Open SharpyByNature opened 3 years ago
As the manufacturer is also the end user, risk documentation should be provided as part of the provided docs.
These should include:
Product Specifications
User Requirements
System Risk Analysis (Hazard and Source Identification)
Design Verification Plan(s)
System Risk Analysis and Mitigation Plan
Design Validation Plan(s)
Manufacturing Plan (build instructions are good I think as long as you include quality control info)
Risk Control
Residual Risk Acceptance
As the manufacturer is also the end user, risk documentation should be provided as part of the provided docs.
These should include:
Product Specifications
User Requirements
System Risk Analysis (Hazard and Source Identification)
Design Verification Plan(s)
System Risk Analysis and Mitigation Plan
Design Validation Plan(s)
Manufacturing Plan (build instructions are good I think as long as you include quality control info)
Risk Control
Residual Risk Acceptance