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Leo Lim

leo@navi.my · Owner / Admin

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Maintenance Records Machines Equipment history Self-inspection

Self-inspection — annual GMP audit

Scheduling — 3 of 10 areas booked
Print register
Findings → CAPA if needed. The cycle is triggered by the annual schedule on the Maintenance register (per PIC/S): QA walks all 10 areas with a cross-functional team, files findings, and raises a CAPA for anything that can't be fixed on the spot. Printed, this table + findings is the self-inspection register (DC4).
2026 cycle — 10 areas — owner: QA (Farah) · due 2026-11-20 · last cycle completed 2025-11-20
Area Planned date Actual date Team members 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 —2026-07-07 Farah (QA) · Ahmad (Op) ScheduledDone — team confirmed1 major → CAPA-26-01
4. FG Warehouse 2026-11-09 (tentative)2026-11-09 — —Farah (QA) · Kevin (Store) PlannedScheduled — team to assignavoid 11/12 — stocktake week
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

Status flow per area: Planned → Scheduled (date + team) → In progress → Done. An area is Done only when its findings are filed — even if the count is zero.

Findings — 2025 cycle — completed 2025-11-20 · 10/10 areas Done · 4 findings (3 minor, 1 major) · 1 CAPA still open
Area Severity Finding CAPA Status
Sanitation & Hygiene Minor Drain cover corroded in Mixing Room — replaced with SS304 cover, drain fogging added to weekly program CAPA-25-07 Closed
Documentation & Records Minor 2 uncontrolled forms in use at Packaging — forms retired, document control register updated CAPA-25-09 Closed
Calibration & Maintenance Major Two balances used past calibration due date — interim verification done; recurrence 2026 (CP-01) keeps the CAPA open CAPA-25-11 Open
Production Area Minor Worn door seal at Filling Room 1 — replaced same day, no CAPA needed — Closed

Open CAPAs from the previous cycle are the first checklist item of the next one — CAPA-25-11 must show effective closure before area 10 can pass in 2026.

Project Gaia — static mockup in Filament v3 idiom. No backend. The 10 areas mirror the GMP reference self-inspection schedule (DC4); people and findings continuous with the other screens.

Self-inspection

Record inspection —

2026 annual cycle · due 2026-11-20 · QA team

Fixed — one of the 10 cycle areas; set when the row was scheduled.

DatePicker — the day the walk was actually done.

Farah QA Lee QC

Farah (QA) leads every area · auditor must be independent of the area audited.

Checklist

Defaults to PASS · only exceptions need a finding

Recheck CAPA-25-09 area — effective closure?

Prior-cycle open CAPA carried into this walk (always checklist item 1).

An area is Done only when findings are filed — a walk with zero exceptions still files (0 findings). A Major recurrence on CAPA-25-11 blocks closing area 10.

finding(s) to file · CAPA

Schedule area — 2026 cycle

due 2026-11-20 · owner QA (Farah)

Team members

Auditor must be independent of the area audited — QC staff cannot audit area 5 (QC Laboratory). The form blocks non-independent picks.

Self-inspection — field manifest

FieldFilament componentTypeSourceFK target
CycleSelect (year) + status chiprecordstored: self_inspection_cycles (factory_id, year, due_date, status) — created automatically by the annual program on the Maintenance registerfactories.id
Area rowRepeater / RelationManager — 10 rows seeded per cyclerecordstored: self_inspections (cycle_id, area enum ×10, planned_date, actual_date, team json [user_id, role], status Planned/Scheduled/In progress/Done)self_inspection_cycles
Team membersSelect multiple → usersjsonrule enforced in form: auditor must be independent of the area audited (QC lab not audited by QC staff)users.id
Findings countTextColumn::counts()derivedcount of findings rows per area; area can only close when findings are filed (0 is a valid filing)findings
Checklist itemRepeater (Toggle PASS default → Finding sub-form on Fail)formper-area checklist seeded from the GMP self-inspection template; item 1 is always the prior-cycle open-CAPA recheck (Pass/Fail); only failed items expand severity + description + Raise CAPAself_inspection_findings
Actual date / Save findingsSlide-over CreateAction (from area row)actionwrites actual_date + team, files each exception as a findings row, sets the area status Done, increments the findings countself_inspections
FindingFindingResource (child of inspection)recordstored: self_inspection_findings (inspection_id, severity Minor/Major, description, corrective_note, capa_id nullable, status Open/Closed)capas.id
CAPACapaResource (stub v1 — shared with returns/deviations later)recordstored: capas (ref, source morph → finding, action, owner, due_date, status, effectiveness_check)users / morph
Print registerHeader action → PDFactionthe DC4 register: schedule table + findings + CAPA refs for the selected cycle—

Engine notes

  • QA owns this screen: only QA can schedule areas, file findings and close them. FM and owner see it read-only; operators don't see it at all.
  • The annual program row on Maintenance (“Self-inspection — 10 areas”) opens the next cycle and sets the due date — one trigger, per PIC/S expectations for periodic self-inspection.
  • Schedule area (header action) moves a Planned row → Scheduled: writes self_inspections (cycle_id, area, planned_date, team json [user_id, role], status Planned→Scheduled). QA-only; FM/owner read-only. Farah (QA) is a mandatory team member on every area and the form blocks non-independent picks (QC staff cannot audit area 5 — QC Laboratory).
  • Findings only become CAPAs when they need tracked corrective action; fixed-on-the-spot items stay as closed findings with a note.
  • Open CAPAs roll into the next cycle's checklist; a Major recurrence (see CAPA-25-11) blocks closing the related area until effectiveness is shown.
  • Recording an area (Save findings) writes actual_date + team, files each exception as a self_inspection_findings row (severity, description, optional CAPA — next number CAPA-26-01), sets the area Done and increments the findings count; zero findings is still a valid filing. Every recorded area opens with the prior-cycle open-CAPA recheck as checklist item 1.