Warehouse Audit Survival Guide: Medical Devices

This article completes our series of "Warehouse Audit Survival Guides" published in Dickson Insights. If you missed our guides on the Pharmaceutical and Food industries, you can find them by clicking here and here.


Know what devices are coming to your facility, are present in your facility, and are leaving your facility at all times.

The FDA’s list of medical devices runs from bed pans to gas analyzers. With this type of variety, the challenges of surviving a medical device audit from a third-party auditor or the FDA are unique and broad. To ensure your warehouse is safe, you need to know exactly what resides in it. Seems simple, but this stretches across multiple departments and individuals. The manager of the warehouse must oversee that the right people know what is where and when it is there. Providing your QA team with advanced notice of a new product entering your warehouse, a product staying extra-long, or a product leaving early will set the warehouse up for quality assurance success. Monitoring your products and their environment then, is a granular job. Keep on top of it.

Don't hinder your internal auditor.

This rule asks different but related things out of management and employees. If you are going to invest in an internal audit, you have to allow that person or team to do their job, particularly if you are worried an FDA auditor may show up at your facility sometime soon. While preparing for your next real audit, management shouldn't impose negative implications on QA managers and floor operators if the mock auditors or internal auditors find something wrong. In fact, they should be happy that the mistakes were found! Mock audits allow companies to see areas for improvement. Harsh penalties instead of opportunity to improve are not the way to go about inspiring better compliance within your organization. In the same vein, floor operators and QA Managers should act as team players during an internal audit. Don't hide results, don't slow down auditors, and don't try to cover up results. It will hurt you in the end.

Create your own survival guide.

You facility is unique to you, so this is the best advice we can give. The above guide provides a template for some common things you absolutely have to know before an auditor knocks on your door. However, you are the one with the experience with your auditors. Validation, SOP's, and verification documents are great, but having a shorter list of things that absolutely, no excuses, have to get done every day, week, or month to help your warehouse survive your next audit will prove invaluable. Customize it, analyze it, and improve it as often as you can.