Triage a late CMC change through evidence, ownership, and regulatory pathway gates.
Late change Three days before lock, a CMC owner calls a mixing-parameter correction minor. Minor is not a regulatory category until impact, evidence, and approval are clear. The decision model DACI plus quality-risk gates Use DACI to clarify decision roles, then use risk gates to keep the change from slipping through on confidence alone. Shortcut Ask CMC if it is minor and keep moving. A change enters the package only after risk, evidence, and authority are visible. Role clarity prevents late-change optimism from becoming submission risk. 01 Define 02 Evidence 03 Commit Define the decision Gate 1
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