After the basic Lean conversion takes place, Lean’s continual improvement culture means that modifications to material inputs, product outputs, non-product outputs, equipment, equipment configurations, and operating parameters are likely to be the norm, and result in a manufacturing environment subject to constant, on-going change. In this environment, even minimal regulatory delay holds the potential to erode quickly a process improvement’s financial return, which, in turn, could result in foregoing the resource productivity enhancements associated with the change. In other words, the business case for Lean initiatives is highly sensitive to implementation time frames. Thus, regulatory agencies have a.
