The element of surprise in warfare is a powerful and deadly weapon. From the Trojan Horse to Little Bighorn, surprise attacks by outsiders have led to dramatic world changes.
But no ambush is more feared and potentially dangerous than that of a governing body auditor showing up at your company unannounced. The horror is unspeakable–like Jason, Freddy Krueger and the Kardashians all rolled up into one. Without a modern product development platform in place, an auditor can set tricks and traps that can run the gamut from a tedious annoyance to potentially shutting you down.
Apical Instruments Director of Regulatory Affairs & Quality Assurance Kim Khoe has over 25 years of experience in the medical device regulatory affairs and quality assurance fields, so she knows how to deal with auditors of all stripes. She even recently survived an ambush from two different auditors–on the same day.
Even the most seasoned regulatory affairs person gets anxious at the prospect of an FDA audit. So what does a “double” audit in the same day do to the average person? We asked Khoe to find out. Here’s her story:
“We had a scheduled FDA audit being conducted when—one hour into the second day—who arrives but the European Notified Body. This was an unscheduled audit, and they would not leave even though the FDA was there. We could not panic as we did not want the FDA nor the Notified Body to think we didn’t have our act together.
“So I took care of the FDA auditor, while the Document Control Manager took care of the Notified Body auditor. As I would check in with the Doc Control Manager to see how things were going I could see a bit of panic in her eyes as she had not hosted an audit before; however, she survived. The company passed both audits with flying colors. Arena, which made finding documents easy, really saved us.”
After a week, the FDA auditor left without any findings. The Notified Body auditor left after two days with only minor findings. Arena makes audits easier and less time consuming with a cloud-based solution that consolidates all compliance information in one centralized system. The solution streamlines management of bills of materials (BOMs), the design history file (DHF), the device master record (DMR) and change orders. This allows medical device companies to perform multiple audits around the world at the same time.
This was not the first time Khoe or any medical device company has been ambushed by two audit bodies simultaneously. “This also happened with our ISO 13485 Registrar and another European Notified Body,” recalls Khoe. “We are a contract manufacturer, so each of our customers has their own Notified Body. It is funny but an audit body never wants to leave because they don’t want the “other” third party to think they are more important. However, I suggest you treat them as if they are all important.”
To learn more how Arena Solutions helped Apical Instruments achieve medical device success, click here.