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Visio risk assessment & capa diagram
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Visio risk assessment & capa diagram

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Generic flow of the risk management process in accordance with ISO 14971

Generic flow of the risk management process in accordance with ISO 14971

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  • 1. RISK ASSESSMENT AND MANAGEMENT AND CAPA CAPA PA PA CA CA REJECT RISK ASSESSMENT PA CA ACCEPT CAPA ACCEPT RISK ASSESSMENT RECEIVING PURCHASING PA SUPPLIER CA CA A P REJECTWAREHOUSE A RM ACCEPT INVENTORY SHIPPINGPRODUCTION RISK ASSESSMENT CA PA RMA REJECT REJECT CUSTOMER ACCEPT END USER CUSTOMER SALES Robert J. Wiebel, CM, SSMBB 3/5/2011