FMEA Analysis

What is FMEA Analysis?

FMEA analysis is a structured process for identifying potential failure modes, understanding their effects, prioritising risk and recommending actions to reduce or eliminate failure.

Traditional FMEA is often performed manually in spreadsheets. A model-based approach, such as MADE, uses a Digital Risk Twin to automatically generate and update FMEA outputs as the system design evolves.

Identifying failure modes

Identifying Failure Modes

Ways in which components, processes or functions could fail.

Analysing effects

Analysing Effects

Assessing the impact each failure could have on the system, mission or customer.

Determining causes

Determining Causes

Identifying root causes and prioritising risk using RPN or S-O-D rankings.

Mitigating failures

Mitigating Failures

Recommending design or process changes to eliminate or control risk.

The Structure of an FMEA/FMECA Analysis

The diagram and table below summarise the standard columns used in traditional FMEA and FMECA, along with typical sources for each type of data.

Model-based RAMS and Reliability Software FMEA Analysis
Column Name Description Typical Source Information
Item/FunctionThe system, subsystem, or component being analysed, along with its intended function.System design documents, block diagrams, P&IDs, functional specifications, or bill of materials.
Failure ModeThe specific way in which a function or component can fail.Historical failure data, SME input, standards and past FMEAs.
Failure CauseUnderlying reason for the failure mode.Root cause analysis, design reviews, field failure reports, engineering judgement.
Failure EffectThe consequence of the failure mode at the local, subsystem, or system level.Engineering analysis, system architecture documents and impact assessments.
SeverityNumerical ranking of how serious the effect of the failure is.Risk criteria, safety requirements, engineering judgement and customer impact analysis.
OccurrenceEstimation of how frequently the failure mode is likely to occur.Reliability data, failure rate databases, field data and expert input.
DetectionLikelihood of detecting the failure before it impacts the system or user.Diagnostics capabilities, testing procedures and quality control documentation.
RPNCalculated as Severity × Occurrence × Detection; used to rank risks.Calculated from assigned S, O and D values.
Criticality IndexUsed in FMECA to combine severity and probability, often incorporating mission impact.Derived from quantitative failure data and criticality formulas.
Recommended ActionProposed mitigation to eliminate or reduce the risk.Engineering countermeasures, design improvements, process changes or controls.
Responsibility & DeadlineIdentifies who is accountable for implementing the action and by when.Assigned during review meetings or project planning.
Action Taken / StatusDocuments whether actions have been implemented and the outcome.Follow-up records, status updates, engineering change documentation and verification results.

FMEA Standards and Guidelines

These standards and guidelines define how to systematically perform FMEA or FMECA, ensuring consistent risk assessment and mitigation across industries.

Standard / Guideline Scope / Use
AIAG & VDA FMEA HandbookAutomotive industry harmonised 7-step approach integrating risk prioritisation.
SAE J1739Automotive and general industry FMEA best practices.
IEC 60812International standard for FMEA application across sectors, including FMECA.
MIL-STD-1629AMilitary standard for FMECA, often used in aerospace and defence.
ARP5580SAE Aerospace guidelines for applying FMEA and FMECA in aerospace systems.
NPR 8705.5 & NASA-HDBK-0005NASA reliability and safety practices, including model-based FMECA guidance.
EN 60812European adoption of IEC 60812.
ISO 14971Medical device risk management where FMEA may be used as part of risk analysis.
IEC 61508 / ISO 26262Functional safety standards requiring structured hazard and risk analysis.

Types of FMEA Analysis

FMEA is a versatile methodology tailored to assess risk across different stages of a system’s lifecycle.

Design FMEA

Automotive, aerospace, electronics

Identifies failure modes related to product design, components, materials and interfaces.

Process FMEA

Manufacturing and quality

Assesses risks associated with manufacturing and assembly processes.

System FMEA

Aircraft, power plants, defence

Analyses failure modes across system interactions and subsystem dependencies.

Software FMEA

Embedded and autonomous systems

Evaluates failure risks in software behaviour, logic errors and communication faults.

Functional FMEA

MBSE and safety-driven design

Examines how functional failures impact overall system operation.

FMECA

Safety-critical sectors

Extends FMEA by adding quantitative criticality analysis.

Why FMEA Matters in Today’s Engineering Environments

As engineering systems grow more complex, traditional document-based risk assessments struggle to keep up. FMEA provides a rigorous framework for identifying hidden risks before they cause costly failures or compromise safety.

Traditional FMEA

  • Manual data entry introduces human error.
  • Limited integration with system models or live design data.
  • Static documents are difficult to update and maintain.
  • Weak traceability between design changes and risk assessments.

Model-Based FMEA

  • Embedded within a Digital Risk Twin.
  • Automatically synchronised with design changes.
  • Consistent data across RAMS, safety, maintainability and diagnostics.
  • Faster analysis, better traceability and stronger decision-making.

Why Model-Based FMEA is Better

A model-based approach transforms FMEA from a static exercise into a dynamic, integrated risk management tool.

Digital Risk Twin Integration

Connects functional behaviour, physical architecture and environmental conditions with failure logic.

Data Consistency and Reuse

Standardised taxonomies and centralised data models ensure consistency and reuse across projects.

Live Synchronisation with Design

Automatically synchronises FMEA data with system design changes, reducing redundant updates.

Better Decision-Making

Integrated simulations and automated risk assessments help engineers evaluate trade-offs earlier.

Model-based FMEA in MADE

Systems are getting more complex. Traditional FMEA processes cannot cope.

As systems grow in complexity and pressure increases to reduce lifecycle costs, model-based FMEA is becoming essential. Tools like MADE embed FMEA in a broader model-based RAMS ecosystem, supporting proactive analysis from concept through operation.

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