Production and service provision

In plain words

8.5 is the heart of the chapter: here the product comes into being, here the service is delivered — and the standard demands that exactly this process runs in control. The frame (8.5.1) is familiar: available specifications, suitable equipment, monitoring at the right places, qualified people, release. Five sub-points each sharpen one aspect: identification and traceability (8.5.2), property belonging to customers or external providers (8.5.3), preservation (8.5.4), post-delivery activities (8.5.5) and the control of changes during production (8.5.6).

It sounds like a lot, but in daily work it is mostly nothing new. In a manufacturing company the already-described order flow with its job cards (8.1) carries most of it. The sub-points add targeted questions: can I later assign a part to the right batch and the right order? How do I handle what the customer supplies to me? Does the part reach the customer undamaged? And: who decides when we change something in the process mid-series?

Three of these sub-points are readiness rows of their own, because they are the most often forgotten — two of them only when they apply to your business.

Why this requirement exists

The actual value creation is the place where conformity is created or lost. All the planning before and all the inspection after are useless if the production process itself is not in control — the wrong specification at the workstation, the unsuitable tool, the step nobody monitors. 8.5.1 forces that control onto exactly the spot where the part comes into being.

The sub-points exist because each names a typical, expensive mishap. Without traceability (8.5.2) a single faulty part becomes a recall of the whole period, because nobody can pin down the affected batch. Whoever handles customer property (8.5.3) carelessly damages someone else’s goods and is liable. Missing preservation (8.5.4) undoes the best production when the part reaches the customer rusted or scratched. And an uncontrolled change mid-series (8.5.6) quietly tips conformity — the classic: “just quickly swapped the tool”.

What good looks like

The production process runs along the job card: specifications at the workstation, inspection steps at the right places, first-piece release settled. On top lie the four targeted additions. Traceability: every lot carries a lot number, and the chain material batch → heat-treatment batch → production lot → delivery is seamless — as far back as customer or industry demand. Customer property: what the customer supplies — blanks, gauges, drawings, data — is checked on receipt, identified, stored separately and reported to the customer on damage or loss. Preservation: deburring, cleaning, corrosion protection, suitable packaging — the part survives storage and transport. Control of changes: whoever changes something during the series — tool, machine, parameter — records what was changed, who released it, and whether an extra check was needed.

What changes as you grow: From around 50 people, traceability moves into the ERP (batch and serial numbers carried automatically), and control of changes gets a small release procedure. From 100–250 people, where customers or industry demand it, production control plans, mix-up-proof identification systems (barcode, DMC) and formal packaging specifications arrive. The core stays the same at every size: the process is in control, the part is assignable, the foreign goods are protected, the result arrives intact.

The minimum to pass

• The production or delivery process is in control (8.5.1): specifications available, equipment suitable, check points set, release settled.
• Identification and, where required, traceability (8.5.2): parts are uniquely assignable; the affected batch can be pinned down. Or justified not applicable.
• Customer property is protected (8.5.3): checked, identified, damage reported. Or justified not applicable, when no foreign goods are in your care.
• Preservation is ensured (8.5.4) — up to delivery, including handling, storage, packaging.
• Changes in the process are controlled (8.5.6): assessed, released, traceable.

What an auditor asks for

• Pick up a part and ask backwards: from which lot, which material batch, which heat treatment? The job card must answer.
• The reverse path: for one material batch, all lots and deliveries made from it — the forward traceability for the recall case.
• For customer property, the receipt record and the identification — and the question: “what happens when supplied material arrives damaged?”
• The preservation evidence in the dispatch area: corrosion protection, packaging — and a transport-damage complaint, if there was one.
• A process change during a series: where is the assessment, who released it, was there an extra check?

Common traps

• Traceability ends at your own door. The production lot is cleanly numbered — but which material batch is in it, nobody knows any more. The chain is only as strong as its weakest link.
• Wanting to trace everything. Whoever keeps the same seamless chain for uncritical everyday parts as for medical technology suffocates in effort. Depth follows requirement and risk — 8.5.2 is explicitly occasion-driven.
• Customer property invisible. Supplied gauges or blanks lie around somewhere, unmarked — and on loss it is word against word. Drawings and data of the customer are customer property too.
• Preservation forgotten. Perfectly made, shipped without corrosion protection — and the precision part arrives with flash rust. The last metre devalues the whole production.
• The silent change. “We only swapped the tool” — mid running series, without a first piece, without a note. 8.5.6 exists precisely for this move.
• Confusing 8.5.6 with 6.3. Two flight levels: 6.3 plans the big changes to the QMS and to processes; 8.5.6 controls the concrete change in the running process. Both are change — but not the same procedure.

Worked example

At Berger Präzisionsteile GmbH the series of medical turned parts runs along the job card — and here it carries several sub-points at once. Traceability: every lot gets a lot number; the job card links it to the material batch (with the steel supplier’s 3.1 inspection certificate — the record carrying the batch’s actual test values), the hardening shop’s heat-treatment batch and the later delivery. When the medical customer asked at the supplier audit (4.2) “show me which raw material this delivered part came from”, Lea walked the chain in both directions — exactly what 8.5.2 means.

Customer property: for another customer Berger machines supplied cast blanks. One delivery arrived with cavities on the machining face; Marco stopped before the first chip fell, Lea documented the condition with photos and reported it to the customer the same day. The customer replaced the batch — and without the documented receiving check a supplier’s error would have become a dispute. Preservation: the finished parts are deburred, cleaned, preserved in VCI paper and packed in shape-retaining inserts — medical technology forgives no scratch.

Control of changes: in the middle of an 800-piece series an indexable-insert type broke more often than expected; Marco switched to a different make. No big deal — but he treated it as 8.5.6: a new first-piece record after the switch, a note on the job card, released by him. When the auditor later asked whether anything was changed during the series, the answer was not “no” (implausible) but a cleanly documented “yes, and this is how we secured it”.

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At Klarwerk GmbH the same chapter looks different but means the same. Controlled process: deployments run only through a documented release chain, not by word of mouth. Traceability: every change to a customer system carries a ticket number, a responsible person and a timestamp — in an incident it can be reconstructed who did what, when. Customer property: the customer’s data and access credentials are foreign goods in the sense of 8.5.3 — access rights regulated, deletion concept agreed, a data loss would be a reportable damage to customer property. Preservation here means backup and recoverability. Different industry, the same five questions.

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