Auditing the Auditor

Global Medical Device Podcast powered by Greenlight Guru

For some people, audits are terrifying. But today’s guest says you need to learn to love the audit process, and she shares information that can help you do that.

Sara Adams is a Medical Device Guru at Greenlight Guru. Medical Device Gurus are part of Greenlight Guru’s “Guru Edge.” Medical Device Guru’s help customers onboard to their new software and guide them through the various regulatory requirements and challenges unique to MedTech companies and Medical Device Professionals.

Listen to the episode to hear Sara share some of her wisdom about audits. She talks about what happens when you don’t accept the finding of an audit, the different types of rules and approaches to different kinds of audits, and the kinds of problems she consistently sees from people when they’re learning to do audits. She also shares details about her own first audit!

Some of the highlights of this episode include:

• Sara’s background and experience with audits
• How Sara trained other people to audit
• How to build a culture of collaboration
• Sara’s first audit experience
• What the process of negotiating an audit finding looks like
• What’s unique about each audit
• The partnership in a supplier audit
• Consistent problems people face during audits and how to overcome them
• What’s important to know about getting ISO certification

Memorable quotes from Sara Adams:

“In an internal audit, you need to avoid a conflict of interest. Like I don’t need to be auditing my own work.”

“Quality is everyone’s responsibility and not just the quality department’s.”

“We all have a first day. Everybody has a first day.”

“Never look at something as just a checkbox.”

Links:

Sara Adams LinkedIn

Etienne Nichols LinkedIn

Greenlight Guru Academy

MedTech Excellence Community

Greenlight Guru