Process Qualification

 

Tool and Plastic conduct Process Qualification studies to demonstrate that the process operates as designed, provides uniform results in products that perform as intended, and is robust under continued use in the production environment.

Tool and Plastic qualify new products using either Process Validation or PPAP Qualification process.

These process qualifications are supported by risk management studies.

 

Process Validation
  • Installation qualification
  • Process optimisation engineering study
  • Operational qualification (OQ Low and OQ High runs)
  • Process Qualification ( 3 production runs at nominal process settings)
  • CPK analysis of CTQ dimensions
  • ISIR study
PPAP Qualification
  • Operational qualification (OQ Low and OQ High runs)
  • Process Qualification
  • Parameters run at nominal
  • Parameters run at low / low
  • Parameters run at high / high
  • Parameters run at Low / High
  • Parameters run at high / low
  • CPK analysis of CTQ dimensions
  • ISIR study
Risk Management
  • Process flow chart
  • Cause and effect analysis
  • FMEA
  • Control plan
Metrology / SPC
  • Hexagon CMM
  • Starlight vision system
  • Optical comparator
  • Tensile tester
  • Torque tester
  • Digital test indicators
  • Micrometers and Vernier callipers
  • Precision pin sets
  • Mitutoyo SPC system

Traceability

Tool and Plastic maintain traceability on each batch of product manufactured. The traceability records are maintained in DHR for the batch, which are retained on file for 5 years.

Labelling

Product is labelled with relevant batch information in machine readable (example: barcode) and human readable formats.

Information on labelling includes following:

  • Customer Product Description
  • Part number (Barcode readable)
  • Purchase Order Number (Barcode readable)
  • Lot Number (Traceability) (Barcode readable)
  • Quantity per carton (Barcode readable)

 

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