Even with COVID19, there is still an expectation your organization is in compliance with quality system regulations and standards, including quality audits. How do you provide an environment for value add audits and/or appraisal activities when you can’t get people performing the working in the same room together? Come hear from staff at Two Harbors Consulting what lessons they have learned from recent remote audits and appraisals performed as such specifically because of COVID19 restrictions Attendees in this session will learn: • Logistic considerations for a successful remote audit/ appraisal • More subjective – or soft considerations for a successful remote audit/ appraisal • “Anti-patterns” or the “what to avoid” when considering a remote audit/ appraisal This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.

1. Two Harbors ConsultingTwo Harbors Consulting
Experience, Integrity, CreativityExperience, Integrity, Creativity
George Zack: george.zack@twohc.comGeorge Zack: george.zack@twohc.com
REMOTE (“VIRTUAL”)
INTERNAL QUALITY
AUDITS:
REMINDERS TO
CONSIDER IN A
COVID19 WORLD

2. “Greenlight Guru Software is the handrail for Medical
Device Development and Documentation”
FEATURED
IN
75
years
industry
experience
275k
podcast
listeners
#1
blog and
podcast in
the industry
90k
look to us for the
latest in medical
device quality
MEDICAL DEVICE QUALITY IS ALL WE DO, AND WE’RE
ALWAYS AHEAD OF THE GAME.
“My QMS is world class”
“One stop shop for MDQMS”

3. 3
 You have an internal / external audit / supplier audit / assessment program
you need to support or execute
 You have a global pandemic – and hence you cannot perform this on-site as
you may have previously
 What are some factors you should consider in supporting / executing your
audit program?
 Will, even with those adjustments, be as effective (or more less)?
 Who am I anyway?
 And here is the basic premise …
WHAT WE ARE COVERING TODAY

4. 4
We are / I am / My firm is … (or organizations I work with if a consultant)
 delaying audit and assessment activities because of COVID 19 and until they can
be performed “normally”
 performing all audit activities, including scheduled on-site activities as we
normally would
 performing all audit activities as scheduled but doing those remotely
 still trying to figure what to do with audits because there are bigger concerns
right now
 Some combination of the above
 None of the above
QUICK POLL

5. 5
Time Zones
Languages (and …)
Internet connectivity
Phone connectivity
Web Tools / security
Plan, plan, plan
BASIC LOGISTICS MATTER

6. 6
LOGISTICS: ARTIFACTS
Where will you share
Confidentiality / security
Destruction after event
Velocity of receipt
(lead time)

7. 7
Multi-tasking
Interview lengths and
camera exhaustion
Interview size
SET EXPECTATIONS: FOCUS

8. 8
Use the Camera
Read the Room / people
Pan the camera
Walk the floor / tours
Multiple cameras
Photographs
VIDEO CAPABILITY

9. 9
Practice ahead of time
 Are cameras working?
 Can everyone mute / unmute?
 Can everyone screenshare?
 Can everyone chat (even to
each other)?
 Can you use polling? Reactions?
 How will you perform a tour?
DRESS REHEARSALS FOR “ON-SITE”

10. 10
 Dogs
 Kids
 Cell phones
 Backgrounds
 Toilet flushes
(refer to Supreme
Court on May 8)
INTERRUPTIONS – PLAN FOR THEM

11. 11
Masks
Distance from
the camera
Multiple people
in the same
room (and
mute)
A FEW “OH YEAH …” MOMENTS
Picture source: WLEX/CNN/Gray News

12. 12
Plan
Backup
No plan goes
100% to plan
Iterate and
modify
KEY TAKE AWAYS

13. 13
• Virtual activities can
be effective
• … or even more
effective
• … but in some cases
maybe not
• … what is really the
value you are trying
to get?
SHOULD YOU DO THESE ?

15. 15
Info@twohc.com or
George.zack@twohc.com
https://twoharborsconsulting.com
Two Harbors Consulting
Becky Fitzgerald Tom Klein Jim Shaver George Zack