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!' t 1 r, w <br />nevi s C,n too, <br />Date: <br />F6 of - <br />10.3 Out -of -Control Situation Response Procedures <br />An out-cf-control situation may t,e i-•®icated by the fol iC,W <br />evert s: - <br />a value outside the control 14mi ts. <br />a series of sever, :uccedsive vc-,ts on the same <br />.i Ce O' the Cen,ra7 l re >`n - -artez <br />series of five successive rcints going in the same <br />direction. <br />-e cyclical reprezentation of ccr.rol values. <br />When an out -of -control situation is retected, efforts are <br />ir.it1--ted tc. determine the cause. Corrective actions are taken to <br />bring the process under control. Cut -or -control situations ani <br />corrective actions taken are fully cocur-ented in the QC iocboow <br />Gate ottained since the last in -control wC is considered invalid <br />and wi11 not be used in subsecuent analyses. Analyses art not <br />continued until the process is aetermined to be under control. <br />in order to demonstrate that the process is again in control, the <br />following conditions must be met: <br />Precision.: a minirr:um of two successive control samples must lie <br />within control bounds. <br />Accuracy: a minimum of three control samples at different <br />concentrations (DL, 5DL, and 10 DL) will be analyzed, and the <br />resultant slope of the regression line must _fa11 within the ?S <br />control limits. The correlation coefficient must be -greater than <br />or equal to the correlation coefficient obtained during <br />certification. (DL` Detection Limit) <br />