Pharmaceutical Technology - October 2020

PharmTech - Regulatory Sourcebook - October

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Pharmaceutical Technology Regulatory Sourcebook October 2020 65 Quality: Viewpoint M anaging people is an art, which makes it tough for man- agers in the pharmaceutical industry. We tend to be sci- entists and engineers. Words like art and culture leave us confused, because they can't be measured. And, we know that if you can't measure it, you can't manage it. When I first came out of R&D and started managing people in manu- facturing, I had a pretty good idea of how the plant should run. I would tell the people what to do and expect results. And I was surprised when they didn't do what I said! Now, it's not that they outright refused orders. No, that would be insubordination. They were far smarter than that. They had a million excuses for staying with the old ways. "Oh, we tried that last year, Norm. It was a disaster. You don't want to do that." But I knew that we had to change. Too many employees were mak- ing too many errors—not big errors, but rather thousands of little ones. We had a decent set of quality procedures in place. Everyone had been trained on the procedures. But we were swimming in small deviations and nonconformances. The investigations were eating us alive. The decision to act I gathered the staff and asked them, "How much are all these errors cost- ing us?" Nobody knew, of course. So, I said that we were going to estimate it right there. Everyone groaned. They knew we'd be there forever. "No," I said, "We don't need to be completely accurate in order to get this done. What we will do, though, is to include all the costs, whether they show up on a cost report, or not." Normally cost analyses would be done with accountants. They would pour over every last decimal point, then present management with a Norm Howe is senior partner, Validation & Compliance Institute. VEGEFOX.COM - STOCK.ADOBE.COM Strong Quality Culture: A How-To for Busy Managers Norm Howe Identifying the underlying causes of quality errors challenges managers at every level. Building employee participation and forming good habits contribute to a company-wide quality culture that pays off.

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