Compliance
PCQI
Preventive Controls Qualified Individual
TL;DR
The FSMA-mandated qualified person who develops or oversees the Food Safety Plan under 21 CFR 117. Training via FSPCA standard curriculum (or equivalent).
Under 21 CFR 117.155, a PCQI is the individual who has successfully completed FDA-recognised training (FSPCA Preventive Controls for Human Food) or who is otherwise qualified by job experience to develop and apply a food safety system. The PCQI must prepare or oversee the Food Safety Plan, validate preventive controls, review records, and re-analyse the plan.
V5 records PCQI assignment per Food Safety Plan and gates plan-approval signatures to the PCQI role.
Regulatory anchors
- 21 CFR 117.155
Related terms
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