Iso 22000 audit checklist
This comprehensive iso 22000 audit checklist converted using DataScope is composed of 5 sections - management responsibility and resources, planning and realization of safe products, validation, verification, and improvement of food safety management system (fsms). this checklist helps evaluate if the organization has implemented, established and maintained an effective fsms. it also ensures control over outsourced processes that may affect end product conformity. use DataScope to generate on the spot reports and assign urgent corrective actions to appropriate team members or vendors.
What does this form include?
This form contains 93 sections:
General Requirements
- Has the organization established, documented and implemented an effective food safety management system in accordance with the requirements of ISO 22000 standard?
- Is the FSMS maintained and updated?
- Is the scope of the FSMS defined?
- Are the products or product categories, processes and production sites that are addressed by the food safety management system specified by scope?
- 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?
- Are the appropriate information - regarding safety issues related to the products - communicated throughout the food chain?
- 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?
- 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?
- Has the organization ensured control over the outsourced processes that may affect end product conformity?
- Is the control of such outsourced processes identified and documented within the FSMS?
Does the FSMS documentation include:
General
- a) Documented statements of a food safety policy and related objectives?
- b) Documented procedures and records required by ISO 22000 standard?
- c) Documents needed by the organization to ensure the effective development, implementation and updating of the food safety management system?
Control of documents
- Are the documents - which are required by the food safety management system - controlled?
- Do the established controls ensure that all proposed changes are reviewed prior to implementation to determine their effects on food safety and their impact on the food safety management system?
Does a documented procedure exist to define the controls needed:
Control of records
- 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?
- Do records remain legible, readily identifiable and retrievable?
- 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?
Please proceed to Section 5.
Management commitment
- Is top management able to provide evidence of its commitment to the development and implementation of the food safety management system?
Is top management able to provide evidence that the effectiveness of the food safety management syste
Food safety policy
- Has top management defined, documented and communicated its food safety policy?
Does top management ensure that the food safety policy:
Does top management ensure that:
Food safety management system planning
- 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?
- b) The integrity of the food safety management system is maintained when changes to the food safety management system are planned and implemented?
Responsibility and authority
- 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?
- Is the responsibility assigned to all personnel to report the problems with the food safety management to identified person(s)?
- Are there designated personnel with defined responsibility and authority to initiate and record actions?
Has top management appointed a food safety team leader who, irrespective of other responsibilities, s
Food safety team leader
- a) To manage a food safety team and organize its work?
- b) To ensure relevant training and education of the food safety team member?
- c) To ensure that the food safety management system is established, implemented, maintained and updated?
- d) To report to the organization's top management on the effectiveness and suitability of the food safety management system?
NOTE: The responsibility of the food safety team leader may include liaison with external parties on
Has the organization established, implemented and maintained effective arrangements for communicating
External communication
- a) Suppliers and contractors?
- 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?
- c) Statutory and regulatory authorities?
- d) Other organizations that have an impact on, or will be affected by, the effectiveness or updating of the food safety management system?
- 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?
- Are records of communications maintained?
- Are the food safety requirements - from statutory and regulatory authorities and customers – available?
- Are there designated personnel with defined responsibility and authority to communicate externally any information concerning food safety?
- Is information obtained through external communication included as input to system updating and management review?
Internal communication
- Has the organization established, implemented and maintained effective arrangements for communicating with personnel on issues having an impact on food safety?
Has the organization ensured that the food safety team is informed in a timely manner of changes, inc
Emergency preparedness and response
- 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?
Does the input to management review include information about:
Review input
- a) Follow-up actions from previous management reviews?
- b) Analysis of results of verification activities?
- c) Changing circumstances that can affect food safety?
- d) Emergency situations, accidents and withdrawals?
- e) Reviewing results of system-updating activities?
- f) Review of communication activities, including customer feed-back?
- g) External audits or inspections?
- Are the data presented in a manner that enables top management to relate the information to stated objectives of the food safety management system?
Does the output from the management review include any decisions and actions related to:
Review output
- a) Assurance of food safety?
- b) Improvement of the effectiveness of the food safety management system?
- c) Resource needs?
- d) Revisions of the organization's food safety policy and related objectives?
Please proceed to Section 6
Provision of resources
- Does the organization provide adequate resources for the establishment, implementation, maintenance and updating of the food safety management system?
