Today’s Webinar:
Best Practices in Medical Device Auditing
MedicalDeviceAcademy.com
Slide 1
Checklists are fast, but you can win
with Turtle Diagrams.
With what?
Resources
Inputs
From
whom/
where
How done?
Methods/
Documentation
With Whom?
Personnel
Process
(specific value
added activities)
Outputs
To whom/
where
What results?
Performance
indicators
Slide 2
Step 1 – Describe the Process
Step 1: Incoming
Inspection
(Clause 7.4.3)
Process Owner:
QC Supervisor
Slide 3
Step 2 - Inputs
Step 2
Process Inputs
Step 1: Describe the
Process
1. Purchase Orders (Clause 7.4.1)
2. Purchasing Info (Clause 7.4.2)
Slide 4
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
Process Inputs
Step 1: Describe the
Process
Step 3
Process Outputs
Slide 5
Step 4 – With What?
With What Equipment
Facilities & Materials?
Step 2
Process Inputs
1.
2.
3.
4.
Step 1: Describe the
Process
Step 3
Process Outputs
Suitable Environment for Inspection (Clause 6.4)
Validation of Software (Clause 7.5.2.1)
Gage R&R Study (Clause 7.5.2.1)
Calibration of Measurement Devices (Clause 7.6)
Slide 6
Step 5 – Who?
With What Equipment
Facilities & Materials?
Who?
Step 2
Process Inputs
Step 1: Describe the
Process
Step 3
Process Outputs
1. Assignment of Responsibilities & Authorities (Clause 5.5.1)
2. Sampling of Training Records (Clause 6.2.2)
Slide 7
Step 6 – How Done?
With What Equipment
Facilities & Materials?
Who?
Step 2
Process Inputs
Step 1: Describe the
Process
Step 3
Process Outputs
How Done?
1. Control of Documents (Clause 4.2.3)
2. Control of External Standards (Clause 4.2.3)
Slide 8
Step 7 - Metrics
With What Equipment
Facilities & Materials?
Who?
Step 2
Process Inputs
Step 1: Describe the
Process
Step 3
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
Checklists are fast, but you can win
with Turtle Diagrams.
With what?
Resources
Inputs
From
whom/
where
How done?
Methods/
Documentation
With Whom?
Personnel
Process
(specific value
added activities)
Outputs
To whom/
where
What results?
Performance
indicators
Slide 10
And on the other side of the planet...
Slide 11
Audit Programme Planning
Slide 12
Begin with the end in mind
Stephen R. Covey,
“The 7 Habits of Highly Effective People”,
the second habit.
Slide 13
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
Once you have a clearly-formed, detailed
outcome for your audit programme, you
will make it happen that way.
Slide 15
What outcomes do you want for
your audit programme?
How do you want your audit programme
to be?
Slide 16
Clarifying Your Outcome
• The big picture
• Requirements
• Soft factors
Slide 17
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
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
Soft Factors?
1.
2.
3.
4.
5.
What worked well?
What learning outcomes for auditees?
How do you want auditors to feel?
What learning outcomes for auditors?
How do you want the audit team and
the audit programme to be perceived?
Slide 20
What outcomes do you want from
your audit programme?
Download the hand-out with the questions:
MedicalDeviceAcademy.com
Slide 21
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
Plan audits to your process,
not the calendar.
Slide 23
Process Interaction Diagram
Management Processes
Risk Management
(7.1)
Post-Market Surveillance
(8.2.1)
Internal Auditing
(8.2.2)
Data Analysis
(8.4)
CAPA
(8.5.2 & 8.5.3)
Management Review
(5.6)
Core Processes
Product Realization Process
Planning
(7.1)
Incoming
Inspection
(7.4.3)
Purchasing
(7.4.1)
Production
(7.5.1)
Final
Inspection
(8.2.4)
Shipping
(7.5.5)
Support Processes
Document Control
(4.2.3)
Record Control
(4.2.4)
Training
(6.2.2)
Validation
(7.5.2)
Calibration
(7.6)
Monitoring
(8.2.3)
Slide 24
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
Adjacent Link Auditing
Product
Realization
Planning
Purchasing
Receiving
Inspection
Production
Direction of Process Flow
Upstream
Downstream
Slide 26
Adjacent Link / Turtle Diagram
With What Equipment
Facilities & Materials?
Who?
Process Inputs
Process Outputs
Describe
the Process
How Done?
Metrics
Slide 27
2012 Audit Agenda
Slide 28
Critical Processes to Audit
• Final Inspection, Test and Release of
Product
• Product Realization Planning
• Final Packaging & Shipping
• Nonconforming Materials & Rework
Processes
Slide 29
Adjacent Processes
Critical Processes to
Audit
Upstream Adjacent
Process
Downstream Adjacent
Process
Product Realization
Planning
Buyer at Customer
Buyer at Supplier
Nonconforming
Materials & Rework
Processes
QC Inspectors at
Supplier
Engineering at
Customer
Final Packaging &
Shipping
QC Inspectors at
Supplier
Receiving Inspection at
Customer
Final Inspection, Test
& Release of Product
Production at Supplier
Final Packaging &
Shipping at Supplier
Slide 30
2013 Audit Agenda
Slide 31
Q&A
Slide 32
Thank You
MedicalDeviceAcademy.com
Early Bird Pricing thru February 18, 2013
Slide 33