ISO 22000 Audit Checklist

• Client / Site

• Conducted on (Date and Time)

  Date

• Inspected by

• Location
  Address

Food Safety Management System

General Requirements

• 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 FSMS maintained and updated?

  Yes

  No

  N/A

• Is the scope of the FSMS defined?

  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

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

  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

• 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

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

  Yes

  No

  N/A

Documentation Requirements

General

• 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

Control of documents

• 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:
  

• a) To approve documents for adequacy prior to issue?

  Yes

  No

  N/A

• b) To review and update as necessary and re-approve documents?

  Yes

  No

  N/A

• c) To ensure that changes and the current revision status of documents are identified?

  Yes

  No

  N/A

• d) To ensure that relevant versions of applicable documents are available at points of use?

  Yes

  No

  N/A

• e) To ensure that documents remain legible and readily identifiable?

  Yes

  No

  N/A

• f) To ensure that relevant documents of external origin are identified and their distribution controlled?

  Yes

  No

  N/A

• g) To prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose?

  Yes

  No

  N/A

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?

  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.

Management responsibility

Management commitment

• 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:

• a) Showing food safety is supported by the business objectives of the organization?

  Yes

  No

  N/A

• b) Communicating to the organization the importance of meeting the requirements of ISO 22000 standard, any relevant statutory and regulatory requirements, as well as customer requirements relating to food safety?

  Yes

  No

  N/A

• c) Establishing the food safety policy?

  Yes

  No

  N/A

• d) Conducting management reviews?

  Yes

  No

  N/A

• e) Ensuring the availability of resources?

  Yes

  No

  N/A

Food safety policy

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

  Yes

  No

  N/A

• Does top management ensure that the food safety policy:

• a) Is appropriate to the role of the organization in the food chain?

  Yes

  No

  N/A

• b) Conforms with both statutory and regulatory requirements and with mutually agreed food safety requirements of customers?

  Yes

  No

  N/A

• c) Is communicated, implemented and maintained at all levels of the organization?

  Yes

  No

  N/A

• d) Is reviewed for continued suitability?

  Yes

  No

  N/A

• e) Adequately addresses communication?

  Yes

  No

  N/A

• f) Is supported by measurable objectives?

  Yes

  No

  N/A

Food safety management system planning

• 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

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?

  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

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

  Yes

  No

  N/A

Food safety team leader

• 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.

Communication

External communication

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

• a) Suppliers and contractors?

  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

• 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

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

  Yes

  No

  N/A

Internal communication

• 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:

• a) Products or new products?

  Yes

  No

  N/A

• b) Raw materials, ingredients, and services?

  Yes

  No

  N/A

• c) Production systems and equipment?

  Yes

  No

  N/A

• d) Production premises, location of equipment, and surrounding environment?

  Yes

  No

  N/A

• e) Cleaning and sanitation programmes?

  Yes

  No

  N/A

• f) Packaging, storage and distribution systems?

  Yes

  No

  N/A

• g) Personnel qualification levels and/or allocation of responsibilities and authorizations?

  Yes

  No

  N/A

• h) Statutory and regulatory requirements?

  Yes

  No

  N/A

• i) Knowledge regarding food safety hazards and control measures?

  Yes

  No

  N/A

• j) Customer, sector, and other requirements that the organization observes?

  Yes

  No

  N/A

• k) Relevant inquiries from external interested parties?

  Yes

  No

  N/A

• l) Complaints indicating food safety hazards associated with the product?

  Yes

  No

  N/A

• m) Other conditions that have an impact on food safety?

  Yes

  No

  N/A

• Does the food safety team ensure that above mentioned information is included in the updating of the food safety management system?

  Yes

  No

  N/A

• Does top management ensure that relevant information is included as input to the management review?

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

Management review

General

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

  Yes

  No

  N/A

• Does this review include assessing opportunities for improvement and the need for changes to the food safety management system, including the food safety policy?

  Yes

  No

  N/A

• Are records from management reviews maintained?

  Yes

  No

  N/A

Review input

• Does the input to management review include information about:

• a) Follow-up actions from previous management reviews?

