Objective: This Standard Operating Procedure (SOP) outlines the procedures for initiating, incorporating, approving, and recording changes to master documents within [Your Company Name] to ensure document control and compliance with regulatory requirements.
Scope: This SOP applies to all master documents, including but not limited to standard operating procedures, policies, work instructions, and other controlled documents, within [Your Company Name].
Responsibilities:
- Document Owner: Responsible for initiating and overseeing changes to master documents.
- Document Author: Responsible for drafting proposed changes.
- Document Reviewer: Responsible for reviewing and approving proposed changes.
- Quality Assurance (QA) Department: Responsible for verifying compliance with regulatory requirements.
- Document Control Department: Responsible for maintaining and controlling document versions.
- Employees: Responsible for following the procedures outlined in master documents.
Procedure:
1. Initiating Document Changes: a. The Document Owner identifies the need for a change to a master document due to factors such as regulatory updates, process improvements, or identified deficiencies. b. The Document Owner completes a "Document Change Request" form, providing a clear rationale for the proposed change and specifying the affected document.
2. Document Authorship: a. The Document Owner assigns an Author to draft the proposed changes. b. The Author creates a new version of the document using the company&39;s document template or editing software.
3. Review and Approval: a. The Author submits the proposed changes to the Document Reviewer for review. b. The Document Reviewer conducts a thorough review, checking for accuracy, completeness, consistency, and compliance with regulatory requirements. c. The Document Reviewer approves or rejects the proposed changes based on their findings. d. If rejected, the Document Reviewer provides feedback and necessary revisions are made. e. Once approved, the Document Reviewer forwards the proposed changes to the QA Department for verification of regulatory compliance.
4. Quality Assurance (QA) Verification: a. The QA Department verifies that the proposed changes align with regulatory requirements. b. If the changes are compliant, QA provides approval. If not, feedback is given, and necessary revisions are made.
5. Incorporating Changes: a. The Document Owner ensures that approved changes are incorporated into the master document. b. The Author updates the document with the approved changes and generates a new version. c. The Document Control Department ensures the new version is properly labeled, including a unique version number and effective date.
6. Approval of Changes: a. The Document Owner reviews the updated document to confirm that the changes have been accurately incorporated. b. The Document Owner then submits the updated document to the Document Reviewer for final approval. c. The Document Reviewer reviews and approves the updated document, verifying that all changes are correctly reflected.
7. Document Distribution: a. The Document Control Department distributes the updated document to all relevant parties. b. All affected employees are notified of the changes and provided access to the updated document.
8. Recording Changes: a. The Document Control Department maintains a "Master Document Change Log" to record all changes made to master documents. The log should include: - Document title and number - Description of the change - Date of the change - Name of the Document Owner - Name of the Author - Name of the Document Reviewer - QA verification status - Approval status
9. Training: a. All employees affected by the updated document are trained on the changes and the revised procedures, if necessary.
10. Document Archiving: a. The obsolete version of the document is archived for a specified period, as per regulatory requirements.
11. Compliance: a. Regularly review and update this SOP to ensure it aligns with current regulations and industry best practices.
12. References: a. List any applicable regulations, guidelines, or internal documents that support this SOP.
13. Revision History: a. Maintain a revision history of this SOP to track changes and updates.
Approval:
Name: [Your Name] Title: [Your Title] Date: [Date]
Review:
Name: [Name of Reviewer] Title: [Title of Reviewer] Date: [Date of Review]
This SOP is considered effective upon approval and should be followed consistently by all personnel involved in initiating, incorporating, approving, and recording changes to master documents within the organization. Any deviations or non-compliance should be reported and addressed in accordance with company procedures.