Dhiana Rose Tulagan

Procedure 1. Spec. No. Rev. QUALITY RISK MANAGEMENT XXX-XXX 1 Page 1 of 1 OBJECTIVE 1.1 To be able to establish a documented procedure that will identify the risk or hazards in the system. 2. SCOPE 2.1 This procedure applies to the facility. 3. RESPONSIBILITIES AND AUTHORITIES 3.1 The Management, Operations Manager and staff shall make sure that this procedure is properly executed. 4. PROCEDURE OR STEPS 4.1 Risk Analysis- identify and document the risks, hazards and potential harms. 4.2 Risk Evaluation – evaluate, categorize, prioritize and document the risk. Including matrices with risks, categories for probability and severity and risk codes. 4.3 Risk Acceptance – compares risk threshold as originally defined with the RPN (Risk Priority Number) obtained after mitigation. Based on the outcome the residual risk is accepted or rejected. 4.4 Risk Control / Mitigation - evaluates alternatives of risk mitigation versus costs. Need to define actions in case modifications are required. It also includes a time schedule for actions and estimates and documents residual risk priority numbers after qualification. 4.5 On-going Monitoring, Reviews and Updates – monitor, report and document the risk during use of the system. Need to define the actions in case new hazards are reported or if the risk level has changed. 5. PROCESS FLOW START Risk Analysis Risk Evaluation NO Risk Acceptance YES Risk Control NO Monitoring OK END