Real Lean Blogs
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?
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.
To an outsider (and often even the insiders) laboratories can seem like a workplace hovering on the brink of chaos. The lab is constantly bombarded with hot requests for this lot or a special test for that project. Investigations, vacations, changes in product, adjustments in mix, FDA inspections, equipment issues and narrowly specialized analysts can often add to this sense of chaos. Usually it is difficult to see how work flows in the lab, if in fact it does flow. It can also be next to impossible to identify what is “normal” behavior. One of the critical steps in creating a Lean Lab is separating the routine (or in some cases, the most routine) from the non-routine or non-predictable.
Slow down....so that you can speed up. Sounds like something Yoda would say. Component sub-optimization for increased system performance.
Deployment of 5S in a laboratory setting is a time consuming effort and one which in itself delivers little in terms of productivity gains. So why bother…?
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.
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.
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.
Recently in laboratories, there has been a notable shift towards dedicating resources to specific work streams and sub-streams, in the attempt to improve service levels. This is due in large part to a misapplication of the key Lean principle of developing ‘Value Streams’.