  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

• 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

Review output

• 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

Resource management

Provision of resources

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

  Yes

  No

  N/A

Human resources

General

• Are the food safety team and the other personnel carrying out activities having an impact on food safety, competent on the basis of appropriate education, training, skills and experience?

  Yes

  No

  N/A

• Are there available records of agreement or contracts defining the responsibility and authority of external experts, where the assistance of external experts is required for the development, implementation, operation or assessment of the food safety management system?

  Yes

  No

  N/A

Competence, awareness and training

• 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

Infrastructure

• 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

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?

  Yes

  No

  N/A

• Please proceed to Section 7.

Planning and realization of safe products

General

• Does the organization plan and develop the processes needed for the realization of safe products?

  Yes

  No

  N/A

• Does the organization implement, operate and ensure the effectiveness of the planned activities and any changes to those activities? Note: This includes PRP(s) as well as operational PRP(s) and/or the HACCP plan.

  Yes

  No

  N/A

Prerequisite programmes (PRPs)

• 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):

• a) Appropriate to the organizational needs with regard to food safety?

  Yes

  No

  N/A

• b) Appropriate to the size and type of the operation and the nature of the products being manufactured and/or handled?

  Yes

  No

  N/A

• c) Implemented across the entire production system, either as programmes applicable in general or as programmes applicable to a particular product or operational line?

  Yes

  No

  N/A

• d) Approved by the food safety team?

  Yes

  No

  N/A

• Does the organization identify statutory and regulatory requirements related to the above?

  Yes

  No

  N/A

• Does the organization consider and utilize appropriate information, when selecting and/or establishing PRP(s)?

  Yes

  No

  N/A

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

• a) Construction and layout of buildings and associated utilities?

  Yes

  No

  N/A

• b) Layout of premises, including workspace and employee facilities?

  Yes

  No

  N/A

• c) Supplies of air, water, energy and other utilities?

  Yes

  No

  N/A

• d) Supporting services, including waste and sewage disposal?

  Yes

  No

  N/A

• e) The suitability of equipment and its accessibility for cleaning, maintenance, and preventative maintenance?

  Yes

  No

  N/A

• f) Management of purchased materials (e.g. raw materials, ingredients, chemicals, and packaging), supplies (e.g. water, air, steam, and ice), disposals (e.g. waste and sewage) and handling of products (e.g. storage and transportation)?

  Yes

  No

  N/A

• g) Measures for the prevention of cross-contamination?

  Yes

  No

  N/A

• h) Cleaning and sanitizing?

  Yes

  No

  N/A

• i) Pest control?

  Yes

  No

  N/A

• j) Personal hygiene?

  Yes

  No

  N/A

• k) Other aspects as appropriate?

  Yes

  No

  N/A

• Is verification of PRP(s) planned?

  Yes

  No

  N/A

• Are PRP(s) modified as necessary?

  Yes

  No

  N/A

• Are records of verifications and modifications maintained?

  Yes

  No

  N/A

• Do documents specify how activities included in the PRP(s) are managed?

  Yes

  No

  N/A

Preliminary steps to enable hazard analysis

General

• Are all relevant information - needed to conduct the hazard analysis - collected, maintained, updated and documented?

  Yes

  No

  N/A

• Are the records related to hazard analysis maintained?

  Yes

  No

  N/A

Food safety team

• Has a food safety team been appointed?

  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

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

  Yes

  No

  N/A

Product characteristics

Raw material, ingredients, and product contacted material

• 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

• 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

• 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

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

Characteristics of end products

• 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

• 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

• 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

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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?

  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

Flow diagrams, process steps, and control measures

Flow diagrams

• 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

• Are flow diagrams clear, accurate and sufficiently detailed?

  Yes

  No

  N/A

• Do flow diagrams, as appropriate, include the following:

• a) The sequence and interaction of all steps in the operation?

  Yes

  No

  N/A

• b) Any outsourced processes and subcontracted work?

  Yes

  No

  N/A

• c) Where raw materials, ingredients, and intermediate products enter the flow?

  Yes

  No

  N/A

• d) Where reworking and recycling take place?

  Yes

  No

  N/A

• e) Where end products, intermediate products, byproducts, and waste are released or removed?

