Glossary Term
Quality Metrics
Definition
Quality metrics are measurable indicators used to assess, monitor, and improve the quality of processes, products, or services. In the context of the medical device industry, quality metrics track various aspects of manufacturing, design, regulatory compliance, customer satisfaction, and product performance. These metrics help organizations gauge the effectiveness of their Quality Management System (QMS) and ensure that products meet safety, performance, and regulatory standards. Common quality metrics include defect rates, customer complaints, product returns, and compliance audit results.
Relevance to the MedTech Industry
Quality metrics provide objective data that helps organizations assess the effectiveness of their quality management practices. By tracking performance over time, organizations can identify areas for improvement, ensure compliance with industry standards, and enhance customer satisfaction. In regulated industries like medical devices, quality metrics also play a crucial role in ensuring product safety and regulatory compliance.
Additional Information & Related Terms
Related Terms
First Pass Yield (FPY): A quality metric that measures the percentage of products that pass the production process without needing rework or repairs, indicating process effectiveness.
Corrective and Preventive Actions (CAPA): A system used to identify the root causes of product defects or quality issues, address them with corrective actions, and prevent recurrence with preventive measures.
Non-Conformance Report (NCR): A report that documents instances where products or processes do not meet quality standards, triggering corrective actions or process improvements.
Statistical Process Control (SPC): A methodology for monitoring and controlling the quality of processes through statistical analysis of performance data, often used in manufacturing environments.