1. Title Page Quality Management @ Mo Samimi, Ph.D. CMQ/OE Presented at the ASQ Biomedical Division Northern California Discussion Group. May 2011

2. A short personal history Finished Ph.D. in Food Science in ’84, and worked as a Post-Doc for 2 years Worked in the Food Industry for 7 years Consulting for 9 years Joined FDA in 2003 –QSM in SAN-DO Lab for ISO-17025 accreditation. –Joined the QMS group in the Office of the ACRA in 2009.

3. Looking from the outside

4. Looking from the inside

5. FDA ORG Chart

6. FDA Organization Charts FDA Organization Charts Centers & Offices Centers & Offices –Office of the Commissioner –Center for Biologics Evaluation and Research (CBER) –Center for Devices and Radiological Health (CDRH) –Center for Drug Evaluation and Research (CDER) –Center for Food Safety and Applied Nutrition (CFSAN) –Center for Tobacco Products (CTP) (New) –Center for Veterinary Medicine (CVM) –National Center for Toxicological Research (NCTR) –Office of Regulatory Affairs (ORA)

7. How do you implement QMS? How do you implement QMS in a bureaucratic –and compartmented- organization? How do you align QMS with the FDA’s mission and vision?

8. How does a large organization, such as the FDA, accomplish it’s mission? Alignment in purpose for all its functional units.

9. FDA Mission FDA is charged with protecting the public health by ensuring the safety, effectiveness, and security of human and veterinary drugs, biological products, and medical devices; ensuring the safety of foods, cosmetics, and radiation-emitting products; and regulating tobacco products. Specifically, FDA is responsible for advancing the public health by: Helping to speed innovations that make foods safer and make medicines and devices safer and more effective; Ensuring the public has accurate, science-based information they need to use medicines, devices, and foods to improve their health; Regulating the manufacture, marketing, and distribution of tobacco products and reducing tobacco use by minors; and, Addressing the Nation’s counterterrorism capability and ensuring the security of the supply of foods and medical products.

10. FDA Vision FDA is dedicated to world-class excellence as a science-based regulatory agency with a public health mission. We aim to provide effective and innovative leadership — both domestically and internationally — to protect health, prevent illness, prolong life, and promote wellness.

11. The mission of HHS is to enhance the health and well-being of Americans by providing effective health and human services and by fostering sound, sustained advances in the sciences needed to promote medicine, public health, and social services. HHS Mission

12. ORA Mission and Vission ORA Vision: All food is safe; all medical products are safe and effective; and the public health is protected and advanced. ORA Mission: Protecting consumers and enhancing public health by maximizing compliance of FDA regulated products and minimizing risk associated with those products.

13. What QMS hopes to achieve Supervisors Employees Management Mandate and Funding (Congress)

14. Staff Manual Guide (SMG) 2020 Similar to the International Standards (ISO, etc.), SMG defines the requirements, and establishes guidelines, to allow each Center or Office, to set up their own QMS.

15. SMG2020 Page

16. QMS at FDA today

17. Strategic Priorities

18. FDA Strategic Priorities

19. QM Plan FOREWORD Quality is defined as a measure of a product's or service's ability to satisfy the customer's stated or implied needs (Staff Manual Guide (SMG) 2020). Quality Systems (also called Quality Management Systems) are formalized business practices that define management responsibilities for organizational structure, processes, procedures, and resources needed to fulfill product/service requirements, customer satisfaction, and continual improvement (SMG 2020). There are many quality process improvement models that take this approach, including the plan– do–check–act cycle included in SMG 2020. Quality Systems are typically documented and managed by means of Quality Management Plans (QMPs).

20. CDRH – Direct Reports

21. CFSAN QA Newsletter

22. CFSAN Lab QM

23. ORA-Timeline1

24. ORA-Timeline2

25. ORA-Timeline3

26. ORA-Timeline4

27. ORA Quality Policy

28. ORA QM

29. ORA Core QMS Procedures ORA-QMS.001 Document Control & Management ORA-QMS.002 Record Control ORA-QMS.003 Management Review ORA-QMS.004 Audits ORA-QMS.005 Control of Non-Conforming Processes, Services or Products ORA-QMS.006 Continual Improvement Procedure ORA-QMS.007 Corrective Action Procedures ORA-QMS.008 Preventive Action Procedure ORA-QMS.009 Complaints and Other Feedback

30. Current State of QMS @ ORA All ORA units have at least one QSM All units of ORA have implemented the core procedures. At least one round of management review is conducted in each business unit. All QSMs will be ASQ certified (CMQ/OE) by the mid FY 2012. Audits performed on all units for basic quality functions (e.g. doc control, records management, etc.)

31. Application of QMS at FDA Documented QMS reviews by the Management. Records of non-conformances for trending and process improvement Addressing internal/external* complaints, and starting corrective actions when needed. Opening proper communications channels between different “pyramids” within the FDA. Making sure the Management takes ownership of quality issues.

32. Inventory Approximate Numbers Inventory Approximate Numbers (not including medical gas) USA 2,000 human drug manufacturing sites 1,100 human drug CGMP inspections/yr 200 pre-market approval inspections 200 pre-market approval inspectionsInternational 3,500 human drug manufacturing sites 200 human drug quality inspections/yr 200 human drug quality inspections/yr

33. FDA’s Foreign Inspection Accomplishments

34. Why QMS is important to the FDA?

35. Thank you! Links and info –www.fda.gov www.fda.gov –Mo.samimi@fda.hhs.gov Mo.samimi@fda.hhs.gov –510-846-7973 and 510-287-2709