GHTF.SG3.N15-R8ImplementationofRiskManagement.pptVIP

September 11, 2001 GHTF.SG3.N15-R8: Implementation of Risk Management Principles and Activities Within a Quality Management System Presented by Carolyn Albertson Gunter Frey Member, SG3 NEMA Medical device manufacturers are generally required to have a quality management system as well as processes for addressing device related risks. These processes have become stand alone management systems. While manufacturers may choose to maintain these two management systems separately, it may be advantageous to integrate them as it could reduce costs, eliminate redundancies, and lead to a more effective management system. This document is intended to assist medical device manufacturers with the integration of a risk management system or the risk management principles and activities into their existing quality management system by providing practical explanations and examples The document is based on general principles of a quality management system and general principles of a risk management system and not on any particular standard or regulatory requirement. An effective quality management system is essential for ensuring the safety and performance of medical devices. It includes safety considerations in specific areas. Given the importance of safety, it is useful to identify some key activities that specifically address safety issues and ensure appropriate input and feedback from these activities into the quality management system. The degree to which safety considerations are addressed should be commensurate with the degree of the risk, the nature of the device and the benefit to the patient. Some devices present relatively low risk or have well-understood risks with established methods of risk control. In general, risk management is characterized by four phases of activities: Determination of acceptable levels of risk Risk analysis Determination of risk reduction measures Risk control and monitoring activities Determination of acceptable levels of risk: R