The Effects of Document Control on Certain Industries and Risk Management

Posted by Romeo Elias on Thu, Mar 15, 2018 @ 09:41 AM

 

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The purpose of document control is to enforce controlled processes and practices in industries such as pharmaceutical, nutrition, and medical where there is a need to create, review, modify, issue, distribute, and access documents. Document control ensures critical data is indexed and searchable. It helps reduce errors in documentation and allows automation of tasks.

Document control ensures that documentation is accessible at all official points within an organization and is trusted by its users to contain accurate, up-to-date information that’s reliable and formally approved.

Document control applies to any business as it ensures efficiency, reliability, traceability, performance, quality, and safety. It is also a requirement from the ISO 9001 international standard which improves your market entry chances and gains your business a decisive competitive advantage.

ISO 9001 sets the foundation for you to increase efficiency and improve your processes and structures while minimizing your liability risk as it establishes the standards for creating and maintaining a quality management system (QMS).

Requirements of ISO 9001

  • Maintain a set of procedures that cover all key processes in the business
  • Monitor processes to ensure that they are effective
  • Keep adequate records
  • Check product output for defects, and use appropriate corrective action when necessary
  • Regularly review individual processes and the quality system itself for effectiveness
  • Facilitate continual improvement according to ISO 9001 standards

The Pharmaceutical Industry

In the pharmaceutical industry, document control is closely intertwined with quality control. According to the Good Manufacturing Practice (cGMP) regulations that are applied in the pharmaceutical industry, the responsibilities and procedures applicable to the quality control unit be in writing. These written procedures must be followed, and any deviations from them must be justified and documented.

The Food Industry

At the core of food control activities is the establishment of standards for safety, quality, and labeling. The food industry has a broad view of food control that involves factors such as safety, nutrition, quality, and value.

In nutrition, controlled processes include maintaining nutrient levels in food ingredients and formulating nutritional profiles that contribute to consumer interest. Appropriate documentation of procedures must be established to ensure that their control systems are defined, recorded, and maintained to permit auditing and verification that the systems have been correctly applied.

The Medical Industry

In the medical industry, document control systems are also at the heart of an effective quality system as it allows organizations to centralize their documents which include everything from work instructions to policies and procedures. An automated document control system has been the key to avoid errors committed by manual and time-consuming processes.

Document Control and Risk Management

These automated document control tools impact risk management as it significantly improves project accountability. Routing for revision and approval is automated, and access to essential documents is centralized.

Having accurate records requires access controls and tracking. Access is limited to individuals with the relevant permissions thus eliminating versioning issues, delays, or lost items. Only a system that automatically creates and stores copies of all date and automatically collects acknowledgment receipts whenever people access specific documents can accomplish that.

 

Topics: Document Control, Quality Management Software, Quality Management System, Risk Management, quality