![]() ![]() ![]() Risk level can determine the extent of CAPA investigations, validations effort, etc.Īpplication of ISO 14971 principles to software risk management will be explained We will explain how to integrate Human Factors studies into the Hazard Analysis and how to integrate Hazard Analysis into the design program. How to deal with residual risk will be discussed. Examples of hazards and hazardous situations will be discussed. We will go step by step through a template for risk analysis so that the process is clear. The confusing terms "hazard", hazardous situation", "harm", "causative event", "ALARP", "risk index", "benefit/ risk ratio", and "residual risk" will be explained. In this webinar we will explain in detail the process of conducting a hazard analysis. FMEA and FTA consider only fault conditions and are more suited as reliability tools than as product safety tools. This is the most powerful of the risk management techniques because it considers risks in normal operation as well as fault conditions. Hazard Analysis is described in ISO 14971. FDA also expects that a post production risk management program be implemented.įDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard. ![]() The US FDA expects that as part of a product development Design Control Program risk management will be conducted.
0 Comments
Leave a Reply. |