Recall, 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.
Recall plan
A written recall plan is required whenever the hazard analysis identifies a hazard requiring a preventive control. It must assign responsibility to competent individuals and describe procedures for notifying direct consignees, conducting effectiveness checks, dispositioning affected food, and public notification where appropriate. FDA recalls are generally firm-initiated; FDA may request a recall and, under FSMA, has mandatory recall authority and can suspend a facility's registration. Recall classes: Class I for a reasonable probability of serious adverse health consequences or death, Class II for temporary or medically reversible harm, Class III for unlikely harm.
Traceability and reporting
- The Food Traceability Rule (21 CFR Part 1 Subpart S) requires persons who manufacture, process, pack, or hold foods on the Food Traceability List to keep Key Data Elements at Critical Tracking Events - growing, receiving, transforming, creating, and shipping - linked by a traceability lot code. The compliance date is 20 July 2028.
- The Reportable Food Registry requires a responsible party to report a reportable food to FDA within 24 hours.
- Food facility registration must be renewed biennially in even-numbered years.
Worked example
A ready-to-eat salad plant learns that a dressing lot tested positive for L. monocytogenes after 400 cases shipped. The recall plan is activated: consignees are identified from shipping records and traceability lot codes, notified in writing, and effectiveness checks confirm receipt; remaining product is quarantined; FDA is contacted; disposition and root cause are documented; the hazard analysis is reanalyzed and sanitation controls revised. Every step was written before the event - that is what the exam rewards.
Traps
- A recall plan with stale consignee contacts or no assigned responsible individuals.
- Never exercising the plan through a mock recall.
- Assuming traceability requirements apply only to "high-risk" foods without checking the Food Traceability List.
- Mixing up recall classes.
- Missing the 24-hour reportable food timeline.