Risk Evaluation is the "process of comparing the estimated risk against given risk criteria to determine the acceptability of the risk." (ISO 14971).  Can you judge acceptability of risk with sigma?

Sigma = #SD from current mean to TEa limit. 

  • Margin for Error is the #SD shift to unacceptable risk. 

Sigma of zero = 50% of results fail TEa limit.

  • ME of zero = the more than the approved acceptable risk level fail TEa limit.

Margin for Error varies with acceptable risk level

Mini-Videos (may be from different dates)

  1. Margin For Error vs Sigma (1 Minute)
  2. Sigma Polls - what is acceptable? (2.5 Minutes)
  3. Sigma Shift - DIMS? (12.5 Minutes)
  4. References x7