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  • bb254 replied to the topic Non-Conformity in the forum Quality Systems Management 7 years ago

    Recently, we received notification of a nonconformance within our instructions for use document which is sold in one of our major product lines. It escalated to a CAPA and HHE. A section of the document was inadvertently omitted. A complete analysis of all the products sold with that instructions for use document was completed along with a complaints analysis. Luckily, no complaints were associated with the nonconformity, Immediate containment actions were placed, and the omission was corrected. Rework procedures were created specifically for the nonconformance. In this case, the nonconformity resulted in many serious and fast paced decision makings. Never worked on a project which had such high scrutiny and stress because of the risk that could have resulted from the nonconformance.