Is Your FMEA Worksheet Holding You Back? Tips from the Experts

I want to share four recent episodes from the Speaking of Reliability podcast that delve into FMEA, including three that I had the pleasure of co-hosting with Carl Carlson. These discussions are designed to offer valuable insights for using FMEA to enhance product safety, optimize design, and improve overall risk management.

What is FMEA?

FMEA (Failure Mode and Effects Analysis) is a tool used to organize information about potential failures for prioritization and risk control/reduction. It’s a commonly used tool in many industries.

Episode 1: SOR 1097 – How HA and FMEA Relate (Co-hosted with Carl Carlson)

In this episode, Carl and I unpack the often misunderstood, relationship between Hazard Analysis (HA) and Failure Mode and Effects Analysis (FMEA). While these two processes are frequently treated as separate activities, we emphasize how their integration is key to achieving comprehensive risk management and enhancing product safety and efficiency.

Here’s a snapshot of what we covered:

FMEA starts with items, functions, then failure modes; HA takes a top-down, system-level view with high-level hazards considering environment and users.
HA quantifies risk by calculating probability of harm. This dimension is often missing from FMEA. It’s valuable because it provides qualitative severity and likelihood of occurrence.
Hazards may occur when a necessary function is not delivered (e.g., “not being able to brake sufficiently” is a hazard for the safety function “being able to slow down”). Identifying new hazards reveals additional functions.
HA and FMEA are most effective when integrated. HA can inform FMEA, or high-severity FMEA findings can prompt HA.
Performing HA and FMEA early in a project is crucial for aligning processes, driving design decisions, prioritizing testing, and improving risk management.

Episode 2: SOR 1098 – Special Characteristics (Co-hosted with Carl Carlson)

In “Special Characteristics,” Carl and I dive into two of the least understood, yet potentially powerful, FMEA data elements: Special Product Characteristics for Design FMEAs, and Special Process Characteristics for Process FMEAs. Understanding how to identify and apply these can profoundly impact your risk management strategy and product quality.

In this episode, we discuss:

Understanding the Concepts: We define what these characteristics are, explore their various names, and how they are effectively applied within FMEAs. This also includes whether special characteristics necessitate extra controls in the Process Control Plan.
Identifying the ‘Vital Few’: The cause description in Design FMEA can identify candidate special product characteristics. Focus on only the “vital few” for effectiveness.
Strategic Prioritization and Process: FMEA’s severity and occurrence ratings support designating special characteristics, requiring a defined company process for consistent assignment

Episode 3: SOR 1096 – How FMEA Worksheets can Help (and Hinder)

While I wasn’t a co-host on this episode, Carl Carlson and Chris Jackson discussed “How FMEA Worksheets can Help (and Hinder)”. An FMEA worksheet is table documenting the FMEA, including functions, failure modes, likelihoods, and actions

In this episode, Chris and Carl explored:

The Pitfalls of ‘Pre-population’: Pre-populating worksheets hinders brainstorming; the facilitator should keep existing knowledge “in the back pocket” for later comparison.
Media for Worksheets: Worksheets can use dedicated software or spreadsheets, which Chris prefers for tailorability.
Facilitation Tips: Chris and Carl share their team facilitation tips for FMEA.

My addition to this topic: the table is just the documented result of a team process and risk assessment activity.

Episode 4: SOR 1102 – The Trouble with Interfaces (Co-hosted with Carl Carlson)

In “The Trouble with Interfaces”, Carl and I discuss the different types of interfaces. We also talk about how they can be included in system reliability models and FMEAs. Carl consistently finds interfaces to be 50% or more of the problems, often ranging from 60% to 70%! Proactively handling them is a good idea, and we share ways you can do that.

Why Listen to These Episodes?

These episodes collectively offer practical insights and techniques to help you conduct more effective risk analyses. This, in turn, helps you make informed design and testing decisions, and ultimately develop safer, more reliable products and processes. Whether you’re integrating HA and FMEA, optimizing your use of special characteristics, or improving your FMEA facilitation, there’s something valuable for listeners.

Don’t miss out on these valuable conversations!

You can listen to SOR 1097: How HA and FMEA Relate, SOR 1098: Special Characteristics, SOR 1096: How FMEA Worksheets can Help (and Hinder), and SOR 1102 The Trouble with Interfaces on Speaking of Reliability wherever you get your podcasts.

For those wanting to deepen their understanding and practical application of FMEA, I invite you to also check out my comprehensive FMEA course. Join over 300 other students in FMEA in Practice: From Plan to Risk-Based Decision Making.

About the podcast episode hosts

Carl Carlson, CRE is author of “Effective FMEAs” and co-author of “The Process of Reliability Engineering”. He’s involved in regulations regarding FMEA and much more. Read more about him in his bio on Accendo Reliability.

Chris Jackson, PhD is also an author and frequently writes article and hosts webinars about reliability. Read more about Chris in his bio on Accendo Reliability.

I’m Dianna Deeney, a Quality advocate for product development and author of the upcoming book, “Pierce the Design Fog”.