FDA ORA Quality Management System Before and After Program Alignment (PA): Improving Effectiveness, Efficiency, & Communication

Transcription

1 FDA ORA Quality Management System Before and After Program Alignment (PA): Improving Effectiveness, Efficiency, & Communication Marlene Garcia Swider, PhD Quality Manager Division Pharmaceutical Quality Operations IV FDA Office of Regulatory Affairs Office of Pharmaceutical Quality Operations October 10,

2 What is ORA QMS? A system that provides feedback to ORA on the quality of our work and the appropriateness of work processes in meeting FDA goals A system that provides for and results in continual improvement of ORA Processes, Products, and Services 2

3 Processes in the System Visual of ORA s Quality Management System Driven By Senior Management Continuously Improving the System Inspections Imports Administrative Start A B C Start A B C Start A B C Compliance B1 End B1 Analytics End Fed/State Relations B1 End Focused Public Health Start A B C Start A B C Start A B C B1 B1 B1 End End End Network of Interrelated Processes 3

4 Quality Management Principles 1. Customer Focus 2. Strong Committed Leadership 3. Involvement of people 4. Process and system approach. 5. System Approach to management. 6. Continuing Improvement 7. Factual Approach to decision making. 8. Mutually beneficial supplier relationship. 4

5 The ORA QMS Difference Dedicated local Quality System Managers Development of 9 Core Procedures Development of Core Processes most important processes, work products or services performed by each unit Establishment of Quality Factors (quality criteria) measure fitness for use of a core process, product or service 5

6 ORA CORE Procedures 6

7 ORA QMS Elements Management QSM Employees ORA Procedures (Core and local) IT Training/ Communication ORA Quality & Policy Manual 7

8 Roles: QSM Ensure the effective implementation of the QMS Maintain the QMS Advocate and coordinates improvements Manage document control systems Coordinate audits and management reviews; Facilitate external audits Track audit accomplishments and corrective action plans, including trend analysis Monitor corrective actions and preventive actions Monitor and coordinate complaints Provide QMS assistance to all employees 8

9 Roles: District Director Develops the strategic direction and is responsible for the quality system from its development through completion of management reviews Provides commitment to the development and implementation of the management system Communicates to the organization the importance of meeting customer requirements as well as statutory and regulatory requirements 9

10 Roles: Branch Directors Ensure QMS is implemented and followed Ensure that qualified, skilled, and trained personnel and other resources are available Ensure that products and services satisfy customer requirements Responsible for area specific quality policies and for system improvement activities. Supervisors Use the tools created by the QMS (training, Procedures, checklists, etc.) to manage their day-today work. 10

11 All Management Plan effective organizational structure Ensure compliance with Quality Principles Ensure effective documentation of processes & procedures Provide adequate resources Utilize customer & stakeholder expectations Monitor performance for continuous improvement

12 Roles: Employees Follow QMS procedures and established business practices; Produce quality work; Identify preventive and corrective actions; Notify supervisor when requirements are not met; Identify changes to methods or procedures (continual improvement); File document change request; and Empowered and expected to use their knowledge and experience to propose corrective actions and continual improvements for the QMS. 12

13 Long Term Quality Management Goals. ORA develops into the most effective organization possible in performing its mission of protecting and promoting public health. 13

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15 Quotes Quality is never an accident; it is always the result of intelligent effort. ~John Ruskin There is nothing permanent except change. ~Heraclitus Progress is impossible without the ability to make mistakes. ~Imai To find out how to improve productivity, quality and performance ask the people who do the work. ~Harvard Business Review 15

16 FDA S OFFICE OF REGULATORY AFFAIRS ALIGNS FOR THE FUTURE What Why How 16

17 Modernize and strengthen the FDA workforce to improve public health response FDA Program Alignment Charge 17

18 OLD Geographically Aligned Organizational Model 18

19 New Program Aligned Organizational Model 19

20 State Contracts, Grants & Agreements State Cooperative Programs Milk, Retail, Shellfish Import Operations Civil & Criminal Investigators Compliance Officers 13 Laboratories Emergency Response Coordinators State Liaisons Quality Systems Managers ORA at a Glance Recall Coordinators Consumer Complaint Coordinators Planning & Evaluation Analysts Official Establishment Inventory Coordinators Operational Policy Analysts Communication s Staff Administrative & Mission Support Training, Education & Development Staff Disclosure & FOIA 20

