Could be. It’s from Quality Digest’s June 2011 release, but it remains a solid critique of current risk analysis methods, such as FMEA, which rely on arbitrary guesswork and bad math to make critical decisions. As I’ve said before, by applying numbers to guesses, we disguise the subjective nature of FMEA and confuse it with science. It isn’t.
In fact, we discover, it’s not even proper four-function math. Says author Donald J. Wheeler:
The problem with FMEA is not the subjective ordering of the three different aspects of a problem. It is not even a problem to have more levels than adjectives. The problem is with the risk priority numbers and their use to create a ranking between the problems.
You can read the entire article here.
With a near-disastrous attempt at incorporating risk management in the upcoming ISO 9001:2015 standard, we can expect lots of consultants pushing FMEA and other risk tools on a suspecting public, not educated in statistics. Like the training matrix, document master lists, Turtle Diagrams, process maps and 5-Why root cause analysis, FMEA stands to become a de facto requirement when dumb Certification Body auditors force it on clients, insisting it’s the only way to do risk assessments. (This is already the case with AS9100, which has had a risk management clause included since 2009.)
FMEA works for some aspects, and can be tooled to work better by following Dr. Wheeler’s advice. But it still won’t work in every situation requiring risk analysis.
Christopher Paris is the founder and VP Operations of Oxebridge. He has over 35 years’ experience implementing ISO 9001 and AS9100 systems, and helps establish certification and accreditation bodies with the ISO 17000 series. He is a vocal advocate for the development and use of standards from the point of view of actual users. He is the writer and artist of THE AUDITOR comic strip, and is currently writing the DR. CUBA pulp novel series. Visit www.drcuba.world
