ISO 22000:2018

Clause 4

4.1 Understanding the Organization and its Context

  • Has the organization determined external and internal issues that are relevant to its purpose and affect its ability to achieve the intended result(s) of its FSMS?

  • Has the organization identified, reviewed and updated information related to these external and internal issues?

4.2 Understanding the Needs and Expectations of Interested Parties

  • Has the organization determined the interested parties that are relevant to the FSMS?

  • Has the organization determined the relevant requirements of the interested parties of the FSMS?

  • Has the organization identified, reviewed and updated information related to the interested parties and their requirements?

4.3 Determining the Scope of the Food Safety Management System

  • Has the organization determined the boundaries and applicability of the FSMS to establish its scope?

  • Does the scope specify the products and services, processes and production site(s) that are included in the FSMS?

  • Does the scope include the activities, processes, products or services that can have an influence on the food safety of its end products?

  • When determining this scope, did organization consider the external and internal issues referred to in 4.1?

  • Is the scope available and maintained as documented information?

4.4 Food Safety Management System

  • Has the organization established, implemented, maintained, updated and continually improved an FSMS in accordance with the requirements of ISO 22000? — This should include the processes needed and their interactions.

Clause 5

5.1 Leadership and Commitment

  • Does top management demonstrate leadership and commitment by ensuring that the food safety policy and the objectives of the FSMS are established and are compatible with the strategic direction of the organization?

  • Does top management demonstrate leadership and commitment by ensuring the integration of the FSMS requirements into the organization’s business processes?

  • Does top management demonstrate leadership and commitment by ensuring that the resources needed for the FSMS are available?

  • Does top management demonstrate leadership and commitment by communicating the importance of effective food safety management and conforming to the FSMS requirements related to food safety? — Including applicable statutory and regulatory requirements and mutually agreed on customer requirements.

  • Does top management demonstrate leadership and commitment by ensuring that the FSMS is evaluated and maintained to achieve its intended result(s)? — See 4.1

  • Does top management demonstrate leadership and commitment by directing and supporting persons to contribute to the effectiveness of the FSMS?

  • Does top management demonstrate leadership and commitment by promoting continual improvement?

  • Does top management demonstrate leadership and commitment by supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility?

5.2.1 Establishing the Food Safety Policy

  • Has top management established, implemented and maintained a food safety policy that is appropriate to the purpose and context of the organization?

  • Has top management established, implemented and maintained a food safety policy that provides a framework for setting and reviewing the objectives of the FSMS?

  • Has top management established, implemented and maintained a food safety policy that includes a commitment to satisfy applicable food safety requirements? — This should include statutory and regulatory requirements and mutually agreed customer requirements related to food safety.

  • Has top management established, implemented and maintained a food safety policy that addresses internal and external communication?

  • Has top management established, implemented and maintained a food safety policy that includes a commitment to continual improvement of the FSMS?

  • Has top management established, implemented and maintained a food safety policy that addresses the need to ensure competencies related to food safety?

5.2.2 Communicating the Food Safety Policy

  • Is the food safety policy available and maintained as documented information?

  • Is the food safety policy communicated, understood and applied at all levels within the organization?

  • Is the food safety policy available to relevant interested parties, as appropriate?

5.3 Organizational roles, responsibilities and authorities

  • Has top management ensured that the responsibilities and authorities for relevant roles are assigned, communicated and understood within the organization?

  • Has top management assigned the responsibility and authority for ensuring that the FSMS conforms to the requirements of ISO 22000?

  • Has top management assigned the responsibility and authority for reporting on the performance of the FSMS to top management?

  • Has top management assigned the responsibility and authority for appointing the food safety team and the food safety team leader?

  • Has top management assigned the responsibility and authority for designating persons with defined responsibility and authority to initiate and document action(s)?

  • Is the food safety team leader responsible for ensuring the FSMS is established, implemented, maintained and updated?

  • Is the food safety team leader responsible for managing and organizing the work of the food safety team?

  • Is the food safety team leader responsible for ensuring relevant training and competencies for the food safety team? — See 7.2

  • Is the food safety team leader responsible for reporting to top management on the effectiveness and suitability of the FSMS?

  • Do all persons have the responsibility to report problem(s) with regards to the FSMS to identified person(s)?

Clause 6

6.1 Actions to Address Risks and Opportunities

  • When planning for the FSMS, has the organization considered the issues referred to in 4.1 and the requirements referred to in 4.2 and 4.3?

  • Has the organization determined the risks and opportunities that need to be addressed to give assurance that the FSMS can achieve its intended result(s)?

  • Has the organization determined the risks and opportunities that need to be addressed to enhance desirable effects?

  • Has the organization determined the risks and opportunities that need to be addressed to prevent, or reduce, undesired effects?

  • Has the organization determined the risks and opportunities that need to be addressed to achieve continual improvement?

  • Has the organization planned actions to address these risks and opportunities?

  • Has the organization planned how to integrate and implement the actions into its FSMS processes?

  • Has the organization planned how to evaluate the effectiveness of these actions?

  • Are the actions taken by the organization to address risks and opportunities proportionate to the impact on food safety requirements?

  • Are the actions taken by the organization to address risks and opportunities proportionate to the conformity of food products and services to customers?

  • Are the actions taken by the organization to address risks and opportunities proportionate to requirements of interested parties in the food chain?

6.2 Objectives of the Food Safety Management System and Planning to Achieve them

  • Has the organization established objectives for the FSMS at relevant functions and levels?

  • Are the objectives of the FSMS consistent with the food safety policy?

  • Are the objectives of the FSMS measurable (if practicable)?

  • Do the objectives of the FSMS take into account applicable food safety requirements? — Including statutory, regulatory and customer requirements.

  • Are the objectives of the FSMS monitored and verified?

  • Are the objectives of the FSMS communicated?

  • Are the objectives of the FSMS maintained and updated as appropriate?

  • Does the organization retain documented information on the objectives for the FSMS?

  • When planning how to achieve its objectives for the FSMS, does the organization determine what will be done?

  • When planning how to achieve its objectives for the FSMS, does the organization determine what resources will be required?

  • When planning how to achieve its objectives for the FSMS, does the organization determine who will be responsible?

  • When planning how to achieve its objectives for the FSMS, does the organization determine when it will be completed?

  • When planning how to achieve its objectives for the FSMS, does the organization determine how the results will be evaluated?

6.3 Planning of Changes

  • When the organization determines the need for changes to the FSMS, are they carried out and communicated in a planned manner? — This includes personnel changes.

  • Does the organization consider the purpose of the changes and their potential consequences?

  • Does the organization consider the continued integrity of the FSMS?

  • Does the organization consider the availability of resources to effectively implement the changes?

  • Does the organization consider the allocation or re-allocation of responsibilities and authorities?

Clause 7

7.1.1 Resources (General)

  • Has the organization determined and provided the resources needed for the establishment, implementation, maintenance, update and continual improvement of the FSMS?

  • Has the organization considered he capability of, and any constraints on, existing internal resources?

  • Has the organization considered the need for external resources?

7.1.2 Resources (People)

  • Has the organization ensured that persons necessary to operate and maintain effective FSMS are competent? — See 7.2

  • Where the assistance of external experts is used, is evidence of agreement or contracts defining the competency, responsibility and authority of external experts retained as documented information?

7.1.3 Resources (Infrastructure)

  • Has the organization provided the resources for the determination, establishment and maintenance of the infrastructure necessary to achieve conformity with the requirements of the FSMS?

7.1.4 Resources (Work Environment)

  • Has the organization determined, provided and maintained the resources for the establishment, management and maintenance of the work environment necessary to achieve conformity?

7.1.5 Externally Developed Elements of the Food Safety Management System

  • When an organization establishes, maintains, updates and improves the externally developed elements of an FSMS, do they ensure that provided elements are developed in conformance with requirements of ISO 22000? — This includes PRPs, the hazard analysis, and the hazard control plan (see 8.5.4).

  • When an organization establishes, maintains, updates and improves the externally developed elements of a FSMS, do they ensure that provided elements are applicable to the sites, processes and products of the organization? — This includes PRPs, the hazard analysis and the hazard control plan (see 8.5.4).

  • When an organization establishes, maintains, updates and improves the externally developed elements of an FSMS, do they ensure that provided elements are specifically adapted to the processes and products of the organization by the food safety team? — This includes PRPs, the hazard analysis, and the hazard control plan (see 8.5.4).

  • When an organization establishes, maintains, updates and improves the externally developed elements of a FSMS, do they ensure that provided elements are implemented, maintained and updated as required by this document? — This includes PRPs, the hazard analysis and the hazard control plan (see 8.5.4).

  • When an organization establishes, maintains, updates and improves the externally developed elements of a FSMS, do they ensure that provided elements are retained as documented information? — This includes PRPs, the hazard analysis and the hazard control plan (see 8.5.4).

7.1.6 Control of Externally Provided Processes, Products or Services

  • Has the organization established and applied criteria for the evaluation, selection, monitoring of performance and re- evaluation of external providers of processes, products and/or services?

  • Has the organization ensured adequate communication of requirements to the external provider(s)?

  • Has the organization ensured that externally provided processes, products or services do not adversely affect the organization's ability to consistently meet the requirements of the FSMS?

  • Has the organization retained documented information of these activities and any necessary actions as a result of the evaluations and re-evaluations?

