Quality

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Certifications

  • ISO – 13485:2016 – Certified Quality System

  • Advanced Product Quality Planning (APQP) 

  • SPC inspection

  • Control plans and process failure mode effects analysis  (pFMEA’s)

  • Product and process risk mitigation methods

  • Continual improvement environment

  • 6S & JIT, Kanban workplace organization

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Full Metrology Department

Zeiss CONTURA X1000mm x Y1200mm x Z580mm Coordinate Measuring Machine with;

- CALYPSO Programming Software with Curve Digital Logic

- Fully Articulating-Probe-Holder RDS-C-CAA

- ZEISS Scanning sensor VAST XXT TL3

OGP Smart Scope

Keyence touch-less measuring system

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QUALITY MANAGEMENT SYSTEM

Cloud based Quality Management System (QMS) that allows for the development of customer specific portals.

The QMS includes the following core tools:

  • Real time SPC, with customer access

  • Advanced Product Quality Planning (APQP)

  • Failure Mode and Effects Analysis (FMEA)

  • Measurement System Analysis (MSA)

  • Real time Statistical Process Control (SPC)

  • Production Part Approval Process (PPAP)

As well as Lean Manufacturing Tools such as:

  • 5S/6S

  • Just-In Time (JIT)

  • Kaizen (continual improvement)

  • Kanban (pull system)

  • KPIs (key performance indicators)

  • Poka-Yoke (error proofing)

  • Root Cause Investigation (5 Why, 8D)

  • Visual Factory