Failure Mode and Effects Analysis (FMEA) is a step-by-step approach to identify all possible failures in a design, a manufacturing or assembly process, or a product or service. This includes identifying ways in which a process or product could fail to meet quality standards or pose safety risks. It’s particularly relevant in manufacturing, automotive, aerospace, and healthcare.

How FMEA works

Typically performed by cross-functional quality and safety teams, FMEA makes plain the potential impact of these failures, including the severity of consequences, the likelihood of occurrence, and the ability to detect the failure.

FMEA can reveal each potential failure based on its severity, occurrence, and detectability. This helps organizations prioritize which risks need to be addressed first based on their potential impact on the operation or product.

Based on the analysis, FMEA creates action plans to either remove or mitigate the risks of failures. This might involve redesigning a process, changing materials, implementing new quality checks, or other corrective actions.

Regular use of FMEA leads to continuous improvements in processes and products. By proactively addressing potential issues, it enhances reliability, safety, and overall quality.

It also serves as a documented approach to risk management, providing a detailed analysis and justification for changes in processes or designs, improving communication and understanding among team members.

Improving FMEA skills

How to Sharpen Your FMEA Skills

Quality sat down with Jay Arthur, president and CEO of KnowWare International, to follow up on his participation in a recent Quality article and delve further into Failure Mode and Effects Analysis, or FMEA.

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Boosting FMEA services starts with the right mix of resources and practical application.

Experts recommend understanding customer-specific requirements, exploring foundational books, and reading industry-standard manuals and online resources.

1. Start with customer expectations

Matt Stanley, director of customer success at 1factory, emphasizes the importance of understanding customer expectations.

“First and foremost, start with the document that dictates what your customer’s expectation is. While AS13004 (Process Failure Mode & Effects Analysis and Control Plans) defines the standard for Aerospace PFMEA, many companies also have their own controlling documents,” he says. Stanley also recommends RM13004, a free resource from SAE International, for its comprehensive guidance and practical examples.

2. Recommended reading for beginners

For beginners, Diane Tilley, senior vice president at SigmaXL, suggests starting with some foundational literature. “A good starter book is, ‘The Basics of FMEA’ by Raymond J. Mikulak, Robin McDermott, Michael Beauregard, and the standard AIAG reference book on FMEA,” says Tilley. These resources offer a solid introduction to the principles and practices of FMEA.

3. Leverage industry standards and online resources

Jay Arthur, president and CEO of KnowWare International, points to the AIAG’s FMEA 5th Edition manual as the standard for the automotive industry. This manual, available at www.aiag.org, provides detailed guidelines and best practices. Arthur also directs individuals to his company’s website for a simple, step-by-step procedure on mistake-proofing, an integral aspect of FMEA, available at www.qimacros.com/lean-six-sigma-articles/mistake-proofing/.

Best practices for conducting effective FMEA

Success in FMEA hinges on involving the right people, simplifying the process where necessary, and nurturing a collaborative environment, experts say.

1. Cross-collaboration is key.

Stanley stresses the importance of involving those who are closely associated with the processes under review.

“Process FMEA: Get up and get out to the process! The best answers to ‘What can go wrong?’ come from the people who live it every day,” he says. “Plant managers can get you started, cell leaders have valuable input, but it’s the machine operators who really provide the solid data when it comes down to it. They’ve seen it all and have had to deal with more failure modes than anyone else.”

Stanley also highlights the need for a diverse team, including staff across engineering, programming, manufacturing, and quality to cover all perspectives.

2. Simplifying the process for transactional FMEAs

Tilley offers advice for transactional processes, suggesting a streamlined approach.

“For transactional processes, it is often best to keep it simple, use a 1 to 5 Severity, Occurrence, Detection scale rather than the usual 1 to 10,” she says. “Also, use the FMEA in conjunction with other tools like the Cause and Effect (XY) Matrix.”

This approach can make the FMEA more manageable and effective for processes that are not manufacturing-centric, she explains.

3. Use visual tools —and collaborate.

FMEA is done well when teams are able to brainstorm and collaborate, Arthur says.

“The most powerful part of FMEA is getting people to sit down and figure out what could go wrong, how catastrophic it might be, how to avoid it, and how to monitor performance to detect aberrations (SPC),” he says. “Make sure you get everyone involved in the room (design and manufacturing). For administrative FMEAs, you might need sales, marketing, purchasing, and accounting. I use Post-it notes and flip charts to capture the discussion.”

By incorporating these best practices, organizations can significantly enhance their FMEA processes, leading to more reliable, safe, and high-quality outcomes in their products and services.