Quality Management - Optelco

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Quality Management

Solution Area
Optel’s Quality Management Module provides quality traceability data, statistical process control, test data and defect logging, and reporting. Optel’s quality management tools provide the ability to capture and manage defects, repairs, testing, DPMO and yield data for circuit assemblies, to the serial number level, for management, supervisors and customer reporting. The Optel Process Traceability and Enforcement Module incorporates the entire electronics assembly process – from panel serialization, circuit assembly, hand placement, box build, rework, and testing to shipment. This module provides process definition and control, multi-level routing, full traceability and data collection from each of the process steps across the entire production facility.

Optel’s Quality Management Module permits automated and manual collection of defect information, defect code management, yield calculations, first article inspection data, alarms, and detailed reporting at the circuit level for all steps in the manufactur-ing process. This module automates control, quality assurance, and data collection for machines such as screen printers, ovens, AOI, flying probe machines, ICT, customer specific test systems, and from hand-testing locations.

Capabilities are provided for capturing defect inputs from quality inspections and repair, and for defect tracking. Defect input parameters can include status, defect type, part number, reference designator, operation step, quantity, time, and placement. Yield data can be collected and displayed for post-reflow visual inspection operations. Yield results can be viewed by work order, assembly part number and revision, and can provide statistics for total assemblies, passed, failed, scrapped, balance, and yield percent. Support for first article inspection includes details for each component part number, package, manufacturing install operations, quantity and graphical board location diagrams. Repair, rework and RMA are also supported.

  • Integrated management, control and reporting via Optel’s centralized database
  • Increased customer satisfaction due more accurate order completion time estimates
  • Reduction in DPMO, significant increases in production yield and product quality
  • Process and quality traceability for each circuit assembly serial number
  • Automated capturing of genealogy data for routing process steps, components, moisture sensitive materials, repairs, defects, cycle times, yield and machine performance – captured to the assembly board serial number level
  • Achievement of quality standards for certifications, including:
    • ISO 13485:2003 Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes
    • FDA Department of Health and Human Services 21 CFR Part 11 Electronic Records; Electronic Signatures
 
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