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FMEA Methodology Overview

The FMEA process in TestAuto2 follows the AIAG-VDA 7-step methodology, with workflow views that adapt as you progress through analysis stages: diagram
TestAuto2 supports three FMEA types: System FMEA (SFMEA) analyzes failures of system functions/subsystems, Design FMEA (DFMEA) focuses on component failures and design causes, and Process FMEA (PFMEA) identifies manufacturing and assembly risks. Start with System FMEA, then decompose to Design and Process FMEAs as needed per your product complexity.

Workflow Structure

GuidePurposeStart With
Create System FMEA DocumentSet up SFMEA module and initialize risksheetNew FMEA analysis
Create Design FMEA DocumentCreate component-level FMEA linked to SFMEADesign decomposition
Create Process FMEA DocumentBuild manufacturing FMEA from process stepsManufacturing planning
Define Failure ModesIdentify potential failures, effects, and causesBrainstorming session
Assess Severity, Occurrence, DetectionRate pre-mitigation risk parametersInitial risk evaluation
Calculate Action PriorityCompute RPN and H/M/L priority classificationRisk ranking
Link to Risk ControlsConnect failure modes to design/process controlsMitigation strategy
Track Post-Mitigation RatingsAssess control effectiveness and residual riskControl verification
Link to Upstream SFMEAEstablish bidirectional DFMEA ↔ SFMEA traceabilityDesign refinement
Use Progressive Workflow ViewsNavigate risksheet views that adapt per analysis stageDaily work
Generate FMEA ReportsProduce compliance reports and risk summariesEvidence generation
FMEA in TestAuto2 must align with ISO 26262 Part 4 (System Design) and Part 6 (Software) requirements. Ensure all high-ASIL failure modes (from HAZID analysis) are included in FMEA scope, and that design controls are traced back to safety goals. Use the FMEA Coverage Report to verify completeness.

Key Concepts

  • Failure Mode: A potential manner in which a system element could fail (e.g., “throttle actuator commands 100% opening when idle”).
  • Severity (S): Rating (1-10) of potential harm if the failure occurs while operating.
  • Occurrence (O): Rating (0-10) of probability the failure will occur during product life.
  • Detection (D): Rating (0-10) of likelihood the control system will detect the failure before harm.
  • Action Priority (AP): High (H), Medium (M), or Low (L) — derived from RPN and Severity, determines mitigation urgency.
  • Risk Control: A design or process change that reduces Severity or Occurrence (e.g., “add redundant sensor”).
  • Post-Mitigation Ratings: Updated S/O/D after control implementation, showing residual risk.

Common Tasks

See also: HARA Workflow — complementary hazard analysis for ISO 26262; Risk Control Types — design vs. process controls; Traceability Management — linking failures to requirements and test cases.