If your hazard analysis identifies a hazard that your supplier controls before the raw material reaches your plant, the FDA requires a risk-based supply-chain program (21 CFR 117.405). The program includes using approved suppliers, deciding which verification to do and how often, doing it and documenting it.
Verification can be onsite audits, sampling and testing, or reviewing the supplier's food safety records. If there is a reasonable probability that the hazard will cause serious adverse health consequences or death, the rule calls for an onsite audit before first use and at least once a year, unless a written determination justifies other verification. If the supplier is a qualified facility, a small farm or an egg producer with fewer than 3,000 hens, the rule allows verification through written assurances. SQF also requires an approved supplier program.
Official sources
- 21 CFR 117.405 (cuándo se requiere)
- 21 CFR 117.410 (programa de cadena de suministro)
- 21 CFR 117.430 (auditorĂa anual en sitio)
- SQFI: Food Safety Code, Food Manufacturing
Sources verified on November 7, 2026.
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