Batch Record

Three Ways our Batch Records set us up for Failure (and how to address them!)

Published by Adrian Fegan in Lean QA on October 9, 2018

One of the ways we can improve Batch Record Right First Time (RFT), and hence throughput time, is by improving the Batch Record design.  By reengineering the document we can reduce the opportunities to make errors.  Batch Record (BR) redesign is an important part of a Lean QA (Lean in Quality Assurance) project, because it not only addresses RFT and throughput time, but it also leads to a reduced review effort (and hence workload) for manufacturing and QA reviewers.

Real Time Batch Record Review – Better Quality, More Speed, Less Cost … and Real Training!

Published by Adrian Fegan in Lean QA on April 11, 2018

Real Time Review™ of Batch Records can be quite a departure from the current review process in most Life Science companies.  It will typically mean migrating from the commonly found process in which you find multiple stages and levels of review, by several Manufacturing and QA personnel, to a quicker, more efficient review process.