Success Of Case For Quality Program Triggers ‘Culture Shift’ At FDA's Device Center, Officials Say
CfQ VIP has pushed “CDRH to rethink how we do things across the whole spectrum of activities,” says the device center’s Vicenty
The US FDA’s Cisco Vicenty and Bleta Vuniqi say the Case for Quality Voluntary Improvement Program has shifted the culture at the agency’s Center for Devices and Radiological Health. That shift is “starting to … feed and percolate into other areas and other activities that the center’s been engaged in,” Vicenty says.
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The Case for Quality Voluntary Improvement Program, run jointly by the US FDA and the Medical Device Innovation Consortium, is leaning heavily on remote quarterly checkpoint meetings with participants in lieu of on-site appraisals. CFQ VIP aims to elevate product, manufacturing and process quality at device firms by assessing the companies against a modified version of the Capability Maturity Model Integration (CMMI) framework.
Chasing Quality Isn't Easy. But An FDA Pilot Aims To Boost Quality By Appraising The Capability Of Manufacturing Sites
The pursuit of quality can be a daunting task for device-makers. One wrong step can cause costly product recalls affecting patient health – among other troubles tied to poor quality products and processes. To help firms move toward a goal of best-in-industry quality, US FDA, through its Case for Quality initiative, has convened a pilot program to measure a manufacturer's capability and maturity to help put it on a path to continuous improvement. The pilot uses an industry-tailored version of the Capability Maturity Model Integration (CMMI) model and method, developed jointly by FDA, industry and CMMI Institute.
The recalled vents are designed to provide high-flow therapy to patients, but problems can crop up “if the system pressure reaches the default maximum limit,” the US agency says. The recall is more bad news for Philips, which recently initiated a separate class I recall of certain breathing and ventilator devices.