7.2 Competence

  • Has the organization determined the necessary competence of person(s), including external providers, doing work under its control that affects its food safety performance and effectiveness of the FSMS?

  • Has the organization ensured that these persons, including the food safety team and those responsible for the operation of the hazard control plan, are competent? — On the basis of appropriate education, training and/or experience.

  • Has the organization ensured that the food safety team has a combination of multi-disciplinary knowledge and experience in developing and implementing the FSMS? — This includes, but is not limited to, the organization’s products, processes, equipment and food safety hazards within the scope of the FSMS.

  • Has the organization where applicable, taken actions to acquire the necessary competence, and evaluate the effectiveness of the actions taken?

  • Has the organization retained appropriate documented information as evidence of competence?

7.3 Awareness

  • Has the organization ensured that all relevant persons doing work under their control are aware of the food safety policy?

  • Has the organization ensured that all relevant persons doing work under their control are aware of the objectives of the FSMS relevant to their task(s)?

  • Has the organization ensured that all relevant persons doing work under their control are aware of their individual contribution to the effectiveness of the FSMS? — This includes the benefits of improved food safety performance.

  • Has the organization ensured that all relevant persons doing work under their control are aware of the implications of not conforming with the FSMS requirements?

7.4.1 Communication (General)

  • Has the organization determined the internal and external communications relevant to the FSMS, including on what it will communicate?

  • Has the organization determined the internal and external communications relevant to the FSMS, including when to communicate?

  • Has the organization determined the internal and external communications relevant to the FSMS, including with whom to communicate?

  • Has the organization determined the internal and external communications relevant to the FSMS, including how to communicate?

  • Has the organization determined the internal and external communications relevant to the FSMS, including who communicates?

  • Has the organization ensured that the requirement for effective communication is understood by all persons whose activities have an impact on food safety?

7.4.2 Communication (External)

  • Has the organization ensured that sufficient information is communicated externally and is available for interested parties of the food chain?

  • Has the organization established, implemented and maintained effective communications with external providers and contractors?

  • Has the organization established, implemented and maintained effective communications with customers and/or consumers, in relation to the following? — - Product information related to food safety, to enable the handling, display, storage, preparation, distribution and use of the product within the food chain or by the consumer; - Identified foods safety hazards that need to be controlled by other organizations in the food chain and/or by consumers; - Contractual arrangements, enquiries and orders, including their amendments; - Customer and/or consumer feedback, including complaints.

  • Has the organization established, implemented and maintained effective communications with statutory and regulatory authorities?

  • Has the organization established, implemented and maintained effective communications with other organizations that have an impact on, or will be affected by the FSMS?

  • Do designated persons have defined responsibility and authority for the external communication of any information concerning food safety?

  • Where relevant, is information obtained through external communication included as input for management review? — See 9.3, 4.4, and 10.3.

  • Has evidence of external communication been retained as documented information?

7.4.3 Communication (Internal)

  • Has the organization established, implemented and maintained an effective system for communicating issues having an impact on food safety?

  • Has the organization ensured that the food safety team is informed in a timely manner of changes in the products or new products?

  • Has the organization ensured that the food safety team is informed in a timely manner of changes in the raw materials, ingredients and services?

  • Has the organization ensured that the food safety team is informed in a timely manner of changes in the production systems and equipment?

  • Has the organization ensured that the food safety team is informed in a timely manner of changes in the production premises, location of equipment and surrounding environment?

  • Has the organization ensured that the food safety team is informed in a timely manner of changes in the cleaning and sanitation programmes?

  • Has the organization ensured that the food safety team is informed in a timely manner of changes in the packaging, storage and distribution systems?

  • Has the organization ensured that the food safety team is informed in a timely manner of changes in the competencies and/or allocation of responsibilities and authorizations?

  • Has the organization ensured that the food safety team is informed in a timely manner of changes in the applicable statutory and regulatory requirements?

  • Has the organization ensured that the food safety team is informed in a timely manner of changes in the knowledge regarding food safety hazards and control measures?

  • Has the organization ensured that the food safety team is informed in a timely manner of changes in the customer, sector and other requirements that the organization observes?

  • Has the organization ensured that the food safety team is informed in a timely manner of changes in the relevant enquiries and communications from external interested parties?

  • Has the organization ensured that the food safety team is informed in a timely manner of changes in the complaints and alerts indicating food safety hazards associated with the end product?

  • Has the organization ensured that the food safety team is informed in a timely manner of changes in the other conditions that have an impact on food safety?

  • Has the food safety team ensured that this information is included when updating the FSMS? — See 4.4 and 10.3

  • Has top management ensured that relevant information is included as input to the management review? — See 9.3

7.5.1 Document Information (General)

  • Do the organization’s FSMS include documented information required by this document?

  • Do the organization’s FSMS include documented information determined by the organization as being necessary for the effectiveness of the FSMS?

  • Do the organization’s FSMS include documented information and food safety requirements required by statutory, regulatory authorities and customers?

7.5.2 Document Information (Creating and Updating)

  • When creating and updating documented information, does the organization ensure appropriate identification and description? — E.g. a title, date, author, or reference number

  • When creating and updating documented information, does the organization ensure appropriate format and media?

  • When creating and updating documented information, does the organization ensure appropriate review and approval for suitability and adequacy?

7.5.3 Document Information (Control of Documented Information)

  • Is documented information required by the FSMS controlled to ensure it is available and suitable for use, where and when it is needed?

  • Is documented information required by the FSMS controlled to ensure it is adequately protected? — E.g. from loss of confidentiality, improper use, or loss of integrity.

  • For the control of documented information, has the organization addressed distribution, access, retrieval and use?

  • For the control of documented information, has the organization addressed storage and preservation, including preservation of legibility?

  • For the control of documented information, has the organization addressed control of changes? — E.g. version control.

  • For the control of documented information, has the organization addressed retention and disposition?

  • Is documented information of external origin determined by the organization to be necessary for the planning and operation of the FSMS identified, as appropriate, and controlled?

  • Is documented information retained as evidence of conformity protected from unintended alterations?

Clause 8

8.1 Operational Planning and Control

  • Has the organization planned, implemented, controlled, maintained and updated the processes needed to meet requirements for the realization of safe products?

  • Has the organization implemented the actions determined in 6.1 by establishing criteria for the processes?

  • Has the organization implemented the actions determined in 6.1 by implementing control of the processes in accordance with the criteria?

  • Has the organization implemented the actions determined in 6.1 by keeping documented information to the extent necessary to have the confidence to demonstrate that the processes have been carried out as planned?

  • Does the organization control planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary?

  • Does the organization ensure that outsourced processes are controlled? — See 7.1.6

8.2 Prerequisite Programmes (PRPs)

  • Has the organization established, implemented, maintained and updated PRP(s) to facilitate the prevention and reduction of contaminants in the products, product processing and work environment?

  • Are the PRP(s) appropriate to the organization and its context with regard to food safety?

  • Are the PRP(s) appropriate to the size and type of the operation and the nature of the products being manufactured and/or handled?

  • Are the PRP(s) implemented across the entire production system, either as programmes applicable in general or as programmes applicable to a particular product or process?

  • Are the PRP(s) approved by the food safety team?

  • When selecting and/or establishing PRP(s), does the organization ensure that applicable statutory, regulatory and mutually agreed customer requirements are identified?

  • Does the organization consider he applicable part of the ISO/TS 22002 series?

  • Does the organization consider applicable standards, codes of practice and guidelines?

  • When establishing PRP(s), does the organization consider construction, lay-out of buildings and associated utilities?

  • When establishing PRP(s), does the organization consider lay-out of premises, including zoning, workspace and employee facilities?

  • When establishing PRP(s), does the organization consider supplies of air, water, energy and other utilities?

  • When establishing PRP(s), does the organization consider pest control, waste and sewage disposal and supporting services?

  • When establishing PRP(s), does the organization consider the suitability of equipment and its accessibility for cleaning and maintenance?

  • When establishing PRP(s), does the organization consider supplier approval and assurance processes? — E.g. raw materials, ingredients, chemicals, and packaging.

  • When establishing PRP(s), does the organization consider reception of incoming materials, storage, dispatch, transportation and handling of products?

  • When establishing PRP(s), does the organization consider measures for the prevention of cross contamination?

  • When establishing PRP(s), does the organization consider cleaning and disinfecting?

  • When establishing PRP(s), does the organization consider personal hygiene?

  • When establishing PRP(s), does the organization consider product information/consumer awareness?

  • When establishing PRP(s), does the organization consider others, as appropriate?

  • Does documented information specify the selection, establishment, applicable monitoring and verification of the PRP(s)?

8.3 Traceability System

  • Is the traceability system able to uniquely identify incoming material from the suppliers and the first stage of the distribution route of the end product?

  • When establishing and implementing the traceability system, does the organization consider the relation of received materials, ingredients and intermediate products to the end products?

  • When establishing and implementing the traceability system, does the organization consider the reworking of materials/products?

  • When establishing and implementing the traceability system, does the organization consider the distribution of the end product?

  • Does the organization ensure that applicable statutory, regulatory and customer requirements are identified?

  • Is documented information as evidence of the traceability system retained for a defined period to include, as a minimum, the shelf life of the product?

  • Has the organization verified and tested the effectiveness of the traceability system?

