Quality control protocol design sample

While methods validation and accuracy testing considerations presented here have been frequently discussed in the literature, they have been included here to emphasize their importance in the design of a total quality control protocol. The Youden two sample quality control scheme has been adapted for continuous analytical performance surveillance. Methods for graphical display of systematic and random error patterns have been presented with simulated performance data. Daily examination of the T, D, and Q quality control plots may be used to assess analytical performance. Once identified, patterns in the quality control plots can be used to assist in the diagnosis of a problem. Patterns of behavior in the systematic error contribution are more frequent and easy to diagnose. However, pattern complications in both error domains are observed and simultaneous events in both T and D plots can help to isolate the problems. Point-by-point comparisons of T and D plots should be made daily (immediately after the data are generated). Early detection of abnormal behavior reduces the possibility that large numbers of samples will require reanalysis. 

While protocol design in terms of collection of a quality data set (numbers of animals, use of radiolabel, analytical concerns) does not inherendy differ from other species, the way the fish are acquired, acclimated, housed, exposed and sampled can influence the variability and data quality. In general, more experimental control is required for studies with fish. This may be a confounding concern as inherent difficulties may exist in obtaining healthy, genetically pure, easily sexed and experimentally acceptable animals. 

Before a suite of samples can be analyzed, a set of protocols, similar in design to other U.S. EPA ICP-MS analytical procedures such as Method 200.8, must be followed to ensure the instrument is working at its optimum performance. A summary of these protocols is shown in Table 20.2. The analytical run sequence outlined should be performed on a daily basis in order to meet all quality control requirements. (Note The samples shown in the top portion [sequence 1-19] must be run once per sequence, while the 10 samples [sequence 20-22] and the final continuing calibration verification [CCV] and continuing calibration blank [CCB] samples must be repeated.)... 

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