In January 2016, MTD Micro Molding in Charlton, MA became the first micro injection molding company to pilot the new MedAccred Plastics Injection Molding audit criteria. Three weeks later, BMP Medical of Gardner, MA became the first injection molding company to complete a pilot audit against the new audit criteria.
The pilot audits follow the successful development of “Audit Criteria for Injection Molding” (AC8160) by the MedAccred Plastics Task Group. The members of the Task Group come from companies including Abbott, Baxter Healthcare, Becton, Dickinson & Co., Boston Scientific, GW Plastics, Johnson & Johnson, Philips, Stryker, Mack Molding, Medtronic, Plastikos, BMP Medical and MTD Micro Molding. The plastics injection molding audit criteria draw from Industry Standards as well as common customer specifications.
MedAccred is an industry managed supply chain oversight program that bolsters patient safety. It does this through clarification of requirements and better identifying how they apply to critical processes used in the production of medical devices.
Reflecting on her company’s experience, Lindsay Mann, Director of Marketing for MTD Micro Molding said, “It was a great opportunity to look closely at our processes in the MedAccred pilot audit and measure our process against the audit criteria created by key members of the medical device industry. Our goal as a supplier is to meet or exceed their needs and requirements. We view the MedAccred plastics accreditation as a very powerful tool for medical OEMs and their suppliers”.
Mike Faulkner, President at BMP Medical, stated that, “Participating in MedAccred has many advantages for BMP Medical and our customers. As always, we strive to ensure that our products are manufactured to the highest quality standards. Our commitment to support the accreditation process will take us to another level, demonstrating that we strive to stay on the cutting edge of continued process improvement as well as meeting and exceeding the requirements of our medical device partners and industry standards.”
The data from the pilot audits will be used to validate the audit criteria, and make adjustments as needed, to ensure that it is a comprehensive and relevant assessment tool that adds value for the medical device industry.
Joe Pinto, Executive Vice President and Chief Operating Officer of PRI commented, “MTD Micro Molding and BMP Medical should be commended for stepping forward to participate in this very important pilot audit. Their efforts, alongside those of their colleagues on the Plastics Task Group, will result in a set of robust audit criteria which will be used to verify critical process compliance for injection molding across the whole of the Medical Device industry.”