Free FMEA Tool - Failure Mode and Effects Analysis with Smart Prompts

RPN Calculator, Environmental Testing Prompts, Risk Assessment, Design Validation, ISO 9001 Compliance

Professional FMEA (Failure Mode and Effects Analysis) tool with intelligent prompts for environmental factors, testing strategies, and mitigation recommendations. Calculate Risk Priority Number (RPN), conduct root cause analysis, and export to CSV/PDF. Used for ISO 9001, IATF 16949, FDA medical device compliance, and product development risk assessment.

Why Do an FMEA? Because Field Failures Are Expensive

FMEA (Failure Mode and Effects Analysis) is your chance to find and fix problems before they reach customers. A failure caught in design costs pennies. The same failure in the field costs thousands in warranty claims, recalls, liability, and reputation damage.

The Reality: Often Just Paperwork

Let's be honest—FMEA is often treated as a compliance checkbox. Fill out the form, get the signatures, file it away. Many companies do FMEA after the design is locked, when it's too late to actually change anything. It becomes a paperwork exercise to satisfy ISO 9001, IATF 16949 (automotive), or FDA requirements (medical devices) rather than a genuine problem-solving tool.

But here's the thing: When done early and properly, FMEA is one of the most powerful tools in product development. It forces you to think systematically about everything that could go wrong—and do something about it before tooling up.

A Brief History of FMEA

FMEA was developed in the 1940s by the U.S. military to prevent catastrophic failures in weapons systems. When a failure meant soldiers' lives, systematic risk analysis became essential. NASA adopted FMEA in the 1960s for the Apollo program—when failure literally meant lives lost in space. Every component, every system underwent rigorous failure mode analysis.

The automotive industry embraced FMEA in the 1970s after expensive recalls demonstrated the staggering cost of design oversights. Toyota integrated FMEA into the Toyota Production System as part of their quality culture. Ford made FMEA mandatory for suppliers in the 1980s. Today's AIAG FMEA standards (now aligned with VDA) are used globally across automotive supply chains.

Where FMEA is Required (Mandatory Compliance)

Automotive Industry: IATF 16949 requires both Design FMEA (DFMEA) and Process FMEA (PFMEA). No FMEA documentation means no Production Part Approval Process (PPAP) approval. Suppliers cannot ship parts without completed FMEA submitted to customers.

Medical Devices: FDA requires risk analysis per ISO 14971 for medical device submissions. FMEA is the standard accepted method for demonstrating systematic risk assessment. Both 510(k) submissions and PMA applications require documented failure analysis.

Aerospace: AS9100 demands rigorous failure analysis for safety-critical components. FMEA documentation is required for aircraft parts, space systems, and defense applications where failure consequences are catastrophic.

General Manufacturing: ISO 9001 requires "risk-based thinking" throughout the quality management system. While ISO 9001 doesn't mandate FMEA specifically, it's the most widely accepted method for demonstrating compliance with risk-based requirements.

Functional Safety: IEC 61508 and ISO 26262 (automotive functional safety) require systematic hazard and risk analysis. FMEA provides the foundation for safety integrity level (SIL) determination.

What is FMEA? The Three-Factor Risk Assessment

FMEA systematically evaluates potential failure modes by rating three factors on a 1-10 scale:

• Severity (S): How bad is the failure? (10 = catastrophic injury/death, 1 = no noticeable effect)
• Occurrence (O): How likely is the failure? (10 = almost certain to happen, 1 = nearly impossible)
• Detection (D): Can you catch it before customers? (10 = cannot detect, 1 = almost certain detection)

The Risk Priority Number (RPN) is calculated as: RPN = Severity × Occurrence × Detection. RPN ranges from 1 to 1000. Generally, RPN ≥ 200 is critical (immediate action required), 100-199 is high risk, 50-99 is moderate risk, and below 50 is acceptable. However, always prioritize high severity failures (S ≥ 9) regardless of RPN.

Design FMEA vs Process FMEA

Design FMEA (DFMEA) focuses on potential failures in the product design itself—analyzing how the product could fail to meet customer requirements due to design weaknesses. Examples: inadequate material selection, insufficient structural strength, poor thermal management, corrosion susceptibility, electrical overstress. DFMEA is conducted during product design phases.

Process FMEA (PFMEA) focuses on potential failures in the manufacturing or assembly process—analyzing how the manufacturing process could create defects even if the design is sound. Examples: machining errors, assembly mistakes, contamination, improper torque, welding defects, mixing errors. PFMEA is conducted when planning manufacturing processes.