8.4.1 Emergency Preparedness and Response (General)

  • Has top management ensured that procedures are in place to respond to potential emergency situations or incidents that can have an impact on food safety?

  • Is documented information established and maintained to manage these situations and incidents?

8.4.2 Emergency Preparedness and Response (Handling of Emergencies and Incidents)

  • Does the organization respond to actual emergency situations and incidents by ensuring applicable statutory and regulatory requirements are identified?

  • Does the organization respond to actual emergency situations and incidents by communicating internally?

  • Does the organization respond to actual emergency situations and incidents by communicating externally? — E.g. suppliers, customers, appropriate authorities, media.

  • Does the organization take action to reduce the consequences of the emergency situation, appropriate to the magnitude of the emergency or incident and the potential food safety impact?

  • Does the organization periodically test procedures where practical?

  • Does the organization review and, where necessary, update the documented information after the occurrence of any incident, emergency situation or tests?

8.5.1.1 Preliminary Steps to Enable Hazard Analysis (General)

  • To carry out the hazard analysis, is preliminary documented information collected, maintained and updated by the food safety team? — This shall include, but not be limited to: - Applicable statutory, regulatory and customer requirements; - The organization’s products, processes, and equipment; - Food safety hazards relevant to the FSMS.

8.5.1.2 Preliminary Steps to Enable Hazard Analysis (Characteristics of Raw Materials, Ingredients and Product Contact Materials)

  • Does the organization ensure that all applicable statutory and regulatory food safety requirements are identified for all raw materials, ingredients and product contact materials?

  • Does the organization maintain documented information concerning all raw materials, ingredients and product contact materials to the extent needed to conduct the hazard analysis? — This should include the following, as appropriate (see 8.5.2): - Biological, chemical and physical characteristics; - Composition of formulated ingredients, including additives and processing aids; - Source (e.g. animal, mineral or vegetable); - Place of origin (provenance); - Method of production; - Method of packaging and delivery; - Storage conditions and shelf life; - Preparation and/or handling before use or processing; - Acceptance criteria related to food safety or specifications of purchased materials and ingredients appropriate to their intended use.

8.5.1.3 Preliminary Steps to Enable Hazard Analysis (Characteristics of End Products)

  • Does the organization ensured that all applicable statutory and regulatory food safety requirements are identified for all the end products intended to be produced?

  • Does the organization maintain documented information concerning the characteristics of end products to the extent needed to conduct the hazard analysis? — This should include the following, as appropriate (see 8.5.2): - Product name or similar identification; - Composition; - Biological, chemical and physical characteristics relevant for food safety; - Intended shelf life and storage conditions; - Packaging; - Labelling relating to food safety and/or instructions for handling, preparation and intended use; - Method(s) of distribution and delivery.

8.5.1.4 Preliminary Steps to Enable Hazard Analysis (Intended Use)

  • Is the intended use considered and maintained as documented information to the extent needed to conduct the hazard analysis? — This includes reasonably expected handling of the end product and any unintended use but reasonably expected mishandling and misuse of the end product, (see 8.5.2).

  • Where appropriate, are groups of consumers/users identified for each product?

  • Have groups of consumers/users known to be especially vulnerable to specific food safety hazards been identified?

8.5.1.5.1 Preparation of the Flow Diagrams

  • Has the food safety team established, maintained and updated flow diagrams for the products or product categories and the processes covered by the FSMS?

  • Do flow diagrams provide a graphic representation of the process?

  • Are flow diagrams used when conducting the hazard analysis as a basis for evaluating the possible occurrence, increase, decrease or introduction of food safety hazards?

  • Are flow diagrams clear, accurate and sufficiently detailed to the extent needed to conduct the hazard analysis?

  • Do flow diagrams include the sequence and interaction of the steps in the operation?

  • Do flow diagrams include any outsourced processes?

  • Do flow diagrams include where raw materials, ingredients, processing aids, packaging materials, utilities and intermediate products enter the flow?

  • Do flow diagrams include where reworking and recycling take place?

  • Do flow diagrams include where end products, intermediate products, by-products and waste are released or removed?

8.5.1.5.2 On-Site Confirmation of Flow Diagrams

  • Does the food safety team confirm on-site the accuracy of the flow diagrams, update the flow diagrams where appropriate and retain as documented information?

8.5.1.5.3 Description of Processes and Process Environment

  • Has the food safety team adequately described the layout of premises, including food and non-food handling areas?

  • Has the food safety team adequately described processing equipment and contact materials, processing aids and flow of materials?

  • Has the food safety team adequately described existing PRPs, process parameters, control measures and the strictness with which they are applied, or procedures that can influence food safety?

  • Has the food safety team adequately described external requirements that can impact the choice and the strictness of the control measures? — E.g. from statutory and regulatory authorities or customers.

  • Are the variations resulting from expected seasonal changes or shift patterns included as appropriate?

  • Are the descriptions updated as appropriate and maintained as documented information?

8.5.2.1 Hazard analysis (General)

  • Has the food safety team conducted a hazard analysis, based on the preliminary information, to determine the hazards that need to be controlled?

  • Does degree of control ensure food safety and, where appropriate, are a combination of control measures used?

8.5.2.2 Hazard analysis (Hazard Identification and Determination of Acceptable Levels)

  • Has the organization identified and documented all food safety hazards that are reasonably expected to occur in relation to the type of product, type of process and process environment? — The identification shall be based on: - The preliminary information and data collected in accordance with 8.5.1; - Experience; - Internal and external information including, to the extent possible, epidemiological, scientific and other historical data; - Information from the food chain on food safety hazards related to the safety of the end products, intermediate products and the food at the time of consumption; - Statutory, regulatory and customer requirements.

  • Have hazards been considered in sufficient detail to enable hazard assessment and the selection of appropriate control measures?

  • Has the organization identified step(s) at which each food safety hazard can be present, be introduced, increase or persist? — E.g. receiving raw materials, processing, distribution and delivery.

  • When identifying hazards, has the organization considered he stages preceding and following in the food chain?

  • When identifying hazards, has the organization considered he stages preceding and following in the food chain?

  • When identifying hazards, has the organization considered the process equipment, utilities/services, process environment and persons?

  • Has the organization determined the acceptable level in the end product of each food safety hazard identified, whenever possible?

  • When determining acceptable levels, did the organization ensure that applicable statutory, regulatory and customer requirements are identified?

  • When determining acceptable levels, did the organization consider the intended use of end products?

  • When determining acceptable levels, did the organization consider any other relevant information?

  • Does the organization maintain documented information concerning the determination of acceptable levels and the justification for the acceptable levels?

8.5.2.3 Hazard analysis (Hazard Assessment)

  • Has the organization conducted a hazard assessment for each identified food safety hazard to determine whether its prevention or reduction to an acceptable level is essential?

  • Has the organization evaluated each food safety hazard with regard to the likelihood of its occurrence in the end product prior to application of control measures?

  • Has the organization evaluated each food safety hazard with regard to the severity of its adverse health effects in relation to the intended use? — See 8.5.1.4.

  • Has the organization identified all significant food safety hazards that were found?

  • Has the methodology used been described, and the result of the hazard assessment maintained as documented information?

8.5.2.4 Hazard analysis (Selection and categorization of control measure(s))

  • Has the organization selected an appropriate combination of control measures that will be capable of preventing or reducing the identified significant hazards to defined acceptable levels?

  • Has the organization categorized the selected identified control measure(s) to be managed as OPRP(s) or at CCPs? — See 3.30 and 3.11.

  • Has the categorization been carried out using a systematic approach?

  • For each control measure, has there been an assessment of the likelihood of failure of its functioning?

  • For each control measure, has there been an assessment of the severity of the consequence in the case of failure of its functioning? — This assessment shall include: - The effect on identified significant food safety hazards; - The location in relation to other control measure(s); - Whether it is specifically established and applied to reduce the hazards to an acceptable level; - Whether it is a single measure or is part of combination of control measure(s).

  • For each control measure, does the systematic approach include an assessment of the feasibility of establishing measurable critical limits and/or measurable/observable action criteria?

  • For each control measure, does the systematic approach include an assessment of the feasibility of monitoring to detect any failure to remain within critical limit and/or measurable/observable action criteria?

  • For each control measure, does the systematic approach include an assessment of the feasibility of applying timely corrections in case of failure?

  • Are the decision-making process and results of the selection and categorization of the control measures maintained as documented information?

  • Have external requirements that can impact the choice and the strictness of the control measures been maintained as documented information? — E.g. statutory, regulatory and customer requirements.

8.5.3 Validation of Control Measure(s) and Combinations of Control Measures

  • Has the food safety team validated that the selected control measures are capable of achieving the intended control of the significant food safety hazard(s)?

  • Was this validation done prior to implementation of control measure(s) and combinations of control measures to be included in the hazard control plan,) and after any change therein? — See 8.5.4, 7.4.2, 7.4.3, 10.2, and 10.3.

  • When the result of validation shows that the control measures(s) are not capable of achieving the intended control, does the food safety team modify and re-assess?

  • Does the food safety team maintain the validation methodology and evidence of capability of the control measure(s) to achieve the intended control as documented information?

8.5.4.1 Hazard control plan (HACCP/OPRP plan) (General)

  • Has the organization established, implemented and maintained a hazard control plan?

