When it comes to audits, Apical Instruments’ Director of Regulatory Affairs & Quality Assurance Kim Khoe has certainly seen it all, including being ambushed by two different auditing bodies on the same day. “Just last Thursday I had a customer audit and then who walks in the second day but a product safety agency to perform a quarterly follow up service audit,” Khoe says.
It’s like the immortal classic film Alien Versus Predator Requiem in which both alien and predator—two very deadly extraterrestrial races—simultaneously descend on a rural town, where the town folk must band together for any chance of survival. Of course, precious few auditors have molecular acid for blood, cloaking devices, or claw-mouth appendages, but you get my point.
In the case of Kim Khoe, she and her teammates kept cool and used quality management jujitsu to manage the auditors. What’s the secret to Khoe’s ability to keep auditors from stepping on her medical device product development processes? Arena’s all-in-one product development platform.
“Arena helps in that their cloud-based product development platform can be in two places at one time – unlike a binder of documents, which we would have to shuffle from one conference room to another,” she says.
To meet FDA and other regulations, Khoe has long since known she must be able to manage information professionally to show evidence of compliance and avoid costly penalties and brand damage. Early in her career, she experienced firsthand the pain and burden of inefficient paper-based manual processes and the risk of compliance exposure caused by misplaced critical documentation that impeded her ability to prove mandatory compliance. And that’s why she relies on Arena.
Arena gave Khoe so much confidence that she said having two audits in the same day actually saved her time and money. “Audits take time and so the good thing about having two audits at one time—it decreases the amount of time during the week/month spent on audits,” says Khoe. “The bad thing is that there is more room for error as there will usually be one of the audits hosted by an employee that is less experienced. I worried about my document control manager but the FDA audit ended well, with no findings; and the Notified Body ended well as well—no major findings.”
According to Khoe, if you’re a medical device company, it’s only a matter of time before you’re ambushed be two auditing bodies at the same time. “Apical continues to get unannounced audits”, says Khoe. “As a contract manufacturer, the Notified Bodies come on their schedule and the product safety follow up audits occur unannounced. We are used to those—but one at a time, not two at a time.”
Khoe has 25 years of quality experience that includes setting up companies’ quality management systems, hosting FDA and 3rd party audits, as well as auditing medical device manufacturers, having been a lead auditor for a European Notified Body. She has also filed a handful of FDA 510(k) submissions resulting in clearances and obtained CE marks for various products. Her final words of advice to anyone who is afraid of scary alien-like auditors bent on world domination is simple: “Don’t panic. Keep calm. And use Arena.”