What Is Failure Mode and Effect Analysis?

You’ll be happy to hear that while product design or manufacturing failures are expensive, they’re also preventable. Failure Mode and Effects Analysis (FMEA) steps in and takes care of the whole process for you. It’s a systematic risk management tool that helps your teams identify potential failure modes, assess their impact, and take proactive measures to prevent issues before they escalate.

It’s not only good for some industries and teams. Actually, FMEA empowers teams across industries to identify risks, improve product reliability, and achieve compliance with ease.

Once you implement FMEA risk assessment in your operations, you’ll see a positive impact on manufacturing processes, reduce failures, improve outcomes, and design fail-proof components.  

Sit down and get a pen, because we’ll break down FMEA, explore its workings, and uncover its real-world applications for boosting efficiency and delivering consistent value.

What Is FMEA? 

Failure Mode and Effects Analysis (FMEA) is a proactive method used to identify and mitigate potential risks in products, processes, or systems. At its core, FMEA systematically evaluates how something could fail, the impact of that failure, and the likelihood of it occurring.

And by using it, you’ll address these risks early in the design or process development phase meaning your products will be reliable, safe and meet customer expectations and regulations. 

FMEA Meaning and Definition

FMEA is both a qualitative and quantitative approach to risk assessment. A “failure mode” refers to any way in which a process, system, or component could fail, while “effects analysis” examines the consequences of those failures.

How Does FMEA Work?

Example of FMEA in Practice

Consider a smartphone manufacturer implementing FMEA for a new device. A potential failure mode identified is overheating in the battery due to insufficient heat dissipation.

Criteria	Details
Severity (S)	8 – Failure can render the device unsafe.
Occurrence (O)	6 – Moderate likelihood based on prior data.
Detection (D)	5 – Difficult to detect during standard quality checks.
Risk Priority Number (RPN)	240 – High-priority risk (Severity × Occurrence × Detection: 8 × 6 × 5).
Corrective Action	Redesigned the battery housing with advanced thermal materials and added temperature sensors to improve detection, reducing the RPN to an acceptable level.

Benefits/Drawbacks of FMEA

FMEA is a powerful tool for risk management, but like any methodology, it comes with advantages and limitations. Understanding these can help you maximize its effectiveness while addressing potential challenges. For instance, teams in manufacturing and energy industries often use these insights to strengthen condition monitoring with FMEA-driven insights, improving overall system reliability.

Benefits of FMEA

Let’s start with the bright side and explore FMEA’s benefits:

Early Risk Identification

FMEA allows you to pinpoint potential failure modes early in the design or process development phase, saving time and costs associated with late-stage corrections.

Example: In automotive design, identifying and mitigating a braking system flaw during the design phase avoids costly recalls and safety incidents later.

Improved Product Reliability

By systematically addressing risks, FMEA enhances the overall reliability and safety of a product.

Example: Medical device manufacturers use FMEA to ensure compliance with stringent safety standards, reducing the likelihood of patient harm.

Prioritized Risk Management

The RPN system helps teams focus on the most critical risks, ensuring that resources are allocated effectively.

Example: A manufacturing company uses FMEA rankings to prioritize upgrades on machinery parts prone to frequent failures, reducing downtime and repair costs.

Enhanced Communication and Collaboration

FMEA brings together cross-functional teams, fostering collaboration between design, manufacturing, and quality departments.

Regulatory Compliance

Industries like automotive, aerospace, and healthcare use FMEA to meet compliance requirements and ensure audit readiness.

Drawbacks of FMEA

Time-Intensive

Conducting a thorough FMEA can be time-consuming, especially for complex systems with many components.

Solution: Use templates and tools to streamline the process and focus on high-impact areas.

Resource Dependency

Effective FMEA requires skilled team members with deep knowledge of the product or process, which can be a constraint in resource-limited organizations.

Solution: Invest in training or engage external experts to support the analysis.

Subjectivity in Rankings

Severity, Occurrence, and Detection rankings can vary based on team judgment, leading to inconsistent results.

Solution: Standardize ranking criteria and conduct calibration sessions to ensure alignment across the team.

