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Mar 13, 2014

Sound Risk-Based Decision Making in Process Validation

By Robyn Barnes, Marketing Communications, MasterControl Inc.

MasterControl’s Walt Murray recently returned from a speaking engagement at MD&M West.  I asked him for impressions of the conference.
Do you know the difference
between the decision-making process
and root cause investigation?

“The exhibition was massive,” he said.  “It was a great event for us.  There were so many people everywhere you went that it felt like a real crush. I’ve got to tell you that a foot massage every night would have been really useful. “
During the meeting, Walt taught a class on “Conducting the Validation Protocol, Collecting and Analyzing the Data.”  
“Normally, this might not be the most exciting class to attend, especially right after lunch,” he says.  “But we had a full room.  The discussion was lively and ranged from the importance of quality decision-making to solid event management.  I was surprised to discover that many people were not clear on what solid event management means.“ 

MD&M West staff asked Walt to conduct a quick process flow and rationale of the root cause investigation process in the steps of a quality event management escalation. To his surprise, many audience members didn’t understand the difference between the decision making (DM) process and root cause investigation (RCI). 

“The two aren’t remotely the same,” Walt exclaims.  “DM requires a process of identifying the objective, criteria, and defined alternatives to make a choice while evaluating the risks. RCI requires data that defines the issue and uses comparatives to distinguish the source of the problem and its likely cause, which is then tested against the facts for verification.  We spent quite a bit of time clearing up this confusion. As a result, the audience was excited with understanding the importance of using critical thinking processes.”

“We also discussed plan analysis (PA) as the third process for correctly implementing the validation plan to remove the recurrence or the choice made to implement a change to the plan.  DM, RCI and PA are all important facets of improving the quality of process validation.”
Murray plans to return to MD&M West to speak next year.  “Maybe we’ll just concentrate on the relationship between DM and RCI, since it confuses so many people,” he says. 
“And I’ll be sure to take better shoes,” he chuckled.

Walt Murray is a consultant in the quality and regulatory profession with more than 25 years’ experience to his credit, working with nationally-recognized companies. He is certified in quality systems auditing, problem solving, and process control using Six Sigma principles that support lean enterprise, including kaizen improvement and advanced planning principles. His extensive audit experience covers several industries and he's successfully brought several medical device companies to full registration under the ISO process model standard. Murray has also worked extensively in risk and supplier management and is frequently sought as a speaker at national quality meetings.

Robyn Barnes, a public relations specialist at MasterControl Inc., writes about the life sciences industry and other regulated environments. Her three decades of marketing and public relations experience include work with USAA, Morrison Knudsen Corp., and KBHome Inc. She holds a bachelor’s degree in journalism and a master’s degree in business from New Mexico State University.






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