RS-031 — Sterilizer network downtime
المخاطر والتحسينCauses, controls, treatment plan and score history for this risk.
Definition
| Field | Value |
|---|---|
| Cause | Aging sterilizer data module |
| Event | Unplanned downtime blocks load records |
| Consequence | Release delays / untracked loads |
| Existing controls | Paper fallback log · weekly calibration |
| Inherent → Residual | 25 → 14 (mitigation in progress) |
Treatment plan
Mitigate — selectedAcceptTransferAvoid
| Action | Owner | Due | Status |
|---|---|---|---|
| Replace data module (IT-8841) | Biomed Eng. | 2026-11-20 | In progress |
| Interim electronic logging app | BB Supervisor | 2026-11-18 | Pending |
| Verify residual score | Risk Director | 2026-12-15 | Planned |
Linked KRIs — thresholds & breach alerts
| KRI | Threshold | Current | Alert |
|---|---|---|---|
| Sterilizer uptime % | ≥ 95 | 92 | BREACH — alert raised |
| Release delay (hrs) | ≤ 4 | 2.5 | OK |
| Repeat record gaps / mo | 0 | 1 | Watch |
Linked objects
MOH-SOP-0331 policyCBAHI MMS.02 standard
CAPA-1042 incident/CAPA