Root Cause Analysis A Key Element Of FDA’s ‘Case For Quality’
• By Shawn M. Schmitt
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.
It’s not unusual for device manufacturers to display tunnel vision after receiving an FDA-483 inspection form, focusing only on quickly fixing the noted violations and failing to dig deeper to discover root causes.
Companies “often concentrate their efforts on addressing quality system citations to the exclusion of systemic fixes,” said Steven Silverman, director...
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