The situation
The plant assembled devices under a quality system that required every operation to be signed and every deviation to be dispositioned before a unit could ship. The operations were real. The records were paper, transcribed into a quality database when someone had time.
That gap created two problems. Units moved forward while their paperwork was still in a tray, so a hold applied late meant recalling work already at the next station. And when an auditor asked for the genealogy of a specific unit, assembling it meant a person walking between a filing cabinet, a spreadsheet and two systems.
What we changed
Sign-off at the station, by the person who did the work
Each operation is confirmed against the routing, with the operator identity, timestamp and the document revision they worked to captured together.
Deviations raised where they are found
A non-conformance is opened at the operation, against the unit and the work order, before the unit can advance.
Routing by severity, not by tray
Disposition routes to the right reviewer automatically, with an escalation path when it sits too long.
Holds that actually hold
A unit or batch under investigation cannot be signed forward, and the block is visible at the station rather than in an email.
Genealogy assembled by query
Material, operation, operator and deviation history for any unit produced as one record, in the order an inspector reads it.
The test we set was an auditor question: pick any unit that shipped last month and show its full history without leaving the screen.
How it went live
One assembly line first, running the new workflow alongside the existing paper process for a full audit cycle. Nothing was switched off until the quality team had reviewed records produced both ways and agreed they matched.
The remaining lines followed one at a time, each with its own routing configuration and document set. Validation documentation was written as the configuration was built rather than reconstructed afterwards, because in this sector the record of how the system was verified is part of the deliverable.
What changed afterwards
Deviations are opened at the station rather than at the end of a shift.
A hold stops the work instead of chasing it.
Genealogy for an audit request is a query, not an afternoon.
Quality review works a queue ordered by severity rather than by arrival.
