Six Sigma provides data-driven techniques that can enhance and improve the EP23 risk management approach for formulating quality control (QC) Plans. Risk analysis has significant drawbacks in its ability to identify and appropriately prioritize hazards and failure modes for mitigation of risks. Six Sigma quality management is inherently risk oriented on the basis of the required tolerance limits that define defective products. Six Sigma QC tools provide a quantitative assessment of method performance and an objective selection/design of statistical QC procedures. Furthermore, the observed sigma performance of a method is useful for prioritizing the need for development of QC plans.