Pharmaceutical Manufacturing spoke with Six Sigma guru Peter Pande about its application in the drug industry. His book, “The Six Sigma Leader” was recently published by McGraw-Hill (visit our web site for a chapter extract). In particular, he was questioned about its use in drug development and R&D, where antipathy appears to be building up against Six Sigma. He suggests that some drug company managers may be trying to fit square pegs into round holes instead of looking at the broader issues that can make Six Sigma work in any area, from discovery and R&D to supply chain management.
PM – Is Six Sigma passé? It’s often lampooned in Dilbert cartoons. Why is this happening?
PP – Any methodology can be misapplied. If you take the misapplications or “failures” and say, that’s what Six Sigma is all about, then everything will be a failure because nothing works perfectly every time. It’s like seeing a broken down car and then saying that all cars are broken down…There’s a little bit of that problem.
But there is an oversimplification of what Six Sigma is. A lot of the mistakes occur when people overly narrow the definition of Six Sigma and try to fit it within a certain set of tools that just don’t apply to the broader array of business issue. It’s like saying, “Six Sigma is a hammer but I have some screws here” – it won’t make sense. That really is where there needs to be a better broadening of the perspective, so that people don’t get locked into thinking, “I’m only doing Six Sigma if I’m doing X.”
PM – Aberdeen conducted a survey recently (copy available on PharmaManufacturing.com) that indicates that most companies that “think” they’re implementing Six Sigma, in fact, aren’t. What is your reaction?
PP – I agree with the Aberdeen report’s summary statement that a lot of companies that say they’re doing Six Sigma aren’t doing it very well. But the first recommendation that’s listed in that digest, about applying DPMO methodology to all business activities, is not a good idea. It’s unproductive because there are plenty of activities in a business where that type of measure is just not relevant, or not the best to evaluate how it’s working.
But that’s an example of how people narrow Six Sigma. People say “you’re not doing Six Sigma if you’re not doing DPMO.” A lot of folks in the pharmaceutical industry see that notion and are legitimately scared by it. That’s where the Dilbert stuff comes in; it’s easy to see why people say, “this isn’t for me.”
From a leadership perspective, you have to look at the breadth of how you’re making improvement and change happen in a business. That’s where you see that the companies that have been most successful doing Six Sigma – and they may not even call it that – are applying a broader array of tools. A key component is that they are using a more effective prioritization process to determine: “What are the things we should be working on?” “How do we integrate them into our operations more effectively?” and “How do we use a broader tool set?” Companies that have done this have had huge success.
PM – How should a group, team or company that is new to Six Sigma focus their efforts initially?
PP – First, you must clarify why you want to do Six Sigma, and what you even mean by Six Sigma. It really means different things in different businesses. For us, it means how to achieve results and to drive change using a variety of methods and tools, but not necessarily limited within some narrow band. Businesses and leaders must define for themselves what’s critical, what the goals and objectives should be.
That’s the first step. Then you must evaluate the most compelling opportunities to apply it to. Have a long- term view to how you’ll integrate it with how your business is managed and led.
Often leaders initiate problem-solving efforts not by defining a problem but by giving everyone a solution. The beginning of the process is supposed to look at the problem, and what we think is happening, not to validate the problem. That’s a management thing that needs to change rather than a tool set.
PM – Six Sigma needs top-down support but there may be organizations where management is oblivious. If projects are done, can this be bottom up driven?
PP – Sure, Becton Dickinson launched its Six Sigma efforts that way. It was mid-management led, applied first in distribution and customer databases. If you look at an ‘05 or ‘06 annual report, the chairman touts Six Sigma as the key to some financial successes. It can definitely begin at that level.
Sometimes it’s easier to do it that way. If you have a leadership group or individual group with the bad habit of dictating the solution, it’s better to operate under the radar screen.
PM – Have you consulted for pharma companies?
PP – I’ve had more work with medical devices than pharma, but I have done some consulting for pharma. I’ve had conversations with folks on how to apply Six Sigma processes. It’s not easy because the business issues aren’t easy. It’s especially hard if you view it as one-size-fits-all.
PM – Can it be applied to R&D?
PP – Yes definitely, but you would need to adjust your definition, and apply it differently to different aspects of R&D. Certainly, in a raw basic research and basic discovery mode, it’s very different from the process of tracking a promising product through the pipeline, from clinical to approval.