I love being audited (really, I do!)

Firstly, it’s a chance to shine: to demonstrate Team Consulting’s compliance to quality and regulatory standards, and to show in a very practical way to our clients how we really understand the medical devices industry and what they require from a trusted partner like Team. It feels great when the audit is finished and we get the thumbs up from their QA team. The fact we keep receiving regular pharma clients means we know we’re getting it right.

A second reason I enjoy the experience is because I often have the opportunity to see our fantastic project teams in action and talking with passion about their technical expertise. It’s so great to find out more about the intricacies of a device, how risks are managed or how a particular material or technology was selected. Whether the project is early or late in the development phase, I always leave the office (even the virtual one!) feeling incredibly proud to be part of that project team in some way, through our quality management system.

Finally, having lost count of how many audits I’ve hosted, I think I have learned so much over the years on the skill (or art?) of good auditing. From good people skills, to killer questions, to further understanding a particular clause in depth that the auditor is passionate about, I get a real feeling for what the industry is looking for and where the standards and regulations are taking us in practical ways.

A recent audit (the first on site since the pandemic), reminded me how data integrity is so critical in device testing, both in generating valuable records but also in storing them. I really had a good discussion with the auditor and was pleased to hear he was, after much poking and prodding, very happy with how Team understood this key regulatory requirement.

Experiences such as these have helped me in my own auditing skills, especially with my own suppliers. To be able to translate to a supplier all the requirements of the client, at a quality level, is a great way to ensure Team really does the best for its clients.