Improvement Tools for the early 21st Century in Pharmaceutical Operations – Operational Excellence by Jim McKiernan and Jim Curry Introduction An important part of the Operations Management Community of Practice (COP) will be to help members understand and share experiences in the use of appropriate improvement tools to ensure that technical operations continuously improve and achieve best in class levels of performance. As we all know, the industry is under unprecedented pressure to deliver innovative health benefits at affordable costs. This means that Operations Management is also challenged to maximize the strategic benefit it provides to the company at an acceptable level of cost. As a key driver to delivering on this challenge, the industry has been adopting practices long since common in other industries and which may be understood as coming under the umbrella term of “Operational Excellence.” Tools included in the Operational Excellence “toolbox” include Lean, Six Sigma, Continuous Improvement (Kaizen), Risk Management, and Design for Manufacturing. Current Status The pioneering pharmaceutical companies in this area mostly started their Operational Excellence journey in the mid- to late-‘90s and there has been a huge uptake during the past ten years. From our perspective, companies are at one of three stages of maturity in implementing these practices: • • • Advanced – actively seeking ways to break traditional pharmaceutical paradigms, challenging long-accepted SOPs and internally generated barriers to change. These companies are looking to industries such as automotive, petrochemicals, aerospace, electronics and consumer goods for ways in which to reconfigure manufacturing practices and supply chain configurations. Intermediate – these companies have been on the journey for about 5 years and are beginning to realize improvements in production change-over times, throughput times as well as the relevance of new performance metrics such as OEE (Overall Equipment Effectiveness). Beginners – these have just started within the past 2 years and are keen to learn from their peer companies in the Intermediate and Advanced stages in order to speed up their implementation and make up for lost time. Next Steps The Operations Management COP Improvement Tools Working Group will be focusing on ways in which information and experience exchanges can take place. We will also be organizing sessions at future ISPE meetings in which Operational Excellence best practices can be shared. In our next E-Letter we will explore the meaning of OEE and how it is being applied in pharmaceutical companies today.