30 tips on how to guarantee your FMEA fails

The magic word is: proactive quality management

It would be so much easier if companies thought about the quality of their products and processes from the very beginning. That is exactly what proactive quality assurance is all about. One of the most important tools for this type of quality assurance is the Failure Mode and Effects Analysis, or FMEA for short.

As part of an FMEA, you use a structured approach within an interdisciplinary team to uncover potential process and product failures early on, thereby reducing risk. Ideally, the FMEA is treated as a living, central knowledge document within the company.

Admittedly, the initial creation of an FMEA requires a certain amount of effort and expertise. However, compared to the costs of a product recall, these are significantly lower. So, does every company absolutely need an FMEA? I say no, it’s not a must. But companies that consciously choose to forgo it must be prepared to accept the consequences that result from poor quality.

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What do sunscreen and quality have in common?

Since we are currently in the holiday season, I’ll use a summer analogy: If you’re heading to the beach, you should apply plenty of sunscreen before sunbathing. But do you really have to apply it if you just don’t feel like it? Sure, some people burn faster than others. But that doesn’t mean you’re forced to use sunscreen. Just don’t complain when you end up with a nasty sunburn.

What does this have to do with poor quality? In both scenarios, you’re wiser after the fact. Because after your first sunburn and your first product recall, you’ll know exactly why you should rely on sunscreen—and proactive quality management—in the future.

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30 anti-tips to guarantee your FMEA fails

Many quality managers have been "burned" before: They know from experience that it makes sense to invest in tools for proactive quality planning.
So that you can learn from them without getting burned yourself, I’ve written down 30 pro-tips on how not to approach an FMEA. My tips will help you if you encounter resistance during your internal mission for proactive quality management.

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1. You create the FMEA because the customer wants it – not because you think it makes sense.
2. You create the FMEA after the product has already been developed.
3. You would rather invest in expensive FMEA software than in high-quality content.
4. You think the software alone determines the quality of your FMEA.
5. You have the FMEA created by a single person working in isolation.
6. You file the FMEA away once it's finished and never look at it again.
7. You ensure that customer complaints are not incorporated into the FMEA.
8. You see no point in conducting periodic FMEA reviews.
9. You cut corners on professional FMEA moderation.
10. You use AI excessively to fill out the FMEA quickly.
11. You save the FMEA in a format that no one can open.
12. You save the file on your personal C: drive.
13. You delete action items that have already been postponed twice.
14. You name the file FMEA_Final_Final_V2_new.xls.
15. You formulate functions as requirements and define their non-fulfillment as the failure mode.
16. You continue to calculate the RPN even though the standard has long since discarded it, and you rely entirely on your own arbitrary threshold.
17. You let your team downplay the ratings until nothing is left above the threshold.
18. You copy an old FMEA into a new project and just update the date – nobody will notice anyway.
19. You have the FMEA created exclusively by the employees who planned the new product or machine.
20. You only buy one FMEA software license to save money.
21. You don't assign any responsibilities so that no one can step on anyone else's toes.
22. You write as vaguely as possible to reduce your workload and make it easier to copy and paste content.
23. You believe that a good FMEA automatically results in a good product.
24. You rely blindly on the FMEA. If it’s not in the document, it won’t happen.
25. You see synergies where no one else does and use the FMEA software for FTA as well.
26. You are the company's top cost-cutting expert: you categorically rule out any measure that might incur costs.
27. You have a hands-on mentality, and your go-to solution for everything is employee training. It always works and costs nothing.
28. You don't involve management because they already have enough on their plates.
29. You only conduct the FMEA reluctantly, because someone has to do it, after all.
30. You always carry a die with you to roll for ratings when in doubt, saving yourself from critical assessments and tedious discussions.

If you follow these tips, you are guaranteed to drive your FMEA into the ground and play right into the hands of your internal critics. However, if you draw the right conclusions from my suggestions for failure, you will succeed with your FMEA.

Ideally, you should make it an integral part of your quality management system. This ensures that changes and new input regularly find their way into the FMEA. And that puts your company in the absolute top tier!

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