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Risk Analysis and Management Process Flow Chart

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Kathy Vinatieri
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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 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

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Risk Analysis and Management Process Flow Chart

  • 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