The Failure Mode and Effect Analysis (FMEA) technique is a powerful tool utilized in order to determine all the possible failures associated with a design or process and then determine the risk level associated with that possible failure.[1] A Process Failure Mode and Effects Analysis (PFMEA) is an FMEA conducted for a specific process. Depending on the need, a PFMEA can be made for the high-level manufacturing process of a product, or it can focus on a specific process within that overall process. An example of such a specific process would be the Incoming Inspection process for materials of the product.

A Design Failure Mode and Effects Analysis (DMFEA) is conducted for the design of the product. All possible failure modes of the product are considered in a DMFEA. This differs from a PFMEA in that regard. A PFMEA is concerned with the process it is analyzing, which may or may not include potential failures related to the final product. The focus of the PFMEA is the process no matter what that may entail. Failures related to the process may include, but are not limited to:

  • Failures that result in faulty product
  • Failures that result in harm to the customer
  • Failures that result in harm to the operator of the process
  • Failures that delay the process
  • Failures that result from a sub-process malfunction

Each failure needs to be taken into consideration and the outcomes (the risk) of those failures determined. One failure may result in multiple risks. The risks are that the direct outcomes of the failures are known as the initial risks. These initial risks are given a risk priority number (RPN) based on the severity of the risk and the probability of it actually occurring. Once all potential failures are assigned and the RPN of each is calculated, mitigation can occur. Mitigation of the risks will result in the ability to reduce the risk. After the mitigations are put into place the RPN of the residual can be calculated.

Risk management is tricky. It can leave a person fumbling about what to do. Thankfully there are many tools, like a PFMEA table, that can be utilized in order to take much of the guesswork out of risk management. EMMA International can help prepare these tools, provide risk management, and even help conduct risk management activities. EMMA International provides Full Circle Consulting services, give us a call at 248-987-4497 or email us at info@emmainternational.com to get in touch with our team of experts today.


[1] ASQ (2022) Failure Mode and Effects Analysis, Retrieved 02/20/2022 from https://asq.org/quality-resources/fmea

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.

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