If the design unit has issued a risk assessment report, how should the manufacturing unit reflect this in the quality certification documents?
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For cases where the design entity has prepared a risk assessment report, how should the manufacturing entity reflect in the quality certification documents the failure modes and protective measures outlined in that risk assessment report?
I’m not sure about the specifics, but from what I understand, he prepared a risk report; for whatever aspect it relates to, you just need to attach the corresponding corrective measures and verification documents.
This post was last edited by bluishice on 2021-10-7 at 10:36. The risk assessment report is intended for users, informing them about the various failure modes of the device; users are also responsible for implementing protective measures. A risk assessment report does not specify how the manufacturer should produce, but is prepared based on the manufacturing process. When design and manufacturing are separated, the designer generally formulates the plan based on the requirements specified in standards.
The manufacturing unit doesn’t need to show anything
This post was last edited by zjq1962 on 2021-10-9 at 12:49. The manufacturer must provide the risk assessment report as part of the delivery documents to the user. It is up to the user to implement how to avoid risks.
Risk assessment identifies the potential risks that may arise during the use of equipment, indicating the areas where users should pay attention and take extra precautions