Assessing the Risks of Risk Analysis

With APQC process engineering, we tend to start where it should end

Just a few reminders to start with: In the automotive supply chain, process failure mode and effects analysis (FMEA) must be based on—or at least must take into consideration—design FMEA. This is the case whether a given supplier is responsible for the design or not.

During an FMEA, severity (S) is ranked from 1 to 10, depending on the severity of an effect on a product, customer, manufacturing process, or operator.

Occurrence (O) is ranked from 1 to 10, based on the number of incidents per items per vehicles. It’s interesting to note that a rank of 1 (i.e., very low) is based on the criterion “failure is eliminated through preventive control.”

Detection (D) is also ranked from 1 to 10. A rank of 1 is based on error prevention, but a rank of 10 is assessed as “no current process control.” Curiously enough, ISO/TS 16949:2009 cites “error prevention” in the notes to clauses 7.1 and 7.3, but then switches to “error-proofing” in the note to clause 7.3.2.2 (“Manufacturing process design input”: mark it!), as well as for clauses 7.3.3.1, 7.3.3.2 (“Manufacturing process design output”), 8.5.2.2, and Annex A, Section A.2d.

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Comments

Risk assessment - a reality check!

What an excellent article, thanks Umberto, some reality at last.

Trying to convince big-buck executives in high-risk businesses of the need for reality in risk assessment is often tedious work. The rolling eyes and the yawn always disclose the rose coloured spectacle approach Umberto so eloquently describes. I also include two other syndromes in the same vein, the sales department’s mantra "The answer's yes, what’s the question?" and the "Solution first, don’t worry about the problem" approach to continual improvement.

I have also promulgated HACCP as easier to understand than FMEA. The trouble is that despite its worldwide use as the regulatory and best practice approach in the food industry it seems to be too simple for the "my business is unique" brigade. That it derives, apparently, from the foundry industry during WW2 seems to have been forgotten in favour of the claim that NASA and Pilsbury came up with it for the Apollo programme in the 1960s.

I remain unimpressed with ISO 31000, even though I use it in my RM training course. I regard it as an attempt by those from the insurance and banking sector to complicate an area well understood in the technical and manufacturing worlds for several generations before most of the perpetrators were born. How they expect to be taken seriously in a Risk Managment standard that does not use the word "hazard" is a complete mystery to me. Didn’t we all learn aeons ago that you can’t manage the risk until you identify the hazard? On the other hand ISO 31010 is a good reference.

Thanks again, Umberto, well done.

Cheers