21 CFR 117.126 - Food Safety Plan

What it says

The facility must prepare, or have prepared, and implement a written food safety plan, and one or more Preventive Controls Qualified Individuals must prepare it or oversee its preparation. The plan includes the written hazard analysis, the preventive controls, the supply-chain program, the recall plan, and the procedures for monitoring, corrective actions and verification.

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

What it means in practice

• The plan pulls the whole system into one document, so each element has to agree with the others.
• A PCQI must be involved in preparing it, which links this section to the qualification expectations in 117.180.
• Because it must reflect real operations, the plan is a living document and must be revised when conditions change.

What FDA inspectors look for

• Whether a written plan exists and contains every required element.
• Whether a qualified individual prepared or oversaw it.
• Whether the plan reflects the products and processes actually in use.

Related regulations