Situation
Design history files were assembled by hand from network folders before each audit. Requirements lived in Word documents, and changes to them were not reliably reflected in test plans.
What we did
- Configured requirements management with links to design outputs and verification records.
- Modelled risk items and CAPA as Windchill objects with affected-item relationships.
- Trained quality and engineering teams on the new process using their own product data.
Outcome
Audit packages are generated from live data. The quality team spends its time on quality rather than on document assembly.
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