CDRH Scorecard Metric Determination. Presentation to the Balanced Scorecard Interest Group March 17, 2005

Transcription

1 CDRH Scorecard Metric Determination Presentation to the Balanced Scorecard Interest Group March 17, 2005

2 Organizational Structure DHHS FDA Food and Drug Administration Department of Health and Human Services ORA Office of Regulatory Affairs CBER Center for Biologics Evaluation and Research CDER Center for Drug Evaluation & Research CDRH Center for Devices and Radiological Health NCTR National Center for Toxiological Research CVM Center for Veterinary Medicine CFSAN Center for Food Safety and Applied Nutrition

3 CDRH Scorecard Development: 2000 CDRH Strategic Plan 2001 Determine Strategy 2002/2003 History Performance Scorecard Implementation 2004 Initiate process to Evaluate & Refine Scorecards

4 2002: Scorecard Development Process Collect Phase: Strategic Goals Determine obligations and commitments by reviewing Department and Agency documents

5 CDRH Strategic Goals Total Product Life Cycle Apply TPLC across Center activities to promote and protect the public health Public Health Impact Measure and communicate our impact on the public health Magnet for Excellence Attract and retain a diverse workforce to accomplish our public health mission Knowledge Management Manage knowledge to support TPLC in the information age

6 Obligations and Commitments President s Management Agenda One HHS Science Review Recommendations GPRA Goals Performance Plans (Commissioner & SES)

7 Create Phase: Develop Executive & Office Scorecards Each Office reviewed their core processes and proposed metrics which would be key indicators of success Philosophy: need an indicator for every process within our Office

8 2003 CDRH Executive Scorecard Key Result Areas (KRA s): 1. Public Health Promotion 2. Public Health Protection 3. Organizational Accountability 4. Stakeholder Collaboration 5. Workforce Excellence 6. Strategic Direction

9 FY-02/03 Metric Development CDRH Executive SC - Public Health Promotion (Expedited Approvals) 1. Average total elapsed days for approval 2. Average total elapsed time for final decisions 3. # of Expedited Applications 4. Average "Public Health Impact Score" based on population affected and risk reduction 5. # of agreement, determination, and other pre- submission meetings 6. % of Investigational Device Exemptions approved in the first 30-day cycle 7. % of submissions citing guidance or recognized standards

10 Office Scorecard Average total elapsed time for approval Median total elapsed time for device application approvals (1) expedited Pre-Market Approval (PMA) originals & expedited panel track PMA Supplements, (2) expedited 510(k)s, (3) Humanitarian Device Exemptions (HDEs( HDEs).

11 FY-02/03 Metric Development CDRH Executive SC Workforce Excellence 1. % CDRH employees receiving training 2. Average # of training hours per employee 3. % of CDRH managers completing core competency requirements 4. % of CDRH employees utilizing distance learning 5. # of CDRH employees participating in leadership programs 6. External Expertise Ratio (# of external engagements/ opportunities for engagements)

12 Office Level % CDRH employees receiving training 1. Staff College programs (in-house) 2. university/college courses 3. professional training programs 4. details 5. sabbaticals 6. fellowships 7. distance learning 8. mentoring 9. professional conferences..

13 2003 Executive & Office Scorecards Cultivate Phase: Gather, display, analyze historical data Did not have systems in place to capture all proposed metrics Reported what was available instead of developing systems to capture data

14 Performance Management System Vision, Mission, Core Values, And Core Passions Refinements Review, Evaluate, And Improve Business Performance Management System Rewards And Recognition Organization-Wide Strategic Planning Process Annual Deployment Cycle Workgroup And Individual Performance Management Process Develop Organization-Wide Performance Scorecard Management Cascade Operating Plans, Budget, And Scorecard Cascading Process Foundations For Achieving Performance Results Teaming System And Skills Process Improvement System And Skills Leadership Development System And Skills Project Management System And Skills Richard Chang Associates

15 Assessed Current Reality Disconnect between Scorecard Measures and Measures used to Manage Workload MDUFMA* Goals data had to be hand calculated from numerous data queries Data systems were not Centralized which impacted on data roll-up Medical Device User Fee and Modernization Act

16 2005 CDRH Executive Scorecard Key Result Areas (KRA s): 1. Public Health Promotion 2. Public Health Protection 3. Effective Management 4. Knowledge Management & Stakeholder Collaboration 5. Workforce Excellence

17 FY-04/05 Metric Development Collect Phase: Determine and prioritize obligations and commitments by reviewing Department and Agency documents Highest priority: MDUFMA requirements GPRA Goals and other Budget Document Obligations

18 Prioritization Goal Statement $ & Strategic Plans Ag. $ FDA CDRH Ctr. Perf. Plans Com MDUFMA 1. Utilize Risk management to target inspection coverage for Class II and Class III domestic medical device manufacturers at 20% or an estimate 5,500 firms. (Also FY 05 Goal-Only the Performance Plan specifies the target percentage) #11 2. Conduct 295 domestic and foreign BIMO inspections with an emphasis on scientific misconduct, data integrity, innovative products, and vulnerable populations. (Also FY 05 Goal) # Complete Review and Decision on premarket FY 2004 actions defined in the MDUFMA Legislation (MDUFMA) 4. Work with Stakeholders to implement MDUFMA. This will include providing MDUFMA training by December (MDUFMA)

19 FY-04/05 Metric Development CDRH Executive SC - Public Health Promotion 1. % on-time decisions and actions 2. % of Investigational Device Exemptions approved in the first 30-day cycle 3. % on-time consults

20 FY-04/05 Metric Development CDRH Executive SC Workforce Excellence 1. Average # of training hours per employee (limited to formal training & conferences) 2. # employees meeting training target 3. % of CDRH managers completing core competency requirements 4. % of operational dollars used for external expertise

21 Utilized the Performance Management System Concept to Assign Resources and Track Progress Project Management Developed Milestones Automate: target funds toward modifying or developing systems to capture high priority metrics Centralize Data Systems: internal benchmarking to develop efficient and productive systems

22 Lessons Learned Assess what is important to Stakeholders & Customers Periodic & Systematic Review Prioritize Systematic Implementation

23 Questions? Questions Comments? Frances A. Benedict