21 CFR 117.180 - Requirements Applicable to a Preventive Controls Qualified Individual

What it says

One or more Preventive Controls Qualified Individuals must prepare, or oversee the preparation of, the food safety plan, validate the preventive controls, review records, and conduct or oversee reanalysis of the plan, and each must have successfully completed training in the development and application of risk-based preventive controls under a curriculum recognized as adequate by FDA, or be otherwise qualified through job experience. The facility must also make sure all personnel have the necessary education, training or experience.

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

What it means in practice

• The PCQI role is central to the rule, and a plan prepared without one does not meet the requirement.
• Training records or documented equivalent experience should be on file for each PCQI.
• An outside consultant can serve as a PCQI, but the facility remains responsible for its plan.

What FDA inspectors look for

• Whether a PCQI is identified and qualified.
• Whether training certificates or experience records are available.
• Whether the PCQI actually performed the tasks assigned to the role.

Related regulations