HACCP Audit Checklist

Use this HACCP Audit Checklist template to assess your HACCP plan and food safety procedures, in preparation for an external audit or certification.

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HACCP Audit Checklist

Control Of Documents

Internal Audit

Site Standards

Purchasing

Control Of Production

Validation Of The Production Process

Identification And Traceability

Control Of Monitoring And Measuring Devices

Monitoring And Measurement Of Processes

Monitoring And Measurement Of The Product

Storage Of Product

Customer Satisfaction

Management Commitment

Control Of Non-Conforming Product

6. Are there documented procedures that establish requirements for reviewing and preventing non-conformities, including customer complaints, determining the reason for nonconformity, taking action to prevent reoccurrence of nonconformity, and recording the results of actions taken?

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Internal Communication

Training

Management Review

1. Does the management review include: • audit results • customer feedback • process performance and product conformity • status of preventive and corrective action • follow-up action from previous management reviews • planned changes that could affect the quality system • recommendations for improvement

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HACCP

2. Has the HACCP team undergone training, and is the training documented for the following: Did the individual developing the hazard analysis, including delineating control measures, successfully complete training in the application of HACCP principles?

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17. Does the hazard analysis list the following hazards:Did the hazard analysis consider possible sources of adulteration, including all process steps such as packaging, storage, transportation, intended use, facility and equipment function and design, and plant sanitation, including human hygiene?

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24. Does the HACCP plan include corrective action plans : Does the corrective action plan describe steps to be taken and assign responsibility in response to deviations from the critical limits, ensuring adulterated product is not distributed or used after the deviation has been identified and before corrective action has been taken, and correcting the deviation?

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25. Does the HACCP plan include corrective action plans : For deviations that occur and the site doesn't have a corrective action plan, are products segregated and held, tested for acceptability, and not used until the product is brought into conformance with the HACCP plan?

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26. Does the HACCP plan include corrective action plans : For deviations that occur and the site doesn't have a corrective action plan, is the cause for the deviation corrected and verified by a trained individual to determine whether the HACCP plan requires modification?

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32. Does the HACCP plan list validation and verification procedures along with their frequency : Is there verification, within 7 days, that critical control point monitoring records were completed, signed, and documented values were within the critical limits?

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33. Does the HACCP plan list validation and verification procedures along with their frequency : Is there verification, within 7 days, that critical control point monitoring records were completed, signed, and documented values were within the critical limits?

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36. Does the HACCP plan list validation and verification procedures along with their frequency : If no significant hazards have been identified, is a reassessment of the hazard analysis adequacy performed annually or after process modification by individuals trained and recorded?

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Quality Manual

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Checklist by GoAudits.com – Please note that this checklist is intended as an example. We do not guarantee compliance with the laws applicable to your territory or industry. You should seek professional advice to determine how this checklist should be adapted to your workplace or jurisdiction.

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HACCP Audit Checklist

Use this HACCP Audit Checklist template to assess your HACCP plan and food safety procedures, in preparation for an external audit or certification.

1. Are document control procedures confirmed, approved for adequacy before use, updated, re-approved, and clearly identified with the current version?

2. Are the records controlled (identify which records are needed and how long they are kept)?

3. Are records, such as those related to Good Manufacturing Practices (GMPs), production records, and master record files, actively maintained as appropriate to the specific product?

1. Are Internal audits performed at scheduled intervals to assess the effectiveness of the Quality Management System (QMS)?

2. Is a specific group of personnel identified and adequately trained to carry out internal audits?

3. Is there documentation available that confirms the implementation of corrective and preventive actions as a result of internal audit findings?

1. Are there established procedures for the review and evaluation of food safety hazards in the event of new or changed facilities at the site?

2. Are buildings and grounds adequately and routinely maintained?

3. Are the buildings consistently kept in a reasonably clean and orderly manner?

4. Are measures taken in the construction of buildings to minimize access to rodents, birds, and other pests?

5. Do the buildings provide sufficient space and lighting for their intended purposes?

6. Is all equipment maintained in a reasonable and orderly manner?

7. Is all equipment at the facility of suitable size, design, construction, precision, and accuracy for its intended use?

8. Is all equipment maintained to prevent lubricants and coolants introduction as unsafe additives to food?

9. Is all equipment designed, constructed, and maintained to facilitate inspection and use of cleanout procedures?

10. Are work areas and equipment used for the manufacture and storage of food kept separate from chemicals?

11. Is all equipment cleaned to prevent unsafe contamination of food?

12. Are there procedures in place controlling the calibration of equipment?

13. Is there a master sheet of all types of equipment?

1. Is there evidence within the documentation that ingredient specifications are consistently provided to suppliers?

2. Are traceability procedures in place to facilitate a product recall if needed?

3. Are there established inspection procedures or other inspection activities to ensure that purchased materials adhere to specified specifications, including measures to prevent contamination?

1. Is a master record file maintained for each product which includes product specifications, formulation, label, and special manufacturing instructions?

