A very common mantra in product development and specifically Design Thinking is to “fail early and often.”
While the headline – The Power of Failure – suggests that I was poised to reiterate this well-understood strategy for innovation, I instead feel inspired to share my perspective on the value of an old-school methodology known as Failure Mode & Effects Analysis (FMEA).
Really, this blog should have been titled, The Power of Failure Mode & Effects Analysis, but that is undoubtedly less catchy, and you may not have actually read this far. Stick with me, I hope you find it worth the read. FMEAs are a systematic technique for identifying and mitigating potential failure modes in a product or process (service). To be clear, I’m not suggesting utilizing a FMEA methodology as an alternative to a Design Thinking approach, it’s more about highlighting that at a certain point in the new product development process your technical risk mitigation activities may need to step up a level and having a proven process to guide those activities can have distinct advantages.
Eventually in the iterative Design Thinking process, it is time to pick your lead horse and chart a path to realization. While failing early when the stakes are lower is a key tenet of Design Thinking that helps push the envelope, it doesn’t mitigate the damage of one-star reviews on Amazon for a clunky consumer product, or the cost of lost market share for a commercial product that’s performance doesn’t stack up against the competition, or the increased development cost and time for a medical device that struggles to perform in verification testing. These are all clear examples of why at a certain point, failure is no longer an option.
Most engineers are hard wired to think about all of the things that can go wrong and quickly identify what they believe are the biggest technical challenges to realize a new product. At Design Concepts, we use that to our advantage by staffing even our earliest conceptualization projects with engineers that can both flex their creative muscles and help identify what technical risks may benefit from early prototyping. In product development there is an inflection point where the focus goes from what should the product be to whether it will actually work. Despite repeated pleading from those in charge, seldom can an engineering team proclaim success is guaranteed. More often than not, if a development team is really moving the needle, there will be technical risks.
FMEAs originated in the 1950s by reliability engineers in the U.S. military, eventually making their way into NASA in the '60s and into automotive design in the '70s. Today, FMEAs are still a common methodology for risk mitigation and are quite prevalent in medical device development and more broadly in healthcare for de-risking processes. I’m just guessing, but I would bet that a FMEA may have led to the practice of a surgeon visiting you in pre-op prior for your knee surgery, during which he or she circles and initials the knee to be operated on as your mind races thinking about the potential implications if that step wasn’t taken.
Nowadays the process of completing a design FMEA typically involves a cross-functional team gathering around a spreadsheet and listing out potential failure modes of a design, potential effects of the failure, potential causes of a failure, and what steps are currently planned as part of the development process to mitigate the risk. While the make-up of the spreadsheet, level of detail, and the exact steps can vary, in general the process includes a ranking step which involves rating the severity of the failure, the probability that the failure could happen, and the likelihood that your current design controls will detect the design flaw. These individual ratings are multiplied together to form a Risk Priority Number (RPN) that helps the team focus continued development efforts in the right spot.
As you can see from the example above, while both of the failures are listed as leaks, a fuel leak is much more severe than a water leak and therefore the severity ranking drives up the RPN.
FMEAs can have a bad reputation of being a monotonous time-suck in which a cross-functional team debates the potential failures, augers in on debating small details, and everyone shares war stories about failures from their past. Having cut my teeth on FMEAs in the 90s as young engineer working as a tier-one automotive supplier to what was the Big Three in Detroit, I understand that reputation.
From my perspective, the magic of doing FMEAs has nothing to do with what form you use or debating rankings. The most powerful aspect is getting a cross-functional team together to get the collective experience of many folks to really dig into the critical aspects of a design. A close second is that you now have a document to help keep the risks in front of the team and that form can also help you communicate risks to other less-involved project stakeholders.
I started with a cliché, I may as well end with one: Failing to plan is planning to fail. Plan your risk mitigation activities.
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