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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
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