Miles To Go? Case For Quality Founding Father Silverman Says Joint FDA/MDIC Initiative Isn't 'Where It Should Be'
Executive Summary
Steve Silverman – one of the original architects of the popular Case for Quality when it was launched by US FDA in 2010 – is disappointed that the initiative hasn't come further over the past eight years. "I don’t think that the Case for Quality is where it should be," Silverman, who currently is AdvaMed's VP of technology and regulatory affairs, said at a Case for Quality open forum. His blunt words came despite the momentum building behind several ongoing Case for Quality projects, including a pilot program to assess device-makers' manufacturing maturity and capability.
You may also be interested in...
Boston Scientific, Edwards Lifesciences, Baxter Used CMMI To Measure Their Manufacturing Capability. Here's What They Said About The Experience
Quality, compliance and regulatory officials at the three large device firms – along with their peers at Steris and CVRx – open up about appraisals conducted at their facilities under a voluntary US FDA pilot program that uses Capability Maturity Model Integration (CMMI) to measure the capability and maturity of their manufacturing sites. Along with providing a step-by-step walk-through of the assessments, the officials explain how a CMMI appraisal is nothing like a typical regulatory audit. They also talk about the types of benefits they're seeing (hint: cost-savings, and better manufacturing capability and quality), and how they network via monthly conference calls linked to the pilot. Also: Baxter Healthcare explains why it made its own maturity model, and how it plans to eventually replace the homemade tool with CMMI at all its facilities.
Device-Makers Like Baxter Are Lining Up To Let CMMI Evaluate Their Manufacturing Site Capabilities. Here's What To Expect If You're Appraised
Baxter Healthcare's Elizabeth Zybczynski was excited when she first heard that her company would join a US FDA pilot program to measure the capability and maturity of medical device manufacturing sites. Having worked in the aerospace and defense industries before moving to the health-care arena, Zybczynski knew that the tried-and-true Capability Maturity Model Integration (CMMI) approach could elevate quality in the device industry. CMMI Institute's Kimberly Kaplan and CMMI appraisers Becky Fitzgerald and George Zack explain the maturity model process that Baxter – and 13 other manufacturers – have gone through, from initial intake phone calls to the unveiling of final appraisal results.
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.