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