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.
A ‘Real Lean’ approach includes active levelling of short interval workloads and generates flow by creating ‘defined work sequences’ that move items quickly through all required activities and reviews. QA activities are then combined into balanced, productive, repeatable roles that use people’s time well. This approach transforms the organization and the QA processes and generates significant productivity and lead time improvements, as well as improving RFT and compliance.
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.
BSM is the global leader in the provision of Real Lean transformation services to life science companies. We have an extensive track record of successful implementations in quality functions.
The authors of this report are Lorcan Mannion and Dr Adrian Fegan. Lorcan is a manager of BSM’s Real Lean Practice, with particular responsibility for the Lean QA discipline. Lorcan has been with BSM for over 12 years and has worked at numerous Life Science sites in that time. He specializes in Lean Laboratory practices as well as Lean in the Quality Assurance environment and has conducted major projects with Pfizer, Novartis, MSD, Roche and Warner Chilcott (now Actavis). Adrian has been a Principal Consultant with BSM for three years prior to which he completed his Ph.D. & postdoctoral research in chemical biology. Adrian has led Lean Laboratory, Lean in Quality Assurance & Lean in R&D projects with Mylan, Pfizer, Warner Chilcott (now Actavis) & Abbott Nutrition.
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