Abstract
The concept of process capability has been used by the manufacturing industry to quantify the relation between product specifications and the measured process performance (1). Various ratios and indices have been developed to describe this relation. We have previously reported the application of the simplest of these, Cp (the capability index or capability ratio), to the selection of quality-control (QC) algorithms appropriate to the specification limits and analytical imprecision (2). Cp is defined as (USL − LSL)/6σ, where USL and LSL are the upper and lower specification limits of an analytical process, and σ is the standard deviation of the process. In contrast to the approach taken by us, the use of medically important critical systematic error (ΔSEC) and critical random error (ΔRE …
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