While Failure Mode and Effects Analysis (FMEA) is a very effective method for driving reliability and quality improvements, when used improperly, this tool can also result in unidentified root causes, inadequate actions or misguided efforts. Too often FMEA issues occur because simple guidelines and best practices were not followed throughout the entire development process. Listed below are five common mistakes and errors to avoid when performing FMEAs.

1. Performing FMEA’s Too Late in the Design Cycle

Many teams will procrastinate, starting their FMEAs until well after the design is established and mature. Unfortunately, this delay greatly reduces the effectiveness of FMEAs because simple changes that could have been implemented upfront are now difficult to incorporate because the design has become more rigid (or even frozen). Instead, try to begin FMEAs before the concept design or process is created. This will establish an earlier reliability framework and allow for improved upfront trade-off decisions and more meaningful feasibility studies. Getting an earlier start on FMEAs will have a more positive overall impact on the product or process design.

2. Not Including System Interfaces in the FMEA

Many teams do an excellent job of properly detailing individual part or subsystem failures, but forget to include the system interface failures that occur between these parts or subsystems. These interface considerations are critical because a large percentage of total failure modes usually occur at these interactions. When performing FMEAs, remember to increase the scope of the analysis to always include all interface and integration failures in both the block diagrams and the failure mode lists.

3. Field Data Not Connected to FMEA

Historical field data contains a wealth of actual failure knowledge that can be translated into FMEAs. Unfortunately, many companies overlook this valuable data and don’t properly link their evaluations to actual field failure data and previous lessons learned. Create more effective FMEAs by incorporating all major historical field data such as field recalls, high warranty failures and excessive spare parts usage. Following this practice will dramatically improve future product performance and help ensure that field problems are not repeated.

4. Not Having the Right People or Commitment

Training and experience count when producing effective FMEA’s. Properly trained teams composed of the right experts who are highly engaged and regularly attend meetings will produce the best results. Use of cross functional, multi-disciplined team members is also important because diverse teams will uncover more hidden failure modes due to their varied perspectives. Strong upper management commitment to the FMEA process and a highly knowledgeable facilitator/trainer should also be present to ensure successful results and the most effective use of resource time.

5. Creating More Effective FMEAs

In addition to avoiding these common mistakes it’s also important to properly prioritize the evaluation efforts up front. Start by focusing on the highest risk areas first such as: new designs/technology, safety issues, field history problems, and any other critical design characteristics. Remember to always be risk conscious and to develop higher amounts analysis detail in the higher risk areas of the design or process. By applying all of these simple guidelines throughout the entire development cycle, your FMEAs will become more effective and produce a more reliable product with the most efficient use of your time.

Greg Jung has more than 25 years of experience designing medical equipment and electro-mechanical products for a wide variety of industries. He also served in various project management roles and has led global, cross-functional development teams for a wide variety of programs. During this time, he developed several award-winning and patented product designs. Greg holds bachelor and master of science degrees in mechanical engineering from the Georgia Institute of Technology.

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