Statistical Concepts in Laboratory Quality Control
Quality control ensures that the performance of a test is within the limits set by validation experiments as well as the requirements of the lab and regulatory bodies. The goal of quality control is to minimize variability and maximize accuracy and precision; this requires measurements of quality metrics and interpretation and analysis of these quality metrics by statistical methods.
Quality control requires frequent monitoring of quality metrics and application of statistical tools to identify possible performance problems. These quality metrics measure variability and error through either internal or external quality control experiments. The statistical tests identify whether the observed variability is random as well as identifying error in excess of the lab’s acceptability criteria.
In this chapter, we will review the statistical concepts that are used in laboratory quality management.
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