For the Love of Internal Auditing


Manage episode 290885544 series 1017311
By Greenlight Guru's Jon Speer + Medical Device Entrepreneurs, Executives, Inventors & Consultants; R&D, Quality, Regulatory, Greenlight Guru's Jon Speer + Medical Device Entrepreneurs, and Consultants; R. Discovered by Player FM and our community — copyright is owned by the publisher, not Player FM, and audio is streamed directly from their servers. Hit the Subscribe button to track updates in Player FM, or paste the feed URL into other podcast apps.

Who loves internal auditing? Probably 99.99 percent of medical device professionals answered “not me!” While it may not be everyone’s favorite pastime, internal audits are very important...especially if you have or want a true quality culture and mindset of continuous improvement.

In this episode of the Global Medical Device Podcast, Jon Speer talks to Sara Adams, a medical device guru at Greenlight Guru.

Sara loves to talk about internal audits. She shares her valuable wisdom of internal audits as well as learnings from leading Corrective and Preventive Action (CAPA) investigations and implementations, process improvements, and supplier and regulatory audits throughout her career in the medical device industry.

Some of the highlights of the show include:

  • Internal audits shouldn’t be about checking a box. If you know about problems, fix them first. Internal auditing offers opportunities for improvement.
  • From a risk perspective, where are the trends and weak areas? Find them before someone else does and causes complaints or extra work. It is valuable to be able to look into those problem areas that need to be fixed.
  • More medical device companies need to change their mindset by embracing quality as part of their culture, not as an obstacle or barrier. Collaborate with other departments because everyone has to own their process and procedure.
  • Quality auditors may say there’s no choice, this has to be done. If the company has a CAPA or other options to be compliant, management will offer its buy-in.
  • Misconceptions about internal audits include conducting internal audits on every process and procedure at least once a year, and if there’s any audit finding, you must create a CAPA.
  • Key Tips: Make a plan/schedule, document and follow internal audit process, and realize that CAPA’s are only meant for major, risk-based, systemic issues.

Memorable quotes from this episode:

“We can always get better. Internal auditing is one method that, done properly, can help us improve our processes and our operations as medical device companies.” Jon Speer

“I like rules. I like boundaries. I like guidelines.” Sara Adams

“You can fix it and not give someone else an opportunity to find that.” Sara Adams

“Your internal audits should be the toughest audits that you ever have.” Jon Speer

“Being able to present options that still will take you into compliance, I think, is huge for getting management’s buy-in.” Sara Adams


Sara Adams

ISO 13485:2016

FDA - Medical Device Single Audit Program (MDSAP)

Greenlight Guru Academy

The Greenlight Guru True Quality Virtual Summit

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru

368 episodes