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