Some would argue that there is a conflict between the idea of lean practices and a highly regulated quality compliant environment. However, upon closer analysis this is not necessarily the case.
Both Lean and Compliance have very definite requirements to operate properly and it’s this discipline of implementation and execution that can bind both rather than separate them as “end-game” outcomes.
Compliance requires systematic control of elements connected to and driving manufacturing compliance functions, where as Lean requires similarly strict adherence to operating modalities that assure efficiency, repeatability and overall process capability.
Where much of the conflict appears to reside is in relation to how that execution is achieved.
However, with the advent of recent new guidance documents which include GMPs for 21st century, ICH Q8, Q9 & Q10, we’re seeing a more pragmatic approach to compliance that is more systematic and which lends itself to fit naturally with Lean concepts of implementation through the application of creative flexible approaches.
Our challenges as manufacturers are to find creative approaches to embrace this marriage of ideas which can be more compatible than many often believe are the case.