QUALITY MANAGEMENT

Why FMEA is often misunderstood.

Even at the age of 12, I was familiar with concepts like QFD and FMEA—QFDs were a standard part of decision-making in our household before any major purchase. 😀

Today, I’m discussing FMEA (Failure Mode and Effects Analysis) with Manfred, focusing on how to demystify this complex tool and make it more accessible to encourage broader engagement and understanding.

Interview Insights

Manfred Mayr-Willius has been driving global product development and product architecture at Whirlpool for over 24 years, with risk analysis always playing a central role. Today, he works as a consultant and teaches these topics at the Duale Hochschule Baden-Württemberg University in Stuttgart.

I asked Manfred whether he recommends conducting a risk analysis even in the absence of experts, despite the potential for inaccuracies, or if FMEAs should be carried out exclusively by experts to be effective.

Manfred responded, that the FMEA is essentially a tool, and like any tool, it is useful. Even if an amateur wants to unscrew a screw, they still need a screwdriver. Of course, a professional is better equipped due to their deeper background and experience. FMEA consolidates the team’s knowledge—even in the worst-case scenario, where that knowledge is limited and the FMEA is incomplete, it still helps to prevent errors.

The FMEA is essentially a tool, and like any tool, it is useful.

Manfred advises not to be discouraged when creating an FMEA for a previously unknown production process or a completely new product with little company experience. Unknown effects are rated as high-risk, which automatically necessitates further investigation as part of the FMEA process. Manfred explains that the first phase of an FMEA involves determining the probability of occurrence. The second phase is critical, as it focuses on developing measures to mitigate high risks. “If something is assessed as unknown with a high risk, it is given high priority.”

Practical Implications

Manfred emphasized that determining the probability of occurrence is part of the development process, not just an FMEA issue. The FMEA identifies critical points, but it remains the responsibility of the product or process development team to address these uncertainties. This might involve, for instance, not rushing into production with an untested process but first developing a prototype to gain insights. For most of the components, there are existing similar applications, so contacting manufacturers to learn from their experiences is advisable.

Future Outlook

When I asked whether FMEA will still be relevant as a tool in 5-10 years, Manfred affirmed that it would be, adding that support from artificial intelligence and big data could expedite the determination of input variables, such as failure probabilities.

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