Limited Scope Without Updates

If not regularly updated, FMEA can become outdated, missing new risks introduced by design or process changes.

Solution: Treat FMEA as a living document and schedule regular reviews.

Types of FMEA

1. Design FMEA (DFMEA)
2. Process FMEA (PFMEA)
3. System FMEA (SFMEA)

Design FMEA (DFMEA)

DFMEA focuses on identifying and mitigating risks during the design phase of a product. The primary goal is to create robust designs that prevent failure and meet performance, reliability, and safety standards.

But how do you perform DFMEA the right way, and what will you get?

But how do you perform DFMEA the right way and what will you get?

• Focus your analysis on components or systems that have historically caused issues or play a critical role in product functionality.
• Use historical failure data from previous models or similar designs to identify failure modes.

For example, you can gather data from warranty claims, field reports, and maintenance logs to predict common issues.

• Test the design under extreme conditions to uncover hidden weaknesses.
• Include designers, engineers, and quality experts to ensure all perspectives are considered.
• Schedule structured brainstorming sessions to identify every possible failure mode.

Real-World DFMEA Example

An automotive company conducted DFMEA for a new electric vehicle to address potential powertrain issues.

• The identified failure mode: Motor controller malfunction caused by inadequate heat management.
• Severity: Rated as 10 due to the complete loss of propulsion, posing significant safety risks.
• Occurrence: Rated as 5 based on moderate likelihood from similar models.
• Detection: Rated as 3 because advanced diagnostics were required to identify the issue during quality checks.
• Calculated RPN: 150, highlighting the need for immediate corrective actions.

Corrective actions:

• Enhanced thermal design: Redesigned the controller housing with high-efficiency thermal materials to improve heat dissipation.
• Added redundancy: Implemented a secondary motor controller to take over in case of failure.
• Improved detection: Introduced thermal monitoring sensors to flag overheating early.
• Reduced RPN: Lowered the RPN from 150 to 45, ensuring reliability and safety while minimizing the risk of recalls.

Process FMEA (PFMEA)

Process FMEA is designed to analyze and mitigate potential failures in manufacturing and assembly processes. The goal is to make sure that production workflows are efficient, defect-free, and cost-effective. 

PFMEA helps identify issues like bottlenecks, defective components, and unsafe practices, enabling you to implement corrective measures before they affect the product.

And how do you perform this type of failure mode and effect analysis?

• Break down the manufacturing or assembly process into individual steps. Make sure that no step is overlooked, including material handling, tooling, and inspection.

Pro tip: Use flowcharts or process maps to visualize the entire workflow.

• Focus on areas prone to variability or human error, such as manual assembly or processes involving multiple suppliers.
• Automate quality checks using vision systems or IoT sensors.
• Regularly collect data from downstream processes or customer complaints and feed it back into the PFMEA to refine workflows.
• Engage operators and maintenance staff who work closely with the process. They often have practical insights that designers may overlook.

Pro tip: Use a CMMS to document and track recurring failures.

PFMEA Example

A beverage company performing PFMEA on its bottling process identified a failure mode: bottle caps not sealing correctly due to inconsistent torque application.

• Failure mode: Improper sealing of bottle caps.
• Severity: 7 – Could lead to product leakage and spoilage.
• Occurrence: 5 – Moderate likelihood due to varying machine settings.
• Detection: 6 – Hard to detect without post-sealing inspections.
• RPN: 7 × 5 × 6 = 210.

Corrective actions:

1. Installed automated torque sensors to apply consistent pressure.
2. Conducted routine machine calibration checks.
3. Introduced a quality control step to verify seal integrity.
4. Reduced RPN to 70 after implementing the changes.

System FMEA (SFMEA)

As the name suggests, System FMEA evaluates risks at the system level, focusing on how various subsystems and components interact. 

Its main task is for the entire system to function as intended by addressing potential failures caused by integration issues, dependencies, or cascading failures. This approach is critical for large-scale, complex systems such as aircraft, manufacturing plants, or energy grids.

