Presented by: Ken Imler Sr. Vice President RAQA Arrow International

1. Working with Suppliers: Forming Strategic Alliances to Accelerate Compliance & Improve Supplier Performance Presented by: Ken Imler Sr. Vice President RAQA Arrow International

2. Supply Chain Management ASQ Biomedical ConferenceManufacturing Compliance For Medical Devices

3. Supply Chain Management An Integrated Approach of Risk Management Project Management ASQ Biomedical ConferenceManufacturing Compliance For Medical Devices

4. Supply Chain Management Suppliers are strategic partners in your ultimate success (or failure). ASQ Biomedical ConferenceManufacturing Compliance For Medical Devices

5. Supply Chain Management • Suppliers must understand and meet not just your product or service requirements. • Products and processes • How their parts of services impact these • They must understand and meet your business requirements. • How they add value • How they impact you ability to do business ASQ Biomedical ConferenceManufacturing Compliance For Medical Devices

6. Supply Chain Management • In an FDA, ISO,CMDRAS, PAL, etc. regulated environment, you are responsible for establishing, monitoring and maintaining an adequate level of control over all suppliers and the materials and services they supply. ASQ Biomedical ConferenceManufacturing Compliance For Medical Devices

7. Supply Chain Management SELECT SUPPLIERS QUALIFY SUPPLIERS Supplier Effective FEEDBACK TO SUPPLIERS MONITOR SUPPLIERS Supplier Ineffective Most organizations look at Supply Chain Management in this manner. ASQ Biomedical ConferenceManufacturing Compliance For Medical Devices

8. QFD & Involvement Supply Chain Management Design Control & Specifications IDENTIFY POTENTIAL RISKS SELECT & QUALIFY SUPPLIERS Risk acceptable FEEDBACK TO SUPPLIERS MANAGE RISK & SUPPLIERS Product Performance & Complaints Risk Unacceptable Lean -Six Sigma Risk Management World-class organizations modify the process ASQ Biomedical ConferenceManufacturing Compliance For Medical Devices

9. Supply Chain Management • You must understand and manage the risks involved and demonstrate the appropriate level of controls necessary to assure, to a high degree of confidence that the products, devices and services provided meet their predetermined specifications and requirements. ASQ Biomedical ConferenceManufacturing Compliance For Medical Devices

10. Supply Chain Management • You must also understand and manage the process and business risks associated with the Supply Chain; to make the process effective, efficient and value added. ASQ Biomedical ConferenceManufacturing Compliance For Medical Devices

11. Supply Chain Management • Risk Based Supply Chain Management • Starts with a cross functional team • Starts in the design and development process • Use a basic FMEA-type approach - Define: • Process steps • Potential failure modes • Potential effects • Potential causes • Detection/Modes of control • Total Risk ASQ Biomedical ConferenceManufacturing Compliance For Medical Devices

12. Supply Chain Management Get the potential suppliers involved in the process, up front. ASQ Biomedical ConferenceManufacturing Compliance For Medical Devices

13. Supply Chain Management Occurrence Safety Quality Business Severity Regulatory ASQ Biomedical ConferenceManufacturing Compliance For Medical Devices

14. Supply Chain Management FMEA Table ASQ Biomedical ConferenceManufacturing Compliance For Medical Devices

15. Supply Chain Management FMEA Table ASQ Biomedical ConferenceManufacturing Compliance For Medical Devices

16. Supply Chain Management Occurrence Safety Safety Highest level of Management & Control Quality Business Business Severity Lowest level of Management & Control Regulatory ASQ Biomedical ConferenceManufacturing Compliance For Medical Devices

17. Supply Chain Management FMEA Table ASQ Biomedical ConferenceManufacturing Compliance For Medical Devices

18. Supply Chain Management • It is about strategic Management of the Supplier and the entire Supply Chain integrated with management of strategic suppliers • It is not just monitoring the deliveries, AQLs and PPVs. • Link strategic suppliers into your quality system ASQ Biomedical ConferenceManufacturing Compliance For Medical Devices

19. Supply Chain Management • More traditional Risk Based methods to manage to and control the supply chain include: • Audits • Certificates of Analysis • Inspection and Testing at the supplier • Inspection and testing in-house • First Article Inspections • Increased sampling • Inspection and testing by a third party • Technical presence on site at the supplier ASQ Biomedical ConferenceManufacturing Compliance For Medical Devices

20. Supply Chain Management • Think more holistically … • Supply Chain Management starts in development and extends through the product life cycle. ASQ Biomedical ConferenceManufacturing Compliance For Medical Devices

21. Supply Chain Management • Project Management is the other activity vital to the success of Supply Chain Management. ASQ Biomedical ConferenceManufacturing Compliance For Medical Devices

22. Supply Chain Management • Project Management establishes a strategic plan that specifically identifies: • Activities • Deliverables • Roles and Responsibilities • Schedules and Milestones • Remember to get the suppliers involved in the beginning. ASQ Biomedical ConferenceManufacturing Compliance For Medical Devices

23. Supply Chain Management • Supply Chain Projects must: • Be prioritized by management • Have adequate resources allocated and assigned to the project • Have a real project manager • Have a budget • Have goals and metrics • Have management oversight ASQ Biomedical ConferenceManufacturing Compliance For Medical Devices

24. Supply Chain Management • Supply Chain Management as a strategic Project is most effectively managed by PURCHASING. • Team members include: • The Supplier(s) • Quality Assurance • Product Development • Sustaining/Manufacturing Engineering • IT • Others as deemed necessary by the team ASQ Biomedical ConferenceManufacturing Compliance For Medical Devices

25. Supply Chain Management Summary • Integrate risk and project management. • Together they create synergies that can be extremely effective and efficient. ASQ Biomedical ConferenceManufacturing Compliance For Medical Devices

26. Supply Chain Management Summary • Use risk management to understand and manage the Supply Chain. • Use project management to strategically apply the appropriate level of control in supplier • Selection, • Qualification, • Monitoring and control. • Provide objective evidence. ASQ Biomedical ConferenceManufacturing Compliance For Medical Devices

27. Supply Chain Management Summary • Get the suppliers involved and engaged, • Keep the suppliers involved and engaged. • Apply state of the art quality, purchasing and business tools to the process. ASQ Biomedical ConferenceManufacturing Compliance For Medical Devices

28. Supply Chain Management In Conclusion EARLY ENOUGH and GOOD ENOUGH … NEVER ARE ASQ Biomedical ConferenceManufacturing Compliance For Medical Devices

29. Supply Chain Management Questions ? ASQ Biomedical ConferenceManufacturing Compliance For Medical Devices