F-QM-002-A-V0 — Document Change, Annual Review, and Disposal Request Form
Type: Form · Version: V0 · Status: DRAFT — UNAPPROVED · Served read-only from the bundled QMS copies. The Drive master is untouched.
Parent document: LAB-QM-002 — Document Control Policy (parent is encoded in the form number)
Rendered in-browser from the project's Word file F-QM-002-A-V0-document-change-and-review-request-form.docx (policies-docx / forms-docx — the file Junry reviews). Formatting is faithful, not pixel-perfect; the DOCX is the official copy.
| Document # | F-QM-002-A-V0 | Parent Document | LAB-QM-002 — Document Control Policy |
|---|
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Part 1 — Document Change Request & Justification
| Request Tracking No.: | DCR-YYYY-____ | Date of Request: | YYYY-MM-DD |
|---|---|---|---|
| Document Number: | Current Version No.: | ||
| Document Title: | Proposed Version No.: | ||
| Laboratory Section: | [ ] Hematology [ ] Clinical Microscopy [ ] Serology [ ] General QM [ ] Cross-Discipline | ||
| Originator / Author: | ____________________________________, RMT |
1.1 Action Requested (Check One)
- [ ] New Document Creation: Establish new policy, SOP, or form for a newly introduced test or clinical workflow.
- [ ] Document Revision / Amendment: Modify procedural steps, reference intervals, controls, or regulatory crosswalks.
- [ ] Periodic / Annual Review (No Substantive Changes): Formal annual review confirming the document is still valid for use.
- [ ] Document Retirement / Obsolescence: Decommission procedure or form due to phased-out equipment or method change.
1.2 Summary of Proposed Changes and Operational Impact
(Specify sections or clauses modified, reason for amendment, and manufacturer/DOH regulatory trigger): ____________________________________________________________________________________________________ ____________________________________________________________________________________________________
- [ ] Staff training required prior to effective date (briefing documented on F-QM-HR-001-A).
- [ ] Related SOPs and forms affected and updated at the same time.
- [ ] Lab-LIS or reporting format impact verified.
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Part 2 — Annual Policy and Procedure Review Tracking Log
The Chief Medical Technologist / Laboratory Quality Manager maintains this log to track the annual review of all controlled documents:
| Document No. | Document Title | Category / Section | Current Ver. | Last Review Date | Review Due Date | Designated Reviewer | Review Outcome (No Change / Revised) | Pathologist Review Date | Remarks / Status |
|---|---|---|---|---|---|---|---|---|---|
| LAB-QM-001 | Quality Management Manual | General QM | V0 | Annual | CMT / LQM | ||||
| LAB-QM-002 | Document Control Policy | General QM | V0 | Annual | CMT / LQM | ||||
| SOP-H-002 | HORIBA ABX Pentra XL 80 CBC and Maintenance SOP | Hematology | V0 | Annual | Medical Technologist | ||||
| SOP-H-001 | Hematology Section Workflow, Quality Control, and Result Validation SOP | Hematology | V0 | Annual | Medical Technologist | ||||
| SOP-S-004 | Dengue Duo and Typhoid Rapid Immunoassay SOP | Serology | V0 | Annual | Medical Technologist | ||||
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Part 3 — Obsolete Master Document and Records Disposal Authorization Log
Document withdrawal and destruction authorization per LAB-QM-002 Section 5.5 and LAB-QM-POST-004:
| Log No. | Document / Record No. | Document Title | Superseded / Retired Version | Effective Retirement Date | Hard Copies Retrieved & Destroyed | Electronic File Archived (Read-Only) | Superseded By (New Doc No. & Ver) | Disposal / Archive Method | Authorized By (CMT / LQM Signature) | Date Completed |
|---|---|---|---|---|---|---|---|---|---|---|
| D-2026-01 | [ ] Yes [ ] N/A | [ ] Yes [ ] N/A | [ ] Shredding [ ] Secure Electronic Archive | |||||||
| D-2026-02 | [ ] Yes [ ] N/A | [ ] Yes [ ] N/A | [ ] Shredding [ ] Secure Electronic Archive | |||||||
| D-2026-03 | [ ] Yes [ ] N/A | [ ] Yes [ ] N/A | [ ] Shredding [ ] Secure Electronic Archive | |||||||
| D-2026-04 | [ ] Yes [ ] N/A | [ ] Yes [ ] N/A | [ ] Shredding [ ] Secure Electronic Archive | |||||||
| D-2026-05 | [ ] Yes [ ] N/A | [ ] Yes [ ] N/A | [ ] Shredding [ ] Secure Electronic Archive |
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Part 4 — Technical Review, Approvals & Controlled Archive Sign-Off
| Review Authority | Name & Designation | Signature | Date |
|---|---|---|---|
| Document Author / Initiator: | |||
| Chief Medical Technologist / LQM: | Junry, RMT | ||
| Pathologist / Head of Laboratory: | |||
| Hospital Director (for Manual/Policies): |
Document Control Master Update Checklist:
- [ ] New master file deposited in controlled repository.
- [ ] Master Document Register (F-QM-002-B) updated.
- [ ] Superseded version marked "OBSOLETE" and moved to archive folder.
- [ ] Hard copies in laboratory testing areas replaced and old copies destroyed. Effective Release Date: YYYY-MM-DD | Verified by (CMT / LQM): _______________________
