FMEA Failure Mode and Effects Analysis | ISO 31010 Risk Technique | growGRC | growGRC
GRC Hub / Article / FMEA: Failure Mode and Effects Analysis as a Risk Assessment Technique FMEA: Failure Mode and Effects Analysis as a Risk Assessment Technique FMEA is a structured risk assessment technique used to identify potential failure modes, analyze their effects, and prioritize preventive actions before failures occur.
Published: 7/30/2026 Updated: 7/30/2026 By growGRC Editorial Team
Executive Summary FMEA is a structured risk assessment technique that identifies potential failure modes, evaluates causes and effects, and prioritizes preventive actions.
Key Takeaways ✓ FMEA identifies failures before they happen. ✓ It is recognized as an ISO 31010 risk assessment technique. ✓ It evaluates severity, occurrence and detection. ✓ It improves reliability and operational resilience. Executive Summary FMEA (Failure Mode and Effects Analysis) is a structured risk assessment technique used to identify how a product, process, system or service can fail, determine the consequences of those failures, and define actions to reduce risk.
The technique is widely adopted in industries where reliability, safety and quality are critical, including:
Automotive. Aerospace. Manufacturing. Healthcare. Energy. Technology. Financial services. Within ISO 31010, FMEA is recognized as a risk assessment technique that supports systematic identification and evaluation of potential failures.
Element Description Full Name Failure Mode and Effects Analysis Spanish Name Análisis de Modos de Fallo y Efectos (AMFE) Technique Type Risk assessment
Frequently asked questions What does FMEA mean? FMEA means Failure Mode and Effects Analysis.
Is FMEA part of ISO 31010? Yes. ISO 31010 recognizes FMEA as a risk assessment technique.
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Main Purpose Identify and reduce failures
Related Standard ISO 31010
Main Industries Manufacturing, engineering, healthcare, technology
Organizations need to answer:
What can fail? Why could it fail? What would happen if it fails? How likely is the failure? How can the organization prevent it? FMEA converts these questions into a structured analysis process.
A failure mode represents a specific way in which a component, process or system can fail to perform its expected function.
Objective Benefit Identify potential failures Early prevention Reduce risks Higher reliability Improve processes Fewer errors Prioritize actions Better resource allocation Capture knowledge Organizational learning
Design FMEA (DFMEA) Evaluates risks related to product or system design.
An electronic component that may overheat.
Process FMEA (PFMEA) Evaluates operational process risks.
Assembly line manufacturing error.
System FMEA Evaluates interactions between system components.
Service FMEA Evaluates failures in delivered services.
1. Define Scope System. Process. Objectives. Participants. Evaluation criteria. From payment request to transaction confirmation.
2. Identify Functions Document expected functions.
Element Function Banking API Process transactions Database Store information User Confirm operation
3. Identify Failure Modes "How could this function fail?"
Function Failure Mode Process payment Transaction rejected Store data Incomplete information
4. Identify Causes Causes represent conditions that create failures.
Failure Cause Service unavailable Lack of redundancy Incorrect data Human error
5. Analyze Effects Effects describe consequences.
Failure Effect System outage Availability loss Calculation error Customer complaints
Traditional FMEA uses three criteria:
Severity (S) Measures impact of failure.
Occurrence (O) Measures likelihood or frequency.
Detection (D) Measures ability to detect failure before impact.
RPN = Severity × Occurrence × DetectionFactor Value Severity 8 Occurrence 5 Detection 4 RPN 160
Higher RPN values indicate higher priority for improvement actions.
System Enterprise software platform.
Function
Failure Mode Users cannot access the platform.
Cause Identity provider unavailable.
Effect
Action Implement redundant authentication services.
Recommended Avoid Use multidisciplinary teams Single-person analysis Review periodically One-time documentation Use operational data Only expert opinions Link findings to controls Analysis without actions
Using FMEA only as documentation FMEA should generate decisions and improvements.
Evaluating only technical failures Organizations should also analyze:
People. Processes. Suppliers. Technology.
Not updating after changes Changes can introduce new risks.
GRC Capability Application Risk Register Register identified risks Controls Library Associate preventive controls Issue Management Track corrective actions Audit Provide evidence KRIs Monitor early warning signals
Manufacturing An automotive manufacturer applies PFMEA to reduce production defects.
Lower rework. Improved quality. Fewer customer complaints.
Healthcare A hospital evaluates medication administration failures.
Improved patient safety. Stronger controls.
Technology A SaaS provider analyzes service availability failures.
Higher resilience. Better operational continuity.
[ ] Define system or process. [ ] Identify functions. [ ] Identify failure modes. [ ] Determine causes. [ ] Analyze effects. [ ] Evaluate priority. [ ] Define actions. [ ] Monitor results.
What does FMEA mean? FMEA means Failure Mode and Effects Analysis.
What is AMFE? AMFE is the Spanish translation of FMEA.
Is FMEA a risk management methodology? No. It is a specific risk assessment technique.
Is FMEA included in ISO 31010? Yes. ISO 31010 recognizes FMEA as a risk assessment technique.
What is the difference between FMEA and a risk matrix? FMEA analyzes specific failure scenarios, while risk matrices classify broader risks.
FMEA is one of the most widely used techniques for anticipating failures and improving reliability across systems, products and processes.
Its preventive approach helps organizations move from reactive incident management toward safer, more resilient and more efficient operations.
