Iso 22000 audit checklist

Are the appropriate information - regarding safety issues related to the products - communicated throughout the food chain?

Yes No N/A

Are the food safety hazards that may be reasonably expected to occur in relation to products within the scope of the system identified, evaluated and controlled in such manner that the products of theorganization do not, directly or indirectly, harm the consumer?

Yes No N/A

Are the information - concerning development, implementation and updating of the FSMS throughout the organization - communicated to the extent necessary to ensure the food safety required by the ISO 22000 standard?

Yes No N/A

Are the products or product categories, processes and production sites that are addressed by the food safety management system specified by scope?

Yes No N/A

Does the organization periodically evaluate FSMS (and update when necessary) to ensure that the system reflects the organization's activities and incorporates the most recent information on the food safety hazards subject to control?

Yes No N/A

Has the organization ensured control over the outsourced processes that may affect end product conformity?

Yes No N/A

Has the organization established, documented and implemented an effective food safety management system in accordance with the requirements of ISO 22000 standard?

Yes No N/A

Is the control of such outsourced processes identified and documented within the FSMS?

Yes No N/A

Is the FSMS maintained and updated?

Yes No N/A

Is the scope of the FSMS defined?

Yes No N/A

Does the FSMS documentation include:

a) Documented statements of a food safety policy and related objectives?

Yes No N/A

b) Documented procedures and records required by ISO 22000 standard?

Yes No N/A

c) Documents needed by the organization to ensure the effective development, implementation and updating of the food safety management system?

Yes No N/A

Are the documents - which are required by the food safety management system - controlled?

Yes No N/A

Do the established controls ensure that all proposed changes are reviewed prior to implementation to determine their effects on food safety and their impact on the food safety management system?

Yes No N/A

Does a documented procedure exist to define the controls needed:

Are required records established and maintained in order to provide evidence of conformity to requirements and evidence of the effective operation of the food safety management system?

Yes No N/A

Do records remain legible, readily identifiable and retrievable?

Yes No N/A

Does a documented procedure exist in order to define the controls needed for the correction, identification, storage, protection, retrieval, retention time and disposition of records?

Yes No N/A

Please proceed to Section 5.

Is top management able to provide evidence of its commitment to the development and implementation of the food safety management system?

Yes No N/A

Is top management able to provide evidence that the effectiveness of the food safety management system is continually improved by:

Has top management defined, documented and communicated its food safety policy?

Yes No N/A

Does top management ensure that the food safety policy:

Does top management ensure that:

a) The planning of the food safety management system is carried out to meet the requirements in clause 4.1, as well as the objectives of the organization that support food safety?

Yes No N/A

b) The integrity of the food safety management system is maintained when changes to the food safety management system are planned and implemented?

Yes No N/A

Are there designated personnel with defined responsibility and authority to initiate and record actions?

Yes No N/A

Does top management ensure that the responsibilities, authorities are defined and communicated within the organization to ensure the effective operation and maintenance of the food safety management system?

Yes No N/A

Is the responsibility assigned to all personnel to report the problems with the food safety management to identified person(s)?

Yes No N/A

Has top management appointed a food safety team leader who, irrespective of other responsibilities, shall have responsibility and authority:

a) To manage a food safety team and organize its work?

Yes No N/A

b) To ensure relevant training and education of the food safety team member?

Yes No N/A

c) To ensure that the food safety management system is established, implemented, maintained and updated?

Yes No N/A

d) To report to the organization's top management on the effectiveness and suitability of the food safety management system?

Yes No N/A

NOTE: The responsibility of the food safety team leader may include liaison with external parties on matters relating to the food safety management system.

Has the organization established, implemented and maintained effective arrangements for communicating with:

a) Suppliers and contractors?

Yes No N/A

Are records of communications maintained?

Yes No N/A

Are the food safety requirements - from statutory and regulatory authorities and customers – available?

