As Failure Mode and Effects Analysis (FMEA) continues to be embraced as an important tool in risk management and quality assurance across various industries, it has evolved over time.

One of the biggest changes has been shifts in requirements across industries.

AIAG’s 5th edition incorporated European standards into a common format. It is significantly different from FMEA 4th edition and it’s focused on automotive. Healthcare does not need all of the detail required of automotive, as the FMEA 4th edition is sufficient, experts say.

“Healthcare is beginning to embrace FMEA as a way to mistake-proof healthcare delivery,” explains Jay Arthur, president and CEO of KnowWare International. For example, the healthcare industry is starting to adopt FMEA to mistake-proof areas such as the emergency department or operating room, focusing on preventing infections or retained foreign objects, for example. Arthur cites Peter Pronovost, M.D.’s five-step procedure to prevent central line bloodstream infections (CLABSI), preventing over 200,000 infections a year — as an example of FMEA’s application in healthcare.

In some fields, such as the automotive sector, companies are focusing on detailed and specific FMEA applications, Arthur explains, mentioning the Automotive Industry Action Group (AIAG)’s 5th edition of FMEA standards, which incorporated European norms. This edition incorporates a more comprehensive approach, particularly suited to the complex requirements of the automotive industry.

Leaders are also reconsidering how FMEA is applied based on the complexity and volume of production. There’s a growing understanding that not all manufacturing or production jobs are the same, and thus, the application of FMEA should vary accordingly. This involves customizing the Risk Priority Number (RPN) assessments and actions based on the part type, complexity, and scale of production.

Matt Stanley, the director of customer at 1factory, discusses the need for an evolution in customer expectations regarding FMEA. He points out that “PFMEA [Process Failure Mode and Effects Analysis] is a valuable tool, but not every job is equal.” He notes the diverse expectations from different companies, with some focusing on reducing the Risk Priority Number (RPN) beyond a certain threshold, while others focus on actions for the top percentage of RPNs. Stanley emphasizes the need for scaling RPN expectations with the complexity and type of part. He cautions against applying a broad scope to all parts, especially for low volume/low-cost orders, which may not fit well into the Production Part Approval Process (PPAP) framework.

Technology’s influence on FMEA

Discussing the impact of technology on FMEA, Stanley emphasizes the importance of quality software. “Without properly tracked and documented data, you’re chasing the current hot topic and often missing the underlying problems when trying to improve your process,” he says. “Quality software and AI initiatives help to show the bigger picture and provide hard data that can steer your attention to recurring issues, as well as justify the effectiveness of implemented solutions.”

Diane Tilley, senior vice president at SigmaXL, mentions the ease that technology brings to FMEA. “The FMEA template in SigmaXL makes it easy to create your FMEA with a ‘sort’ button for RPN scores.” Arthur also suggests a future role for AI, asking it: ‘How could this process fail?’ ‘How could we prevent it?’

As technology makes FMEA processes more efficient and data-driven, the potential role of AI in suggests a future where technology not only supports but also enhances decision-making in risk assessment. FMEA’s journey from a one-size-fits-all approach to a more nuanced, industry-specific tool reveals its growing importance in a wide array of sectors.