Are you Ready for a Notified Body Unannounced Audit?

By Sangita Viswanathan
September 10, 2014


• Categories: 05-Quality/Regulatory, RC - Medical Device Audits, Certification & Verification

The panel includes Elisabethann Wright, Partner, at Hogan Lovells; Doug Reimer, Senior Director, MD&D Supply Chain Compliance, Johnson & Johnson; Joachim Wilke, Director, Regulatory Affairs & Policy, Medtronic Europe; and Hendrik Heinze, Director, Quality & Regulatory Affairs, Berlin Heart GmbH.

Moderating the panel, Elisabethann Wright, explains that the industry has to organize its people and be prepared to approach unannounced audits. But when someone’s knocking on your door, saying we are here to do an unannounced audit, what are things you need to do such as having your processes and documents and prototypes in place?

Berlin Heart’s Heinze advises companies to look at their processes, past audit reports and issues such as non-conformances, and apply these to write new procedures for unannounced audits.

“From my perspective, there’s a big gap between a regular audit or FDA inspection and the new product-specific unannounced audits. So use your history and experience from previous audits, against your company’s processes, and prepare a new procedure that will help you be better prepared,” Heinze advises.

The most important thing is creating awareness that unannounced audits exist, says Medtronic’s Joachim Wilke. The requirement is here to stay, and based on this, you need to at least inform your quality people what its intent would be, and how these unannounced audits will be different from current and past audits, he explains.

“There also needs to be internal discussions on supplier management, and how to deal with suppliers about an unannounced audit. For instance, if the inspector is doing sampling, and wants to take away several samples outside for external testing, then contingencies like these have to be discussed,” he explains.

Wilke advises companies to reach out to their Notified Bodies to discuss and understand more about unannounced audits: “Collaborate with your Notified Bodies about issues you have had to be better prepared in the future.”

J&J’s Doug Reimer says while device manufacturers are preparing for unannounced inspections, there is actually a lot we know about what to expect. There needs to be preparation throughout and a mindset that you are audit-ready every day, he says.

“Unannounced audits should not be a major disruption. When you get that call and are told that an inspector is in the lobby, your heart skips a beat, and there is fear, but in reality, this should not be a frightening event. Make sure people in your facility know that it’s going to happen, and convince them that what the auditor is trying to do is actually help check your product and facility and making sure everything is fine,” Reimer explains.

Reimer advises companies to talk to personnel in their own facility and ask them directly, ‘if I told you that there was a regulator in the lobby right now, what would worry you the most,’ and then go fix that issue that very same day. Companies should try this with their vice presidents of quality, lab managers etc., so that they are better prepared for such inspections.

How are you preparing for unannounced audits? Have you had one yet? What have you learned? Share you insights.