Nonconformities & CAPA
How the laboratory records occurrences and corrective actions. These live on the QMS forms — LUIB has no module for them — so this page explains the system and shows clearly-labelled sample records.
Verified fact: LUIB contains no nonconformity, CAPA, incident or complaint
module and no such data (full-text code inspection, Deliverable 02/03). Occurrences and CAPAs live on the QMS
forms F-QM-010-A-V0 and F-QM-011-A-V0.
LAB-QM-011 §5.2 also requires human screening by the CMT/LQM before any event becomes a CAPA — this dashboard
therefore tracks nothing automatically. The records below are samples only, modelled on those forms.
See also the occurrence triage flowchart and the
CAPA closed-loop flowchart.
SAMPLE — demonstration only, not laboratory records
Occurrences (SAMPLE)
| ID | Date | Type | Severity | Description | Immediate containment | Status | Form |
|---|---|---|---|---|---|---|---|
| SAMPLE-OCC-001 | 2026-10-15 | Pre-analytical | Minor | SAMPLE: Hemolyzed specimen received from ward; recollected. | SAMPLE: Specimen rejected, recollection requested same shift. | Closed locally (SAMPLE) | F-QM-010-A-V0 |
| SAMPLE-OCC-002 | 2026-10-18 | Analytical | Major | SAMPLE: Repeated QC rejection on chemistry analyzer. | SAMPLE: Testing halted, analyzer quarantined pending check. | Escalated to CAPA (SAMPLE) | F-QM-010-A-V0 |
SAMPLE — demonstration only, not laboratory records
CAPA records (SAMPLE)
| ID | Source | RCA method | Root cause | Actions | Owner | Target date | Status | Effectiveness check |
|---|---|---|---|---|---|---|---|---|
| SAMPLE-CAPA-001 | SAMPLE-OCC-002 | Fishbone (Ishikawa) — SAMPLE | SAMPLE: Expired control material in use. | SAMPLE: Replace control lot; add expiry check to bench card; retrain bench staff. | CMT/LQM (SAMPLE) | 2026-11-15 | Open (SAMPLE) | SAMPLE: Pending — 30–90 day check per LAB-QM-011 §5.5 not yet due. |
Workflow as written: LAB-QM-010 (report ≤ 24 h; Minor/Major/Sentinel) → screening → LAB-QM-011 (5 Whys or Fishbone RCA; owner + target date per plan; effectiveness check typically 30–90 days; no fixed CAPA closure deadline exists in policy).
