Control Chart Package

Current version: Technical Preview for version 1 (build 37), Release date: August 16, 2021

Abstract

The Control Chart Package allows sophisticated statistical process control by plotting Shewhart I-Charts as recommended in the USP <1010>. It provides visualization options for intervals, subcharts and sidecharts, and allows you to define colors by a secondary characteristic. You can also define rules based on events and time frames.

To support you in setting up your control mechanisms, the Control Chart Package employs a set of concepts, such as rule sets, data series, subcharts and sidecharts. For details on each concept, please consult the Getting Started Guide.

Sample documents

To illustrate how you can use the Control Chart Package, we provide sample documents you can download when activating the Control Chart Package add-on in PLA 3.0. Additional information about each sample document is provided in the document's Comment section. The following images show two charts from our sample documents.

The first chart from the '03 Performing Statistical Process Control with Events' sample document visualizes events, including the detection of out-of-control data based on Nelson rule 1 (beyond 3*SD). The second chart from the '01 Coloring by Secondary Characteristic' sample document visualizes observation values plotted in the color according to the operator who performed the assay.