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Corrective and Preventive Action: What Does FDA Look For During Inspection?

This is a first of a series of articles addressing the topic of what FDA seeks during an inspection. This article also serves to introduce my lecture and workshop scheduled for OMTEC 2011, relative to FDA inspections. (Further details are available following this article.)

The orthopaedic industry faces strong pressure from regulatory bodies as well as from the industry to maintain the quality of medical devices and, concurrently, to lower expenditures as much as possible. An effective corrective and preventive action (CAPA) process is one means to achieve these objectives.

The CAPA subsystem serves to collect and analyze information, identify and investigate product and quality problems and take appropriate and effective corrective and preventive action to prevent recurrence. Risk management tools play a large role in this process, and it involves every facet of the Quality Management System (QMS). A key part of CAPA is root cause analysis, which is utilized to ascertain the source of a problem, non-conformity or defect so that corrective or preventive action can be taken to address the issue.

Verifying or validating corrective and preventive actions, communicating corrective and preventive action activities to responsible people, providing relevant information for management’s review and documenting these activities are essential in dealing effectively with product and quality problems, preventing their recurrence and preventing or minimizing device failures. Today’s FDA investigator is more sensitive to these deliverables because of accelerated and more intense internal training, as well as on-the-job training for new investigators at the district level.

Defined Significance and Scope

Corrective and preventive action(also called corrective action/preventive action) is a concept embodied in 21 CFR, Part 820 (Good Manufacturing Practices, Quality System Regulation – cGMP-QSR) and ISO 13485:2003 (ISO 13485). CAPA focuses on the systematic investigation of discrepancies (failures and/or deviations) in an attempt to prevent their recurrence (for corrective action) or prevent from occurrence (for preventive action). To ensure that corrective and preventive actions are effective, the systematic investigation of failure incidence is pivotal in identifying the corrective and preventive actions undertaken. CAPA, next to Management Responsibility, is the most important process of the overall QMS.

The significance of the device (and any hazard the defective device presents) and/or the process failure should be taken into consideration when determining compliance with corrective and preventive action requirements. Analysis should be taken to the level necessary to determine the actual failure mechanism, e.g., defective component, incorrect raw material, systemic issue, process aberration, etc. The cause of failure is obvious in some cases, and a formal investigation may not be needed. In that case, just a correction might be in order. A record of the investigation, follow up and conclusions shall be made in accordance with 21 CFR, Part 820, section 820.100 and ISO 13485:2003, sections 8.5.2 and .3.