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Taking the sting out of audits: Dos and don'ts

Calvin London (calvin@thecomplianceconcierge.com) is the Founder and Principal Consultant of The Compliance Concierge.

Companies operating in the regulated environment of pharmaceuticals, medical devices, and biopharmaceuticals are used to audits. However, the mention of an audit by a government regulatory agency such as the Food and Drug Administration (FDA), the Department of Justice, or the Securities and Exchange Commission will still send a shiver down the spine of even the most resilient. Most employees find an internal audit stressful enough, but these are no match for the anxiety associated with an external audit.

The most desirable outcome of course is to have a peaceful and productive short audit with no observations. To do it, the company must have pristine data, mature systems that run like a Swiss train, and employees that are so well trained, they enjoy being audited. Very few companies can boast such credentials.

I have been fortunate (or unfortunate) enough to have been on the front line of many external audits by government regulatory agencies in Australia, Asia, Europe, and the United States. Some of these have been a delight, others not so much—and one in particular was a disaster ending in the recall of thousands of batches of product. Five auditors, auditing every day for over five months, and the eventual closure of the facility. Direct from the front line, here are five of the best and five of the worst things that you can do when faced with an audit. Note this is not a recipe for guaranteed success, rather comments that in my experience have helped to make an audit run smoothly.

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