Quick answer
A traceable lot connects the finished components to their materials, method, people, checks and release decision. Every record needs one clear lot reference.
Scope of this guide: This guide offers a practical record map for an early programme review. The device manufacturer must decide which regulatory, customer and retention requirements apply to the component.
How should the lot be identified?
Choose one lot or batch reference before work starts. Use it on material, assembly, inspection and release records. Do not rely on a filename or a person’s memory.
Test the link in both directions. Start with a finished lot and find its material lots. Then start with one material lot and find every finished lot that used it.
What should the work record show?
Record the drawing and work-instruction revision used for the lot. Add the operator, date, main steps and any fixture or tool reference required by the programme.
Record stops, approved changes and rework against the same lot. Show who reviewed the event and which parts it affected.
What should the inspection record show?
Link each result to a named requirement. A measurement needs a feature, unit, method, limit and result. A visual check needs a clear description of an acceptable result.
The record should show whether the item was released, reworked or rejected. The decision and its reviewer should remain linked to the lot.
Can your records answer these questions?
ISO 13485 and the FDA QMSR provide quality-system context. The responsible teams still need to define the exact record set for the programme.
- Which material lots were used in this finished lot?
- Which drawing and instruction revisions controlled the work?
- Who completed and inspected the work, and when?
- Which results support the release decision?
- How are changes, rework and rejected parts recorded?
- Who keeps the records, and how long must they be kept?
Sources: ISO — ISO 13485: quality management for medical devices · FDA — Quality Management System Regulation (QMSR)
Source notes
Sources and further reading
- ISO — ISO 13485: quality management for medical devices
ISO explains the purpose and scope of ISO 13485. The practical checklists in this guide are AJSM suggestions, not text from the standard.
- FDA — Quality Management System Regulation (QMSR)
FDA explains the current US medical-device quality-system regulation and its use of ISO 13485:2016 by reference.