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.
The third of a multi-part Medtech Insight feature series on the appraisal of manufacturing capability and maturity, and what it means for the medical device industry.
[Editor's note:This is the third of a multi-part Medtech Insight feature series on the appraisal of manufacturing capability and maturity, and what it means for the medical device industry. Check out Part 1 at https://bit.ly/2jGPlL1, Part 2 at https://bit.ly/2K6TWRV, and Part 4 at https://bit.ly/2pnSFNR.]
Four years ago, Baxter Healthcare Corp. wanted to get a bird's-eye view of how well its quality system was functioning, so it crafted its own maturity model. Dubbed...
In the context of manufacturing, "maturity" means a firm has adequately developed practices and processes to ensure that quality is pervasive throughout its organization, which in turn should lead to...
