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
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NORM HOWE is senior partner, Validation & Compliance Institute.
NORM HOWE
Regulatory Sourcebook Quality: Viewpoint