There are many factors that OEMs should consider when choosing a plastic injection molder – and quality is at the top of the list! A supplier’s quality planning and assurance program is more than just meeting the requisite ISO and FDA requirements – it represents their proven way to ensure consistent quality plastic injection molded parts. When assessing a potential molding partner, OEMs should consider the following about their project and the supplier being evaluated:

  • What inspections and standards does my product have to meet?
  • What certifications and registrations such as ISO, FDA, and ITAR does the supplier have?
  • Does the supplier have experience manufacturing products for my industry and have they been recognized?
  • Does the supplier utilize the latest quality software and machine technologies?
  • What is the supplier’s quality track record and the typical level of rework due to quality issues?
  • What is the supplier’s preventative maintenance plan for your injection mold?

It takes a team of quality specialists equipped with the right tools and technologies to ensure every injection molded product meets its standards and specifications. Additionally, quality assurance is not just a part of production but is integrated into the product design process and depends on several design decisions such as material selection, the desired physical properties, and product dimension tolerances. This is why it is imperative for OEMs to partner with an injection molder who has Design for Manufacturability (DFM) expertise; this simply means the design and manufacturing teams are integrated to allow potential quality issues to be identified and addressed during the design process instead of during production – saving OEMs significant time and cost!

Crescent’s Quality Standards and Practices

Partnering with an experience injection molder like Crescent allows for the necessary production planning needed to meet all of the necessary regulatory, quality, and commercial standards. Crescent is devoted to providing quality excellence, and we will work with you to develop a customized set of standards for your project!  Our quality team is made up of engineers and technicians that ensure all parts meet compliance standards and customer specifications. Below is a sample of the standards we meet.

  • ISO:13485 Registered
  • FFL & ITAR Registered
  • ISO Class 7 (10K) clean room
  • FDA Registered
  • ISO Class 8 (100K) Clean Room
  • Cage Code 4A8G2

 Crescent practices Statistical Process Control (SPC) for measuring and controlling quality during the manufacturing process.  Our equipment and gauges are used to verify critical dimensions on validation protocols, capability studies, first articles, production runs and final inspections. Our highly-trained quality associates practice routine inspections on all shifts. Below are practices that are part of our Quality Control process.

  • First Article, in-process, and final inspections
  • DOE’s, SPC, Capability Studies, Control Plans, Master Plan Validation
  • Validated QMS Module within our ERP system provides full-lot traceability
  • Complete incoming material inspections
  • Robust Corrective & Preventative Action Reports
  • Risk Mitigation through Process/Product Failure Mode and Effects Analysis (PFMEA)
  • Manage customer audits and internal audits of their QMS
  • Validation Protocols that follow IQ/OQ/PQ and PPAP Requirements
  • Coordinated testing of material with our outsourced partners

Crescent’s Quality Control Technologies

We are 100% invested in maintaining the highest quality standards with our state-of-the-art quality lab. Our sophisticated quality lab is equipped with video measuring and inspection equipment, optical comparators that deliver accurate, detailed measurements and inspections. We utilize over 488 gauges which are maintained and kept in good working order through our in-house calibration system.

 As a contract manufacturer focused on leveraging the latest technology for the benefit of our customers, we utilize a 3D laser scanner in our quality inspection lab. Our ShapeGrabber Ai310 uses an indexing turntable to scan all sides of an object in order to construct a true 3D model. One of the benefits of this particular scanner is the modular design, which allows us to benefit from scanhead upgrades with little or no disruption for our OEM customers, who benefit from a reliable supply of high quality, tightly toleranced, in-spec parts and complete devices. Below are additional details about our quality equipment. 

  • Shape Grabber: Automated 3D scanning measuring system for complex shaped parts where speed and complete coverage are important. Measures the multi-curved surfaces of an injection molded plastic part and any associated warpage. Click here for a video of our shape grabber. 
  • Optek Videomic: Video inspection and measurement system that performs automatic, non-contact, 3 axis coordinate measurement with increased accuracy. 
  • Micro-Vue vision System: This system has vision, touch probe and laser measurement capabilities. Touch probe improves 3D measurement capabilities and laser measurements improve speed for scanning and z height measurements. 
  • Hel-Mel CMM: provide efficient and repeatable inspection through touch probes that delivers precise measurements of any part quickly and automatically. 
  • RAM Optical: Provides automated optical inspections with pieces auto-focused to speed up throughput and improve repeatability. 
  • Deltronic Optical Comparator: projects images of parts onto a glass screen using illumination sources, lenses and mirrors on a vertical screen for easy viewing for purpose of making 2-d measurements. 

Crescent Industries has an extremely knowledgeable team to assist with all of your quality, design, and production questions – contact us today to learn how we can assist with your injection molding project!

Topics: injection mold building, injection molding