FDA Audit Process Training using turtle diagrams presented by Rob Packard, founder of http://MedicalDeviceAcademy.com and Brigid Glass, CEO of Brigid Glass & Associates.

1. Today’s Webinar:
Best Practices in Medical Device Auditing
MedicalDeviceAcademy.com
Slide 1

2. Checklists are fast, but you can win
with Turtle Diagrams.
With what? With Who?
Resources Personnel
Inputs
From
Process Outputs
(specific value To whom/
whom/
added activities) where
where
How done? What results?
Methods/ Performance
Documentation indicators
Slide 2

3. Step 1 – Describe the Process
Step 1: Incoming
Inspection
(Clause 7.4.3)
Process Owner:
QC Supervisor
Slide 3

4. Step 2 - Inputs
Step 2 Step 1: Describe the
Process Inputs Process
1. Purchase Orders (Clause 7.4.1)
2. Purchasing Info (Clause 7.4.2)
Slide 4

5. Step 3 - Outputs
1. Inspection Record (Clause 7.4.3)
2. Nonconforming Material (Clause 8.3)
3. Acceptance Sticker (Clause 7.5.3)
Step 2 Step 1: Describe the Step 3
Process Inputs Process Process Outputs
Slide 5

6. Step 4 – With What?
With What Equipment
Facilities & Materials?
Step 2 Step 1: Describe the Step 3
Process Inputs Process Process Outputs
1. Suitable Environment for Inspection (Clause 6.4)
2. Validation of Software (Clause 7.5.2.1)
3. Gage R&R Study (Clause 7.5.2.1)
4. Calibration of Measurement Devices (Clause 7.6) Slide 6

7. Step 5 – Who?
With What Equipment
Facilities & Materials?
Who?
Step 2 Step 1: Describe the Step 3
Process Inputs Process Process Outputs
1. Assignment of Responsibilities & Authorities (Clause 5.5.1)
2. Sampling of Training Records (Clause 6.2.2)
Slide 7

8. Step 6 – How Done?
With What Equipment
Facilities & Materials?
Who?
Step 2 Step 1: Describe the Step 3
Process Inputs Process Process Outputs
How Done?
1. Control of Documents (Clause 4.2.3)
2. Control of External Standards (Clause 4.2.3)
Slide 8

9. Step 7 - Metrics
With What Equipment
Facilities & Materials?
Who?
Step 2 Step 1: Describe the Step 3
Process Inputs Process Process Outputs
Metrics
How Done?
1. Quality Objectives (Clause 5.4.1)
2. Monitoring & Measurement of Processes (Clause 8.2.3)
3. Data Analysis (Clause 8.4)
Slide 9

10. Checklists are fast, but you can win
with Turtle Diagrams.
With what? With Who?
Resources Personnel
Inputs
From
Process Outputs
(specific value To whom/
whom/
added activities) where
where
How done? What results?
Methods/ Performance
Documentation indicators
Slide 10

11. And on the other side of the planet...
Slide 11

12. Audit Programme Planning
Slide 12

13. Begin with the end in mind
Stephen R. Covey,
“The 7 Habits of Highly Effective People”,
the second habit.
Slide 13

14. Begin with the End in Mind
• The first creation is in your mind
• Have clarity on your outcomes and your
mental filters will find for you the
resources and opportunities that you
need.
• The second creation is where you make it
happen.
Slide 14

15. Once you have a clearly-formed, detailed
outcome for your audit programme, you
will make it happen that way.
Slide 15

16. What outcomes do you want for
your audit programme?
How do you want your audit programme
to be?
Slide 16

17. Clarifying Your Outcome
• The big picture
• Requirements
• Soft factors
Slide 17

18. The Big Picture
1. What do your audit policy and objectives
say?
2. What are your key processes?
3. What changes is the business plan
flagging?
4. What do top management want you to
audit?
5. What should be the range and scope?
Slide 18

19. Audit Criteria
1. What regs and standards?
2. What regs and standards are changing?
3. What other management systems can
you integrate into your audits?
4. What customer requirements?
Slide 19

20. Soft Factors?
1. What worked well?
2. What learning outcomes for auditees?
3. How do you want auditors to feel?
4. What learning outcomes for auditors?
5. How do you want the audit team and
the audit programme to be perceived?
Slide 20

21. What outcomes do you want from
your audit programme?
Download the hand-out:
MedicalDeviceAcademy.com
Slide 21

22. The Challenge
• Create in your mind the
equivalent of my food
garden,
– supplying delicious food
all year and
– an energising place to
hang out.
• Begin with the end
in mind.
Slide 22

23. Plan audits to your process,
not the calendar. Slide 23

24. Process Interaction Diagram
Management Processes
Risk Management Post-Market Surveillance Internal Auditing Data Analysis CAPA
(7.1) (8.2.1) (8.2.2) (8.4) (8.5.2 & 8.5.3)
Management Review
(5.6)
Core Processes
Product Realization Process
Incoming Final
Planning Purchasing Production Shipping
Inspection Inspection
(7.1) (7.4.1) (7.5.1) (7.5.5)
(7.4.3) (8.2.4)
Support Processes
Document Control Record Control Training Validation Calibration Monitoring
(4.2.3) (4.2.4) (6.2.2) (7.5.2) (7.6) (8.2.3)
Slide 24

25. New Definitions
Adjacent Links in the Product Realization Process
= Major Steps in the Process
Adjoining Links in the Product Realization Process
= Communication of Information &
Transport of Materials between Dept.
Slide 25

26. Adjacent Link Auditing
Product
Receiving
Realization Purchasing Production
Inspection
Planning
Direction of Process Flow
Upstream Downstream
Slide 26

27. Adjacent Link / Turtle Diagram
With What Equipment
Facilities & Materials? Who?
Process Inputs Process Outputs
Describe
the Process
How Done? Metrics
Slide 27

28. 2012 Audit Agenda
Slide 28

29. Critical Processes to Audit
• Final Inspection, Test and Release of
Product
• Product Realization Planning
• Final Packaging & Shipping
• Nonconforming Materials & Rework
Processes
Slide 29

30. Adjacent Processes
Critical Processes to Upstream Adjacent Downstream Adjacent
Audit Process Process
Product Realization Buyer at Customer Buyer at Supplier
Planning
Nonconforming QC Inspectors at Engineering at
Materials & Rework Supplier Customer
Processes
Final Packaging & QC Inspectors at Receiving Inspection at
Shipping Supplier Customer
Final Inspection, Test Production at Supplier Final Packaging &
& Release of Product Shipping at Supplier
Slide 30

31. 2013 Audit Agenda
Slide 31

32. Q&A
Slide 32

33. Thank You
MedicalDeviceAcademy.com
Early Bird Pricing thru February 18, 2013
Slide 33