Yes No N/A

Are there designated personnel with defined responsibility and authority to communicate externally any information concerning food safety?

Yes No N/A

b) Customers or consumers, in particular in relation to product information (including instructions regarding intended use, specific storage requirements and, as appropriate, shelf life), inquiries, contracts or order handling including amendments, and customer feedback including customer complaints?

Yes No N/A

c) Statutory and regulatory authorities?

Yes No N/A

d) Other organizations that have an impact on, or will be affected by, the effectiveness or updating of the food safety management system?

Yes No N/A

Does such communication provide information on food safety aspects (especially to known food safety hazards that need to be controlled by other organizations in the food chain) of the organization's products that may be relevant to other organizations in the food chain?

Yes No N/A

Is information obtained through external communication included as input to system updating and management review?

Yes No N/A

Has the organization established, implemented and maintained effective arrangements for communicating with personnel on 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, including but not limited to the following:

Has top management established, implemented and maintained procedures to manage potential emergency situations and accidents that can impact food safety and which are relevant to the role of the organization in the food chain?

Yes No N/A

Does the input to management review include information about:

a) Follow-up actions from previous management reviews?

Yes No N/A

Are the data presented in a manner that enables top management to relate the information to stated objectives of the food safety management system?

Yes No N/A

b) Analysis of results of verification activities?

Yes No N/A

c) Changing circumstances that can affect food safety?

Yes No N/A

d) Emergency situations, accidents and withdrawals?

Yes No N/A

e) Reviewing results of system-updating activities?

Yes No N/A

f) Review of communication activities, including customer feed-back?

Yes No N/A

g) External audits or inspections?

Yes No N/A

Does the output from the management review include any decisions and actions related to:

a) Assurance of food safety?

Yes No N/A

b) Improvement of the effectiveness of the food safety management system?

Yes No N/A

c) Resource needs?

Yes No N/A

d) Revisions of the organization's food safety policy and related objectives?

Yes No N/A

Please proceed to Section 6

Does the organization provide adequate resources for the establishment, implementation, maintenance and updating of the food safety management system?

Yes No N/A

Does the organization:

a) Identify the necessary competencies for personnel whose activities have an impact on food safety?

Yes No N/A

b) Provide training or take other action to ensure personnel have the necessary competencies?

Yes No N/A

c) Ensure that personnel responsible for monitoring, corrections and corrective actions of the food safety management system are trained?

Yes No N/A

d) Evaluate the implementation and the effectiveness of the actions taken in a), b) and c)?

Yes No N/A

e) Ensure that the personnel are aware of the relevance and importance of their individual activities in contributing to food safety?

Yes No N/A

f) Ensure that the requirement for effective communication is understood by all personnel whose activities have an impact on food safety?

Yes No N/A

g) Maintain appropriate records of training and actions described in b) and c)?

Yes No N/A

Does the organization provide the resources for the establishment and maintenance of the infrastructure needed to implement the requirements of ISO 22000 standard?

Yes No N/A

Does the organization provide the resources for the establishment, management and maintenance of the work environment needed to implement the requirements of ISO 22000 standard?

Yes No N/A

Please proceed to Section 7.

Has the organization established, implemented and maintained PRP(s) to assist in controlling:

a) The likelihood of introducing food safety hazards to the product through the work environment?

Yes No N/A

b) Biological, chemical and physical contamination of the product(s), including cross-contamination between products?

Yes No N/A

c) Food safety hazard levels in the product and product processing environment?

Yes No N/A

Are the PRP(s):

Does the organization consider the following (when establishing PRP(s)):

Are records - that demonstrate that the food safety team has the required knowledge and experience - maintained?

Yes No N/A

Do the members of the food safety team provide a combination of multi-disciplinary knowledge and experience in developing and implementing the food safety management system? Note: This includes, but need not be limited to, the organization's products, processes, equipment and food safety hazards within the scope of the food safety management system.

Yes No N/A

Has a food safety team been appointed?

