Failure Mode and Effects Analysis – Definition, Process, and Use Case

If you look at any successful business, you’ll find a tale of risk and the attempt to mitigate those risks. Failure Mode and Effects Analysis is a risk mitigation strategy that helps you find areas that can fail and build safeguards beforehand.

In other words, it increases your chances of success.

In this guide, you’ll learn what Failure Mode and Effects Analysis is, the steps involved, and different applications of this type of analysis.

What Is Failure Mode and Effects Analysis (FMEA)?

Failure Mode and Effects Analysis (FMEA) is a structured process used to find areas that can fail within processes, products, and systems. After identifying the potential areas for failure, their impact is assessed and prioritized then corrective actions are taken to reduce those risks.

It its core FMEA is a way to figure out why something may fail, determine how impactful it’ll be, and put measures in place to prevent or mitigate the impact. You’ll find FMEA in various industries – especially manufacturing, engineering, and healthcare. Places where failure can have an outsized impact.

Origin of FMEA

In the 1940s, the U.S. military developed the original form of FMEA as a type of quality control system for weapons and other military systems. About 20 years later, NASA adopted it to improve the safety of manned and unmanned space missions.

Not long after, in the 1970s, the automotive industry saw the benefits of FMEA and started to adopt it to improve quality control. Now, it’s considered a standard form of quality control and risk assessment in multiple industries.

Types of FMEA

FMEA is the general term that encompasses many types of risk assessment activities. It can be tweaked or changed depending on the kind of risk management being performed. While the core aspects remain consistent, it may be more or less involved depending on where it’s being used.

Design FMEA (DFMEA)

Design Failure Mode and Effects Analysis (DFMEA) looks at products or systems that are still being designed and tries to mitigate risks before they go into production. This is what prevents product recalls.

DFMEA is used to analyze components, subsystems, and overall system designs with the goal of ensuring they’re safe, reliable, and compliant with relevant regulations. Starting early in the design process and scrutinizing various components prevents expensive defects and safety hazards. DFMEA is commonly applied in industries like automotive, aerospace, and consumer electronics to enhance product durability and functionality.

Process FMEA (PFMEA)

Process Failure Mode and Effects Analysis (PFMEA) focuses on risk mitigation for manufacturing and or service related processes. It’s used to find areas where a process can fail, what causes the failure, and the ultimate impact on the quality and safety of the product or service.

It can identify problems related to human error, faulty equipment, the process itself due to inevitable variability, and more. You’re able to quantify the potential risk and build in contingencies, improve the processes, and reduce waste.

System FMEA

System Failure Mode and Effects Analysis (SFMEA) zooms out a bit and doesn’t focus on the individual components within a system but the entire system. When a process is made up of multiple subsystems, which many complex processes are, SFMEA looks at how these subsystems interact.

Points of failure are identified and their impact is quantified. This is important because if one part of a complex system fails, the entire system may be negatively impacted.  From there, mitigation strategies are developed.

One of the major goals here is to introduce redundancy and strong fault tolerance across the subsystems.

FMEA Process: Step-by-Step Guide

1. Define the Scope and Objective

Before you do any analysis, you need to know what you’re trying to accomplish. Are you looking at the product design, the system design, the process design, or something else? Understanding this will help you narrow your focus and move more efficiently. After you determine what you want to analyze, identify the specific components, processes, systems, etc. that will be part of the analysis. Again, this saves you time and energy while making your analysis more useful.

2. Identify Failure Modes

A failure mode is simply how something EG a product, process, or system, may fail. It could be a catastrophic failure in which it breaks down or simply not meeting performance expectations. Analyze each part that was identified in the previous step and note the failure modes. Every failure mode is fair game at this point. Later on in the process, you’ll prioritize the failure modes based on multiple criteria so you know which ones to work with first.

3. Assess Failure Effects

What impact does the failure mode you identified have on the products, processes, and or systems? What are the consequences or the worst-case scenario? These can run the gamut from a dissatisfied customer, losing millions of dollars, regulatory investigations, or even death. This will help you determine which failure mode to prioritize.

