Learn the importance of the Quality System Record (QSR) in medical device manufacturing. Understand its role in FDA compliance, documentation, traceability, and quality control. Essential guide for manufacturers to maintain regulatory standards and improve product safety.
The Quality System File is the foundation for compliance with the FDA Quality System Regulation (QSR), found in Part 820. Such a repository is the ideal place to store, index and organize all information from the robust regulatory background set that drives the life cycle of a medical device. The QSR is essential in maintaining quality control processes that manufacturers must follow from the concept/design/development phase all the way through to post-market surveillance.
What is the Quality System Record (QSR) in Medical Devices?
Purpose of this article is to delve into the utmost importance of Quality System Record (QSR) in medical devices industry. Our study breaks down the key components and prerequisites of QSR, its complex role in aiding patient safety and product effectiveness, as well as how it allows manufacturers to yield inherent benefits. It is our hope that medical device manufacturers will fill the gaps in their oversight systems to close any exposure to noncompliance and suboptimal quality systems by providing a detailed knowledge of the Quality System File. This assures them to handle regulations better and further elevating their commitment to compliance, quality, and continuous improvement towards designing innovative lifesaving and life changing medical devices.
Highlights From the Medical Device Quality System Regulation
Applicability and Scope: The quality system regulation (QSR) applies to all manufacturers of a medical device, regardless of the class or type. That adherence to the QSR is necessary to obtain FDA clearance for sale of medical devices in the United States.
Detailed Documentation: According to the QSR, it is necessary for manufacturers of medical devices to maintain a Quality System Record (QSR). The purpose of these record is to consolidate the device manufacturing process, procedure and documentation into centralized repository.
Subpart M of the Quality System Regulation is “Records”. It describes the conditions of record-keeping for the manufacturing and quality control in medical devices.
Quality System Record (QSR): The Quality System Record – Consists of general records, not device specific.
Device Master Record (DMR): Information such as the location of procedures and the documentation of activities, which is required by the regulations contained in Part 820.
Procedures and Documentation are key part of the Quality System Record (QSR). This section will include a quick definition on the procedures that all medical device manufactures need to have in place. These are needed by Part 820 and to be used for compliance to regulatory requirements.
Preparation and Approval:
The QSR must be properly prepared and approved in accordance with requirements outlined in Section 820.40. Such a practice assures that the records are complete, accurate and meets with regulatory obligations as well with FDA guidelines and requirements.
Availability of Records:
The QSR records must be available to FDA employees during scheduled inspections. Ready availability of these records permits the FDA to assesing a manufacturer’s compliance with the QSR.
Records Retention: Medical device manufacturers are required to maintain the Quality System Record (QSR) for a specific period in order to facilitate FDA review. By having records more readily available during inspections, the evaluation process becomes less cumbersome.
The Importance of Quality System Records:
The Medical Device Quality System Regulation includes a proper enforcement in the form of a documentation practice to record all QSR activities, with good reason.
Importance of maintaining a full QSR:
Maintaining a full Medical Device QSR is important for a variety of reasons.
Compliance Verification:
The QSR outlines a map for manufacturers to follow to demonstrate that they comply with FDA regulations. FDA inspectors will be able to determine if the processes used by a manufacturer in producing its devices meet these standards, thus improving the safety and effectiveness of medical devices.
Traceability and Accountability:
The QSR delivers traceability and accountability throughout the manufacturing process by including documentation of activities / procedures. If there is any problem or concern, then QSR enables to identify the source and apply correction immediately.
Better Quality Control:
The QSR serves as a tool for those who develop medical devices to observe and continuously improve the quality controls. It enables regular checks for improving specific areas of the process and ensures that quality standards are upheld within a team.
FDA Inspections:
When FDA sends inspectors, they can ask a registrar to provide the entire quality system record (QSR) and ISO 13485 records for that manufacturer. This allows inspections to be quicker and less disruptive to manufacturing since these data are easy to access.
Compliance with the QSR: Medical device manufacturers need to do several things to be in compliance with the FDA’s Medical Device Quality System Regulation, including:
Diligent Documentation: Manufacturers must have in place rigorous processes to document any and every relevant activity during the manufacturing process. This includes design, development, and production till post-market surveillance.
Training and Awareness: It is important that employees involved in the manufacturing process have the right level of training, they must also be aware about bio burden limits and motivated to follow established procedures. Knowing what they must do to maintain compliance fosters a culture of quality and safety in the organization.
A follow-up system is in place: Proper document control ensures accuracy, completion and accessibility of records. This includes version control, approval processes, and safe storage of documents.
As a part of the QSR, Manufacturers must keep the Quality System Record for the appropriate duration — typically at least two years after shipping the last device. Furthermore, some records like Device Master Records (DMRs) and Production and Process Control records have longer retention periods.
Ongoing Compliance:
Audit the QS program with regular internal audits and management review to identify areas for improvement and ensure compliance with the QSR. CAPAs should be implemented quickly whenever there are problems.
What is the FDA Medical Device Quality System Regulation (QSR)?
The biggest take-home points from this regulation are the need to have a Quality System Record (QSR) in place and to document everything that is done and the expectations for what that means. The QSR functions is a key to offering compliance verification, strengthening quality control measures, and managing seamless FDA inspections.
Conclusion
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