Food Safety Command Center 15 items
FSMA 204 Food Traceability Rule Readiness Checklist
Assess readiness to maintain and share Key Data Elements for Critical Tracking Events on the Food Traceability List.
FSMAFSMA 20421 CFR 1 Subpart S
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Scope & Applicability
- Has the facility determined whether it handles foods on the Food Traceability List (FTL)? *
- Have applicable exemptions been evaluated and documented? *
- Are the Critical Tracking Events (CTEs) the facility performs identified (harvest, cooling, initial packing, transformation, shipping, receiving)? *
Traceability Plan
- Is a written traceability plan maintained describing recordkeeping procedures? *
- Does the plan describe how Traceability Lot Codes (TLCs) are assigned? *
- Is a point of contact for traceability records identified in the plan? *
- For FTL produce/aquaculture, is a farm map of growing areas maintained? *
Key Data Elements Capture
- Are Traceability Lot Codes established at initial packing, transformation, or first land-based receiving? *
- Are required KDEs captured and linked at receiving (TLC, quantity, location, date, source)? *
- Are required KDEs captured at shipping (TLC, ship-to, ship-from, date, reference document)? *
- Are transformation KDEs captured linking input and output lot codes? *
Records Availability & Response
- Can traceability records be provided to FDA within 24 hours of request? *
- Can an electronic sortable spreadsheet of records be produced within 24 hours when requested during an outbreak/recall? *
- Are traceability records retained for 2 years? *
- Has a traceability test/exercise been performed to validate data retrieval?
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