How can you use FMEA to identify and mitigate risks in your processes?

In manufacturing, a pFMEA (process Failure Mode and Effects Analysis), is an indispensable tool for identifying potential problems, causes, and their effects in a production process. Most often this analysis is augmented with a Criticality assessment (FMECA), where the Severity (S), Occurrence (O), and Detection (D) of the effects, failure modes, and controls, respectively, are quantified. A scale of 1 to 5 or from 1 to 10 is assigned to each S, O, and D, and then multiplied to obtain a risk priority number (RPN). The higher the RPN, the higher the assigned risk. Although developing an FMEA is time-consuming and often takes several sessions, the wealth of knowledge gained is well worth it IF done sufficiently early in process development.

FMEA is a proactive tool that aims to identify potential failure modes, assess their impact, and prioritize them based on their significance. By tackling high RPN values first, organizations can mitigate risks effectively and enhance product reliability and safety

“If we were to all meet again in a year to solve the top problems affecting this new Product / Process, what would those be?” - this is the question I like to use to get the team thinking about risk on a first PFMEA or DFMEA activity. - give each participant sticky notes - ask for at least 3 risks per participant - collect them anonymously (or not), depends on the group - go over them —> identify common threads —> gets good examples that will engage the team to walk through the FMEA process in detail and start demonstrating the benefits.

Conducting FMEA, from an operational excellence perspective, starts by defining the scope, assembling a cross-functional team, and identifying failure modes. For instance, in the beverage industry, a failure mode might be incorrect bottle sealing. Determine the effect (leakage) and rate its severity. Identify causes, perhaps a misaligned sealer, and assess their occurrence rate. By understanding and prioritizing these failures, corrective actions can be strategically implemented to enhance product quality and efficiency.

Here's my pFMEA trifecta: #1 - Assemble the right team. Make sure it includes a person initimately familiar with the process - especially an OPERATOR! And someone not familiar with the process at all. Why? “In the beginner’s mind there are many possibilities, but in the expert’s there are few”― Shunryu Suzuki. #2 - Map the steps of the process. Break it down into smaller steps (use the Work Instruction!), to more clearly brainstorm what can go wrong at each step. #3 - NEVER show up to the first session with a blank sheet of paper (or blank screen)! Always come prepared with a draft which everyone feels free to add, change, or remove from. Bonus: meeting in-person instead of Zoom, means you'll get tons more engagement and a better FMEA!

+1 to Thomas’ point. Also I would add, look into the risks that the team didn’t identify but it is obvious to the facilitators. It helps avoid “survivorship bias” like conditions.

It proactively identifies and prioritizes potential failures, enabling targeted improvement actions. In my experience with nonwoven fabric production, using FMEA helped detect a weave inconsistency risk. The proactive resolution led to enhanced product quality. Moreover, FMEA reduces costly late-stage corrections, improves customer satisfaction, and fosters team collaboration, driving a culture of continuous improvement and risk mitigation.

As an operational excellence professional, I recall a project involving Business Process Reengineering (BPR) at a stitching floor of a furniture company. Our objective was to enhance throughput and quality. We initiated an FMEA session, wherein a potential failure mode was identified: inconsistent thread tension across machines, leading to irregular stitching quality. The severity of having furniture returns was high, but detection was low in initial stages. By using FMEA, we adjusted machine calibrations uniformly and introduced routine checks, mitigating the risk and ensuring uniform high-quality stitching.