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.
