – 01 The organization does consider and utilize appropriate information, when selecting and/or establishing PRP(s).
  • 7.2.3 – 02 a When establishing PRP(s).the organization does consider construction and lay-out of buildings and associated utilities.
  • 7.2.3 – 02 b When establishing PRP(s).the organization does consider lay-out of premises, including workspace and employee facilities.
  • 7.2.3 – 02 c When establishing PRP(s).the organization does consider supplies of air, water, energy and other utilities.
  • 7.2.3 – 02 d When establishing PRP(s).the organization does consider supporting services, including waste and sewage disposal.
  • 7.2.3 – 02 e When establishing PRP(s).the organization does consider the suitability of equipment and its accessibility for cleaning, maintenance and preventative maintenance.
  • 7.2.3 – 02 f When establishing PRP(s).the organization does consider 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).
  • 7.2.3 – 02 g When establishing PRP(s).the organization does consider measures for the prevention of cross contamination.
  • 7.2.3 – 02 h When establishing PRP(s).the organization does consider cleaning and sanitizing.
  • 7.2.3 – 02 i When establishing PRP(s).the organization does consider pest control.
  • 7.2.3 – 02 j When establishing PRP(s).the organization does consider personnel hygiene.
  • 7.2.3 – 02 k When establishing PRP(s).the organization does consider other aspects as appropriate.
  • 7.2.3 – 03 Verification of PRP(s) is planned.
  • 7.2.3 – 04 PRP(s) are modified as necessary.
  • 7.2.3 – 05 Records of verifications and modifications are maintained.
  • 7.2.2 – 03 Documents do specify how activities included in the PRP(s) are managed.

7.3.1 General preliminary steps to enable hazard analysis

  • 7.3.1 – 01 All relevant information – needed to conduct the hazard analysis – is collected, maintained, updated and documented.
  • 7.3.1 – 02 The records related to hazard analysis are maintained.

7.3.2 Food safety team

  • 7.3.2 – 01 A food safety team has been appointed.
  • 7.3.2 – 02 The members of the food safety team do provide a combination of multi-disciplinary knowledge and experience in developing and implementing the food safety management system.
  • 7.3.2 – 03 Records – that demonstrate that the food safety team has the required knowledge and experience – are maintained.

7.3.3.1 Raw material, ingredients and product-contacted material

  • 7.3.3.1 – 01 a All raw materials, ingredients and product-contact materials are described in documents to the extent needed to conduct the hazard analysis, including biological, chemical and physical characteristics, as appropriate.
  • 7.3.3.1 – 01 b All raw materials, ingredients and product-contact materials are described in documents to the extent needed to conduct the hazard analysis, including composition of formulated ingredients, including additives and processing aids, as appropriate.
  • 7.3.3.1 – 01 c All raw materials, ingredients and product-contact materials are described in documents to the extent needed to conduct the hazard analysis, including origin, as appropriate.
  • 7.3.3.1 – 01 d All raw materials, ingredients and product-contact materials are described in documents to the extent needed to conduct the hazard analysis, including method of production, as appropriate.
  • 7.3.3.1 – 01 e All raw materials, ingredients and product-contact materials are described in documents to the extent needed to conduct the hazard analysis, including packaging and delivery methods, as appropriate.
  • 7.3.3.1 – 01 f All raw materials, ingredients and product-contact materials are described in documents to the extent needed to conduct the hazard analysis, including storage conditions and shelf life, as appropriate.
  • 7.3.3.1 – 01 g All raw materials, ingredients and product-contact materials are described in documents to the extent needed to conduct the hazard analysis, including preparation and/or handling before use or processing, as appropriate.
  • 7.3.3.1 – 01 h All raw materials, ingredients and product-contact materials are described in documents to the extent needed to conduct the hazard analysis, including food safety-related acceptance criteria or specifications of purchased materials and ingredients appropriate to their intended uses, as appropriate.
  • 7.3.3.1 – 02 The organization does identify statutory and regulatory food safety requirements related to the raw materials, ingredients and product-contact materials.
  • 7.3.3.1 – 03 The descriptions are kept up-to-date including, when required.