Most products need both: DFMEA ensures the design is robust, PFMEA ensures manufacturing can consistently produce it correctly.

Practical Insights from 30+ Years in Product Development

Do it early. Conduct FMEA during concept and design phases—not after CAD is finished and tooling quotes are approved. Early FMEA catches problems when fixes are cheap: change a dimension, add a fillet radius, select a different material, add a protective coating. Late FMEA just documents risks you can no longer afford to fix. It becomes a record of known problems rather than a prevention tool.

Think environmental factors. This is where most FMEAs fail. Engineers analyze mechanical stress and electrical loads but forget real-world environmental conditions. Does your product see temperature cycling (expansion/contraction fatigue)? Humidity and condensation (corrosion, electrical shorts)? Vibration during transport or operation (fastener loosening, wire fatigue)? UV exposure (plastic degradation)? Salt spray (accelerated corrosion)? Dust and contamination? This FMEA tool specifically prompts you to consider these factors systematically.

Testing is your best mitigation. You can't always redesign to eliminate every risk. Budget constraints, size limitations, cost targets—sometimes you must accept calculated risks. But you can test to validate your design and reduce occurrence ratings. FEA analysis shows stress concentrations before you build prototypes. Accelerated life testing reveals time-dependent failures. Environmental chamber testing exposes weaknesses to temperature, humidity, vibration. Standards compliance testing (UL, IEC, ASTM, MIL-STD) demonstrates performance under defined conditions. Design of Experiments (DOE) optimizes multiple parameters simultaneously.

Leverage prior experience. Have you used this component successfully in previous products? That's documented evidence of low occurrence. Copy proven designs. Review warranty data and field failure reports from earlier products—they tell you exactly what fails in real-world use. Benchmark competitors' products—how do they solve similar problems? Standing on proven designs isn't cheating; it's smart engineering that reduces risk.

Root causes, not symptoms. FMEA forces you to think about causes, not just effects. A component breaks—why? Because stress exceeds strength—why? Because the load is higher than expected—why? Because users operate it differently than specified—why? Because instructions are unclear. Now you have actionable root causes: improve instructions, add load limiting, increase strength, or redesign to prevent misuse.

Make it useful, not perfect. Don't get paralyzed trying to create the perfect FMEA document with flawless formatting and comprehensive documentation of every conceivable failure. Use this tool to capture your thinking quickly and systematically. Export to CSV and paste into your company's official template. Export to PDF for design reviews. The value is in the analysis and the mitigations you implement—not in document perfection.

What This FMEA Tool Does Differently

Most FMEA software gives you a blank spreadsheet or form and says "good luck filling this out." This tool actively prompts you to think comprehensively about factors engineers commonly overlook:

• Environmental Factor Prompts: Did you consider corrosion from humidity or salt? Temperature extremes causing expansion/contraction? Thermal cycling fatigue? Vibration loosening fasteners? UV degradation of plastics? Dust and contamination? The tool prompts you systematically.
• Failure Mode Suggestions: Common failure modes organized by type—mechanical fractures, leaks, electrical failures, jamming, overheating, wear, corrosion, deformation. Examples trigger ideas you might have missed.
• Effects Prompts: Consider safety risks, product inoperability, performance degradation, regulatory non-compliance, customer dissatisfaction, warranty costs, downstream system effects, property damage.
• Root Cause Categories: Six systematic cause categories with icons—Environmental factors, Operational stress, Time-based degradation, Design/manufacturing defects, Human factors, Electrical issues. Ensures comprehensive thinking.
• Mitigation Strategy Suggestions: Specific recommendations—conduct FEA/CAE analysis, perform hand calculations with safety margins, execute testing (accelerated, environmental, standards), use Design of Experiments, leverage proven components from prior products, add redundancy or fail-safe mechanisms, improve manufacturing controls.
• Testing Strategy Prompts: Suggests accelerated life testing, environmental stress screening, standards compliance testing (UL, IEC, ASTM), thermal cycling, vibration testing, salt spray, humidity chambers.
• Customizable Rating Scales: Adapt severity, occurrence, and detection scales to match your company standards—AIAG (automotive), ISO 14971 (medical devices), or custom scales.
• Multi-Level Analysis: Organize analysis by System, Subsystem, or Component levels. Maintain proper structure for complex products.
• Visual Risk Dashboard: See your highest RPN items instantly color-coded (red for critical ≥200, orange for high 100-199, yellow for moderate 50-99). Focus attention where it matters most.
• Export Flexibility: Export to CSV (opens in Excel—easy to copy/paste into company templates), PDF (formatted reports for design reviews), or JSON (backup files to continue later).
• Action Item Tracking: Assign responsibility, set target dates, track completion status. Ensure mitigations don't just get documented—they get implemented.

