Free FMEA Template
Your failure modes need more than a column in a risk register.
A free FMEA spreadsheet for medical device and regulated product development. Gives risk analysis a structured shape: item, failure mode, downstream effect, Severity × Occurrence × Detection scoring, recommended actions, mitigation tracking, and direct cross-references to your requirements and risk register. Use it standalone or alongside the RTMify Requirements Tracking Template. No account, no gate.
Linked REQ / Linked Risk ID cross-references.What FMEA requires you to do
Failure Mode and Effects Analysis is one of the primary risk analysis methods identified in ISO 14971 §5.4. For each item or function, you identify how it could fail, what happens downstream if it does, and how likely and detectable that failure is. RPN = Severity × Occurrence × Detection gives you a relative number for prioritizing action. Important: RPN is an internal prioritization tool, not a compliance threshold. ISO 14971:2019 evaluates risk acceptability using a 2D Probability × Severity matrix defined in your Risk Management Plan — RPN alone cannot justify a finding of acceptable risk. For automotive contexts, ISO 26262 (2018) and the AIAG-VDA FMEA alignment have largely replaced RPN with Action Priority (AP): High, Medium, or Low.
Identify before you build
FMEA is most valuable during design, identifying failure modes before hardware or software is committed. Post-build FMEA satisfies regulatory requirements but cannot prevent failures already embedded in the design.
Risk controls become requirements
Every recommended action that mitigates a risk should become a verifiable requirement in your SRS. The Linked REQ column makes that linkage explicit. ISO 14971 §5.5 requires it.
Residual risk needs re-scoring
After controls are applied, re-score Severity, Occurrence, and Detection. If residual RPN remains above your acceptance threshold, iterate. The Revised S/O/D/RPN columns document this loop explicitly.
Field reference — FMEA tab
One row per failure mode. If one item has multiple failure modes, each gets its own row and FMEA ID.
| Column | What goes here |
|---|---|
| FMEA ID | Unique identifier for each failure mode (FMEA-001, FMEA-002…). One failure mode per row. |
| Item / Function | The component, subsystem, or function being analyzed. Be specific: "Temperature sensor analog front-end" not "sensor." |
| Potential Failure Mode | How this item or function could fail. State the failure, not the cause: "Reads 2°C high" not "Solder joint cracks." |
| Potential Effect(s) | Downstream consequence of the failure, including harm to patient, user, or operator. ISO 14971 requires identifying the hazardous situation and the resulting harm. |
| Severity (S) | How serious is the effect if the failure occurs? 1 = negligible, 5 = catastrophic. See Scales tab. Severity almost never decreases with mitigation. If it does, document why. |
| Potential Cause(s) | Root cause or mechanism that produces the failure mode. One failure mode may have multiple causes; use separate rows or comma-separate if they share the same S/O/D profile. |
| Occurrence (O) | How likely is this cause to produce the failure? 1 = remote, 5 = frequent. Based on historical data, test results, or engineering judgment. |
| Current Controls — Prevention | Existing design or process controls that prevent the cause or failure mode from occurring. "TCXO specified in BOM" or "Input range check in firmware." |
| Current Controls — Detection | Controls that detect the failure before it reaches the user. "Power-on self-test" or "Automated boundary scan during manufacturing." |
| Detection (D) | How likely are current controls to detect the failure before it reaches the user? 1 = certain detection, 5 = undetectable. The scale is inverted, so lower is better. |
| RPN | Risk Priority Number = S × O × D. Calculated automatically. Range 1–125 with 1–5 scales. Use RPN to prioritize actions internally. It is not a compliance threshold: ISO 14971:2019 requires acceptability to be determined by a Probability × Severity matrix in your Risk Management Plan, not by an RPN cutoff. For automotive (ISO 26262 / AIAG-VDA), consider replacing RPN with Action Priority (High / Medium / Low). |
| Recommended Action | What should be done to reduce risk? Target the highest contributor: reduce Occurrence (better design), improve Detection (better testing), or both. Severity reduction requires a fundamental design change. |
| Action Taken | What was actually implemented (not just the plan). Document the mitigation as it was built and verified. |
| Revised S / O / D / RPN | Re-score after mitigation is implemented. Revised RPN is calculated automatically. If residual risk remains above your acceptance threshold, iterate. |
| Linked REQ | Requirement ID from the RTMify Requirements Tracking Template. Every risk control measure should trace to a verifiable requirement (ISO 14971 §5.5). |
| Linked Risk ID | Risk ID from the RTM Risks tab. Maps this FMEA entry to the summary risk register for bidirectional traceability between detailed per-failure-mode analysis and top-level risk assessment. |
Standards coverage
FMEA is required or commonly expected across all major regulated-product standards. The specific clause, required rigor, and documentation depth differ by standard and product class.
| Standard | Relevant clause | Why the template helps |
|---|---|---|
| ISO 14971:2019 | §5.4 Risk analysis, §5.5 Risk evaluation | Implements the ISO 14971 risk cycle: hazard identification, risk estimation, control documentation, and residual risk assessment via revised scoring. Note: ISO 14971:2019 determines risk acceptability using a Probability × Severity matrix defined in the Risk Management Plan. RPN is useful for internal prioritization but cannot by itself justify a finding of acceptable risk. |
| ISO 13485:2016 | §7.1 risk-based approach, §7.3.3 design inputs | FMEA findings feed design inputs (§7.3.3). Risk control measures link directly to requirements, giving auditors the chain from hazard to design output to verification test. |
| IEC 62304:2006+A1 | §7 Software risk management | Software-specific failure modes (race conditions, buffer overflows, state machine errors) are analyzed alongside hardware. Software safety class (A/B/C) drives which failure modes require analysis. Class C requires analysis of all failure modes. |
| AS9100 Rev D | §6.1 Actions to address risks and opportunities, §8.3.5 design verification | AS9100 does not mandate FMEA by name, but it is the most common method used to satisfy §6.1 for product-level risk analysis. Failure modes link to verification activities in the test plan. |
| ISO 26262:2018 | Part 5 §7 hardware FMEA, Part 11 method description | ASIL C and D components typically require systematic hardware FMEA. Note: ISO 26262 (2018) and the AIAG-VDA FMEA methodology have moved away from RPN in favor of Action Priority (AP): High, Medium, or Low — based on Severity, Occurrence, and Detection bands rather than a multiplied score. Note the ASIL assignment in the Notes column. For software, fault tree analysis is more common but FMEA is an accepted method. |
Using this alongside the RTM template
The FMEA template is designed to work alongside the RTMify Requirements Tracking Template. The connection runs through two cross-reference columns and a shared scoring scale.
References requirement IDs (REQ-001, REQ-002…) from the RTM Requirements tab. Every risk control measure in the FMEA should trace to a requirement that can be verified in the test plan.
References risk IDs (RSK-101, RSK-102…) from the RTM Risks tab. Creates bidirectional traceability between the detailed per-failure-mode FMEA analysis and the summary risk register.
Severity and Occurrence use the same 1–5 scales as the RTM Risks tab. Risk assessments made in either document are directly comparable without translation.
Working with top-level hazards alongside failure modes? The Hazard Log template uses the same Severity and Occurrence scales and shares the Linked FMEA ID column to connect per-failure-mode analysis back to top-level hazards.
Download the FMEA template
Free FMEA template for ISO 14971, ISO 13485, IEC 62304, AS9100, and ISO 26262. Works in Excel and Google Sheets.