Does the organization:
Competence, awareness and training
- a) Identify the necessary competencies for personnel whose activities have an impact on food safety?
- b) Provide training or take other action to ensure personnel have the necessary competencies?
- c) Ensure that personnel responsible for monitoring, corrections and corrective actions of the food safety management system are trained?
- d) Evaluate the implementation and the effectiveness of the actions taken in a), b) and c)?
- e) Ensure that the personnel are aware of the relevance and importance of their individual activities in contributing to food safety?
- f) Ensure that the requirement for effective communication is understood by all personnel whose activities have an impact on food safety?
- g) Maintain appropriate records of training and actions described in b) and c)?
Infrastructure
- Does the organization provide the resources for the establishment and maintenance of the infrastructure needed to implement the requirements of ISO 22000 standard?
Work environment
- 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?
Please proceed to Section 7.
Has the organization established, implemented and maintained PRP(s) to assist in controlling:
Prerequisite programmes (PRPs)
- a) The likelihood of introducing food safety hazards to the product through the work environment?
- b) Biological, chemical and physical contamination of the product(s), including cross-contamination between products?
- c) Food safety hazard levels in the product and product processing environment?
Are the PRP(s):
Does the organization consider the following (when establishing PRP(s)):
Food safety team
- Has a food safety team been appointed?
- 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.
- Are records - that demonstrate that the food safety team has the required knowledge and experience - maintained?
Are all raw materials, ingredients and product-contact materials described in documents to the extent
Raw material, ingredients, and product contacted material
- a) Biological, chemical, and physical characteristics?
- b) Composition of formulated ingredients, including additives and processing aids?
- c) Origin?
- d) Method of production?
- e) Packaging and delivery methods?
- f) Storage conditions and shelf life?
- g) Preparation and/or handling before use or processing?
- h) Food safety-related acceptance criteria or specifications of purchased materials and ingredients appropriate to their intended uses?
- Does the organization identify statutory and regulatory food safety requirements related to the raw materials, ingredients and product-contact materials?
- Are the descriptions kept up-to-date including, when required?
Are the characteristics of end products described in documents to the extent needed to conduct the ha
Characteristics of end products
- a) Product name or similar identification?
- b) Composition?
- c) Biological, chemical and physical characteristics relevant to food safety?
- d) Intended shelf life and storage conditions?
- e) Packaging?
- f) Labeling relating to food safety and/or instructions for handling, preparation, and usage?
- g) Method(s) of distribution?
- Does the organization identify statutory and regulatory food safety requirements related to the characteristics of end products?
- Are the descriptions kept up-to-date including, when required?
Intended use
- 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?
- 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?
- Are the descriptions kept up-to-date including, when required?
Flow diagrams
- Are flow diagrams prepared for the products or process categories covered by the food safety management system?
- Do flow diagrams provide a basis for evaluating the possible occurrence, increase or introduction of food safety hazards?
- Are flow diagrams clear, accurate and sufficiently detailed?
Do flow diagrams, as appropriate, include the following:
Description of process steps and control measures
- 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?
- Are external requirements (e.g. regulatory authorities ore costumes) that may impact the choice or rigorousness of the control measures described and updated?
Hazard identification and determination of acceptable levels
- Are all food safety hazards that are reasonably expected to occur in relation to the type of product, type of process and actual processing facilities identified and recorded?
Is the identification based on:
Is the consideration - when identifying the hazards - given to:
Hazard assessment
- 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?
- Is each food safety hazard evaluated according to the possible severity of adverse health effects and the likelihood of their occurrence?
- Is the methodology used for the hazard described?
- Are the results of the food safety hazard assessment recorded?
Selection and assessment of control measures
- 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?
- Is each of the selected control measures reviewed with respect to its effectiveness against the identified food safety hazards?
Is each selected control measure categorized as to whether it needs to be managed through operational
Establishing the operational prerequisite programmes (PRPs)
- Are the operational PRPs documented?
Are the operational PRPs included the following information for each programme:
HACCP plan
- Is the HACCP plan documented?
Is the HACCP plan included the following information for each identified critical control point (CCP)
Identification of critical control points
- Are CCP(s) identified for the control measures identified, for each hazard that is to be controlled by the HACCP plan?
Determination of critical limits forCCP(s)
- Are critical limits determined for the monitoring established for each CCP?
- 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?
- Are critical limits measurable?
