CAPA-1042 — Sterilization load release
عدم المطابقة والإجراءاتInvestigation, root cause, actions and verification for this case.
DetailsRoot CauseAction PlanEffectiveness VerificationLinksAudit Trail
Record
| Field | Value |
|---|---|
| Source | Audit · AUD-2026-004 / F-03 |
| Severity | Critical |
| Entity | Blood Bank Centre |
| Opened | 2026-11-12 · by Audit Director |
| SLA due | 2026-11-30 · 17 days |
| Status | Verification |
SLA & escalation
17 days to SLA
5 Whys chain builder
Why 1 — load released without Bowie-Dick record?
Record was on paper log, machine offline
Why 2 — machine offline?
Data module not connected to hospital network
Why 3 — not connected?
IT request pending since Sep (ticket 8841)
＋ Add why…
chain continues until systemic cause
Fishbone categories
Equipment ● selectedMethodPeopleEnvironment
Primary category: Equipment · contributing: Method (paper log allowed)
Action plan
| Type | Action | Owner | Due | Evidence | Status |
|---|---|---|---|---|---|
| Immediate | Quarantine loads released 20–22 Oct | Dr. N. Ali | 2026-11-14 | 2 files | Done |
| Corrective | Connect sterilizer data module to network (IT-8841) | IT + BB Dept. | 2026-11-20 | 1 file | In progress |
| Corrective | Retrain staff on load release checklist | BB Supervisor | 2026-11-22 | — | Planned |
| Preventive | Electronic interlock: no release without record | Biomed Eng. | 2026-12-15 | — | Planned |
Verification checklist
| Check | Result | Comment |
|---|---|---|
| No repeat findings in 30-day window | Pass | 0 repeats |
| Electronic interlock live | Pending | due 15 Dec |
| Staff re-training completed | Pending | scheduled 22 Nov |
Graph view — linked objects
MOH-SOP-0154 policyCBAHI MMS.02 standard
AUD-2026-004 auditRS-018 risk
CRS-77 training
Immutable audit trail
| Timestamp | Actor | Action | Detail |
|---|---|---|---|
| 2026-11-12 14:02 | Audit Director | create | NC raised from F-03 (critical) |
| 2026-11-12 14:20 | CAPA Quality Manager | accept | triage accepted · SLA set 2026-11-30 |
| 2026-11-13 08:05 | System (SoD) | sod_block | action owner cannot verify effectiveness |