  Yes

  No

  N/A

• Does the food safety team verify the accuracy of the flow diagrams by on-site checking?

  Yes

  No

  N/A

• Are verified flow diagrams maintained as records?

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

• 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

Hazard analysis

General

• Does the food safety team conduct a hazard analysis to determine which hazards need to be controlled, the degree of control required to ensure food safety, and which combination of control measures is required?

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

• Is the identification based on:

• a) The preliminary information and data collected in preliminary steps to enable hazard analysis?

  Yes

  No

  N/A

• b) Experience?

  Yes

  No

  N/A

• c) External information including, to the extent possible, epidemiological and other historical data?

  Yes

  No

  N/A

• d) Information from the food chain on food safety hazards that may be of relevance for the safety of the end products, intermediate products, and the food at consumption?

  Yes

  No

  N/A

• Are the step(s) (from raw materials, processing, and distribution) - at which each food safety hazard may be introduced – indicated?

  Yes

  No

  N/A

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

• a) The steps preceding and following the specified operation?

  Yes

  No

  N/A

• b) The process equipment, utilities/services, and surroundings?

  Yes

  No

  N/A

• c) The preceding and following links in the food chain?

  Yes

  No

  N/A

• Are the acceptable level of the food safety hazard in the end product determined (whenever possible) for each of the food safety hazards identified?

  Yes

  No

  N/A

• Does the determined level take into account established statutory and regulatory requirements, customer food safety requirements, the intended use by the customer and other relevant data?

  Yes

  No

  N/A

• Are the justification for, and the result of, the determination of the acceptable level of the food safety hazard recorded?

  Yes

  No

  N/A

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?

  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

• Are the results of the food safety hazard assessment recorded?

  Yes

  No

  N/A

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?

  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:

• a) Its effect on identified food safety hazards relative to the strictness applied?

  Yes

  No

  N/A

• b) Its feasibility for monitoring (e.g. ability to be monitored in a timely manner to enable immediate corrective actions)?

  Yes

  No

  N/A

• c) It is placed within the system relative to other control measures?

  Yes

  No

  N/A

• d) The likelihood of failure in the functioning of a control measure or significant processing variability?

  Yes

  No

  N/A

• e) The severity of the consequence(s) in the case of failure in its functioning?

  Yes

  No

  N/A

• f) Whether the control measure is specifically established and applied to eliminate or significantly reduce the level of hazard(s)?

  Yes

  No

  N/A

• g) Synergistic effects (i.e. interaction that occurs between two or more measures resulting in their combined effect being higher than the sum of their individual effects)?

  Yes

  No

  N/A

• Are control measures - categorized as belonging to the HACCP plan – implemented?

  Yes

  No

  N/A

• Are other control measures implemented as operational PRPs?

  Yes

  No

  N/A

• Are the methodology and parameters - used for this categorization - described in documents?

  Yes

  No

  N/A

• Are the results of the assessment recorded?

  Yes

  No

  N/A

Establishing the operational prerequisite programmes (PRPs)

• Are the operational PRPs documented?

  Yes

  No

  N/A

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

• a) Food safety hazard(s) to be controlled by the programme?

  Yes

  No

  N/A

• b) Control measure(s)?

  Yes

  No

  N/A

• c) Monitoring procedures that demonstrate that the operational PRPs are in place?

  Yes

  No

  N/A

• d) Corrections and corrective actions to be taken if monitoring shows that the operational PRPs are not in control?

  Yes

  No

  N/A

• e) Responsibilities and authorities?

  Yes

  No

  N/A

• f) Record(s) of monitoring?

  Yes

  No

  N/A

Establishing the HACCP plan

HACCP plan

• Is the HACCP plan documented?

  Yes

  No

  N/A

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

• a) Food safety hazard(s) to be controlled at the CCP?

  Yes

  No

  N/A

• b) Control measure(s)?

  Yes

  No

  N/A

• c) Critical limit(s)?

  Yes

  No

  N/A

• d) Monitoring procedure(s)?

  Yes

  No

  N/A

• e) Corrections and corrective action(s) to be taken if critical limits are exceeded?

  Yes

  No

  N/A

• f) Responsibilities and authorities?

