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  • neb2 replied to the topic Non-Conformity in the forum Quality Systems Management 7 years, 12 months ago

    Recently at work, we faced that most real time products coming out of the chamber were dictated as non-conforming upon pressure decay testing. At first, R&D engineers thought that probably the technician was not performing the test as specified in the test instruction. Nevertheless, after trying the test by themselves, they found out that the product was failing. Then quality engineers got involved in this issue since non-conforming products under real time testing are a delicate matter due to the fact that this product is already in the market. It turned out that the instrument used for this special test has been sent for repair four times already. Therefore quality decided to start a CAPA investigation, which is still undergoing, in order to find out the causes in which the machine keeps on failing and keep this situation from happening in the future. I think and believe this is the case in which a product was deemed as non-conforming but was caused due to the malfunctioning of the instrument.