Quality Document Control


Quality Document Control: The Most Critical Quality Assurance Discipline

During the manufacturing process, all regulated organizations must adhere to quality document control best practices. This is dictated by stringent ISO quality standards as well as rigorous regulations issued by the FDA and other global regulatory authorities. Because documentation drives almost every action in a company, the ability to control it can mean the difference between an organization's survival and extinction in the competitive life sciences and manufacturing industries. Regulated companies that are able to effectively control and retrieve the information they need, such as SOPs, work instructions, engineering change orders and the like, during critical audits and inspections, can more easily avoid the manufacturing mistakes that ultimately lead to fines, penalties, and costly production delays. For this reason, quality document control continues to be the most critical quality assurance discipline, and the most important aspect of any quality management system (QMS).


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How You Determine Whether a Document Requires Quality Document Control Measures

Companies should not view quality document control mandates, such as ISO 9001, as a curse. In truth, they can be blessings in disguise. Organizations that effectively control and manage their documented information enjoy a distinct competitive advantage, not to mention a more efficient quality team, enhanced product quality, improved brand equity, and, ultimately, a reduced cost of compliance. This begs the question: given all of the advantages of effective document management, why do so many regulated companies continue to struggle with or postpone the implementation of effective quality document control procedures? For many, it's a simple as knowing which documents need to be controlled and which do not. While this seems quite basic, it makes sense when one considers the vast amount of documentation that might require control within an organization. Although FDA regulations and international standards require regulated companies to establish compliant documentation processes, few, if any, concrete guidelines are given. Conversely, the ISO 9001 standard provides direct guidance on this matter.

Section 4.2.3 of the standard states: "All documents required by the quality management system shall be controlled." In other words, if the document in question relates to any of the requirements discussed in ISO 9001, quality document control measures are required. For example, if the information contained in the document guides the production of the goods or services provided by the company, it must be controlled. If personnel make production decisions based on the information contained in the document, it must be controlled. If the information contained in the document is critical to product safety, the document must be controlled. Finally, if the verification, inspection, or testing of the company's products, i.e., goods or services, are guided by the information contained in the document, quality document control procedures are necessary.

The Basic Tenets of Effective Quality Document Control

While not exhaustive, the aforementioned examples illustrate some of the considerations an organization should examine when determining whether a document should be controlled. Once this fundamental determination is made, the quality team can move on to the actual process of controlling the document by employing several quality document control procedures. These procedures include:

  • Document Approval - Before a document is utilized, it must be approved for accuracy and/or adequacy. In paper-based document management systems, this is usually achieved by requiring authorized persons to sign or initial the document. This can be a complex and time consuming process, particularly if the document requires the approval of several employees from different departments. When these departments are spread out geographically, the complexity increases.
  • Periodic Document Review, Revision, and Reapproval - ISO 9001introduced the quality document control procedure of requiring companies to routinely review their documents for continued validity. It's important to note, however, that this requirement goes beyond routine document revision. Rather, it refers to the process of periodically recalling documents to determine whether the information contained in the document is still accurate and relevant. Depending upon the findings, the document will either be reapproved as is, updated as necessary, or retired. These types of quality document control reviews can either be triggered on a strictly periodic basis, e.g., annually, or because of business events (e.g., product changes), technological breakthroughs and the like. One disadvantage of the periodic approach is, unless an automated document management system is in place, its success depends heavily upon the employee in charge, and whether he or she is disciplined enough to conduct the reviews within the specified time frame in addition to performing all of his or her other daily tasks.
  • Revision Status Control - A document's current revision status must always be identified. This important quality document control procedure prohibits the use of obsolete or unapproved documents, which can compromise compliance. With electronic systems, the most current document version is provided automatically. However, with paper-based systems, human error can often lead to mistakes in tracking and identifying the most current revision number.
  • Document Accessibility - If a document is not easy to access precisely when it is needed, it's virtually useless. It also contradicts the ISO 9001 requirement that "relevant versions of applicable documents are available at points of use." Making documents easily accessible throughout the document lifecycle is another important quality document control tenet.

As you can see, the basic tenets of document control are relatively simple, and simplicity is key. Just as some companies make of the mistake of not having enough document controls in place, others make the equally critical mistake of implementing too much complexity into their document procedures, which can lead to ambiguity, and an excessive supply of unnecessary information. Good documentation practices can dramatically improve an organization's efficiency and effectiveness. Implementing the basic tenets of quality document control will unburden your quality management system of superfluous documentation.

Find the Right Balance Between Quality Document Control and Simplicity with MasterControl

MasterControl Inc. is the foremost global provider of enterprise quality document control management software specifically designed to ensure conformance with regulatory requirements such as ISO 9001:2000. Web-based and configurable, the MasterControl document control management solution, MasterControl Documents, enables highly regulated companies to streamline their document control processes, and to provide its users with the relevant documentation they need quickly and easily. Furthermore, MasterControl makes is possible to connect document management with other quality process, such as CAPA and change control, ensuring that compliance and overall quality improvements are continually promoted across the enterprise. Here are just some of the ways in which MasterControl Documents simplifies the quality document control procedures outlined above.

  • Automates document routing, escalation, and approval - Typically, product documentation has a complex lifecycle that is further complicated with workflows and routing. MasterControl reduces document cycle time by automating routing and approval and incorporating escalation for overdue tasks. Automating these processes helps sustain compliance - and eliminates the human error than can occur with the periodic approach to document review.
  • Eliminates out-of-sync metadata - Any change made to document metadata, which includes document attributes like title, author, etc., must be tracked, and a reason for the change must be provided. This is simply a fact of good quality document control. When revising a Microsoft Word® document, updated metadata information can be automatically transferred to the document header from the InfoCard, which is the MasterControl tool used to provide basic document information.
  • Improves change control - With MasterControl, users are able to seamlessly track the changes between the revisions of an item in the MasterControl system and make them available for review.
  • Simplifies revision number control - Being able to control the revision number of a document is one of the most challenging aspects of quality document control, particularly in paper-based systems where human error is inevitable. MasterControl's automatic revision control feature ensures that only the most recent version of a document is made available, which helps users avoid the mistake of obtaining information from obsolete or unapproved documents.
  • Promotes fast, easy document accessibility - Because MasterControl allows you to capture and store all of your important documentation in one secure, centralized location, employees across departments, as well as across the world, can easily search for an access the information they need. Furthermore, automating your paper processes with MasterControl enables you to implement consistent, efficient quality document control workflow processes that minimize the time it takes to locate, revise, and approve documents, which can help you avoid being unable to locate an important document during a critical audit or inspection.

For More Information about Quality Document Control

For more information about quality document control management, please contact a MasterControl representative.