FMEA (Failure Mode and Effect Analysis)

Posted on: March 28th, 2018  /  By:  /  Posted in: #QUALiTYViVA, CTQ, IATF, IATF16949, ISO, ISO 9001:2015, ISO/IEC 17025:2017, ISO45001, lean, QMS, Quality, Quality Circle, Safety, Safety , OHSAS OH&S, VOC  /  Comment: 0

FMEA is a tool to reduce the risk. This tool use in Six Sigma as part of Improve Phase. How to choose FMEA topic? Choose topic base on following:
  1. Critical to Quality(CTQ)
  2. Voice of Customer(VOC)
  3. Customer complaint
  4. Diversion
  5. Pareto diagram
  6. Risk analysis
Formula for RPN (Risk Priority Number): RPN = Severity X Occurrence X Detection Rule for RPN (Risk Priority Number):
  1. There is no such rule for RPN number.
  2. 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.
  1. If 120<RPN<250, Required to take actions on these to reduce the RPN to <120 and then review control plan for further improvement.
  2. If RPN>250, then problem to be solve through use of statistical analysis.
Reference of usefulness of FMEA Methodology:
  1. In Safety for Risk analysis.
  2. In IATF 16949:2016 e.g. clause : 4.4.1.2,7.2.3 , 7.5.3.2.2,8.3.2.1,8.3.5.1,8.5.1.1,9.1.1.1,9.2.2.3 , 10.2.3 , 10.2.4
For more details, refer to “A Review: Implementation of Failure Mode and Effect Analysis” in published paper section. Published Papers