1. Lean Six Sigma for Pharmaceutical, Biotech and Medical Device ExcellencePaul Nelson, Operational Excellence Leader at Shire Pharmaceuticals, knows thatwhen implementing a new product into the supply chain there are many keyissues that need to be taken into consideration and assessed. At the upcomingLSS for Pharmaceutical, Biotech and Medical Device Excellence conference, PaulNelson will present as case study a new product supply success story. He joinsPharma IQ for an interview to discuss LSS trends and the tools or programs forsustaining excellence.Amber Scorah: What is new in Lean Six Sigma?Paul Nelson: From what I have seen recently I would say that the LSS methodology andthe tools are not really ‘new’; however, the way that this is employed in our industry hasevolved. The classical implementation used to focus mostly on cost savings; e.g., how tolean out a manufacturing process in order to reduce inventory and people costs. Whilecost is still an important consideration, the companies that work within our industry arefocused more externally - on innovation and providing value to our patients – thaninternally for cost savings. Thus, LSS is seen to provide value by focusing improvementefforts on the business processes that support innovation, speed to market, andsustainable growth. So the cost savings are seen as a result of these efforts.Amber Scorah: What new trends and old trends continue?Paul Nelson: LSS continues to find its most friendly audience in manufacturing. Perhapsthis is because of the evolution through such programs as the statistical methods ofDeming and Juran, Malcolm Baldrige, JIT, Right First Time, re-engineering, theory ofconstraints, and the myriad of other manufacturing-based programs that were introducedin the 20th century. But whatever the reason, functional areas outside of manufacturingtake a little longer to gain momentum in LSS.As for new trends, I have seen senior management supporting LSS in areas notpreviously considered for this. For example, we continue to see consolidation in ourindustry via mergers and acquisitions and the acquiring company must be able toaccurately assess what they are looking to acquire (the Due Diligence process), as wellas successfully integrate the new acquisition (the Post-Acquisition Integration process).Reducing the time it takes to complete these activities, improving the effectiveness, andreducing the variation & risk are all areas of interest for senior management and aperfect fit for LSS.Amber Scorah: Have any activities failed?Paul Nelson: Of course! If we were successful 100% of the time I would be worried –because in my mind that would indicate a lack of innovation and improvement. However,some failures are repeated and they are avoidable. For instance, there are manyinstances of companies that make an attempt at putting in some form of LSS program
2. only to have it lose momentum and fail to deliver what was expected (I can think of twoin my own experience). There has been much research in this area and there is so muchinformation available to us that clearly show what works and what doesn’t. We know thata lack of a senior level sponsor welcomes failure. We know that a tools-based approachrather than cultural shift is not sustainable. We know that we must support the LSSinitiative with people dedicated as full-time change agents. We know that projects mustdeliver results quickly – usually in less than six months – in order to sustain momentum.Yet, we continue to see these basic tenants violated with predictable results. We do notlearn from repeating these types of failures.It is expected that when working to innovate and improve that the occasional failure willbe realized and then we learn from it. That’s how we make progress.Amber Scorah: What practices and approaches are being adopted from otherindustries?Paul Nelson: For me, I think the most exciting adoption of practice is in the area ofprocess understanding and product characterization. It is a fantastic example of usingthe six sigma concepts from mature industries and applying them to newer areas inbiotechnology. In the mature and highly automated industry of fine chemicals, forexample, the manufacturing processes are extremely well defined. Every variable thatcan affect the product quality is well understood. The process is capable of producingthe product with its intended characteristics and the variability is controlled viaautomation. There is very little product testing required at the back end of the processsince product quality is tested and controlled at each step in manufacturing.Our industry has lagged in that area but I have seen some good progress recently.Amber Scorah: What tools or programs do you find are really sustainingexcellence?Paul Nelson: In my own recent experience I have seen excellent success from one verysimple tool: Failure Modes and Effects Analysis (FMEA). Senior leaders in our industry(as in other industries) are interested in managing risk (supply risk, regulatory risk,financial risk, etc.). I have seen a very successful program put in place by a seniorleader using this tool to prioritize the areas of risk, improve those areas by removingwaste to improve efficiency & effectiveness, re-assess the risk scores to ensure the riskhas been mitigated appropriately, then move to the next priority risk and repeat theexercise. Sometimes having a senior leader driving an improvement with a simple toolyields very substantial business results! Paul Nelson, Operational Excellence Leader Shire PharmaceuticalsFoster a culture of continuous improvement. Join us July 20 to 22, 2011, in SanDiego, CA for the 12th Annual Lean Six Sigma for Pharmaceutical, Biotech andMedical Device Excellence conference. For more information visitwww.lsspharma.com, or email email@example.com.