Product, process and document traceability.
People often mean product traceability, such as lot or serial tracking from supplier material to shipped product. It helps to separate three layers, because each answers a different question.
- Product traceability: which lot of material went into which finished lot, and where it shipped.
- Process traceability: which line, equipment, settings and checks applied when it was made.
- Document and people traceability: which revision of the instruction was in force, who approved it, and whether the people doing the work had been trained.
What the standards expect.
ISO 9001 clause 8.5.2 addresses identification and traceability: where it is needed to ensure conformity, you identify outputs and keep the information needed to trace them. Automotive customers and IATF 16949 add expectations that are often more demanding, and customers frequently set their own requirements for labeling, lot size and record retention. Read your customer-specific requirements and agree on a traceability level for each product family instead of assuming one standard applies to everything.
What to record.
The records you need depend on the product, but a workable starting set is short.
- Identification of incoming material by supplier and lot.
- The link between material lots and production lots.
- Key process checks and inspection results by lot.
- Nonconforming product and its disposition.
- Shipment records by lot.
- The revision of the controlled instruction in effect when the lot was made.
Test it with a mock trace.
The best way to know whether your traceability works is to try it. Pick a finished lot, trace it back to its material lots and the instructions in force, and then pick a material lot and trace it forward to every customer shipment. Time the exercise, write down what was hard to find, and repeat after you fix it. A mock trace is also a good way to prepare for a customer or certification audit.
A mock recall exercise is only convincing if it uses real records and a real clock. If it took three days to find the answer, then you now know what to improve.
Common gaps.
Plants that run a mock trace for the first time usually find the same few gaps. Material lots are recorded on receiving but not linked to the production lots that consumed them. Rework and repacking create new containers with no link to the original lot. Records exist but live in different places, so assembling the answer takes a day instead of an hour. Labels are applied inconsistently, so the physical product cannot be matched to the record. Fixing even one of these usually improves your ability to contain a problem.
Document and training traceability.
When a defect or complaint leads you to ask whether people were working to the right instruction, you are using document and training traceability. That requires the instruction’s revision history, the approval record, and the training completion for the people involved. These records are often kept in separate places, which is why they are slow to assemble.
Where STRATUM MES is today.
STRATUM Document Control keeps document history and traceability for controlled instructions, with revision history and approval records, and STRATUM Training keeps completion records, which supports document and people traceability. Lot, material and production traceability depends on production and material capabilities that remain under development; they are not available in today’s plans. Paid subscriptions are not open yet.
What’s live and what’s comingDocument control softwareCustomer audit readiness (CauseLogic)