ISO 22000:2018 Compliance Audit

• Site

• Conducted on (Date and Time)

  Date

• Inspected by

• Location
  Address

4.1 Understanding the Organization and its Context

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

  Yes

  No

  N/A

4.2 Understanding the Needs and Expectations of Interested Parties

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Is the scope available and maintained as documented information?

  Yes

  No

  N/A

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.

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

• 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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

5.2.2 Communicating the Food Safety Policy

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

5.3 Organizational roles, responsibilities and authorities

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

• 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)?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Are the objectives of the FSMS monitored and verified?

  Yes

  No

  N/A

• Are the objectives of the FSMS communicated?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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.

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Has the organization considered the need for external resources?

  Yes

  No

  N/A

7.1.2 Resources (People)

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

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

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).

  Yes

  No

  N/A

• 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).

  Yes

  No

  N/A

• 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).

  Yes

  No

  N/A

• 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).

  Yes

  No

  N/A

• 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).

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

7.3 Awareness

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

  Yes

  No

  N/A

• 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)?

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

7.4.1 Communication (General)

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

7.4.3 Communication (Internal)

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

7.5.1 Document Information (General)

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• Does the organization periodically test procedures where practical?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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.

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

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).

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Do flow diagrams include any outsourced processes?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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.

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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).

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

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)?

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

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

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Are critical limits at CCPs measurable?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Are action criteria for OPRPs measurable or observable?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Does this information include monitoring methods or devices used?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Does this information include monitoring frequency?

  Yes

  No

  N/A

• Does this information include monitoring results?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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.

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

8.8.1 Verification

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Are verification results retained as documented information and communicated?

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

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.

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Does this information include the nature of the nonconformity?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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.?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

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

  Yes

  No

  N/A

8.9.4.2 Handling of Potentially Unsafe Products (Evaluation for Release)

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

9.1.1 Monitoring, Measurement, Analysis and Evaluation (General)

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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.

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

9.3.2 Management Review Input

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

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

• Does the management review consider the adequacy of resources?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

• Does the management review consider opportunities for continual improvement?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

9.3.3 Management Review Output

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

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

10.2 Continual Improvement

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

  Yes

  No

  N/A

• Does top management ensure that the organization continually improves the effectiveness of the FSMS?<br>— 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).<br>

  Yes

  No

  N/A

10.3 Update of the food safety management system

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

• 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)

  Yes

  No

  N/A

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

  Yes

  No

  N/A

Completion

• Recommendations

• Auditor (Full Name and Signature)

  Sign