Plastics extrusion has been added to the list of audit opportunities available through MedAccred, the medical device industry's collective approach to critical process supply chain oversight. Sunlite Plastics (Germantown, WI) is the first manufacturing facility in the world to achieve plastics extrusion accreditation through the organization. The scope of accreditation covers tubing/profile extrusion.
|Sunlite Plastics is the first extrusion technology company serving medical device OEMs to achieve MedAccred accreditation.|
As PlasticsToday reported in 2016, the accreditation program replaces some of the routine critical process supplier audits conducted by many OEMs and contract manufacturers (CMs) with a single, robust audit. It is administered by the Performance Review Institute (PRI), a not-for-profit organization that also supports the Nadcap accreditation program for the aerospace industry. MedAccred is modeled after this successful program that has been operating for more than a quarter century.
The plastics extrusion audit covers tubing/profile, sheet, film, blown film, over-jacketing, co-extrusion and ram extrusion. The audit criteria were developed by leaders in the medical device industry who are part of the MedAccred program and are focused on improving product quality and patient safety.
Following an audit, technical experts from leading medical device companies typically review the findings and corrective actions before voting on granting MedAccred accreditation. Medical device manufacturers have pledged their support of the accreditation process, writes Sunlite Plastics on its website, and that is why it chose to put its processes “under the microscope.” Sunlite’s MedAccred accreditation “ensures you’re getting extrusions manufactured under controlled and independently audited processes,” said the company.
In 2016, when MedAccred announced the first plastics injection molder to achieve accreditation through its program— MTD Micro Molding (Charlton, MA)—John Hastings of Johnson & Johnson, one of several medical device companies participating in the MedAccred Plastics Task Group, explained its scope. MedAccred accreditation is not the same as ISO certification, he told PlasticsToday. "ISO is an inch deep and a mile wide, whereas a MedAccred audit is an inch wide and a mile deep for the critical process," he explained. "Our audit criteria are developed for specific processes collaboratively with OEMs and relevant CMs."
In addition to plastics extrusion, the MedAccred program offers industry-recognized accreditation for cable and harness, heat treating, plastics injection molding, printed circuit board assembly, sterilization and welding.