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ISO 22000 Internal Audit Checklist
Section 1: Management Responsibility
1. 1. Is there evidence to show management commitment to Food Safety system application? Are these shown in the related objectives? Are objectives measurable?
Yes
No
N/A
2. 2. Does the organisation have a food safety policy?
Yes
No
N/A
3. 3. Has a HACCP plan been developed? Does the plan cover all end products?
Yes
No
N/A
4. 4. Has a multidisciplinary Food Safety team been formed?
Yes
No
N/A
5. 5. Have the organisation appointed a Food Safety team leader and defined the responsibilities and authorities?
Yes
No
N/A
6. 6. Does the organisation define the responsibility and authority of the Food Safety team?
Yes
No
N/A
7. 7. Is the knowledge of the Food Safety team suitable and appropriate?
Yes
No
N/A
8. 8. How is internal and external communication controlled and who has responsibility? Is the communication effective?
Yes
No
N/A
9. 9. Do the company have emergency preparedness and response procedures in place? Have they been verified?
Yes
No
N/A
10. 10. Is a Management Review activity carried out as required? Is it effective?
Yes
No
N/A
Section 2: Product Specification
1. 1. Has the product or product range been fully described?
Yes
No
N/A
2. 2. Does the specification include safety information (such as PH, aw, etc.)?
Yes
No
N/A
3. 3. Does the specification include details of raw material and ingredients?
Yes
No
N/A
4. 4. Does the specification include the type of packaging?
Yes
No
N/A
5. 5. Does the specification include the storage conditions?
Yes
No
N/A
6. 6. Does the specification include labelling instruction?
Yes
No
N/A
7. 7. Does the specification include the method of distribution (in detail)?
Yes
No
N/A
8. 8. Does the specification include shelf life and storage conditions?
Yes
No
N/A
9. 9. Does the specification include the intended use?
Yes
No
N/A
10. 10. Does the specification include the appropriate consumer?
Yes
No
N/A
11. 11. Does the specification include the specific methods of use?
Yes
No
N/A
Section 3: Process Flow Diagram
1. 1. Is the process flow diagram comprehensive?
Yes
No
N/A
2. 2. Are all raw materials, ingredients, packaging materials and process/storage activities included in the process flow diagram?
Yes
No
N/A
3. 3. Have changes been made since the process flow diagram was established?
Yes
No
N/A
4. 4. How does the HACCP team get notified of changes to the process or product parameters?
Yes
No
N/A
5. 5. How were the changes recorded and approved?
Yes
No
N/A
6. 6. Were any changes discussed with HACCP team before implementation?
Yes
No
N/A
7. 7. Has the process flow diagram been verified on-site for the compliance with the actual operation?
Yes
No
N/A
Section 4: Hazards Analysis And Preventive Measures
1. 1. How was the hazard analysis conducted?
2. 2. Have all hazards been evaluated qualitatively and/or quantitatively?
Yes
No
N/A
3. 3. Have all raw materials been included?
Yes
No
N/A
4. 4. Have all process steps been considered?
Yes
No
N/A
5. 5. Have the hazards been specifically identified or just in general?
6. 6. How did the team assess the likelihood of occurrence?
7. 7. What information sources were utilised?
8. 8. Have appropriate preventive measures been set up for each hazard?
Yes
No
N/A
9. 9. Do the measures prevent or reduce to an acceptable level the hazards and how were the measures were validated?
Yes
No
N/A
10. 10. Are all preventive measures in place at the plant level?
Yes
No
N/A
Section 5: Critical Control Points
1. 1. How were the CCPÕs identified?
2. 2. By the use of a CCP decision tree?
Yes
No
N/A
3. 3. Have all necessary CCPÕs been identified?
Yes
No
N/A
Section 6: Critical Limits
1. 1. Have critical limits been established for each CCP?
Yes
No
N/A
2. 2. How were the critical limits established? Is there evidence? (national/ international standard, requirements of relevant legislation, experimental data, literature references etc)?
3. 3. What validation exists to confirm that the critical limits can prevent possible occurrence of hazards?
4. 4. How does the organisation differentiate the critical limits from operational limits?
5. 5. Are the critical limits implemented at plant level?
Yes
No
N/A
Section 7: Monitoring Procedures
1. 1. Have monitoring procedures been established for all CCP's established?
Yes
No
N/A
2. 2. Is there any evidence that procedures are being followed consistently?
Yes
No
N/A
3. 3. What is the status of monitoring equipment?
4. 4. Are the sampling plans statistically valid?
Yes
No
N/A
5. 5. Have the organisation a clear system for product identification of product to ensure traceability if deviation occurs?
Yes
No
N/A
6. 6. Have the organisation taken any actions when deviation occurred?
Yes
No
N/A
7. 7. Are monitoring personnel trained and qualified?
Yes
No
N/A
8. 8. Have monitoring results been recorded?
