Medical Devices
Part Validation IQ/OQ/PQ

Which manufacturing processes must be validated?

  • IQ validates that equipment is correctly installed. IQ is the first step in the validation process. ...
  • OQ validates that equipment operates as intended. OQ is the second step in the validation process. ...
  • PQ validates process stability over time. PQ is the third and last step of the validation process. ...

Triplax can assist with your Part Validation from IQ through to PQ:

  • IQ/OQ/PQ Protocols
  • Process Flow
  • PFMEA's
  • Control Plans
  • MSA Protocols/reports
  • Shrinkage studies
  • ISIR's
  • Capability Studies
  • Visual Inspection
  • IQ/OQ/PQ reports

 18 Eelements of PPAP/APQP

  1. Design Record
  2. Engineering Change Documentation
  3. Customer Engineering Approval
  4. Design Failure Mode and Effects Analysis (DFMEA)
  5. Process Flow Diagram
  6. Process Failure Mode and Effects Analysis (PFMEA)
  7. Control Plan
  8. Measurement System Analysis (MSA) Studies GRR
  9. Dimensional Testing
  10. Record of Material / Performance Test Results
  11. Initial Process Studies – SPC
  12. Qualified Laboratory Documentation
  13. Appearance Approval Report
  14. Sample Production Parts
  15. Master Sample
  16. Checking Aids
  17. Customer Specific Requirements
  18. Part Submission Warrant

The purpose of PPAP/APQP is to determine if all customer engineering design record and specification requirements are properly understood by the organisation and that the manufacturing process has the potential to produce product consistently meeting those requirements during an actual production run


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