Wednesday, May 30, 2012

Process Capability Indices in Medical Device Manufacturing

is being presented by Dan O’Leary, President, of Ombu Enterprises, LLC, and airs on Thursday, June 7th, 2012.  For more details, or to register please visit our site at www.fxconferences.com

Process capability analysis examines the inherent variability in a process, including the statistical distribution of the process output. When the measurement uses variables, data process variability is the “spread” of a process in statistical control. When the measurement involves attributes, process capability is often the proportion of nonconforming units. Often, process capability uses an index that relates process variability and process specifications.

This audio conference explains the underlying statistics of the most commonly used capability indices. In particular, the presentation shows how to use data from x-bar and R charts to calculate these process capability indices. With an understanding of process capability indices, the speaker then examines applications for medical devices. This immediately brings in the FDA QSR requirement to identify valid statistical techniques to control process capability and product characteristics. The audio conference illustrates applications of process capability indices in both FDA QSR and ISO 13485 systems using both examples and FDA Warning Letters to illustrate the issues.