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Types of FMEA
- Design FMEA: looks at a product or component in development, for example whether a seal can fail at temperature.
- Process FMEA: looks at manufacturing or assembly steps, for example whether a screw can be tightened with the wrong torque.
- FMEA-MSR: extends the design FMEA with monitoring and system response in operation, for example in vehicle electronics.
Seven steps according to AIAG-VDA
- 1
Planning and preparation
Define scope, team and schedule.
- 2
Structure analysis
Break down the system, components or process steps.
- 3
Function analysis
Describe the functions and requirements of each element.
- 4
Failure analysis
Link failure effects, failure modes and failure causes.
- 5
Risk analysis
Rate severity, occurrence and detection and determine the action priority.
- 6
Optimisation
Define, implement and re-rate actions.
- 7
Results documentation
Record and communicate the results.
In 2019 the joint AIAG and VDA handbook replaced the risk priority number (RPN) with the action priority (AP). It gives severity more weight and avoids overlooking very severe failures with rare causes because of a low product number.
Common mistakes
- The FMEA is created once for production launch and not maintained afterwards.
- Lessons from complaints do not flow back into the FMEA.
- A single person fills it in instead of a cross-functional team.
When an FMEA pays off
An FMEA takes time because several specialists work together. It pays off mainly for new products, new manufacturing processes, safety-relevant characteristics and after serious complaints. For simple, proven processes a lean risk review is often enough.
FMEA and docxpert
docxpert has no FMEA module of its own. You control FMEA files from specialist tools as documents with version and approval. The product development template covering APQP, PPAP, FMEA and the control plan describes the approach. Lessons from complaints are tracked in CAPA management, where you record “update FMEA” as an action.
Frequently asked questions
Is FMEA mandatory under ISO 9001?
No. ISO 9001 requires [risk-based thinking](content:term-risk-based-thinking) but no particular method. IATF 16949 requires FMEA for automotive suppliers.
What is action priority?
A high, medium or low rating derived from severity, occurrence and detection. Since the 2019 AIAG-VDA handbook it replaces the RPN.
Who should take part in an FMEA?
A cross-functional team from design, production, quality and, where relevant, purchasing and service.
When is an FMEA updated?
With product or process changes, after complaints and failures, and regularly as part of product maintenance.