Real Lean Transformation

Lean Quality Assurance

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

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.

Deviation and CAPA Management – Milestone Management for a Robust, Transparent and Efficient Process

 

 

It is an inescapable fact that deviations will occur at various points along the production cycle. An organization’s discrete approach to the management of such deviations will define how laborious and complicated the ensuing investigation and correction process is. In this blog, we outline BSM’s approach for the simple and effective management of deviation and CAPA (Corrective and Preventive Action) systems.

Goals of our systems include:

Flow

Paperwork Review in QC Labs – are Dedicated Resources a good idea?

Pharmaceutical testing laboratories face many challenges including high volatility in incoming workloads, non-optimized analyst roles and undefined testing sequences. These issues are often ‘managed’ by dedicating resources to specific tasks and creating subject-matter experts in an attempt to improve performance and reduce errors. More recently there has been a move towards dedicated reviewers, where analysts are “promoted” off the bench into full-time review roles.