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  • sns34 replied to the topic Audits in the forum Quality Systems Management 7 years, 11 months ago

    Great question! Gh56 goes into wonderful detail about the pros and cons of conducting an internal audit and I’m sure all students can agree with his response. From the time that I started working at the medical device company that I am currently employed at, I have been fortunate enough to be a part of two external audits and one internal audit conducted by QA. Although quality is quite familiar with the R&D lab, he still made a thorough and efficient run through the equipment and asked detailed questions when he was unsure about what the equipment actually does and when it was last calibrated/how often it goes out for calibration. The audit was completely unbiased and it greatly impacts the future of the company in beneficial ways because it helps us prepare for external audits and helps us focus on lab procedures, documentation, and equipment that might be questioned. It helped all employees prepare for upcoming questions asked by other audits that are critical to the success of the company. However, I can see how internal audits can be a problem in different companies because the process can be bias and whoever is conducting the audit can be unwilling to voice their opinion and point out major or minor flaws.