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PHARMA-COMPLIANCE5 MIN READ

QRM Facilitation Deck

Use quick facilitation prompts to reduce subjectivity in quality risk management discussions.

HACR What four prompts restart a stuck QRM discussion? Hazard, assumption, control, review. We've never seen this failure before. A team wants low risk because the event has not occurred historically. Facilitator line That helps probability, but let's also ask whether our history would detect the failure if it occurred and whether severity still requires prevention. Treating absence of evidence as proof of control. It respects experience while separating occurrence evidence from detectability and severity. Severity versus detectability Do not lower severity because you believe you can detect the failure. What makes a risk score defensible? A stated failure pathway,…

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