And here is how to do it right without overwhelming your teams:

• Clearly outline what is included in the system under analysis and what is external. This prevents scope creep and ensures focus on relevant interactions.
• Focus on interactions between components or subsystems where failures are most likely or impactful.
• Analyze how failures in one subsystem can propagate to others and magnify the impact.
• Include mechanisms that monitor system performance in real time and provide corrective actions when failures occur.
• Employ IoT sensors and predictive analytics to detect anomalies before they escalate.

Real-World System FMEA Example

A manufacturing plant performing System FMEA on its assembly line identified a failure mode: a robotic arm malfunction disrupting the entire production flow.

• Failure mode: Robotic arm malfunction during assembly.
• Severity: 8 – Halts production and causes delivery delays.
• Occurrence: 4 – Low likelihood with routine maintenance.
• Detection: 5 – Moderate difficulty without real-time monitoring.
• RPN: 8 × 4 × 5 = 160.

Corrective actions:

1. Installed IoT-enabled sensors on the robotic arm to monitor performance in real time.
2. Scheduled predictive maintenance based on usage patterns.
3. Added a manual override to bypass the robotic arm in emergencies.
4. Reduced RPN to 48 after implementing the changes.

How to Choose the Right FMEA Type

FMEA Type	When to Use	Key Benefit
DFMEA	During the product design phase.	Prevents design flaws and enhances reliability.
PFMEA	For evaluating manufacturing or assembly processes.	Reduces defects and improves efficiency.
System FMEA	For large-scale systems with multiple interacting components.	Reduces system-level failures and downtime.

How to Perform FMEA

We want to set you up for success, as that’s the whole point of an FMEA. Because of that, we’ve prepared a step-by-step guide on how to perform FMEA with actionable tips and examples that can serve as your roadmap in this process.

Step 1: Define the Scope

Clearly define the boundaries and objectives of the analysis. This includes identifying the system, component, or process under review and its relationship to the broader operation.

Actions to take:

• Break down the product or process into subsystems or individual steps.
• Document the purpose of the FMEA (e.g., reducing safety risks, improving reliability).
• Use flowcharts, system diagrams, or process maps to illustrate the scope visually.

Example:

A pharmaceutical company analyzing its tablet-coating process defines the scope to include machinery settings, raw materials, and environmental conditions that impact coating quality.

Step 2: Assemble a Cross-Functional Team

FMEA is only as good as the people conducting it. Assemble a team with diverse expertise to cover all aspects of the product or process.

Actions to take:

• Include design engineers, process experts, quality assurance specialists, and operators.
• Assign specific roles, such as a facilitator to guide the process and a scribe to document findings.
• Schedule dedicated sessions for FMEA to maintain focus and momentum.

Step 3: Identify Potential Failure Modes

Failure modes describe how a component, process, or system could fail to meet its intended function.

Actions to take:

• Brainstorm failure modes for each part or process step.
• Use historical data, warranty claims, and past defect reports as references.
• Identify common causes of failure, such as wear and tear, design flaws, or environmental conditions.

Step 4: Analyze Failure Effects

Evaluate the impact of each failure mode on the product, process, or end user.

Actions to take:

• Describe the consequences of the failure, such as safety hazards, operational downtime, or regulatory non-compliance.
• Link effects to tangible business outcomes, like increased costs or customer dissatisfaction.

Step 5: Assign Severity, Occurrence, and Detection Ratings

Quantify the risks associated with each failure mode to prioritize mitigation efforts.

Actions to take:

• Use a 1–10 scale to rate:
  • Severity (S): The impact of the failure on functionality or safety.
  • Occurrence (O): The likelihood of the failure occurring.
  • Detection (D): The ability to detect the failure before it impacts users.
• Calculate the Risk Priority Number (RPN):
  

RPN = Severity × Occurrence × Detection.

Example:

In a compressor system:

• Severity = 8 (critical downtime risk).
• Occurrence = 6 (moderate likelihood).
• Detection = 5 (hard to detect early).

