FMEA: Definition, Types, Process, Requirements, and Example

Failure Modes and Effects Analysis (FMEA) is a structured risk management methodology used to proactively identify, assess, and mitigate potential failure modes in products, processes, or systems. FMEA helps organizations reduce risks, improve quality, and comply with regulatory requirements across various industries. There are several types of FMEA tailored to specific areas – Design FMEA, Process FMEA, System FMEA, Service FMEA, and Software FMEA.

The FMEA process involves a step-by-step approach, including identifying potential failure modes, analyzing their causes and effects, assigning severity, occurrence, and detection ratings, calculating the Risk Priority Number (RPN), and prioritizing corrective actions.

Incorporating FMEA into quality systems often supports or enhances compliance with regulatory standards such as ISO 14971, ISO 13485, FDA 21 CFR Part 820, IEC 60812, ICH Q9, and EU MDR.

Organizations can use structured FMEA templates to streamline documentation, visualize risks, and improve prioritization. Additionally, QMS software like SimplerQMS enhances FMEA execution through built-in templates, automated workflows, and integrated risk management modules that support end-to-end traceability and regulatory compliance.

Book a demo to see how SimplerQMS can simplify your risk management and overall quality management processes.

What Is FMEA (Failure Modes and Effects Analysis)?

Failure Modes and Effects Analysis (FMEA) is a structured risk assessment method used to identify failure modes in systems, processes, or products and analyze their causes and effects. The primary goal of FMEA is to detect and prioritize risks based on severity, likelihood, and detectability, enabling improvements that prevent failures.

The FMEA process begins by identifying potential failure modes, evaluating their causes and effects, assigning ratings for severity, occurrence, and detection, and calculating the Risk Priority Number (RPN), to prioritize corrective actions by risk level.

As part of risk management, FMEA  systematically ranks failures by impact, probability of occurrence, and detectability. It supports overall quality management by enhancing regulatory compliance and proactively addressing patient safety and product quality concerns.

In the context of product and process improvement, FMEA highlights vulnerabilities that affect reliability or efficiency, facilitating targeted corrective actions and fostering continual improvement.

Cross-functional teams comprising quality, process, and design professionals typically conduct the FMEA, guided by a trained facilitator who ensures methodological consistency and impartiality. This collaborative approach strengthens the overall effectiveness of the risk assessment.

FMEA originated in the 1940s as part of the U.S. military standard MIL-P-1629 and was later embraced by NASA, aerospace, and automotive sectors. Today, it remains essential in regulated industries as a central tool for quality assurance and risk management.

When to Use FMEA?

Failure Modes and Effects Analysis (FMEA) can be used proactively to detect risks early, enhance quality, and prevent costly failures. Incorporating FMEA at critical stages of product and process lifecycles helps ensure safer, more reliable, and compliant outcomes.

FMEA is most effectively applied in the following situations.

• Design and Development of New Products or Processes: Detect potential issues early and ensure robust, reliable designs and workflows.
• Modifications to Existing Designs or Processes: Analyze risks related to upgrades, design changes, or process optimizations.
• Introduction of New Equipment or Technology: Evaluate failure risks when integrating new machinery, systems, or automation.
• Process Validation and Qualification Activities: Confirm that processes meet required performance and quality standards.
• Identification of Significant Nonconformities or Failures: Apply FMEA reactively to investigate root causes, prevent recurrence, and improve corrective actions.
• Response to Regulatory or Customer Requirements: Demonstrate systematic risk assessment to satisfy standards, audits, or client expectations.
• Continuous Improvement Initiatives: Identify new risks and opportunities for enhancement during routine quality initiatives.
• Preparation for Audits, Certifications, or Regulatory Inspections: Showcase proactive risk management practices and documented controls.

Why is FMEA Important in Life Sciences?

In life sciences, FMEA plays a critical role in mitigating risks that impact product quality, patient safety, regulatory compliance, and operational efficiency. In industries such as pharmaceuticals, biotechnology, and medical devices, even small failures can lead to serious health, safety, and financial consequences.

