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FDA's New Process Validation Guidance Recommends Team Approach

Article Description:
====================

The November 2008 FDA draft guidance for process validation says
"We recommend an integrated team approach to process validation
that includes expertise from a variety of disciplines..." But
when different people from different backgrounds work together,
disagreements can stall your team. How do you get your project
back on track?


Additional Article Information:
===============================

665 Words; formatted to 65 Characters per Line
Distribution Date and Time: 2009-01-21 12:36:00

Written By: Norm Howe
Copyright: 2009
Contact Email: mailto:info@...



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FDA's New Process Validation Guidance Recommends Team Approach
Copyright (c) 2009 Norm Howe
Validation and Compliance Institute
http://www.vcillc.com



The November 2008 FDA draft guidance for process validation says
"We recommend an integrated team approach to process validation
that includes expertise from a variety of disciplines..." But
when different people from different backgrounds work together,
disagreements can stall your team. How do you get your project
back on track?

In fact, a certain level of conflict, properly managed, is
essential for a high performance team. If you're a team leader,
you have to deal with conflict as part of your daily job.
Sometimes it can take up all your time and leave you feeling
stressed out before the day is over. You may wonder, "Why can't
they just get along?" and wish that your team could be
transformed into a group of angels. But the reality is that you
don't want that either. Here's why.

You need a diverse assortment of talent in order to cover all the
types of technical expertise that are required by the project. In
today's complex world those different technical specialties are
becoming even more necessary.

In addition to the diverse technical skills the team also needs
people who think differently. It needs detail people and
big-picture people. It needs people who like to work with others
and those who can work alone. It needs people who insist on
taking the time to get the job done right and also those who are
driven by deadlines. All these different types of people will
contribute to better decision making on your team. Truly high
performance teams need to have diversity in their personnel.(1)

But people who have diverse ways of thinking don't easily come
to agreement with one another. There is a myth that opposites
attract, but, in fact, people who are most alike get along
better.(2) People who think differently will take longer to reach
agreements. Thus we have met the essential dilemma of high
performance teams. If we want high performance teams, then they
must be diverse. But diversity also implies conflict. Therefore,
our high performance team leader must accept the premise that
some level of conflict will always be present in the team. The
question is, how does the leader channel that conflict into
creative energy?

One typical answer is to have the team members learn something
about the technical functions that other members of the team must
execute. If, for example, manufacturing personnel spend some time
in the lab, they may learn why sample analyses sometimes take
longer than they'd like. This knowledge doesn't mean that the
samples immediately get done any quicker, but at least
manufacturing understands why. And this new familiarity with each
others' problems can then form the foundation for continued
dialogue and mutual problem solving.

However, different technical functions are far from the only
characteristic that can make two people different. It's not
widely known, but people simply think differently, and this leads
to many misunderstandings. For instance, some people focus on
details and some people focus on the big picture. One is NOT
better than the other. But you really need to have BOTH
viewpoints on your project, (and they can't be fighting
eachother) if you want it to be done right.

How do you make that happen? That understanding can be gained
through an instrument like Meyers-Briggs Personality Types. If,
by analogy to the cross-functional training mentioned above, we
could train employees to understand how their teammates think, we
would be well on the way to developing a better relationship
among the employees.

This new familiarity with each others' ways of thinking can then
form the foundation for continued dialogue and mutual problem
solving. There are consultants that provide Myers-Briggs based
training to help companies improve team performance in a
regulated environment.

(1) The Decision Maker Matters: Individual versus Group Behaviour
in Experimental Beauty-contest Games by Martin Kocher and
Matthias Sutter‍Economic Journal, January, 2005.

(2) Assortative Mating and Marital Quality in Newlyweds: A
Couple-Centered Approach. By Luo, Shanhong; Klohnen, Eva
C.Journal of Personality and Social Psychology. 88(2), Feb 2005,
304-326




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Norm Howe, Senior Partner at Validation and Compliance Institute,
consultants for the pharmaceutical and medical device industries.
He got his BS at UC, Berkeley, and a Ph.D. in chemistry at UCLA.
He has held many management positions in FDA regulated industries,
most at BASF. http://www.vcillc.com


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