7.3.3.2 Characteristics of end products

  • 7.3.3.2 – 01 a The characteristics of end products are described in documents to the extent needed to conduct the hazard analysis, including information on product name or similar identification, as appropriate.
  • 7.3.3.2 – 01 b The characteristics of end products are described in documents to the extent needed to conduct the hazard analysis, including information on composition, as appropriate.
  • 7.3.3.2 – 01 c The characteristics of end products are described in documents to the extent needed to conduct the hazard analysis, including information on biological, chemical and physical characteristics relevant for food safety, as appropriate.
  • 7.3.3.2 – 01 d The characteristics of end products are described in documents to the extent needed to conduct the hazard analysis, including information on intended shelf life and storage conditions, as appropriate.
  • 7.3.3.2 – 01 e The characteristics of end products are described in documents to the extent needed to conduct the hazard analysis, including information on packaging, as appropriate.
  • 7.3.3.2 – 01 f The characteristics of end products are described in documents to the extent needed to conduct the hazard analysis, including information on labeling relating to food safety and/or instructions for handling, preparation and usage, as appropriate.
  • 7.3.3.2 – 01 g The characteristics of end products are described in documents to the extent needed to conduct the hazard analysis, including information on method(s) of distribution, as appropriate.
  • 7.3.3.2 – 02 The organization does identify statutory and regulatory food safety requirements related to the characteristics of end products.
  • 7.3.3.2 – 03 The descriptions are kept up-to-date including, when required.

7.3.4 Intended use

  • 7.3.4 – 01 The intended use, the reasonably expected handling of the end product, and any unintended but reasonably expected mishandling and misuse of the end product are considered and described in documents to the extent needed to conduct the hazard analysis.
  • 7.3.4 – 02 Groups of users and, where appropriate, groups of consumers are identified for each product, and consumer groups known to be especially vulnerable to specific food safety hazards considered.
  • 7.3.4 – 03 The descriptions are kept up-to-date including, when required.

7.3.5.1 Flow diagrams

  • 7.3.5.1 – 01 Flow diagrams prepared for the products or process categories are covered by the food safety management system.
  • 7.3.5.1 – 02 Tlow diagrams do provide a basis for evaluating the possible occurrence, increase or introduction of food safety hazards.
  • 7.3.5.1 – 03 Flow diagrams are clear, accurate and sufficiently detailed.
  • 7.3.5.1 – 04 a Flow diagrams, as appropriate, do include the sequence and interaction of all steps in the operation.
  • 7.3.5.1 – 04 b Flow diagrams, as appropriate, do include any outsourced processes and subcontracted work.
  • 7.3.5.1 – 04 c Flow diagrams, as appropriate, do include where raw materials, ingredients and intermediate products enter the flow.
  • 7.3.5.1 – 04 d Flow diagrams, as appropriate, do include where reworking and recycling take place.
  • 7.3.5.1 – 04 e Flow diagrams, as appropriate, do include where end products, intermediate products, byproducts and waste are released or removed.
  • 7.3.5.1 – 05 The food safety team does verify the accuracy of the flow diagrams by on-site checking.
  • 7.3.5.1 – 06 Verified flow diagrams are maintained as records.

7.3.5.2 Description of process steps and control measures

  • 7.3.5.2 – 01 The existing control measures process parameters and/or the rigorousness with which they are applied, or the procedures that may influence food safety, are described to the extent needed to conduct the hazard analysis.
  • 7.3.5.2 – 02 External requirements (e.g. regulatory authorities ore costumes) that my impact the choice or rigorousness of the control measures are described and updated.

