Use of Change-Point Analysis for Process Monitoring and Control

Change-point analysis is an effective and powerful statistical tool for determining if and when a change in a data set has occurred. The tool provides a confidence level that indicates the likelihood of the change. Change-point analysis can be used in three distinct applications: 1) determining if improvements or process changes may have led to a shift in an output, 2) problem solving, and 3) trend analysis. This paper describes how the tool can be used in the pharmaceutical industry for the three applications. Two case studies are presented to show how change-point analysis was used to verify the potential effect of process changes.