  • Is the hazard control plan maintained as documented information for each control measure at each CCP or OPRP?

  • Does the control plan include the following information about food safety hazard(s) to be controlled at the CCP or by the OPRP?

  • Does the control plan include the following information about critical limit(s) at CCP or action criteria for OPRP?

  • Does the control plan include the following information about monitoring procedure(s)?

  • Does the control plan include the following information about correction(s) to be made if critical limits or action criteria are not met?

  • Does the control plan include the following information about responsibilities and authorities?

  • Does the control plan include the following information about records of monitoring?

8.5.4.2 Hazard control plan (HACCP/OPRP plan) (Determination of Critical Limits and Action Criteria)

  • Have critical limits at CCPs and action criteria for OPRPs been specified?

  • Has the rationale for their determination been maintained as documented information?

  • Are critical limits at CCPs measurable?

  • Does conformance with critical limits ensure that the acceptable level is not exceeded?

  • Are action criteria for OPRPs measurable or observable?

  • Does conformance with action criteria contribute to the assurance that the acceptable level is not exceeded?

8.5.4.3 Hazard control plan (HACCP/OPRP plan) (Monitoring Systems at CCPs and for OPRPs)

  • At each CCP, has a monitoring system been established for each control measure or combination of control measure(s) to detect any failure to remain within the critical limits?

  • Does the system include all scheduled measurements relative to the critical limit(s)?

  • For each OPRP, has a monitoring system been established for the control measure or combination of control measure(s) to detect failure to meet the action criterion?

  • Does the monitoring system, at each CCP and for each OPRP, consist of documented information?

  • Does this information include measurements or observations that provide results within an adequate time frame?

  • Does this information include monitoring methods or devices used?

  • Does this information include applicable calibration methods or, for OPRPs, equivalent methods for verification of reliable measurements or observations? — See 8.7.

  • Does this information include monitoring frequency?

  • Does this information include monitoring results?

  • Does this information include responsibility and authority related to monitoring?

  • Does this information include responsibility and authority related to evaluation of monitoring results?

  • At each CCP, are the monitoring method and frequency capable of timely detection of any failure to remain within critical limits, to allow timely isolation and evaluation of the product? — See 8.9.4.

  • For each OPRP, are the monitoring method and frequency proportionate to the likelihood of failure and the severity of consequences?

  • When monitoring an OPRP that is based on subjective data from observations, is the method supported by instructions or specifications? — E.g. visual inspection.

8.5.4.4 Hazard control plan (HACCP/OPRP plan) (Actions when Critical Limits or Action Criteria are not Met)

  • Has the organization specified corrections and corrective actions to be taken when critical limits or action criterion are not met? — See 8.9.2 and 8.9.3.

  • Do these corrections and corrective actions ensure that the potentially unsafe products are not released? — See 8.9.4.

  • Do these corrections and corrective actions ensure that the cause of nonconformity is identified?

  • Do these corrections and corrective actions ensure that the parameter(s) controlled at the CCP or by the OPRP is (are) returned within the critical limits or action criteria?

  • Do these corrections and corrective actions ensure that recurrence is prevented?

  • Does the organization make corrections in accordance with 8.9.2 and corrective actions in accordance with 8.9.3?

8.5.4.5 Hazard control plan (HACCP/OPRP plan) (Implementation of the Hazard Control Plan)

  • Has the organization implemented and maintained the hazard control plan, and retained evidence of the implementation as documented information?

8.6 Updating the Information Specifying the PRPs and the Hazard Control Plan

  • Following the establishment of the hazard control plan, has the organization updated information related to characteristics of raw materials, ingredients and product-contact materials?

  • Following the establishment of the hazard control plan, has the organization updated information related to characteristics of end products?

  • Following the establishment of the hazard control plan, has the organization updated information related to intended use?

  • Following the establishment of the hazard control plan, has the organization updated information related to flow diagrams and descriptions of processes and process environment?

  • Has the organization ensured that the hazard control plan and/or the PRP(s) are up to date?

8.7 Control of Monitoring and Measuring

  • Has the organization provided evidence that the monitoring and measuring methods and equipment in use are adequate for activities related to the PRP(s) and the hazard control plan?

  • Is the monitoring and measuring equipment calibrated or verified at specified intervals prior to use?

  • Is the monitoring and measuring equipment adjusted or re-adjusted as necessary?

  • Is the monitoring and measuring equipment identified to enable the calibration status to be determined?

  • Is the monitoring and measuring equipment safeguarded from adjustments that would invalidate the measurement results?

  • Is the monitoring and measuring equipment protected from damage and deterioration?

  • Are the results of calibration and verification retained as documented information?

  • Is the calibration of all the equipment traceable to international or national measurement standards? — Where no standards exist, the basis used for calibration or verification shall be retained as documented information.

  • Does the organization assess the validity of the previous measurement results when the equipment or process environment is found not to conform to requirements?

  • Does the organization take appropriate action in relation to the equipment or process environment and any product affected by the non- conformance?

  • Are the assessment and resulting action maintained as documented information?

  • Has software used in monitoring and measuring within the FSMS been validated by the organization, software supplier or third party prior to use?

  • Has documented information on validation activities been maintained by the organization and has the software been updated in a timely manner?

  • Are changes, including software configuration/modifications to commercial off-the- shelf software, authorized, documented and validated before implementation?

8.8.1 Verification

  • Has the organization established, implemented and maintained verification activities?

  • Does the verification planning define purpose, methods, frequencies and responsibilities for the verification activities?

  • Do the verification activities confirm that the PRP(s) are implemented and effective?

  • Do the verification activities confirm that the hazard control plan is implemented and effective?

  • Do the verification activities confirm that hazard levels are within identified acceptable levels?

  • Do the verification activities confirm that input to the hazard analysis is updated?

  • Do the verification activities confirm that other actions determined by the organization are implemented and effective?

  • Does the organization ensure that verification activities are not carried out by the person responsible for monitoring the same activities?

  • Are verification results retained as documented information and communicated?

  • Where verification of samples shows nonconformity, does the organization handle the affected lot(s) as potentially unsafe and apply corrective actions in accordance with 8.9.3? — See 8.5.2.2 and 8.9.4.3.

8.8.2 Analysis of Results of Verification Activities

  • Does the food safety team conduct an analysis of the results of verification that are used as an input to the performance evaluation of the FSMS? — See 9.1.2.

8.9.1 Control of Product and Process Nonconformities (General)

  • Does the organization ensure that data derived from the monitoring of OPRPs and at CCPs is evaluated by competent designated persons who have the authority to initiate corrections and corrective actions?

8.9.2 Control of Product and Process Nonconformities (Corrections)

  • Does the organization ensure that when critical limits at CCP(s) or action criteria for OPRPs are not met, the products affected are identified and controlled with regard to their use and release?

  • Has the organization established, maintained and updated documented information that includes a method of identification, assessment and correction for affected products to ensure proper handling?

  • Has the organization established, maintained and updated documented information that includes arrangements for review of the corrections carried out?

  • When critical limits at CCPs are not met, are affected products identified and handled as potentially unsafe products? — See 8.9.4.

  • Where action criteria for an OPRP are not met, does the organization determine the consequences of that failure with respect to food safety?

  • Where action criteria for an OPRP are not met, does the organization determine the cause(s) of failure?

  • Where action criteria for an OPRP are not met, does the organization identify the affected products and handling in accordance with 8.9.4?

  • Does he organization retain results of the evaluation as documented information?

  • Is documented information retained to describe corrections made on nonconforming products and processes?

  • Does this information include the nature of the nonconformity?

  • Does this information include the cause(s) of the failure?

  • Does this information include the consequences as a result of the nonconformity?

8.9.3 Corrective Actions

  • Is the need for corrective actions evaluated when critical limits at CCP(s) and/or action criteria for OPRPs are not met.?

  • Has the organization established and maintained documentation that specifies appropriate actions to identify and eliminate the cause of nonconformities, to prevent recurrence, and to return the process to control?

  • Do these actions include reviewing nonconformities identified by customer and/or consumer complaints and/or regulatory inspection reports?

  • Do these actions include reviewing trends in monitoring results that can indicate loss of control?

  • Do these actions include determining the cause(s) of nonconformities?

  • Do these actions include determining and implementing actions to ensure that nonconformities do not recur?

  • Do these actions include documenting the results of corrective actions taken?

  • Do these actions include verifying corrective actions taken to ensure that they are effective?

  • Does the organization retain documented information on all corrective actions?

8.9.4.1 Handling of Potentially Unsafe Products (General)

  • Does the organization prevent potentially unsafe products from entering the food chain, unless it can demonstrate that the hazard is reduced to the defined acceptable levels?

  • Does the organization prevent potentially unsafe products from entering the food chain, unless it can demonstrate that the hazard will be reduced to acceptable levels prior to entering?

  • Does the organization prevent potentially unsafe products from entering the food chain, unless it can demonstrate that the product still meets the defined acceptable level despite the nonconformity?

  • Does The organization retain products that have been identified as potentially unsafe under its control until the products have been evaluated and the disposition has been determined?

  • If products that have left the control of the organization are subsequently determined to be unsafe, does the organization notify relevant interested parties and initiate a withdrawal/recall? — See 8.9.5.

  • Are the controls and related responses from relevant interested parties and authorization for dealing with potentially unsafe products retained as documented information?