7.4.1 General hazard analysis

  • 7.4.1 – 01 The food safety team does 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 All food safety hazards that are reasonably expected to occur in relation to the type of product, type of process and actual processing facilities are identified and recorded.
  • 7.4.2.1 – 02 a The identification is based on the preliminary information and data collected in preliminary steps to enable hazard analysis.
  • 7.4.2.1 – 02 b The identification is based on experience.
  • 7.4.2.1 – 02 c The identification is based on external information including, to the extent possible, epidemiological and other historical data.
  • 7.4.2.1 – 02 d The identification is based on 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 – 03 The step(s) (from raw materials, processing and distribution) – at which each food safety hazard may be introduced – are indicated.
  • 7.4.2.2 – 01 a The consideration – when identifying the hazards – is given to the steps preceding and following the specified operation.
  • 7.4.2.2 – 01 b The consideration – when identifying the hazards – is given to the process equipment, utilities/services and surroundings.
  • 7.4.2.2 – 01 c The consideration – when identifying the hazards – is given to the preceding and following links in the food chain.
  • 7.4.2.3 – 01 The acceptable level of the food safety hazard in the end product determined (whenever possible) for each of the food safety hazards are identified.
  • 7.4.2.3 – 02 The determined level does 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 The justification for, and the result of, the determination of the acceptable level of the food safety hazard are recorded.

7.4.3 Hazard assessment

  • 7.4.3 – 01 A hazard assessment is 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 Each food safety hazard is evaluated according to the possible severity of adverse health effects and the likelihood of their occurrence.
  • 7.4.3 – 03 The methodology used for hazard is described.
  • 7.4.3 – 04 The results of the food safety hazard assessment are recorded.

7.4.4 Selection and assessment of control measures

  • 7.4.4 – 01 An appropriate combination of control measures are 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 Each of the selected control measures is reviewed with respect to its effectiveness against the identified food safety hazards.
  • 7.4.4 – 03 a Each selected control measure is 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 its effect on identified food safety hazards relative to the strictness applied.
  • 7.4.4 – 03 b Each selected control measure is 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 its feasibility for monitoring (e.g. ability to be monitored in a timely manner to enable immediate corrective actions).
  • 7.4.4 – 03 c Each selected control measure is 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 its place within the system relative to other control measures.
  • 7.4.4 – 03 d Each selected control measure is 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 likelihood of failure in the functioning of a control measure or significant processing variability.
  • 7.4.4 – 03 e Each selected control measure is 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 severity of the consequence(s) in the case of failure in its functioning.
  • 7.4.4 – 03 g Each selected control measure is 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 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 Control measures – categorized as belonging to the HACCP plan – are implemented.
  • 7.4.4 – 05 Other control measures are implemented as operational PRPs.
  • 7.4.4 – 06 The methodology and parameters – used for this categorization – are described in documents.
  • 7.4.4 – 07 The results of the assessment are recorded.

7.5 Establishing the operational prerequisite programmes (PRPs)

  • 7.5 – 01 The operational PRPs are documented.
  • 7.5 – 02 a The operational PRPs included food safety hazard(s) to be controlled by the programme.
  • 7.5 – 02 b The operational PRPs included control measure(s).
  • 7.5 – 02 c The operational PRPs included monitoring procedures that demonstrate that the operational PRPs are in place.
  • 7.5 – 02 d The operational PRPs included corrections and corrective actions to be taken if monitoring shows that the operational PRPs are not in control.
  • 7.5 – 02 e The operational PRPs included responsibilities and authorities.
  • 7.5 – 02 f The operational PRPs included record(s) of monitoring.

