Chapter 11

1. Chapter 11 Principle 7: Record-Keeping Procedures

2. In this chapter you will learn: • What records are needed • How to develop appropriate records • How to conduct a record review • How computerized records may be used

3. Six types of records are needed in a HACCP system: 1) The HACCP plan and supporting documentation 2) CCP monitoring records 3) Corrective action records 4) Verification records 5) Sanitation control records 6) Importer verification records

4. 1) The HACCP plan and its supporting documentation

5. Examples of HACCP Plan Support Documents: • Data from published scientific studies • Data from in-plant studies conducted by processing authorities • Data from equipment manufacturers or other authorities • Data gathered in the Preliminary Steps • Pre-requisite programs including sanitation control procedures • Written hazard analysis worksheets

6. 2) CCP monitoring records HACCP monitoring records are used to document that food safety hazards have been controlled at each CCP.

7. Information required on HACCP monitoring records: • Title of record (e.g. Shellfish Receiving Log) • Firm name and location • Product identification (if applicable) • Date and time of monitoring observation • Actual measurement or observation taken • Signature or initials of the person performing the monitoring activity • Signature of the trained person reviewing the monitoring record and the date of review

8. Monitoring Record Examples – Go to page 146

9. 3) Corrective action records

10. 4) Verification records

11. Verification Records document the results of: • Accuracy checks and calibration of process-monitoring instruments • Record reviews • Laboratory test results • In-plant studies or challenge tests • Audits and inspections

12. Electronic or computerized monitoring records must be equivalent to paper records and handwritten signatures.

13. An effective electronic record keeping system must: • Be authentic, accurate and protected; • Provide accurate and complete copies of records; • Protect records for later retrieval; • Limit access to authorized individuals; • Provide a secure record audit trail; and • Be reviewed by HACCP trained individual.

14. Daily Cooker Temperature Log – Go to page 150

15. Continuous temperature record with periodic monitoring – Go to page 151

16. Weigh/Pack/Label Log (Monitoring Record) - Go to page 152

17. Corrective Action Report (Corrective Action Record) • Go to page 152

18. Daily Thermometer Accuracy Log (Verification Record) - Go to page153

19. Quarterly Thermometer Calibration Log (Verification Record) - Go to page 153

20. Finished Product Microbiological Evaluation Report (Verification Record) • Go to page 154

21. Raw Product Chemical Evaluation Report (Verification Record) - Go to page 155

22. May 9, 2011 John J. Smith, President ABC Shrimp Company One Saltwater Lane Seaside, FL 33333 Dear Mr. Smith, Heat penetration tests have been completed for your “Ready-to-eat, peeled and deveined shrimp” processed in a continuous steam cooker at your facility on April 19, 2010 using a portable data logger and 12 thermocouple leads. Observations were made of internal product temperatures for six shrimp from individual lots of large (3.5 to 5.0 shrimp per oz.), medium (5.0 to 9.0 shrimp per oz.) and small (9.0 to 17.0 shrimp per oz.) processed in the steam cooker during production runs at 212°F for three minutes. The internal temperature of large shrimp exceeded 165°F; medium shrimp, 170°F and small shrimp, 180°F. The internal product temperatures noted during these tests exceed your firm’s HACCP critical limits of an internal temperature of 165°F for 40 seconds. Our studies revealed that shrimp processed at 212°F for three minutes delivered an internal product temperature above 165°F for a minimum of 40 seconds. These temperatures are equivalent to a 6-D process for elimination of Listeriamonocytogenes. These data serves as your annual thermal process validation study. If parameters change, such as cooking temperature, time, shrimp size, shrimp volumes, then you should repeat the thermal process validation study to ensure an adequate cook is being achieved in your process. Sincerely, I.M. Helpful Seafood Processing and Research Unit Seafood Process Authority Annual Thermal Process Validation Report (Verification Record)

23. May 9, 2011 John J. Smith, President ABC Shrimp Company One Saltwater Lane Seaside, FL 33333 Dear Mr. Smith, Temperature distribution tests were performed on April 19, 2011 on the steam cooker located at ABC Shrimp Company in Sunshine, Florida. Data was collected from ten thermocouples and continuous temperature logger during three production runs. Test results indicate that temperature distribution profiles in your cooker ranged from 212 to 214°F. These studies show that your steam cooker, when run properly, continues to operate as designed. Sincerely, I.M. Helpful Seafood Processing and Research Unit Your State University Annual Thermal Equipment Validation Report (Verification Record)

24. Annual HACCP Plan Verification Report (Verification Record) • Go to page 157

25. Employee Training Report (Pre-requisite Document) - Go to page 157

26. Histamine Fish Receiving Log (CCP Monitoring Record) - Go to page 159

27. Histamine Fish Refrigeration Log (CCP Monitoring Record) - Go to page 159

28. Packing Room Log (CCP Monitoring Record) - Go to page 160

29. HACCP Plan Form - Go to page 161