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Final product release lead time was too long due to quality and processing issues with documentation.
The batch documentation for a complex sterile product was very complex. The
‘right first time’ (RFT) from documentation for final batch release was <10% and
release lead-time after the final processing step was too long (4 days).
The goal was to dramatically improve RFT and to reduce the lead-time.
- Documentation was simplified (remove unnecessary activity)
- A Documentation Room (D Room) was created to allow documents to ‘flow’ through the process with errors being quickly corrected
- Structure was added to documentation activities
- Visual Management techniques were employed
- Documents processed in sequence rather than ‘by preference’
- Documentation RFT improved to >90%
- Lead Time dramatically reduced (4 days to <1 day)
- Documentation seen as core part of them process rather than a necessary evil