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