CHA CHA Corrective Actions & Record Keeping 2 — Questions and Answers
Question 1: What is the minimum record retention period recommended by Codex HACCP guidelines for HACCP records?
- 6 months
- At least long enough to accommodate the product shelf-life plus a reasonable additional period (Correct answer)
- 10 years
- 30 days
Correct answer: At least long enough to accommodate the product shelf-life plus a reasonable additional period
Codex recommends retaining HACCP records for at least the shelf-life of the product plus additional time to support investigations and regulatory inquiries.
Question 2: An auditor reviewing CCP monitoring records notices that some temperature readings were recorded after the fact rather than in real time. This is an example of:
- An acceptable industry practice for efficiency
- Record falsification or back-dating, a serious nonconformance (Correct answer)
- A minor formatting issue with no food safety impact
- A corrective action already addressed by the team
Correct answer: Record falsification or back-dating, a serious nonconformance
Recording CCP monitoring data after the fact rather than at the time of monitoring is a serious nonconformance that undermines the integrity of the HACCP system.
Question 3: Which of the following HACCP records is used specifically to document that a deviation from a critical limit was identified and addressed?
- CCP monitoring log
- Corrective action record (Correct answer)
- Verification audit report
- Supplier certificate of analysis
Correct answer: Corrective action record
The corrective action record specifically documents deviations from critical limits and the actions taken to address both the affected product and the root cause.
Question 4: Under FDA's Preventive Controls for Human Food rule (21 CFR Part 117), how long must records documenting the implementation of food safety plans generally be retained?
- 6 months
- 2 years (Correct answer)
- 5 years
- 10 years
Correct answer: 2 years
21 CFR Part 117 requires that most food safety plan records be retained for at least 2 years after the date the record was created.
Question 5: When conducting a HACCP records review, an auditor should verify that monitoring records include all of the following EXCEPT:
- The actual value or observation at the CCP
- The date and time of monitoring
- The identity of the person performing the monitoring
- The personal home address of the monitoring employee (Correct answer)
Correct answer: The personal home address of the monitoring employee
HACCP monitoring records must capture the measured value, date and time, and identity of the monitor, but personal home addresses are irrelevant and not required.
Question 6: Electronic HACCP records are acceptable under regulatory requirements provided they:
- Are printed and stored on paper immediately after entry
- Are protected from alteration, accessible to authorized personnel, and can be reproduced in a readable format (Correct answer)
- Use only government-approved software platforms
- Are reviewed by a third-party auditor monthly
Correct answer: Are protected from alteration, accessible to authorized personnel, and can be reproduced in a readable format
Electronic records are acceptable when they have controls preventing unauthorized alteration, are accessible for review, and can be printed or reproduced in a readable format for regulators.
CHA CHA Corrective Actions & Record Keeping 2
What is the minimum record retention period recommended by Codex HACCP guidelines for HACCP records?