Abstract

[This abstract is based on the author's abstract.]Quality Risk Management (QRM) applies risk management practices to quality assurance by helping organization to better understand the manufacturing process, identify risks that could product quality and user safety, and focus organizational resources on managing those risks. A framework for QRM planning developed by the pharmaceutical industry is applicable to any manufacturing process. The methodology described here uses templates and step-by-step procedures to simplify application of the framework in any manufacturing situation.