The Failure Mode and Effects Analysis (FMEA) tool allows an organization to examine the possible hazards and risks associated with a product or process. The Design Failure Mode and Effects Analysis, a DFMEA, is done for a product. The DFMEA is conducted to review all possible risks associated with the design of the product, establish risk mitigation options, and then determine any potential risk that might remain after the mitigation. A FMEA used for a process is known as a PFMEA.

FMEAs, DFMEA or PFMEA, can be used in multiple situations. A DMFEA should be utilized when the product is being designed, redesigned, or being used in a new way.[1] The DFMEA should take all possible risks of the design into consideration. Risks related to the design will vary depending on the type of product utilized. A few points to consider when creating a DMFEA are:

  • Can an aspect of the design harm the user in some way?
  • Can an aspect of the design prevent proper usage of the product in some way?
  • Can an aspect of the design result in damage to the product in some way?

The DFMEA should utilize the above and then determine the risk with the following:

  • The design feature
  • The potential failure mode of the feature
  • The potential cause of the failure mode
  • The hazard associated with the cause
  • The harm associated with the hazard
  • The severity level and probability of the harm
  • The risk priority determined from the severity and probability levels
  • The mitigation steps taken
  • The residual risk after mitigation

It is important to remember that while risks may be similar to each other they may have a different probability of occurrence. Meaning they should be listed separately on the DFMEA, even if every other part of the risk is the same. Even a tiny difference such as that warrants a different separate analysis.

It is challenging to create a DFMEA, even more so to determine all the possible risks of a product. EMMA International can help put a process in place to ensure the creation of a proper DMFEA or even help with the creation of the DMFEA itself. EMMA International provides Full Circle Consulting services, give us a call at 248-987-4497 or email us at to get in touch with our team of experts today.

[1] ASQ (2022) Failure Mode and Effects Analysis, Retrieved 02/20/2022 from

Gabe Kadoo

Gabe Kadoo

Mr. Kadoo is a Quality Engineer at EMMA International. He has experience in statistical analysis, performance improvement, quality assurance, and value stream mapping in the clinical setting. Mr. Kadoo also has experience as a clinical researcher and medical technologist. Mr. Kadoo holds a Bachelor of Science in Biology and a Master of Public Administration with a concentration in Healthcare Administration. He is also a Six Sigma Green Belt.

More Resources

Process Validation

Process Validation

All right, you have just gotten all of your paperwork together, submitted the right forms to the right people, set up your factory, hired and trained your staff; now it’s time to make the medical devices. The regulatory nonsense is over and done, right?
The Role of Management in Product Quality

The Role of Management in Product Quality

Depending on the factory, some production employees may find it surprising that management has an important role to play in a quality system.  21 CFR 820.20 mandates that “Management with executive responsibility shall establish objectives for, and commitment to, quality”.[1]  The Federal Government expects that management takes an active interest in improving the output of their company, at least in the case of medical device manufacturers.
Corrective and Preventive Action

Corrective and Preventive Action

In addition to helping manufacturers make better products, corrective and preventive actions are important because the process is legally required by the FDA when making medical devices for the US market.

Ready to learn more about working with us?

Pin It on Pinterest

Share This