Quality

Quality Assurance for Custom Contract Manufacturing

At Flexan, following ISO, FDA and other international quality standards and industry practices is only the start. We weave quality assurance into every step of the manufacturing process, from design, process development to final production. Flexan works with clients in numerous industries that have strict quality standards including implantable medical devices and components and aerospace/defense applications. We apply that knowledge of best practices in quality with all our clients.

Pre-Production Quality Assurance

  • Customer Project/Print/Specification Quotation
  • NPI/Design Control (New Products & Processes)
  • Product/Process Validation
  • Supplier Quality Management
  • Risk Identification and Management
  • Quality Metrics/Continuous Improvement

Regulatory Affairs & Compliance 

  • QMS ensures required regulatory compliance
  • External National/International Compliance Includes:
    • ISO 9000 Quality Management Systems
    • ISO 13485 Medical Devices – Quality Management Systems
    • US FDA 21 CFR 820 Quality System Regulation¬†
    • ROW Standards (SFDA, JMHLW, ANVISA)
    • Ancillary Standards¬†

Production Quality Control

  • Incoming Quality Control (IQC)
  • In-Process Quality Control (IPQC)
  • Outgoing Quality Control (OQC)
  • Non-Conformance Management (MRB)
  • Quality Metrics

Material Quality Assurance

  • ASTM testing on materials
  • FDA and NSF/ANSI 61 compliant materials
  • Material sourcing from proven suppliers
  • Material batch testing from in-house and independent labs
  • 100% material tracking

Developing Components of Quality

Our quest for quality begins with the tightest process controls and the rigorous use of quality tools from design through production. To ensure patient safety, we provide 100 percent inspection of every single component before it ships.

Quality Control Processes

  • Global quality standards as required by ISO 13485:2016
  • Six Sigma for continuous process improvement
  • Advanced Product Quality Planning (APQP)
  • Validation of parts and processes employing Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
  • Process Failure Mode Effects Analysis (PFMEA)
  • Measurement System Analysis (MSA)
  • Gage Repeatability and Reproducibility (GR&R)
  • Control Plans
  • Mold management, tool condition analysis and trend reports
  • Quality metrics and management review

Quality Control Equipment

  • Automated measuring equipment, including high-tech automated vision systems