Case Studies

This case study was for a well-established Pharma company who had traditionally managed operations through a daily production meeting which had over time become ineffective and very time consuming. The challenge was to replace this with a Gemba management system as pioneered by Toyota Motors.

This case-study is a synopsis of an article authored by Noel Hennessey which appeared in the Lean Management Journal in September 2012. (Not for reproduction with the prior authorisation of the author.)
Manufacturing guide wires is a very intricate operation involving a variety of both manual and automated tasks. Despite the heavy ISO and FDA focus on procedures, the majority of medical device recalls can be traced back to a failure to follow procedure.  Therefore, within the manufacturing of medical devices, a company’s adherence to ‘standard work’ is critical.

A week long Kaizen (rapid improvement) event was planned to achieve a >10% increase in labour efficiency in a production cell containing six semi-automated machines, each operated by two production associates. However, since the machines were first introduced a number of years earlier, predicting the actual daily output from the machines had been very difficult. Also because of the inherent variation in the machine and components, attempts to find the root cause of this problem had proven unsuccessful.