Prepared by: [Your Name]

I. Introduction

This SOP outlines the procedures for managing and controlling documents within the Quality Management Department of [Your Company Name]. The document control process ensures that all documents are reviewed, approved, and distributed appropriately, maintaining accuracy and compliance with regulatory requirements.

II. Purpose

The purpose of this SOP is to define the standardized process for creating, reviewing, approving, and controlling documents to ensure that only current and approved versions are used within [Your Company Name]. This process helps to maintain the integrity and traceability of all documents.

III. Scope

This SOP applies to all employees within the Quality Management Department at [Your Company Name] who are responsible for document creation, review, approval, and distribution. The procedures cover all types of controlled documents, including but not limited to, policies, procedures, work instructions, and forms.

IV. Definitions

• Document Control: The process of managing documents to ensure that only current and approved versions are available for use.

• Controlled Document: Any document that is subject to revision control and must be approved before distribution.

• Revision: A change made to a document that requires review and approval.

V. Roles and Responsibilities

Document Controller:

• Manages the document control process, including the creation, review, approval, and distribution of documents.

• Maintains the document control system and ensures all documents are up to date.

• Archives obsolete documents and maintains records of revisions.

Department Manager:

• Reviews and approves documents relevant to their department.

• Ensures that employees are informed of and have access to the most current versions of documents.

• Provides feedback on document revisions and suggests improvements.

Quality Assurance (QA) Team:

• Conducts periodic audits to ensure compliance with document control procedures.

• Reviews and verifies that documents meet regulatory and company standards before approval.

VI. Procedure

Step 1: Document Creation

1. Drafting:

   • The document originator drafts a new document or revises an existing one using the standard document template.

   • The draft should include a clear title, document number, revision number, and date.

2. Initial Review:

   • The draft document is submitted to the Department Manager for initial review and feedback.

   • Any necessary revisions are made before moving to the approval stage.

Step 2: Document Review and Approval

1. Review Process:

   • The draft document is reviewed by the Document Controller to ensure it meets all formatting and content requirements.

   • The document is then sent to relevant stakeholders, including the QA Team, for review.

2. Approval Process:

   • Once the document passes the review stage, it is submitted for final approval to the Department Manager and any other required approvers.

   • Approved documents are signed off electronically and given a final revision number.

Step 3: Document Distribution

1. Controlled Distribution:

   • The approved document is uploaded to the Document Management System (DMS).

   • Notifications are sent to relevant departments to inform them of the new or revised document.

2. Access Control:

   • Access to controlled documents is restricted to authorized personnel based on their role.

   • Obsolete documents are removed from circulation and archived in the DMS.

Step 4: Document Revision and Obsolescence

1. Revision Process:

   • When a document requires revision, the originator drafts changes and follows the same review and approval process as for new documents.

   • Revised documents are assigned a new revision number and date.

2. Obsolescence Management:

   • Obsolete documents are archived in the DMS with a clear indication of their obsolescence.

   • A record of all obsolete documents is maintained for reference and audit purposes.

VII. Documentation and Records

VIII. Compliance and Quality Assurance

Compliance Measures:

• All controlled documents must go through the review and approval process before use.

• Only the most current version of a document should be in circulation.

Quality Assurance Audits:

• The QA Team will conduct semi-annual audits to verify compliance with document control procedures.

• Any non-compliance will be documented, and corrective actions will be taken.

Metrics:

• Document Turnaround Time: The time taken from document creation to approval should not exceed 30 days.

• Revision Compliance Rate: Target of 100% compliance with document revision procedures.

IX. Revision History

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