Regulated under frameworks such as FDA regulations, ISO 13485, and Good Manufacturing Practice (GMP) guidelines, life sciences organizations are required to perform documented risk assessments, implement preventive actions, and engage in continuous improvement processes. FMEA supports these requirements through a structured, repeatable process that anticipates potential issues, improves designs, and optimizes processes.

 Below are the key benefits of FMEA in life sciences.

• Enhancing Patient Safety: Identify and mitigate risks that could lead to product malfunctions, contamination, or patient harm.
• Ensuring Regulatory Compliance: Provide documented, systematic risk assessments aligned with FDA, EMA, EU regulations, and ISO expectations.
• Improving Product and Process Quality: Reduce the likelihood of defects, deviations, and nonconformities by addressing risks early in development and manufacturing.
• Reducing Costs Associated With Failures: Minimize costs related to recalls, rework, corrective actions, and legal liabilities through preventive risk management.
• Supporting Continuous Improvement Initiatives: Facilitate ongoing monitoring and improvement of products and processes based on newly identified risks and data trends.

What Are the Types of FMEA?

FMEA can be categorized into different types based on focus areas such as design, process, system, service, and software. Each type of FMEA uses the core principles of identifying potential failures, analyzing their effects, and prioritizing corrective actions. However, the methodology is tailored to the specific needs of various industries, functions, and stages of development.

The different types of FMEA are described in the list below.

• Design FMEA (DFMEA): Design FMEA focuses on identifying and mitigating potential failures related to product design before the product is finalized. DFMEA aims to ensure that the final design meets the intended requirements and functions reliably under expected operating conditions. DFMEA is typically applied during the early stages of product development to enhance design robustness and reliability.
• Process FMEA (PFMEA): Process FMEA is used to analyze risks within manufacturing and assembly processes. PFMEA helps identify possible failure modes that could occur during production and affect product quality or efficiency. By addressing these risks proactively, PFMEA supports the implementation of preventive controls early in the process lifecycle.
• System FMEA: System FMEA evaluates the overall system architecture and its interactions between subsystems and components. It identifies potential system-level failures that could compromise overall performance, safety, or compliance. This type of FMEA is commonly applied in complex systems where interdependencies can increase risk exposure.
• Service FMEA: Service FMEA analyzes service-related operations, including customer-facing processes and support activities. It identifies failure modes that may occur during service delivery and assesses their impact on customer satisfaction and operational performance. Service FMEA supports quality improvement initiatives in service industries by reducing errors and inefficiencies.
• Software FMEA: Software FMEA examines potential failure modes within software applications and embedded systems. It focuses on identifying risks associated with software bugs, logic errors, interface issues, and integration problems. Software FMEA is particularly important in safety-critical environments where software failures could have significant consequences.

What Are the FMEA Process Steps?

The FMEA process follows a structured sequence of steps that enable organizations to systematically identify, assess, and reduce risks associated with product designs, processes, or systems. Each step builds upon the previous one to ensure a thorough and actionable risk assessment.

The typical FMEA process includes the following elements, as listed below.

1. Select the Process or Product for Analysis
2. Build a Cross-Functional Team
3. Review the Process, Product, or System
4. Identify the Functions and Requirements
5. Identify Potential Failure Modes
6. Determine the Effects of Each Failure Mode
7. Identify Potential Causes
8. Assign Severity Ratings (S)
9. Assign Occurrence (O) Ratings
10.  Identify Existing Controls
11.  Assign Detection (D) Ratings
12.  Calculate the Risk Priority Number (RPN)
13.  Prioritize Actions Based on RPN
14. Implement Risk Mitigation Actions
15.  Recalculate RPN After Mitigation

1. Select the Process or Product for Analysis

The FMEA process begins by selecting the specific product, process, or system to be analyzed.

Clearly defining the scope ensures a focused and relevant risk assessment. This includes outlining the boundaries, objectives, and justification for the analysis.

For example, a team may analyze the syringe assembly process of a Class II medical device to identify risks related to sterility. Establishing a clear purpose, such as meeting ISO 14971 requirements, helps guide the team’s efforts and ensures alignment with quality and regulatory goals.

2. Build a Cross-Functional Team

Forming a cross-functional team is essential for effective FMEA.

The team should include experts from various departments such as design, engineering, quality assurance, production, maintenance, and operations.

