LSS Trends and the Tools or Programs for Sustaining 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 Amber Scorah from Pharma IQ for an interview to discuss LSS trends and the tools or programs for sustaining excellence.

A Scorah: What is new in Lean Six Sigma?

P 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.

A Scorah: What new trends and old trends continue?

P 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.

A Scorah: Have any activities failed?

P 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 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 realised and then we learn from it. That’s how we make progress.

A Scorah: What practices and approaches are being adopted from other industries?

P Nelson: For me, I think the most exciting adoption of practice is in the area of process understanding and product characterisation. 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.

A Scorah: What tools or programs do you find are really sustaining excellence?

P 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 prioritise 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!