In the field of medical products, devices, and components, regulatory requirements and customer expectations are demanding. Throughout the world, manufacturers and their suppliers are expected to comply with the highest standards and regulations.
The last few years have provided ample evidence that control of food safety is critical. Recent media reports have clearly documented supply chain shortcomings that have threatened consumers’ health and safety. These ongoing problems and the need for consumer safety cry out for additional tools to dramatically reduce or eliminate risks.
In 1988, Motorola Corp. became one of the first companies to receive the Malcolm Baldrige National Quality Award. The award strives to identify those excellent firms that are worthy role models for other businesses. One of Motorola's innovations that attracted a great deal of attention was its Six Sigma program. Six Sigma is, basically, a process quality goal. As such, it falls into the category of a process capability (Cp) technique.
Because information in document form drives nearly every action in any organization, the ability to control this information usually means the difference between success and failure. Thus, document control remains the single most critical quality assurance discipline. As with many other systems, document control is more successful if it's simple, intuitive and user-friendly. And the first step toward this end is deciding exactly which documents need to be controlled.