8.9.4.2 Handling of Potentially Unsafe Products (Evaluation for Release)

  • Is aach lot of products affected by the nonconformity evaluated?

  • Are products affected by failure to remain within critical limits at CCPs handled in accordance with 8.9.4.3 rather than being released?

  • Are products affected by failure to meet action criteria for OPRPs only released as safe when any of the following conditions apply? — - Evidence other than the monitoring system demonstrates that the control measures have been effective; - Evidence shows that the combined effect of the control measures for that particular product conforms to the performance intended (i.e. identified acceptable levels); - The results of sampling, analysis and/or other verification activities demonstrate that the affected products conform to the identified acceptable levels for the food safety hazard(s) concerned.

  • Are results of evaluation for release of products retained as documented information?

8.9.4.3 Handling of Potentially Unsafe Products (Disposition of Nonconforming Products)

  • Are products that are not acceptable for release reprocessed or further processed within or outside the organization to ensure that the food safety hazard is reduced to acceptable levels?

  • Are products that are not acceptable for release redirected for other use as long as food safety in the food chain is not affected?

  • Are products that are not acceptable for release destroyed and/or disposed as waste?

  • Is documented information on the disposition of nonconforming products, including the identification of the person(s) with approving authority retained?

8.9.5 Withdrawal/Recall

  • Is the organization able to ensure the timely withdrawal/recall of products that have been identified as potentially unsafe, by appointing competent person(s) with the required authority?

  • Has the organization established and maintained documented information for notifying relevant interested parties? — E.g. statutory and regulatory authorities, customers and/or consumers.

  • Has the organization established and maintained documented information for handling withdrawn/recalled products as well as products still in stock?

  • Has the organization established and maintained documented information for performing the sequence of actions to be taken?

  • Are withdrawn/recalled products and end products still in stock secured or held under the control of the organization until they are managed in accordance with 8.9.4.3?

  • Are the cause, extent and result of a withdrawal/recall retained as documented information and reported to the top management as input for the management review? — See 9.3.

  • Does the organization verify the implementation and effectiveness of withdrawals/recalls through the use of appropriate techniques and retain documented information? — E.g. mock withdrawal/recall or practice withdrawal/recall.

Clause 9

9.1.1 Monitoring, Measurement, Analysis and Evaluation (General)

  • Has the organization determined what needs to be monitored and measured?

  • Has the organization determined the methods for monitoring, measurement, analysis and evaluation, as applicable, to ensure valid results?

  • Has the organization determined when the monitoring and measuring shall be performed?

  • Has the organization determined when the results from monitoring and measurement shall be analysed and evaluated?

  • Has the organization determined who shall analyse and evaluate the results from monitoring and measurement?

  • Does the organization retain appropriate documented information as evidence of the results?

  • Does the organization evaluate the performance and the effectiveness of the FSMS?

9.1.2 Monitoring, Measurement, Analysis and Evaluation (Analysis and Evaluation)

  • Does the organization analyse and evaluate appropriate data and information arising from monitoring and measurement? — Including the results of verification activities related to PRPs and the hazard control plan (see 8.8 and 8.5.4), the internal audits (see 9.2) and external audits.

  • Is analysis carried out to confirm that the overall performance of the system meets the planned arrangements and the FSMS requirements established by the organization?

  • Is analysis carried out to identify the need for updating or improving the FSMS?

  • Is analysis carried out to identify trends which indicate a higher incidence of potentially unsafe products or process failures?

  • Is analysis carried out to establish information for planning of the internal audit programme related to the status and importance of areas to be audited?

  • Is analysis carried out to provide evidence that corrections and corrective actions are effective?

  • Are the results of the analysis and the resulting activities retained as documented information?

  • Are the results reported to top management and used as input to the management review and the updating of the FSMS? — See 9.3 and 10.3.

9.2 Internal Audit

  • Does the organization conduct internal audits at planned intervals to provide information on whether the FSMS conforms to the organization’s own requirements for its FSMS?

  • Does the organization conduct internal audits at planned intervals to provide information on whether the FSMS conforms to the requirements of ISO 22000?

  • Does the organization conduct internal audits at planned intervals to provide information on whether the FSMS is effectively implemented and maintained?

  • Has the organization planed, established, implemented and maintained an audit programme which considers the the processes, FSMS changes, and results of monitoring, measurement and previous audits? — Including the frequency, methods, responsibilities, planning requirements and reporting.

  • Does the organization define the audit criteria and scope for each audit?

  • Does the organization select competent auditors and conduct audits to ensure objectivity and the impartiality of the audit process?

  • Does the organization ensure that the results of the audits are reported to the food safety team and relevant management?

  • Does the organization retain documented information as evidence of the implementation of the audit programme and the audit results?

  • Does the organization make the necessary corrections and take the necessary corrective actions within the agreed time frame?

  • Has the organization determined if the FSMS meets the intent of the food safety policy and objectives of the FSMS? — See 5.2 and 6.2.

  • Do follow-up activities by the organization include the verification of the actions taken and the reporting of the verification results?

9.3.1 General Management Review

  • Does top management review the organization’s FSMS, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness?

9.3.2 Management Review Input

  • Does the management review consider the status of actions from previous management reviews?

  • Does the management review consider changes in external and internal issues that are relevant to the FSMS, including changes in the organization and its context? — See 4.1.

  • Does the management review consider information on the performance and the effectiveness of the FSMS? — This includes the following: - Result(s) of system updating activities (see 4.4 and 10.3); - Monitoring and measurement results; - Analysis of the results of verification activities related to PRPs and the hazard control plan (see 8.8.2); - Nonconformities and corrective actions; - Audit results (internal and external); - Inspections (e.g. regulatory, customer); - The performance of external providers; - The review of risks and opportunities and of the effectiveness of actions taken to address them (see 6.1); - The extent to which objectives of the FSMS have been met.

  • Does the management review consider the adequacy of resources?

  • Does the management review consider any emergency situation, incident or withdrawal/recall that occurred? — See 8.9.5 and 8.4.2.

  • Does the management review consider relevant information obtained through external and internal communication, including requests and complaints from interested parties? — See 7.4.2 and 7.4.3.

  • Does the management review consider opportunities for continual improvement?

  • Is the data presented in a manner that enables top management to relate the information to stated objectives of the FSMS?

9.3.3 Management Review Output

  • Do the outputs of the management review include decisions and actions related to continual improvement opportunities?

  • Do the outputs of the management review include any need for updates and changes to the FSMS, including resource needs and revision of the food safety policy and objectives of the FSMS?

  • Does the organization retain documented information as evidence of the results of management reviews?

Clause 10

10.1 Nonconformity and Corrective Action

  • When a nonconformity occurs, does the organization react to the nonconformity and, as applicable take action to control and correct it?

  • When a nonconformity occurs, does the organization react to the nonconformity and, as applicable deal with the consequences?

  • When a nonconformity occurs, does the organization evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere? — This should be done by: - reviewing the nonconformity; - determining the causes of the nonconformity - determining if similar nonconformities exist, or could potentially occur

  • When a nonconformity occurs, does the organization implement any action needed?

  • When a nonconformity occurs, does the organization review the effectiveness of any corrective action taken?

  • When a nonconformity occurs, does the organization make any necessary changes to the FSMS?

  • Are corrective actions appropriate to the effects of the nonconformities encountered?

  • Does the organization retain documented information as evidence of the nature of the nonconformities and any subsequent actions taken?

  • Does the organization retain documented information as evidence of the results of any corrective action?

10.2 Continual Improvement

  • Does the organization continually improve the suitability, adequacy and effectiveness of the FSMS?

  • Does top management ensure that the organization continually improves the effectiveness of the FSMS?
    — This should be done through the use of communication (see 7.4), management review (see 9.3), internal audit (see 9.2), analysis of results of verification activities (see 8.8.2), validation of control measure(s) and combination(s) of control measure(s) (see 8.5.3), corrective actions (see 8.9.3) and FSMS updating (see 10.3).

10.3 Update of the food safety management system

  • Does top management ensure that the FSMS is continually updated?

  • Does the food safety team evaluate the FSMS at planned intervals?

  • Does the team consider whether it is necessary to review the hazard analysis, established hazard control plan and established PRPs? — See 8.5.2, 8.5.4, and 8.2.

  • Are updating activities based on the following? — - Input from communication, external as well as internal (see 7.4); - Input from other information concerning the suitability, adequacy and effectiveness of the FSMS; - Output from the analysis of results of verification activities (see 9.1.2); - Output from management review (see 9.3)

  • Are system updating activities retained as documented information and reported as input to the management review? — See 9.3.

ISO/TS 22002-1:2009

ISO/TS 22002-1

4. Construction and layout of buildings

4.1 General requirements

  • Buildings shall be designed, constructed and maintained in a manner appropriate to the nature of the
    processing operations to be carried out, the food safety hazards associated with those operations and the
    potential sources of contamination from the plant environs.

  • Buildings shall be of durable construction which
    presents no hazard to the product.
    NOTE: An example of “durable construction” is self-draining roofs which do not leak.

4.2 Environment

  • Consideration shall be given to potential sources of contamination from the local environment.

  • Food production should not be carried out in areas where potentially harmful substances could enter the
    product.

