Revised Schedule M: Quality Risk Management (QRM)

“Quality Risk Management (QRM) is a proactive process that identifies, assesses, and mitigates potential risks to ensure pharmaceutical quality, patient safety, and regulatory compliance. Effective QRM strategies leverage risk assessment tools, failure mode and effects analysis (FMEA), and risk-based thinking to minimize errors, optimize processes, and enhance product quality. By integrating QRM into your quality management system, you can reduce risk, improve compliance, and drive business success in the pharmaceutical and medical device industries.”