Managing your Risk Has its Rewards: Making the Case for Risk Assessment in Streamlining your Quality and Compliance Processes

In today's Quality Management systems, the ability to control and correct processes is key to maintaining a high level of compliance within an organization. Whether it is tracking incoming customer complaints, identifying nonconforming materials from production, or using corrective and preventive actions (CAPA) to correct events within the system, having defined quality management processes in place can improve quality, reduce legal liability and make compliance a competitive advantage.

In this paper, we will examine a real-world example of how using a risk assessment model in a quality management system can identify critical events, mitigate the risk, and prevent re-occurrence of these events.