1.
Does benefit
outweigh RISK?
Is the risk
reducable?
Is risk
acceptable?
Are all identified
HAZARDS
evaluated?
Are other
HAZARDS
generated?
Is overall RISK
acceptable?
Is the Residual RISK
acceptable?
Implement, document, and verify
appropriate measures
Unacceptable
Refer to 7.7(5)
No
No
No
No
No
No
No
No
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Continue gathering
CAPA information
Intended purpose
Identify characteristics
Identify known and foreseeable
HAZARDS
Start
Estimate risk for each HAZARDusing
FOR 1022980
Has new information
been receieved?
Gather CAPA information
Risk Analysis Summary Report
Risk
Evaluation
Post-market
Information
Risk
Evaluation
Risk
Analysis
Risk
Control