GLI GLI Quality Tool
GLI Quality Tool — Version 2.0

TB laboratory document control essentials

A TB laboratory’s quality system depends on staff finding the current procedure, form or policy when they need it. Creating a TB lab document master list and document change request matrix makes that possible by showing what is controlled, who owns it and how revisions are authorised. Together, these records turn scattered files into traceable quality evidence.

The master list is the authoritative index of issued documents. The change request matrix records proposed alterations, assessment and decisions. Keeping them separate prevents drafts from appearing current while giving each approved revision a defined route through review, approval, publication and withdrawal. The approach can suit a large metropolitan laboratory and a regional service working from shared folders.

The GLI Quality Tool organises improvement through four phases and twelve Quality Systems Essentials, including safety, personnel, equipment, documentation, assessment and continual improvement. A controlled-document register supports all twelve because every essential relies on current instructions and defensible records. It should accommodate digital systems, hybrid workflows and limited staffing rather than assuming a dedicated quality manager is always available.

Feature Master document list Change request matrix
Purpose Show current controlled documents Plan and assess a proposed change
Scope One row per document ID One row per request
Key fields Title, owner, version, status, location, review date Requester, reason, impact, risk, approval, due date
Evidence Current file, approval and supersession record Assessment, decision, validation and training evidence
Rhythm Scheduled or event-based review Approval, publication, withdrawal and closure

Set the quality boundary

Start by deciding what belongs in scope. Include policies, SOPs, worksheets, request forms, result-report templates, laboratory information, risk assessments, training materials and decision rules. Add relevant external documents, such as manufacturer instructions, reference methods and applicable national guidance, because they also affect consistent work. Give each item a unique identifier so the same procedure is not duplicated under several labels.

For Australian laboratories, document which accreditation and legal requirements apply. Many services seek NATA accreditation against ISO 15189, while governance, health-records rules and public-health notifications differ across states and territories. Depending on the service, this may involve the Privacy Act 1988, Victorian or New South Wales health-records legislation, and instructions from the relevant communicable-disease control unit. Confirm local requirements rather than applying one national retention rule to every record.

Build the document master list

Perform a physical and digital inventory. Search the quality-management platform, laboratory information system, network drives, email folders, local computers and printed binders used in Melbourne, Sydney or regional locations. Ask supervisors to identify unofficial shortcuts, such as a current worksheet saved only on a bench computer. Each discovery should become an inclusion decision, an owner-assignment task or a documented disposal action.

Capture fields that answer everyday questions: document ID, title, category, version, issue and expiry dates, owner, approver, controlled location, revision history and next review date. Laboratories starting with modest systems can use the Phase 1 guidance to connect the register with phase-specific checks. Avoid free-text-only lists; controlled fields support filtering, alerts and audit trails.

Use a clear naming convention, such as category, short title and version. Link each entry to the authoritative file rather than storing multiple copies inside the register. Mark superseded material as archived or obsolete, remove it from operational links, and retain it only where policy requires. A master list should show the current state of every document, not serve as an indiscriminate file library.

Assign ownership and access

Name a document controller or assign that function to a specific role, with a backup. The controller maintains identifiers, routes requests, checks publication and preserves evidence, but the document owner supplies the technical content. Authors, reviewers and approvers should be recorded by role as well as name where staffing changes. Unclear ownership is a common reason that an old method remains in use.

Control access by audience. A superseded version may be available to the quality manager for audit but hidden from bench staff. Printed copies need a matching printed identifier and a process for removing obsolete pages. This matters in Australian services where email requests, Microsoft Teams conversations, shared drives and paper approvals may all occur during a working day. Define one authoritative channel even when those tools support the workflow.

Create the document change request matrix

Open a request for new documents and for changes caused by incidents, corrective actions, audit findings, new assays, software upgrades, manufacturer instructions or revised guidance. State the reason and exact clause affected, rather than merely requesting that a document be updated. A small change can still alter specimen handling, reporting or staff safety, so technical impact needs assessment.

Give each request an identifier and capture requester, date, document ID, current version, proposed wording, urgency, affected sites, risk rating, required reviewers, approval decision and target implementation date. Assess whether validation, staff training, patient notification or a change to controlled records is needed. Approvals should be proportionate and time-stamped; email evidence can support the matrix if it remains linked to the request.

After approval, update the master list, publish the new version, withdraw the old one and record completion. If rejected or deferred, retain the reason and any conditions for reconsideration. Reviewers who alter proposed wording should record that a new submission is required. This preserves the distinction between the request history and the issued document.

Connect documents to laboratory work

Give new staff the current SOP during induction, display a controlled copy where work occurs, and provide a route for reporting a missing or incorrect page. Internal audits can sample the master list and verify the version on the bench. Quality indicators can reveal where control is failing: leaders can use the weekly indicator review guide to turn repeated errors into specific change requests. Rising amended-result rates, for example, may expose an ambiguous reporting instruction.

Australian procurement adds local information that belongs in the document record. When a service buys assays, media, extraction platforms or analyser maintenance from an Australian distributor, capture the manufacturer, local sponsor or supplier, product code, instrument model and authorised support contact. An invoice or purchase order alone may not identify the applicable manufacturer instructions. Reconcile procurement changes with product files, staff training and method validation before release.

Safety documents must remain aligned with specimen movement. Australian laboratories may use same-city couriers or interstate transport, so retain current receiving and dispatch procedures, packaging records and carrier requirements under document control. Relevant material may cover Biological Substance, Category B transport and associated dangerous-goods rules. For regional operations, maintain approved arrangements for delayed collections and extreme heat without embedding unstable contact details in permanent SOPs.

Introduce the system through the roadmap

Sequence implementation around the GLI phases instead of attempting a perfect register immediately. Phase 1 can establish baseline lists and basic ownership; later phases can strengthen assessment, competence and improvement. The downloadable GLI resources provide a practical starting point for adapting checklists and user instructions to the laboratory’s size and document platform.

Pilot the register in one section and test it through realistic activities before expansion. A pilot might process a new smear SOP, an instrument software update and an incident-driven change in one week. Record how long each step takes, where duplicate copies appear and which fields staff understand. Then amend the workflow before adding every department or site.

Rollout actions should remain practical and owned.

Train staff to recognise controlled copies and report suspected obsolete material. Include the register in induction and annual competency refreshers, then test access after role changes or network migration. Keep quick guides for requesters, but link them to the current workflow rather than maintaining a second unofficial procedure.

Keep control active

Review register performance monthly: overdue reviews, open change requests, documents awaiting approval, obsolete copies and staff access problems. Trend these measures so the quality team can distinguish routine housekeeping from systemic failure. Include results in management review and allocate resources when recurring delays indicate that the system needs stronger support.

Periodically sample the register against bench copies, training records, supplier files, software configurations and audit evidence. Remove cancelled documents, check that superseded items cannot be selected, and verify that approved changes reached every affected location. Feed lessons from drills, complaints and quality-indicator reviews back into the change request process.

Nominate the document controller this week, enter the current approved documents in the master list, and book the first monthly review.