Quality risk management (QRM) has become a crucial tool for ensuring regulatory compliance worldwide. It plays a central role in ISO management system standards and regulations, as well as the EU Medical Device Regulation (MDR/IVDR), FDA 21 CFR 820, and ICH Q10 in the pharmaceutical and biotech industries.

However, many organizations fail to fully close the loop on risk management, leaving risks unmitigated and opening the door to customer complaints and rising costs. This article outlines four essential steps to establish a robust, closed-loop quality risk management process within an enterprise quality management system (EQMS).

Step 1: Identifying quality risks

The first step in quality risk management is identifying risks or potential safety hazards. Capturing risk data in a centralized system is essential for prioritization and effective mitigation, rather than addressing risks on an ad-hoc basis.

 …