7.6.1 Establishing the HACCP plan

  • 7.6.1 – 01 The HACCP plan is documented.
  • 7.6.1 – 02 a Is the HACCP plan included food safety hazard(s) to be controlled at the CCP.
  • 7.6.1 – 02 b Is the HACCP plan included control measure(s).
  • 7.6.1 – 02 c Is the HACCP plan included critical limit(s).
  • 7.6.1 – 02 d Is the HACCP plan included monitoring procedure(s).
  • 7.6.1 – 02 e Is the HACCP plan included corrections and corrective action(s) to be taken if critical limits are exceeded.
  • 7.6.1 – 02 f Is the HACCP plan included responsibilities and authorities.
  • 7.6.1 – 02 g Is the HACCP plan included record(s) of monitoring.

7.6.2 Identification of critical control points

  • 7.6.2 – 01 CCP(s) are 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 Critical limits are determined for the monitoring established for each CCP.
  • 7.6.3 – 02 Critical limits are 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 Critical limits are measurable.
  • 7.6.3 – 04 The rationale for the chosen critical limits are documented.
  • 7.6.3 – 05 Critical limits – based on subjective data (such as visual inspection of product, process, handling, etc.) – are 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 A monitoring system is established for each CCP to demonstrate that the CCP is in control.
  • 7.6.4 – 02 All scheduled measurements or observations – relative to the critical limit(s) – are included in the monitoring system.
  • 7.6.4 – 03 a The monitoring system does consist of relevant procedures, instructions and records that cover measurements or observations that provide results within an adequate time frame.
  • 7.6.4 – 03 b The monitoring system does consist of relevant procedures, instructions and records that cover monitoring devices used.
  • 7.6.4 – 03 c The monitoring system does consist of relevant procedures, instructions and records that cover applicable calibration methods.
  • 7.6.4 – 03 d The monitoring system does consist of relevant procedures, instructions and records that cover monitoring frequency.
  • 7.6.4 – 03 e The monitoring system does consist of relevant procedures, instructions and records that cover responsibility and authority related to monitoring and evaluation of monitoring results.
  • 7.6.4 – 03 f The monitoring system does consist of relevant procedures, instructions and records that cover record requirements and methods.
  • 7.6.4 – 04 The monitoring methods and frequency are 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 Planned corrections and corrective actions – to be taken when critical limits are exceeded – are specified in the HACCP plan.
  • 7.6.5 – 02 a The actions do ensure that the cause of nonconformity is identified.
  • 7.6.5 – 02 b The actions do ensure that the parameter(s) controlled at the CCP is (are) brought back under control.
  • 7.6.5 – 02 c The actions do ensure that recurrence is prevented.
  • 7.6.5 – 03 Documented procedures are 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 a The organization does update product characteristics in operational PRP(s) and/or the HACCP plan, if necessary.
  • 7.7 – 01 b The organization does update intended use in operational PRP(s) and/or the HACCP plan, if necessary.
  • 7.7 – 01 c The organization does update flow diagrams in operational PRP(s) and/or the HACCP plan, if necessary.
  • 7.7 – 01 d The organization does update process steps in operational PRP(s) and/or the HACCP plan, if necessary.
  • 7.7 – 01 e The organization does update control measures in operational PRP(s) and/or the HACCP plan, if necessary.
  • 7.7 – 02 The HACCP plan and the procedures and instructions are specifying the PRP(s) amended, If necessary.

7.8 Verification planning

  • 7.8 – 01 Verification planning does define the purpose, methods, frequencies and responsibilities for the verification activities.
  • 7.8 – 02 a The verification activities do confirm that the PRP(s) are implemented.
  • 7.8 – 02 b The verification activities do confirm that input to the hazard analysis is continually updated.
  • 7.8 – 02 c The verification activities do confirm that the operational PRP(s) and the elements within the HACCP plan are implemented and effective.
  • 7.8 – 02 d The verification activities do confirm that hazard levels are within identified acceptable levels.
  • 7.8 – 02 e The verification activities do confirm that other procedures required by the organization are implemented and effective.
  • 7.8 – 03 The output of verification planning is in a form suitable for the organization’s method of operations.
  • 7.8 – 04 Verification results are recorded and communicated to the food safety team.
  • 7.8 – 05 Verification results are provided on a such way to enable the analysis of the results of the verification activities.
  • 7.8 – 06 The affected lots of product are 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 The organization has 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 The traceability system is able to identify incoming material from the immediate suppliers and the initial distribution route of the end product.
  • 7.9 – 03 Traceability records are 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 Records are in accordance with statutory and regulatory requirements and customer requirements.

