For our plastics injection molding services, FAI involves detailed measurements and evaluations of the initial part against design specifications and tolerances. This step helps identify discrepancies early, allowing for adjustments before full-scale production begins. By choosing Aprios, you can be confident that we will catch issues at the outset, ensuring that the final production runs smoothly and meets your quality standards from the very first part.
Production Part Approval Process (PPAP)
For many industries, a strong set of documentation provides additional assurance that the production process for your product is robust. At Aprios, our experience with PPAP includes thorough documentation such as PFMEA, Control Plans, and Validation. This process helps ensure that our ongoing manufacturing processes meet your stringent quality standards. PPAP is an additional service we offer to provide further confidence in the production quality and consistency.
Validation Protocols
Process Validation: IQ/OQ/PQ
By maintaining comprehensive Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) processes, we ensure that our equipment and processes are thoroughly vetted and capable of meeting your production needs. This meticulous approach helps minimize risks, improve product quality, and streamline your supply chain operations.
IQ is the process of ensuring that equipment is properly installed according to manufacturer specifications and industry standards. For our plastics injection molding and additive manufacturing services, IQ involves verifying that major equipment, such as Injection Molding Machines and Sonic Welders, are set up correctly and safely. This step helps prevent issues that could arise from improper installation, ensuring that your production starts on a solid foundation. By working with us, you can be confident that our equipment is installed correctly, reducing downtime and avoiding costly installation errors.
The purpose of OQ is to ensure that key process parameters produce repeatable parts within the process limits. OQ generally consists of production runs at the low and high process window limits, with a statistically relevant sampling of components. This procedure provides confidence that the parts will be in spec when run within the process window. By partnering with us, you benefit from our thorough OQ procedures, which guarantee that our production capabilities will meet your quality and performance requirements.
PQ is the final step that involves validating that the process and equipment consistently produce products that meet all predefined criteria under real-world conditions. For our company, this means running the equipment under normal production conditions at nominal process parameters to ensure that every part we produce meets your quality standards. PQ ensures that the entire manufacturing process is capable of delivering high-quality, consistent results. When you choose our services, you can trust that our PQ validation processes will help you achieve reliable, high-quality output, reducing the risk of defects and ensuring customer satisfaction.
Advanced Equipment and Certifications
We utilize advanced measurement and inspection equipment to maintain high standards of quality.
Coordinate Measuring Machines (CMMs)
Two Zeiss Contura CMMs, programmable with touch probe-based scanning for comparison to CAD models, ensure precise measurements.
Microscopes and Vision Systems
MicroVu Vertex 200 and MicroVu Vertex 420 vision systems provide detailed inspection capabilities for complex parts.
Certifications
Our commitment to quality is demonstrated by our compliance with industry standards and certifications, including:
FDA
ITAR
ISO 13485
ISO 9001
UL Listed
These certifications highlight our dedication to maintaining rigorous quality standards across all our processes and services. At Aprios, we strive to exceed your expectations by delivering reliable and efficient manufacturing solutions that enhance your supply chain and ensure the highest level of customer satisfaction.
These certifications highlight our dedication to maintaining rigorous quality standards across all our processes and services.
At Aprios, we strive to exceed your expectations by delivering reliable and efficient manufacturing solutions that enhance your supply chain and ensure the highest level of customer satisfaction.
We have a robust quality management system that includes thorough testing, inspection, and documentation processes. Our commitment to quality is demonstrated by our compliance with industry standards and certifications, which you can view on our Certifications Page.
Our quality management system holds various industry certifications that ensure our processes meet stringent standards. Please visit our Certifications page for detailed information on our certifications.
We have a systematic approach to handling quality issues, which includes root cause analysis, corrective actions, and continuous improvement measures. Our goal is to resolve any issues promptly and prevent recurrence.
Yes, we provide comprehensive quality documentation for all products, including inspection reports, material certifications, and compliance certificates, ensuring transparency and traceability.
We stay up-to-date with industry standards and regulations, and our quality management system is designed to ensure full compliance. Regular audits and continuous training help us maintain high standards of quality and compliance.
