Auditing is a reality in the world of medical devices. There are many types of audits, including, but not limited to, first-party, internal, independent, supplier, external and agency audits. Regardless of the audit’s nature and scope, the outcome is basically the same. Typical audit outcomes require some sort of action to come into compliance with standards or regulations and make improvements to quality management systems.
A quality system audit is one of the most important Good Manufacturing Practice (GMP) requirements. Auditing medical device quality systems is like auditing quality systems everywhere, but with a distinct difference. Whereas other quality systems may look more at quality as a component of customer satisfaction, a medical device audit focuses on ensuring compliance with US Food and Drug Administration (FDA) or other regulatory agency requirements and applicable regulations with the goal of achieving patient safety and product effectiveness. Auditing any quality system will include auditing the quality system requirements (QSRs) and examining areas such as how to ensure products meet specification and whether they meet customer expectations.
FDA’s Quality System Inspectional Technique (QSIT) is designed to determine, for each subsystem, whether a firm has the appropriate controls in place and follows procedures to ensure its products conform to specifications. From these observations, FDA forms an impression of the quality system’s overall adequacy; and using QSIT, an FDA investigator will examine different products and different processes during each inspection.
Regardless of an audit’s nature and scope, corrective and preventive actions (CAPAs) typically are identified to help drive compliance to standards and continuous improvement(s). Audits often identify areas that need improvement and offer valuable insight into the proper functioning of a compliant quality system.