Lot Traceability
QualityAlso known as: lot tracking, batch traceability, supply chain traceability, lot genealogy
The ability to trace an ingredient from raw material source through every processing step to the finished product batch.
What It Means
Lot traceability is the operational capability to follow an ingredient through the entire supply chain: raw material sourcing, processing/extraction, intermediate storage, finished ingredient production, and delivery to the manufacturer. The real test of traceability is speed and completeness when requested — can the supplier trace a specific lot back to its origin within hours? Under 21 CFR Part 111, manufacturers must maintain records linking each lot of finished product to the lots of components used. Without lot-level traceability, quality problems cannot be contained and recall obligations cannot be met.
What It Is Not
Lot traceability is NOT the same as country-of-origin labeling. Origin is one static data point; traceability is an operational system that can be tested in real time. A 24-hour recall trace is fundamentally different from 'we keep records somewhere.' Traceability also does not guarantee quality — it ensures that when problems occur, they can be isolated and addressed.
Evidence and References
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