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QUESTION: From: Yusri Sent: Aug. 12, 2014 To: Q-Blog, Ask the Experts Subject: API Q1, clause 5.3, Risk Assessment Requirements Yusri asks the following questions about API Q1: API Q1, requires the organization to maintain a documented procedure for risk assessment and management. What parameters need to be considered for determining risk and their impact on delivery and quality of product? Should the risk assessment be performed before manufacturing, during manufacturing or after manufacturing? RESPONSE: