Release of products and services

In plain words

This clause is the doorman: nothing goes to the customer before someone has checked that the requirements are met. The planned checks (from 8.1) must be carried out and passed before delivery — and it must be traceable what was checked and who released it.

The standard explicitly demands two records: the evidence that the acceptance criteria are met, and the traceability to the person who took responsibility for the release. That is not signature bureaucracy — it is the simple question: who said “good” here, and against what did they measure it?

And the exception is built in: delivering before all checks are complete is allowed only with the approval of an authorised body — and, where applicable, the customer. An expedited release is permitted; a silent expedited release is not.

Why this requirement exists

Between “finished making” and “may go to the customer” lies a decision — and exactly that one is most easily lost in the rush of dispatch day. The delivery date presses, the carrier waits, “it’ll be fine”. The clause sets a deliberate threshold at this spot: first the evidence, then the delivery. It thereby protects not only the customer but you too — in a complaint or liability case (product liability) the release record is the document that shows your process worked.

The personal assignment serves the same purpose. Not to find culprits — but because a release belonging to nobody is not a decision but a wave-through. Responsibility with a name changes the care taken.

What good looks like

Final inspection is a defined step with defined criteria — the inspection plan from order planning (8.1) — not a glance over the crate. The result is an inspection record that sets the measured values against the criteria, and a recognisable release mark: initials on the job card, a stamp, a digital release. Who may release is fixed — and it is not everyone.

You recognise good by two things. First: the inspection depth fits the risk — 100% inspection where the part demands it, sampling by plan where the series is stable; both deliberately decided rather than grown. Second: the special case is settled before it occurs — who may approve an expedited release, when the customer must consent, how it is marked.

What changes as you grow: From around 50 people, roles separate — whoever makes does not release alone — and the release moves from initials into the system (an ERP status change with user ID). From 100–250 people, where customers demand it, formal first-article inspection reports, inspection certificates per delivery and defined special-release procedures (concession) with customer involvement arrive. The core stays: first the evidenced yes-decision, then the delivery.

The minimum to pass

• The planned checks are carried out before delivery — and the result is recorded.
• The evidence shows the fulfilment of the acceptance criteria — measured values against tolerances, not just a tick.
• The releasing person is recognisable — initials, stamp or user ID.
• Who may release is regulated.
• For delivery before completed inspection there is a defined approval path — or it does not occur.

What an auditor asks for

• For any delivery, the release record: inspection record, criteria, result, the mark of the releasing person.
• The sample backwards: from a delivery note to the job card to the final inspection — does the chain close?
• The rule on who may release — and the cross-check in conversation: does the person at the dispatch station know what they must not touch without a release?
• An expedited case, if there was one: who approved, was the customer involved, how was it re-checked?
• On first orders: the first article or first-piece release — how was the very first part released to the customer?

Common traps

• Release without a criteria reference. A tick “checked” with no measured values behind it. In the audit the first query, in a liability case worthless — the evidence must show against what it was measured.
• Everyone releases. When nobody is named, the release is an incidental move. The standard demands the traceability to the authorised person — authorised meaning: determined beforehand.
• The silent expedited release. The date presses, the last check is missing, delivered all the same — without approval, without a note. Exactly the case the clause expressly regulates; unregulated it is a major finding.
• Inspection depth out of habit. 100% checked for years because it was always so — or sampling because nobody ever thought about it. Both unplanned; the depth belongs deliberately decided and, on a stable series, deliberately reduced.
• Release and dispatch mixed up. The dispatch worker packs whatever looks finished. Without a recognisable separation between “made” and “released”, someone eventually reaches into the wrong shelf — the counterpart to segregation in 8.7.

Worked example

At Berger Präzisionsteile GmbH the release is the last block on the job card. For the medical series that means: final inspection to the inspection plan — the critical dimensions at 100%, the rest as a sample —, measured values in the inspection record next to the tolerances, visual check, then the initials of Lea or her named deputy. Only these initials turn the shelf spot “made” into the shelf spot “ready to ship”. Dispatch packs only what carries the mark.

The real test came with the assembly pilot order (4.3): the torque check of the bolted joint was still unpractised as a new inspection step, the delivery date stood. Frau Berger decided — documented — to release the first part-delivery only after complete inspection and to deliver two days later instead; the customer was informed (the “hold the date or flag early” policy from 5.2 in action). Not an expedited release, but the deliberate decision against one — that too is 8.6. And for the very first lot of revision C (8.2) a first-article inspection report preceded the delivery: the release of the first part before the series even started.

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At Klarwerk GmbH the release is not a dispatch step but a hand-over point: a customer portal goes live only when the agreed acceptance criteria from the specification are met and confirmed by the customer — the pilot weeks (8.3) were exactly this check. For running operation the same holds in miniature: a change goes to the production environment only when the tests are green and the release is documented in the ticket, with a name. “Deploying because it’s Friday” does not exist — that is the silent expedited release of the IT world.

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