Risk Analysis and Management Process Flow Chart
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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 HAZARD using 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
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Transcript of Risk Analysis and Management Process Flow Chart
Does benefitoutweigh RISK?
Is the riskreducable?
Is risk acceptable?
Are all identif iedHAZARDSevaluated?
Are otherHAZARDSgenerated?
Is overall RISKacceptable?
Is the Residual RISKacceptable?
Implement, document, and verifyappropriate measures
UnacceptableRefer to 7.7 (5)
No
No
No
No
No
No
No
No
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Continue gatheringCAPA informat ion
Intended purposeIdentify characteristics
Identify known and foreseeableHAZARDS
Start
Estimate risk for each HAZARD usingFOR 1022980
Has new informat ionbeen receieved?
Gather CAPA informat ion
Risk Analysis Summary Report
RiskEvaluation
Post-marketInformation
RiskEvaluation
RiskAnalysis
RiskControl
