Root Cause Analysis: A Key Element Of FDA’s ‘Case For Quality’
This article was originally published in The Gray Sheet
Executive Summary
CDRH is highlighting poor root cause analysis as part of its “Case for Quality,” an initiative to encourage companies to make quality assurance an organization-wide concern.
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 of CDRH’s Office of Compliance.
Most firms “understand that they have 15 days to respond to an FDA-483,” he said. “Because of that limited time to provide that response, the entire dialogue becomes about the FDA-483.
“In some cases that’s OK,” Silverman said. “But in other cases I think the question we need to consider is: Does that create a disincentive to a more thoughtful systemic look at quality issues within the firm and a deeper dive into the root causes of those quality problems?”
In 2009, FDA directed manufacturers to write response letters that thoroughly address inspectional observations within 15 work days after the close of an inspection. (See (Also see "FDA 15-Day Post-Inspection Response Window Can Produce Panic Or Success" - Medtech Insight, 24 Jan, 2011.).)
Since then, FDA has seen a wide range of responses from manufacturers, including some that offer a meaningful, in-depth analysis of issues cited on the FDA-483 and appropriate plans for resolving problems.
However, “other firms seem to take more of a checklist approach and simply want to explain how they are going to quickly fix the specific issues identified on the FDA-483 without demonstrating a deeper understanding of what caused those violations and what needs to happen to prevent those violations from occurring going forward,” Silverman said.
CDRH is highlighting poor root cause analysis in its “Case for Quality,” an initiative to encourage companies to make quality assurance an organization-wide concern rather than the responsibility of a discrete quality assurance unit. (See (Also see "CDRH Quality Initiative Responds To Globalization" - Medtech Insight, 4 Jul, 2011.).)
The Case for Quality was previously called the “Business Case for Compliance.”
The device center teamed with FDA’s Office of Regulatory Affairs (ORA) to create the Case for Quality. The initiative has been in the works since early 2011 and is expected to begin rolling out in December, according to CDRH’s 2012 strategic priorities list.
FDA also plans to review its approach to manufacturing facility inspections.
"If we determine that we can take alternative inspectional approaches that produce an outcome of better device quality, then we're going to consider whether to modify our inspectional approach," said Silverman.
[Editor’s note: A detailed look at FDA’s Case for Quality, plus an article about the agency’s recently proposed rule for unique device identification (UDI), can be found in the July 2012 issue of “The Silver Sheet,” Elsevier Business Intelligence’s monthly newsletter on device quality and compliance issues. For a free trial, call 1-800-332-2181.]