Process Excellence Network http://tiny.cc/tpkd0

1. Lean Six Sigma for Pharmaceutical,
Biotech and Medical Device Excellence
Paul Nelson, Operational Excellence Leader at Shire Pharmaceuticals, knows that
when implementing a new product into the supply chain there are many key
issues that need to be taken into consideration and assessed. At the upcoming
LSS for Pharmaceutical, Biotech and Medical Device Excellence conference, Paul
Nelson will present as case study a new product supply success story. He joins
Pharma IQ for an interview to discuss LSS trends and the tools or programs for
sustaining 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 and
the tools are not really ‘new’; however, the way that this is employed in our industry has
evolved. The classical implementation used to focus mostly on cost savings; e.g., how to
lean out a manufacturing process in order to reduce inventory and people costs. While
cost is still an important consideration, the companies that work within our industry are
focused more externally - on innovation and providing value to our patients – than
internally for cost savings. Thus, LSS is seen to provide value by focusing improvement
efforts on the business processes that support innovation, speed to market, and
sustainable 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. Perhaps
this is because of the evolution through such programs as the statistical methods of
Deming and Juran, Malcolm Baldrige, JIT, Right First Time, re-engineering, theory of
constraints, and the myriad of other manufacturing-based programs that were introduced
in the 20th century. But whatever the reason, functional areas outside of manufacturing
take a little longer to gain momentum in LSS.
As for new trends, I have seen senior management supporting LSS in areas not
previously considered for this. For example, we continue to see consolidation in our
industry via mergers and acquisitions and the acquiring company must be able to
accurately assess what they are looking to acquire (the Due Diligence process), as well
as successfully integrate the new acquisition (the Post-Acquisition Integration process).
Reducing the time it takes to complete these activities, improving the effectiveness, and
reducing the variation & risk are all areas of interest for senior management and a
perfect 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 many
instances 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 two
in my own experience). There has been much research in this area and there is so much
information available to us that clearly show what works and what doesn’t. We know that
a lack of a senior level sponsor welcomes failure. We know that a tools-based approach
rather than cultural shift is not sustainable. We know that we must support the LSS
initiative with people dedicated as full-time change agents. We know that projects must
deliver 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 not
learn from repeating these types of failures.
It is expected that when working to innovate and improve that the occasional failure will
be realized and then we learn from it. That’s how we make progress.
Amber Scorah: What practices and approaches are being adopted from other
industries?
Paul Nelson: For me, I think the most exciting adoption of practice is in the area of
process understanding and product characterization. It is a fantastic example of using
the six sigma concepts from mature industries and applying them to newer areas in
biotechnology. In the mature and highly automated industry of fine chemicals, for
example, the manufacturing processes are extremely well defined. Every variable that
can affect the product quality is well understood. The process is capable of producing
the product with its intended characteristics and the variability is controlled via
automation. There is very little product testing required at the back end of the process
since 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 sustaining
excellence?
Paul Nelson: In my own recent experience I have seen excellent success from one very
simple 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 senior
leader using this tool to prioritize the areas of risk, improve those areas by removing
waste to improve efficiency & effectiveness, re-assess the risk scores to ensure the risk
has been mitigated appropriately, then move to the next priority risk and repeat the
exercise. Sometimes having a senior leader driving an improvement with a simple tool
yields very substantial business results!
Paul Nelson,
Operational Excellence Leader
Shire Pharmaceuticals
Foster a culture of continuous improvement. Join us July 20 to 22, 2011, in San
Diego, CA for the 12th Annual Lean Six Sigma for Pharmaceutical, Biotech and
Medical Device Excellence conference. For more information visit
www.lsspharma.com, or email info@iqpc.com.