  • The effectiveness of measures taken to protect against potential contaminants shall be periodically reviewed.

4.3 Locations of establishments

  • The site boundaries shall be clearly identified.

  • Access to the site shall be controlled.

  • The site shall be maintained in good order. Vegetation shall be tended or removed. Roads, yards and parking
    areas shall be drained to prevent standing water and shall be maintained.

5. Layout of premises workspace

5.1General requirements

  • Internal layouts shall be designed, constructed and maintained to facilitate good hygiene and manufacturing practices.

  • The movement patterns of materials, products and people, and the layout of equipment, shall be designed to protect against potential contamination sources.

5.2 Internal design, layout and traffic patterns

  • The building shall provide adequate space, with a logical flow of materials, products and personnel, and physical separation of raw from processed areas.
    - Flow of materials, products & personnel

  • Openings intended for transfer of materials shall be designed to minimize entry of foreign matter and pests

5.3 Internal structures and fittings

  • Process area walls and floors shall be washable or cleanable, as appropriate for the process or product hazard. Materials of construction shall be resistant to the cleaning system applied.

  • Wall floor junctions and corners shall be designed to facilitate cleaning. It is recommended that wall floor junctions be rounded in processing areas.

  • Floors shall be designed to avoid standing water.

  • In wet process areas, floors shall be sealed and drained. Drains shall be trapped and covered.

  • Ceilings and overhead fixtures shall be designed to minimize build-up of dirt and condensation.

  • External opening windows, roof vents or fan, where present, shall be insect screened.

  • External opening doors shall be closed or screened when not in use.

5.4 Location of equipment

  • Equipment shall be designed and located so as to facilitate good hygiene practices and monitoring.

  • Equipment shall be located to permit access for operation, cleaning and maintenance.

5.5 Laboratory facilities

  • In-line and on-line test facilities shall be controlled to minimize risk of product contamination.

  • Microbiology laboratories shall be designed, located and operated so as to prevent contamination of people,
    plant and products. They shall not open directly on to a production area.

5.6 Temporary or mobile premises and vending machines

  • Temporary structures shall be designed, located and constructed to avoid pest harbourage and potential contamination of products.

  • Additional hazards associated with temporary structures and vending machines shall be assessed and
    controlled.

5.7 Storage of food, packaging materials, ingredients and non-food chemicals

  • Facilities used to store ingredients, packaging and products shall provide protection from dust, condensation, drains, waste and other sources of contamination.

  • Storage areas shall be dry and well ventilated. Monitoring and control of temperature and humidity shall be applied where specified.

  • Storage areas shall be designed or arranged to allow segregation of raw materials, work in progress and finished products.

  • All materials and products shall be stored off the floor and with sufficient space between the material and the walls to allow inspection and pest control activities to be carried out.

  • The storage area shall be designed to allow maintenance and cleaning, prevent contamination and minimize deterioration.

  • A separate, secure (locked or otherwise access controlled) storage area shall be provided for cleaning materials, chemicals and other hazardous substances.

  • Exceptions for bulk or agricultural crop materials shall be documented in the food safety management system.

6. Utilities – air, water, energy

6 Utilities — air, water, energy

  • The provision and distribution routes for utilities to and around processing and storage areas shall be designed to minimize the risk of product contamination.

  • Utilities’ quality shall be monitored to minimize product contamination risk.

6.2 Water supply

  • The supply of potable water shall be sufficient to meet the needs of the production process(es).

  • Facilities for storage, distribution and, where needed, temperature control of the water shall be designed to meet specified water quality requirements.

  • Water used as a product ingredient, including ice or steam (including culinary steam), or in contact with products or product surfaces, shall meet specified quality and microbiological requirements relevant to the product.

  • Water for cleaning or applications where there is a risk of indirect product contact (e.g. jacketed vessels, heat exchangers) shall meet specified quality and microbiological requirements relevant to the application.

  • Where water supplies are chlorinated, checks shall ensure that the residual chlorine level at the point of use remains within limits given in relevant specifications.

  • Non-potable water shall have a separate supply system that is labelled and not connected to the potable water system. Take measures to prevent non-potable water refluxing into the potable system.

  • It is recommended that water that can come into contact with the product should flow through pipes that can be disinfected.

6.3 Boiler chemicals

  • Boiler chemicals, if used, shall be either:
    a) approved food additives which meet relevant additive specifications; or
    b) additives which have been approved by the relevant regulatory authority as safe for use in water intended for human consumption.

  • Boiler chemicals shall be stored in a separate, secure (locked or otherwise access-controlled) area when not in immediate use.

6.4 Air quality and ventilation

  • The organization shall establish requirements for filtration, humidity (RH%) and microbiology of air used as an ingredient or for direct product contact.

  • Where temperature and/or humidity are deemed critical by the organization, a control system shall be put in place and monitored.

  • Ventilation (natural or mechanical) shall be provided to remove excess or unwanted steam, dust and odours, and to facilitate drying after wet cleaning.

  • Room air supply quality shall be controlled to minimize risk from airborne microbiological contamination. Protocols for air quality monitoring and control shall be established in areas where products which support the
    growth or survival of microorganisms are exposed.

  • Ventilation systems shall be designed and constructed such that air does not flow from contaminated or raw areas to clean areas. Specified air pressure differentials shall be maintained. Systems shall be accessible for cleaning, filter changing and maintenance.

  • Exterior air intake ports shall be examined periodically for physical integrity.

6.5 Compressed air and other gases

  • Compressed air, carbon dioxide, nitrogen and other gas systems used in manufacturing and/or filling shall be constructed and maintained so as to prevent contamination.

  • Gases intended for direct or incidental product contact (including those used for transporting, blowing or drying materials, products or equipment) shall be from a source approved for food contact use, filtered to remove dust, oil and water.

  • Where oil is used for compressors and there is potential for the air to come into contact with the product, the oil used shall be food grade.

  • Use of oil free compressors is recommended.

  • Requirements for filtration, humidity (RH%) and microbiology shall be specified.

  • Filtration of the air should be as close to the point of use as is practicable.

6.6 Lighting

  • The lighting provided (natural or artificial) shall allow personnel to operate in a hygienic manner.

  • The intensity of the lighting should be appropriate to the nature of the operation.

  • Light fixtures shall be protected to ensure that materials, product or equipment are not contaminated in the case of breakages.

7. Waste disposal

7.1 General requirements

  • Systems shall be 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

  • Containers for waste and inedible or hazardous substances shall be clearly identified for their intended purpose

  • Containers for waste and inedible or hazardous substances shall be located in a designated area

  • Containers for waste and inedible or hazardous substances shall be constructed of impervious material which can be readily cleaned and sanitized

  • Containers for waste and inedible or hazardous substances shall be closed when not in immediate use

  • Containers for waste and inedible or hazardous substances shall be locked where the waste may pose a risk to the product.

7.3 Waste management and removal

  • Provision shall be made for the segregation, storage and removal of waste.

  • Accumulation of waste shall not be allowed in food-handling or storage areas. Removal frequencies shall be managed to avoid accumulations, with a minimum daily removal.

  • Labelled materials, products or printed packaging designated as waste shall be disfigured or destroyed to ensure that trademarks cannot be reused. Removal and destruction shall be carried out by approved disposal contractors. The organization shall retain records of destruction.

7.4 Drains and drainage

  • Drains shall be designed, constructed and located so that the risk of contamination of materials or products is avoided.

  • Drains shall have capacity sufficient to remove expected flow loads.

  • Drains shall not pass over processing lines.

  • Drainage direction shall not flow from a contaminated area to a clean area.

8. Equipment suitability, cleaning and maintenance

  • 8.1 General requirements

8.1 General requirements

  • Food contact equipment shall be designed and constructed to facilitate cleaning, disinfection and maintenance.

  • Contact surfaces shall not affect, or be affected by, the intended product or cleaning system.

  • Food contact equipment shall be constructed of durable materials able to resist repeated cleaning.

8.2 Hygienic design

  • Equipment shall be smooth, accessible, cleanable surfaces, self draining in wet process areas

  • Use of materials compatible with intended products and cleaning or flushing agents;

  • Framework not penetrated by holes or nuts and bolts.

  • Piping and ductwork shall be cleanable, drainable, and with no dead ends.

  • Equipment shall be designed to minimize contact between the operator’s hands and the products.

8.3 Product contact surfaces

  • Product contact surfaces shall be constructed from materials designed for food use. They shall be impermeable and rust or corrosion free.

8.4 Temperature control and monitoring equipment

  • Equipment used for thermal processes shall be able to meet the temperature gradient and holding conditions given in relevant product specifications.

  • Equipment shall provide for the monitoring and control of the temperature.

8.5 Cleaning plant, utensils and equipment

  • Wet and dry cleaning programmes shall be documented to ensure that all plant, utensils and equipment are cleaned at defined frequencies.

  • The programmes shall specify what is to be cleaned (including drains), the responsibility, the method of cleaning (e.g. CIP, COP), the use of dedicated cleaning tools, removal or disassembly requirements and methods for verifying the effectiveness of the cleaning.

8.6 Preventive and corrective maintenance

  • A preventive maintenance programme shall be in place.

  • The preventive maintenance programme shall include all devices used to monitor and/or control food safety hazards.
    NOTE: Examples of such devices include screens and filters (including air filters), magnets, metal detectors and X-ray detectors.

