ASQ - Audit Division

How to Apply Risk to your Quality Management System: Defining and Building a Risk Management Strategy for Quality and Compliance Management Systems

Abstract: This session will explore the strategy behind risk in compliance; define the various ways and terms associated with risk; and discuss how business processes are incorporating risk throughout the enterprise, driving a proactive approach to continuous improvement. We will specifically address how risk is shaping compliance within industries today, and illustrate where risk can be applied to ensure the highest level of quality and compliance, including: • Risk in Design: We will explore the concept of incorporating risk-based methods into the design phase of the product lifecycle. Through the use of risk-based tools (FMEA, Hazard Analysis, etc.) organizations can identify potential risks early in design, reduce the number of in-field failures, and take a proactive approach to risk mitigation. • Risk in Process: We will examine the benefits of incorporating risk into the many post-market processes that affect quality and compliance. Most significantly, we will look at how risk assessment uses tools such as a risk matrix to determine which events are most critical to an organization. Risk assessment can then effectively filter critical events in a quality system, shifting the focus to those events that pose the greatest risk to the organization. • Enterprise Risk Management: Finally, we will discuss how risk methodologies and risk-based tools apply to the enterprise as a whole. Enterprise Risk Management utilizes risk at all levels of the organization (financial, HR, GRC, operations, etc.), but the tools and the process of identifying and mitigating risk remain similar. We will look into the common practices of enterprise risk management and how to effectively mitigate risk on an enterprise level.

Keywords: QMS - Risk - Risk Management

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