From the Editor: Lessons from Shingo

Our survey on pharmaceutical operational excellence suggests that many drug companies still fail to take seriously two fundamental principles of manufacturing.

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By Agnes Shanley, Editor in Chief

‘Those who are not dissatisfied will never make any progress.’

—Shigeo Shingo

“Visuality” and customer focus are the keys to productivity. They’re the rule in other manufacturing industries, and they don't even require FDA approval. So why do so many drug companies still appear to ignore them? Perhaps they seem too trivial to elite pharma, which, after all, has the highest concentration of Ph.D. chemists, biologists and engineers of any industry. The tenets of manufacturing may be dull, and we've all heard them, but they can't be ignored:

  • The customer is the center of the universe


  • Waste is the nemesis

Pharmaceutical Manufacturing’s first survey on pharmaceutical operational excellence (see "Pharma Sharpens Its Game: Results of Our First OpEx Survey") suggests that some drug companies still fail to take these tenets seriously — most respondents admit that they don’t engage their customers regularly and deeply, to determine their needs and how they are being met. They also admit that manufacturing and other operations aren’t set up to eliminate waste, particularly motion.

The most insidious form of waste, motion includes unnecessary movement, the extra effort expended to find tools or information needed, quickly, to see KPIs, performance and compliance reports on the manufacturing floor, or to wrest siloed information from the tribal chieftains guarding it at the plant.

Our survey also suggests the need to work more closely with material suppliers and equipment vendors, and indicates that pharma companies are paying lip service to process capability analysis and statistical process control, but aren’t using the concepts all that much yet.

Pharmaceutical companies were conspicuously absent on April 21, when the winners of the 2006 Shingo prize for excellence in manufacturing were announced in a ceremony in Grand Rapids, Mich. Dubbed the “Nobel Prize of manufacturing,” the prize is as low-key as its namesake, but honors those who are dead serious about productivity. Shigeo Shingo, who worked closely with Taiichi Ohno to develop the Toyota Production System, made huge contributions to manufacturing science, including the concept of “source inspection” and SMED (single-minute exchange of dies), both of which are gaining acceptance in pharma.

Shingo also introduced error-proofing, or poka yoke, to prevent the human errors that lead to batch failures, accidents and downtime. These ideas are not just for hard-core aerospace and automotive engineers. His concepts can be applied even in the lab.

Striving for the ideals that Shingo advanced are the finalists for 2006 Team of the Year. In this issue, we announce the winners, selected by our editorial advisory board and a panel of outside experts.

We also feature an essay on “Transformational Leadership” by Pankaj Mohan, global process engineering manager at Eli Lilly, and his colleagues at the University of Newcastle. This excerpt from their new book suggests that anyone can be a leader in his or her own sphere of influence. Dr. Mohan will soon contribute a regular column on operational excellence.

I urge more pharma companies to shake off the false modesty or fear, and to apply for some of the quality awards that are out there. Not just TOTY but the ASQ “Team Excellence” award, which Baxter’s North Carolina team (also a 2005 TOTY award winner) won last year. Just applying can bring more focus to your continuous improvement efforts. Then, who knows, a Baldrige or a Shingo prize may be in your future.

In the meantime, remember that the journey is more important than the destination, and look forward to more articles and more (and better) benchmarking tools to help sustain you on that journey.

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