The Second Annual Medical Device Regulatory, Reimbursement and Compliance Congress

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

2. 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. Quality Systems

3. What are Management Controls?

4. Quality System Inspectional TechniquesManagement Controls

5. 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. 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. Determination of Requirements • Statutory and regulatory requirements related to the product, process and the quality system • Any additional requirements determined by the organization

9. Statutory and RegulatoryRequirements • Management should ensure that the organization has the knowledge of applicable governing requirements as it applies to: • Products • Processes • Systems

10. Definition 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)

11. Definition 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

12. 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. Quality Planning Purpose 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.

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

16. Quality Planning Example Decision Criteria • Quality system sustainability and management control practices are affected? • 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

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

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

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

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

21. Quality Planning Process Things to Consider… • Strategy for … • Control of documents and data • Change management • Control of records

22. Review

23. Management Review Purpose 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.

24. Management Review Establish whether or not the … • 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?

25. Management Review Applicability • Executive management • Corporate level • Operational management • Business unit level • Site level • Functional management • Department level

26. Metrics

27. Balance Scorecard Approach to Strategic Management • 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.

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

29. Balance Scorecard Methodology • 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.

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

31. Balance Scorecard Management Controls Tool • 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.

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

33. Key Performance Indicators Traditional

34. System Performance Indicators FDA 483 Observations

35. System Performance Indicators FDA 483 Observations

36. System Performance Indicators FDA 483 Observations

37. System – Level Process Measures Management Performance • Quality policy and objectives • Management review • Quality planning • Qualification and training of personnel • Corrective and preventive actions • Internal/External • Quantitative/Qualitative • Change management • Control of documents and records • Quality audits

38. THANK YOU