Sub-module
Process Deviation
Capture departures from the approved process and connect them to affected output.
What changes
An operator adjusts a parameter to protect the batch during a disturbance.
The deviation, authority, evidence and downstream review remain attached to the resulting material.
Operational boundary
- What it doesCapture departures from the approved process and connect them to affected output.
- What the team gainsThe deviation, authority, evidence and downstream review remain attached to the resulting material.
- What it does not ownA deviation record is not automatic quality acceptance.