Medical device companies must establish and maintain an effective quality assurance process that includes the establishment of user needs, regular quality assurance inspections and a functioning CAPA process that addresses product non-conformance events.
The establishment and maintenance of a quality system is one of the most important requirements for medical device companies that wish to sell their products in the United States and around the world. In the US, medical device companies must comply with the FDA QSR as codified in 21 CFR Part 820. Section 820.70 of this part deals with production and process controls and can be satisfied by implementing a comprehensive quality assurance process.
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.
Components of the Quality Assurance Process
Quality management systems are largely based on the Plan, Do, Check, Act (PDCA) cycle first defined by W. Edwards Deming in the 1950's. Each part of the cycle has its own analog in the quality assurance process.
Plan: Defining User Needs
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.
Do: Manufacturing Medical Devices
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.
Check: Quality Assurance Inspections
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.
Act: Corrective and Preventive Actions (CAPA)
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.
Greenlight Guru's Quality Management Software Platform Integrates the Quality Assurance Process
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.