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Knudsen Plast Quality


Knudsen Plast has a standard validation approach:


  • On mould


  • Run-in
  • First Article Measurement
  • Measurement of critical dimensions
  • Multiple-choice system based on risk


  • Test run
  • Capability analysis on critical dimensions

*Customer specific requirements can be incorporated.
*Customer approved validation protocol and validation report.


Knudsen Plast can document the activities and validation during development by a PPAP (Production Part Approval Process) according to the PPAP Fourth Edition.

The PPAP provides an excellent overview of the documentation and demonstrates the ability to deliver products compliant to the purchase specification.

PPAP content:

  • Design Record
  • Engineering Change Document
  • Engineering Approval
  • Design FMEA
  • Process Flow Diagram
  • Process Risk Assessment
  • Control Plan
  • Measurement System Analysis (Gauge R&R)
  • Dimensional Results
  • Records of Materials / Performance Test Results
  • Initial Process Studies
  • Master Sample
  • Checking Aids
  • Part Submission Warrant

Want to know more?

Download ISO13485


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