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Risk Documentation #103

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SharpyByNature opened this issue Mar 4, 2021 · 0 comments

SharpyByNature commented Mar 4, 2021

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

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