Verification, Validation, and Corrective Actions
Domain 4 separates three terms the exam loves to mix: validation, verification, and corrective action (117.150–117.170).
Validation versus verification
- Validation is obtaining and evaluating scientific and technical evidence that a control measure, or the plan as a whole, is capable of effectively controlling the identified hazard when properly implemented. Process controls (cook, retort, acidification) must be validated; allergen and sanitation controls must be validated when necessary to ensure control.
- Verification is activity, other than monitoring, confirming the plan is implemented and effective: instrument calibration, product testing, environmental monitoring, record review within 7 working days, supplier verification, and reanalysis.
- Validation should precede implementation; if that is not practicable, it may be completed within 90 calendar days after production of the first batch, with a written justification in the food safety plan.
Corrective actions under 117.150
When a control deviates you must identify and correct the cause; reduce the hazard to an acceptable level or prevent adulteration; evaluate affected food for safety before release; if the food has entered commerce, evaluate it and act, including recall where needed; and reanalyze as appropriate. The record must be made within 24 hours of the action. A "correction" such as regrading or reworking is not a complete corrective action unless the cause is addressed.
Worked example
A metal detector fails its hourly check and the package just tested is rejected. Hold all product back to the last successful check; re-run held product through a re-verified detector; document the detector fault, repair, and re-verification; record within 24 hours; verify the record within 7 working days; then ask whether the maintenance schedule failed. If it did, reanalyze the plan. Note what is not done: releasing product simply because "the next check passed."
Traps
- Calling calibration or record review "validation".
- Releasing held product after a passing re-check without evaluating the affected lot for safety.
- Missing the 24-hour corrective action record and the 7-working-day review.
- Skipping reanalysis after repeated corrective actions on the same control.
- Validating a process using a study on a different product or line with no written justification.