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.