In the latest managing continuous improvement webinar from IBS America, Inc., attendees learned how to use Corrective Actions to improve quality, enhance interdepartmental communications, and increase customer satisfaction. In this webinar, we covered: -Why Corrective Actions are important -How to get the entire enterprise involved -What tools you can use to manage the process Visit the IBS Blog for more information and to register for our next webinar: http://info.ibs-us.com

1. Corrective Action: The
Heart of Continuous
Quality
IBS America
THE PRODUCTIVITY ADVANTAGE

2. Agenda and Introduction
Agenda and Introduction
What is CAPA & 7 Essentials of CAPA
Getting Management Buy-In / What Makes a
Good System
CAPA Solutions Demonstration
Q&A – 10 minutes
IBS Overview THE PRODUCTIVITY ADVANTAGE

3. What is CAPA?
Method to communicate, evaluate, analyse, resolve
current and potential problems in products, materials,
processes, suppliers.
 Key tactic in continuous improvement
 Tool for cost reduction
Provides foundation for increased customer
satisfaction and market share
© IBS AG Slide 3 IBS Overview THE PRODUCTIVITY ADVANTAGE

4. 7 Steps of an Effective CAPA
 Analyze Data
 Customer Complaints
 Inspection Information
 Supplier Performance
 Legal Issues
 Employees
 Identify Appropriate Actions
 Clear step by step plan
 Risks, Impact
© IBS AG Slide 4 IBS Overview THE PRODUCTIVITY ADVANTAGE

5. 7 Steps of an Effective CAPA
 Get to the Root Cause
 Design
 Materials
 Process
 Training
 Multiple
 Validate Actions
 Measure effectiveness
 Did it help?
 Adjust actions based on findings
 Rethink processes
© IBS AG Slide 5 IBS Overview THE PRODUCTIVITY ADVANTAGE

6. 7 Steps of an Effective CAPA
 Communicate changes to appropriate personnel
 Process changes
 Training changes
 Material changes
 Management Review
 Management is aware of issues
 Management signs off on CARS/PARS
© IBS AG Slide 6 IBS Overview THE PRODUCTIVITY ADVANTAGE

7. Agenda and Introduction
Agenda and Introduction
What is CAPA & 7 Essentials of CAPA
Getting Management Buy-In / What Makes a
Good System
CAPA Solutions Demonstration
Q&A – 10 minutes
IBS Overview THE PRODUCTIVITY ADVANTAGE

8. How Does CAPA Support the Organizations Initiatives?
Quality Systems act
Market Higher Quality = EPS / like levers to reduce cost
Share Higher Market Share Shareholder
Value
Sustainability
Compliance To Standards
Manage
Liability Records, Controls
Schedules, Training
and Verifiable Proof
© IBS AG Slide 8 IBS Overview THE PRODUCTIVITY ADVANTAGE

9. Operational Management
New Product  Refine processes
Introduction
Asset Performance  Increase productivity
Operating Budget vs.
 Reduce scrap and rework
Plan
Operating Margins
 Lower Costs
vs. Plan
Employee Safety &  Prevent Accidents
Asset Protection
Compliance to  ISO & Governmental
Standards
© IBS AG Slide 9 IBS Overview THE PRODUCTIVITY ADVANTAGE

10. Users
 Do Jobs Correctly  Work instruction change notification
 Efficiency  Communicate new training needed
 Know How  Best Practices
 Safety  Videos / Graphics / Pictures
 Input / Feedback  Handling and safety info changes
 Corrective and Preventative action
requests
IBS Overview THE PRODUCTIVITY ADVANTAGE

11. Strategy
Alignment with Executive and
Operational Strategies and
Plans
IBS Overview THE PRODUCTIVITY ADVANTAGE

12. Example 1
 Top Management Increase
Market Share
New
Operational Product
Products /
Increase
Management Quality Production
Features
 Analyze Data  Analyze Process Data  Less Rework
 Identify Issues  Identify Issues  Less Scrap
 Fix Problems  Fix Problems  Less Labor
 Increased Quality  Improve Efficiency  Increase Throughput
and Initial Quality
IBS Overview THE PRODUCTIVITY ADVANTAGE

13. Example 2
 Top Management Increase
EPS
Reduce
Increase Increase
Warranty
Margin Throughput
Costs
 Indentified Problems  Reduce Scrap  Increase Productive
Time
 Quickly Fix  Reduce Labor
 Decrease Non-
 Reduce # of  Reduce Rework
Productive Activities
Problems in cost hands
IBS Overview THE PRODUCTIVITY ADVANTAGE

14. Example 3
Reduce
 Top Management Liability
Product OH&S
 Preventative  Preventative
 Corrective  Corrective
IBS Overview THE PRODUCTIVITY ADVANTAGE

15. INPUTS are Varied and Many….
• Inspection Analysis
• Non-Conforming
Material
• Employee • Government
Suggestions Regulations
• Supplier
• Compliance Issues
• Audits
Issues
• Change
• Customer Requests
Complaints
IBS Overview THE PRODUCTIVITY ADVANTAGE

16. CAPA Functionality
 Workflows
 Internal / External Assignments
 Containment
 Evaluate / Remodel / Long Term
 Containment
 Root Cause Problem Solving
 Review and Verification
 Management Review
IBS Overview THE PRODUCTIVITY ADVANTAGE

17. System Functionality
 Document Integration
 Alerts and Escalations
 Security
 Flexibility
 Notifications
 Communication
 Change Procedures
 Documentation
 Workflow
 Audit Trail
IBS Overview THE PRODUCTIVITY ADVANTAGE

18. Agenda and Introduction
Agenda and Introduction
What is CAPA & 7 Essentials of CAPA
Getting Management Buy-In / What Makes a
Good System
CAPA Solutions Demonstration
Q&A – 10 minutes
IBS Overview THE PRODUCTIVITY ADVANTAGE

19. Corrective Actions Compliant Pro
IBS
THE PRODUCTIVITY ADVANTAGE

20. Corrective and Preventive Action
The bedrock of a
healthy quality system
A barometer
of system health
Mitigates risk
Assures control
© IBS, 2006 Page 20 IBS Overview THE PRODUCTIVITY ADVANTAGE

21. Energy Management as Part of a Total Solution
© IBS, 2006 Page 21 IBS Overview THE PRODUCTIVITY ADVANTAGE

22. Integrated Functionality
© IBS, 2006 Page 22 IBS Overview THE PRODUCTIVITY ADVANTAGE

23. High Level Approach to Corrective Action
© IBS, 2006 Page 23 IBS Overview THE PRODUCTIVITY ADVANTAGE

24. CAPA
© IBS, 2006 Page 24 IBS Overview THE PRODUCTIVITY ADVANTAGE

25. Information is Power
Effective
anticipatory
Reports & remedial
& management
CAPA decisions
Analysis
Data
© IBS, 2006 Page 25 IBS Overview THE PRODUCTIVITY ADVANTAGE

26. Thank You! Questions?
IBS America, Inc.
www.ibs-us.com
(781) 862-9002
PRESENTER: Tim Gamble – tim.gamble@ibs-ag.com
(781) 862-9002 ext. 137
Quality Management 2.0
http://info.ibs-us.com
@IBSAmerica
IBS Overview THE PRODUCTIVITY ADVANTAGE