Ensuring Critical Manufacturing Process Quality

After establishing a foundational understanding of MedAccred, we conducted an internal review of the injection molding audit criteria and engaged with PRI to gain a comprehensive understanding of the audit and accreditation process. As the MedAccred program evolved, plastics assembly was gradually incorporated, providing an opportunity to participate in the pilot phase of the audit criteria.

Given our existing partnerships with several MedAccred Subscribers, including work in plastics assembly, participating in the plastics assembly pilot was a natural progression. This opportunity enabled us to gain valuable insight into the audit process. Following accreditation in plastics assembly, we plan to pursue injection molding accreditation. With a compressed timeline of only a few months, we worked diligently to understand the plastics assembly audit criteria and implement all required processes and controls.

Prior to pursuing MedAccred accreditation, our plastic assembly processes were guided by equipment supplier recommendations and documented through part-specific work instructions. Over the years, we have successfully undergone numerous customer audits, consistently leveraging feedback and observations as opportunities for continuous improvement. PTA Plastics has also benefited from long-standing relationships with MedAccred Subscribers, incorporating applicable best practices into our operations wherever feasible.

 Despite this strong foundation, a comprehensive MedAccred gap analysis identified several areas requiring further development. In response, we established a cross-functional team that met weekly to address nonconformities. Responsibilities were distributed across team members, with each focus area assigned a dedicated champion to drive timely and thorough resolution.

By formally documenting processes that were not previously required under ISO, we have effectively mitigated risks associated with tribal knowledge. Particular emphasis has been placed on enhancing work instructions to ensure they are clearer, more comprehensive, and easier to follow.

In addition to the tangible benefits of achieving MedAccred accreditation, our organization has earned a strong reputation among industry professionals worldwide. As a company committed to remaining at the forefront of innovation, PTA Employee-Owners take great pride in being the first to achieve global accreditation for plastics assembly. This accomplishment is reflected within our facility, where our MedAccred certificate is prominently displayed.

Since the MedAccred Audit, PTA Plastics has:

• Reduced finishing defects
• Improved total internal scrap (including molding and finishing)

MedAccred

MedAccred is a consensus-driven approach managed by the industry to maintain process quality in the medical device supply chain. Audits are performed by subscribing members who use jointly established criteria. Accreditation is given and approved by MedAccred subscribing OEM members. The audit criteria integrates industry-accepted performance standards and manufacturer specifications that fulfill regulatory requirements.