A medical device manufacturer had a failing QC testing group. Sister facilities in Europe had a higher rate of productivity and much higher rate of efficiency in terms of fewer laboratory investigations and samples analyzed.

The project was to analyze the situation and produce a new lean laboratory solution to establish at least parity with the European laboratory.

The Process:

Both laboratories were assessed using a proprietary Smart Pharmaceutical Consulting tool and the results were process mapped to elucidate the differences between the laboratories. Following this process the analytical laboratories were reviewed for similarities and a best practice was developed for the process going forward.

With the best practice in place a gap analysis was developed and a forward implementation plan was crafted. Part of the solution was a total Lean Laboratory design of the analytical laboratory as well as an upgrade of the operating practices.


The result of the project was a vastly improved operating situation with reduced laboratory investigations and an improved level of productivity and operating efficiency incorporating Lean Laboratory design and operating practices.