Glossary Term
Non-Conformance
Definition
Non-conformance refers to the failure of a product, process, or system to meet established specifications, standards, or regulatory requirements. In the MedTech industry, non-conformance occurs when a medical device or component deviates from the required standards during manufacturing, testing, or post-market surveillance. Identifying and addressing non-conformance is crucial for ensuring product quality, safety, and compliance with regulatory bodies like the FDA or ISO.
Relevance to the MedTech Industry
Non-conformance is essential for maintaining product integrity and patient safety. By detecting and addressing non-conformances, companies can prevent defective products from reaching the market, avoid regulatory penalties, and protect the health and well-being of patients. The process of managing non-conformance ensures that medical devices are consistently safe, effective, and compliant with industry standards.
Additional Information & Related Terms
Key Features of Non-Conformance
Deviation from Specifications:
Non-conformance occurs when a product or process deviates from the predefined specifications, quality standards, or regulatory requirements.
Example: A batch of medical devices is found to have incorrect dimensions that do not meet design specifications.
Risk to Patient Safety:
Non-conformances may pose a risk to patient safety, requiring prompt action to prevent harm and mitigate risk.
Example: A pacemaker fails to meet the required battery life, potentially affecting its performance in patients.
Regulatory Impact:
Non-conformance can affect a company’s ability to meet regulatory requirements, which may lead to fines, product recalls, or halted production.
Example: Failure to meet sterilization requirements in a batch of surgical instruments leading to a recall.
Corrective and Preventive Action (CAPA):
Non-conformance often triggers the CAPA process, which investigates the root cause, implements corrective actions, and ensures preventive measures are put in place.
Example: A failure in assembly that leads to non-conformance is addressed through process changes and employee training to prevent future occurrences.
Examples of Non-Conformance in MedTech
Manufacturing Defects:An NCR is issued when a batch of medical devices is found to have faulty components, such as defective sensors in an infusion pump, which are traced back to improper calibration during manufacturing.
Sterilization Issues:A non-conformance is recorded when a batch of surgical tools fails to meet sterility standards during testing, leading to a review and update of sterilization protocols.
Labeling Errors:An NCR is raised when a medical device is incorrectly labeled with the wrong usage instructions, requiring a recall and updated packaging procedures.
Software Malfunctions:A non-conformance is reported when a medical device’s software fails to meet the expected functionality, causing errors during clinical use, prompting software reprogramming and updates.
Related Terms
Corrective and Preventive Action (CAPA): Non-conformance often triggers the CAPA process, which investigates the cause and implements actions to correct and prevent recurrence of the issue.
Deviation: Deviation is a term that refers to any departure from established processes, which may or may not result in a non-conformance, but still requires documentation and resolution.
Quality Management System (QMS): Non-conformance is an integral part of a QMS, ensuring that all issues are properly identified, tracked, and resolved to maintain compliance and quality standards.
Root Cause Analysis (RCA): Root cause analysis is used to identify the underlying cause of non-conformances, ensuring that corrective actions address the source of the issue, not just the symptoms.
Regulatory Compliance: Non-conformance can jeopardize a company’s regulatory compliance, which is why issues must be promptly reported and addressed to meet industry standards like ISO 13485 or FDA 21 CFR Part 820.