Lean QA

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.

A recent bestseller expounds the benefits of a simple tool that is being used to save lives in hospitals around the world. How can we apply the same tool to improve quality outcomes in other processes?

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.

Most pharmaceutical companies have a cGMP auditing program administered at the site and corporate levels of the organization. Given the success seen through the implementation of Lean in QC and Manufacturing, many organizations wish to extend these initiatives to their audit function in order to improve productivity and service level, and lower costs. However, faced with a constantly evolving regulatory environment and increasingly varied processes and facility types (manufacturing, warehousing, contractors, suppliers etc.), can Internal Audit functions improve their operational effectiveness while maintaining the same level of regulatory oversight?

Slow down....so that you can speed up. Sounds like something Yoda would say. Component sub-optimization for increased system performance.