FAQ
Document Control

Document control is the systematic and organised management of documents within an organisation throughout their lifecycle, from creation to archiving. It ensures that the correct version of a document is available to the right people at the right time. This is crucial for maintaining quality, integrity, and compliance, as well as ensuring information traceability and preventing the use of outdated or unauthorised documents, which can lead to errors, inefficiencies, and potential risks in various industries.

Key components include creating document templates to ensure consistency, developing a clear labeling or naming convention for easy identification and retrieval, establishing a central document storage system (ideally an electronic document management system (EDMS)), implementing version control to track revisions, defining review and approval workflows, defining document access controls for security, and developing a process for disposing of obsolete documents in accordance with regulations. The processes involved cover document creation, review, modification, approval, dissemination, distribution, tracking, archiving, and disposal.

Although the terms are related, document management is a broader term encompassing the organisation and storage of documents. Document control focuses specifically on the systematic management of documents to ensure accuracy, integrity, and exclusive use of approved and current versions. Document control often includes more rigorous procedures for versioning, approval workflows, and access control than general document management. The goal of document control is to regulate documents throughout their lifecycle to prevent errors and ensure compliance.

Effective document control often involves a variety of roles. The document author is responsible for the creation and initial formatting of the document. Reviewers (often document controllers) ensure compliance with procedures, templates, and quality standards. Approvers, typically project managers or technical leads, authorise document release. The document controller plays a central role in document lifecycle management, including registration, quality checks, distribution, maintaining the master document register (MDR), and ensuring compliance with document control procedures and naming conventions. Clients and partners may also have responsibilities related to the review and approval of document deliverables.

The Master Document Register (MDR) is a comprehensive list or database that records all documents related to a project or department, whether deliverables or internal documents. It contains vital information such as document identification details, revision history, review and approval status, distribution details, and transmission information. The MDR is crucial for maintaining an overview of all documentation, tracking the status and lifecycle of documents, ensuring all necessary documents are accounted for, and facilitating audits and traceability.

Document review and approval processes involve defined workflows that specify who should review and approve different types of documents at different stages of their lifecycle. For deliverable documents, this often includes an internal review followed by a client review. Return codes are typically used by reviewers to indicate the outcome of their review (e.g., accepted, commented, not accepted, rejected). These processes ensure that documents are technically accurate, meet quality standards, and are formally authorised before use or distribution. Traceability of comments and approvals is maintained through systems such as comment forms and MDR.

Document statuses indicate the current stage or purpose of a document (e.g., Issued for Review, Issued for Approval, Approved for Design, Issued for Information). These statuses are crucial for understanding a document’s lifecycle. Revision control is the process of managing changes to a document. Each change results in a new version, and once a document is officially submitted or approved, it becomes a new revision. Previous revisions are typically archived to ensure traceability. Proper revision control ensures that everyone is working with the latest approved version and that the change history is recorded.

A distribution matrix (DM) is a controlled document that specifies who should receive copies of particular documents and for what purpose (the “reason” for distribution). It describes the recipients (often by role, function, or department, and can include internal and external stakeholders) for different types of documents or specific documents within a project or organisation. The DM ensures that the relevant personnel receive the necessary information while controlling document distribution. It helps manage communication, ensures the identification of reviewers and approvers, and provides a record of which documents have been issued to whom. The DM is typically established and maintained by authorised personnel and is updated based on project needs or changes in organisational structure. The reason for distribution (specified in the DM) is separate from the document’s status (which reflects its stage in the lifecycle).

Document control is a fundamental principle of quality management systems and is essential for achieving compliance with various standards, including ISO 9001 (Quality Management Systems). These standards have specific requirements for controlling documented information to ensure quality, consistency, and traceability. Effective document control helps organisations meet regulatory requirements, minimise risks, ensure accountability, and demonstrate continuous improvement of their processes and products. For highly regulated industries like medical devices, robust document control is not only a best practice, but a necessity to prevent product failures and ensure patient safety.

Document control systems offer significant benefits to a wide range of industries, particularly those dealing with complex processes, strict regulatory requirements, and large volumes of documentation. Here are some key industries that benefit significantly from these systems:

• Pharmaceutical and Biotechnology Industry: Ensure compliance with strict regulations (e.g., GMP), manage research data, manufacturing processes, and quality control documentation.
• Construction and Engineering: Manage project plans, drawings, specifications, contracts and ensure compliance with standards and regulations.
• Aerospace and Defense: Control design documents, manufacturing procedures, maintenance manuals and comply with rigorous safety and quality standards.
• Manufacturing: Manage production processes, quality assurance documents, work instructions, and safety procedures to ensure product quality and consistency.
• Healthcare: Manage patient records, medical procedures, regulatory documents and ensure data integrity and confidentiality.
• Energy (oil and gas, nuclear): Control technical documentation, safety procedures, operating manuals and comply with strict safety and environmental regulations.
• Finance: Manage financial records, compliance documents, audit trails and ensure compliance with regulations.
• Food and Beverage: Managing production processes, quality control records, safety standards, and regulatory compliance.

Essentially, any organisation that needs to maintain the accuracy, consistency, compliance, and traceability of its information can benefit from a well-implemented document control system.