Glossary Term
Non-Conformance Report (NCR)
Definition
A Non-Conformance Report (NCR) is a formal document used to report a failure to meet specified requirements, standards, or regulations in a product, process, or system. The NCR details the nature of the non-conformance, its root cause, corrective and preventive actions taken, and ensures the issue is resolved and does not recur. NCRs are crucial in regulated industries like MedTech to maintain product quality and regulatory compliance.
Relevance to the MedTech Industry
NCRs are essential for identifying quality issues in medical devices and processes, enabling timely corrective actions. This ensures that products are safe, effective, and compliant with regulatory standards, helping to prevent risks to patient safety and minimize non-compliance with standards like ISO 13485 or FDA regulations.
Additional Information & Related Terms
Related Terms
Corrective and Preventive Action (CAPA): NCRs often trigger the CAPA process to investigate, correct, and prevent future non-conformances.
Deviation: A term used to describe instances where established processes are not followed, similar to NCRs but may not always indicate a failure to meet standards.
Quality Management System (QMS): NCRs are a key part of a QMS, helping track and resolve non-conformances to maintain product quality and compliance.
Root Cause Analysis (RCA): A critical step in NCRs, RCA helps identify the underlying causes of non-conformances to prevent recurrence.
Regulatory Compliance: Ensuring non-conformances are addressed properly is critical to maintaining regulatory compliance with standards like FDA 21 CFR Part 820 and ISO 13485.