![]() ![]() In the sections below, we will look into each of the three basic terms - hazard, hazardous situation and harm - in more detail. ![]() The result is a disastrous fatal crash with no survivors. The hazardous situation in this case, as shown in the bottom right of the graphic above, is the failure to achieve altitude after take off due to these events. This sequence of events is shown in the top right of the graphic above. When the pilots tried to counter by trying to manually get the plane to nose-up, the MCAS continued to issue the nose-down commands. The trigger event was faulty sensor data from the Angle of Attack (AOA) sensor which caused the MCAS to activate in an effort to stabilize the plane by lowering the nose. In both of these crashes, a sequence of events unfolded due to the interaction between pilot actions and a software control called the Maneuvering Characteristics Augmentation System (MCAS). Last year, we were reminded of the risk by two nearly back-to-back fatal crashes of the Boeing 737 Max 8 aircraft that led to a combined 346 fatalities and the worldwide grounding of the entire fleet. Yet, despite a strong track record of safety, commercial aviation is a hazardous activity. Certification on successful completion of course.Flying is a routine activity and there are thousands of commercial flights every day. Learn about the overall process of risk management, the tools and techniques used and how to develop a safe medical device according to regulatory requirements. ![]() Take a look at our online course: Introduction to Risk Management for Medical Devices and ISO 14971. Need risk management training and a course certificate? They should be removed and the example text customised to work with your current project. Texts that most certainly should be replaced or updated are identified by the characters. All texts that are not blue are example texts that can and should be edited by you. Instructions and explanations should be removed before use of the document. In this template, instructions and/or explanations are included using blue italic texts such as these. ![]() Note that the plan shall be maintained that is, it should reflect what you are doing and not the other way around. If you are making a revision of an old product or adding a product to a range that this plan applies to, the plan might only have to be updated slightly. If you are developing a brand-new product, establish as much as possible of this plan in the planning phase of your project. The plan provides the roadmap for risk management, encourages objectivity and helps prevent essential elements from being forgotten. A risk management plan is required by ISO 14971:2019 and if enables the effective risk management. ![]()
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