21 CFR 117.165 - Verification of Implementation and Effectiveness

What it says

The facility must verify that preventive controls are consistently implemented and effective, through activities that include calibration of monitoring and verification instruments, review of records, and, as appropriate to the facility, the food and the nature of the control, product testing and environmental monitoring, with records of the verification.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Verification answers whether the system works, not only whether someone did the monitoring task, so the review of records by someone other than the monitor matters.
• Environmental monitoring is especially relevant where ready-to-eat food is exposed to the environment before packaging and an environmental pathogen is a hazard.
• Calibration of thermometers and other instruments underpins every monitoring record that depends on them.

What FDA inspectors look for

• Whether monitoring and corrective action records are reviewed within the timeframe the plan sets.
• Whether instruments used for monitoring are calibrated and the records are available.
• Whether environmental monitoring or product testing is performed where the plan calls for it and results are acted upon.

Related regulations