HACCP Documentation & Record Keeping 3 — Questions and Answers
Question 1: When a deviation from a critical limit occurs, which record must be created immediately in addition to the standard monitoring log?
- A new HACCP plan
- A corrective action record (Correct answer)
- A consumer advisory notice
- A revised flow diagram
Correct answer: A corrective action record
A corrective action record must document what happened, what was done with the affected product, and how recurrence will be prevented.
Question 2: Electronic HACCP records are acceptable provided they:
- Are printed and signed daily
- Include audit trails showing original entries and any modifications (Correct answer)
- Are stored only on cloud servers approved by the FDA
- Replace all paper records without exception
Correct answer: Include audit trails showing original entries and any modifications
Electronic records must maintain audit trails that preserve original data and show who made changes and when, equivalent to the paper correction standard.
Question 3: A HACCP team is validating a new cooking process. Which type of record would document the scientific or technical evidence supporting the critical limit chosen?
- CCP monitoring log
- Corrective action report
- Validation record (Correct answer)
- Supplier certificate of analysis
Correct answer: Validation record
Validation records contain the scientific evidence (challenge studies, peer-reviewed literature, regulatory guidelines) that supports a critical limit's ability to control the hazard.
Question 4: Under 21 CFR Part 123 (Seafood HACCP), records must be available for inspection:
- Only during scheduled FDA inspections
- At any reasonable time during business hours (Correct answer)
- Within 72 hours of a written request
- Only after a formal subpoena is issued
Correct answer: At any reasonable time during business hours
FDA seafood HACCP regulations require that records be available for inspection at any reasonable time during business operations.
Question 5: Which of the following is the BEST practice for storing completed HACCP monitoring forms?
- Shred them after the product is shipped to free up storage space
- Store them in a secure, organized manner accessible to authorized personnel for the required retention period (Correct answer)
- Keep them only in the production manager's personal office
- Send them to the corporate office immediately after completion
Correct answer: Store them in a secure, organized manner accessible to authorized personnel for the required retention period
Records must be retained for the required period, kept organized and secure, and accessible to authorized personnel including regulators.
Question 6: A HACCP plan requires pH monitoring every 2 hours, but the log shows a 6-hour gap with no readings. This gap is best characterized as:
- Acceptable if the product passed final inspection
- A monitoring frequency deviation that requires a corrective action record and product hold (Correct answer)
- Not a concern if other CCPs were monitored correctly
- Only significant if a recall has already been initiated
Correct answer: A monitoring frequency deviation that requires a corrective action record and product hold
A gap in required CCP monitoring creates uncontrolled product that must be held and evaluated, and the deviation must be documented in a corrective action record.
Question 7: What does the term 'record review' mean in the context of HACCP verification?
- Employees reading back their own entries for typos
- A trained individual examining completed monitoring records to confirm they were properly completed and within critical limits (Correct answer)
- Auditors reviewing only corrective action records
- Management approving records before they are created
Correct answer: A trained individual examining completed monitoring records to confirm they were properly completed and within critical limits
Record review is a verification activity where a qualified person examines completed HACCP records to confirm proper completion, signatures, and compliance with critical limits.
HACCP Documentation & Record Keeping 3
When a deviation from a critical limit occurs, which record must be created immediately in addition to the standard monitoring log?