A nonconformance report (NCR) is a document that identifies and records a deviation from a product or process specification, standard, or requirement. It is typically used in quality management systems to document and track issues that may affect the safety, performance, or compliance of a medical device. NCRs are generated when a nonconformance is identified during the course of an audit, inspection, testing, or manufacturing process. The report typically includes details about the nonconformance, such as the location, description, severity, and root cause, as well as any corrective and preventive actions taken to address it. NCRs are an important tool for identifying and addressing quality issues, and are often used in conjunction with other quality management tools, such as corrective and preventive action (CAPA) processes.
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