This blog is straight talk about quality assurance in the pharmaceutical industry. Not the technical aspects as much as the challenges faced by company management and their internal quality assurance professionals—sometimes side-by-side and often toe-to-toe.
Saturday, October 2, 2010
Root Cause Analysis: the 5 "Who's" Behind the 5 "Why's"
I think it is time to add the "Five Who's" to the "Five Why's" in the Quality Tool Box. The “Five Why’s” is a common technique used to derive the root cause for a problem. The idea is if one keeps asking "why" enough times—like a persistent child—the layers will peel off and the true reason will surface.
But sometimes the reason for a “why” is a “who.” For example:
“Inadequate training” really means: "Joan said he likes they way he does it better."
“Equipment failed” really means: "Ted did not want to shut down for preventive maintenance."
“Inadequate mixing” really means: "Fred said that mixing studies were not necessary."
“Leaking tanks” really means: "Jane didn’t want to spend the money to replace them."
Some say that the problem is always with the system, never a person. I doubt that, unless we run our businesses with robots. Even then, someone had to program them. Decisions don’t make themselves. And as long as fear reigns supreme in a punitive organizational culture, getting at “who”—and true root causes—for learning and accountability purposes will be elusive.
This is one reason the BP investigation into the Deepwater Horizon rig explosion was less than satisfying to Najmedin Meshkati, a professor at the Viterbi School of Engineering at the University of Southern California.
He said of BP's nearly 200-page internal accident report, "How could you call this great work accident investigation...(without) addressing human performance issues and organization issues, and decision-making issues?"1
As far as the FDA is concerned, the question of personal accountability has already been asked and answered by the U.S. Supreme Court. (See The QA Pharm 9/11/10).
It is interesting to watch hearings in Congress--or Whoville--over pharma failures lately. There is more interest in who was in charge and who made the decision than operatives who were in the room at the time of the incident.
To quote Dr. Seuss: Today you are you, that is truer than true. There is no one alive who is youer than you. It's time to be honest, direct, and create a supportive and learning culture, if we are ever to really excel and compete.
1 Associated Press, 9/29/10, Engineering Expert Takes Issue with BP’s Oil Spill Report, submitted by Jessica Durando.