FMEA confusion

The recent letter regarding failure mode and effects analysis (FMEA) ("Use With Caution," March 2012) risks confusing readers, rather than clarifying the overall subject of risk analysis. Some of the statements in the letter appear to be counter to what most readers understand.

Many organizations use FMEA and base their use of it on ISO 14971. Annex G of the standard states that FMEA is an available technique for risk analysis, but the letter says, "FMEA is not risk analysis."

In addition, FMEA has always operated by analyzing a failure mode in terms of severity of harm, probability of the harm’s occurrence and detectability of the failure mode. But the letter states that risk analysis is different from FMEA because risk analysis "analyzes the severity of harm and the probability of the harm’s occurrence."

Additionally, the letter states that FMEA "was designed as a reliability tool." But FMEA, as described in the standard, does not appear to be significantly connected to reliability.

FMEA does not significantly interact with mean time between failures, mean time to failure, infant mortality, product life cycle or any of the most common reliability concepts.

I think readers would appreciate guidance as to what approach they should take, rather than guidance that appears to say "everything you know is wrong" without really providing any direction. Perhaps I am interpreting this incorrectly. I have been using FMEA successfully for more than 20 years, and I am open to learning more about it.

Tom DuBois
Glen Falls, NY

ISO 9001 resistance

I just finished reading "Taken for Granted" (February 2012), and I can’t understand why there is such reluctance in following and championing ISO 9001. It boils down to common sense and good business practice.

I think those who are reluctant to embrace it don’t equate it to their life experiences. If they owned a company, wouldn’t they want a consistent quality product to be correctly delivered to a satisfied customer?

I constantly hear how paperwork doesn’t make money. Try not doing the paperwork and then being forced to repeat the design process because you forgot how you originally built the product. Time costs money. Ship a customer a product that isn’t the same quality as the last order they received. Lost customers cost money.

I find it takes no more time to do something right than to do it wrong, and in most cases it takes additional time to correct the mistake. Next time you bellyache about doing paperwork, think about how you would feel if your accounting department gave you less money this week because they didn’t like to do their paperwork.

Tom Herr
Huntingdon Valley, PA

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