GLOSSARY

Quality Assurance Auditing

Quality assurance auditing is a critical component of an effective QMS which focuses on reviewing and inspecting the processes and procedures that are used to manufacture medical devices.

Medical device companies selling products around the world must establish a quality management system to ensure that their products are safe and effective for the end user. Quality assurance auditing is an important aspect of the overall quality management system, helping to ensure that manufacturing processes and procedures involved in medical device production are producing devices that conform to the desired specifications.

The objective of quality assurance auditing is to collect information about the ongoing status and functioning of key processes in the medical device manufacturing workflow and to evaluate the performance of those processes against established criteria for process performance. When a process results in too many instances of non-conforming products, quality managers can introduce preventive actions, modifying the process to improve results.

Quality Assurance is a Bench-marking Process

The goal of quality assurance auditing is to gain a better understanding of how manufacturing processes are performing at your medical device company. The performance of each process can be compared to published standards, competitor companies, or targets set by your organization. No process is perfect, but the capacity of medical device companies to compare their processes to an existing standard or specification can indicate which processes can be improved to decrease instances of non-conforming product.

Quality Assurance Auditing Drives Improvement and Compliance

Medical device companies should not be afraid of conducting internal quality assurance auditing. Quality assurance audits are a mechanism for driving improvement within medical device companies by highlighting the best areas of opportunity for improving the manufacturing process to achieve better results. Quality assurance audits can reveal:

Manufacturing techniques that are under-performing compared to defined targets or standards
Opportunities to correct deficiencies in staff or operator knowledge and competence, reducing non-conformance events
Problems with incoming materials that can be corrected by changing suppliers or revisiting purchasing agreements and policies
Process issues that lead to non-conformance events

Quality assurance auditing is also necessary for medical device companies to demonstrate compliance with medical device quality system regulations. Medical device manufacturers that market or sell their devices in the United States must comply with the FDA quality system regulations outlined in 21 CFR Part 820, while those in the European marketplace are subject to the requirements of ISO 13485, the international standard for medical device quality systems published by the ISO.

Quality Assurance Auditing and Your QMS

Quality assurance auditing supports critical aspects of your medical device QMS. The outcomes of quality assurance audits serve as inputs for the corrective and preventive actions (CAPA) process of the QMS, which is used to correct or prevent issues that lead to non-conforming product. Any quality issues discovered through internal quality assurance auditing can trigger a CAPA event, leading to further analysis and the development of strategies to prevent the issue from recurring.

Effective quality assurance auditing is also an essential component of risk management for medical device companies. Manufacturing non-conforming products wastes resources and could pose a safety risk to the end user. Quality assurance auditing helps ensure the safety of manufactured products, reduces waste and limits the risk of product recalls or consumer adverse events that can result from non-conforming product.

Greenlight Guru's eQMS Software Supports Quality Assurance Auditing

Quality assurance audits are mandated by the FDA and required as part of conformance with the ISO 13485 standard. Greenlight Guru's eQMS software makes it easy for medical device companies to transparently schedule and conduct quality assurance auditing, securely store the related documents, and track any CAPA or risk management activities that result from audits. Medical device companies can create a comprehensive paper trail to demonstrate their compliance with ISO 13485 or the FDA QSR.