Yes No N/A

Are all raw materials, ingredients and product-contact materials described in documents to the extent needed to conduct the hazard analysis, including the following, as appropriate:

a) Biological, chemical, and physical characteristics?

Yes No N/A

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

Yes No N/A

b) Composition of formulated ingredients, including additives and processing aids?

Yes No N/A

c) Origin?

Yes No N/A

d) Method of production?

Yes No N/A

Does the organization identify statutory and regulatory food safety requirements related to the raw materials, ingredients and product-contact materials?

Yes No N/A

e) Packaging and delivery methods?

Yes No N/A

f) Storage conditions and shelf life?

Yes No N/A

g) Preparation and/or handling before use or processing?

Yes No N/A

h) Food safety-related acceptance criteria or specifications of purchased materials and ingredients appropriate to their intended uses?

Yes No N/A

Are the characteristics of end products described in documents to the extent needed to conduct the hazard analysis, including information on the following, as appropriate:

a) Product name or similar identification?

Yes No N/A

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

Yes No N/A

b) Composition?

Yes No N/A

c) Biological, chemical and physical characteristics relevant to food safety?

Yes No N/A

d) Intended shelf life and storage conditions?

Yes No N/A

Does the organization identify statutory and regulatory food safety requirements related to the characteristics of end products?

Yes No N/A

e) Packaging?

Yes No N/A

f) Labeling relating to food safety and/or instructions for handling, preparation, and usage?

Yes No N/A

g) Method(s) of distribution?

Yes No N/A

Are groups of users and, where appropriate, groups of consumers identified for each product, and consumer groups are known to be especially vulnerable to specific food safety hazards considered?

Yes No N/A

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

Yes No N/A

Are the intended use, the reasonably expected handling of the end product, and any unintended but reasonably expected mishandling and misuse of the end product considered and described in documents to the extent needed to conduct the hazard analysis?

Yes No N/A

Are flow diagrams clear, accurate and sufficiently detailed?

Yes No N/A

Are flow diagrams prepared for the products or process categories covered by the food safety management system?

Yes No N/A

Do flow diagrams provide a basis for evaluating the possible occurrence, increase or introduction of food safety hazards?

Yes No N/A

Do flow diagrams, as appropriate, include the following:

Are external requirements (e.g. regulatory authorities ore costumes) that may impact the choice or rigorousness of the control measures described and updated?

Yes No N/A

Are the existing control measures process parameters and/or the rigorousness with which they are applied, or the procedures that may influence food safety, described to the extent needed to conduct the hazard analysis?

Yes No N/A

Are all food safety hazards that are reasonably expected to occur in relation to the type of product, type of process and actual processing facilities identified and recorded?

Yes No N/A

Is the identification based on:

Is the consideration - when identifying the hazards - given to:

Are the results of the food safety hazard assessment recorded?

Yes No N/A

Is a hazard assessment conducted to determine, for each food safety hazard identified, whether its elimination or reduction to acceptable levels is essential to the production of a safe food and whether its control is needed to enable the defined acceptable levels to be met?

Yes No N/A

Is each food safety hazard evaluated according to the possible severity of adverse health effects and the likelihood of their occurrence?

Yes No N/A

Is the methodology used for the hazard described?

Yes No N/A

Is an appropriate combination of control measures selected (based on the hazard assessment), which is capable of preventing, eliminating or reducing these food safety hazards to defined acceptable levels?

Yes No N/A

Is each of the selected control measures reviewed with respect to its effectiveness against the identified food safety hazards?

Yes No N/A

Is each selected control measure categorized as to whether it needs to be managed through operational PRP(s) or by the HACCP plan, using a logical approach that includes assessments with regard to the following:

Are the operational PRPs documented?

Yes No N/A

Are the operational PRPs included the following information for each programme:

Is the HACCP plan documented?

