1. eQMS Implementation at CoorsTek Medical
Amanda Black, Quality Systems Manager
May 10, 2017

2. Agenda
CoorsTek Medical Overview
eQMS Advantages
Implementation Techniques
Benefits Achieved
Lessons Learned
Summary

3. Introduction to CoorsTek Medical

5. Vision, Mission, Values VISION MISSION VALUES
VISION We make lives measurably better
VISION
MISSION
MISSION CoorsTek Medical is the partner of choice for medical innovators and medical-device providers worldwide whose success requires access to leading-edge medical device development experts and the related set of specialized product development and manufacturing capabilities
VALUES
VALUES In everything, we do to others what we would have them to do us
We do what we say, and say what we mean
We create outstanding value for our customers
We work together to make our company the best

6. Full Service Offerings

7. CoorsTek Medical Portfolio
Spine Solutions
Sports Medicine & Trauma
Extremities
Reconstruction

8. Footprint Legend Portland Dayton Logan Golden Grand Junction Phoenix
Fort Worth
Bologna
Manufacturing
Product Development
Legend
Leadership Office

9. Manufacturing Overview
Producing over 1,000,000 medical components and devices across more than 15 product sectors in a typical year
~230,000 square feet of capacity
FDA compliance
ISO registered facilities
Lean manufacturing operations
Ability to manufacture high-quality, complex products

10. eQMS Advantages

11. eQMS Advantage
Consistent Regulatory Compliance
Globalized System
Centralized Data
Increased Visibility
Equivalent Metrics Across the Business

12. How do Regulatory Requirements Affect CoorsTek Medical?
CoorsTek Medical is a FDA registered Medical Device Manufacturer supplying products to the US market, therefore the US Quality System Regulations apply to the company
Operating to a Quality System is also smart business as it minimizes errors and improves quality
Failure to comply with QSR regulations can result in Warning Letters, import restrictions, penalties, recall of products, loss of customer accounts and litigation
Other regulatory requirements: MDD, MHLWA, ANVISA, CMDCAS, KFDA 12

13. Why eQMS?

14. Implementation Techniques

15. Quality: Formula for Success
People
Planning
Best Practices
Institutionalize
Control
Culture
Customer Value
Quality
Customers

16. Module Go-Live Outline
Discovery session-creating requirements the system must meet
Creation of user requirement document
Creation of pilot site
CRP1-review test pilot site
Improvements made to pilot site from feedback made during CRP1
CRP2-review of the test pilot site after improvement made
CoorsTek Medical project team creates draft SOPs and draft work instructions
Module validation
CoorsTek Medical project team approves validation results and conclusions
Train the trainer-CoorsTek Medical users will receive training on how to use the module
Go Live
QAD QMS team will still provide post-live production support

17. CoorsTek Medical eQMS Current State
Live Modules:
Nonconformance
CAPA
Customer Complaints
Training
Modules in Development:
Document Control: go-live Q2 2017
Audit: go-live Q2 2017
Gage: go-live Q3 2017
Equipment Management: go-live Q4 2017
Future Modules:
APQP
Supply Controls

18. Benefits Achieved at CoorsTek Medical

19. Benefits Achieved at CoorsTek Medical Increased Visibility
Nonconformance and CAPA:
Printable reports
Generated metrics from data
notification
Tracking/trending

20. Benefits Achieved at CoorsTek Medical Equivalent metrics across the business
Nonconformance and CAPA:
Data comparison
Increase in collaboration between sites
Elimination of waste
Trending
More reliable data

21. Metrics Done Wrong

22. Benefits Achieved at CoorsTek Medical
Customer interface: Global Harmonization cited as a major impact by customers for improved compliance and quality
Overall increase in production first pass yields
Reduction in nonconformance across the business: On average,15% reduction in NCs
Addition reduction found across the business:
CAPAs
Customer returns
Reduction in audit findings

23. Lessons Learned

24. Key Lessons Learned Maintain and Update your Parking Lot
Risk Management
Listen to your Team
Over Communicate
Accommodate Business Needs
Have a Change Management System in Place
Verify and Validate your Software
SOPs and Training in place before launch
Establish an IT Change Control System 24

25. Summary

26. Key Points Remember an eQMS System is an organization tool
Listen to your customers
You are always in continuous improvement
Make data driven decisions
Measure effectiveness 26

27. Questions and Answers Amanda Black Quality Systems Manager 27

28. Thank You
May 10, 2017