4. Determine Failure Causes

Failures are prevented when you understand the root cause by performing a root cause analysis. Techniques like the 5 Whys (asking “why” repeatedly to trace the issue to its source) or Fishbone Diagrams (categorizing causes into areas like people, process, materials, and environment). Pinpointing the exact causes makes it possible to create lasting solutions.

5. Assign Risk Priority Numbers (RPN)

The Risk Priority Number (RPN) is a technique in FMEA that assigns failure modes numerical values to represent its priority. These numerical values are based on three factors:

• Severity (S): How serious are the consequences of failure?
• Occurrence (O): How frequently is the failure likely to happen?
• Detection (D): How easily can the failure be detected before it causes harm?

Each factor is scored on a scale (typically 1-10), and the RPN is calculated as S × O × D. Higher RPN values indicate higher risks, guiding you to focus on the most critical failure modes first.

6. Develop, Implement, and monitor Action Plans

Once high-risk failure modes are identified, create action plans to mitigate or eliminate them. Actions might include design changes, process improvements, additional quality checks, or training programs.

Each action should have a clear owner, deadline, and expected outcome. Implementation ensures that risk-reducing measures are put into practice effectively.

After you’ve put the changes in place, monitor their effect over time and make additional changes as needed.

Use Case: Failure Mode and Effects Analysis in Food Processing

Example Scenario: Food Processing – Contamination in a Bottled Juice Production Line

Imagine you are managing a juice manufacturing plant, and your goal is to ensure that the final bottled product is free from contamination. To prevent quality and safety issues, you conduct a Process FMEA (PFMEA) on the bottling stage of production.

Step-by-Step FMEA Analysis

1. Define the Scope and Objective
   The focus is on the bottling and sealing process, where contamination risks could compromise product safety. The objective is to identify potential failure modes that could introduce contaminants into the juice and impact consumer health.
2. Identify Failure Modes
   Potential failure modes in the bottling process include:
   • Bottles not being properly sterilized
   • Foreign particles entering the juice before sealing
   • Incorrect sealing, leading to leaks and microbial growth
   • Improper handling by workers, introducing contaminants
3. Assess Failure Effects
   Each failure mode has serious consequences:
   • Unsterilized bottles → Bacterial growth → Foodborne illnesses → Product recalls
   • Foreign particles in juice → Consumer complaints → Brand reputation damage
   • Leaking seals → Juice spoilage → Shortened shelf life
   • Improper handling → Cross-contamination → Regulatory non-compliance
4. Determine Failure Causes
   Using 5 Whys and Fishbone Diagrams, you analyze the root causes:
   • Bottles not sterilized → Incomplete sterilization cycle → Malfunctioning UV sanitation equipment
   • Foreign particles → Poor filtration → Worn-out filter in the filling machine
   • Incorrect sealing → Temperature fluctuation in sealing machine → Inconsistent heat application
   • Improper handling → Lack of hygiene training → Non-compliance with food safety protocols
5. Assign Risk Priority Numbers (RPN)
   You score Severity (S), Occurrence (O), and Detection (D) on a 1-10 scale and calculate the RPN for each failure mode:

Failure Mode	Severity (S)	Occurrence (O)	Detection (D)	RPN (S × O × D)
Bottles not sterilized	10	4	5	200
Foreign particles in juice	8	6	6	288
Incorrect sealing	7	5	7	245
Improper handling by workers	9	4	5	180

6. The highest RPN (288) is for foreign particles in juice, making it the top priority for corrective actions.
7. Develop and Implement Action Plans
   Based on the analysis, you implement the following actions:
   • Install an advanced filtration system with automated clog detection to prevent foreign particles.
   • Schedule regular maintenance of the sterilization and sealing machines to ensure consistent performance.
   • Enhance worker training on hygiene and contamination control to reduce handling risks.
   • Increase quality checks by introducing automated bottle inspection before filling.

Conclusion

FMEA comes in many shapes and sizes. It can deal with entire systems, the components of a system, individual processes, and much more.

This guide has shown you the scope and applicability of FMEA and how to effectively use it.

Now, it’s your turn. Start small and analyze your processes or systems so you can improve them over time while mitigating risks.