As a premier supplier to the medical device industry and OEM’s of complex commercial products, Forum Plastics LLC has to have a robust Quality System to ensure we are meeting the demanding and ever changing requirements of the marketplace. If we are to truly add value to your supply chain, then we must perform not only on our strong engineering platform, but across all sectors of our enterprise. We see the attribute of Quality, not as a means of checking if the parts produced meet requirement, but as the systemic nature of how we do everything within the confines of our business. We treat both our internal and external customers with the same level of respect and effort, so that our performance in every measurable attribute is considered key to success.
Forum continually tracks and monitors our client’s ratings on customer service, product quality and conformance to schedule. We are ISO 13485:2016 certified (see our accompanied certification in PDF format). Our quality system has been audited by and passed, without non-conformances by all of our large and small OEM’s.
Since every client has a different approach to product and component validation, FPL has developed several templates for validations dependent on client needs. We have the ability to provide clients with a range of validation intensity to suit your requirements. Our goal is to provide your organization with the scope of a validation required to suit your system needs without expenditure of studies that do not add value to the robustness of the product realization process.
Forum Plastics LLC routinely performs a full complement of Quality confirmations which collectively comprise the Validation Package or PPAP. Our manufacturing systems have all undergone an IQ/OQ/PQ protocol, inclusive of periodic routine maintenance checks and reviews. Our Quality Metrology Department has state of the art measurement equipment and a protocol of training inclusive of our Optical Inspection Systems and GD&T. Of course all of our measurement equipment, regardless of departmental location, is on a full calibration schedule. Our capabilities and outputs range from partial First Article Inspections on design changes up to and including new Part Submission Warrants, Design Records, Process Flow Diagram, PFMEA, Control Plans, Production Engineering Samples, Gage Reproducibility and Repeatability Studies with calculated MSA, FAI, Initial Process Studies, Capability Studies at varying parameters, Design Documents Package, Certifications, Records of Compliance and Preventative Maintenance Plan.
We employ one Quality System approach, whether the client is medical or commercial based. We maintain product retains for every run and a full documentation package for a minimum of seven years from date of manufacture.
View our Quality Operations.