Quality Management System

We provide a completely seamless Quality Management System (QMS) that ensures the quality of everything that we do for you. Our system is designed and conducted to enable us to meet your design, manufacturing quality, and regulatory compliance requirements.

The Four Key Components of Our QMS

Pre-Production Quality Assurance (PPQA)

We maintain a broad array of assurance tools in order to meet all customer design and manufacturing requirements up-front, including:

  • Feasibility Analysis, confirming that Flexan can reliably provide the customer with an end-to-end manufacturing solution
  • Contract Review, performing an in-depth, cross-functional review ensuring that all project risks have been identified and mitigated
  • Supplier Quality Management, assuring that every aspect of our supply chain has been audited and approved
  • Metrology and Inspection Analysis, ensuring that all critical variables and attributes have been identified, and that all Gauge Study requirements have been met
  • Employee Training, ensuring that Flexan employees have received the training and certificates required for them to perform their assigned tasks

Manufacturing Transfer

Critical to providing a holistic contract manufacturing solution is ensuring that the product design has been appropriately transferred to Flexan. We maintain a comprehensive “checklist” process confirming transfer of:

  • Prints and Specifications
  • Validation Documentation
  • Incoming, In-Process and Outgoing QC Requirements
  • Supplier Management Requirements
  • Required Certification/Release Documentation

Production Quality Control (QC)

In addition to meeting all customer-specified QC requirements, we conduct a thorough analysis to determine the appropriate quality control program. Tools employed include:

  • Supplier Risk Assessment
  • Process Failure Mode Effects Analysis (PFMEA)
  • Control Plan Development

Regulatory Compliance

As a Medical Device solution provider, we actively support all customer regulatory/approval activities, supporting global filings and compliance efforts. These include:

  • Biocompatibility Studies
  • MDSAP/Third Party Audit Participation
  • STED File Completion
  • 510k/PMA Filing Support
  • Global Filing Support
  • REACH/RoHS Accreditation

Features of Our QMS

Our Quality Management System is implemented to improve overall speed and efficiency. In addition to providing operational alignment to safety, quality, delivery, cost and innovation goals through the Hoshin Kanri Policy Deployment in Operations method, other features of our QMS include:

  • Real-time status views
  • Managed tool status
  • Full traceability
  • Product tracking
  • Version control of all documents
  • Phase-gate approach in concept to commercialization
  • Lean Six Sigma Transformation led by our VP of Operational Excellence
  • 3 Master Black Belts
  • ~150 Belted Employees