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Table of Content
1. What is Document Control?
The discipline's definition and key concepts
2. The Role of the Document Controller
Tasks of Document Controllers; Description of the role of a Document Controller
3. Document Processes
Typical processes to manage documents: internal documents, project documents; typical interactions between interfaces (authors, Document Controllers, external entities, etc.
4. Checking Documents
What are the Document Control checks on documents, and what should the Document Controller do in the event of a document anomaly?
5. Document Numbering/Referencing
Document numbering and referencing requirements and concepts
6. Revision Control
Difference between revision and version, types of revision systems, introduction to document status
7. Document Register
What is a document register, and its importance?
1. What is Document Control?
Document control is the practice and technique of enforcing document management rules within a defined scope, such as a workplace. It is the systematic, standardized, and regulated arrangement of documents, data, and information. It is a type of quality control that entails developing and enforcing a set of procedures, control processes, and practices that govern the creation, identification, definition of responsibilities, approval, storage, and protection, distribution, efficacy and release, versioning, periodic review, revision, retention, and disposal of documents within a specific setting.
Document control ensures that all information about a certain part of the workplace is accurate and consistent. Document control also ensures that documentation is reliable and accurate.
According to ISO 9001:2015, organizations must maintain control over the documentation necessary by the quality management system. All of ISO 9001:2015's standards are generic, meaning they may be applied to any business, regardless of its size, type, or products and services. This standard states notably that: "A documented controls procedure shall be established to define the controls needed:
• To approve documents for adequacy prior to their issue,
• To review and update documents as needed, and to re-approve documents,
• To ensure that changes and the current revision status of documents are identified,
• To ensure that documents remain legible and readily identifiable.
• To ensure that documents of unknown origin are identified and distributed controlled, and to prevent the unintended use of
• Obsolete documents, and to apply suitable identification to them if they are retained for any purpose."
• To ensure that relevant versions of applicable documents are available at points of use.
Furthermore, records must be kept and controlled as proof of specification compliance and to demonstrate the success of the quality management system's functioning.
The Document Control Values
• Traceability - Strict revision and modification control ensure that all changes can be tracked and audited. Document deliveries must be documented and tracked (e.g. with transmittal sheets). MDRs, Transmittal Registers, and other registers must be kept up to date with accurate information.
• Integrity - If a document is not fit for use, it should not be issued, published, or circulated. It must, for example, be readable and have no missing pages or attachments. Identification information (e.g. document number, title, revision index, revision date, etc.) must be consistent, correct, and adhere to both internal and external rules (e.g. Document Control method). Issuing or disseminating a document that isn't fit for the purpose might have major effects, including safety issues, legal ramifications, and financial costs.
• Compliance & Gatekeeping – Quality checks, formal reviews and comments, approvals for issuance, registration, modification, and revision control are all processes that documents must go through before being issued. Documents with flaws must not be permitted through review gates. Documents must be processed in a controlled manner, and company regulations and procedures must be followed.
• Consistency - is obtained through following protocols, norms, processes, and rules in a methodical manner. Company templates, which are generated and utilized for four purposes, must also be enforced by Document Controllers:
a. To create a visual identity for the business;
b. To ensure that critical metadata or fields (e.g. author, date, revision number, etc.) are filled out;
c. Authors of documents will save time;
d. To ensure that the appearance of documents is consistent.
Maintaining uniformity, and so indirectly protecting the company's reputation, interests, and expenditure, is part of the Document Controller's job.
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