Classifying Information in a QMS provides the Foundation for Practical Quality Management

Posted on March 29, 2012 under Advice by

Manufacturing organizations produce an overwhelming amount of information associated with a variety of processes. Adequately managing processes and the associated information and documents that relate to them (such as inspection sheets, audit reports, nonconformance documents, corrective and preventative actions (CAPA), customer complaints and inquiries) can be daunting and resource-draining tasks, but doing so is mandatory to ensure quality objectives are met.

Organizations that effectively manage their mission-critical quality-related processes and information do so by proactively classifying the information and documentation they develop and manage during the course of business.

Classifying information associated with manufacturing and related quality processes ensures that important information is easy to locate, manage and track. The classification structure paints a comprehensive picture of the information and documentation that, for instance, can impact quality, standard operating procedures (SOP) and related instructions, what decisions were made during various processes (including why certain alternatives were rejected), how processes and resulting products were validated and/or tested, as well as why that testing was reasonable and adequate. Another important objective is to show how a company responsibly processes and responds to errors, deviations, mishaps and complaints.

Below are examples of process categories companies typically established in a quality management system (QMS):

  1. Document control
  2. Personnel
  3. Audits and findings follow-up
  4. Deviations and CAPA processing
  5. Customer feedback processing
  6. Repetitive quality control tasks
  7. Inventories and database listings

Furthermore,  sub-categories under “Document Control” may include specific documents such as:

  1. Quality manuals
  2. Standard Operating Procedures(SOPs) and instructions
  3. Personnel files
  4. Training documents
  5. Quality control task-specific documents (e.g., audit certificates, deviation specific files or photos, customer feedback-related email, etc.)
  6. Item -specific documents (i.e., product documentation or other files associated with equipment such as a user guide, technical specifications or maintenance manual)
  7. Product documents, files linked to equipment, etc….

Quality management systems can be divided into two broad categories: those that simply create and maintain electronic quality manuals, and those that actually manage daily quality-related processes and information. A QMS that organizes, manages and tracks processes and information is fundamentally different from those that focus simply on creating and maintaining an electronic quality manual. In contrast to those systems that focus on the quality manual alone, systems that actually classify, manage and track information and processes make quality management a practical part of daily business operations that ensures quality processes are actually being followed.

In the M-Files white paper, Leveraging Information Management to Improve Quality Systems and Processes, we discuss the importance of classifying content and processes in a quality management system, as well as a variety of other important factors related to practical, day-to-day quality management.

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M-Files dynamic content management solutions are revolutionizing the ECM market by transforming how businesses manage, secure and share information with a unique metadata-powered approach that organizes and processes content based on what it is, rather than where it resides. Thousands of businesses in over 100 countries use M-Files on-premise, in the cloud or in hybrid environments to improve productivity and quality, and to ensure compliance with industry regulations and standards, including companies such as SAS, Elekta and EADS.

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