7.10.1 Corrections

  • 7.10.1 – 01 The organization does 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.
  • 7.10.1 – 02 a A documented procedure is established and maintained defining the identification and assessment of affected end products to determine their proper handling.
  • 7.10.1 – 02 b A documented procedure is established and maintained defining a review of the corrections carried out.
  • 7.10.1 – 03 Potentially unsafe products – manufactured under conditions where critical limits have been exceeded – are handled in accordance with clause ‘Handling of potentially unsafe products’.
  • 7.10.1 – 04 Products – manufactured under conditions where operational PRP(s) have not been conformed with – are evaluated with respect to the cause(s) of the nonconformity and to the consequences thereof in terms of food safety.
  • 7.10.1 – 05 These products, where necessary, are handled in accordance with ‘Handling of potentially unsafe products’.
  • 7.10.1 – 06 The evaluation is recorded.
  • 7.10.1 – 07 All corrections are 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 Data – derived from the monitoring of operational PRPs and CCPs – are evaluated by designated person(s) with sufficient knowledge and authority to initiate corrective actions.
  • 7.10.2 – 02 Corrective actions are initiated when critical limits are exceeded or when there is a lack of conformity with operational PRP(s).
  • 7.10.2 – 03 The organization has 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 Corrective actions are recorded.

7.10.3.1 General handling of potentially unsafe products

  • 7.10.3.1 – 01 a The organization does handle nonconforming products by taking action(s) to prevent the nonconforming product from entering the food chain unless it is possible to ensure that the food safety hazard(s) of concern has(ve) been reduced to the defined acceptable levels.
  • 7.10.3.1 – 01 b The organization does handle nonconforming products by taking action(s) to prevent the nonconforming product from entering the food chain unless it is possible to ensure that the food safety hazard(s) of concern will be reduced to identified acceptable levels prior to entering into the food chain.
  • 7.10.3.1 – 01 c The organization does handle nonconforming products by taking action(s) to prevent the nonconforming product from entering the food chain unless it is possible to ensure that 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 All lots of product – that may have been affected by a nonconforming situation – are held under control of the organization until they have been evaluated.
  • 7.10.3.1 – 03 The organization does notify relevant interested parties and initiate a withdrawal, if products that have left the control of the organization are subsequently determined to be unsafe.
  • 7.10.3.1 – 04 The controls and related responses and authorization for dealing with potentially unsafe products are documented.

7.10.3.2 Evaluation for release

  • 7.10.3.2 – 01 a Each lot of product is affected by the nonconformity released as safe only when any of the following conditions apply evidence other than the monitoring system demonstrates that the control measures have been effective.
  • 7.10.3.2 – 01 b Each lot of product is affected by the nonconformity released as safe only when any of the following conditions apply evidence shows that the combined effect of the control measures for that particular product complies with the performance intended.
  • 7.10.3.2 – 01 c Each lot of product is affected by the nonconformity released as safe only when any of the following conditions apply 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 The lot of product – which is not acceptable for release – is handled (after evaluation) by a) reprocessing or further processing within or outside the organization to ensure that the food safety hazard is eliminated or reduced to acceptable levels or b) destruction and/or disposal as waste.

