I was wondering if someone can help me and explain how to document change happen on initial device requirement after risk assessment over requirements?
Typically the Product Requirements and Risk Management File are documents/records under documentation control. A new requirement added can lead to risk analysis and similarly risk analysis determining a new risk control measure can lead to a new product requirement. Handle this with document change control to both the documents - typically in revision history capture the reason for change and the changes done. Some organizations may have a DCO (document change order) process in place and DCO # can be referenced for traceability.
Hoy may have two control sn
One for the design change and other for the risk .
Now with 2015, it is recommended to have a risk register, on it, you can use it for tracking risks.
Hope this helps oí
Hoy may have two control sn
One for the design change and other for the risk .
Now with 2015, it is recommended to have a risk register, on it, you can use it for tracking risks.
Hope this helps oí
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