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Home » Articles » FMEA Quality Objective 9: Design Improvements

by Carl S. Carlson 2 Comments

FMEA Quality Objective 9: Design Improvements

FMEA Quality Objective 9: Design Improvements

Progressive improvement beats delayed perfection. Mark Twain

In this article, I will outline how to evaluate an individual Design FMEA or Process FMEA against the FMEA Quality Objective for design improvements.

What is meant by “design improvement”?

An essential part of FMEA procedure is for the FMEA team to recommend and implement actions to reduce risk to an acceptable level. For Design FMEAs, this includes actions to improve the product design. For Process FMEA, this includes actions to improve the design of the manufacturing or assembly process. Of course, there are other types of actions that can be recommended, such as test improvements; but this quality objective is focused on design improvements.

Why is it a primary objective of FMEA to improve the design?

Years ago, many FMEAs did not recommend action to improve product designs or testing. They merely identified risk, which is important, but misses opportunities. When FMEA procedure identifies failure modes, effects and causes, it is a value-added step to go further and determine what can be done to reduce risk; and that often means changing and improving the design. Today, FMEAs are leveraged to improve designs, and achieve risk reduced to an acceptable level.

One of the reasons FMEA can improve designs is because the FMEA team is made up of a cross-functional team. The team includes experts in product design and other skills. It is a natural extension of the risk identification to recommend actions to reduce severity and occurrence risk by changing the design.

What is the FMEA Quality Objective related to design improvements?

FMEA Quality Objective 9: The FMEA drives actions to improve product or process designs as the primary objective.

How can you assess how well an FMEA meets the Quality Objective for Design Improvements?

Review the FMEA Recommended Actions. See how many of them improve the product design (for Design FMEAs) or the process design (for Process FMEAs). See if they were implemented.

What is an example of assessing Quality Objective # 9?

As an example, we’ll use an excerpt from a fictitious Design FMEA on a bicycle handbrake to assess Quality Objective 9.

BicycleHandBrakeExampleDFMEA

Based on the excerpt of the handbrake DFMEA, here is an example of the evaluation of FMEA Quality Objective # 9: Design Improvements.

HandbrakeDI

Tip

In addition to reviewing the FMEA Recommended Actions, you should also talk to the FMEA team. You want to determine how well the team focused on design improvements. Was it their primary objective.

Summary

One of the primary objectives of an FMEA is to improve the product design (for Design FMEAs), and improve the process design (for Process FMEAs). By following these simple steps you can ensure the FMEA is high value, and meets Quality Objective # 9.

Filed Under: Articles, Inside FMEA Tagged With: FMEA Quality Objectives

About Carl S. Carlson

Carl S. Carlson is a consultant and instructor in the areas of FMEA, reliability program planning and other reliability engineering disciplines, supporting over one hundred clients from a wide cross-section of industries. He has 35 years of experience in reliability testing, engineering, and management positions, including senior consultant with ReliaSoft Corporation, and senior manager for the Advanced Reliability Group at General Motors.

« Reliability Testing 101: Purpose, Timing and Value
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Comments

  1. JB says

    November 8, 2025 at 4:07 AM

    Hi Carl,

    Insightful as always and hopefully this is considered business as usual for most practitioners.

    I would like to ask your opinion on the following resistance I often hear from those facilitating FMEAs, which is….”As a facilitator, I cannot suggest design improvements because I am not an expert on this discipline/product/system”. My response is always that the facilitator is there to do just that, facilitate the process, which includes guiding the team down the path of identifying design improvements (and other mitigations within scope) regardless of their own knowledge in that area.

    Ideally the facilitator would have detailed knowledge of failures within the product, but often qualified facilitators may support other areas. For example I have a mechanical engineering background but I may facilitate an FMEA on an electrical product, with some research of failures in the area an understanding of the system form, function and context (operating modes etc.), I am well placed to guide an FMEA using the experts in the room to identify the primary content of the FMEA. Design changes are they teased out and triaged with regards to their impact on reliability. For example, asking questions to identify relating to how the stress-strength interface may be reduced, but doing this is a way such that the team is not exposed to unfamiliar technical terms that could detract from the purpose of the workshop, and ultimately identify possible design changes.

    I would very much like to hear your thoughts on this. I suspect some of you Thought Starter Questions in your book Effective FMEAs would cover this to an extent?

    Kind regards, Jamie

    Reply
    • Carl S. Carlson says

      November 8, 2025 at 5:41 PM

      Hello Jamie,

      I think there is a balance here. The best FMEA facilitation is when the facilitator is skilled in FMEA fundamentals as well as being trained in facilitation skills. The facilitator wears two hats, so to speak. One is facilitator, the other is FMEA team member. And, as you pointed out, the facilitator should have some degree of knowledge of the item being analyzed, not as an expert, but to be able to effectively lead the team. I agree with your point about your being able to lead an FMEA on an electrical product, with moderate preparation. Fred and I podcasted on this subject in the link directly below. After listening to the podcast, let me know if this answers your questions.

      https://accendoreliability.com/podcast/sor/sor-1022-facilitator-and-deep-understanding/

      Carl

      Reply

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Articles by Carl Carlson
in the Inside FMEA series

Logo Info

Information about FMEA Icon

Inside FMEA can be visually represented by a large tree, with roots, a solid trunk, branches, and leaves.

- The roots of the tree represent the philosophy and guiding principles for effective FMEAs.
- The solid trunk of the tree represents the fundamentals for all FMEAs.
- The branches represent the various FMEA applications.
- The leaves represent the valuable outcomes of FMEAs.
- This is intended to convey that each of the various FMEA applications have the same fundamentals and philosophical roots.

 

For example, the roots of the tree can represent following philosophy and guiding principles for effective FMEAs, such as:

1. Correct procedure         2. Lessons learned
3. Trained team                 4. Focus on prevention
5. Integrated with DFR    6. Skilled facilitation
7. Management support

The tree trunk represents the fundamentals of FMEA. All types of FMEA share common fundamentals, and these are essential to successful FMEA applications.

The tree branches can include the different types of FMEAs, including:

1. System FMEA         2. Design FMEA
3. Process FMEA        4. DRBFM
5. Hazard Analysis     6. RCM or Maintenance FMEA
7. Software FMEA      8. Other types of FMEA

The leaves of the tree branches represent individual FMEA projects, with a wide variety of FMEA scopes and results.

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