← Back to Self-inspection Prints the selected cycle — 2026 · CYTO-11 · schedule + prior-cycle findings

CYTOWELL SDN BHD (CTSB)

CYTO-11 — Balakong Jaya

SELF-INSPECTION REGISTER (DC4)

Doc NoCTSB-QA-DC4
Rev03
Effective2026-01-02
Page1 of 1

2026 cycle · owner QA (Farah) · due 2026-11-20 · last cycle completed 2025-11-20 · status: Scheduling — 3 of 10 areas booked · printed 2026-07-07

Schedule — 10 areas

Area Planned Actual Team Status Findings Remarks
1. Raw Material Storage 2026-11-02 Farah (QA) · Lee (QC) Scheduled team confirmed
2. Production Area 2026-11-03 Farah (QA) · Sarah (FM) Scheduled production paused 1 shift
3. Packaging Area 2026-11-04 Farah (QA) · Ahmad (Op) Scheduled team confirmed
4. FG Warehouse 2026-11-09 (tentative) Planned team to assign
5. QC Laboratory 2026-11-10 (tentative) Planned independent auditor — not QC staff
6. Documentation & Records 2026-11-11 (tentative) Planned recheck CAPA-25-09 area
7. Sanitation & Hygiene 2026-11-12 (tentative) Planned recheck CAPA-25-07 area
8. Water System 2026-11-16 (tentative) Planned with June micro results on hand
9. Pest Control 2026-11-17 (tentative) Planned Rentokil trend reports Jan–Oct
10. Calibration & Maintenance 2026-11-18 (tentative) Planned watch item: CP-01 overdue history

Findings — 2025 cycle (completed 2025-11-20 · 4 findings: 3 minor, 1 major · 1 CAPA open)

Area Severity Finding CAPA Status
Sanitation & Hygiene Minor Drain cover corroded in Mixing Room — replaced SS304, drain fogging added to weekly program CAPA-25-07 Closed
Documentation & Records Minor 2 uncontrolled forms at Packaging — retired, register updated CAPA-25-09 Closed
Calibration & Maintenance Major Two balances used past calibration due — interim verification done; 2026 recurrence (CP-01) keeps CAPA open CAPA-25-11 Open
Production Area Minor Worn door seal Filling Room 1 — replaced same day, no CAPA Closed

Open CAPAs carry into the next cycle — CAPA-25-11 must show effective closure before area 10 can pass in 2026.

Prepared by QA — Farah (wet-ink)

Approved by Managing Director — Leo Lim (wet-ink)