Standard Operating Procedure (SOP)

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.

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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.

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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.

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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.

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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.

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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.

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VII. Documentation and Records

Document	Location	Retention Period
Controlled Documents	Document Management System (DMS)	10 Years
Revision Logs	Document Controller’s Office	10 Years
Approval Records	DMS	10 Years

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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.

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IX. Revision History

Revision No.	Description of Changes	Date
1	Initial SOP implementation	2050-02-01
2	Added access control procedures	2051-04-10
3	Updated audit frequency and metrics	2052-07-25

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