Production Quality Tools

Production Quality Tools:

  • Device Master Record (DMR) & Device History Record (DHR)
  • Statistical Methods
  • Training
  • Traceability
  • Engineering Change Control
  • Environmental Control

Device Master Record (DMR) & Device History Record (DHR)

The Device Master Record (DMR) outlines product requirements, manufacturing operational specifications, test methods, inspection and test requirements.  The Device History Record (DHR) documents fulfillment of the requirements of the DMR. 

Statistical Methods

Dielectrics statistical tools include process capability and analysis, Analysis of Variance (ANOVA), and Design of Experiments (DOE). 

Training

Dielectrics' operations personnel receive appropriate training of our ISO 13485 compliant manufacturing documentation system.  Detailed work instructions and inspection protocols provide all necessary information to ensure compliance with specifications. 

Traceability

All products shipped are traceable through our MRP system.  Products are traceable back through to raw materials and into our supplier's control system. 

Engineering Change Control

A comprehensive engineering change control process is utilized to manage and document all permanent changes such as, but not limited to, the process, materials, and environment.  

Environmental Control

We have multiple Class 7 and 8 cleanroom environments which are annually certified to ISO 14644-1.