Worked scenario
Production started on material still under quarantine
Quarantine that is a label rather than a system control will eventually be bypassed by someone with a production target.
4 min read
Incoming material is tested before use. Testing takes time, and production schedules do not always wait for it.
A label is not a control
Where status is a sticker on a drum, drawing from an unreleased lot requires only that someone is in a hurry. Nothing records that it happened.
Exceptions should be visible, not invisible
There are legitimate reasons to proceed at risk. The problem is not the exception but the exception that leaves no record, because the finished batch then has no traceable relationship to the status of what went into it.
What changes
- Release status held against the specific lot
- Material issue blocked while a lot is unreleased
- Exceptions recorded with authorisation rather than happening quietly
- Traceability from finished batch back to lot status at issue
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