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.
