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    Traceability: can you show what happened?

    Traceability is the ability to follow a part or a measured value back through manufacturing: which part number and order, which material, which machine, who measured, with which gauge and when. It decides how quickly and how narrowly you can contain a problem when something has gone wrong.

    The customer asks about a serial number

    A customer gets in touch: a part with a certain serial number has failed in the field. The customer wants to know whether it is a single failure or whether more parts may be affected, and wants an answer within a couple of days.

    To answer, you need to know which order the part was made in, which material batch it came from, in which machine and with which tool it was machined, which measurements were made and what they showed, who measured and with which gauge. If all of that is linked to the serial number, you can say within a few hours which other parts share the same conditions. If it is not, you have to guess, or treat everything made over a long period as suspect.

    What traceability covers

    Traceability is usually divided into three parts that belong together:

    • Product traceability: which part it is, and which part number, drawing revision, order, batch or serial number it belongs to. It lets you follow a part forward to the customer and back to the material.
    • Process traceability: how the part was made. Which machine, which tool, which program or setting, which shift, and whether anything deviated during the run.
    • Measurement traceability: how the part was inspected. Which characteristic was measured, against which requirement, with which gauge, by whom and when, and what the result was.

    The word traceability is also used in metrology, for the unbroken chain of calibrations from a gauge to national standards. That is a different thing, but the two meet here: for a measurement to be credible, you need to be able to show that the gauge was calibrated and approved when the measurement was made.

    Where does the information lose its context, from the customer requirement to the evidence the customer gets back?

    Illustration
    1. 01

      Customer requirementCustomer

      Who: Customer, quality

      Where: The customer's drawing and requirement documents

    2. 02

      Planning

      Who: Engineering

      Where: Drawing, tolerances, control plan

      Context lost · The tolerances are copied by hand into the instruction.

    3. 03

      ProcessSupplier

      Who: Engineering, production

      Where: Process settings, instructions

      Context lost · The material batch is not linked to the parts it was used for.

    4. 04

      Machine

      Who: Operator

      Where: The machine control system (PLC)

      Context lost · The measurement is done in the measuring room, while the process settings are in the machine.

    5. 05

      Measurement

      Who: Operator, measuring room

      Where: Gauge, measuring machine (CMM)

      Context lost · The value has no order, tool or shift.

    6. 06

      Quality

      Who: Quality

      Where: Quality system, spreadsheets

    7. 07

      Decision

      Who: Operator, quality, production

      Where: Conversations, meetings, email

    8. 08

      Action

      Who: Production, engineering

      Where: Order, maintenance, instruction

      Context lost · The evidence for the customer is compiled by hand.

    9. 09

      EvidenceCustomer

      Who: Quality

      Where: Reports and certificates

    What must be recorded when it happens

    Most of the context only exists in the moment. The operator knows who she is, which gauge she has in her hand and which order is running. A week later nobody knows for sure. So the context must be captured when the measurement is made, not when someone asks.

    A measured value without context can only be compared with its limit. With the context you can answer questions nobody had thought of asking when the measurement was made. Is it one particular cavity that deviates? Does the fault only concern one material batch? Were all the parts measured with the same gauge?

    Why do annotations make a measured value more useful?

    Illustration · Example data

    A value without context can only be compared with its limit. With operator, serial number, order, machine and cavity it can be filtered, compared and traced.

    Step by step

    • The value 12.51 is linked to operator, serial number, order, machine and cavity.
    • The cavity number makes it possible to compare cavities with each other.
    • Serial number and order make it possible to trace a single part and answer the customer.

    A few things make it easier to get the recording right:

    • Let the context come along automatically where possible, for example order and part number from planning and the gauge from its identity, instead of being typed in by hand.
    • Record deviations and actions against the measured value they concern, with time and name. A note in a separate binder can rarely be linked to the right part afterwards.
    • Keep the original value. If a value is corrected, both the original and the new value should remain, with who changed it and why.
    • Decide how long the data should be kept. Customers in the automotive industry, for example, often specify long retention periods.

    How fine should the traceability be?

    Traceability costs. Recording a serial number for every part is reasonable for a safety-critical component, but may be unnecessary for a simple washer where a batch is enough. The question to ask is what happens if something goes wrong: how small a quantity do you want to be able to contain the problem to? The finer the traceability, the less has to be blocked and sorted when there is a fault, but the more has to be recorded every day.

    A good starting point is to go through the customer’s requirements and the characteristics that are especially important in the FMEA and the control plan, and decide the level of traceability from them.

    Requirements from customers and standards

    ISO 9001:2015 (clause 8.5.2) requires the organisation to identify its products and their status with respect to inspections, and to control the unique identification and retain the documented information needed when traceability is a requirement. Clause 7.1.5 also requires that the calibration status of measuring equipment can be determined.

    IATF 16949:2016 (clause 8.5.2.1) goes further. The organisation shall analyse the internal, customer and regulatory requirements for traceability, and develop a plan for how they will be met, including for parts with safety or regulatory requirements.

    The customer’s own requirements may be stricter than the standards, both on what is to be traced and how long it is to be kept. Always read the customer’s requirements.

    Summary

    Traceability is not something you build when the auditor or the customer asks. It is the result of the context being recorded every time a part is made and measured. When it is in place, a complaint becomes a contained investigation instead of a broad block, and a measured value becomes evidence instead of just a number.

    Key takeaways

    • Traceability covers the product, the process and the measurement: which part, how it was made and how it was inspected.
    • The context must be recorded when the measurement is made. Who measured, with which gauge and on which order can rarely be reconstructed afterwards.
    • How good the traceability is becomes clear when something goes wrong: it decides whether you can contain the problem to one batch or have to block everything.
    • ISO 9001 requires traceability when it is a requirement. IATF 16949 requires a plan for how it will be met. The customer's own requirements may go further.

    Where Rektron can help

    In Eyesight, measured values are linked to annotations such as operator, serial number and order, and events are noted in a log book. Inspection instructions, inspection reports and quality certificates can be produced as reports in Eyesight. Rektron SQC is available in an edition with an audit trail with support for FDA 21 CFR Part 11.

    Sources

    • ISO, ISO 9001, Quality management systems, Requirements (clauses 8.5.2 and 7.1.5), 2015
    • IATF (International Automotive Task Force), IATF 16949, Quality management system requirements for the automotive industry (clause 8.5.2.1), 1st edition, 2016

    Written by: Rektron. Reviewed by Lana Donoga (provisionally approved 2026-10-21) 2026-10-21. Published 2026-10-21.