Yes
No
N/A
Section 8: Corrective Actions
1. 1. Are the corrective action procedures in place?
Yes
No
N/A
2. 2. What evidence is there to demonstrate that effective corrective actions are taken in the event of a CCP deviation?
3. 3. Has the responsibility and authority for corrective action been defined?
Yes
No
N/A
4. 4. How non-conforming product controlled and recorded?
Yes
No
N/A
5. 5. How does the organisation dispose of any affected products?
6. 6. Has corrective action been recorded and how is the effectiveness verified?
7. 7. Do these corrective actions consider modifying the process or HACCP plan, if the critical limit is violated consistently
Yes
No
N/A
Section 9: Verification Procedures
1. 1. Have verification procedures been established?
Yes
No
N/A
2. 2. Have the responsibilities, authorities, methods, frequency and type of verification been defined in the procedures?
Yes
No
N/A
3. 3. Are the methods and frequency sufficient to ensure that the system is working correctly, effectively and complies with relevant regulations.
Yes
No
N/A
4. 4. How did the organisation conduct the initial validation of HACCP plan
5. 5. Do the procedures include review of records?
Yes
No
N/A
6. 6. Is there a regular review of CCP failure and product dispositions?
Yes
No
N/A
7. 7. Do the procedures include calibration of monitoring and measuring equipment?
Yes
No
N/A
8. 8. Have personnel responsible for verification been trained?
Yes
No
N/A
9. 9. Do the procedures include evaluation of customer and consumer complaints?
Yes
No
N/A
10. 10. Is there a regular review of results of sanitation control procedures?
Yes
No
N/A
11. 11. How is the data from verification being used to improve the HACCP system?
Section 10: Documentation And Record Keeping
1. 1. What procedure does the organisation follow to manage system documents?
2. 2. Does the documentation cover all of the HACCP system operation?
Yes
No
N/A
3. 3. Have documents been properly approved by authorised personnel before issue?
Yes
No
N/A
4. 4. How is the documentation controlled?
5. 5. Has the organization obtained related codes, standards, legislation and regulation to the food product?
Yes
No
N/A
6. 6. How does the organisation control document changes? Are all documents current?
7. 7. Are the records accessible?
Yes
No
N/A
8. 8. Are the HACCP records clearly identified?
Yes
No
N/A
9. 8. Are the HACCP records clearly identified?
Yes
No
N/A
10. 9. Has the documentation and record control system been set up in consideration of the size and nature of the organization?
Yes
No
N/A
11. 9. Has the documentation and record control system been set up in consideration of the size and nature of the organization?
Yes
No
N/A
12. 10. Are the HACCP records retained in the proper conditions to prevent damage, deterioration or loss?
Yes
No
N/A
13. 10. Are the HACCP records retained in the proper conditions to prevent damage, deterioration or loss?
Yes
No
N/A
14. 11. How long does the organization retain the records?
15. 11. How long does the organization retain the records?
Section 11: Training
1. 1. Have they developed a training procedure for identifying training needs and training personnel?
Yes
No
N/A
2. 1. Have they developed a training procedure for identifying training needs and training personnel?
Yes
No
N/A
3. 2. Does the organisation have training plans?
Yes
No
N/A
4. 2. Does the organisation have training plans?
Yes
No
N/A
5. 3. How many personnel have been trained in HACCP principles and the relevant legislation and regulations?
6. 3. How many personnel have been trained in HACCP principles and the relevant legislation and regulations?
7. 4. How many personnel have been trained to perform internal audits?
8. 4. How many personnel have been trained to perform internal audits?
9. 5. How does the organization train personnel on sanitation control?
10. 5. How does the organization train personnel on sanitation control?
11. 6. How does the organisation verify the effectiveness of training?
12. 6. How does the organisation verify the effectiveness of training?
Section 12: Recall
1. 1. Does the organisation have a procedure to manage product recall?
Yes
No
N/A
2. 1. Does the organisation have a procedure to manage product recall?
Yes
No
N/A
3. 2. In what circumstance do the products need to be recalled?
4. 2. In what circumstance do the products need to be recalled?
5. 3. Have the responsibility and authority been defined?
Yes
No
N/A
6. 3. Have the responsibility and authority been defined?
Yes
No
N/A
7. 4. Has there been a full or partial product recall?
Yes
No
N/A
8. 4. Has there been a full or partial product recall?
Yes
No
N/A
9. 5. How many products were concerned?
10. 5. How many products were concerned?
11. 6. What was the reason?
12. 6. What was the reason?
13. 7. How did the organisation handle these products?
14. 7. How did the organisation handle these products?
15. 8. How did the organisation ensure all affected product was identified and recalled?
16. 8. How did the organisation ensure all affected product was identified and recalled?
Section 13: Complaint
1. 1. Does the organisation have a procedure to deal with all consumer and customer complaints?
