HACCP Documentation & Record Keeping 3

Question 1

When a deviation from a critical limit occurs, which record must be created immediately in addition to the standard monitoring log?

Accepted Answer

A corrective action record

Answer

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:

Accepted Answer

Include audit trails showing original entries and any modifications

Answer

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?

Accepted Answer

Validation record

Answer

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:

Accepted Answer

At any reasonable time during business hours

Answer

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?

Accepted Answer

Store them in a secure, organized manner accessible to authorized personnel for the required retention period

Answer

Records must be retained for the required period, kept organized and secure, and accessible to authorized personnel including regulators.

HACCP - Hazard Analysis Critical Control Points Practice Test

HACCP - Hazard Analysis Critical Control Points Practice Test

HACCP Documentation & Record Keeping 3