FSMA PCQI study guide
FSMA PCQI · Work through your exam, one topic at a time.
The Preventive Controls Qualified Individual (PCQI) designation reflects completion of training aligned with the FDA's FSMA Preventive Controls for Human Food rule (21 CFR Part 117). Under that rule, a PCQI is someone who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized by FDA, or is otherwise qualified through job experience. The FSMA PCQI study guide has 7 sections and about 3,109 words.
01Food Safety Hazards and Preventive Controls Overview
Domain 1 asks you to classify hazards and explain how the risk-based preventive controls of 21 CFR Part 117 build on HACCP. Expect scenarios showing a process, with questions on the hazard type present and the control category that should manage it.
436 words, about 2 min02Hazard Analysis and Risk-Based Preventive Controls
Domain 2 covers 21 CFR 117.130: identifying known or reasonably foreseeable hazards, then evaluating them to decide which require a preventive control. The written hazard analysis is the hinge of the entire plan.
476 words, about 2 min03Preventive Controls Management and Monitoring
Domain 3 examines 117.135–117.145: how preventive controls are written, monitored, and recorded. The exam tests whether your monitoring design is specific enough that another trained operator could execute it identically.
441 words, about 2 min04Verification, Validation, and Corrective Actions
Domain 4 separates three terms the exam loves to mix: validation, verification, and corrective action (117.150–117.170). Validation is obtaining and evaluating scientific and technical evidence that a control measure, or the plan as a whole, is capable of effectively controlling the identified hazard when properly implemented.
448 words, about 2 min05Supply-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.
410 words, about 2 min06Food Safety Plan Development and Records
Domain 6 covers building and maintaining the food safety plan (117.126) and its records (117.165, 117.170). Questions turn on who signs, what is retained, and for how long.
466 words, about 2 min07Recall, Traceability, and Regulatory Compliance
Domain 7 connects the plan to the outside world: recall readiness under 117.139, traceability, and the compliance machinery that surrounds FSMA. A written recall plan is required whenever the hazard analysis identifies a hazard requiring a preventive control.
432 words, about 2 min