Excluded age group reached triage

CAPA-007 · from INC-011 · opened 19 Sept 2026 · ISO 13485 8.5.2 and 8.5.3

Task
Stage
Check effectivenessOwnerBCDue16 OctINC-011H-03Intended Purpose v2P-01

Problem

Three patients under 16 completed triage before the exclusion was shown.

Investigation

Root cause
Exclusions shown after entry, not before
Method
5 whys · confirmed by Zak, 21 Sept
Contributing
Process: no release check for exclusionsTechnical: age asked late

Actions

Correction
Contacted the 3 families affected · done 19 Sept
Corrective
Age check moved to the first screen · release 2.3, 30 Sept
Preventive
Exclusions added to the release checklist · Change control workflow v3

History

Moved to Check effectiveness
Balraj · 30 Sept · check scheduled for 16 Oct
Moved to Implement
Balraj · 24 Sept
Plan confirmed
Zak · 22 Sept
Draft confirmed
Zak · 19 Sept · drafted by Qyro from INC-011