Medical Electronics Manufacturing
Medical Manufacturing companies looking for a manufacturing partner for their custom electronic assemblies require strict quality requirements that follow FDA-Good Manufacturing Practice (GMP) standards defined by the FDA 21 CFR Part 820 QSR and ISO 13485. These standards require manufacturers to implement a quality system for designing, manufacturing, packaging, labeling, storing, and delivering medical devices sold within the United States and Europe. ADCO customers are assured of compliant product due to our quality systems which are compliant to FDA regulations and ISO13485. ADCO's industry leading quality control systems and a manufacturing culture steeped in lean manufacturing and 5-S, combined with advanced material logistic processes, deliver complex medical devices on-time and on-budget.
ADCO has been a supplier to the Medical industry for much of our 30+ years in the industry. Familiarity with the associated quality requirements and supplier responsibilities have resulted in ADCO developing process's such as a web based customer quality documentation portal and an on-line CAPA system that empower customers to work with ADCO on a team basis.
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Customer focused Program Manager and Material Buyer.
- Project plans formulated in Microsoft Project
- A defined and reliable New Product Introduction (NPI) process that starts with Advanced Production Quality Planning (APQP) process
- Customer focused teams comprised of program manager, material buyer, production planner, manufacturing line leader, and quality inspectors.
- For product design requirements, ADCO utilizes long term design engineering partners to manage schematic design, board layout, and mechanical design
- For test design, ADCOs internal engineering team can author technical specifications, fabricate the necessary fixturing, and validate the test process
Material Control and Planning is a large element of the risk associated with any electronic assembly, and to a large extent, also determines success or failure. In meeting delivery objectives every program has its unique challenges and ADCO repeatably delivers quality product on-time.
- Flexible contract management adaptive to the customers forecast-kanban or forecast-firm release systems
- Advanced ERP planning with an exclusive multi-level forecast system shared directly with vendors to ensure supply
- Experienced and well staffed purchasing department
- Automated PO release and replenishment system on-line with the leading component distributors
- Web based automated material quoting system
- On-line documentation integrated with the P.O. release system for custom fabricated components.
- Item specific quality codes integrated with the purchasing and incoming inspection systems.
- Automated stockroom with barcode scanning and lot tracking.
Advanced Manufacturing and Test Capabilities at ADCO are meeting today's industry challenges that include RoHs compliance, challenging designs (01005's, micro BGA's, etc.), and increased product reliability requirements. ADCO's continuous investment in training, capital equipment, and process development, result in a world class manufacturing and test facility that is the basis for our strong delivery and quality ratings.
- In-house design review for manufacturability and testability
- On-line documentation at the mfg. workstations
- Enterprise wide work instruction system for consistent production, traceability, adherence to compliance requirements
- 5-S, Kaizen, and Lean Manufacturing disciplines
- Full humidity and ESD controlled manufacturing environment.
- 3 Flex-SMT lines with micro-BGA and 01005 capability
- In-line Automated Optical Inspection (AOI)
- Lead-free wave and re-flow soldering
- Automated selective soldering
- Conformal coating and potting
- Test Assets include ICT, flying-probe, functional, environmental ovens, and vibe
ADCO's Quality Management System (QMS) is the foundation upon which the program management, material management, manufacturing, and test rest. The QMS controls all processes, tracks quality data, and is the basis for continuous improvement.
- ISO/TS-16949, ISO-9001, and ISO-13485 certification
- APQP, FAI, and FMEA processes
- On-line, desktop based, QMS system
- In-house training and certification to IPC 610 / J-STD-001 Class III workmanship standards
- On-line quality data system with dashboards (production yield data, vendor quality data, etc)
- 8-D based on-line corrective action / preventative action (CAPA) system
- Web based customer portal