The Metrics of Process Monitoring & Understanding the Risks of Variation

The truth of product quality is hidden in the data. Statistical methods provide objective evidence in meeting goals of compliance and performance. This course provides guidance to identify and use statistical process monitoring methods to validate, calibrate, maintain, and troubleshoot. The course will convey the appropriate use of statistical methods at a level and in a way that will be easily understood. Hands-on experience using a syringe filler will generate data to measure, quantify, and compare sources of variation. Common methods such as comparing sample summary parameters, confidence intervals vs tolerance intervals, and control charts will be described, typical applications will be identified and pros and cons of each method will be examined. Examples of each method will be described to show how they can be used in a real-world setting. This course will utilize PDA Technical Report No. 59, Utilization of Statistical Methods for Production Monitoring as a resource.