Involving diverse roles ensures that all risk areas are considered and no critical perspectives are missed during evaluation.

3. Review the Process, Product, or System

Understanding the system under analysis is a key early step. Teams should use diagrams like process flows, system maps, or schematics to visualize how components interact and where failures might occur.

These visual tools help identify interfaces, dependencies, and complex risk points that might not be obvious from documentation alone.

4. Identify the Functions and Requirements

Documenting each component’s or step’s functions and requirements provides the foundation for identifying potential failures. This includes detailing expected performance, user needs, and regulatory requirements.

Understanding the “what” and “why” behind each element provides the foundation for identifying potential failures.

5. Identify Potential Failure Modes

With functions defined, the next step is to identify all possible ways each function could fail.

Use brainstorming, technical expertise, and historical data to generate a thorough list. Examples might include seal leakage, software timeout, or material degradation. A complete set of failure modes is essential for accurate risk assessment.

6. Determine the Effects of Each Failure Mode

Once failure modes are identified, evaluate the potential consequences of each. Consider the effect on product performance, user safety, regulatory compliance, and business operations.

For instance, a failed temperature control during sterilization could compromise patient safety. This step forms the basis for assigning severity ratings.

7. Identify Potential Causes

For every failure mode, determine the underlying cause or causes. This may include design weaknesses, process inefficiencies, material issues, or human factors that could lead to failure.

Identifying causes accurately is key to selecting effective mitigation strategies. For example, a potential cause of mislabeling might be unclear work instructions or software glitches.

8. Assign Severity Ratings (S)

Assign a severity rating to each failure effect based on its potential impact.

Ratings typically range from 1 (minor) to 10 (catastrophic). A high severity score signals significant harm to users, regulatory noncompliance, or major operational disruption.

This step helps prioritize which failure modes demand urgent attention.

9. Assign Occurrence (O) Ratings

Estimate how likely each failure cause is to occur using a standardized rating scale. Ratings typically range from 1 (extremely unlikely) to 10 (almost certain). Higher occurrence ratings indicate a greater risk of the failure happening under normal conditions.

For example, if a process frequently experiences operator error, it would receive a higher occurrence score, prompting preventive measures.

10. Identify Existing Controls

Document the current measures and controls in place to prevent or detect each failure mode or its causes. These controls may include inspections, automated alerts, or standard operating procedures.

Understanding what safeguards already exist allows the team to assess whether additional actions are needed.

11. Assign Detection (D) Ratings

Rate the ability of existing controls to detect a failure before it reaches the end user. Ratings typically range from 1 (high detectability) to 10 (unlikely to be detected).

Lower detection scores indicate more reliable systems, while higher scores suggest weak or absent monitoring.

This rating helps determine how likely a failure is to go unnoticed and cause harm or disruption.

12. Calculate the Risk Priority Number (RPN)

The Risk Priority Number (RPN) is calculated by multiplying the Severity (S), Occurrence (O), and Detection (D) ratings for each failure mode.

The RPN calculation formula is shown below.

RPN=Severity (S) × Occurrence (O) × Detection (D)

This numerical value provides a quantifiable measure of risk, helping teams prioritize which issues require the most immediate attention.

13. Prioritize Actions Based on RPN

After calculating RPNs, rank the failure modes from highest to lowest. This prioritization helps identify the most critical risks to address first.

Focusing on high-RPN items ensures that mitigation efforts have the greatest impact on product safety, performance, and compliance.

14. Implement Risk Mitigation Actions

Develop and execute actions to reduce Severity, Occurrence, or improve Detection for the most critical failure modes.

Assign responsibilities, set deadlines, and monitor progress. Risk mitigation actions may include design changes, process improvements, or new quality checks aimed at reducing risk.

15. Recalculate RPN After Mitigation

Once mitigation actions are completed, reassess the affected failure modes. Update the S, O, and D ratings accordingly and recalculate the new RPN values.

Confirm that risk has been effectively reduced and update the FMEA documentation. Verify risk mitigations have been implemented correctly and are effective.

Treat the FMEA as a living document—review and revise it regularly as systems or processes evolve.

What Are the Regulatory Requirements Related to FMEA?

