Improving Right First Time (RFT), by creating a simpler and more user friendly batch record.


Our client, a Quality Assurance (QA) organization, had recently initiated a program to improve batch record format and layout. The ultimate aim of this initiative was to increase Right First Time (RFT), review lead-time performance and productivity by creating a simpler and more user friendly batch record.

Solutions Deployed

  • Mapping of the manufacturing process with all relevant groups. This included process engineers, manufacturing QA, OPS and disposition QA.
  • Mapping batch record life cycle with all relevant groups, including tech services, batch record issuance, QA and document control.
  • Analysis of investigations where the root cause was a ‘failure to follow’ batch record instructions.
  • Categorization of entries in the batch record and identification of common sources of error.
  • Workshops with all user groups to challenge entries with the aim to reduce or simplify.
  • Data masking and shading to error proof document.
  • Combinations of classroom training and media fill dry runs.
  • Tracker to capture and trend documentation errors.

example lead-time performance chart


  • Reduced page count by 62% (370 to 139 pages)
  • Reduced entry count by 58%
  • Reduction in transcription entries of 77%
  • Improved organization and flow
  • Improved compliance
  • Reduction in time taken to compile record
  • Improved RFT performance
  • Reduction in throughput time for QA review

Client Environment

Contract Development and Manufacturing of drug substances and drug products.


North America