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  • vcf3 replied to the topic Form 483 in the forum Quality Control and Quality Assurance 6 years, 7 months ago

    I don’t believe companies intentionally want to fail to adhere to the rules. With the analogy of the speed ticket, for instance, let say you are rushing to get somewhere and unfortunately get pulled over and get a ticket. I don’t think your goal was to get one; perhaps you were hoping you might go unnoticed. We are all flawed in that way; sometimes we do stupid things hoping we might go unnoticed. The same reasoning can be applied to companies. There are instances where companies get caught up and fail to adhere to regulations in hope that it might go undetected. Indeed some missed regulations do go undetected.
    However, I believe should try their best not to depend on luck. The Quality Control (QC) should ensure adhering to all regulatory rules even if it means disagreeing with others. Like Dr. Simon mentioned, the research scientists tend to have a hard time adhere to regulations if those regulations don’t equate with scientific norms. I think management should periodically set up meetings to provide updates on current procedures and regulations.