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Expert Excerpts: Thomas Bertels on Process Improvement in Pharmaceuticals - GoLeanSixSigma.com

Whether you’re just starting your Lean Six Sigma journey, or you’re in the middle of improving a process, guidance from Experts can help make your efforts easier – and more successful! In this Expert Excerpt, we interview process improvement expert, Thomas Bertels, who shares key insights to being successful with process improvement in the Pharmaceuticals industry.

Thomas Bertels is a co-founder and Partner of Valeocon Management Consulting, a global consulting firm focused on helping clients achieve sustainable results and develop organizational capabilities. Over the last twenty years, he has worked with companies such as J&J, Novartis, Sanofi, Roche, Siemens, FedEx, Lincoln Financial, and Mitsubishi Chemical. He is a prolific writer who has published several books and numerous articles on process improvement, change management, and organizational learning.

What advice do you have for someone that is getting started with applying process improvement in pharmaceuticals?

Over the last twenty years, almost all of the larger pharmaceutical companies invested in formal process improvement programs and dedicated resources to tackling process-related business programs. Within the manufacturing functions, many companies have created an internal capability to support process improvement efforts as well as implemented lean-based production systems. However, when it comes to non-manufacturing functions, success has been limited. The challenge has been one of scope and scale: processes such as clinical development or adverse event reporting are often global in scale. For these challenges, the structure of most process improvement programs is often inadequate.

In addition, achieving real breakthroughs in performance requires also tackling issues related to technology, structure, governance, etc. – which requires skills that go beyond the classical Lean Six Sigma curriculum. So for somebody being asked to create a process improvement program, I would advise them to focus on the manufacturing function first. That does not mean there aren’t significant opportunities to improve business processes in other areas, but successfully tackling these opportunities requires a much broader, multi-disciplinary approach.

What are some common mistakes you see people make with process improvement in a pharmaceutical company?

Probably the biggest mistake process improvement professionals make is that they try to introduce new language and tools. The typical business user really does not care what tool you use or whether you are using Lean or Six Sigma. They care about the results, how what you do will make their organizations better. Yes, there are some leaders who see the potential and become true believers, but there are countless others that do not care.

Another typical mistake is not understanding how the industry works. Efforts that try to create a continuous improvement culture in the pharmaceutical industry have failed, and often for good reasons: the industry is highly regulated, so processes are not supposed to change, and especially not all the time. To be successful, focus on the business issue, avoid the jargon, and make it minimally invasive.

Is there anyone who has significantly influenced you over the years?

There are a number of people who have shaped my thinking over the last twenty years. Alan Rush, who has been a true mentor and inspiration, has given me invaluable advice on how senior executives tackle problems and stay focused on their leadership agenda. The work of Hackman and Oldman on work design, to whom I was introduced by John Uzzi, has been a real eye opener, highlighting the importance of designing jobs that provide meaningful work, autonomy, and feedback – which is often overlooked when designing efficient processes. Ohno’s classic work on the Toyota production system taught me that what Toyota created was in response to their specific problems, so copying and pasting their solutions without understanding your own challenges deeply is bound to fail. Jerry Sternin introduced me to the topic of positive deviance, which focuses on identifying those in the organization who have already solved the problem – and finding ways to identify and teach the behaviors that make them successful to others. I have learned a tremendous amount from my clients, most importantly that every situation is different and requires a careful, comprehensive diagnosis that goes beyond the stated problem.

Why do you do what you do? (What motivates you?)

I deeply enjoy helping clients and their teams tackle important organizational challenges, and to make that process fun, interesting, and rewarding. Nothing feels better than seeing a client a year after the project was completed raving about what they accomplished. Beyond that, it is rewarding to work with clients over years and sometimes decades, as a trusted advisor.

What’s something exciting that you’re currently working on?

With the increased rate of change that many of my clients struggle with, it has become clear to me that the typical transformation model (conducting a thorough analysis of the problem, designing a comprehensive solution, and then implementing this solution) is too slow to meet their needs. In large companies, there is only a short window of three to six months to deliver a real impact, before major changes (M&A, restructuring, executive changes) occur.

I have become intrigued by the Agile software development model, which focuses on delivering viable products early and often, instead of developing big bang solutions. We have incorporated these principles in how we work with clients, which not only has the benefit of delivering ‘good enough’ improvements faster but also helps the client to become more agile.

What’s your favorite application of process improvement in your personal life (away from work)?

I am a big fan of ‘Getting Things Done’, the personal productivity system David Allen developed. He advocates a set of routines (processes) that really help to free up your mind, by making sure all the work that needs to get done ends up in the system. While it is an ongoing struggle to capture all the work that needs to get done and process it accordingly, it has been a major help in staying on top of things. I have been using his process now for several years and am starting to see the value of a rigorous process – it frees up time to be creative.

Have a question for Thomas? Please feel free to ask in the comments below.

Thomas Bertels

Thomas Bertels is a co-founder and Partner of Valeocon Management Consulting, a global consulting firm focused on helping clients achieve sustainable results and develop organizational capabilities. Over the last twenty years, he has worked with companies such as J&J, Novartis, Sanofi, Roche, Siemens, FedEx, Lincoln Financial, and Mitsubishi Chemical. He is a prolific writer who has published several books and numerous articles on process improvement, change management, and organizational learning.