Preventive Controls and the PCQI

What FSMA Preventive Controls add beyond HACCP, and the PCQI role that gate-keeps it.

1. What FSMA Preventive Controls add on top of HACCPThe gap between a classic HACCP plan and the written Food Safety Plan the Preventive Controls rule requires — the allergen, sanitation, and supply-chain controls, the recall plan, and the qualified individual who has to sign it off.
2. The PCQI: what the role is and who can fill itWho the Preventive Controls Qualified Individual is, the activities only they are allowed to do under 21 CFR 117, the two ways a person qualifies, and whether your own owner or staff can be it.
3. Process, allergen, and sanitation controls in practiceHow to actually run the three non-CCP preventive controls the rule expects — a process parameter with a limit, allergen cross-contact plus the label, and sanitation you can prove — each with its own monitoring, records, and the reason allergen and sanitation controls get verified rather than validated.
4. Qualifying suppliers and the supply-chain programHow to build the Subpart G supply-chain program the Preventive Controls rule requires when a supplier controls a hazard before it reaches you — deciding which ingredients need it, approving the supplier, matching a verification activity to how serious the hazard is, and keeping the proof where receiving can reach it.