Guide to Failure Mode and Effects Analysis (FMEA)

In a competitive market, identifying problems and anomalies early is of significant importance. Customers place high expectations on manufacturers and failure to deliver quality and reliability can be expensive. Developed in 1950, FMEA (Failure Mode and Effects Analysis) is one of the most effective ways of reducing the risk of failure and maintaining high quality throughout the manufacturing process. In this article, we will look at FMEA in more detail, covering types, how to perform FMEA, and when to take corrective action.

What is FMEA?

FMEA is a structured, qualitative approach used by manufacturers to proactively identify risks, anticipate failures and understand how those failures could affect product performance, safety or customer experience. Rather than waiting for issues to appear on the production floor or in the field, FMEA allows teams to evaluate a product or process step by step, uncovering where and how it might fail—and how severe, frequent or detectable those failures might be.

FMEA doesn’t highlight potential issues; it also outlines the possible causes behind each failure mode and evaluates the likelihood of each one occurring. This enables manufacturers to prioritize risks based on their potential impact and implement corrective actions before anomalies reach customers.

By examining designs, materials, processes and workflows in detail, FMEA supports more informed decision-making across engineering, quality and operations teams. The result is a host of measurable benefits: reduced waste and scrap, fewer production disruptions, lower warranty costs, stronger regulatory compliance, improved customer satisfaction, and ultimately, healthier profit margins.

Key Components of FMEA

1. Failure Modes

These are the specific ways a product, component or process step could fail. A failure mode describes what could go wrong, such as a material anomaly, improper assembly or incorrect measurement.

2. Effects of Failure 

This captures the consequences of each failure mode. Effects may range from minor performance issues to major safety risks or complete system failure. Understanding the impact helps teams evaluate how serious each potential issue is.

3. Causes of Failure 

For each failure mode, teams identify the underlying causes. These may include design flaws, inadequate controls, environmental conditions, operator error or process variability.

4. Severity (S) 

Severity measures how serious the effect would be if the failure occurred. It is typically scored on a scale (for example, 1–10), with higher numbers indicating more severe outcomes.

5. Occurrence (O)

Occurrence reflects how likely the failure is to happen. This score is also ranked on a scale and is based on historical data, expert knowledge or process capability.

6. Detection (D)

Detection indicates how likely it is that the failure will be identified before reaching the customer. Lower detection capability results in a higher score, signaling greater risk.

7. Risk Priority Number (RPN)

RPN is calculated by multiplying the Severity, Occurrence and Detection scores (RPN = S × O × D). This gives teams a way to prioritize which issues need attention first. In some methodologies, Action Priority (AP) is used instead of RPN.

8. Recommended Actions 

Based on the highest-risk items, teams develop actions to reduce severity, lower the likelihood of occurrence or improve detection. These may include redesigns, process adjustments, improved controls or new testing methods.

9. Responsible Parties and Target Dates

For each action, teams assign ownership and deadlines to confirm execution and accountability.

10. Results and Follow-Up

After implementing improvements, the FMEA is updated with new S, O, and D scores. This step validates the effectiveness of the corrective actions and maintains the FMEA as a living document.

Applications of FMEA

1. New Product & Process Development

Used during design and early process planning to identify potential failures, refine concepts and build more reliable products and workflows.

2. Quality & Reliability Improvement

Helps teams uncover anomalies, reduce scrap and rework, strengthen controls and boost overall product reliability.

3. Safety & Regulatory Compliance

Supports safety assessments and documentation required for industries with stringent standards, confirming risks are mitigated and compliance is met.

4. Maintenance & Operational Efficiency

Guides preventive and predictive maintenance strategies while helping reduce downtime, optimize equipment performance and extend asset life.

5. Continuous Improvement & Change Management 

Drives Lean/Six Sigma efforts and provides a structured way to evaluate risks during product, material or process changes.
 

DFMEA, PFMEA, and FMECA

To fully understand FMEA, it’s important to understand the different types. There are three main categories for FMEA – FMEA, PFMEA, FMECA. We will cover each one in more detail in this section.

What is DFMEA?

DFMEA (Design Failure Mode and Effects Analysis) looks deeper at the possibility of product-specific malfunctions, product lifespan and safety concerns regarding:

• Material Properties
• Geometry
• Tolerances
• Interfaces with other components and/or systems
• Engineering Noise: environments, user profile, degradation, systems interactions

DFMEA helps engineers detect issues and anomalies in products early so they can be corrected early. It is employed across a range of industries including automotive, software, healthcare and more.

What is PFMEA?

PFMEA (Process Failure Mode and Effects Analysis) focuses on identifying failures that impact product quality, reduce the reliability of certain processes, cause customer dissatisfaction, or lead to safety or environmental concerns regarding:

• Human factors
• Methods followed while processing
• Materials used
• Machines utilized
• Measurement systems impact on acceptance
• Environment Factors on process performance

PFMEA does this by conducting a detailed analysis of each step in the process and scoring it out of 10. They are scored on severity, occurrence, detection and risk priority number (RPN).

What is FMECA?

FMECA (Failure Mode, Effects & Criticality Analysis) involves quantitative failure analysis that creates a series of links between potential failures, the impact on the mission and the cause of failure. It is different to FMEA but still falls under the same category. It builds upon the FMEA process by not only identifying potential failures but investigating and isolating these failures through a series of actions. The extra criticality analysis action taken by FMECA compares the probability of failure against the impact of the consequences, allowing manufacturers to focus on the most serious risks. FMEA is required for this criticality analysis to take place.

How is FMEA scored?

As previously mentioned, FMEA conducts a detailed analysis of products and processes and scores it out of 10 on severity, occurrence, detection and risk priority number (RPN). In this section, we will look at this scoring in more detail. FMEA is usually scored out of 10, but in some cases is scored out of 5; the higher the number, the higher the risk,

FMEA is scored on the following variables:

• Severity: This is the impact of the failure. In most cases, severity exceeding a score of 8 will require a fault tree analysis. This estimates the probability of the failure by breaking it down into sub-elements.
• Occurrence: This is the chance of a failure happening. A low score could represent a failure that happens every 10 years, while a high score could mean a failure that occurs as regularly as every hour.
• Detection: This is the likelihood of the failure being detected. Low scores mean it has a high chance of being detected. A high score means it’s likely the issue won’t be identified.
• Risk Priority Number (RPN): This is a calculation of all the above scores to give an overall score to a failure. Usually, a failure scoring over 80 RPN requires correction, which ideally leads to a lower RPN number.

Why Perform FMEA?

FMEA is one of the most reliable methods used to detect failures earlier. Historically, detecting failures earlier means they’re easier to fix and cost less money. There are several benefits to deploying an FMEA system:

• Captures the knowledge of a team
• Improves the quality, reliability, and safety of processes
• Logical, structured approach to identifying failures
• Reduces process development time
• Reduces cost
• Documents and tracks risk reduction activities
• Helps to identify critical to quality characteristics
• Provides historical records
• Increases customer satisfaction and safety

All the benefits of FMEA are realized because organizations can identify failures earlier and carry out corrective action based on the severity of the issue.

When Should You Use FMEA?

Now you understand the value, it’s important to also know when it makes sense to perform Failure Mode and Effects Analysis (FMEA). You should consider performing FMEA when:

• You are designing a new product, process, or service
• You are planning on changing an existing process
• You have a quality improvement goal for a process
• You must understand and take corrective action against a failure

Even when none of the above apply, it’s recommended to perform an FMEA occasionally throughout the lifetime of a process. The quality and efficiency of products and processes should be consistently examined to achieve optimal results and customer satisfaction.