What is failure mode and effects analysis? | FMEA Software

What is failure mode and effects analysis (FMEA)?

Failure mode effects analysis (FMEA) is a structured methodology used to identify potential failure modes within a product or process, assess their impact, and prioritize actions to mitigate risk. By systematically analyzing where and how failures might occur, FMEA helps organizations improve reliability, enhance patient safety, reduce medical errors, and comply with safety standards. This process is essential in safety-critical industries such as automotive, aerospace, semiconductor, and MedTech, where risk assessment and reliability engineering are paramount. FMEA supports requirements management and integrates seamlessly with PLM and ALM technologies, ensuring robust documentation and continuous improvement.

When is FMEA performed and why is it important?

FMEA is typically performed during the early stages of product or process design, before implementation, and throughout the lifecycle to address new risks. Its importance lies in proactively identifying and mitigating potential failures, reducing costly recalls, and ensuring compliance with safety standards. By integrating FMEA into development workflows, organizations achieve better risk management, improved product quality, and enhanced reliability.

The different types of FMEA

Design FMEA (DFMEA)

Focuses on identifying potential failures in product design, ensuring reliability and safety before manufacturing begins. DFMEA helps reduce failure rates and supports compliance with safety standards.

Process FMEA (PFMEA)

Analyzes risks in manufacturing and assembly processes, aiming to prevent defects and improve operational efficiency. PFMEA is vital for Six Sigma and continuous improvement initiatives.

System FMEA (SFMEA)

Evaluates failures at the system level, considering interactions between components and processes. SFMEA is essential for complex products in safety-critical industries.

The benefits of FMEA software

FMEA software transforms risk management by automating and streamlining the identification, analysis, and mitigation of potential failures. By integrating with PTC’s PLM and ALM platforms, organizations gain real-time visibility, robust documentation, and actionable insights that drive product quality, compliance, and operational efficiency. These solutions empower teams to collaborate across the product lifecycle, reduce costs, and accelerate innovation, making FMEA a strategic advantage for modern enterprises.

Cost reduction

FMEA software helps organizations avoid costly recalls and warranty claims by identifying risks early and enabling proactive corrective actions. Automated workflows reduce manual effort and streamline compliance.

Enhanced reliability and safety

By systematically analyzing failure modes, FMEA software improves product reliability and safety, supporting compliance with industry standards and regulatory requirements.

Improved product quality

Continuous risk assessment and documentation ensure that quality issues are addressed before products reach customers, resulting in higher satisfaction and fewer defects.

Better risk management

FMEA software supports comprehensive risk analysis and documentation, facilitating compliance and audit readiness.

Supports compliance

FMEA software simplifies regulatory reporting and audit preparation, ensuring organizations meet global safety and quality standards.

Strengthened documentation

Automated record-keeping and traceability support continuous improvement and knowledge sharing, making it easier to learn from past projects and drive future success.

How to perform failure mode and effects analysis

A successful FMEA process requires a structured approach, cross-functional collaboration, and the right tools to ensure risks are identified and mitigated.

Performing FMEA is a cornerstone of effective risk management in product and process development. The process begins with assembling a diverse team, defining the scope, and gathering all relevant information. Each step is designed to uncover potential failure modes, assess their impact, and prioritize actions that safeguard reliability and compliance. Leveraging PTC’s PLM and ALM solutions, organizations can automate and document every phase of FMEA, ensuring transparency, accountability, and continuous improvement. This structured approach not only reduces risk but also accelerates innovation and supports regulatory compliance across industries.

1. Build a team

Assemble a cross-functional team with expertise in design, engineering, manufacturing, and quality assurance. Diverse perspectives ensure comprehensive risk identification and effective mitigation strategies. Collaboration is key—PTC’s platforms facilitate seamless teamwork, enabling stakeholders to contribute insights and track actions in real time.

2. Set the scope

Clearly define the boundaries and objectives of the FMEA study. Determine which product, process, or system will be analyzed, and establish criteria for success. Setting a precise scope helps focus resources and ensures that all relevant risks are addressed. PTC’s solutions allow teams to document scope and link it to requirements and compliance standards.

3. Identify information

Gather all necessary data, including requirements, bill of materials, historical failure rates, and process documentation. Comprehensive information enables accurate risk assessment and supports traceability. PTC’s platforms centralize data, making it accessible and actionable for all team members.

