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  • pi29 replied to the topic QA vs QC in the forum Project Management Knowledge Areas 6 years, 1 month ago

    QA or Quality Assurance makes sure that the project is meeting all industry regulations. For example if you want to set new storage conditions for one of your devices, you consult the quality assurance specialist to make sure that this is 1) meeting industry regulations and 2) all labels and customer letter and product inserts are updated to include the new storage conditions. They are in charge of properly communicating these so that it meets any labeling requirements.

    QE or Quality Engineering is more in charge of the process to validate and should consult with QA to make sure the outputs meet standards. For example, to set those new storage conditions the QE would have to do verifications and validations to support that the new storage conditions are adequate for the product.