  Yes

  No

  N/A

• g) Record(s) of monitoring?

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

Determination of critical limits forCCP(s)

• 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 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

System for the monitoring of critical control points

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

  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

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

• a) Measurements or observations that provide results within an adequate time frame?

  Yes

  No

  N/A

• b) Monitoring devices used?

  Yes

  No

  N/A

• c) Applicable calibration methods?

  Yes

  No

  N/A

• d) Monitoring frequency?

  Yes

  No

  N/A

• e) Responsibility and authority related to monitoring and evaluation of monitoring results?

  Yes

  No

  N/A

• f) Record requirements and methods?

  Yes

  No

  N/A

• Are the monitoring methods and frequency capable of determining when the critical limits have been exceeded in time for the product to be isolated before it is used or consumed?

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

• Do the actions ensure that:

• a) The cause of nonconformity is identified?

  Yes

  No

  N/A

• b) The parameter(s) controlled at the CCP is (are) brought back under control?

  Yes

  No

  N/A

• c) Recurrence is prevented?

  Yes

  No

  N/A

• Are documented procedures established and maintained for the appropriate handling of potentially unsafe products to ensure that they are not released until they have been evaluated?

  Yes

  No

  N/A

Updating of preliminary information and documents specifying the PRPs and the HACCP plan

• 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

• 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

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

  Yes

  No

  N/A

Verification planning

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

  Yes

  No

  N/A

• Do the verification activities confirm that:

• a) The PRP(s) are implemented?

  Yes

  No

  N/A

• b) Input to the hazard analysis is continually updated?

  Yes

  No

  N/A

• c) The operational PRP(s) and the elements within the HACCP plan are implemented and effective, d) hazard levels are within identified acceptable levels?

  Yes

  No

  N/A

• e) Other procedures required by the organization are implemented and effective?

  Yes

  No

  N/A

• Is the output of verification planning in a form suitable for the organization's method of operations?

  Yes

  No

  N/A

• Are verification results recorded and communicated to the food safety team?

  Yes

  No

  N/A

• Are verification results provided on such way to enable the analysis of the results of the verification activities?

  Yes

  No

  N/A

• Are the affected lots of product handled as potentially unsafe, if system verification is based on testing of end product samples, and where such test samples show lack of conformity with the acceptable level of the food safety hazard?

  Yes

  No

  N/A

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?

  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

• 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

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

  Yes

  No

  N/A

Control of nonconformity

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?

  Yes

  No

  N/A

• Is a documented procedure established and maintained defining:

• a) The identification and assessment of affected end products to determine their proper handling?

  Yes

  No

  N/A

• b) A review of the corrections carried out?

  Yes

  No

  N/A

• Are potentially unsafe products - manufactured under conditions where critical limits have been exceeded - handled?

  Yes

  No

  N/A

• Are products - manufactured under conditions where operational PRP(s) have not been conformed with - evaluated with respect to the cause(s) of the nonconformity and to the consequences thereof in terms of food safety?

  Yes

  No

  N/A

• Are these products, where necessary, handled?

  Yes

  No

  N/A

• Is the evaluation recorded?

  Yes

  No

  N/A

• Are all corrections approved by the responsible person(s), and recorded together with information on the nature of the nonconformity, its cause(s) and consequence(s), including information needed for traceability purposes related to the nonconforming lots?

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

• 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

• 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?<br>Note:<br>These actions include <br>a) reviewing nonconformities (including customer complaints), <br>b) reviewing trends in monitoring results that may indicate development towards loss of control, <br>c) determining the cause(s) of nonconformities,<br>d) evaluating the need for action to ensure that nonconformities do not recur,<br>e) determining and implementing the actions needed,<br>f) recording the results of corrective actions taken, and<br>g) reviewing corrective actions taken to ensure that they are effective.

  Yes

  No

  N/A

• Are corrective actions recorded?

  Yes

  No

  N/A

Handling of potentially unsafe products

General

• 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

• a) The food safety hazard(s) of concern has(ve) been reduced to the defined acceptable levels?

  Yes

  No

  N/A

• b) The food safety hazard(s) of concern will be reduced to identified acceptable levels prior to entering into the food chain?

