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.
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 defined
- Optimal heat weld operating parameters are identified using (as a minimum) a matrix of time, pressure and power
- Client approval of an internal, product-specific SOP
- First Article (FA) sent to client for approval
- Production operators 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 Genesis can help.