QRM Not the Same as Root Cause Analysis
This article was originally published in The Gold Sheet
Executive Summary
William Miele of Pfizer Global Manufacturing discussed the differences between quality risk management as espoused under the ICH Q9 guideline and root cause analysis at the 11 APIC/CEFIC European conference on APIs Oct. 23 in Paris. He said that "root cause analysis is retrospective, examining what has already occurred to determine what happened, why it happened and how it can be prevented from happening again. Risk management looks at the dataset and what are the potential future consequences and identifies potential risks and analyzes potentials risks; these actions are all focused on making decisions related to potential future events." He also noted that QRM "is a tool to complement existing works processes" and that "the primary outputs of QRM are decisions to identify the actions needed to controls risk.