2. Are the frequency and quantity of samples required during production for each batch determined and documented?

3. Are proper identification and date of manufacture provided?

4. Are production records maintained, including formulation, date of production, and date of shipment, to facilitate recall procedures if necessary?

5. Are work instructions for proper manufacturing procedures available to personnel?

6. Are production records inspected for accuracy at scheduled intervals?

7. Is the equipment suitable for manufacturing products to specification?

8. Are monitoring devices available and used?

1. Are validation procedures in place and conform to science-based performance standards?

1. Is the finished product properly packaged and labeled for identification, including name, product description, net weight (or bulk statement), lot number, shelf life date, and all label regulatory requirements?

2. Are procedures for product traceability documented?

3. Are retained samples identified for traceability (shelf life)?

1. Are monitoring and measuring devices used in the manufacturing process properly maintained, calibrated, and recorded?

2. Are the instrumentation and devices used for calibrating monitoring and measuring devices verified at specified intervals against a standard?

1. Have monitoring procedures been established to evaluate the manufacturing processes, where deemed appropriate?

2. Have scheduled monitoring activities been established?

1. Are procedures in place that ensure the product conforms to the requirement?

1. Are products identified, stored, handled, and controlled to maintain identity and integrity?

1. Are there established procedures for recording and evaluating complaints?

1. Does senior management ensure that responsibilities and authorities are defined and effectively communicated within the company?

1. Are procedures established to control non-conforming products?

2. Is a non-conforming product identified and stored in a specified location?

3. Is there documentation of the final disposition of non-conforming products, which may include rework and re-verification?

4. Are procedures established for product recall or customer notification in case of a non-conforming product after delivery?

5. Are there established procedures for handling returned goods?

6. Are there documented procedures that establish requirements for reviewing and preventing non-conformities, including customer complaints, determining the reason for nonconformity, taking action to prevent reoccurrence of nonconformity, and recording the results of actions taken?

1. Is there a well-established communication and reporting channel between senior management and personnel?

1. Are records available that demonstrate the competence and training of personnel?

2. Are job descriptions available that include the responsibilities and skills required for each employee?

3. Are personnel adequately trained in personal hygiene where necessary to avoid contamination?

4. Is there a training matrix in place?

5. Are procedures established for refreshing training when necessary?

6. Are training records available for personnel dealing with Critical Control Points (CCPs)?

1. Has the HACCP team undergone training, and is the training documented for the following: Are the names of HACCP team members included, along with their training and job experience that qualifies them in the application of HACCP principles?

2. Has the HACCP team undergone training, and is the training documented for the following: Did the individual developing the hazard analysis, including delineating control measures, successfully complete training in the application of HACCP principles?

3. Has the HACCP team undergone training, and is the training documented for the following: Did the individual developing a HACCP plan that is appropriate for a specific site complete training in the application of HACCP principles?

4. Has the HACCP team undergone training, and is the training documented for the following: Did the individual verifying and modifying the HACCP plan successfully complete training in the application of HACCP principles?

5. Has the HACCP team undergone training, and is the training documented for the following:Did the individual performing the record review successfully complete training in the application of HACCP principles?

6. Is the HACCP plan specifically tailored to the location and site?

7. Is the HACCP plan designed to be specific to the ingredient, food, or process?

8. If ingredients, food, or processes are grouped in a single plan, is there evidence that they share common hazards?

9. Does the hazard analysis list the following hazards: Does the written hazard analysis, possibly in table form, identify hazards for each process step or include the statement "none identified at this time"?

10. Does the hazard analysis list the following hazards:Is the written hazard evaluation science-based, considering hazard frequency and severity, and performed for every identified hazard?

11. Does the hazard analysis list the following hazards:Have the control measures for significant hazards been identified?

12. Does the hazard analysis list the following hazards:For significant hazards, do prerequisite programs exist and are they correctly referenced in the HACCP plan?

13. Does the hazard analysis list the following hazards:Did the hazard analysis procedure include an evaluation of Standard Operating Procedures (SOPs), and were modifications performed if necessary?

14. Does the hazard analysis list the following hazards:Are there identified critical control points for significant hazards?

15. Does the hazard analysis list the following hazards:Does the hazard analysis consider both external and internal hazards

16. Does the hazard analysis list the following hazards:Is there evidence that the HACCP team considered, at a minimum, biological, chemical, and physical hazards listed in this section?

17. Does the hazard analysis list the following hazards:Did the hazard analysis consider possible sources of adulteration, including all process steps such as packaging, storage, transportation, intended use, facility and equipment function and design, and plant sanitation, including human hygiene?

18. Have all identified hazards been evaluated for their significance?

19. Are Critical Control Points (CCPs) assigned for significant hazards?

20. If applicable to the process flow and hazard evaluation, are CCPs assigned for significant hazards outside the site?

21. Are critical limits identified for each CCP?

22. Do procedures exist for monitoring each CCP?

23. Does the monitoring frequency ensure adherence to the critical limits?