Real Lean
Lean in Regulatory Operations
BSM have been pioneering applied research into the utilization of Real Lean methodologies to solve problems and generate efficiencies in Regulatory Affairs Operations (Reg Ops) in large life science companies. Operations from a Regulatory perspective encompasses the standard activities that accompany the filing of Regulatory submissions such as Labelling, Publishing, Production, Archiving etc. “Real Lean” is the term used to describe BSM’s approach to implementing Lean in a wide variety of industrial settings. We use this term to distinguish our approach from generic Lean implementations which primarily focus on elimination of the seven wastes. “Real Lean” has at its core a commitment to incorporate the key principles of Levelling, Flow and Standard Work as a basic operating system.
Slow down… so that you can speed up
Slow down....so that you can speed up. Sounds like something Yoda would say. Component sub-optimization for increased system performance.
Lean Thinking for Laboratories
While it might sound like some sort of fad diet, “lean” in the context of business improvement refers to a specific methodology that originated in the Japanese motor industry toward the end of the 1980s. Over the decades, this lean philosophy has been successfully adopted by many companies across a broad spectrum of industries and, more recently, lean thinking has filtered into laboratories. The focus of a lean laboratory is to test samples in the most efficient way possible in terms of cost, or speed, or both. Although most of the key principles of lean apply in labs, the specific challenges facing laboratories require significant adaptation of standard lean tools.
Synchronising Planning, Manufacturing & QC
Day to day operations of individual departments in life science companies rely on many decisions made outside of each department’s own remit. When embarking on a Lean strategy, the pillars of operational excellence (Levelling and Flow) can be supported by increasing awareness of how each department functions and explaining constraints.
Why are Lab SOPs and Work Instruction so Bad?
Typically, laboratory Standard Operating Procedures and Work Instructions are wordy, patch-worked documents and a hindrance to testing analysts and reviewers alike. Over their life cycle, procedures usually become increasingly difficult to decipher due to multiple disjointed revisions. As a result, training and routine testing often relies on the retained knowledge of key experienced personnel, with an accepted culture of ‘Chinese whispers’. This dependence on undocumented hints and reminders can be tackled by applying Lean thinking to the design and layout of Laboratory SOP’s.
