In this article, I’m going to explain why it’s worthwhile to complete an FMEA. Let’s start with a general discussion, without regard to Process FMEA or Design FMEA. The major issues are the same, although the details can (and often do) diverge. FMEA is crtical tool in Product Development processes, and you should understand why that’s true.
Point 1: FMEA is NOT an End Point.
If you complete an FMEA, heave a sigh of relief, and don’t use the results for meaningful and significant actions, don’t waste your time doing FMEA studies. FMEA is all about improving products and processes, and if you think a finished FMEA is useful because it checks off a “to-do” on some list of deliverables in a project, you are missing the point completely. You’ll spend time (and money) and get little or nothing in return. The FMEA form is just a place to keep track of what can and should be done as a result of the study.
Point 2: You Need to Make Changes As A Result of Every FMEA Study
If you’ve done an FMEA study correctly, you are going to find some cause-mode-effect chains (or rows on the FMEA form) that have a risk you aren’t comfortable with. In those cases you have two choices. You can agree, with an eyes-wide-open perspective, to accept the risk as it sits and move on. But you can also devise a plan to take a direct action, choosing a design change (for either DFMEA or PFMEA) or a process change (PFMEA only) that will address the risk.
If you never try to do anything except go forward the way you planned before starting the FMEA, you are making a terrible mistake. Worse, you are devaluing the FMEA process—and once you do that, you will find that each successive FMEA has less and less significance. Eventually, you’ll just be checking the box and filing the form away in some obscure folder, drive, or database.
Point 3: You Need to Implement The Controls
If you’ve done a decent job on the FMEA study, you will have a long list of prevention controls as well as detection controls. Do you need to add every single one to the Design Verification Plan (DFMEA) or the Manufacturing Control Plan (PFMEA)?
In a perfect world, the answer would be yes. And, there are plenty of OEM customers (and engineering managers) who will insist that you reach for a perfect world. However, reality is somewhat different. In a sound FMEA, there will be a number of controls that you would like to apply, but are either too expensive, take too long, or are otherwise unlikely to be carried out.
In those situations, you again have to deal with an eyes-wide-open risk. Either spend the money and/or time to carry out the controls, change the design or process, or accept the risk.
On the other hand, there will also be one, two, or even several controls that you really should add to the list for verification or control plans. They might add a bit of cost, they might add time to a project, or they might intrude on issues that veer into the “we don’t do that here” mentality of your organization.
If you aren’t actually applying some of these out of every FMEA, you simply aren’t getting to the main point. At the same time, if you are skipping or omitting one, two, or more of the controls you’d normally do for the same kind of product or process, you are—again—missing the boat.
What You Can Do
I’ve been doing FMEA studies since 1978. I’ve learned something about the methodology every time I use it, and I’ve been involved, either as an active participant, instructor, or facilitator, in hundreds of DFMEA and PFMEA studies.
When the results are applied, good things happen. When results are not applied, the outcome is worse than “nothing happened.” What almost always occurs is that FMEA becomes devalued, and another group of engineers walks away with more than a bit of loathing for using this valuable technique.
And, while I suspect that many of you think this advice is too obvious to worry about, I will add this. Even in the past five years, the number of FMEA’s I have seen that have resulted in no meaningful action exceeds 80%. I would say 95%, but in truth I don’t always know if action has been taken in every case.
Use the results. Make something positive happen with what you learn from each and every FMEA.