Deviation Tracker
Cross-batch view of all deviations, root cause, CAPA and closure.
| Deviation | Batch | Date | Status |
|---|---|---|---|
| DEV-2026-014 | ZBL-2026-001 | 20-Mar-2026 | CLOSED |
DEV-2026-014
CLOSEDLinked Batch
Stage
Stage 3 — Manufacturing
Date / Time
20-Mar-2026 · 10:30
Severity
Minor
Description
Compression speed reduced from 40 rpm to 32 rpm at 10:30 due to low hardness readings (7.1 kP vs minimum 8.0 kP).
Root Cause
Feeder speed set incorrectly at batch start — SOP not followed for initial speed verification.
Linked IPC
IPC-05 — Hardness 7.1 kP at Compression — StartFAIL
Linked CAPA
CAPA-2026-008 — PENDING REVIEW
SOP-MFG-012 updated to include mandatory feeder speed verification before compression start.
Due 15-Apr-2026 · Assigned to Dr. Nair
Closed By
Dr. Nair (QA Head)
Closure Date
25-Mar-2026