Yes
No
N/A
2. 1. Does the organisation have a procedure to deal with all consumer and customer complaints?
Yes
No
N/A
3. 2. Have the responsibility and authority been defined?
Yes
No
N/A
4. 2. Have the responsibility and authority been defined?
Yes
No
N/A
5. 3. Did the complaints concern product safety?
Yes
No
N/A
6. 3. Did the complaints concern product safety?
Yes
No
N/A
7. 4. What actions have the organisation taken?
8. 4. What actions have the organisation taken?
9. 5. Have these complaints been documented?
Yes
No
N/A
10. 5. Have these complaints been documented?
Yes
No
N/A
11. 6. Have these complaints been utilized for verification of the system?
Yes
No
N/A
12. 6. Have these complaints been utilized for verification of the system?
Yes
No
N/A
Section 14: Sanitation Control
1. 1. Does the organisation have documented hygiene control procedures?
Yes
No
N/A
2. 1. Does the organisation have documented hygiene control procedures?
Yes
No
N/A
3. 2. Has the organisation tested water quality, how often and by whom?
Yes
No
N/A
4. 2. Has the organisation tested water quality, how often and by whom?
Yes
No
N/A
5. 3. Do the hygiebe control procedures cover all aspects of sanitation and hygiene?
Yes
No
N/A
6. 3. Do the hygiebe control procedures cover all aspects of sanitation and hygiene?
Yes
No
N/A
7. 4. Does the condition of food contact surfaces meet the requirement of hygiene?
Yes
No
N/A
8. 4. Does the condition of food contact surfaces meet the requirement of hygiene?
Yes
No
N/A
9. 5. Have sanitation procedures been verified for effectiveness?
Yes
No
N/A
10. 5. Have sanitation procedures been verified for effectiveness?
Yes
No
N/A
11. 6. Is the layout, flow of material and personnel sufficient to prevent cross contamination?
Yes
No
N/A
12. 6. Is the layout, flow of material and personnel sufficient to prevent cross contamination?
Yes
No
N/A
13. 7. What actions did the organisation take when the procedures were violated?
14. 7. What actions did the organisation take when the procedures were violated?
15. 8. How does the organisation maintain these facilities?
16. 8. How does the organisation maintain these facilities?
17. 9. Are packaging materials stored in good condition?
Yes
No
N/A
18. 9. Are packaging materials stored in good condition?
Yes
No
N/A
19. 10. Has the organisation appointed personnel responsible for toxic compounds?
Yes
No
N/A
20. 10. Has the organisation appointed personnel responsible for toxic compounds?
Yes
No
N/A
21. 11. Are there any procedures to control employee health and sanitation condition?
Yes
No
N/A
22. 11. Are there any procedures to control employee health and sanitation condition?
Yes
No
N/A
23. 12. Does the organisation have a pest control plan/system?
Yes
No
N/A
24. 12. Does the organisation have a pest control plan/system?
Yes
No
N/A
25. 13. Are walls and floors in good condition?
Yes
No
N/A
26. 13. Are walls and floors in good condition?
Yes
No
N/A
27. 14. How does the organisation control waste?
28. 14. How does the organisation control waste?
Section 15: Internal HACCP Audit
1. 1. Does the organisation have an internal audit plan for HACCP?
Yes
No
N/A
2. 1. Does the organisation have an internal audit plan for HACCP?
Yes
No
N/A
3. 2. At what frequency does the organisation conduct internal audits?
4. 2. At what frequency does the organisation conduct internal audits?
5. 3. Have the audit purpose, criteria, scope and methods been defined?
Yes
No
N/A
6. 3. Have the audit purpose, criteria, scope and methods been defined?
Yes
No
N/A
7. 4. How does the organisation ensure that the program covers all aspects of HACCP system?
8. 4. How does the organisation ensure that the program covers all aspects of HACCP system?
9. 5. Have the auditors been trained?
Yes
No
N/A
10. 5. Have the auditors been trained?
Yes
No
N/A
11. 6. Have the responsibilities and requirements for audit been defined?
Yes
No
N/A
12. 6. Have the responsibilities and requirements for audit been defined?
Yes
No
N/A
13. 7. How does the organisation ensure the independence and impartiality of the activities?
Yes
No
N/A
14. 7. How does the organisation ensure the independence and impartiality of the activities?
Yes
No
N/A
15. 8. Have the purposes of audit been achieved?
Yes
No
N/A
16. 8. Have the purposes of audit been achieved?
Yes
No
N/A
17. 9. Is the audit data utilised for improvement of the HACCP system?
Yes
No
N/A
18. 9. Is the audit data utilised for improvement of the HACCP system?
Yes
No
N/A
19. 10. Have the audit results been documented?
Yes
No
N/A
20. 10. Have the audit results been documented?
Yes
No
N/A