Preparing for an Audit: A Three-Part Series on Audit Readiness

Based on a presentation given by Dr. Maria E. Donawa, President, Roger Gray, VP Quality and Regulatory, Donawa Lifescience Consulting, at the Kaplan EduNeering European Knowledge Summit in 2009.

Part One: What You Need to Know

Expecting an Unexpected Inspection

Few business sectors are as closely regulated or scrutinized as the pharmaceutical, biologics and medical device industries (life sciences). The growing complexity of technologies and the continued globalization of markets and supply chains will only intensify the attention of regulators, particularly in the area of product quality.

Part Two: What You Should Do

What the Auditor Already Knows

When a regulatory auditor arrives at your door, he or she will be prepared. The auditor will have reviewed the facility’s product specifications, its production processes and its compliance history. Before the first “Hello,” the auditor will know the focus and findings of the last auditor, any recalls of products from your plant or even a nonrelated facility using the same suppliers, and any quality problems noted at your company’s other facilities. You have to be just as well-prepared. Good preparation for a regulatory audit involves practical actions that extend from the CEO’s office to the shop floor and loading dock.

Part Three: What You Should Learn

The Audit as Opportunity

The regulatory audit will demonstrate the effectiveness of your preparation. It can also open the door to better operations, cost-control and compliance. Companies that insist on seeing regulatory audits as necessary evils to be endured and promptly forgotten will miss out on those opportunities to improve their competitiveness and performance going forward.