Genesis Process Validation

What Does IQ, OQ and PQ Mean to You?

Guided by a robust quality system, Genesis Plastics Welding employs a rigorous validation process, comprising installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) to validate the production of our clients’ products within our facility.

Validation process plastics welding contract manufacturing

Industry Validation Processes

A well-planned and performed IQ, OQ, PQ validation process is important to ensure that there is a well-controlled manufacturing process consistently producing products that conform to client specifications. A successful validation process can also lead to improved productivity, reduced risk of recall, and a less burdensome process for investigating consumer complaints.

What occurs during IQ, OQ, PQ:

    • Dies (transferred or new) are inspected and compared to print
    • Calibration status of all test equipment is verified
    • Maintenance status of all manufacturing equipment is verified
    • Sampling plan and data collection points are defined
    • Optimal heat weld operating parameters are identified using (at a minimum) a matrix of time, pressure and power
    • Client approves an internal, product-specific SOP
    • First article (FA) is sent to client for approval
    • Production operators are trained
    • 3 performance qualification validation batches are run, with a minimum batch size of 25-500 pieces, depending upon product characteristics and client need for design V&V parts.

Curious to learn more about outsourcing your RF welding contract manufacturing needs with Genesis Plastics Welding? Contact us today and let’s discuss how we can help.

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