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Today’s Webinar: Best Practices in Medical Device Auditing

MedicalDeviceAcademy.com

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With what? Resources

Outputs To whom/

where

What results? Performance

indicators

Inputs From

whom/ where

How done? Methods/

Documentation

With Who? Personnel

Process (specific value

added activities)

Checklists are fast, but you can win with Turtle Diagrams.

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Step 1 – Describe the Process

Step 1: Incoming Inspection

(Clause 7.4.3)

Process Owner: QC Supervisor

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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)

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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)

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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)

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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)

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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

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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

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With what? Resources

Outputs To whom/

where

What results? Performance

indicators

Inputs From

whom/ where

How done? Methods/

Documentation

With Who? Personnel

Process (specific value

added activities)

Checklists are fast, but you can win with Turtle Diagrams.

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And on the other side of the planet...

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Audit Programme Planning

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Begin with the end in mind

Stephen R. Covey, “The 7 Habits of Highly Effective People”,

the second habit.

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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.

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Once you have a clearly-formed, detailed outcome for your audit programme, you

will make it happen that way.

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What outcomes do you want for your audit programme?

How do you want your audit programme

to be?

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Clarifying Your Outcome

• The big picture

• Requirements

• Soft factors

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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?

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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?

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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?

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What outcomes do you want from your audit programme?

Download the hand-out: MedicalDeviceAcademy.com

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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.

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Plan audits to your process, not the calendar.

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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)

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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.

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Adjacent Link Auditing

Direction of Process Flow

Receiving Inspection

Purchasing Product

Realization Planning

Production

Upstream Downstream

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Adjacent Link / Turtle Diagram

Metrics

Process Outputs Process Inputs

Who?

How Done?

With What Equipment Facilities & Materials?

Describe the Process

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2012 Audit Agenda

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Critical Processes to Audit

• Final Inspection, Test and Release of Product

• Product Realization Planning

• Final Packaging & Shipping

• Nonconforming Materials & Rework Processes

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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

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2013 Audit Agenda

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Q & A

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Thank You

MedicalDeviceAcademy.com

Early Bird Pricing thru February 18, 2013