F-QM-012-A-V0 — Annual Internal Audit Schedule, Plan, Report & Follow-Up Log
Type: Form · Version: V0 · Status: DRAFT — UNAPPROVED · Served read-only from the bundled QMS copies. The Drive master is untouched.
Parent document: LAB-QM-012 — Internal Audit Policy (parent is encoded in the form number)
Rendered in-browser from the project's Word file F-QM-012-A-V0-internal-audit-plan-and-report.docx (policies-docx / forms-docx — the file Junry reviews). Formatting is faithful, not pixel-perfect; the DOCX is the official copy.
| Document # | F-QM-012-A-V0 | Parent Document | LAB-QM-012 — Internal Audit Policy |
|---|
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Part 1 — Annual Internal Audit Program Schedule
Annual audit schedule covering all clinical laboratory sections and QMS processes twice yearly:
| Audit Cycle | Scheduled Period | Target Laboratory Scope / Processes | Lead Auditor | Support Auditor | Target Report Date | Status |
|---|---|---|---|---|---|---|
| Cycle 1 (H1) | March – April | Pre-Examination, Accessioning, Hematology, QC, Reagents | Trained MT Lead | CMT / LQM | April 30 | [ ] Scheduled [ ] Completed |
| Cycle 1 (H1) | May – June | Clinical Microscopy, Serology, Reporting, Critical Values | Trained MT Lead | CMT / LQM | June 30 | [ ] Scheduled [ ] Completed |
| Cycle 2 (H2) | September | Facilities, Biorisk Safety, Equipment Maintenance, POCT | Trained MT Lead | Safety Officer | September 30 | [ ] Scheduled [ ] Completed |
| Cycle 2 (H2) | October – November | Document Control, Records, Personnel Files, Management Review | CMT / LQM | Pathologist | November 30 | [ ] Scheduled [ ] Completed |
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Part 2 — Individual Audit Plan & Independence Verification
| Field | Details |
|---|---|
| Audit Reference No.: | IA-YYYY-____ |
| Audit Objectives: | Evaluate conformity to DOH A.O. 2021-0037, DOH QMS Tool, and ISO 15189:2022. |
| Scope & Processes: | [ ] Pre-Examination [ ] Examination [ ] Post-Examination [ ] Safety & Biorisk [ ] Quality Management |
| Audit Criteria / Standards: | Relevant laboratory policies, technical SOPs, and manufacturer instructions. |
| Lead Auditor / Audit Team: | Name: ____________________________________ Staff ID: _________________ |
| Auditee Representatives: | |
| Audit Scheduled Date & Time: | YYYY-MM-DD / HH:MM |
Auditor Independence Safeguard:
- [x] Confirmed: Auditors do not audit their own routine bench activities or directly assigned processes (per LAB-QM-012 Section 5.1).
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Part 3 — Audit Conduct & Objective Evidence Record
| Actual Conduct Date(s): | YYYY-MM-DD | Total Time Spent: | _____ Hours |
|---|---|---|---|
| Records & Documents Audited: | List worksheets, maintenance logs, QC charts, patient reports reviewed: ________________________________ | ||
| Personnel Interviewed: | Staff names and designations: _________________________________________________________________________ | ||
| Equipment & Areas Observed: | Testing benches, waste areas, reagent storage areas inspected: ________________________________________ |
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Part 4 — Audit Findings & Reporting Matrix
Finding Type: C = Conformity | OB = Observation | OFI = Opportunity for Improvement | NC = Nonconformity (Minor / Major)
| Finding # | Clause / Criteria Ref | Specific Finding Description (Objective Evidence) | Finding Type | Severity (NC only) | Auditee Corrective Action Commitment | Target Closure Date |
|---|---|---|---|---|---|---|
| F-01 | ||||||
| F-02 | ||||||
| F-03 | ||||||
| F-04 |
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Part 5 — Internal Audit Finding Disposition & Follow-Up Log
The CMT / LQM maintains this log to monitor findings through verified completion and closure:
| Finding Ref # | Finding Type | Severity | Routing (CAPA / Local) | Action Plan Summary | Follow-up Verification Details | Status | Date Closed | Verified By (Initials) |
|---|---|---|---|---|---|---|---|---|
| F-01 | [ ] Open [ ] Closed | |||||||
| F-02 | [ ] Open [ ] Closed | |||||||
| F-03 | [ ] Open [ ] Closed | |||||||
| F-04 | [ ] Open [ ] Closed |
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Part 6 — Audit Team & Administrative Sign-Off
| Role | Name | Signature | Date |
|---|---|---|---|
| Lead Internal Auditor: | |||
| Chief Medical Technologist / LQM: | Junry, RMT | ||
| Pathologist / Head of Laboratory: | |||
| Hospital Director: |