For Medical Devices
Quality Audit: Most Common Pitfall for Medical Device FirmsAn FDA Medical Device Investigator Talks About Common Problems Pertaining to Quality Audit
The FDA requires medical device firms to conduct quality audits to help ensure product quality and safety, but many firms apparently don't comply. Lack of audit procedures or audit schedule are among the most common problems for these companies during inspections, according to an FDA medical device specialist.
FDA requirements found in the Quality System Regulation call for medical device manufacturers to conduct quality audits to ensure that the quality system is compliant (Sec. 820.22). Firms may choose to conduct internal quality audit either using a system-based approach or a procedure-based approach.
The system approach is broad and may include CAPA, design, production, and management, including system procedures and personnel training. The procedure approach will focus on a single aspect of a manufacturing process. Firms determine the approach that works best for them, and yet, many firms still find it difficult to comply with FDA audit requirements.
Lori A. Carr, medical device specialist with the FDA's Office of Regulatory Affairs (ORA) in the Denver District Office, said the following are some of the most common problems related to GMP audit procedure:
In an interview with MasterControl Inc., Carr, who has been inspecting both domestic and international medical device firms for more than a decade, discusses a wide range of topics related to FDA audit requirements and the GMP audit procedure. Among other things, she talks about the most common problems of medical device firms pertaining to quality audit; things that FDA investigators look for in terms of CAPA and training control, and how to prepare for an FDA inspection.
Read the interview in its entirety: