The time to prevent inspection observations is before the inspectors arrive! If you aren’t making effective use of your internal audit programs to identify and remediate problems and trends, you should start work to improve them immediately. Even if you are being diligent with your quality systems, you will still run the risk of one or more observations during any inspection. What do you do? Monitor your inspection closely and identify potential issues as they are mentioned by the inspectors. Stay calm – treat the inspectors as if they are colleagues working to help you improve (which they are). Follow your procedures and the appropriate agency requirements when responding and be decisive in your responses. If you haven’t done the risk assessment that gives you the confidence that your answer is correct, keep working on the response. If you are struggling with a particular point, get some help – there are plenty of consultants available on relatively short notice, but you should consider developing a few relationships in advance of need.

Text Copyright © Katrina Rogers 2018