  Yes

  No

  N/A

• c) The product still meets the defined acceptable level(s) of the food safety hazard(s) of concern despite the nonconformity?

  Yes

  No

  N/A

• Are all lots of product - that may have been affected by a nonconforming situation - held under control of the organization until they have been evaluated?

  Yes

  No

  N/A

• Does the organization notify relevant interested parties and initiate a withdrawal, if products that have left the control of the organization are subsequently determined to be unsafe? Note: The term “withdrawal” includes recall.

  Yes

  No

  N/A

• Are the controls and related responses and authorization for dealing with potentially unsafe products documented?

  Yes

  No

  N/A

Evaluation for release

• 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

Disposition of nonconforming products

• 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

Control of nonconformity

Withdrawals

• 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

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

  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

• 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

• 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.

Validation, verification, and improvement of the FSMS

General

• Does the food safety team plan and implement the processes needed to validate control measures and/or control measure combinations, and to verify and improve the food safety management system?

  Yes

  No

  N/A

Validation of control measure combinations

• 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

• 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

• 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

• 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

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?

  Yes

  No

  N/A

• Are the measuring equipment and methods used:

• a) Calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards? Note: Where necessary to ensure valid results

  Yes

  No

  N/A

• b) Adjusted or re-adjusted as necessary?

  Yes

  No

  N/A

• c) Identified to enable the calibration status to be determined?

  Yes

  No

  N/A

• d) Safeguarded from adjustments that would invalidate the measurement results?

  Yes

  No

  N/A

• e) Protected from damage and deterioration?

  Yes

  No

  N/A

• Are records of the results of calibration and verification maintained?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Does the organization take action appropriate for the equipment and any product affected, If the measuring equipment is non-conforming?

  Yes

  No

  N/A

• Are records of such assessment and resulting actions maintained?

  Yes

  No

  N/A

• Is the ability of computer software confirmed to satisfy the intended application when used in the monitoring and measurement of specified requirements?

  Yes

  No

  N/A

• Is the confirmation of computer software undertaken prior to initial use and reconfirmed as necessary?

  Yes

  No

  N/A

FSMS verification

Internal audit

• 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

• b) Is effectively implemented and updated?

  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

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

  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

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

  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

• 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

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

  Yes

  No

  N/A

Evaluation of individual verification results

• 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:

• a) Existing procedures and communication channels?

  Yes

  No

  N/A

• b) The conclusions of the hazard analysis, the established operational PRP(s) and the HACCP plan?

  Yes

  No

  N/A

• c) The PRP(s)?

  Yes

  No

  N/A

• d) The effectiveness of human resource management and of training activities?

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

• Is the analysis carried out in order

• a) To confirm that the overall performance of the system meets the planned arrangements and the food safety management system requirements established by the organization?

  Yes

  No

  N/A

• b) To identify the need for updating or improving the food safety management system?

  Yes

  No

  N/A

• c) To identify trends which indicate a higher incidence of potentially unsafe products?

  Yes

  No

  N/A

• d) To establish information for planning of the internal audit programme concerning the status and importance of areas to be audited?

  Yes

  No

  N/A

• e) To provide evidence that any corrections and corrective actions that have been taken are effective?

  Yes

  No

  N/A

• Are the results of the analysis and the resulting activities recorded and reported, in an appropriate manner, to top management as input to the management review?

  Yes

  No

  N/A

• Are the results of the analysis and the resulting activities used as an input for updating the food safety management system?

  Yes

  No

  N/A

Improvement

Continual improvement

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

  Yes

  No

  N/A

Updating the food safety management system

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

  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

• Are the evaluation and updating activities based on:

• a) Input from communication, external as well as internal?

  Yes

  No

  N/A

• b) Input from other information concerning the suitability, adequacy, and effectiveness of the food safety management system?

  Yes

  No

  N/A

• c) Output from the analysis of results of verification activities?

  Yes

  No

  N/A

• d) Output from management review?

  Yes

  No

  N/A

• Are system updating activities recorded and reported, in an appropriate manner, as input to the management review?

  Yes

  No

  N/A

Completion

• Recommendation

• Inspector's Full name and Signature

  Sign