The Genealogy You Need to Be Able to Produce
Two directions matter. Backward: given a finished lot or serial number, list the material lots with mill certs, the work orders, machines, tooling, calibrated gauges, operators, outside processors and their certs of compliance, and the inspection records. Forward: given a suspect material lot or a failed gauge calibration, list every work order, finished lot and customer shipment affected.
A contract manufacturer should test both directions each quarter with a mock recall. If it takes a full day of searching binders to answer, the system is not ready for a real event, whatever the procedure says.
ERP Setup That Makes Traceability Real
Traceability only works if the system forces it at the moment of the transaction, not afterward.
- Lot-controlled flags on every raw material, component and finished item
- Material issues to a work order by scanned lot, with no default or bulk issue
- Cert of conformance and mill cert attached to the receiving lot record
- Outside processing receipts that carry the processor's lot and cert
- Split and merge rules that preserve the parent-child lot link
- Quality hold status that blocks issue and shipment until disposition
Where Genealogy Breaks in Practice
The usual weak points are not exotic. Operators issue the last bar of a lot and the next lot together without scanning. Bulk packaging components are backflushed rather than lot-tracked.
Rework creates a new unit with no link to the original lot. Parts go out for passivation and return merged into a different container. A cert is received but filed in a drawer, not tied to the lot.
Walk one product through the shop and mark every place a lot could lose its identity. Each of those spots needs either a system control or a documented physical segregation step.
Try it here, free
Job Shop ERP Glossary Reference
Plain-language definitions of job shop terms, with where each one shows up in ERP data.
Serialization, Implants and Longer Retention
Serial numbers are required when the device or the OEM's risk classification demands it, and implantable and life-sustaining devices have additional tracking requirements under 21 CFR Part 821 and customer agreements. Serialized work needs a unique ID applied or marked early, often by laser marking, and a verification step that the mark is legible and recorded against the right unit. Retention requirements for traceability records follow the device life and customer agreement, which can mean many years.
Decide up front how you will archive older records and keep them searchable when an ERP upgrade or migration happens.
When a Simple System Is Enough
If you make a small number of non-implant parts, ship in single-lot batches and every work order consumes one material lot, a disciplined traveler and receiving log may fully meet the requirement, and adding system complexity creates more risk than it removes. The case for stronger system control grows with the number of material lots per work order, kitting, outside processing, rework loops and customer demands for rapid genealogy reports. Match the control to the complexity of your actual flow, and prove it with a timed mock recall.
Frequently asked questions
What does ISO 13485 require for traceability?
Clause 7.5.9 requires documented procedures for traceability, with the extent defined by your needs and regulations, and records for implantable devices of the components, materials and environmental conditions that could cause the device not to meet specifications. Many OEM quality agreements require lot-level traceability for all supplied parts.
How fast should a contract manufacturer produce a genealogy report?
Quality agreements vary, but a few hours to 24 hours is common for a customer-requested trace, and faster for an active recall. Test it with a timed mock recall covering both forward and backward trace, and record the result as evidence for audits.
Do I need serial numbers for every medical device part?
No. Many components are lot-traced only. Serialization is driven by the OEM's specification, device risk class and regulations for implantable or life-sustaining devices. Confirm requirements in the drawing, purchase order and quality agreement for each part.
Netray can build a natural-language genealogy query over your ERP so quality can run a forward and backward trace in minutes, on your own network and with the query shown.