| name | Quality deviation report |
| description | Record a deviation, contain it, and set up the investigation without pre-judging it. |
| category | qa |
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.