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
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