Quality deviation report

Reporting a quality deviation

The report has one job: make the investigation possible. Containment happens in parallel, not afterwards.

Containment first

What is affected — batch, lot or serial range, with the boundaries stated · where that material is now, including anything already shipped · whether it is on hold · whether the process is stopped.

Then the record

What was observed against what was specified, with the measurement and the tolerance · when detected and by whom, by role · how detected — inspection, in process, or by the customer · the traceability chain back to material and supplier.

The boundary question

How far back does it go? The last known-good check defines the suspect window, and if it cannot be established, say so — that is a wider recall, and hiding it is worse.

Never

Record a cause. "Operator error" as an entry ends the investigation before it starts, and the cause is almost never the operator.