Quality Audit: Most Common Pitfall for Medical Device Firms

An 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:

  • No audit procedures.
  • No audit schedule.
  • Schedule (or changes to it) was not approved.
  • Schedule is not followed.
  • Schedule does not include required areas according to the firm's own requirements.
  • When audits are not conducted according to the proper procedure (checklist), there's no documented reason for it.
  • Poor auditor training or no evidence of auditor training.
  • No re-audits (or change in schedule) despite failed audits from CAPA.
  • No tie-in to CAPA or management review.
  • GMP audit procedure does not require challenging the system in terms of sample size, time frame being covered, and review of records.
  • Quality audit is inadequate because it looks only for existence of procedures and records, not the accuracy or completeness of records.
  • No procedure for (or records of results) of any informal audits.

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: