I agree that Risk Management should be considered a living document to help a company document and keep track of their product post production. There are some issues that a product can experience after production their complaints can help a company create a better version of the said product. This piece of information can also help the FDA identify any common issues that other similar devices may have after gathering this data. Risk management help determine the hazards that the product may experience, this is where Risk Management is different from QA and QC, those two departments ensures that the device meets the need of the customer, performs validation and verification to ensure the device meets the gold standard, but does not take into consideration the hazards and how to plan against them.