Manufacturing
Lot Traceability
In one line
Ability to trace materials, processes, and devices forward and backward through the supply chain by lot number.
Definition
21 CFR 820.65 requires traceability for devices intended for surgical implant or whose failure could cause significant injury. Lot traceability links UDI-PI to inputs, processes, and finished-goods distribution records.
Under the QMSR, traceability follows ISO 13485 clause 7.5.9, with extra requirements for implantable devices including records of components, materials and work environment conditions. Good traceability lets a company scope a recall to specific lots. The EU MDR also requires distributors and health institutions to store UDIs for certain implantable devices.
Why it matters
Effective traceability is the difference between scoping a recall to a few lots versus the entire installed base.
Common pitfalls
- •Failing to link all unique device identification, production identifiers (UDI-PI) to their corresponding manufacturing records and raw material lots is a common mistake.
- •Inadequate documentation of each stage of the manufacturing process, from raw materials to final distribution, can severely hamper traceability efforts during an audit or recall.
- •Lax control over third-party logistics and distribution partners can create gaps in the traceability chain.
- •Not regularly testing or auditing the traceability system through mock recalls is a critical oversight.
- •Relying solely on paper-based systems without adequate backups or digital integration can lead to data loss and inefficiencies.
Sources
- 21 CFR 820.65 · eCFR
- ISO 13485 Standard Page · ISO
- GHTF/IMDRF Process Validation Guidance · IMDRF/GHTF