Document Control — Healthcare & Allied Health 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 clinical record management system with version control capabilities
- Defined clinical record hierarchy and numbering convention
- Appointed clinical record controller with authority to manage the system
Includes safeguards for Australian Privacy Principles (APPs), Medicare compliance, and health record management under the My Health Records Act. All patient data handling follows AHPRA guidelines.
Step-by-Step Procedure
Initiate Clinical record Request
A new clinical record or revision is requested by submitting a clinical record change request with justification for the creation or change.
- 1.1Complete the clinical record change request form with the proposed content or changes
- 1.2Provide justification for the new clinical record or revision
- 1.3Submit the request to the clinical record controller
Draft the Clinical record
Prepare the clinical record content using the approved template and formatting standards.
- 2.1Use the correct clinical record template for the clinical record 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
- Use clear, concise language and avoid jargon where possible
Review the Clinical record
Circulate the draft clinical record 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
Approve the Clinical record
Submit the reviewed clinical record 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
Publish and Distribute
Publish the approved clinical record in the clinical record management system and distribute to relevant personnel.
- 5.1Upload the approved clinical record to the clinical record management system with correct metadata
- 5.2Set access permissions for relevant users and departments
- 5.3Notify affected personnel that a new or revised clinical record is available
Manage Obsolete Documents
Withdraw the previous version of the clinical record 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 clinical record management system
- 6.3Retain the obsolete version in the archive for reference
- Conduct periodic checks to ensure no obsolete documents remain at points of use
Quality Checkpoints
Common Mistakes to Avoid
Expected Outcomes
Percentage of documents that are current and within their scheduled review date.
Average time from clinical record change request to approved publication, measuring efficiency of the control process.
Frequently Asked Questions
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 patient requirements.
Can employees 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.
What is the difference between a controlled and uncontrolled clinical record?
A controlled clinical record is managed through the clinical record control process, ensuring it is current, approved, and traceable. An uncontrolled clinical record is a copy that is not guaranteed to be current, typically marked as such.
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