How to Conduct an FMEA Study

New product developers can identify how and where a process might fail and then assess the effects of the failures by conducting Failure Mode and Effects Analysis (FMEA) study. Problems with new products can be quite costly to a company especially if they are found later in the development process. They can also cause significant delays to production and release schedules.

With FMEA, you can find the possible causes of the failure and the chances of these failures being found before they actually occur. The goals of this approach are to prevent failure modes and causes of the new product or process in terms of reliability. It also helps limit the risk involved in altering the new product. Developers should use this approach to help identify areas that have the biggest effect on customers.

FMEA was first used in the 1960s during the Apollo missions. In the 1970s, the automobile industry was urged to use FMEA because of rising liability costs and later to reduce risks related to an automobile’s poor quality.


Steps to Conducting a FMEA Study

Now that you understand the logistics behind a FMEA test, here are some steps to conducting this study:

  1. Review the product or process: A process flowchart can help identify each component of the product or the process
  2. Brainstorm possible failures: Go over existing data or documentation for any indications
  3. List possible effects of the failures: It is possible to have more than one effect per failure
  4. Assign severity ratings: This is based on the degree of the failure consequences
  5. Assign occurrence ratings: This is based on how often the cause of the cause will happen
  6. Assign detection ratings: This is based on the changes that the failure will be detected before the customer finds it
  7. Calculate the Risk Priority Number (RPN): This is Severity (times) Occurrence (times) Detection
  8. Design an action plan: Outline which team member will do what on the project
  9. Take action: Your team should implement the improvements to failures
  10. Calculate a final RPN: Re-evaluate the possible failures once improvements have been made and determined the improvement’s impact on the new product and customer.

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Ground Rules for Conducting a FMEA Study

Before beginning a FMEA analysis, the new product developers need to discuss and document very specific guidelines on how the study will be performed. Some of the ground rules might have already been determined by the company’s FMEA standard practices, but some may be specific to a particular project or product. The rules are important so the new product development team can go through the analysis effectively. Some of the ground rules you can use include:

  • What constitutes a failure mode?
  • What are some of the assumed operating and environmental conditions?
  • Will the study “consider” failures resulting from abuse or neglect?
  • What is the timescale and budget for this entire project?
  • Where and when will the team meet and who is the facilitator?
  • How will decisions be made and conflicts settled?
  • What type of rating scale will be used?
  • What type of format will be used on the analysis worksheet?

FMEA studies should be conducted when plans are being made to change something in the workplace. For instance, you can conduct it:

  • At the project’s beginning where it can help the team better understand the types of failures and by zoning in on a specific type of problem
  • When new products, processes or systems are being introduced and designed
  • When existing products, processes or designs are being altered
  • When you define product or process functions but before specific new product designs are finalized or before it is released to manufacturing

New project developers using a FMEA study for the first time should keep everything basic and simple. This will help your team thing about possible failures that might not have been thought of before. FMEA works best in a team atmosphere when workers have skills in different areas and functions.


FMEA Study Situations

Here are three possible examples in which a FMEA study would be beneficial to your company and your new product:

  • Manufacturing: A supervisor or team manager is given the responsibility to move a production or manufacturing operation to a new building. She needs to be sure that the transition goes smoothly with little to no surprises.
  • Design: A new product design engineer wants to come up with all the potential ways a new product being designed could fail so the problems could be fixed before the product is released.
  • Software: A new product software engineer wants to think of potential problems a software product could fail when up against large databases. This is a main situation facing the Internet these days.

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Jarrod Barker
About the Author
Jarrod Barker
Jarrod has a keen interest in technology development and operations. He has an honours degree in Mechanical Engineering and his industry experience spans product design, sports technology, medical device engineering and power generation. He has worked for a leading design consultancy in Cambridge, UK and now runs the Outerspace branch in San Diego USA.

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