Real Lean in Quality Assurance Report

In pharmaceutical companies, the Quality Assurance (QA) function is usually directly on the critical path for the release of product and is often a significant cost center in its own right. QA functions are complex areas with volatile, short interval workloads and often suffer from poor or inconsistent performance. While it is not obvious how the principles of lean and operational excellence can be applied to such areas, BSM have developed methodologies and tools based on the ‘Real Lean’ principles of leveling, flow and standard work that enable QA functions to significantly improve operational performance and consistency.

In this paper we describe the Real Lean concepts that can be used to address the process and volatility issues described above and create robust, fast processes supported by visual management that allow QA groups to consistently meet target release dates in the most productive way possible.