21 CFR 117.3 - Definitions

What it says

Section 117.3 defines the terms used throughout 21 CFR Part 117. Important definitions include hazard, known or reasonably foreseeable hazard, hazard requiring a preventive control, preventive controls qualified individual, qualified facility, ready-to-eat food, environmental pathogen, monitor, validation and verification. These definitions fix what the rule means by each term.

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

What it means in practice

• A hazard requiring a preventive control is a known or reasonably foreseeable hazard that a person knowledgeable about food safety would control after a hazard analysis. This definition drives the whole food safety plan.
• Validation and verification are separate defined terms. Validation is the collection and evaluation of scientific and technical information to show that the plan, properly implemented, will control the hazards. Verification covers the methods and checks, other than monitoring, used to show that controls operate as intended.
• Terms such as qualified facility and preventive controls qualified individual decide who must do what, so getting them wrong can mean the wrong requirements are applied.

What FDA inspectors look for

• Whether the food safety plan and procedures use the defined terms consistently, particularly hazard, monitoring, validation and verification.
• Whether the facility has correctly determined its own status, such as whether it is a qualified facility, using the definitions.
• Whether the person acting as the preventive controls qualified individual meets the definition.

Related regulations