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  • aaq2 replied to the topic Manage Risk in the forum Risk Analysis for Medical Devices 7 years, 4 months ago

    For low severity I would rely on accepting the risk. Accepting the risk occurs when the price to pay for managing a type of risk is accepted due to the risk involved not adequate enough to warrant the added cost it will take to avoid that risk. This would be a good strategy to implement if it involves a very small risk.

    Risk control involves avoiding the risk entirely or mitigation the risk. I prefer mitigation for high severity. This is achieved by lowering the probability of magnitude loss. Most of the time many risks cannot be avoided but most of the risks may be mitigated through the use of control. Even though mitigated risks may be minimized by control they can still be expensive.
    Avoidance can be a safe bet as many manufactures can avoid manufacturing particular products to avoid legal risks.

    Risk acceptance does not reduce any effects but can be used as a strategy. This is a wise option when the cost of risk management outweighs the cost of the risk itself.