FSMA PCQI case studies
FSMA PCQI · Put your knowledge to work in context.
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 case studies are 5 cases and about 3,279 words.
1Refrigerated Chicken Salad: New Dill Supplier and Environmental Listeria Controls
A 40-employee processor manufactures refrigerated ready-to-eat chicken salad. The formulation includes cooked chicken breast from a co-packer, mayonnaise, celery, spices, and fresh dill.
750 words, about 4 min2Thermal Process Deviation in Refrigerated Soup: Hold, Release, and Corrective Action
A food manufacturer produces refrigerated ready-to-eat soup in 2,000-case batches. The food safety plan identifies a continuous thermal process with a critical limit of 90°C for 30 seconds to control vegetative pathogens.
663 words, about 3 min3Allergen Cleaning Change on a Shared Cookie Line: Validation Versus Verification
A bakery makes two cookie lines: one containing milk powder and one labeled 'milk-free.' Both run on the same conveyor and depositor. The allergen preventive control is a wet cleaning procedure followed by a quaternary ammonium sanitizer and an ELISA swab for milk on food-contact surfaces.
646 words, about 3 min4Spice Supplier COA and Salmonella Control in RTE Hummus
A processor makes ready-to-eat hummus. The process includes soaking, grinding, blending, filling, and refrigeration; there is no kill step for the spice ingredients.
615 words, about 3 min5Undeclared Sesame: Mock Recall, Traceability Gaps, and Public Warning
On June 10, a granola bar manufacturer learned that a reformulated lot contained sesame flour but the label did not declare sesame. The lot, 12,000 units, was distributed to three distributors; two have electronic lot-level records, one uses paper invoices without lot codes.
605 words, about 3 min