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FSMA 204 Food Traceability Rule Readiness Checklist
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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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