QUALITY & REGULATORY SERVICES

Overview:

Quality & Regulatory

“More than you expected” – This is Key Electronics’ commitment to our customers. This commitment starts with a management strategy whereby our quality management systems are process based to ensure products and services consistently meet applicable standards and customer expectations. Our system plans, monitors, inspects, analyzes, records and evaluates “standards of quality” across all areas of the company. The collection and analysis of data throughout the manufacturing process is paramount for management of the quality management system and structured problem-solving.

Certifications:
Key Electronics has recognized the business benefits of adhering to industry standards for meeting customer requirements on a consistent basis. The following certifications and/or compliant systems are in place:
  • ISO 9001:2008
  • ISO 13485:2003
  • FDA – Quality Systems Regulations (QSR) compliant for Class II Medical Devices
  • AS9100 Rev C
  • ESD S20.20 Control Program

Associate Training:
Key Electronics understands its competitive edge is based on employees and culture, and has implemented significant training programs focusing on employee development as well as establishing a culture with top-down, bottom-up approach for process improvement. All manufacturing employees are required to attend a 40-hour class covering electronic manufacturing concepts, quality management system overview and the “Key Operating and Leadership Culture”. Additionally, employees are trained in the following standards as required to perform their job functions:
  • IPC-A-610 Acceptability of Electronic Assemblies
  • IPC J-STD-001 Requirements for Soldered Electrical and Electronic Assemblies
  • IPC 7711/7721 Rework, Modification, and Repair of Electronic Assemblies
  • Leadership 101
  • Advanced Leadership
  • Change Management
  • Certification for Yellow Belt Lean Manufacturing
  • Certification for Green Belt Lean Manufacturing
  • Certification for Black Belt Lean Manufacturing

Export Compliance:
Key Electronics has implemented an Export Management and Compliance Program (EMCP) that includes the policy of fully complying with all laws and regulations governing the export of its products, services, software and technical data. Restricted Items are conducted in a manner to comply with:
  • Export Administration Regulations (EAR)
  • International Traffic in Arms Regulation (ITAR)
  • Office of Foreign Assets Control (OFAC)

Quality Control:
Key Electronics has invested in system implementations to maintain and evaluate the data necessary to continually improve product quality and reduce process waste and variation. These systems allow customer and manufacturing teams to analyze real-time manufacturing information as follows:
  • First Pass Yield for each process, customer, assembly, shop order and date
  • Rolled Throughput Yield
  • Process Traceability by Serialized PCBA
  • Material Traceability by Serialized PCBA
  • Inspection Tracking results by Inspection Process
  • Defect Reporting by Process area
  • Customer Communications

Continuous Improvement:
A primary objective of our Quality Management System is to drive continual improvement throughout Key Electronics. The continual improvement aspect of the system encourages our associates to offer new ideas that lead to quality enhancements and in turn benefit our customers.

Lean Six-Sigma:
Our Lean / Six Sigma program is designed to help our employees identify the ‘waste’ and ‘variation’ that is occurring in daily operations and reduce or eliminate these non-value added activities. Our Yellow Belt Program requires 20 hours of applied training and participation on a Project Team; Green Belt focuses on the DMAIC methodology and requires an additional 20 hours of applied training and leading a Project Team; and our Black Belt program, focusing on statistical process controls, requires a further 40 hours of applied training and leading a major project effort.

Regulatory Agencies:
Key Electronics works with the various regulatory agencies such as TUV, UL, CUL, etc. for Factory Inspection Audits.

Configuration Management:
The overall purpose of Configuration Management is to establish and maintain the integrity of work products and may include plans, process descriptions, requirements, drawings, and manufacturing documentation. Key Electronics provides Configuration Management deliverables as specified in the customer’s requirements and/or to meet flow-down requirements of a particular government contract.
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