Introduction

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 many cases, the ability to discern the overall impact of events is a subjective determination, often relying on the individuals assigned to make the decision of whether the event is critical to the business or not. Being subjective can result in major errors and affect the overall compliance within an organization, and possibly lead to increased legal liability. Given the increasing scrutiny of regulatory bodies leads to an ever-growing list of reported events, the likelihood of a severe non-compliance is greater than ever. How can organizations effectively measure events from an objective standpoint to assess the overall impact? The answer is Risk Assessment and Risk Mitigation.

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 reoccurrence of these events.

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