today’s webinar: best practices in medical device auditing · today’s webinar: best practices...
TRANSCRIPT
Slide 1
Today’s Webinar: Best Practices in Medical Device Auditing
MedicalDeviceAcademy.com
Slide 2
With what? Resources
Outputs To whom/
where
What results? Performance
indicators
Inputs From
whom/ where
How done? Methods/
Documentation
With Whom? Personnel
Process (specific value
added activities)
Checklists are fast, but you can win with Turtle Diagrams.
Slide 3
Step 1 – Describe the Process
Step 1: Incoming Inspection
(Clause 7.4.3)
Process Owner: QC Supervisor
Slide 4
Step 2 - Inputs
Step 1: Describe the Process Process Inputs
Step 2
1. Purchase Orders (Clause 7.4.1) 2. Purchasing Info (Clause 7.4.2)
Slide 5
Step 3 - Outputs
Step 1: Describe the Process Process Outputs Process Inputs
Step 2 Step 3
1. Inspection Record (Clause 7.4.3) 2. Nonconforming Material (Clause 8.3) 3. Acceptance Sticker (Clause 7.5.3)
Slide 6
Step 4 – With What?
Step 1: Describe the Process Process Outputs Process Inputs
Step 2 Step 3
With What Equipment Facilities & Materials?
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 7
Step 5 – Who?
Step 1: Describe the Process
Who?
With What Equipment Facilities & Materials?
Process Outputs Process Inputs
Step 2 Step 3
1. Assignment of Responsibilities & Authorities (Clause 5.5.1) 2. Sampling of Training Records (Clause 6.2.2)
Slide 8
Step 6 – How Done?
How Done?
Process Outputs Process Inputs
Step 2 Step 3
Who?
With What Equipment Facilities & Materials?
1. Control of Documents (Clause 4.2.3) 2. Control of External Standards (Clause 4.2.3)
Step 1: Describe the Process
Slide 9
Step 7 - Metrics
Metrics
Process Outputs Process Inputs
Step 2 Step 3
Who?
How Done?
With What Equipment Facilities & Materials?
1. Quality Objectives (Clause 5.4.1) 2. Monitoring & Measurement of Processes (Clause 8.2.3) 3. Data Analysis (Clause 8.4)
Step 1: Describe the Process
Slide 10
With what? Resources
Outputs To whom/
where
What results? Performance
indicators
Inputs From
whom/ where
How done? Methods/
Documentation
With Whom? Personnel
Process (specific value
added activities)
Checklists are fast, but you can win with Turtle Diagrams.
Slide 11
And on the other side of the planet...
Slide 12
Audit Programme Planning
Slide 13
Begin with the end in mind
Stephen R. Covey, “The 7 Habits of Highly Effective People”,
the second habit.
Slide 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 15
Once you have a clearly-formed, detailed outcome for your audit programme, you
will make it happen that way.
Slide 16
What outcomes do you want for your audit programme?
How do you want your audit programme
to be?
Slide 17
Clarifying Your Outcome
• The big picture
• Requirements
• Soft factors
Slide 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 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 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 21
What outcomes do you want from your audit programme?
Download the hand-out with the questions: MedicalDeviceAcademy.com
Slide 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 23
Plan audits to your process, not the calendar.
Slide 24
Process Interaction Diagram
Planning (7.1)
Production (7.5.1)
Final Inspection
(8.2.4)
Shipping (7.5.5)
Core Processes
Product Realization Process
Support Processes
Document Control (4.2.3)
Record Control (4.2.4)
Training (6.2.2)
Calibration (7.6)
Validation (7.5.2)
Monitoring (8.2.3)
Management Processes
CAPA (8.5.2 & 8.5.3)
Internal Auditing (8.2.2)
Data Analysis (8.4)
Purchasing (7.4.1)
Incoming Inspection
(7.4.3)
Post-Market Surveillance (8.2.1)
Management Review (5.6)
Risk Management (7.1)
Slide 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 26
Adjacent Link Auditing
Direction of Process Flow
Receiving Inspection
Purchasing Product
Realization Planning
Production
Upstream Downstream
Slide 27
Adjacent Link / Turtle Diagram
Metrics
Process Outputs Process Inputs
Who?
How Done?
With What Equipment Facilities & Materials?
Describe the Process
Slide 28
2012 Audit Agenda
Slide 29
Critical Processes to Audit
• Final Inspection, Test and Release of Product
• Product Realization Planning
• Final Packaging & Shipping
• Nonconforming Materials & Rework Processes
Slide 30
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 31
2013 Audit Agenda
Slide 32
Q & A
Slide 33
Thank You
MedicalDeviceAcademy.com
Early Bird Pricing thru February 18, 2013