Failure Mode and Effects Analysis (FMEA) plays a significant role in supporting compliance with various quality and risk management regulatory frameworks.

While FMEA itself may not always be explicitly mandated, it is widely recognized as a best practice tool that supports key principles of risk management, quality assurance, and regulatory compliance.

Below are key standards and regulations where FMEA plays a supporting role.

• ISO 9001 – Quality Management Systems: ISO 9001 provides a framework for consistent quality in products and services through a process-based approach. FMEA supports ISO 9001 compliance by proactively identifying and controlling potential risks in processes, ensuring continual improvement and prevention of nonconformities.
• ISO 14971 – Application of Risk Management to Medical Devices: ISO 14971 outlines requirements for risk management throughout the lifecycle of medical devices. FMEA supports this by helping identify hazards, evaluate risks, and define control measures, particularly during product development and lifecycle management.
• 21 CFR Part 820 – FDA Quality System Regulation (QSR): The FDA’s QSR requires medical device manufacturers to establish and maintain procedures for identifying and mitigating product risks. FMEA supports compliance by enabling risk-based decision-making throughout the design and manufacturing processes, thereby enhancing product safety and effectiveness.
• IEC 60812 – Failure Modes and Effects Analysis (FMEA) Standard: This international standard specifies best practices for conducting FMEA. While not a regulatory requirement itself, IEC 60812 provides a globally accepted framework that aligns with regulatory expectations and enhances audit readiness.
• EU MDR (Medical Device Regulation 2017/745): The EU Medical Device Regulation (EU MDR 2017/745) provides a comprehensive regulatory framework governing the safety, performance, and risk management of medical devices marketed in the European Union. It emphasizes risk management throughout the entire product lifecycle, from design and development to post-market surveillance. Failure Modes and Effects Analysis (FMEA) supports compliance with EU MDR by offering a systematic method for identifying, evaluating, and mitigating risks in both product design and manufacturing processes. This structured approach helps meet key regulatory obligations, including those outlined in Annex I – General Safety and Performance Requirements and post-market risk monitoring activities.
•  ISO 13485 (Medical Devices – Quality Management Systems): ISO 13485 outlines the requirements for a quality management system specific to organizations involved in the design, production, installation, and servicing of medical devices. It requires companies to demonstrate their ability to consistently meet both customer expectations and applicable regulatory requirements. FMEA supports ISO 13485 compliance by promoting risk-based thinking throughout product design, manufacturing, and process control activities. By identifying potential failures early, FMEA enables preventive actions and supports continuous improvement within the quality management system.

What Are the Advantages and Limitations of FMEA?

FMEA helps identify and prioritize potential failures early, supporting reliability and risk mitigation. However, it can be subjective, time-consuming, and may miss broader system-level risks if not regularly updated.

Listed below are the advantages of FMEA.

• Proactive Risk Identification: Enables early identification of potential failure modes, allowing teams to implement risk mitigation controls before issues arise.
• Enhanced Product and Process Quality: Improves reliability, safety, and performance by systematically analyzing and mitigating risks.
• Prioritized Risk Mitigation Efforts: Utilizes the Risk Priority Number (RPN) method to focus efforts on the most critical risks, optimizing resource allocation.
• Structured Regulatory Compliance Support: Provides structured, documented risk assessments that support compliance with industry regulations such as ISO 14971, ISO 13485, and FDA QSR.
• Collaborative Cross-Functional Evaluation: Encourages knowledge sharing among design, engineering, quality, and operations teams, leading to comprehensive risk assessments.

The limitations of FMEA are listed below.

• Subjective Risk Assessment: Assigning severity, occurrence, and detection ratings often involves subjective judgment, which can introduce variability or bias into the risk prioritization process.
• Resource-Intensive Process: Performing a thorough FMEA requires significant personnel involvement, technical expertise, and time.
• Limited System-Level Visibility: Focuses on individual failure modes and may not fully capture complex system-level interactions.
• Knowledge-Dependent Accuracy: The quality of the analysis depends on the experience and thoroughness of the participating team; knowledge gaps can lead to missed risks.
• Static Without Regular Updates: If not continuously reviewed and updated, an FMEA can become outdated and ineffective, failing to reflect new risks arising from design changes, process modifications, or real-world usage feedback. This may result in non-compliance with regulatory requirements and leave risks unaddressed, potentially compromising product safety.

