Real Lean Transformation

Adrian Fegan's blog

3 Important Questions to Consider when Designing Labs with Lean in Mind

Building (or refurbishing) laboratories is a costly and time-consuming activity for a company. Poorly designed spaces can be costly in terms of lost productivity, slower turn around times and higher inventory of equipment and consumables. It is also common for the process to become a bartering exercise between groups for space, equipment and resources.

1. How will the space be used? Read more about 3 Important Questions to Consider when Designing Labs with Lean in Mind

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

The Paradox of Data in R&D Labs

R&D labs are in the business of generating, analyzing, reviewing and validating data. Data rules the decisions on how projects move forward through the development phases. However, we generally find that R&D labs have little or no data on their own capacity and performance. Without sufficient statistical data, the labs cannot meaningfully analyze past performance and identify opportunities to improve future performance. Read more about The Paradox of Data in R&D Labs

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

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

Managing Non-Routine Work

Every Department (QC, QA, R&D, RA, Manufacturing, etc.) has its share of non-routine work that must be completed.  This can include new instrument qualifications, method validations/transfers, SOP reviews, batch record updates, etc. It is easy for these tasks to get lost in the mix of all the other work. This is of course until there is a hard deadline or annual reviews are approaching! Then resources have to be dedicated to these non-routine projects to ensure that they are completed on time. While this is happening routine work is building up and once the project is cleared we have to set about dealing with the backlog. Read more about Managing Non-Routine Work