7.10.4 Withdrawals

  • 7.10.4 – 01 Top management has appointed personnel having the authority to initiate a withdrawal and personnel responsible for executing the withdrawal, to enable and facilitate the complete and timely withdrawal of lots of end products which have been identified as unsafe.
  • 7.10.4 – 02.1 The organization has established and it does maintain a documented procedure for notification to relevant interested parties (e.g. statutory and regulatory authorities, customers and/or consumers), to enable and facilitate the complete and timely withdrawal of lots of end products which have been identified as unsafe.
  • 7.10.4 – 02.2 The organization has established and it does maintain a documented procedure for handling of withdrawn products as well as affected lots of the products still in stock, to enable and facilitate the complete and timely withdrawal of lots of end products which have been identified as unsafe.
  • 7.10.4 – 02.3 The organization has established and it does maintain a documented procedure for the sequence of actions to be taken, to enable and facilitate the complete and timely withdrawal of lots of end products which have been identified as unsafe.
  • 7.10.4 – 03 Withdrawn products are 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 The cause, extent and result of a withdrawal are recorded and reported to top management as input to the management review.
  • 7.10.4 – 05 The organization does verify and record the effectiveness of the withdrawal programme through the use of appropriate techniques (e.g. challenge testing, mock withdrawal or practice withdrawal).

8.1 General validation, verification and improvement of the FSMS

  • 8.1 – 01 The food safety team does 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 The organization does validate (prior to implementation of control measures to be included in operational PRP(s) and the HACCP plan and after any change therein) that the selected control measures are capable of achieving the intended control of the food safety hazard(s) for which they are designated.
  • 8.2 – 02 The organization does validate (prior to implementation of control measures to be included in operational PRP(s) and the HACCP plan and after any change therein) that 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 – 03 The control measure and/or combinations thereof are 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 There are evidences that the specified monitoring and measuring methods and equipment are adequate to ensure the performance of the monitoring and measuring procedures.
  • 8.3 – 01 There are no evidences that the specified monitoring and measuring methods and equipment are adequate to ensure the performance of the monitoring and measuring procedures.
  • 8.3 – 02 The measuring equipment and methods used are calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards.
  • 8.3 – 03 The basis used for calibration or verification is recorded, where no such standards exist.
  • 8.3 – 04 The measuring equipment and methods used are adjusted or re-adjusted as necessary.
  • 8.3 – 05 The measuring equipment and methods used are identified to enable the calibration status to be determined.
  • 8.3 – 06 The measuring equipment and methods used are safeguarded from adjustments that would invalidate the measurement results.
  • 8.3 – 07 The measuring equipment and methods used are protected from damage and deterioration.
  • 8.3 – 08 Records of the results of calibration and verification are maintained.
  • 8.3 – 09 The organization does assess the validity of the previous measurement results when the equipment or process is found not to conform to requirements.
  • 8.3 – 10 The organization does take action appropriate for the equipment and any product affected, If the measuring equipment is nonconforming.
  • 8.3 – 11 Records of such assessment and resulting actions are maintained.
  • 8.3 – 12 The ability of computer software is confirmed to satisfy the intended application when used in the monitoring and measurement of specified requirements.
  • 8.3 – 13 The confirmation of computer software is undertaken prior to initial use and reconfirmed as necessary.

8.4.1 Internal audit

  • 8.4.1 – 01 The organization does conduct internal audits at planned intervals to determine whether the food safety management system conforms to the planned arrangements, to the food safety management system requirements established by the organization, and to the requirements of this International Standard.
  • 8.4.1 – 02 The organization does conduct internal audits at planned intervals to determine whether the food safety management system is effectively implemented and updated.
  • 8.4.1 – 03 An audit programme is 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 – 04 The audit criteria, scope, frequency and methods are defined.
  • 8.4.1 – 05 The selection of auditors and the conduct of audits do ensure objectivity and impartiality of the audit process.
  • 8.4.1 – 06 It is ensured that auditors do not audit their own work.
  • 8.4.1 – 07 The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records are defined in documented procedure.
  • 8.4.1 – 08 The management responsible for the area being audited does ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes.
  • 8.4.1 – 09 Follow-up activities do 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 The food safety team does systematically evaluate the individual results of planned verification.
  • 8.4.2 – 02 The organization does take action to achieve the required conformity, when verification does not demonstrate conformity with the planned arrangements.
  • 8.4.2 – 03 Action – taken for achieving the required conformity – does include (but is not limited to), review of existing procedures and communication channels.
  • 8.4.2 – 04 Action – taken for achieving the required conformity – does include (but is not limited to), review of the conclusions of the hazard analysis, the established operational PRP(s) and the HACCP plan.
  • 8.4.2 – 05 Action – taken for achieving the required conformity – does include (but is not limited to), review of the PRP(s).
  • 8.4.2 – 06 Action – taken for achieving the required conformity – does include (but is not limited to), review of the effectiveness of human resource management and of training activities.

