Automotive
FMEA: Failure Mode and Effects Analysis (AIAG and VDA FMEA Handbook)
A structured way to anticipate what can go wrong, how serious it would be, and what prevents and detects it.
01Purpose
FMEA is a team based analytical method to identify potential failure modes of a design or process, evaluate their risk and define actions to reduce it. The AIAG and VDA FMEA Handbook harmonised North American and German approaches.
02Scope
Used for design FMEA (DFMEA), process FMEA (PFMEA) and FMEA for monitoring and system response (FMEA-MSR).
03Main requirements
- Seven steps: planning and preparation, structure analysis, function analysis, failure analysis, risk analysis, optimisation and results documentation
- Severity, occurrence and detection rated on 1 to 10 scales
- Action priority (high, medium, low) replaces the traditional risk priority number (RPN) in the harmonised handbook
- Link to control plan and special characteristics
04Typical applications and industries
Mandatory in automotive and useful in any industry where failure consequences are significant. Try the RPN calculator and the root cause guide.
05Audit and inspection considerations
- Does the PFMEA follow the actual process flow?
- Are prevention and detection controls realistic?
- Are actions completed and ratings updated?
06Common nonconformities
- FMEA copied from another product
- Occurrence ratings not based on data
- Detection rated low for visual inspection only
- Not updated after complaints
07How QUALITAS TR can support
We review FMEAs during process audits and help suppliers build them during supplier development.