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:
training” really means: “Joe said he likes they way he does it better.”
failed” really means: “Tom did not want to shut down for preventive
mixing” really means: “Ryan said that mixing studies were not necessary.”
tanks” really means: “John didn’t want to spend the money to replace the
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
To quote Dr. Seuss: Today
you are you, that is truer than true. There is no one alive who is youer than
Press, 9/29/10, Engineering Expert Takes Issue with BP’s Oil Spill Report,
submitted by Jessica Durando.
About The QA
“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