What is Document Control in Engineering Projects?

 Document control is the systematic process used to control documents throughout their lifecycle. The document control process involves establishing procedures for reviewing, approving, tracking, and managing document versions. This process ensures that only the most recent document versions are used.

Companies can implement a document control system to handle document control processes. A document control system is a structured set of processes and procedures designed to ensure control of documents.

Why Is Document Control Important?

This document control process makes sure everyone is always using the latest versions of their files. It achieves this by carefully managing the versioning and approval of documents.

Having a system for document control isn't just a good idea; it's actually required by many rules, standards, and guidelines across lots of different industries.

Document control is really important because it helps keep things consistent, makes it easy to track changes and who made them (traceability and accountability), and keeps the whole process open and clear (transparency). Essentially, it gives you a structured way to manage your documents and helps you meet all the requirements and keep that compliance going.

What Is the Document Control Process?

So, what exactly is the document control process? It’s basically a system of steps used to manage documents from the very beginning all the way through to the end of their useful life.

Here’s a look at the key steps involved:

1. Document Identification: This means giving each document a unique ID number and version number. It’s also important to make sure things like titles and other details (metadata) follow a consistent format.
2. Document Review: Send the document out to the right people so they can look it over and provide feedback.
3. Document Approval: Once reviewed, submit the document for final approval by the people who have the authority to sign off on it. Make sure to keep track of details like the approval date and who approved it.
4. Document Access: Keep all documents stored in one central, secure location. You’ll also need to manage who can see or access them, ensuring only authorized people get in.
5. Document Tracking: Keep records of any changes made to documents and track different versions. This helps you understand the document’s history and current status.
6. Document Retirement: When documents are no longer needed or are outdated, get rid of them or remove them from active use. It’s also wise to mark them clearly as retired so nobody accidentally uses them by mistake.

The illustration below presents a diagram of the document control process.

What Is a Document Control System?

A document control system involves a set of processes and procedures designed to control documents throughout their lifecycle. The document control system ensures that documents are properly identified, reviewed, approved, versioned, and tracked.

A document control system includes processes for maintaining document security, managing version control, and overseeing document review, approval, and submission.

The document control system helps employees stay aware of the document’s state and ensures that only the latest approved document version is accessible while outdated versions are archived.

Document control systems can be paper-based, hybrid (combining paper and digital formats), or fully electronic, depending on the company’s needs and the resources available.

What Is the Difference Between a Document Control System and a Document Management System?

The main difference between a document control system and a document management system lies in their focus.

The document control system controls the review, approval, tracking, and versioning of controlled documents. A document control system ensures only the most recent approved versions of documents are accessible and archives outdated versions. It helps employees know the current state of each document.

The document management system provides functionalities for storing, managing, and distributing documents across a company. A document management system helps users create, find, and share the latest document versions.

Both document management and document control systems are essential and interconnected. A controlled document is a managed document, but not all managed documents are controlled. A controlled document cannot exist without practicing document management.

The illustration below presents the main differences between document control and document management systems.

What is the precise function of a Document Control System in a Quality Management System (QMS)?

In essence, the Document Control System is essential to ensuring that all papers are accurately identified, verified, authorised, and monitored. It all comes down to making sure documents are handled correctly and in accordance with all applicable regulations.

This system is crucial for managing the actual QMS documents. This includes items like records and documentation that outline and support a business's quality procedures, demonstrate that they are adhering to legal requirements, and demonstrate that they are constantly seeking methods to improve.

What Types of Documents Need To Be Controlled?

Document control handles a variety of documents depending on specific industry requirements and company policies.

Documents typically controlled under a quality management system include manuals, policies, standard operating procedures (SOPs), specifications, forms, templates, and records, as described below.

• Quality Manuals: Outline the company’s quality system and its compliance with relevant requirements.
• Quality Policy and Objectives: Define the company’s commitment to quality and its specific goals.
• Standard Operating Procedures (SOPs): Provide directions on how tasks and processes should be carried out within a company.
• Specifications: Describe in detail the requirements that products or materials used or made during manufacture must comply with. Specifications serve as a basis for quality evaluation.
• Forms and Templates: Standardized documents used to consistently capture data and information and support document creation.
• Records: Provide evidence of completed actions in accordance with procedures, work instructions, and specifications.

These examples represent documents across various industries that need to be controlled to maintain quality and compliance.

What Are the Key Components of Effective Document Control?

Listed below are the key components of a document control system.

• Document Number
• Version Control
• Audit Trail
• Periodic Review of Documents
• Access Control
• Change Control

The implementation of these components, along with document approval, updates, and control of external documents, is detailed in document control SOPs and work instructions.

Which Companies Could Benefit From a Document Control System?

Several types of companies can benefit from a document control system, such as the following.

• Medical Device
• Pharmaceutical
• Laboratory
• Healthcare
• Manufacturing
• Engineering and Construction
• Information Technology
• Legal and Professional Services