  • Corrective maintenance shall be carried out in such a way that production on adjoining lines or equipment is not at risk of contamination.

  • Maintenance requests which impact product safety shall be given priority.

  • Temporary fixes shall not put product safety at risk. A request for replacement by a permanent repair shall be included in the maintenance schedule.

  • Lubricants and heat transfer fluids shall be food grade where there is a risk of direct or indirect contact with the product.

  • The procedure for releasing maintained equipment back to production shall include clean up, sanitizing, where specified in process sanitation procedures, and pre-use inspection.

  • Local area PRP requirements shall apply to maintenance areas and maintenance activities in process areas. Maintenance personnel shall be trained in the product hazards associated with their activities.

9. Management of purchased materials

9.1 General requirements

  • Purchasing of materials which impact food safety shall be controlled to ensure that the suppliers used have the capability to meet the specified requirements.

  • The conformance of incoming materials to specified purchase requirements shall be verified.

9.2 Selection and management of suppliers

  • There shall be a defined process for the selection, approval and monitoring of suppliers. The process used shall be justified by hazard assessment, including the potential risk to the final product

  • Include assessment of the supplier’s ability to meet quality and food safety expectations, requirements and specifications

  • Include description of how suppliers are assessed;
    NOTE: Examples of a description of how suppliers are assessed include:
    1) audit of the supplying site prior to accepting materials for production;
    2) appropriate third party certification.

  • Include monitoring the performance of the supplier to assure continued approval status.
    NOTE: Monitoring includes conformity with material or product specifications, fulfilment of COA requirements, satisfactory audit outcomes.

9.3 Incoming material requirements (raw/ingredients/packaging)

  • Delivery vehicles shall be checked prior to, and during, unloading to verify that the quality and safety of the material has been maintained during transit (e.g. integrity of seals, freedom from infestation, existence of temperature records).

  • Materials shall be inspected, tested or covered by COA to verify conformity with specified requirements prior to acceptance or use. The method of verification shall be documented.

  • Materials which do not conform to relevant specifications shall be handled under a documented procedure which ensures they are prevented from unintended use.

  • Access points to bulk material receiving lines shall be identified, capped and locked. Discharge into such systems shall take place only after approval and verification of the material to be received.

10. Measures for prevention of cross contamination

10.1 General requirements

  • Programmes shall be in place to prevent, control and detect contamination. Measures to prevent physical, allergen and microbiological contamination shall be included.

10.2 Microbiological cross-contamination

  • Areas where potential for microbiological cross-contamination exists (airborne or from traffic patterns) shall be identified and a segregation (zoning) plan implemented.

  • A hazard assessment shall be carried out to determine potential contamination sources, susceptibility of the product and control measures suitable for these areas as follows:
    a) separation of raw from finished or ready to eat (RTE) products;
    b) structural segregation — physical barriers, walls or separate buildings;
    c) access controls with requirements to change into required workwear;
    d) traffic patterns or equipment segregation — people, materials, equipment and tools (including use of dedicated tools);
    e) air pressure differentials.

10.3 Allergen management

  • Allergens present in the product, either by design or by potential manufacturing cross-contact, shall be declared.

  • The declaration shall be on the label for consumer products, and on the label or the accompanying documentation for products intended for further processing.

  • Products shall be protected from unintended allergen cross-contact by cleaning and line change-over practices and/or product sequencing.
    NOTE: Manufacturing cross-contact can arise from either:
    1) traces of product from the previous production run which cannot be adequately cleaned from the product line due to
    technical limitations; or
    2) when contact is likely to occur, in the normal manufacturing process, with products or ingredients that are produced
    on separate lines, or in the same or adjacent processing areas.

  • Rework containing allergen(s) shall be used only:
    a) in products which contain the same allergen(s) by design; or
    b) through a process which is demonstrated to remove or destroy the allergenic material.
    NOTE: For general rework requirements, see Clause 14.

  • Employees handling food should receive specific training in allergen awareness and associated manufacturing practices.

10.4 Physical contamination

  • Where brittle materials are used, periodic inspection requirements and defined procedures in case of breakage shall be put in place.

  • Brittle materials, such as glass and hard plastic components in equipment, should be avoided where possible.

  • Glass breakage records shall be maintained.

  • Based on hazard assessment, measures shall be put in place to prevent, control or detect potential contamination.
    NOTE 1: Examples of such measures include:
    a) adequate covers over equipment or containers for exposed materials or products;
    b) use of screens, magnets, sieves or filters;
    c) use of detection or rejection devices such as metal detectors or X-ray.
    NOTE 2: Sources of potential contamination include wooden pallets and tools, rubber seals, and personal protective clothing and equipment.

11. Cleaning and sanitizing

  • 11.1 General requirements

11.1 General requirements

  • Cleaning and sanitizing programmes shall be established to ensure that the food-processing equipment and environment are maintained in a hygienic condition.

  • Programmes shall be monitored for continuing suitability and effectiveness.

11.2 Cleaning and sanitizing agents and tools

  • Facilities and equipment shall be maintained in a condition which facilitates wet or dry cleaning and/or sanitation.

  • Cleaning and sanitizing agents and chemicals shall be clearly identified, food grade, stored separately and used only in accordance with the manufacturer’s instructions.

  • Tools and equipment shall be of hygienic design and maintained in a condition which does not present a potential source of extraneous matter.

11.3 Cleaning and sanitizing programmes

  • Cleaning and sanitizing programmes shall be established and validated by the organization to ensure that all parts of the establishment and equipment are cleaned and/or sanitized to a defined schedule, including the cleaning of cleaning equipment.

  • Cleaning and/or sanitizing programmes shall specify at a minimum:
    a) areas, items of equipment and utensils to be cleaned and/or sanitized;
    b) responsibility for the tasks specified;
    c) cleaning/sanitizing method and frequency;
    d) monitoring and verification arrangements;
    e) post-clean inspections;
    f) pre start-up inspections.

11.4 Cleaning in place (CIP) systems

  • CIP systems shall be separated from active product lines.

  • Parameters for CIP systems shall be defined and monitored (including type, concentration, contact time and temperature of any chemicals used).

11.5 Monitoring sanitation effectiveness

  • Cleaning and sanitation programmes shall be monitored at frequencies specified by the organization to ensure their continuing suitability and effectiveness.

12. Pest control

12.1 General requirements

  • Hygiene, cleaning, incoming materials inspection and monitoring procedures shall be implemented to avoid creating an environment conducive to pest activity.

12.2 Pest control programmes

  • The establishment shall have a nominated person to manage pest control activities and/or deal with appointed expert contractors.

  • Pest management programmes shall be documented and shall identify target pests, and address plans, methods, schedules, control procedures and, where necessary, training requirements.

  • Programmes shall include a list of chemicals which are approved for use in specified areas of the establishment.

12.3 Preventing access

  • Buildings shall be maintained in good repair. Holes, drains and other potential pest access points shall be sealed.

  • External doors, windows or ventilation openings shall be designed to minimize the potential for entry of pests.

12.4 Harbourage and infestations

  • Storage practices shall be designed to minimize the availability of food and water to pests.

  • Material found to be infested shall be handled in such a way as to prevent contamination of other materials,
    products or the establishment.

  • Potential pest harbourage (e.g. burrows, undergrowth, stored items) shall be removed.

  • Where outside space is used for storage, stored items shall be protected from weather or pest damage (e.g.
    bird droppings).

12.5 Monitoring and detection

  • Pest-monitoring programmes shall include the placing of detectors and traps in key locations to identify pest
    activity. A map of detectors and traps shall be maintained. Detectors and traps shall be designed and located so as to prevent potential contamination of materials, products or facilities.

  • Detectors and traps shall be of robust, tamper-resistant construction. They shall be appropriate for the target pest.

  • The detectors and traps shall be inspected at a frequency intended to identify new pest activity.

  • The results of inspections shall be analysed to identify trends.

12.6 Eradication

  • Eradication measures shall be put in place immediately after evidence of infestation is reported.

  • Pesticide use and application shall be restricted to trained operatives and shall be controlled to avoid product safety hazards.

  • Records of pesticide use shall be maintained to show the type, quantity and concentrations used; where,
    when and how applied, and the target pest.

13. Personnel hygiene and employee facilities

13.1 General requirements

  • Requirements for personal hygiene and behaviours proportional to the hazard posed to the process area or product shall be established and documented.

  • All personnel, visitors and contractors shall be required to comply with the documented requirements.

13.2 Personnel hygiene facilities and toilets

  • Personnel hygiene facilities shall be available to ensure that the degree of personal hygiene required by the organization can be maintained.

  • The facilities shall be located close to the points where hygiene requirements
    apply and shall be clearly designated.

  • Provide adequate numbers, locations and means of hygienically washing, drying and, where required, sanitizing hands (including wash-basins, supply of hot and cold or temperature controlled water, and soap and/or sanitizer);

  • Have sinks designated for hand washing, whose taps should not be hand operated, separate from sinks for food use and equipment-cleaning stations;

  • Provide an adequate number of toilets of appropriate hygienic design, each with hand-washing, drying and, where required, sanitizing facilities;

  • Have employee hygiene facilities that do not open directly on to production, packing or storage areas

  • Have adequate changing facilities for personnel

  • Have changing facilities sited to enable personnel handling food to move to the production area in such a way that risk to the cleanliness of their workwear is minimized.

