Quality audits: gathering evidence that the process is what the paperwork says

System, process and product audits answer different questions

A system audit asks whether the management arrangements exist, are followed and are reviewed. A process audit follows one operation in detail — the setup, the parameters, the checks, the reaction to an out-of-limit result — and is usually where the real discoveries happen. A product audit takes finished goods already released and re-verifies them against the customer specification, which is the only one of the three that tests the whole chain of controls simultaneously. Plants that run only the first type accumulate tidy documentation and are repeatedly surprised by defects, because nobody has looked at a part.

Sampling determines what an audit is worth

Auditors cannot examine everything, so the choice of what to look at carries most of the value. Following one part number from order through to dispatch, and demanding each piece of evidence in turn, exposes breaks that no amount of departmental interviewing would. Picking the areas nobody suggests, the shift that was not expecting a visit, and the process that has recently changed produces more than working through a checklist front to back. An audit that examines only what the host offers has tested the host's preparation rather than the plant.

Evidence, not impressions

A finding needs a specific artefact behind it: a document at a revision that is no longer current, a gauge whose calibration lapsed, a result recorded outside a limit with no reaction, a container without identification. Impressions such as an area feeling disorganised may prompt the search but cannot support the finding. This discipline protects the audit in both directions — it stops arguments about opinion during the closing meeting, and it stops an auditor being talked out of something they actually saw. Record the identifier of every item examined, because a finding that cannot be located again will be disputed away.

The pressure to downgrade a finding is constant

Once written, findings cost money and attention, and there is always a case for calling something an observation, an opportunity, or an isolated incident. Sometimes that is right. Often it is the path of least resistance, and the same issue reappears at the next audit under a softer heading. Two questions help: could this condition have allowed nonconforming product to reach a customer, and does the evidence suggest a single lapse or a control that does not function. Keeping a register of previous findings makes the recurring ones visible and difficult to reclassify.

What an audit cannot tell you

It cannot establish that a plant is capable of the tolerances it has quoted, that a process is stable, or that behaviour on the unobserved shift resembles what was seen. It samples a moment, and people behave differently while being watched. So an audit result belongs alongside other evidence rather than instead of it: defect and complaint history, delivery performance against quality holds, scrap trends, and the plant's own record of finding and reporting its own problems. A site that surfaces uncomfortable issues without prompting is usually in better shape than one with an unblemished audit history.

Frequently asked questions

What is the difference between a finding and an observation?

A finding states that a defined requirement was not met and is supported by evidence, so it obliges a response and a correction. An observation flags something that meets the requirement today but is heading somewhere unhelpful, or a practice that could be improved, and it carries no obligation. The distinction matters because organisations that record most issues as observations produce audit reports with nothing to act on and no way to show a trend.

How much notice should be given before an audit?

Enough that the right people and records are available, and not so much that the area is rebuilt for the visit. Announcing the day but not the specific processes or shifts is a reasonable compromise. Unannounced visits reveal the working state more accurately but cost goodwill and can waste a day if key staff are absent, so they suit follow-up on a known problem better than routine coverage of a whole site.

Can an audit report be used as evidence that our product is good?

Only weakly. An audit examines arrangements and samples of activity at a point in time; it does not verify a shipment. Customers who treat a clean audit as product assurance are conflating two things, and the plants that encourage them regret it when a defect arrives. Product conformity is evidenced by inspection and test records tied to the specific lot, with the audit supporting the argument that those records mean what they say.