How to Conduct an Effective FMEA: Step-by-Step

1. Project Setup: Create your FMEA project. Choose analysis level (System, Subsystem, Component). List all items to analyze. Optionally customize rating scales to match company standards.
2. Define Function and Purpose: For each item, clearly state WHY it exists (purpose) and WHAT happens if it's not there (criticality). This context helps identify meaningful failure modes.
3. Identify Failure Modes: How could this component fail to perform its function? Click "Show Ideas" for common modes: breaks, cracks, leaks, bursts, electrical failures, jams, overheats, wears prematurely, corrodes, deforms.
4. Analyze Effects: What happens when this failure occurs? Consider: safety risks, product stops working, performance degrades, regulations violated, customer dissatisfied, warranty claims, downstream effects on other systems.
5. Identify Root Causes: WHY does this failure occur? Click "Show Thinking Prompts" for systematic categories: Environmental (temperature, corrosion, vibration), Operational stress (overload, fatigue), Time-based (aging, creep), Design/manufacturing defects, Human factors (misuse, maintenance), Electrical issues.
6. Document Current Controls: What prevention and detection methods already exist? Design features, process controls, inspections, testing currently performed.
7. Rate Severity, Occurrence, Detection: Use the 1-10 scales with detailed descriptions. Add justification notes explaining your ratings. This documentation demonstrates thorough thinking.
8. Review RPN and Prioritize: Tool calculates RPN automatically (S × O × D). Focus mitigation on highest risks first. Critical items (RPN ≥ 200) shown in red demand immediate action.
9. Define Mitigations: Click "Show Mitigation Ideas" for strategies: Design changes, FEA/testing/calculations, manufacturing controls, proven components, redundancy, fail-safe mechanisms. Choose the most effective and practical mitigations.
10. Assign Responsibility and Dates: Each action needs an owner and target completion date. This creates accountability and enables progress tracking.
11. Export and Implement: Export to CSV for company templates, PDF for reviews, or JSON backup. The real value comes from implementing mitigations—not just documenting them.
12. Track Progress: Use the Stats dashboard to monitor critical items, completion status, and top risks. Update your FMEA as design evolves and mitigations are verified.

Common FMEA Mistakes to Avoid

• Doing FMEA too late: After design is locked and tooling committed. Early FMEA enables cheap fixes; late FMEA just documents problems you can't afford to solve.
• Focusing only on mechanical/electrical: Forgetting environmental factors (corrosion, temperature, vibration) that cause most real-world failures.
• Stopping at first-level causes: Identifying "material fatigue" as the cause instead of asking WHY fatigue occurred (stress concentration, inadequate safety factor, unexpected loading).
• Rating occurrence without data: Guessing instead of using test results, field data, supplier Cpk, or engineering calculations to justify ratings.
• Accepting high-severity risks without mitigation: Any failure with Severity ≥ 9 (safety risk, injury potential) requires mitigation regardless of RPN.
• Making FMEA a paperwork exercise: Filling out forms to satisfy auditors instead of genuinely analyzing risks and implementing mitigations.
• Doing FMEA alone in an office: Effective FMEA requires cross-functional teams—design engineers, test engineers, manufacturing, quality, field service who know different failure modes.
• Not updating FMEA: Treating it as a one-time document instead of a living record that evolves with design changes, test results, and field feedback.

FMEA in Different Industries

Automotive: IATF 16949 mandates DFMEA and PFMEA. Tier 1 suppliers must submit completed FMEAs as part of PPAP. Focus on warranty prevention, safety compliance, production capability (Cpk requirements).

Medical Devices: FDA requires risk analysis per ISO 14971. FMEA demonstrates systematic hazard identification and risk control. Both usability (use errors) and device failures must be analyzed. Risk documentation required for 510(k), PMA, and design history files.

Aerospace: AS9100 quality standard requires configuration management and risk analysis. Safety-critical components need FMEA with emphasis on single-point failures. Often combined with Fault Tree Analysis (FTA) for system-level risks.

Consumer Products: While not always mandated, FMEA prevents expensive recalls and liability claims. Focus on foreseeable misuse, child safety, fire/electrical hazards, compliance with CPSC, UL, IEC standards.

Industrial Equipment: OSHA and machinery safety standards require risk assessment. FMEA identifies hazards requiring guarding, lockout/tagout, operator protection. Often drives CE marking requirements for European markets.

