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

2. ASQ Biomedical ConferenceManufacturing Compliance For Medical Devices 2

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

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

5. ASQ Biomedical ConferenceManufacturing Compliance For Medical Devices 5 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

6. ASQ Biomedical ConferenceManufacturing Compliance For Medical Devices 6 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.

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

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

9. ASQ Biomedical ConferenceManufacturing Compliance For Medical Devices 9 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.

10. ASQ Biomedical ConferenceManufacturing Compliance For Medical Devices 10 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.

11. ASQ Biomedical ConferenceManufacturing Compliance For Medical Devices 11 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

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

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

14. ASQ Biomedical ConferenceManufacturing Compliance For Medical Devices 14 Process StepPotential Failure SPotential Effect Potential Cause PDetection/ Mode of Control RPN Selection Qualification Monitoring Feedback FMEA Table

15. ASQ Biomedical ConferenceManufacturing Compliance For Medical Devices 15 Process StepPotential Failure S 1-5 Potential Effect Potential Cause P 1-5 Detection/ Mode of Control RPN Selection Select ineffective supplier 4-5Bad components Ineffective supplier 2Supplier Audit First Article Inspection 8-10 Qualification Underestimate capabilities 3-4Inadequate quantities Supplier capability underestimated 2-3Supplier Audit On site engineer 6-12 Monitoring Poor performance 3Continued receipt of wrong/bad components Inadequate purchasing data 2-3Establish correct data/metrics 6-9 Feedback No link to CAPA3No improvement No communication with supplier 3Monthly feedback reports and communication 9 FMEA Table

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

17. ASQ Biomedical ConferenceManufacturing Compliance For Medical Devices 17 Risk CategoryPotential Failure SPotential Effect Potential Cause PDetection/ Mode of Control RPN Safety Performance or functional failure 5Harm to patient User or mfg personnel Faulty design Mfg errors 1-2Inspection and/or testing 5-10 Quality Reliability Out of box failure Rework or scrap 3-4Unable to use Back orders Low yields Faulty design Mfg errors 3Design validations Inspection and testing 9-12 Regulatory Lack of proper 510 k, PMA, CE certificate or PAL 2-3Need new submission Lack of Understanding of regulations 3Submission Review Supplier Audit 6-9 Business Lack of detail in contract/agree ment 3Increased cost, schedule and/or resources Inefficient mfg, standards or documentation 4Supplier Audit Supplier monitoring 12 FMEA Table

18. ASQ Biomedical ConferenceManufacturing Compliance For Medical Devices 18 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

19. ASQ Biomedical ConferenceManufacturing Compliance For Medical Devices 19 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

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

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

22. ASQ Biomedical ConferenceManufacturing Compliance For Medical Devices 22 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.

23. ASQ Biomedical ConferenceManufacturing Compliance For Medical Devices 23 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

24. ASQ Biomedical ConferenceManufacturing Compliance For Medical Devices 24 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

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

26. ASQ Biomedical ConferenceManufacturing Compliance For Medical Devices 26 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.

27. ASQ Biomedical ConferenceManufacturing Compliance For Medical Devices 27 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.

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

29. ASQ Biomedical ConferenceManufacturing Compliance For Medical Devices 29 Questions