Knudsen Plast Quality
Well-documented validation - from start to finish
Knudsen Plast has a standard validation approach:
IQ
- On mould
OQ
- Run-in
- First Article Measurement
- Measurement of critical dimensions
- Multiple-choice system based on risk
PQ
- Test run
- Capability analysis on critical dimensions
*Customer specific requirements can be incorporated.
*Customer approved validation protocol and validation report.
PPAP
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
Download ISO13485
Knudsen Plast A/S
Industrivej 21 · DK-3300 Frederiksværk · Denmark
Tel +45 47 76 01 01
info@knudsen-plast.dk
Danish Contacts:
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Knudsen Plast s.r.o.
Herlanska 547 093 03 Vranov nad Top’lou Slovakia
Tel +421 574 486 203
son@knudsen-plast.dk
Slovak Contacts:
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