What is FMEA?
FMEA stands for Failure Mode and Effects Analysis — a structured analysis method used to identify possible failure modes of a product, process or system, assess their consequences, and prioritise the resulting risks.
FMEA helps you to proactively prevent failures before they occur.
It is widely used in industries such as automotive, manufacturing, pharmaceuticals, medical technology, aerospace and energy.
🎯 What is the purpose of FMEA?
- Identify possible failure modes
- Analyse the effects and causes of those failures
- Assess risks based on severity, frequency and detectability
- Prioritise improvement measures
- Prevent quality issues, downtime, incidents or recalls
🧱 How does FMEA work?
For each component, process step or system element, you answer three core questions:
- What can go wrong? (Failure Mode)
- What happens if it does? (Effect)
- Why does it happen? (Cause)
You then assess each risk using three scores:
| Score type | Description |
|---|---|
| Severity (S) | How serious is the effect of the failure? |
| Occurrence (O) | How often does this cause occur? |
| Detection (D) | How likely are you to detect it in time? |
From these you calculate the RPN (Risk Priority Number):
RPN = Severity × Occurrence × Detection
The higher the RPN, the higher the priority for action.
🧠 Example table
| Failure Mode | Effect | Cause | S | O | D | RPN |
|---|---|---|---|---|---|---|
| Valve sticks open | Overpressure in tank | Broken spring | 9 | 5 | 3 | 135 |
| Sensor fails | Incorrect reading | Moisture in connector | 6 | 4 | 4 | 96 |
After analysis, you implement mitigating actions, such as preventive maintenance, redesign or monitoring.
🔗 Types of FMEA
| Type | Application |
|---|---|
| Design FMEA (DFMEA) | For products and designs |
| Process FMEA (PFMEA) | For production processes and operations |
| System FMEA | For complex installations and systems |
| FMEA-MSR | For monitoring & system response (e.g. in automotive software) |
✅ Benefits of FMEA
- Prevents failures before they occur
- Promotes risk-aware design and process setup
- Measurable and structured risk management
- Supports compliance with standards such as ISO 9001, IATF 16949, IEC 61508
- Documentable and repeatable for audits and reviews
📌 In summary
FMEA is a methodical approach to identifying and managing risks in design or process by analysing failure modes, their causes and consequences.
It helps teams to take preventive measures that improve reliability and safety.