TRACEABILITY RECORDING (ONE UP / ONE DOWN)
Distribution
Traceability Recording (One Up / One Down)
PrerequisiteAlso: lot traceability · one-up one-down · tracking
Capturing the immediate supplier (one back) and immediate customer (one forward) for each lot, plus key attributes (date, quantity, lot code) to enable a recall.
Typical Hazards
- BBiologicalInability to locate contaminated product on recall
Typical Controls
- Lot-code generation rule documented
- Inbound + outbound traceability records per lot
- Mock recall exercise on schedule (typically annually) with effectiveness metric
Regulatory Citations
6 cross-references across 3 documents
21 CFR Part 117
9 CFR Part 418