Yes No N/A

Is the HACCP plan included the following information for each identified critical control point (CCP):

Are CCP(s) identified for the control measures identified, for each hazard that is to be controlled by the HACCP plan?

Yes No N/A

Are critical limits - based on subjective data (such as visual inspection of product, process, handling, etc.) - supported by instructions or specifications and/or education and training?

Yes No N/A

Are critical limits determined for the monitoring established for each CCP?

Yes No N/A

Are critical limits established on such a way to ensure that the identified acceptable level of the food safety hazard in the end product is not exceeded?

Yes No N/A

Are critical limits measurable?

Yes No N/A

Are the rationale for the chosen critical limits documented?

Yes No N/A

Are all scheduled measurements or observations - relative to the critical limit(s) - included in the monitoring system?

Yes No N/A

Is a monitoring system established for each CCP to demonstrate that the CCP is in control?

Yes No N/A

Does the monitoring system consist of relevant procedures, instructions, and records that cover the following:

Are planned corrections and corrective actions - to be taken when critical limits are exceeded - specified in the HACCP plan?

Yes No N/A

Do the actions ensure that:

Does the organization update the following information in operational PRP(s) and/or the HACCP plan, if necessary:

a) Product characteristics?

Yes No N/A

Are the HACCP plan and the procedures and instructions specifying the PRP(s) amended, if necessary?

Yes No N/A

b) Intended use?

Yes No N/A

c) Flow diagrams?

Yes No N/A

d) Process steps?

Yes No N/A

e) Control measures?

Yes No N/A

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

Yes No N/A

Do the verification activities confirm that:

Are records in accordance with statutory and regulatory requirements and customer requirements?

Yes No N/A

Are traceability records maintained for a defined period for system assessment to enable the handling of potentially unsafe products and in the event of product withdrawal?

Yes No N/A

Has the organization established and does it apply a traceability system that enables the identification of product lots and their relation to batches of raw materials, processing, and delivery records?

Yes No N/A

Is the traceability system able to identify incoming material from the immediate suppliers and the initial distribution route of the end product?

Yes No N/A

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

Yes No N/A

Is a documented procedure established and maintained defining:

Are corrective actions initiated when critical limits are exceeded or when there is a lack of conformity with operational PRP(s)?

Yes No N/A

Are corrective actions recorded?

Yes No N/A

Are data - derived from the monitoring of operational PRPs and CCPs - evaluated by designated person(s) with sufficient knowledge and authority to initiate corrective actions?

Yes No N/A

Has the organization established and does it maintain documented procedures that specify appropriate actions to identify and eliminate the cause of detected nonconformities, to prevent recurrence, and to bring the process or system back into control after nonconformity is encountered?Note:These actions include a) reviewing nonconformities (including customer complaints), b) reviewing trends in monitoring results that may indicate development towards loss of control, c) determining the cause(s) of nonconformities,d) evaluating the need for action to ensure that nonconformities do not recur,e) determining and implementing the actions needed,f) recording the results of corrective actions taken, andg) reviewing corrective actions taken to ensure that they are effective.

Yes No N/A

Does the organization handle nonconforming products by taking action(s) to prevent the nonconforming product from entering the food chain unless it is possible to ensure that

Is each lot of product affected by the nonconformity released as safe only when any of the following conditions apply:

a) Evidence other than the monitoring system demonstrates that the control measures have been effective?

Yes No N/A

b) Evidence shows that the combined effect ofthe control measures for that particular product complies with the performanceintended?

Yes No N/A

c) The results of sampling, analysis and/or other verification activities demonstrate that the affected lot of product complies with the identified acceptable levels for the food safety hazard(s) concerned?

Yes No N/A

Is the lot of product - which is not acceptable for release - handled (after evaluation) by one of the following activities:

a) Reprocessing or further processing within or outside the organization to ensure that the food safety hazard is eliminated or reduced to acceptable levels?

Yes No N/A

b) Destruction and/or disposal as waste?

