Abstract

As a vital component of a quality system, controlled documentation provides benefits such as: currency and availability of information; preservation of knowledge; management of revisions and obsolete documents; and authoritative approval. Typical documents in a document control system are work instructions, procedures, policies, and verification information about the quality system. There are six basic elements of a document control system. First, the need for documentation follows from customer requirements, regulations, standards, and business objectives. Second, design of the system covers such factors as: ease of use; cost effectiveness; compliance issues; distributive versus centralized control; tight control versus wide access; adequacy of document content; and the application of information technologies. Third, there must be resources such as personnel, training, and equipment, as well as demonstrated support from management. Fourth, the document control system implementation plan should be distributed throughout the organization, so that everyone's activities and responsibilities are clear. Fifth, the system is said to be implemented only after all documents are distributed and all users are trained. Sixth, an organization's regularly scheduled audits should include assessment of the document control system.