What is FMEA? Failure Mode and Effects Analysis Overview

Through FMEAs, product development teams are able to determine potential failures within a project and improve them to mitigate risk. The most efficient way to conduct a failure mode and effects analysis is through an automated tool. This blog will provide an overview of FMEAs and highlight the many benefits they can have on your product. 

What is Failure Mode and Effects Analysis (FMEA)?

FMEAs, or failure mode and effects analysis, is a step-by-step process for identifying possible failures in a design product or service. 

FMEAs help companies identify hazards that may arise from known risks — both in the design of the product and in the way users interact with it. When thinking about FMEA, it helps to think about the old maxim, ‘an ounce of prevention is worth a pound of cure’. Adjusted for inflation, that ounce might be worth several tons of cure for companies operating in safety-critical industries. 

Just ask any company that has experienced release delays or product recalls due to safety defects in their product. The cost of such defects is measured not only in the dollars spent to fix them but sometimes in lives lost because of it. 

For any industry — and particularly for safety-critical ones — it is increasingly important to identify and prevent product errors before the product goes to market. To do that, many companies rely on a process called failure modes and effects analysis (FMEA).

What Role Do FMEAs Play in Product Development? 

Depending on the risk and the hazard, the role of FMEAs begins with the company determining if an FMEA is warranted. Conducting FMEAs early in development allows the company to make more informed decisions about the risks they eventually uncover.  Because FMEAs can significantly reduce the number of defects prior to the product’s release, they are particularly beneficial to companies in safety-critical industries where product safety and reliability are especially important. 

Additionally, FMEAs can help evaluate proposed changes. Companies that treat risk assessment as a one-time event miss the opportunity to evaluate changes and ensure they are not introducing new risks into the product. New risks can occur any time an element of the product design changes — as a result of addressing a previous risk, a new feature request, requirement, or any other change. 

When made visible to the testing and quality assurance teams, FMEAs can improve the testing effort by identifying areas of risk that might need additional testing. For example, a requirement calls for additional power to a device for the cleaning cycle only. If used for any other cycle, it may pose a risk to the user. The team might want to change some of the testing to make sure that additional power can’t be selected for any of the non-cleaning cycles. Establishing and maintaining a good FMEA process can strengthen the risk mitigation process and help avoid costly product recalls, regulatory actions, and user harm. 

What Reduces FMEA Efficacy?

 Although many companies use FMEAs as a risk prevention strategy, most FMEAs do not have the visibility needed to be effective. Sometimes this is due to the company generating FMEAs after development is completed, in order to comply with auditor requirements or ease customer concerns. Lack of FMEA visibility can also be due to a lack of communication between the FMEA team and the development, testing, and quality assurance teams. This is often the case when companies use spreadsheets and other manual, document-based methods to perform FMEAs.

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Regardless of the reason, the lack of FMEA visibility often results in companies failing to see the business improvement opportunities that FMEAs offer. This is where automated solutions — such as Helix ALM from Perforce Software — can help improve the process as well as streamline information management and reporting throughout the product development lifecycle. With Helix ALM, companies can ensure FMEAs are visible and being conducted properly and thoroughly, leaving no FMEA missed.

How Does Helix ALM Support FMEAs? 

While it is possible to perform FMEAs with documents and spreadsheets, using Helix ALM to support the FMEA effort provides added benefits. With Helix ALM, teams can manage the timing of FMEAs, set ownership, and define the individuals responsible for specific FMEAs, and most importantly, generate automated traceability reports. And when an FMEA report is needed, it can be easily generated directly from Helix ALM. 

Helix ALM makes the FMEA process faster and easier by putting vital data just a few clicks away and automating traceability matrices and FMEA reports. With Helix ALM, SMEs can easily manage FMEAs and continually monitor their status as the product moves through the stages of the development cycle. The end result is reduced risk, lower development costs, and faster time to market.

Download our FMEA whitepaper to learn more about how Helix ALM assists in closing the loop, reveals process issues, and delivers visibility across the entire development process.