8.4.3 Analysis of results of verification activities

  • 8.4.3 – 01 The food safety team does analyse the results of verification activities, including the results of the internal audits and external audits.
  • 8.4.3 – 02 The analysis is carried out in order to confirm that the overall performance of the system meets the planned arrangements and the food safety management system requirements established by the organization.
  • 8.4.3 – 03 The analysis is carried out in order to identify the need for updating or improving the food safety management system.
  • 8.4.3 – 04 The analysis is carried out in order to identify trends which indicate a higher incidence of potentially unsafe products.
  • 8.4.3 – 05 The analysis is carried out in order to establish information for planning of the internal audit programme concerning the status and importance of areas to be audited.
  • 8.4.3 – 06 The analysis is carried out in order to provide evidence that any corrections and corrective actions that have been taken are effective.
  • 8.4.3 – 07 The results of the analysis and the resulting activities are recorded and reported, in an appropriate manner, to top management as input to the management review.
  • 8.4.3 – 08 The results of the analysis and the resulting activities are used as an input for updating the food safety management system.

8.5.1 Continual improvement

  • 8.5.1 – 01 a Top management does ensure that the organization continually improves the effectiveness of the food safety management system through the use of communication.
  • 8.5.1 – 01 b Top management does ensure that the organization continually improves the effectiveness of the food safety management system through the use of management review.
  • 8.5.1 – 01 c Top management does ensure that the organization continually improves the effectiveness of the food safety management system through the use of internal audit.
  • 8.5.1 – 01 d Top management does ensure that the organization continually improves the effectiveness of the food safety management system through the use of evaluation of individual verification results.
  • 8.5.1 – 01 e Top management does ensure that the organization continually improves the effectiveness of the food safety management system through the use of analysis of results of verification activities.
  • 8.5.1 – 01 f Top management does ensure that the organization continually improves the effectiveness of the food safety management system through the use of validation of control measure combinations.
  • 8.5.1 – 01 g Top management does ensure that the organization continually improves the effectiveness of the food safety management system through the use of corrective actions.
  • 8.5.1 – 01 h Top management does ensure that the organization continually improves the effectiveness of the food safety management system through the use of food safety management system updating.

8.5.2 Updating the food safety management system

  • 8.5.2 – 01 Top management does ensure that the food safety management system is continually updated.
  • 8.5.2 – 02 The food safety team does evaluate the food safety management system at planned intervals in order to achieve that FSMS is continually updated.
  • 8.5.2 – 03 The team does consider whether it is necessary to review the hazard analysis, the established operational PRP(s) and the HACCP plan.
  • 8.5.2 – 04 a The evaluation and updating activities are based on input from communication, external as well as internal.
  • 8.5.2 – 04 b The evaluation and updating activities are based on input from other information concerning the suitability, adequacy and effectiveness of the food safety management system.
  • 8.5.2 – 04 c The evaluation and updating activities are based on output from the analysis of results of verification activities.
  • 8.5.2 – 04 d The evaluation and updating activities are based on output from management review.
  • 8.5.2 – 05 System updating activities are recorded and reported, in an appropriate manner, as input to the management review.