www.biopharminternational.com October 2020 BioPharm International eBook 53
giving away the company's money,
and amazingly, more effective.
WORK TEAMS
Employees were grouped into reg-
ular work teams (production shifts,
shipping/receiving, laboratory, engi-
neering, etc). Each team was asked
to think of something that they
did that affected GMP compliance.
They were then asked to develop
SMART goals—Specific, Measurable,
Attainable, Relevant, Time-bound—
that, if achieved, would result in
improved GMP compliance. The
fact that the goals were team based
encouraged the employees to help
each other to achieve the goals.
The critical aspect of the goal
setting process was that the goals
for each team had to be something
that the individual team had control
over. They could not change con-
trolled processes without following
our change control procedure.
Some of the managers struggled
when the time came to free the
teams to work toward achieving
the goals in their own way. With
repeated achievements, though, the
managers learned how to provide
enough room for the teams to find
their own way to success. They dis-
covered that the teams felt more
ownership of the results and were
more likely to comply with the pro-
cedures that they had shaped.
As the teams progressed toward
fulfilling their goals, they charted
their improvement. The charts were
posted in visible locations, thus pro-
viding proof of their achievements,
one of Herzberg's true employee
motivators. Management invested
their time to support the process.
This consisted of effortless things,
like asking random employees how
the process was going, then remov-
ing barriers as necessary.
The most important job of man-
agement was to show up—in per-
son—to recognize the achievements
of the teams. This could be some-
thing as effortless as serving ice
cream to the packaging crew when
they had achieved their goal of peer-
to-peer garb inspections when enter-
ing the cleanroom.
RESULTS
Did the program work? Yes, for
example:
• T he r ate of p e r fe c t b atc h
records was improved from
70% to 99+% in the second
year. A perfect batch record
means no GDP errors.
• In the third year, first-pass
quality yield improved from
91% to 96%.
Figure 1 shows the cumulative
cost/savings for the project. The costs
are primarily employee hours. It's
important to note that this effort is
not a get-rich-quick scheme; it is an
investment in the people and the
organization that takes time. It is
not expensive, however, requiring
approximately an hour per week per
employee, including managers.
Another benefit, which is not
readily measured, is very tangible.
Managers learned how to delegate
better. Many of them overcame
that one roadblock that was pre-
venting them from taking on more
responsibility.
REFERENCES
1. FDA, Request for Quality Metrics,
Guidance for Industry (July 2015).
2. A. Harrison, S.J. Schniepp, BioPharm
International, 28 (9) 18–21 (2015).
3. J. M. Juran, A. B. Godfrey, Juran's Quality
Handbook, 5th Edition, McGraw-Hill
22.65 (1999).
4. D. T. Neal, et al, Personality and Social
Psychology Bulletin, 37 (11) 1428–1437
(November 2011).
5. F. Herzberg, "One More Time: How Do
You Motivate Employees?" Harvard
Business Review, January 2003.
BP
Regulatory Sourcebook Quality: Viewpoint
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