13.3 Staff canteens and designated eating areas

  • Staff canteens and designated areas for food storage and consumption shall be situated so that the potential for cross-contamination of production areas is minimized.

  • Staff canteens shall be managed to ensure hygienic storage of ingredients and preparation, storage and serving of prepared foods.

  • Storage conditions and storage, cooking and holding temperatures, and time
    limitations, shall be specified.

  • Employees’ own food shall be stored and consumed in designated areas only.

13.4 Workwear and protective clothing

  • Personnel who work in, or enter into, areas where exposed products and/or materials are handled shall wear work clothing that is fit for purpose, clean and in good condition (e.g. free from rips, tears or fraying material).

  • Clothing mandated for food protection or hygiene purposes shall not be used for any other purpose.

  • Workwear shall not have buttons. Workwear shall not have outside pockets above waist level. Zips or press stud fastenings are acceptable.

  • Workwear shall be laundered to standards and at intervals suitable for the intended use of the garments.

  • Workwear shall provide adequate coverage to ensure that hair, perspiration, etc. cannot contaminate the product.

  • Hair, beards, and moustaches shall be protected (i.e. completely enclosed) by restraints unless hazard analysis indicates otherwise.

  • Where gloves are used for product contact, they shall be clean and in good condition. Use of latex gloves should be avoided where possible.

  • Shoes for use in processing areas shall be fully enclosed and made from non-absorbent materials

  • Personal protective equipment, where required, shall be designed to prevent product contamination and maintained in hygienic condition.

13.5 Health status

  • Employees shall undergo a medical examination prior
    to employment in food contact operations (including site catering), unless documented hazard or medical
    assessment indicates otherwise.

  • Additional medical examinations, where permitted, shall be carried out at intervals defined by the organization.

13.6 Illness and injuries

  • Employees shall be 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.

  • People known or suspected to be infected with, or carrying, a disease or illness transmissible through food shall be prevented from handling food or materials which come into contact with food.

  • In food-handling areas, personnel with wounds or burns shall be required to cover them with specified dressings. Any lost dressing shall be reported to supervision immediately.
    NOTE: Dressings should be brightly coloured and metal detectable where appropriate.

13.7 Personal cleanliness

  • Personnel in food production areas shall be required to wash and, where required, sanitize hands:
    a) before starting any food-handling activities;
    b) immediately after using the toilet or blowing the nose;
    c) immediately after handling any potentially contaminated material.

  • Personnel shall be required to refrain from sneezing or coughing over materials or products. Spitting (expectorating) shall be prohibited.

  • Fingernails shall be kept clean and trimmed.

13.8 Personal behaviour

  • A documented policy shall describe the behaviours required of personnel in processing, packing and storage areas.

  • The policy shall at a minimum cover:
    a) permissibility of smoking, eating, chewing in designated areas only;
    b) 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;
    c) permissibility of personal items, such as smoking materials and medicines, in designated areas only;
    d) prohibition of the use of nail polish, false nails and false eyelashes;
    e) prohibition of carrying of writing implements behind the ears;
    f) maintenance of personal lockers so that they are kept free from rubbish and soiled clothing;
    g) prohibition of storage of product contact tools and equipment in personal lockers.

14. Rework

14.1 General requirements

  • Rework shall be stored, handled and used in such a way that product safety, quality, traceability and regulatory compliance are maintained.

14.2 Storage, identification and traceability

  • Stored rework shall be protected from exposure to microbiological, chemical or extraneous matter contamination.

  • Segregation requirements for rework (e.g. allergen) shall be documented and met.

  • Rework shall be clearly identified and/or labelled to allow traceability. Traceability records for rework shall be maintained.

  • The rework classification or the reason for rework designation shall be recorded (e.g. product name, production date, shift, line of origin, shelf-life).

14.3 Rework usage

  • Where rework is incorporated into a product as an “in-process” step, the acceptable quantity, type and conditions of rework use shall be specified.

  • The process step and method of addition, including any necessary pre-processing stages, shall be defined.

  • Where rework activities involve removing a product from filled or wrapped packages, controls shall be 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

  • Systems shall be in place to ensure that products failing to meet required food safety standards can be identified, located and removed from all necessary points of the supply chain.

15.2 Product recall requirements

  • A list of key contacts in the event of a recall shall be maintained.

  • Where products are withdrawn due to immediate health hazards, the safety of other products produced under the same conditions shall be evaluated. The need for public warnings shall be considered.

16. Warehousing

16.1 General requirements

  • Materials and products shall be stored in clean, dry, well-ventilated spaces protected from dust, condensation, fumes, odours or other sources of contamination.

16.2 Warehousing requirements

  • Effective control of warehousing temperature, humidity and other environmental conditions shall be provided where required by product or storage specifications.

  • It is recommended that where products are stacked, consideration is given to measures necessary to protect the lower layers.

  • Waste materials and chemicals (cleaning products, lubricants, and pesticides) shall be stored separately

  • A separate area or other means of segregating materials identified as non-conforming shall be provided.

  • Specified stock rotation systems (FIFO/FEFO) shall be observed.

  • Gasoline- or diesel-powered fork-lift trucks shall not be used in food ingredient or product storage areas.

16.3 Vehicles, conveyances, and containers

  • Vehicles, conveyances, and containers shall be maintained in a state of repair, cleanliness, and condition consistent with requirements given in relevant specifications.

  • Vehicles, conveyances, and containers shall provide protection against damage or contamination of the product.

  • Control of temperature and humidity shall be applied and recorded where required by the organization.

  • Where the same vehicles, conveyances, and containers are used for food and non-food products, cleaning shall be carried out between loads.

  • Bulk containers shall be dedicated to food use only. Where required by the organization, bulk containers shall be dedicated to a specified material.

17. Product information/consumer awareness

  • Information shall be presented to consumers in such a way as to enable them to understand its importance and make informed choices.

  • Information may be provided by labelling or other means, such as company websites and advertisements, and may include storage, preparation and serving instructions applicable to the product.

18. Food defence, biovigilance and bioterrorism

18.1 General requirements

  • Each establishment shall assess the hazard to products posed by potential acts of sabotage, vandalism or terrorism and shall put in place proportional protective measures.

18.2 Access controls

  • Potentially sensitive areas within the establishment shall be identified, mapped, and subjected to access control.

  • Where feasible, access should be physically restricted by use of locks, electronic card key or alternative systems.

Additional FSSC 22000 requirements

FSSC Additional Requirement 2.5

2.5.1. MANAGEMENT OF SERVICES

  • in case external laboratory analysis services are used for the verification and/or validation of food safety, these shall be conducted by a competent laboratory that has the capability to produce precise and repeatable test results using validated test methods and best practices (e.g. successful participation in proficiency testing programs, regulatory approved programs or accreditation to international standards such as ISO 17025).

2.5.2. PRODUCT LABELLING

  • Finished products are labelled according to all applicable food safety (including allergens) statutory and regulatory requirements in the country of intended sale

2.5.3 FOOD DEFENSE

2.5.3.1 THREAT ASSESSMENT

  • Shall have a documented procedure in place to:
    a) Conduct a threat assessment to identify and assess potential threats;
    b) Develop and implement mitigation measures for significant threats

2.5.3.2 PLAN

  • a) The organization shall have a documented food defense plan specifying the mitigation measures covering the processes and products within the FSMS scope of the organization.
    b) The food defense plan shall be supported by the organization’s FSMS.
    c) The plan shall comply with applicable legislation and be kept up-to-date.

2.5.4 FOOD FRAUD MITIGATION

2.5.4.1 VULNERABILITY ASSESSMENT

  • Shall have a documented procedure in place to:
    a) Conduct a food fraud vulnerability assessment to identify and assess potential vulnerabilities;
    b) Develop and implement mitigation measures for significant vulnerabilities.

2.5.4.2 PLAN

  • a) The organization shall have a documented food fraud mitigation plan specifying the mitigation measures covering the processes and products within the FSMS scope of the organization.
    b) The food fraud mitigation plan shall be supported by the organization’s FSMS.
    c) The plan shall comply with the applicable legislation and be kept up-to-date.

2.5.5 LOGO USE

  • Use the FSSC 22000 logo only for marketing activities such as organization's printed matter, website and another promotional material.

  • Use of the logo in black and white is permitted when all other text and images are in black and white.

  • The certified organization is not allowed to use the FSSC 22000 logo, any statement or make reference to its certified status on:
    i. a product;
    ii. its labelling;
    iii. its packaging (primary, secondary or any other form);
    iv. in any other manner that implies FSSC 22000 approves a product, process or service.

2.5.6 MANAGEMENT OF ALLERGENS

  • Documented allergen management plan that includes:
    a) Risk assessment covering all potential sources of allergen cross-contamination and;
    b) Control measures to reduce or eliminate the risk of cross-contamination.

2.5.7 ENVIRONMENTAL MONITORING

  • The organization shall have in place:
    a) Risk-based environmental monitoring program;
    b) Documented procedure for the evaluation of the effectiveness of all controls on preventing contamination from the manufacturing environment and this shall include, at a minimum, the evaluation of microbiological and allergen controls present;
    c) Data of the monitoring activities including regular trend analysis.

Completion

  • Overall Comment

  • Auditor's Name and Signature

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