FMEA (Failure Mode and Effect Analysis)
FMEA is a tool to reduce the risk.
This tool use in Six Sigma as part of Improve
How to choose FMEA topic?
Choose topic base on following:
Formula for RPN (Risk Priority Number):
RPN = Severity X Occurrence X Detection
Rule for RPN (Risk Priority Number):
- Critical to Quality(CTQ)
- Voice of Customer(VOC)
- Customer complaint
- Pareto diagram
- Risk analysis
- There is no such rule for RPN number.
- No criteria, what is max or min RPN number.
Base on Max RPN number i.e. 10X10X10 = 1000 (a big number)
Below is proposed as a thumb rule:
If RPN<120, No special focus/ action required to be taken i.e. current controls are sufficient.
Reference of usefulness of FMEA Methodology:
- If 120<RPN<250, Required to take actions on these to reduce the RPN to <120 and then review control plan for further improvement.
- If RPN>250, then problem to be solve through use of statistical analysis.
- In Safety for Risk analysis.
- In IATF 16949:2016 e.g. clause : 220.127.116.11,7.2.3 , 18.104.22.168.2,22.214.171.124,126.96.36.199,188.8.131.52,184.108.40.206,220.127.116.11 , 10.2.3 , 10.2.4
For more details, refer to “A Review: Implementation of Failure Mode and Effect Analysis” in published paper section.