FMEA Q and A

In this Q and A article, a reader asks a challenging question about the linkage between FMEA boundary diagrams and Design FMEAs. There are many linkages between different elements of FMEAs, and this question/answer highlights one of the key linkages.

“In all affairs, it’s a healthy thing to hang a question mark on the thing you have long taken for granted.”
Bertrand Russell

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Problems and Solutions

Can you identify the effect of the door latch-pin failure in this case study? The loss of the aft cargo door on the American Airlines DC-10 aircraft will be the focus of this Problems and Solutions article. This real-life case study is being used to practice identifying FMEA elements.

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If a Tree Falls in a Forest . . .

Why do you think FMEA procedure requires effects to be taken to the system or end user? Why not describe the consequence only at the local level. If a bolt in a complex system fails, the parts that the bolt was clamping together may come apart. Isn’t that enough?

“Wisdom consists of the anticipation of consequences.”
Norman Cousins

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FMEA Q and A

In this Q and A article, a reader asks an interesting question about whether or not to update a System FMEA, when making subsequent changes to lower-level items. This is an excellent question, and shows the reader has good insight into the application of FMEA.

“Judge a man by his questions, not his answers.”
Voltaire

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Problems and Solutions

Whether you are new to FMEA or more experienced, these problems will challenge your skills. The intermediate/advanced problem uses an actual airline disaster to challenge readers with an FMEA problem, and practice identifying the elements of an FMEA.

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Why Describing the Mode of Failure is Essential

Do you know why we ask for the “mode” of failure when performing FMEAs? This article will provide theory and practical examples of defining failure modes, and highlight an application tip that can improve your FMEA effectiveness.

“I haven’t failed, I’ve just found ten thousand ways that don’t work”
Thomas Edison

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FMEA Q and A

In this question, a reader asks how to define system-level functions, and how they are different from subsystem and component functions.

“A prudent question is one-half of wisdom.”
Francis Bacon

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Problems and Solutions

Do you consider yourself an FMEA beginner or are you more experienced? Challenge yourself with these problems about FMEA functions, and see how you do. One of the best ways to learn is by pondering application problems and seeing of you can solve them.

If you haven’t yet read last week’s article Understanding FMEA Functions – Part 1, it would be a good idea to read it now, as the questions are based on that article.

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The Essence of the Item

What is the essence of properly defined FMEA Functions? More than half of FMEA practitioners miss a key element when defining FMEA functions. This first article in the FMEA Definitions and Concepts Series will discuss functions and their application in FMEAs.

“A perfection of means, and confusion of aims, seems to be our main problem.”
Albert Einstein

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3 Medical Device Questions

FMEA Q & A

In these series of questions, a reader asks about whether system FMEAs in the medical device industry should include human interactions, and the difference between system and application FMEAs.

“The art of proposing a question must be held of higher value than solving it.”  Georg Cantor

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