Ask the Regulatory Risk Question First
Use quality-risk framing to classify a regulatory issue by decision impact instead of anxiety.
The reframe: classify the decision before you classify the issue. Regulatory issues feel urgent because they arrive close to deadlines, involve experts, and carry agency visibility. That urgency can distort judgment unless the team names the decision at stake. Quality risk starts with impact ICH Q9 frames risk around product quality and patient protection. For RA, the equivalent is decision impact. A data irregularity matters differently if it affects a proposed claim, a release specification, an inspection commitment, or a low-level narrative clarification. Use severity, probability, and detectability Severity asks how bad the outcome is if the concern is real.…
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