1. The Second Annual Medical Device Regulatory, Reimbursement and Compliance Congress Presented by J. Glenn George Thursday, March 29, 2007 Day II – Track A: Quality Systems Using Management Controls to Translate Policies into Practice

2. March 29, 20072 Learning Objectives: To provide knowledge and understanding of the value of meaningful quality planning and its relationship to a systems approach to managing results oriented performance.

3. March 29, 20073 What are Management Controls?

4. March 29, 20074 Quality System Inspectional Techniques Management Controls

5. March 29, 20075 Functions of the Management Controls System 1. Provide the organizational freedom for systems and processes to be established 2. Provide adequate resources 3. Assure systems and processes are managed and functioning properly 4. Monitor systems and processes 5. Make adjustments (as necessary)

6. March 29, 20076 Management Controls A quality system that has been implemented effectively and is monitored to identify and address problems is more likely to produce finished product that functions as intended.

7. Requirements

8. March 29, 20078 Determination of Requirements Statutory and regulatory requirements related to the product, process and the quality system Any additional requirements determined by the organization

9. March 29, 20079 Statutory and Regulatory Requirements Management should ensure that the organization has the knowledge of applicable governing requirements as it applies to: –Products –Processes –Systems

10. March 29, 200710 Quality The totality of features and characteristics that bear on the ability of a device to satisfy fitness-for-use, including safety and performance. Source: 21 CFR 820(s) Definition

11. March 29, 200711 Quality Ability of a set of inherent characteristics of a product, process, or system to fulfill requirements of customers and other interested parties Source: ISO9000:2000 Definition

12. March 29, 200712 Related Regulatory Requirements Labeling (801) MDR (803,804) Corrections and Removals (806) Establishment Registration (807) Device Listing (807) IVDs (809) IDE and PMA (812, 814) Tracking (821)

13. Planning

14. March 29, 200714 Quality Planning Ensure specified requirements for product, process and the quality system will be achieved, including the identification of where changes to the existing quality system are needed. Purpose

15. March 29, 200715 Quality Planning 1.New product realization and/or business development? 2.Product and/or service requiring cross- functional support? 3.Functional responsibilities and/or cross- functional interactions are affected? 4.Require sourcing, qualification and monitoring of suppliers? 5.Quality/Regulatory/Compliance requirements are affected? Example Decision Criteria

16. March 29, 200716 Quality Planning 6.Quality system sustainability and management control practices are affected? 7.Specification/requirement changes? Compatibility and/or Interfaces Labeling and/or packaging Testing and/or acceptance criteria Physical and/or environmental Material handling and/or storage Serviceability and/or maintainability Example Decision Criteria

17. March 29, 200717 Quality Planning Process Establish objectives at relevant functions and management responsibilities: –Executive management –Operational management –Functional management Measurable Consistent with the governing requirements Things to Consider…

18. March 29, 200718 Quality Planning Process Project definition/value proposition Alignment with strategy Stakeholder identification and approvals Governing requirements Things to consider…

19. March 29, 200719 Quality Planning Process Management control strategy –Critical success factors –Role of quality and regulatory compliance management –Role of corrective and preventive actions Communication plan Risk management plan Things to consider…

20. March 29, 200720 Quality Planning Process Resource management plan –Human resources Quantitative: Headcount Qualitative: Competency –Knowledge –Skills –Abilities –Financial –Infrastructure Things to consider…

21. March 29, 200721 Quality Planning Process Strategy for … –Control of documents and data –Change management –Control of records Things to Consider…

22. Review

23. March 29, 200723 Management Review Establish whether the quality system as a whole is suitable and effective for its intended purpose and satisfies applicable requirements, including the company’s own policies and objectives. Purpose

24. March 29, 200724 Management Review System is being managed and maintained? Audit program is effective, including assessing management controls? Requirements are being satisfied and are the result of good practices? System requires change as a result of changing business needs? System provides meaningful and relevant information to manage the business? Establish whether or not the …

25. March 29, 200725 Management Review Executive management –Corporate level Operational management –Business unit level –Site level Functional management –Department level Applicability

26. Metrics

27. March 29, 200727 Balance Scorecard Developed in the early 1990’s by Drs. Robert Kaplan (Harvard Business School) and David Norton As a concept for measuring a company’s activities in terms of its vision and strategies, to give managers a comprehensive view of the performance of a business. Approach to Strategic Management

28. March 29, 200728 Marketing; Communications Business Management System Distribution Idea & Product Development; Strategic Planning Finance; Investor Relations Product Life Cycle Material Handling Human Resource Management; Training Operations Information System Manufacturing; Facilities Customer Value; Customer Service Health and Safety; Environmental Supply Chain Data Entry; Order Processing Quality Management Risk Management; Crisis Management An Organized Business Management System

29. March 29, 200729 Balance Scorecard Provides feedback for an assessment of both: –Business outcomes; Financial Human issues –Internal business processes; –External outcomes focused on the continuous improvement of strategic business performance and results. Methodology

30. March 29, 200730 Inspection & Test: Equipment, Status Quality Management System Purchasing Corrective & Preventive Action Design Control Identification & Traceability Internal audits Statistical Methods Servicing Training Management Responsibility Records Contracts Non-conforming Materials Process Control Document & Data Control Materials Management An Organized Quality Management System

31. March 29, 200731 Balance Scorecard Provides feedback for an assessment of both: –Business outcomes; Resource management –Core business processes; –Desired outcomes focused on quality system performance and results, including the achievement of: Quality, Regulatory, and Compliance management objectives. Management Controls Tool

32. March 29, 200732 Balance Scorecard 1.Translate requirements into good practices; 2.Establish quality, regulatory, and compliance management objectives; 3.Communicate the expectations of suitable and effective management controls and link them to individual performance; 4.Ensure that quality planning occurs when quality planning is required; 5.Develop feedback loops and lessons learned in order to achieve sustainability. Implementation

33. March 29, 200733 Key Performance Indicators Traditional

34. March 29, 200734 System Performance Indicators FDA 483 Observations

35. March 29, 200735 System Performance Indicators FDA 483 Observations

36. March 29, 200736 System Performance Indicators FDA 483 Observations

37. March 29, 200737 System – Level Process Measures 1.Quality policy and objectives 2.Management review 3.Quality planning 4.Qualification and training of personnel 5.Corrective and preventive actions Internal/External Quantitative/Qualitative 6.Change management 7.Control of documents and records 8.Quality audits Management Performance

38. THANK YOU