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: "Joe said he likes they way he does it better."
“Equipment failed” really means: "Tom did not want to shut down for preventive maintenance."
“Inadequate mixing” really means: "Ryan said that mixing studies were not necessary."
“Leaking tanks” really means: "John didn’t want to spend the money to replace the aging tanks."
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, reluctant, or uninviting 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).
So, it will be interesting to see what comes out of Whoville when the J&J congressional hearings are over and the finger pointing is done.
To quote Dr. Seuss: Today you are you, that is truer than true. There is no one alive who is youer than you.
1 Associated Press, 9/29/10, Engineering Expert Takes Issue with BP’s Oil Spill Report, submitted by Jessica Durando.
About The QA Pharm:
"I am an observer of the pharmaceutical industry from inside and out with over 30 years experience from the lab bench to the management board. If you have a passion for the value and the direct relationship that quality assurance and current Good Manufacturing Practices have to your patients and your business, you will find a kindred spirit here." For more insight from The QA Pharm visit his blog here.
Pharmaceutical Processing has been given permission to reprint The QA Pharm's blogs as long as his identity remains a secret.