The establishment and maintenance of a quality system
Under this legislation, medical device companies must develop, conduct, control and monitor their production processes to ensure that medical devices conform to the required specifications.
Quality management systems are largely based on the Plan,
The goal of quality assurance is to gather information about the on-going status of processes and use that information to evaluate their performance against defined criteria. The first step to organizing a quality assurance process, therefore, is the definition of user needs and the translation of those user needs into requirements for the manufacturing process. Performance criteria for manufacturing processes can be derived from a variety of sources, but the first step is to establish specifications that manufacturing processes can be measured against.
Once a medical device company has gotten through the design controls process, it's time to start manufacturing devices. Criteria for workmanship in the manufacturing process should be clearly expressed in documented standards and SOPs that control the manner of production for medical devices.
Once the manufacturing process has begun, regular quality assurance inspections should be conducted to monitor output quality on a continual basis and drive improvement throughout the product realization and manufacturing processes. Regular quality assurance inspections should include reviews of environmental and contamination controls, equipment and maintenance schedules, personnel and training, materials, and the manufacturing processes themselves. The results of quality management inspections should be documented and securely stored in the medical device QMS.
When a quality assurance inspection reveals inconsistencies in production or other issues that could lead to product non-conformance, medical device companies and quality managers should take action to correct the issue. Through the corrective and preventive actions (CAPA) process of the QMS, medical device companies can create reports on known quality issues, conduct a root cause analysis to determine where the problem originated and create, implement and review a strategy for correcting the problem and preventing a recurrence.
Compliance with the FDA QSR is a mandatory requirement for medical device companies in the United States, but a focus on true quality in production can help you build better devices and reduce risk, while protecting your company's reputation. Greenlight Guru's eQMS software creates a single source of truth for medical device quality data, including all documentation generated through the quality assurance process.
With Greenlight Guru, medical device companies can easily track and manage their device specifications, manufacturing SOPs, quality audit results and CAPA activities to ensure compliance, better quality in production and decreased time to market.