RPN = 240 (high-priority risk)

Example Workflow for Performing FMEA

Step	Example	Action Taken
Define scope	Focused on wind turbine gearbox failures.	Analyzed key components prone to wear and tear.
Assemble team	Included mechanical engineers, quality experts, and field technicians.	Ensured comprehensive expertise in analysis.
Identify failure modes	Listed vibration issues, material fatigue, and lubrication failures.	Documented in the FMEA worksheet.
Analyze failure effects	Determined vibration leads to higher wear rates and potential downtime.	Quantified operational and cost impacts.
Rate Severity, Occurrence, Detection	Severity: 8, Occurrence: 5, Detection: 4.	RPN calculated as 160.
Prioritize risks	Focused on vibration as it had the highest RPN.	Elevated it for immediate action.
Develop actions	Added vibration dampers and scheduled regular lubrication checks.	Reduced occurrence and impact.

Industries & Use Cases of FMEA

For anyone looking to improve efficiency, reduce costs and deliver higher-quality products, FMEA is a versatile tool that will find applications in your line of work. 

Automotive Industry

The automotive sector relies heavily on FMEA to ensure safety and compliance with stringent regulations. Design and System FMEA are integral to developing reliable vehicles and preventing costly recalls.

Use case:

An automotive manufacturer uses DFMEA to evaluate the steering system of a new vehicle. During analysis, the team identifies a potential failure mode: loss of steering control due to gear misalignment. Corrective actions include refining gear manufacturing tolerances and adding quality checks during assembly, reducing the likelihood of failure.

Outcome:

Improved vehicle safety and reduced warranty claims related to steering issues.

Aerospace Industry

With lives depending on the reliability of systems, the aerospace industry uses FMEA to evaluate risks in design, assembly, and operation. Functional and System FMEA are especially critical.

Use case:

A jet engine manufacturer conducts System FMEA on the fuel delivery system. The analysis highlights a failure mode where a clogged injector could disrupt engine performance. The team implements redundant injectors and real-time monitoring sensors to mitigate the risk.

Outcome:

Enhanced system reliability and compliance with FAA safety standards.

Medical Devices

FMEA ensures medical devices meet stringent safety requirements and function reliably in critical situations. DFMEA is often used to evaluate design risks, while PFMEA focuses on manufacturing processes. For example, addressing potential failures in medical device components highlights how FMEA helps ensure product safety and compliance with FMEA in pharma.

Use case:

A company designing a heart rate monitor identifies through DFMEA that battery failure could result in device shutdown during use. Corrective actions include integrating a battery life indicator and adding a backup battery.

Outcome:

Increased patient safety and adherence to ISO 13485 standards for medical devices.

Manufacturing Sector

FMEA plays a crucial role in optimizing production processes and reducing defects. PFMEA is widely applied to identify bottlenecks, inefficiencies, and quality issues in manufacturing workflows.

Use case:

A beverage company uses PFMEA to analyze its bottling line. The team identifies a failure mode: inconsistent filling levels due to faulty nozzles. Corrective actions include installing sensors to monitor nozzle performance and scheduling preventive maintenance.

Outcome:

Consistent product quality and reduced downtime on the production line.

Do you work in the manufacturing industry? Learn how FMEA drives quality and reliability in manufacturing.

Renewable Energy

The renewable energy sector relies on FMEA to ensure the reliability of wind turbines, solar panels, and other infrastructure. System FMEA is commonly applied to assess risks in large-scale systems.

Use case:

A wind turbine manufacturer conducts FMEA to evaluate the rotor assembly. The analysis reveals a potential failure mode: blade cracks due to high wind stress. The team reinforces blade material and implements vibration monitoring systems.

Outcome:

Extended turbine lifespan and improved energy output. 

Eager to learn more? Explore how FMEA enhances asset management strategies.

Consumer Electronics

Electronics companies use FMEA to ensure products meet consumer expectations for reliability and safety. DFMEA is frequently employed to address design risks.

Use case:

A smartphone company identifies overheating in the battery as a potential failure mode. Corrective actions include redesigning the thermal management system and adding software-based temperature monitoring.

Outcome:

Safer devices and fewer customer complaints about overheating issues.

