Inspection stories? We've all got them. The inspector who had a meltdown! The new VP who found himself in the inspection hot seat his first week! The receptionist who heard FOOD and Drug Administration and took the inspector on a tour of the cafeteria!
One common thread is that emotions run high during an inspection. No matter how much you practice, when the inspector walks through the door, everyone involved suddenly gets a touch of nerves, like third graders in a school play. Some folks handle it surprisingly well; others, surprisingly poorly. Tears are not uncommon. Raised voices are likely. After two weeks of takeout meals, bloating is a near certainty.
One thing that surprised me about myself during my first inspection was how hard it was to focus. With the heightened awareness that accompanied my nervousness, I found I had a tendency to insert myself into every discussion. In subsequent inspections, I found that teams who had clearly-defined roles, responsibilities, and workflows worked much more efficiently than teams where everyone was getting involved in every request. When we developed Ready Room, we made a conscious effort to build in visual cues to help people like me "stay in their lane." We find it cuts down on the tears and yelling, although there is no discernible effect on weight gain.
We hope you enjoy our "inspection bingo" card. We're always interested in hearing good inspection stories.
Denise DeRenzo Lacey, RQAP-GCP, has over twenty years’ experience in clinical Quality Assurance and clinical development operations. Her practice focuses on application of quality risk management techniques for clinical studies, including risk-based approaches to auditing, data quality and integrity, and SOP development. She has provided consulting services to a wide range of pharmaceutical, medical device, biotech and CRO clients in the US and Europe and has held senior positions at Vertex Pharmaceuticals and Radius Health.