Understanding Quality Risk Management
Risk management is a widely practiced approach across various business sectors, aimed at reducing and mitigating the potential and actual impacts of unpredictable events, as well as capitalizing on opportunities. Quality Risk Management (QRM), on the other hand, is a structured approach aimed at identifying and managing quality-related risks in the pharmaceutical industry, where product quality directly impacts consumer health and safety, through thorough evaluation and assessment. With QRM, pharmaceutical companies can identify potential quality issues that might harm consumers before they occur, assess a product's overall impact on patient health, and implement strategies to mitigate these risks. This makes Quality Risk Management a key approach not only for achieving regulatory compliance but also for establishing and embedding a proactive approach to risk management within a pharmaceutical organization's culture.