6 Must-Haves For A Quality Management System (QMS)

By Brian Curran

How much does quality cost? Most companies would be hard-pressed to translate “quality” into a monetary value – that is, in real dollars and cents. What they do realize, however, is that a lack of quality could cost millions of dollars in rework, scrap, recall, or even liability lawsuits. An equally important, but more positive question is, how much does quality earn? Better quality reduces costs, but it also increases sales, brand equity, and productivity.

In regulated environments, such as those under the jurisdiction of the U.S. Food and Drug Administration (FDA) and/or International Organization for Standardization (ISO), quality is closely incorporated into regulations and standards. Quality, therefore, isn’t just good business sense, but also a matter of compliance.

The FDA explicitly states that the overarching philosophy of the pharmaceutical current good manufacturing practice (CGMP) regulations is this: “Quality should be built into the product, and testing alone cannot be relied on to ensure product quality.” Similarly, the ISO 9000 series of standards articulate the importance of making quality an integral part of a manufacturer’s daily operations.

The best way to build quality into a product is with an effective, connected quality management system (QMS), which serves as the foundation for long-term regulatory compliance and market success. However, not every QMS has the same capabilities and connectivity. A QMS that isn’t connected to other areas of the enterprise still slows down quality processes and introduces the possibility of more human error. In this article we highlight six features of a QMS system that will help companies realize maximum value for years to come.