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May I please ask how could I open the website that you showed in your thread? It seemed an invalid path… that I could not open.
I’m a QA in a medical product manufacturing company, mostly are injetion molding products. Before, we followed one of the customers to conduct the process validation and have been moving on the smooth track. They used challenge test analysis during the OQ molding process by set one of the parameter holding pressure at high and low (10%) setting to check the molded parts and Cpk. And run 3 consecutive shifts as PQ for the challenge.
But now, we’re meeting a new challenge, another customer is going to conduct the DOE and would like to use DOE as the validation analysis method. So, at this circumstance, I would like to know would there be any difference between the process validation before and after conduct DOE? Would love to have a more clearer explanation from you if it would be possible. Thank you very much!
Try the link now it works