Audits are a fact of life in the medtech industry, whether internal audits, supplier audits, or notified body audits. While previously most audits were conducted on-site and in person, the industry has had to pivot to remote auditing wherever possible. In this session, Cannon Quality Group founder/CEO Nicolle Cannon will share CQG’s experiences as an early adopter of remote auditing. CQG has conducted numerous internal and supplier audits remotely as well as supported clients undergoing remote notified body audits. The presentation will cover both the hard skills of getting comfortable with various technology platforms as well as the soft skills of effective communication between auditor and auditee. Many now predict remote auditing will remain the default option in the coming years. This presentation originally aired during the 2021 State of Medical Device Virtual Summit.

1. AUDITS:
Let’s get back
to auditing,
remotely!

2. MEDICAL DEVICE QUALITY IS ALL WE DO,
AND WE’RE ALWAYS AHEAD OF THE GAME.
© Copyright 2020 by Greenlight Guru

3. Nicolle
Cannon
Founder and CEO
Cannon Quality Group, LLC

4. 2020 Strong

5. February 2020
• Audit Plans and schedules were rolling
• Q1 Internal Audit was under way
• Notified Body Audit was scheduled

6. March 2020

7. Back on track
Assess Plan Prepare
Test
Run

8. 2.
3.
4.
1. Assess

9. External
Supplier
Internal

10. Is the
organization
ready for
remote
Auditing?

11. 2.
3.
4.
1.
Plan

12. External
Supplier
Internal

13. Audit Agenda and Flow
Document
Reading
Record
Review
Physical
Inspection

14. Audit Agenda and Flow
People
Time

15. On-site vs. Remote
• White board?
• Food?
• Whose
Documenting?
Room
• How will we stage?
• Share Screen?
• Electronic File
Access?
Files • Platform?
• Breakout rooms?
• Staying On-line?
Interaction

16. 2.
3.
4.
1.
Prepare

17. Clarify the Process
Agenda & Flow
Document
Review
Record Review
and Storage
Process Tour /
Product Show
Interaction &
Food

18. External
Supplier
Internal

19. 2.
3.
4.
1.
Test Run

20. Repeat
External
Supplier
Internal

21. Sum
Up
Assess
1.
2.
3.
4.
Plan
Prepare
Test Run
5. De Brief

22. 6 Tips to Remote
Auditing
quality@cannonqg.com

23. Share
Your
Experience
#StateofMD21

24. About
Cannon
Quality
Group, LLC
Cannon Quality Group has served
over 200 companies to date with
88% of past clients still in business.
30% have been acquired or gone
public. Cannon Quality Group helps
startups set up their first quality
management systems, achieve
compliance to FDA standards and ISO
13485. Learn more at:
www.cannonqualitygroup.com