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  • ih37 replied to the topic Mange Project Risks in the forum Project Management Process and Medical Device Development 6 years, 2 months ago

    As learned in lecture, stakeholders can be a wide variety of individuals ranging from patients to the financial investors that support the project. This goes to state that risk can come in many forms and can actually become more prominent as a project progresses. One method to identify risk is to generate a risk matrix, which associates a risk’s likelihood of occurrence with the severity should it occur. The resulting product will decide if a project factor has low, medium, or high risk, which in turn should determine how the risk will be handled. Another technique for assessing risk is through FMECA (failure mode effects and criticality analysis), which asks “how” something can fail, along with its probability of occurring and its severity. The risks determined using FMECA can even possibly be used to generate the risk matrix.

    Risk management is initiated during the planning phase and is carried out for the remainder of a project (ideally). Once the potential risks are measured, they can be handled through a means of avoidance, mitigation, transferance, or acceptance. What is the difference between transferance and acceptance? How might these methods be applied to a hip stem that demonstrates a risk of cytotoxicity a few months post-implantation? How might an early detection of risks affect a project’s life cycle? Who is ultimately responsible for deciding how risks will be handled?