Risk Analysis Program

The Changing Role of Risk Analysis Programs in Quality Management

In a regulated company, when a consumer is harmed as a result of a defective drug, device, or product, risk managers and quality managers immediately attempt to identify what led to the defect. Unfortunately, their parallel investigations often take them down separate paths with risk managers focused on financial loss or litigation and quality managers focused on improving the overall quality of their quality program. Today, as the shift to more proactive risk-based quality management continues, it is imperative for regulated manufacturers to ensure that their risk analysis program and quality management program are operating in sync.

MasterControl Risk