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My June 2025 article, “How to Avoid FDA Warning Letters,” points out that inadequate corrective and preventive action (CAPA) is a major reason for warning letters, and also introduces the role of failure mode effects analysis (FMEA) in preventing trouble in the first place. The U.S. Food and Drug Administration’s keyword-searchable warning letter database, however, shows only five entries for FMEA vs. 574 for CAPA. One reason might be that while CAPA is required according to the Code of Federal Regulations (21 CFR 820.100—“Corrective and preventive action”), FMEA is apparently not—and FDA inspectors work according to the CFR. This article will take an actual FDA warning letter and show how it might have been avoided through use of FMEA.
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FMEAs prevent a lot of problems.
Find out more about AIAG/VDA FMEA here: https://www.qimacros.com/lean-six-sigma-articles/fmea-template/.
FMEAs prevent a lot of problems. It's easier than one might think.
FMEAs Are Very Powerful But the AIAG/VDA Method Is Flawed
FMEAs are an extremely powerful tool for managing medical device risk but are misunderstood by most people in the medical industry trying to use them. I wrote an article titled "Solving the Problem of Medical Device Poor Quality published by IEEE where I explained the the power of properly used FMEAs in a process called Risk Based Medical Device Lifecycle Management® (aka Risk Based MDLM®). (Video: https://www.harpcosystems.com/learn/resources/solving-medical-device-poor-quality-costs-video Article: https://www.harpcosystems.com/wp-content/uploads/2022/07/Solving-Problem-Medical-Device-Poor-Quality-Costs-RichHarpster.pdf )
Although FMEAs are an extremely powerful tool in managing medical device risk, the AIAG/VDA FMEA methodology unfortunately is a fundamentally flawed process whose origin is traceable back to 1987. I presented a paper explaining its weaknesses at the ASQ 2020 World Conference titled "AIAG VDA FMEA Handbook Methodology Demystified". https://www.harpcosystems.com/learn/resources/aiag-vda-handbook-demystified
I also wrote an article titled "The Case Against the AIAG/VDA DFMEA" which was published in Quality Digest ( https://www.qualitydigest.com/inside/risk-management-column/case-against-aiag-vda-dfmea-013118.html ). The paper played an important role in preventing the AIAG VDA FMEA Methodology from becoming an automotive industry standard because of the weaknesses that it exposed.
Finally, I recently provided a webinar for the ASQ Reliability Division titled "AIAG VDA Failure Modes and Effects Analysis Handbook - Is It Now the Standard" that explains the method's weaknesses and why it will likely never become an automotive standard - see https://www.harpcosystems.com/learn/resources/aiag-vda-fmea-standard
My focus is on PFMEA
Richard,
My article focuses on PFMEA, for which the AIAG/VDA manual looks best but, from what I remember of the 4th edition AIAG manual, the latter also looks viable except for the Risk Priority Number issue. Both improve on previous versions by using the nature of the Prevention controls to determine the Occurrence rating, as opposed to requiring the user to estimate the nonconforming fraction (e.g. 1 in 10,000). My primary experience is however with "what happens once the design is handed over to production?" as opposed to the design itself, although I do know from experience what happens in the production line when something is not designed for manufacture.
The articles you posted are definitely worth looking at, especially with regard to DFMEA. Figure 3 in https://www.harpcosystems.com/wp-content/uploads/2022/07/Solving-Problem-Medical-Device-Poor-Quality-Costs-RichHarpster.pdf shows manufacturing-side failure causes (formerly known as failure mechanisms) such as use of expired mold seal compound as well as design related ones.
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