Prozanta Template
FMEA risk analysis
Failure Mode and Effects Analysis — proactive risk management
Process / Product:
Team:
Date / Rev:
How to use this template — RPN = S × O × D
FMEA (Failure Mode and Effects Analysis) is a structured method for identifying potential failures, assessing their risk and taking preventive action before the failure occurs. Each failure mode is scored on three factors whose product gives the RPN (Risk Priority Number).
S — Severity
- 10 = safety hazard or legal requirement
- 9 = product unusable
- 7-8 = significant loss of function
- 4-6 = partial loss
- 1-3 = cosmetic or no effect
Scale: 1–10
O — Occurrence
- 10 = happens almost always (>1 per 10 units)
- 7-9 = frequent
- 4-6 = occasional
- 2-3 = rare
- 1 = extremely unlikely (<1 per 1,000,000)
Scale: 1–10
D — Detectability
- 10 = no control / cannot be detected
- 7-9 = unlikely to be caught before delivery
- 4-6 = can be detected
- 2-3 = likely to be detected
- 1 = always caught before the customer
Scale: 1–10
RPN > 200
STOP — act now, before production starts
RPN 100–200
High priority — act within 30 days
RPN 50–100
Medium — consider actions
RPN < 50
Low — acceptable risk, monitor
Watch out
- RPN is a prioritisation number, not an absolute risk score — two failures with the same RPN can have very different profiles (e.g. S=10, O=1, D=1 vs. S=3, O=3, D=3).
- High S (severity) must always be acted on, regardless of RPN — a rare but catastrophic failure is not accepted.
- An FMEA that is never updated loses its value — review it on process changes and after serious deviations.
Example
Failure mode: wrong torque on a screw. Effect: product comes loose (S=8). Cause: operator uses the wrong wrench (O=4). Control: no visible control (D=7). RPN = 8×4×7 = 224 — STOP. Action: introduce a click torque wrench and mark the correct wrench with colour.
Method: AIAG FMEA-4 standard; used in IATF 16949, ISO 9001 and general risk management.
FMEA analysis
| Process step / Function | Failure mode | Effect of failure | S | Cause of failure | O | Current control | D | RPN S×O×D | Recommended action | Owner / Due |
|---|---|---|---|---|---|---|---|---|---|---|
Action follow-up — top RPN priorities
| Failure mode (from analysis) | Current RPN | Action implemented | New RPN | Owner | Closed? |
|---|---|---|---|---|---|
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FMEA risk analysis
Next review: _________ · Rev: _____