Supply-Chain Program and Ingredient Risk
Domain 5 covers the supply-chain program at 21 CFR 117.405–117.475. It applies only when the hazard analysis identifies a hazard requiring a supply-chain control - a hazard the receiving facility relies on its supplier to control.
Core requirements
- A written supply-chain program for each raw material or other ingredient carrying such a hazard.
- Supplier approval documented before use, plus verification activities that may include onsite audits, sampling and testing, review of the supplier's food safety records including certificates of analysis, or other appropriate activities.
- Onsite audits before first use and generally at least annually, with frequency adjusted for supplier performance - reduced where history is strong, increased where problems appear. Audits may be done by the facility or its agent.
- Where another entity in the supply chain controls the hazard, written procedures plus annual written assurance that the control is being applied.
- Records of approvals, verification results, audits, and assurances, retained for 2 years.
Worked example
A facility buys pasteurized liquid egg for a ready-to-eat mousse with no kill step. Salmonella in the egg must be controlled by the supplier, so it is a hazard requiring a supply-chain control: the PCQI approves the supplier based on an onsite audit, requires a certificate of analysis per lot, and adds periodic sampling and testing. Now move the same egg into a baked custard with a validated cook step. The receiving facility controls Salmonella itself, so no supply-chain control is needed for that hazard. The ingredient did not change; the process did. That contrast is exactly what the exam probes.
Traps
- Writing a supply-chain program for every ingredient "to be safe" rather than hazard-driven.
- Relying solely on supplier certificates of analysis without justifying that they verify control.
- Approving a supplier with no documented basis, or letting approval lapse.
- Forgetting the written procedures and annual written assurances required when a third party controls the hazard.
- Auditing only when a problem arises, with no stated frequency rationale.