21 Program Alignment: Key Changes From Geographic management of operations SES Regional Food & Drug Directors Degrees of program specialization for investigations, compliance and operational managers 20 District Directors who manage the geographic district and all programs operations within the district One import district and a range of import operations embedded within the 16 other districts To Program management of operations, management teams based on staff: Bioresearch Monitoring 2 management teams Biologics 2 management teams Human and Animal Food 12 management teams Medical Device and Radiological Health 3 management teams Pharmaceutical Quality 4 management teams Tobacco Plus Imports as a program 5 management teams SES Program Directors Exclusive specialization in one program for investigations, compliance and operational managers 20 District Directors who manage the geographic district and only one program for operations. Plus eight new program division directors who manage program operations only total 28 management teams Five import divisions (four new import divisions) covering all borders, managing import operations nationally as a program 21

22 Program Alignment: Key Changes From 13 labs reporting into the regions National Lab Management - 13 labs reporting into ORA s Office of Regulatory Science with three additional directors managing separate program operations Division of Human Resource Development within the Office of Resource Management State Cooperative Programs decentralized across five regions shellfish, milk, retail To Office of Training, Education and Development Office of State Cooperative Programs under the Human and Animal Food Operations, as a single national program(s) Functions based in geography: consumer complaint coordinators, state liaisons, emergency response coordinators Functions decentralized local reporting: Freedom of Information (FOI) staff, industrial hygienists (IH), and administrative staff Retain certain functions based in geography: consumer complaint coordinators, state liaisons, emergency response coordinators Staff remain embedded locally, but report into a single office: FOI staff report into Division of Information Disclosure; IHs report into the Office of Regulatory Science; administrative staff report into the Office of Management 22

23 Offices of Melinda Plaisier, MSW Associate Commissioner for Regulatory Affairs Doug Stearn, JD Director, Office of Enforcement and Import Operations Paul Norris, DVM, MPA Director, Office of Regulatory Science 23

24 Office of Enforcement and Import Operations Doug Stearn, JD Director, Office of Enforcement and Import Operations 24

25 Office of Enforcement and Import Operations 25

26 Office of Regulatory Science Paul Norris, DVM, MPA Director, Office of Regulatory Science 26

27 Office of Regulatory Science 27

28 Office of Partnerships Barbara Cassens, Barbara Cassens Director, Director Office of Office Partnerships of Partnerships 28

29 Office of Training, Education and Development Patricia Alcock, Director Office of Training, Education, and Development 29

30 Office of Medical Products and Tobacco Operations Ellen Morrison Assistant Commissioner Office of Medical Products and Tobacco Operations Director Tobacco Staff [vacant] Ginette Michaud, MD Director, Office of Biological Products Operations Chrissy Cochran, PhD Director, Office of Bioresearch Monitoring Operations Jan Welch Director, Office of Medical Device and Radiological Health Operations Alonza Cruse Director, Office of Pharmaceutical Quality Operations 30

31 Office of Biological Products Operations Ginette Michaud, MD Director, Office of Biological Products Operations 31

32 Office of Biological Products Operations 32

33 Office of Bioresearch Monitoring Operations Chrissy Cochran, PhD Director, Office of Bioresearch Monitoring Operations 33

34 Office of Bioresearch Monitoring Operations 34

35 Office of Medical Device and Radiological Health Operations Jan Welch Director, Office of Medical Device and Radiological Health 35

36 Office of Medical Device and Radiological Health Operations 36

37 Office of Pharmaceutical Quality Operations Alonza Cruse Director, Office of Pharmaceutical Quality Operations 37

38 Office of Pharmaceutical Quality Operations 38

39 Office of Human and Animal Food Operations Michael Rogers, MS Assistant Commissioner for Human and Animal Foods [acting] Ellen Buchanan Director, Audit Staff Laurie Farmer Director, Office of State Cooperative Programs [acting] Vinetta Howard -King Director, Office of Human and Animal Foods East [acting] Joann Givens Director, Office of Human and Animal Foods West 39

40 Office of Human and Animal Food Operations 40

41 ORA Ombudsman Jessica Zeller, JD, MA Ombudsman Informally and impartially addresses concerns, complaints, and disputes between ORA and external parties: Industry Federal, state, territory, and tribal government entities Public Contact: or PUBLIC HEALTH PARTNERSHIPS: Enhancing ORA operations by serving as an objective, neutral resource to improve communication channels, resolve disputes, and foster positive relationships with internal and external stakeholders. 41

42 Resources and Contacts ORA Organization Charts and Boundary Maps Fact Sheets ORA s New Structure Operational Offices Investigations Operations Manual Headquarters, District/Division Contact Information ORA Contacts State and local inquiries District Director/Program Division Directors State Liaison General Inquiries engageora@fda.hhs.gov Partnerships OP-ORA@fda.hhs.gov 42

43 Thank You Questions and Discussion 43

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