Documentation & Record Keeping Flashcards
7 cards from real HACCP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Documentation & Record Keeping flashcards as text
When a deviation from a critical limit occurs, which record must be created immediately in addition to the standard monitoring log?
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.
Electronic HACCP records are acceptable provided they:
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.
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?
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.
Under 21 CFR Part 123 (Seafood HACCP), records must be available for inspection:
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.
Which of the following is the BEST practice for storing completed HACCP monitoring forms?
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.
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:
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.
What does the term 'record review' mean in the context of HACCP verification?
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.