21 CFR 117.140 - Preventive Control Management Components

What it says

Section 117.140 requires that preventive controls include management components as appropriate to the facility, the food and the nature of the control. The components are monitoring, corrective actions and corrections, and verification. Together they show that each preventive control is working, that problems are fixed and that the system as a whole is effective.

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

What it means in practice

• Not every preventive control needs every component to the same degree. The right mix depends on the control and its role in the food safety system, and the plan should explain the choice.
• The rule leaves the extent of each component to the facility to justify, so the written plan needs to show why the chosen frequency and approach are adequate.
• Monitoring, corrective actions and verification each have their own section of the rule and their own record requirements.

What FDA inspectors look for

• Whether each preventive control has defined monitoring, corrective action and verification arrangements, or a documented reason why a component is not needed.
• Whether the frequency and method of monitoring are justified for the hazard.
• Whether records show that the components operated as written.

Related regulations