How Does FMEA Differ Compared to Other Risk Management Tools?

FMEA is a proactive and structured risk management tool that focuses on identifying potential failure modes, analyzing their effects, and prioritizing actions before failures occur. This sets FMEA apart from other techniques that are reactive, high-level, or event-focused. Choosing the right risk assessment method depends on project goals, lifecycle stage, and the nature of potential hazards.

Below is a comparison of FMEA to other commonly used risk management tools.

• FMEA vs Root Cause Analysis (RCA): FMEA is preventive and conducted before failures occur. RCA is reactive and used after a failure to trace its root cause. FMEA helps avoid issues, while RCA corrects them post-occurrence.
• FMEA vs Hazard Analysis: Hazard Analysis provides a broad overview of potential risks by evaluating hazards that could lead to harm, typically without analyzing individual failure mechanisms. FMEA dives deeper by examining specific failure modes, their causes, and their consequences.
• FMEA vs Fault Tree Analysis (FTA): FMEA uses a bottom-up approach, starting with components or steps to assess possible failure modes. FTA takes a top-down approach, starting with an undesired event and working backward to map contributing causes. FMEA is best for detailed failure mode review, while FTA is ideal for analyzing complex failure pathways.

What Is an Example of an FMEA and a Template to Use?

Below is a simplified FMEA example based on a real-world life sciences scenario involving cross-contamination during a manufacturing process.

Process Step	Function	Potential Failure Mode	Potential Effect(s)	Severity (S)	Potential Cause(s)	Occurrence (O)	Existing Control(s)	Detection (D)	RPN	Recommended Actions
Cleaning of the production line	Removes product residues	Ineffective cleaning	Cross-contamination	9	Inadequate cleaning procedure	6	Visual inspection only	7	378	Revise cleaning SOP, implement swab testing, and retrain staff
Material transfer	Move materials between rooms	Improper segregation	Product contamination	8	Human error, poor workflow design	5	Manual checks, verbal communication	6	240	Barcode tracking, physical barriers

A standard FMEA template can be used to organize key elements such as failure modes, causes, effects, and risk ratings into a structured table. This allows teams to visualize risks and determine the most critical areas for corrective action.

What Is the Role of QMS Software in Streamlining Risk Management and the Use of FMEA?

QMS software streamlines risk management and FMEA by digitizing workflows, enabling consistent risk identification, assessment, mitigation, and documentation across the product and process lifecycle. These risk management capabilities help organizations take a proactive approach to managing quality-related risks while ensuring compliance with applicable regulatory requirements.

Modern QMS software, such as SimplerQMS, includes a built-in risk management module, which is essential for conducting effective Failure Modes and Effects Analysis (FMEA) and other approaches to risk management.

The risk management module includes configurable FMEA templates and automated workflows for documenting potential risks and failure modes. This module enables teams to calculate Risk Priority Numbers (RPNs), assign corrective and preventive actions (CAPAs), and ensure complete risk traceability. All risk-related activities are managed within a centralized system designed to be audit-ready and compliant with regulatory requirements.

SimplerQMS is specifically developed for life sciences companies, including pharmaceutical manufacturers, medical device companies, biotechnology firms, and other regulated life science organizations. Its risk management functionality is fully integrated into the broader QMS software platform, allowing companies to manage risks as part of their overall quality processes.

In addition to risk management, SimplerQMS supports a broad range of quality management system processes through its integrated modules, such as document control, training management, CAPA management, supplier management, audit management, complaint handling, and more.

By providing an integrated solution, SimplerQMS helps ensure that all quality and compliance activities are connected, traceable, and easy to manage from a single platform.

SimplerQMS also helps life sciences companies meet key regulatory requirements by supporting compliance with standards such as ISO 14971 (Application of Risk Management to Medical Devices), ICH Q9 (Quality Risk Management in Pharmaceuticals), FDA 21 CFR Part 820 (Quality System Regulation for Medical Devices), and other applicable global requirements.

Book a demo to see SimplerQMS QMS software in action and explore how the solution simplifies risk management within your quality management processes.