No one sets out to create a product that’s an abject failure, which is one of the reasons Failure Mode and Effects Analysis (FMEA) exists.
FMEA is one way to identify the many ways something could go wrong with, among other things, a product or service. Understanding how a product could malfunction and what can be done to prevent it is an especially important task in safety-critical markets such as aviation, automotive, and medical devices.
Even still, development teams are under such tight deadlines to bring products to market quickly that approaches like FMEA can get brushed aside. Then, when a problem with an already-released product emerges, there’s a mad dash to correct things, which can throw an organization’s momentum, strategies, and resources off course.
“Do you want to think about this stuff early and ahead of time, when it’s private and less expensive?,” asks Bethany Quillinan, Senior Quality Systems Consultant with Oregon Bioscience Association, “Or, do you want to wait until it’s public, embarrassing, and you’ve had a big recall, or you’re testifying in front of Congress?”
What is FMEA?
Failure Mode and Effects Analysis (FMEA) originally started in the military in the 1940s, as a way to test mission-critical safety. It’s since expanded into a variety of industries, perhaps most notably in the automotive industry.
It’s mainly used for risk management with international standards like ISO 14971 and ISO 13485 (medical devices), IATF 16949 (automotive), and AS9100 (aerospace). In these types of regulated industries, FMEA is a way to accomplish a lot of risk management tasks to provide proof of compliance.
FMEA’s value extends far beyond the simple checking of a box for compliances purposes though. In performing FMEA, you’re not only capturing organizational knowledge around a given product, but you’re also simultaneously preserving that information for future development cycles. And by collecting that data, you’re including not only what could go wrong with a product, but also the decisions that were made, actions that were taken, and suggestions that were rejected.
“It preserves history for people,” Quillinan says. “It’s that hackneyed saying of, ‘If you don’t remember your history, you’re doomed to repeat it.’ We don’t want to do that in product development.”
Why Use FMEA?
One of the biggest mistakes a company can make around risk is thinking you’re infallible from a gigantic misstep. And when something like that does happen, it can be a major shock, complete with bad publicity, recalls, product corrections, lawsuits, and worse.
Even if those heavy consequences don’t come to bear, even light issues with your product can eat at your reputation and bottom line, sending everyone from engineers to your customer service team running backward and extinguishing fires. And if your teams are constantly running around firefighting, they’re not spending that time designing new features or pushing your product forward.
“So often, we’re reworking things, we’re rewriting things, we’re doing failure analysis, we’re appeasing unhappy customers, we’re fixing bugs,” Quillinan says. “From that day-to-day level, it’s a huge energy, time, and money drain of dealing with stuff after the fact.”
Plus, when it comes time to develop the next generation of product, you’ll likely already be behind on time and, odds are, the competition.
When to do FMEA?
It’d be hard to imagine a company releasing a product after a single design review.
In a similar way, FMEA is not a one-time endeavor limited to just the risk management process. FMEA should be done continuously throughout the development cycle and be used for different objectives at different points.
Unfortunately, many developers look at FMEA initially, realize it’s going to be a lot of effort, and try and do it all at once. And that can become overwhelming for everyone involved, further limiting the work to only those who are involved in the risk management process.
To ensure the best results with FMEA and risk analysis, it helps to have as many cross-functional minds thinking about what could go wrong with your product as soon as possible.
Learn how to do FMEA correctly by registering for our webinar, Best Practices for Improving Risk Management Using FMEA, happening on July 11 in the USA and on July 16 in EMEA. Register here for the USA webinar, and here for EMEA.
- The Seven Steps to Performing FMEA - February 22, 2024
- Overview of FDA ISO 13485 and 21 CFR Part 820 Harmonization - February 20, 2024
- Secure by Design: A Crucial Imperative for Medical Device Teams - February 15, 2024