Glossary Term
Quality Risk Management (QRM)
Definition
Quality Risk Management (QRM) is a structured process for identifying, assessing, controlling, and monitoring risks throughout the lifecycle of a product or process to ensure that it meets quality standards. In regulated industries like medical devices, QRM helps mitigate potential risks that could affect product safety, efficacy, and regulatory compliance. The process involves evaluating potential hazards, understanding their likelihood and impact, and implementing controls to minimize or eliminate those risks. QRM is a key part of quality management systems (QMS) and is essential for maintaining consistent product quality and meeting regulatory requirements.
Relevance to the MedTech Industry
The aim of Quality Risk Management processes are to ensure that risks are systematically identified, assessed, and controlled throughout the product lifecycle, from design through post-market surveillance. QRM helps organizations prioritize their resources and efforts on the most critical risks, thereby improving product safety, regulatory compliance, and operational efficiency. In the medical device industry, QRM is essential for ensuring that products are safe for patient use and that the company meets the stringent quality and regulatory standards set by agencies like the FDA and ISO.
Additional Information & Related Terms
Related Terms
ISO 14971: An international standard for risk management in medical devices, providing a structured process for identifying, assessing, and controlling risks throughout the device lifecycle.
Risk Assessment: The process of evaluating risks by identifying hazards, estimating the likelihood of their occurrence, and assessing their potential impact on the product, patient, or process.
Risk Control: Actions taken to eliminate or reduce identified risks to acceptable levels, often through design changes, process controls, or protective measures.
Corrective and Preventive Action (CAPA): A process within QRM that focuses on addressing root causes of identified risks or quality issues to prevent recurrence.
Post-Market Surveillance: Ongoing monitoring of product performance and safety after market launch to identify new risks or validate the effectiveness of risk controls.