Why does pharma still hate Lean?

Many in the drug industry still dismiss lean manufacturing, kaizen, Six Sigma, 5-S, Poka Yoke and other operational excellence methodologies as management gobbledygook. A recent posting on In the Pipeline may indicate how many people in the industry feel. And pharma's knowledge workers may feel superior to their peers in widget manufacturing, potato chip and soap flake making. But I believe that more of them should acknowledge the waste within the industry---within both R&D and manufacturing---and keep an open mind about concepts that have worked for decades in other industries and are starting to work in their own. I'm sure that many pharma "operational excellence" programs have been utterConsultant failures, but I suspect that, in such cases, companies allowed three-ring-binder-toting consultants to run the whole show. Companies that are succeeding with Lean, etc., use consultants only briefly, to train staff on general concepts, so that they can go on to make positive changes, themselves, day by day, in the areas that they have control over. Some of the exercises that these consultants use may seem downright silly. Surely, we have more important things to do than to simulate what goes on in the plant or laboratory with Legos or sticklebricks. Or so it would appear...but in reality, these exercises break down barriers between different, siloed organizational groups (e.g., manufacturing and packaging) and help them see a much bigger picture. What could happen, for example, if R&D and manufacturing teams collaborated more closely, sooner in the drug development process, or IT and automation groups? The problem with these programs is resources and exaggerated expectations of quick results. Engaging staff, and keeping them involved, takes commitment and time at the beginning; these programs also require good data and trending studies. Some firms may take short cuts or hope, naively, that the consultant will make everything work. Pharma companies that are doing "op ex" right are also creating---excuse the cliche---empowered workers capable of analyzing and solving problems. You see the difference immediately, especially in non-degreed operations staff. True, Toyota Production system concepts certainly can't be applied directly to drug manufacturing, without some tweaking and translation. Most drug companies that are succeeding with their efforts are picking aspects of different "tools" that they like and that work for them---typically, they start with 5-S and value stream mapping, incorporate DMAIC from the Six Sigma methodology and throw in some kaizen and OEE. When applied correctly, these tools have saved individual facilities (and may save entire companies) from extinction. Can they be applied outside of manufacturing? Clearly, some of them can. Consider the simplicity of 5-S, designed to eliminate waste and motion, and error-proofing. These concepts work as easily in the laboratory as they do on the plant floor. How many facilities have I visited where labs, while scrupulously clean and "neat", are still disorganized. Setting things up the right way, to eliminate wasted time and effort moving from point A to point B, looking for a reagent, spare part, manual or other information that should be available and accessible to all, can help any lab. Sure, each improvement is small, but they add up (and to quite a total, when you actually track the data). It would seem that "Value Stream Mapping" should also guide more drug development efforts, ensuring better outcomes and less time spent on compounds that can't be manufactured. And, after analyzing where most errors are being made, day to day, in a lab, couldn't "error proofing" be applied easily enough, to prevent technicians from adding the wrong reagent or making data entry errors. The problem is, all this takes extra time and effort, and requires good data and trending, and everyone's already working full out. However, the efforts pay off. Can an industry that spends so much money each year working on "undevelopable" compounds and that has one of the highest waste and rework levels, and the highest cycle times, on its manufacturing side, afford to ignore these concepts? -AMS

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