Root Cause Analysis A Key Element Of FDA’s ‘Case For Quality’
This article was originally published in The Silver Sheet
Executive Summary
CDRH is highlighting poor root cause analysis as part of its “Case for Quality,” an initiative that encourages companies to make quality assurance an organization-wide concern. Since FDA directed firms in 2009 to write FDA-483 response letters within 15 workdays after an inspection, the agency has been concerned that companies might feel compelled to fix every citation listed on the inspection form quickly without considering root causes. “What we are worried about is that this perceived need to respond in such a manner may prevent firms from taking time for a greater root cause assessment of the systemic problems that gave rise to the FDA-483 citations,” CDRH Office of Compliance Director Steven Silverman said. The Case for Quality will also examine how companies are inspected and how to make device quality data more accessible to firms.
You may also be interested in...
Ex-FDA Device Compliance Chief Steve Silverman Joins AdvaMed
Steve Silverman, former director of compliance at FDA's device center, has moved from a consulting role at McKinsey & Co. to AdvaMed, where he will serve as VP of technology and regulatory affairs.
Guest Column: Understanding AdvaMed's ‘Library Of Successful Quality Practices’
AdvaMed’s Sharon Segal introduces the device industry group’s new “Library of Successful Quality Practices,” a resource for manufacturers to enhance their own quality processes.
GUEST COLUMN: New AdvaMed ‘Library Of Successful Quality Practices’
Online-Only Content >>> AdvaMed’s Sharon Segal introduces the device industry group’s new “Library of Successful Quality Practices,” a resource for manufacturers to enhance their own quality processes.