Commit to a CAPA Effectiveness Check

Add a measurable effectiveness check to an active CAPA or remediation item. Use this for a GMP deviation action, audit finding, repeated documentation error, supplier-quality issue, or change-control remediation where action completion could be mistaken for effectiveness. For [failure mode], I will verify [evidence source] across [number/timeframe of comparable opportunities]. The CAPA is effective only if [threshold] is met; if not, I will [reopen/escalate action]. Owner: [name]. Review date: [date]. In 3 days, check whether the effectiveness criterion was added with owner, evidence source, threshold, and review date. An open CAPA after repeated line-clearance documentation misses in packaging. A deviation…

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