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Episode 199  |  33:27 min

For the Love of Internal Auditing

Episode 199  |  33:27 min  |  04.26.2021

For the Love of Internal Auditing

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This is a podcast episode titled, For the Love of Internal Auditing. The summary for this episode is: <p><span style="color: rgb(0, 0, 0); background-color: transparent;">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.&nbsp;&nbsp;</span></p><p><span style="color: rgb(0, 0, 0); background-color: transparent;">In this episode of the Global Medical Device Podcast, Jon Speer talks to Sara Adams, a medical device guru at Greenlight Guru.</span></p><p><span style="color: rgb(0, 0, 0); background-color: transparent;">Sara loves to talk about internal audits. She shares her valuable wisdom of internal audits as well as learnings from</span><span style="color: rgb(48, 55, 53);"> leading Corrective and Preventive Action (CAPA) investigations and implementations, process improvements, and supplier and regulatory audits throughout her career in the medical device industry.</span></p><p><br></p><h3><strong style="color: rgb(67, 67, 67); background-color: transparent;">Some of the highlights of the show include:</strong></h3><ul><li><span style="background-color: transparent;">Internal audits shouldn’t be about checking a box. If you know about problems, fix them first. Internal auditing offers opportunities for improvement.&nbsp;</span></li><li><span style="background-color: transparent;">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.&nbsp;</span></li><li><span style="background-color: transparent;">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.</span></li><li><span style="background-color: transparent;">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.&nbsp;</span></li><li><span style="background-color: transparent;">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.&nbsp;</span></li><li><span style="background-color: transparent;">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.</span></li></ul><p><span style="background-color: transparent;"></span></p><h3><strong style="color: rgb(67, 67, 67); background-color: transparent;">Memorable quotes from this episode:</strong></h3><p><em style="color: rgb(0, 0, 0); background-color: transparent;">“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.”</em><span style="color: rgb(0, 0, 0); background-color: transparent;"> Jon Speer</span></p><p><em style="color: rgb(0, 0, 0); background-color: transparent;">“I like rules. I like boundaries. I like guidelines.”</em><span style="color: rgb(0, 0, 0); background-color: transparent;"> Sara Adams</span></p><p><em style="color: rgb(0, 0, 0); background-color: transparent;">“You can fix it and not give someone else an opportunity to find that.”</em><span style="color: rgb(0, 0, 0); background-color: transparent;"> Sara Adams</span></p><p><em style="color: rgb(0, 0, 0); background-color: transparent;">“Your internal audits should be the toughest audits that you ever have.”</em><span style="color: rgb(0, 0, 0); background-color: transparent;"> Jon Speer</span></p><p><em style="color: rgb(0, 0, 0); background-color: transparent;">“Being able to present options that still will take you into compliance, I think, is huge for getting management’s buy-in.”</em><span style="color: rgb(0, 0, 0); background-color: transparent;"> Sara Adams</span></p><p><br></p><h3><strong style="color: rgb(67, 67, 67); background-color: transparent;">Links:</strong></h3><p><a href="https://www.greenlight.guru/blog/meet-sara-adams" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Sara Adams</a></p><p><a href="https://www.iso.org/standard/59752.html" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">ISO 13485:2016</a></p><p><a href="https://www.fda.gov/medical-devices/cdrh-international-programs/medical-device-single-audit-program-mdsap" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">FDA - Medical Device Single Audit Program (MDSAP)</a></p><p><a href="https://www.greenlight.guru/academy" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Greenlight Guru Academy</a></p><p><a href="https://virtual-summit.greenlight.guru/" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">The Greenlight Guru True Quality Virtual Summit</a></p><p><a href="https://www.youtube.com/channel/UCYfQsPqHW8H8mZ4xpM4gn1Q" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Greenlight Guru YouTube Channel</a></p><p><a href="https://www.greenlight.guru/podcast-mtqs" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">MedTech True Quality Stories Podcast</a></p><p><a href="https://www.greenlight.guru/" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Greenlight Guru</a></p>

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


Links:

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

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Regulatory Tips & Pointers from a Former FDA Reviewer