Electronics: FMEA addresses electrical overstress, thermal management, EMI/ESD sensitivity, connector reliability, solder joint fatigue. Often combined with highly accelerated life testing (HALT) to find weak points.

FMEA and Other Quality Tools

FMEA integrates with other problem-solving and quality methodologies:

• 5 Whys: Use to drill down to root causes before rating occurrence and planning mitigations.
• Fishbone Diagram (Ishikawa): Visualize multiple potential causes before FMEA analysis.
• Fault Tree Analysis (FTA): Top-down system analysis (starts with failure, works backward). FMEA is bottom-up (starts with components, works forward). Use together for comprehensive coverage.
• Design of Experiments (DOE): Test mitigations systematically. Optimize multiple parameters to reduce occurrence ratings.
• Statistical Process Control (SPC): Monitor manufacturing processes to maintain low occurrence ratings validated during PFMEA.
• 8D Problem Solving: When field failures occur, use 8D to investigate. Feed learnings back into FMEA updates.
• APQP (Advanced Product Quality Planning): FMEA is a required deliverable in automotive APQP process.

From a Design Engineer with 100+ Patents

I've conducted hundreds of FMEAs across automotive components, consumer products, and industrial equipment over 30+ years. Early in my career, I treated FMEA as annoying paperwork—something to complete because customers demanded it. Then I experienced a costly field failure that FMEA would have caught if I'd done it properly and early. That failure cost hundreds of thousands in warranty claims and damaged customer relationships.

Now I start FMEA during concept design, before detailed CAD. I use it to guide material selection, identify testing needs, and catch problems when fixes are trivial. The environmental thinking prompts in this tool mirror my mental checklist: corrosion? temperature extremes? vibration? These factors cause most field failures, yet engineers often overlook them during analysis.

Testing is almost always my primary mitigation strategy. When I can't eliminate a risk through design changes (due to cost, size, or performance constraints), I test to validate the design margin. FEA analysis, accelerated life testing, and environmental stress screening have saved me countless times by revealing weaknesses before production.

This tool is designed to make FMEA useful, not perfect. Use it to capture your thinking quickly, export to your company's format, and focus on the mitigations that actually reduce risk. That's what FMEA was meant to be—a thinking tool, not a compliance burden.

Interactive FMEA Tool Features

• Multi-level analysis structure (System/Subsystem/Component)
• Guided step-by-step wizard for thorough analysis
• Intelligent prompts for environmental factors, failure modes, effects, causes
• Mitigation strategy suggestions (FEA, testing, proven components)
• Customizable rating scales (AIAG, ISO 14971, custom)
• Automatic RPN calculation with color-coded risk levels
• Current controls documentation for existing mitigations
• Recommended actions with responsibility and date tracking
• Visual dashboard showing critical items and completion status
• Export to CSV (Excel-compatible for company templates)
• Export to PDF (formatted reports for design reviews)
• Save/load JSON backup files to continue work later
• Copy all data for easy documentation
• Mobile-responsive design for use anywhere
• No login required—completely free forever
• No data uploaded to servers—everything stays in your browser

Getting Started with FMEA

1. Create a new FMEA project and name it (product name, project code)
2. Choose your analysis level and add components to analyze
3. For each component, work through the guided wizard systematically
4. Use the prompt buttons to ensure comprehensive thinking
5. Focus on high RPN items (especially those with high severity)
6. Document practical mitigations you can actually implement
7. Assign responsibility and dates to ensure actions happen
8. Export to your company's template format
9. Update your FMEA as design evolves and test results come in
10. Review field failures and feed learnings back into future FMEAs

FMEA Resources for Product Developers

Combine FMEA with other invention and problem-solving tools: TRIZ for technical contradictions and inventive principles, SCAMPER for creative design alternatives, Design Thinking for user-centered innovation, Six Thinking Hats for structured decision making, Jobs-to-be-Done for understanding customer needs. Each technique serves different purposes in the product development process.

Free FMEA Tool—No Catch

This FMEA tool is completely free with no limitations, no premium features locked behind paywalls, no required login, no data collection. It's designed as a starter tool to help engineers, inventors, and product developers conduct thorough risk analysis with intelligent prompting. The tool runs entirely in your browser—no data is sent to servers. Export your completed FMEA to CSV/PDF and transfer to your company's official templates for final documentation.

FMEA methodology is public domain knowledge refined over decades by practitioners worldwide. This free tool makes professional-grade FMEA accessible to everyone committed to building better, safer, more reliable products.

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