November 16, 2012

FDA Scrutiny of Medical Device Firms' Quality Systems Continues

This week I attended a review of recent FDA activities presented by the law firm Pepper Hamilton.  It was an interesting presentation, and while several topics were discussed, one that caught my attention  was the continued concerns for quality system deficiencies, especially for medical device manufacturers.

In 2011, 70% of FDA warning letters sent to medical device firms were for quality system deficiencies, with the most common related to Corrective and Preventive Action (CAPA) requirements.  Consistent themes included CAPA procedures that were lacking or inadequate, the lack of verification/validation of CAPAs,  and the inadequate implementation of CAPAs.   Inadequate CAPA procedures included:
  1. Failure to analyze all sources of quality data (e.g., complaints, adverse events, non-conformances, or deviations) with appropriate statistical methods to detect quality problems;
  2. Failure to initiate CAPAs in response to possible quality problems, and
  3. Inadequate documentation of CAPAs. 
Similar trends are recurring for 2012.

Much of my career has been spent in a manufacturing environment (not in medical devices), and these types of quality issues have been around for more than 30 years.  While good quality systems can be expensive to implement, the ultimate savings, good customer will, and improved plant (and company) culture they provide can be eye-opening.  These programs usually also require a culture change throughout the organization (not just in manufacturing), and they must be driven from top management to be effective.  Perhaps these commitments are why quality system efficiencies still exist today? 

The author of this blog, Mike Fisher, is the President of The CECON Group, Inc.  and has a background in engineering, marketing, and strategic planning.


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