Yes No N/A

To enable and facilitate the complete and timely withdrawal of lots of end products which have been identified as unsafe

a) Has top management appointed personnel having the authority to initiate a withdrawal and personnel responsible for executing the withdrawal?

Yes No N/A

Are the cause, extent and result of a withdrawal recorded and reported to top management as input to the management review?

Yes No N/A

Are withdrawn products secured or held under supervision until they are destroyed, used for purposes other than originally intended, determined to be safe for the same (or other) intended use, or reprocessed in a manner to ensure they become safe?

Yes No N/A

b) Has the organization established and does it maintain a documented procedure for 1) notification to relevant interested parties (e.g. statutory and regulatory authorities, customers and/or consumers), 2) handling of withdrawn products as well as affected lots of the products still in stock, and 3) the sequence of actions to be taken?.

Yes No N/A

Does the organization verify and record the effectiveness of the withdrawal programme through the use of appropriate techniques (e.g. challenge testing, mock withdrawal or practice withdrawal)?

Yes No N/A

Please proceed to Section 8.

Does the organization validate (prior to implementation of control measures to be included in operational PRP(s) and the HACCP plan and after any change therein) that:

a) The selected control measures are capable of achieving the intended control of the food safety hazard(s) for which they are designated?

Yes No N/A

Are the control measure and/or combinations thereof modified and re-assessed when the result of the validation shows that one or both of the above elements cannot be confirmed?

Yes No N/A

b) The control measures are effective and capable of, in combination, ensuring control of the identified food safety hazard(s) to obtain end products that meet the defined acceptable levels?

Yes No N/A

Note: Modifications may include changes in control measures (i.e. process parameters, rigorousness and/or their combination) and/or change(s) in the raw materials, manufacturing technologies, end product characteristics, methods of distribution and/or intended use of the end product.

Yes No N/A

Is there evidence that the specified monitoring and measuring methods and equipment are adequate to ensure the performance of the monitoring and measuring procedures?

Yes No N/A

Are the measuring equipment and methods used:

Does the organization conduct internal audits at planned intervals to determine whether the food safety management system:

a) Conforms to the planned arrangements, to the food safety management system requirements established by the organization, and to the requirements of this International Standard?

Yes No N/A

Are the audit criteria, scope, frequency, and methods defined?

Yes No N/A

Are the responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records defined in documented procedure?

Yes No N/A

b) Is effectively implemented and updated?

Yes No N/A

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

Yes No N/A

Do the selection of auditors and the conduct of audits ensure objectivity and impartiality of the audit process?

Yes No N/A

Does the management responsible for the area being audited to ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes?

Yes No N/A

Is an audit programme planned, taking into consideration the importance of the processes and areas to be audited, as well as any updating actions resulting from previous audits?

Yes No N/A

Is it ensured that auditors do not audit their own work?

Yes No N/A

Does the food safety team systematically evaluate the individual results of planned verification?

Yes No N/A

Does the organization take action to achieve the required conformity, when verification does not demonstrate conformity with the planned arrangements?

Yes No N/A

Does action – taken for achieving the required conformity – include (but is not limited to), review of:

Does the food safety team analyze the results of verification activities, including the results of the internal audits and external audits?

Yes No N/A

Is the analysis carried out in order

Does top management ensure that the organization continually improves the effectiveness of the food safety management system through the use of:- communication,- management review,- internal audit,- evaluation of individual verification results,- analysis of results of verificationactivities,- validation of control measurecombinations,- corrective actions and- food safety management system updating?

Yes No N/A

Does the food safety team evaluate the food safety management system at planned intervals in order to achieve that FSMS is continually updated?

Yes No N/A

Does the team consider whether it is necessary to review the hazard analysis, the established operational PRP(s) and the HACCP plan?

Yes No N/A

Does top management ensure that the food safety management system is continually updated?

Yes No N/A

Are the evaluation and updating activities based on:

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Iso 22000 audit checklist

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