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