1. Slide 1 of 21 Robert Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com Supplier Auditing & Remote Auditing

2. Slide 2 of 21 Robert Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com Purpose of Supplier Audits Qualify a New Supplier On-going Evaluation of a Supplier CAPA or Complaint Investigation

3. Slide 3 of 21 Robert Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com Can I justify fewer supplier audits?

4. Slide 4 of 21 Robert Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com Can you justify more supplier audits?

5. Slide 5 of 21 Robert Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com Costs of Poor Quality (COPQ)

6. Slide 6 of 21 Robert Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com Auditing 100% of your critical suppliers may seem impossible due to limited resources, but have you ever seen a cost/benefit analysis?

7. Slide 7 of 21 Robert Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com 4 Most Common Auditing Methods 1.Element Approach 2.Procedural Approach 3.Product Approach 4.Process Approach

8. Slide 8 of 21 Robert Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com Prioritizing Supplier Audits FDA Approach Risk-based Approach Logistical Approach Strategic Approach

9. Slide 9 of 21 Robert Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com Risk-Based Approach Critical Subcontractors – Finished Device Manufacturers – Contract Sterilizers – Contract Labeling & Packaging Crucial Components Suppliers http://bit.ly/Audit-Recommendations

10. Slide 10 of 21 Robert Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com Strategic Selection of Auditors Select Auditors with Technical Expertise Training Opportunities for New Auditors Gathering Technical Information Discussion of Design Changes / Process Changes Use the Adjacent Link Auditing Approach http://bit.ly/AdjacentLinkAuditing

11. Slide 11 of 21 Robert Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com Use Supplier Audit Template Focus on Production & Process Controls – Shipping – Final Inspection – Manufacturing – In-Process Inspection – Labeling – Warehouse – Incoming Inspection – Purchasing

12. Slide 12 of 21 Robert Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com Supplier Audit Agenda

13. Slide 13 of 21 Robert Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com Auditing SCAR Closure http://www.medicaldeviceacademy.com/supplier-auditing-tool-kit

14. Slide 14 of 21 Robert Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com Remote Auditing “Any time you can audit in a conference room, you could probably do the audit remotely.” http://medicaldeviceacademy.com/4-ways-make-best-use-remote-audits/

15. Slide 15 of 21 Robert Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com When NOT to Audit Remotely Onsite visits facilitate the building of supplier- customer relationships. Touring facilities and watching demonstration of processes improves understanding of a supplier’s processes better than reading documents and records can. Cleanliness and capabilities of suppliers are best evaluated onsite, where camera angles can be used to crop out important details Sometimes suppliers misrepresent their capabilities by showing photographs on their website of other companies.

16. Slide 16 of 21 Robert Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com What Areas Can You Audit Remotely?

17. Slide 17 of 21 Robert Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com Examples of Remote Audits CAPA & SCARs Management Review Internal Auditing Supplier Controls Complaint Handling Adverse Event Reporting

18. Slide 18 of 21 Robert Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com Other Remote Audits… Re-Audits (i.e., SCAR follow-up) When a critical team member can’t travel or is only needed for a short duration To address issues of confidentiality when competitor product is also made at supplier. Pre-cursor to a “for cause” audit / investigation Participation in opening / closing meetings

19. Slide 19 of 21 Robert Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com Allocation of Resources

20. Slide 20 of 21 Robert Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com Q & A rob@13485cert.com

21. Slide 21 of 21 Robert Packard, President www.MedicalDeviceAcademy.com rob@13485cert.com Need a quotation for a supplier audit? Rob Packard rob@13485cert.com +1.802.281.4381 rob13485