The IQ/OQ/PQ phase demonstrates the achievement of a stable process using statistical process controls to validate new custom injection molds and manufacturing equipment. The Natech Process Engineers use Design of Experiments (DOE) during Validation to achieve a stable process earlier.
Operational Qualification (OQ) – For the OQ phase of validation, Scientific Molding establishes a universal setup process window. Rather than defining a machine-parameter-driven setup process, Scientific Molding develops plastic-parameter-driven set-ups. This leads to time-efficient development of a molding window via precise Design of Experiments (DOE) execution.
Performance Qualification (PQ) – For the PQ phase of validation, the Processing Engineer measures and analyzes critical dimensions for capability. Capability Analyses are performed on one or more production lots across one or more lots of raw material.