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Risk Management Process 57
Hazard
Is the
hazard mitigated
by compliance to a Yes
harmonized
Std?
No
Is the
hazard mitigated
by compliance to a Yes
recognized international
or national
Std?
No
No
Can you
Perform additional Yes think of anything else No Is the residual
mitigation to reduce the risk ≤ SOTA?
risk?
Yes
Yes
No Will the
additional mitigation Can
significantly reduce Yes risk be feasibly reduced
reliability, usability further?
or benefit?
No
Do
stakeholder
concerns require No
further mitigation?
Yes
Will
the additional
mitigation reduce No
Yes overall
risk?
End Mitigation
Figure 11.2 Risk reduction end-point logic (with SOTA).