CAPA log
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Four open. One check due.

Export for auditNew CAPA
Open 4Checks due 2Closed 9All 13
Any sourceISO 13485
IDProblemSourceStageOwnerDueEffectiveness
CAPA-008Everyday chest pain words missedINC-014 Draft
Plan
ZY30 Oct–
CAPA-009Surname variants create duplicate recordsINC-013 Draft
Investigate
EN30 Oct–
CAPA-007Excluded age group reached triageINC-011
Check effectiveness
BC16 OctDue in 2 days
CAPA-006Document approvals not recordedInternal audit Q3
Implement
ZY24 OctSet for 24 Nov
CAPA-004Red-flag synonyms incompleteINC-009
Closed
ZYAugEffective

CAPA-007 Excluded age group reached triage

INC-011H-03Intended Purpose v2
Root cause
Exclusions shown after entry, not before
Correction
Contacted the 3 families affected
Corrective
Age check moved to the first screen
Preventive
Exclusions added to the release checklist
Effectiveness check · scheduled by the Planner

Review four weeks of triage sessions. Passes if no excluded patient reaches triage.