1. State Assessment Observations Tressa Madden, MPH, RES CSO/Standards Implementation Staff FDA Tuesday, March 11, 2014 9:00 am – 10:00 am

2. MFPRS Performance Element Worksheets “Performance Indicator” worksheet was designed for use in 2012 Promote standardized interpretation of MFRPS program elements Facilitate MFRPS meetings and dialogue Provide states with a quality checklist to facilitate implementation

3. Performance Element Worksheets Office of Partnerships collect and analyze the MFRPS PE Worksheets Information is based on “real time” implementation data obtained during state visits The goal was to complete a baseline by the end of FY2013

4. PE Data Collection The OP/Standards Implementation Staff mark a “Yes” when it is determined that they are implementing a program element A “No” or “NA” is marked when determined they are not fully implementing an element or does not apply – addressed in comment area A “No” should be addressed on your state programs strategic plan

5. PE Data Analysis Baseline data collected is used to track MFRPS Implementation by state program or nationally – % Programs that fully or partially implement each standard – Overall rating for each standard fully implemented nationally – Overall rating for programs fully or partially implementing a standard annually

6. PE Data Limitations PE Data is an indicator of progress Must be used in conjunction with other information from the program – Resources – Strategic Plans – Timeframes for completion – Variables beyond the programs control (i.e. Emergency Response Event)

7. Example of PE Worksheet

8. Standard One

10. 1.a – The state program currently adopted FDA laws and regulations by reference (1.5) (See Appendix 1 for FD&C Act and CFR listing) 2.b Records describing terms of adoption and equivalency are clearly defined (1.2 and 1.5)

11. Standard Two

13. Breakout Session Focus Elements 2.1.a State programs have training plan that ensures all inspectors received training adequate to perform their work assignment Elements 2.2.b & 2.3.b Field Training – Focus on conducting joint inspections and inspection audits – Frequency and time requirements

14. Standard Three

16. Breakout Session Focus Element 3.2.b The state program has written policies and procedures for inspecting food plants that require inspectors to: (items listed in Section 3.3.b1-22) Elements3.3.b-3.3.e Recall System Written procedures for sharing information Written procedures for removing product Written procedures for performing recall checks Written procedures for maintaining records about recall information

17. Standard Four

19. Breakout Session Focus Elements 4.2b &c, 4.3b & c, and 4.4b & c Implementation of the 3 Types of Audits – Field Inspection – Inspection Report – Sampling

20. Standard Five

22. Breakout Session Focus Element 5.2d System for traceback and trace-forward of food implicated in an illness, injury or outbreak Element 5.2g System for distribution of final report of illness, injury and outbreak Element 5.2i Establish criteria for releasing information to the public

23. Standard Six

25. Breakout Session Focus Elements 6.2a.1, 2a.2 and 2a.3 Conduct performance review of enforcement strategies every 12 mo. Calculate overall rating to interpret compliance and enforcement Performance below 80%, needs improvement

26. Standard Seven

28. Breakout Session Focus Element 7.2.a Documentation of outreach activities

29. Standard Eight

31. Standard Nine

33. Breakout Session Focus Elements 8.2.a and 8.2.b Strategic plan development, implementation and monitoring A system to maintain documents that are current and fit-for-use

34. Standard Ten

36. Breakout Sessions Objectives Identify resources that currently exist Identify best practices in SOP development and implementation that has been used by state programs Identify what internal verification procedures are being utilized by state programs

37. Best Practices Will be identified and shared during the MFRP Alliance meeting AFDO Portal for MFRPS will post information for state programs to utilize when building and improving their programs

38. Instructions You were given a number when you arrived You will attend breakout sessions specific to Standards 2,3, 4, 5, 6, 7 and 9 No. 1 = Standards 2 today and 4 &7 tomorrow No. 2 = Standards 3 today and 6 tomorrow No. 3 = Standards 5 today and 9 tomorrow

39. Questions?

40. Contact Information Tressa Madden CSO/Standards Implementation Staff FDA/ORA/OP Tressa.madden@fda.hhs.gov