BioPharm International - October 2020

BioPharm- October - Regulatory Sourcebook

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50 BioPharm International eBook October 2020 www.biopharminternational.com Strong Quality Culture: A How-To for Busy Managers Building employee participation and forming good habits contribute to a company-wide quality culture that pays off. M anaging people is an art, which makes it tough for managers in the pharma- ceutical 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 manufacturing, 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 employ- ees were making 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 for all these transgressions were eating us alive. THE DECISION TO ACT I gathered the staff and asked them, "How much are all these errors costing us?" Nobody knew, of course. So, I vegefox.com - Stock.adobe.com NORM HOWE is senior partner, Validation & Compliance Institute. NORM HOWE Regulatory Sourcebook Quality: Viewpoint

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