4. Set scope functions

Define the intended functions and performance criteria for the product or process. Understanding what success looks like helps teams identify where failures could impact reliability, safety, or compliance. PTC’s tools link functional requirements to risk analysis, ensuring alignment throughout development.

5. Identify failure potential

List all possible failure modes, their causes, and contributing factors. Use brainstorming, historical data, and industry standards to ensure thorough coverage. PTC’s FMEA modules provide templates and checklists to guide teams through this critical step.

6. Identify consequences

Assess the impact of each failure mode on safety, reliability, quality, and compliance. Consider downstream effects and potential regulatory implications. PTC’s solutions enable teams to document consequences and link them to mitigation actions.

7. Rate severity and determine root causes

Prioritize risks based on severity, likelihood, and detectability. Use scoring systems to focus resources on the most critical issues. Investigate root causes and develop targeted mitigation plans. PTC’s platforms automate scoring, track actions, and provide dashboards for ongoing monitoring and improvement.

Industries that use FMEA software

FMEA software is essential across industries where reliability, safety, and compliance are mission-critical. From automotive and aerospace to semiconductor and MedTech, organizations rely on FMEA to prevent failures, meet regulatory requirements, and deliver high-quality products. PTC’s solutions are trusted by leaders in these sectors to drive innovation and operational excellence.

Automotive

Automotive manufacturers use FMEA to ensure vehicle safety, reliability, and compliance with global standards. Early risk detection helps prevent recalls and supports continuous improvement.

Aerospace

Aerospace companies leverage FMEA to safeguard mission-critical systems, enhance safety, and meet stringent regulatory requirements. FMEA supports reliability engineering and risk management throughout the lifecycle.

Semiconductor

Semiconductor manufacturers depend on FMEA to prevent defects, optimize processes, and ensure high reliability in complex production environments. FMEA supports Six Sigma and continuous improvement initiatives.

MedTech

MedTech organizations use FMEA to enhance patient safety, reduce medical errors, and comply with regulatory standards. FMEA is integral to quality management and risk assessment in medical device development.

Automotive Automotive manufacturers use FMEA to ensure vehicle safety, reliability, and compliance with global standards. Early risk detection helps prevent recalls and supports continuous improvement.

Aerospace Aerospace companies leverage FMEA to safeguard mission-critical systems, enhance safety, and meet stringent regulatory requirements. FMEA supports reliability engineering and risk management throughout the lifecycle.

Semiconductor Semiconductor manufacturers depend on FMEA to prevent defects, optimize processes, and ensure high reliability in complex production environments. FMEA supports Six Sigma and continuous improvement initiatives.

MedTech MedTech organizations use FMEA to enhance patient safety, reduce medical errors, and comply with regulatory standards. FMEA is integral to quality management and risk assessment in medical device development.

Real world applications of FMEA

See how leading organizations in automotive, aerospace, semiconductor, and MedTech have leveraged PTC’s FMEA solutions to reduce risk, improve quality, and achieve compliance.

FMEA drives safer automotive innovation

Veoneer uses Codebeamer to streamline FMEA workflows, ensuring compliance and reducing risk across complex automotive systems.

Read the Case Study

Driving safety with FMEA and Codebeamer

Navya leverages Codebeamer to manage FMEA processes, ensuring risk mitigation and compliance for autonomous vehicle development.

Read the Case Study

PTC’s FMEA software products

Windchill provides robust PLM capabilities for FMEA, enabling teams to manage risk, automate documentation, and ensure compliance across the product lifecycle.

Codebeamer delivers advanced ALM functionality for FMEA, integrating requirements, risk analysis, and quality management in a single collaborative platform.

Explore more about FMEA, risk management, and quality improvement through our curated resources, including guides, webinars, and industry insights.

Failure Mode and Effects Analysis (FMEA) frequently asked questions

Who performs an FMEA?

FMEA is typically conducted by cross-functional teams including design engineers, quality specialists, manufacturing experts, and project managers.

What are common mistakes in FMEA?

Common mistakes include incomplete identification of failure modes, lack of cross-functional input, and insufficient follow-up on recommended actions.

What are some limitations of the FMEA method?

FMEA may overlook complex interactions, rely on subjective assessments, and require significant time and resources for thorough analysis.

Failure Mode and Effects Analysis (FMEA)