- Are the rationale for the chosen critical limits documented?
- 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?
System for the monitoring of critical control points
- Is a monitoring system established for each CCP to demonstrate that the CCP is in control?
- Are all scheduled measurements or observations - relative to the critical limit(s) - included in the monitoring system?
Does the monitoring system consist of relevant procedures, instructions, and records that cover the f
Actions when monitoring results exceed critical limits
- Are planned corrections and corrective actions - to be taken when critical limits are exceeded - specified in the HACCP plan?
Do the actions ensure that:
Does the organization update the following information in operational PRP(s) and/or the HACCP plan, i
Updating of preliminary information and documents specifying the PRPs and the HACCP plan
- a) Product characteristics?
- b) Intended use?
- c) Flow diagrams?
- d) Process steps?
- e) Control measures?
- Are the HACCP plan and the procedures and instructions specifying the PRP(s) amended, if necessary?
Verification planning
- Does verification planning define the purpose, methods, frequencies, and responsibilities for the verification activities?
Do the verification activities confirm that:
Traceability system
- 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?
- Is the traceability system able to identify incoming material from the immediate suppliers and the initial distribution route of the end product?
- 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?
- Are records in accordance with statutory and regulatory requirements and customer requirements?
Corrections
- 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?
Is a documented procedure established and maintained defining:
Corrective actions
- 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?
- Are corrective actions initiated when critical limits are exceeded or when there is a lack of conformity with operational PRP(s)?
- 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.
- Are corrective actions recorded?
Does the organization handle nonconforming products by taking action(s) to prevent the nonconforming
Is each lot of product affected by the nonconformity released as safe only when any of the following
Evaluation for release
- a) Evidence other than the monitoring system demonstrates that the control measures have been effective?
- b) Evidence shows that the combined effect ofthe control measures for that particular product complies with the performanceintended?
- 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?
Is the lot of product - which is not acceptable for release - handled (after evaluation) by one of th
Disposition of nonconforming products
- a) Reprocessing or further processing within or outside the organization to ensure that the food safety hazard is eliminated or reduced to acceptable levels?
- b) Destruction and/or disposal as waste?
To enable and facilitate the complete and timely withdrawal of lots of end products which have been i
Withdrawals
- a) Has top management appointed personnel having the authority to initiate a withdrawal and personnel responsible for executing the withdrawal?
- 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?.
- 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?
- Are the cause, extent and result of a withdrawal recorded and reported to top management as input to the management review?
- 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)?
Please proceed to Section 8.
Does the organization validate (prior to implementation of control measures to be included in operati
Validation of control measure combinations
- a) The selected control measures are capable of achieving the intended control of the food safety hazard(s) for which they are designated?
- b) The control measures are effective and capable of, in combination, ensuring control of the identified food safety hazard(s) to obtain end products that meet the defined acceptable levels?
- 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?
- 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.
Control of monitoring and measuring
- Is there evidence that the specified monitoring and measuring methods and equipment are adequate to ensure the performance of the monitoring and measuring procedures?
Are the measuring equipment and methods used:
Does the organization conduct internal audits at planned intervals to determine whether the food safe
Internal audit
- 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?
- b) Is effectively implemented and updated?
- 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?
- Are the audit criteria, scope, frequency, and methods defined?
- Do the selection of auditors and the conduct of audits ensure objectivity and impartiality of the audit process?
- Is it ensured that auditors do not audit their own work?
- Are the responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records defined in documented procedure?
- 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?
- Do follow-up activities include the verification of the actions taken and the reporting of verification results?
Evaluation of individual verification results
- Does the food safety team systematically evaluate the individual results of planned verification?
- Does the organization take action to achieve the required conformity, when verification does not demonstrate conformity with the planned arrangements?
Does action – taken for achieving the required conformity – include (but is not limited to), review o
Analysis of results of verification activities
- Does the food safety team analyze the results of verification activities, including the results of the internal audits and external audits?
Is the analysis carried out in order
Continual improvement
- 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?
Updating the food safety management system
- Does top management ensure that the food safety management system is continually updated?
- Does the food safety team evaluate the food safety management system at planned intervals in order to achieve that FSMS is continually updated?
- Does the team consider whether it is necessary to review the hazard analysis, the established operational PRP(s) and the HACCP plan?
Are the evaluation and updating activities based on:
Recommendation
Inspector's Full name and Signature
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