How LLumin Enhances FMEA

Incorporating LLumin’s advanced maintenance and asset management tools into your FMEA process will help you structure it and improve the outcomes by providing:

Centralized Data for Accurate Analysis

LLumin’s CMMS+ system consolidates asset data, maintenance logs, and performance records in one place. This means you have access to the accurate, real-time information needed for a comprehensive FMEA.

• LLumin eliminates the risk of working with outdated or incomplete data during risk assessment.

Predictive Analytics for Proactive Risk Management

LLumin integrates IoT sensors and predictive analytics to monitor equipment and processes in real time. You’ll identify early warning signs of potential failures, as LLumin supports FMEA by lowering occurrence and improving detection rankings.

Collaboration Across Teams

LLumin facilitates collaboration among design, quality, and maintenance teams by providing a centralized platform for sharing insights and updates.

Automating FMEA Updates

With LLumin, updates to FMEA are simplified. As processes or designs evolve, real-time data from LLumin can inform necessary revisions to keep your FMEA relevant.

• LLumin saves time and ensures your FMEA reflects the current state of operations.

Actionable Insights for Decision-Making

LLumin’s reporting and analytics tools allow you to visualize risks and track the effectiveness of implemented actions.

By integrating LLumin into your FMEA workflows, you’ll benefit from:

• Faster identification of failure modes with real-time data.
• Improved collaboration between departments.
• Reduced costs and downtime through predictive maintenance.
• A continuously updated FMEA that evolves with your operations.

Ready-to-Use FMEA Templates

Section	Details to Include
Scope	Define the process, system, or component under analysis.
Potential failure mode	List all possible ways the system or component could fail.
Failure effects	Describe the impact of each failure mode on safety, performance, or compliance.
Severity (S)	Rate the criticality of the failure on a scale of 1 to 10.
Occurrence (O)	Assess the likelihood of the failure occurring, rated 1 to 10.
Detection (D)	Evaluate how easily the failure can be detected, rated 1 to 10.
RPN	Calculate Severity × Occurrence × Detection to prioritize risks.
Corrective actions	Document steps to reduce severity, occurrence, or improve detection.
Responsible party	Assign ownership of the corrective action to a team or individual.
Review date	Schedule follow-up to monitor the effectiveness of implemented actions.

Conclusion

Investing in FMEA, supported by tools like LLumin, positions your organization for long-term success in an increasingly competitive and quality-driven marketplace.

When you proactively identify potential failures and implement targeted corrective actions, you can achieve measurable outcomes: reduced downtime, lower maintenance costs, and higher customer satisfaction. 

In real life, you can expect something like cutting warranty claims by 20% or slashing production delays by addressing design flaws before they hit manufacturing.

When paired with LLumin, these outcomes become even more achievable. Real-time data, predictive insights, and streamlined updates allow you to make faster, smarter decisions that directly improve your bottom line. With fewer failures and better resource allocation, your team can focus on innovation, delivering consistent quality, and driving profitability.

FAQs About FMEA

What are the 5 Ts in FMEA?

The 5Ts—Team, Timing, Tasks, Tools, and Techniques—are the foundational elements for executing an effective FMEA, ensuring collaboration, structured planning, and proper methodologies throughout the process.

How long should FMEA take?

The duration of an FMEA depends on the complexity of the system or process. For simple designs, it can take a few days, while complex systems may require weeks or months for a thorough analysis.

What is the difference between risk analysis and FMEA?

Risk analysis is a broad process for identifying and evaluating risks in general, while FMEA is a specific methodology focused on systematically identifying failure modes and their effects to prioritize and mitigate risks.

How often should FMEA be reviewed and updated?

FMEA should be reviewed and updated whenever there are significant design or process changes, new risks are identified, or performance data highlights recurring issues—typically at least annually for critical systems.

How do you prioritize risks in an FMEA?

Risks in FMEA are prioritized using the Risk Priority Number (RPN), calculated by multiplying Severity, Occurrence, and Detection rankings. Focus on addressing the failure modes with the highest RPNs first.