21 CFR 117.135 - Preventive Controls

What it says

For each hazard requiring a preventive control, the facility must identify and implement preventive controls that significantly minimize or prevent the hazard, which may include process controls, food allergen controls, sanitation controls, supply-chain controls and a recall plan, along with the management components needed to make them work, such as monitoring, corrective actions and verification.

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

What it means in practice

• A preventive control is only as good as its parameters, so process controls need defined values, such as time and temperature, that the facility can monitor.
• Allergen controls cover labeling and preventing cross-contact, and sanitation controls matter most where contamination of ready-to-eat food by the environment is a concern.
• Where a hazard is controlled by a supplier, the supply-chain control is the preventive control, and the facility has to verify it.

What FDA inspectors look for

• Whether each significant hazard has an identified preventive control with defined parameters.
• Whether monitoring records show the control operating within its parameters.
• Whether allergen and sanitation controls are applied in the way the plan describes.

Related regulations