FDA's New Process Validation Guidance Recommends Team Approach

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Copyright © 2009 Norm Howe


The November 2008 FDA draft guidance for process validation says "We recommend an integrated team approach to process validation that includes expertise from a variety of disciplines..."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


About the Author:
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