Glossary / Lexicon

Deutsch: Dokumentenlenkung / Español: Control de documentos / Português: Controle de documentos / Français: Contrôle des documents / Italiano: Controllo dei documenti

Document control in the quality management context refers to the systematic management, creation, distribution, and maintenance of documents that are essential for ensuring the consistent application of quality standards across an organisation. These documents can include standard operating procedures (SOPs), quality manuals, work instructions, forms, records, and any other documentation that guides or records processes, compliance, or product specifications. Effective document control ensures that only the most current and approved versions of documents are in use, reducing errors and maintaining compliance with quality standards and regulations.

Description

In quality management, document control plays a critical role by ensuring that accurate and up-to-date information is accessible to the right people at the right time. Properly controlled documents are essential for ensuring consistency, transparency, and compliance with industry standards, such as ISO 9001 or other regulatory frameworks.

Key aspects of document control include:

• Creation and approval: Documents must be created following specific guidelines and approved by authorised personnel before they are used.
• Version control: Every document must have a system for identifying versions, so that older versions are archived and only the most recent, approved documents are used.
• Access control: Ensuring that only authorised personnel can access, edit, or approve critical documents helps maintain their integrity and security.
• Distribution and availability: Documents need to be distributed and accessible to employees and stakeholders who require them for their tasks.
• Archiving and retention: Older or obsolete documents must be archived properly for reference, legal, or compliance purposes while ensuring they are not mistakenly used in current operations.
• Audits and reviews: Regular audits of the document control system are essential to ensure that all documents remain up to date and comply with regulatory or operational standards.

The ISO 9001 standard requires organisations to establish a clear document control system as part of their quality management system (QMS). This ensures that all critical documents related to processes, procedures, and quality standards are properly managed and controlled throughout their lifecycle.

Application Areas

Document control is applicable in various quality management areas, including:

• Standard operating procedures (SOPs): Ensuring that the most up-to-date versions of SOPs are used across the organisation to maintain consistency in operations.
• Compliance documentation: Managing documents related to regulatory compliance, certifications, and audits to meet industry or legal standards.
• Product specifications and quality manuals: Controlling design documents and quality manuals ensures that all specifications are followed and any changes are documented and communicated.
• Training records: Ensuring that training materials and records are updated and maintained to show that staff are trained according to the latest processes and standards.
• Customer and supplier agreements: Maintaining proper control over contracts and agreements ensures that quality requirements and specifications are clear and adhered to by all parties involved.

Well-Known Examples

• Pharmaceutical companies: In the pharmaceutical industry, document control is essential for maintaining compliance with regulatory bodies such as the FDA or EMA. Strict control over manufacturing documents, batch records, and validation protocols ensures product safety and quality.
• Automotive industry: Automotive manufacturers use document control systems to manage engineering documents, quality standards, and process instructions, ensuring compliance with industry standards like IATF 16949.
• ISO 9001-certified organisations: Any organisation certified under ISO 9001 is required to have a robust document control system in place, ensuring that documents like quality manuals, policies, and procedures are regularly reviewed and updated.

Treatment and Risks

Managing document control is essential to ensure that processes remain consistent and compliant. However, there are several risks and challenges if document control is poorly managed:

• Outdated documents: If employees use outdated or unapproved documents, it can lead to errors, non-compliance, or product defects.
• Lack of version control: Without proper version control, older versions of documents may be mistakenly used, causing inconsistencies in processes or product specifications.
• Inefficient access: If key personnel cannot quickly access necessary documents, it can lead to delays in production, decision-making, or compliance.
• Audit failures: Poorly controlled documents can result in failing external audits, leading to fines, penalties, or loss of certifications.

To mitigate these risks, companies use several strategies:

• Digital document management systems (DMS): These systems automate version control, approval workflows, and access management, ensuring that documents are always up to date and easily accessible.
• Training and awareness: Employees must be trained on the importance of document control and how to access the most current versions of documents.
• Regular reviews and updates: Organisations should schedule regular reviews of all critical documents to ensure they remain relevant and compliant with industry standards.

Similar Terms

• Records management: Similar to document control but focuses specifically on managing and archiving records for compliance, legal, or operational purposes.
• Change management: The process of managing changes to documents, systems, or processes in a controlled manner to ensure consistency and compliance.
• Information governance: The broader term for managing and controlling all types of information across an organisation, which may include documents, records, and data.

Weblinks

• environment-database.eu: 'Document Control' in the glossary of the environment-database.eu

Summary

In quality management, document control refers to the systematic handling of documents to ensure accuracy, consistency, and compliance with quality standards. It involves managing the creation, approval, distribution, and archiving of critical documents, ensuring that the right information is available when needed. Effective document control is crucial for maintaining regulatory compliance, reducing errors, and supporting continuous improvement within the organisation.

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