Track: Quality Engineering, Control and Management

Abstract

In this paper, the measurement system of a pharmaceutical company is evaluated by Gauge Repeatability and Reproducibility study. The objectives are to identify inadequacies of the measurement system and provide guidelines for performance improvement. Measurement variability is evaluated by two components which are the variability due to the operators (reproducibility) and the variability due to the gauge itself (repeatability). In this study, designed experiments are used to isolate and estimate the components of variability in the measurement system. The data are analyzed by Analysis of Variance and gauge capability is evaluated by precision-to-tolerance ratio and the percent contribution of variance components to the total variability. The results are interpreted and suggestions are made to improve the performance of the measurement system.