For years, the term Lean manufacturing conjured images of “Lean and Mean,” with the ultimate goal of eliminating jobs. Even the word Lean inspired contempt in many facilities, where “drive by Kaizen events” (as one observer called them) and consultant-driven “flavor of the month” programs that had only the lip service support of senior management gave the concept a bad name.
In other cases, dedicated change agents in operations who had immersed themselves in Lean were working all out, using Lean improvements within their own lines or operations. They often achieved amazing results, only to find that nobody else was buying in within their companies. There were small, localized successes that failed to transform operations.
Six years ago, Derek Lowe lambasted these trends memorably in his blog, In the Pipeline:
“At many drug companies, a new fad comes rolling along every few years — some new buzzword-laden scheme that promises to re-invent, re-do, re-invigorate and basically make things work like it says in the three-ring binder that comes with the off-site course where you learn it all…The contempt that most of the scientific staff has for “modern management techniques” is hard to underestimate... Most of the time, there’s no data (other than anecdotal fairy tales) to back up the latest six-sigma-good-to-great-seven-habits-of-continuous-improvement craze.”
At that time, I wondered why the best concepts of Lean and Six Sigma couldn’t be brought to other aspects of pharma, including the laboratory and even R&D labs.
Since then, there has been a great deal of progress in applying both concepts beyond the plant floor. Two articles in this month’s Lean-themed issue examine Lean’s application to the Quality Control laboratory. By now, most people have a much better understanding of what Lean really is. Even if they’ve never actually used it, they know that it aims to reduce the sources of wasted time and motion in the workplace, standardize and error-proof work processes and optimize the interface between operator and equipment.
Lean’s greatest strength is its ability to help control the cost of quality. Unfortunately, at many companies today (and not just in pharma), consultants say there is still too great a focus on revenue improvement per se without recognizing the fact that reducing the cost of quality will lead to revenue improvement.
In a recent survey of 400 corporate executives, the consulting group LNS Research found that nearly 60% of respondents saw revenue growth as their top goal with just over 35% citing reducing the cost of quality. Perhaps they don’t see the connection between the two? Reduce the cost of wasted or recalled product and prevent compliance problems and you’ll have saved millions, if not much more.
As competitive pressures tighten, there is more pressure than ever to focus on increasing production efficiency and allowing quality to take a back seat, as Andrew Skibo, EVP of operations and manufacturing at MedImmune, said at an FDA/ISPE conference over the summer. Over the past few years, the industry’s increased focus on reducing manufacturing costs has also resulted in a dramatic increase in quality failures.
Skibo asked, pointedly, whether drug manufacturers were evaluating cost savings in the full context of risk versus value to the enterprise. “Pharma must ensure that quality is not compromised as manufacturing costs are reduced,” he said.
Management support and a crossfunctional approach are essential. “It is top down, rather than bottom up,” he said, “and... it’s about the environment and atmosphere in which we ask our people to work.” Let’s hope that, at pharma’s plants and labs, this atmosphere remains true to what Lean really is, and not the “Lean and Mean” that have resulted in so many consent decrees, product recalls and expensive compliance and quality problems.
