Ensuring Critical Manufacturing Process Quality
Greg Fish, Corporate Director of Quality at PTA Plastics, discusses the reasons for pursuing MedAccred® accreditation, the obstacles faced, and the advantages gained from being accredited.
Following our initial knowledge of MedAccred, we internally examined the injection molding audit criteria and had discussions with PRI to comprehensively grasp the audit and accreditation process. As part of the MedAccred program, plastics assembly was slowly being integrated, allowing for participation in the audit criteria pilot.
Since we have already conducted business with many MedAccred Subscribers, including plastics assembly work, it was logical for us to participate in the plastics assembly pilot. This allowed us to familiarize ourselves with the audit process. Once we obtain accreditation for plastics assembly, we will pursue injection molding accreditation. We were suddenly on a tight schedule, having only a few months to familiarize ourselves with the plastics assembly audit criteria and implement all the necessary requirements.
Before embarking on MedAccred, we relied on our plastic assembly equipment supplier’s guidance and documented the processes in part-specific instructions. Throughout the years, we’ve undergone countless customer audits, utilizing every input and observation as a chance to improve. PTA Plastics has gained valuable insights from our long-standing subscribers, who have been with us for many years. We have incorporated their best practices into our operations whenever feasible. Despite our extensive experience, a MedAccred gap analysis revealed significant work that needed to be done. Once we completed a gap analysis, we established a cross-functional team and conducted weekly meetings to tackle non-compliant areas. These were distributed among the team members, with each topic being assigned a champion to ensure a swift and thorough resolution.
By documenting processes that were not required for ISO in the past, we have resolved problems associated with tribal knowledge. Particular effort has been made to enhance work instructions by making them clearer, more comprehensive, and easier to follow.
In addition to the measurable advantages of achieving MedAccred accreditation, our reputation is highly regarded by industry professionals worldwide. Working for a company that aims to be on the cutting edge, PTA employees are proud to have been the first to achieve global accreditation for plastics assembly. Our facility proudly displays our MedAccred Certificate, framed and prominently placed alongside the MedAccred flag.
Since the MedAccred Audit, PTA Plastics has:
• Reduced finishing defects from an average of just under 1,000 parts per month to 134 parts per month
• Improved total internal scrap (including molding and finishing) from 2.78% to 1.81% of parts produced
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.