Six Sigma DMAIC Process - Improve Phase - Failure Mode Effect Analysis (FMEA)

FMEA identifies all the probable failure modes for the product or process. It prioritizes the failure modes for focused attention by using a scoring model based on Severity (S), Occurrence (O) and Detect ability (D).

RPN = S*O*D

Based on the above suitable action plans can be created to contain the risk. It is used as a living document and could be a good foundation for building robustness.

Definition of Terms:
  • Failure Mode – The way in which a specific process input fails
  • Effect – The impact the failure has on the Critical Quality Parameter
  • Cause – The source of variation that caused the process to fail
  • Current controls – Systemized devices in place to prevent or detect the failure
  • Severity – Importance of an effect on critical quality parameter (1-Not severe; 10 – very severe)
  • Occurrence – Frequency with which a cause occurs (1-Not likely; 10-Very likely)
  • Detection – Ability of current control to detect the cause before creating a failure mode (1-likely to detect; 10-not likely to detect)
  • RPN is an acronym for Risk Priority Number. It is calculated by multiplying the Severity, Occurrence and Detectability.

Failure Mode Effect Analysis (FMEA) - 1



Failure Mode Effect Analysis (FMEA) - 2




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