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Quality Management
Manufacturing
Updated March 2026

Document Control — Manufacturing Edition

A procedure for managing the creation, review, approval, distribution, and revision of controlled documents within the quality management system.

Purpose

To ensure that only current, approved documents are available at points of use, preventing the use of obsolete or unauthorised documents that could lead to quality errors.

Scope

Covers all controlled documents including policies, procedures, work instructions, forms, specifications, and records across all departments within the quality management system.

Prerequisites

  • Established document management system with version control capabilities
  • Defined document hierarchy and numbering convention
  • Appointed document controller with authority to manage the system
Compliance Note

Designed to support ISO 9001 quality management, workplace health and safety regulations, and environmental compliance reporting under Australian standards.

Step-by-Step Procedure

1

Initiate Document Request

A new document or revision is requested by submitting a document change request with justification for the creation or change.

  • 1.1Complete the document change request form with the proposed content or changes
  • 1.2Provide justification for the new document or revision
  • 1.3Submit the request to the document controller
Document Author
15 minutes
Document Change Request Form, Document Management System
2

Draft the Document

Prepare the document content using the approved template and formatting standards.

  • 2.1Use the correct document template for the document type
  • 2.2Draft the content following the organisation writing and formatting standards
  • 2.3Include all required sections such as purpose, scope, responsibilities, and procedure steps
Document Author
1 to 4 hours
Document Template, Word Processing Software
Tips
  • Use clear, concise language and avoid jargon where possible
3

Review the Document

Circulate the draft document to relevant stakeholders for review. Collect and incorporate feedback.

  • 3.1Send the draft to identified reviewers with a review deadline
  • 3.2Collect feedback from all reviewers
  • 3.3Incorporate feedback and resolve any conflicting comments
Document Controller
3 to 5 days
Document Management System, Collaboration Platform
4

Approve the Document

Submit the reviewed document to the designated approver for formal approval and sign-off.

  • 4.1Present the final draft to the approver with a summary of review comments addressed
  • 4.2Obtain formal approval signature or electronic sign-off
  • 4.3Record the approval date and approver identity
Document Approver
1 day
Document Management System
5

Publish and Distribute

Publish the approved document in the document management system and distribute to relevant personnel.

  • 5.1Upload the approved document to the document management system with correct metadata
  • 5.2Set access permissions for relevant users and departments
  • 5.3Notify affected personnel that a new or revised document is available
Document Controller
15 minutes
Document Management System, Notification System
6

Manage Obsolete Documents

Withdraw the previous version of the document from circulation and mark it as obsolete in the system.

  • 6.1Remove or restrict access to the obsolete version at all distribution points
  • 6.2Mark the obsolete version clearly in the document management system
  • 6.3Retain the obsolete version in the archive for reference
Document Controller
10 minutes
Document Management System
Tips
  • Conduct periodic checks to ensure no obsolete documents remain at points of use

Quality Checkpoints

Document uses the correct template and follows formatting standards
All required reviewers have provided feedback before approval
Obsolete versions are withdrawn from all distribution points
Document metadata including revision number and approval date is accurate

Common Mistakes to Avoid

Distributing documents without formal approval, creating uncontrolled copies
Failing to withdraw obsolete versions, leading to use of outdated procedures
Not notifying affected staff when documents are revised
Inconsistent use of document templates and numbering conventions

Expected Outcomes

Document Currency Rate

Percentage of documents that are current and within their scheduled review date.

Document Revision Cycle Time

Average time from document change request to approved publication, measuring efficiency of the control process.

Frequently Asked Questions

What is the difference between a controlled and uncontrolled document?

A controlled document is managed through the document control process, ensuring it is current, approved, and traceable. An uncontrolled document is a copy that is not guaranteed to be current, typically marked as such.

What types of documents need to be controlled?

All documents that direct or record activities affecting quality should be controlled. This includes policies, procedures, work instructions, forms, specifications, and quality records.

How often should documents be reviewed?

Documents should be reviewed at defined intervals, typically annually or biannually. Additionally, reviews should be triggered by changes in regulations, processes, or customer requirements.

Can operators keep printed copies of controlled documents?

Printed copies should be minimised and are typically considered uncontrolled. If printed copies are necessary, a controlled copy register should track their distribution and ensure they are updated when revisions are issued.

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