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State Assessment Observations. Tressa Madden, MPH, RES CSO/Standards Implementation Staff FDA. Tuesday, March 11, 2014 9:00 am – 10:00 am. MFPRS Performance Element Worksheets. “Performance Indicator” worksheet was designed for use in 2012
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State Assessment Observations Tressa Madden, MPH, RES CSO/Standards Implementation Staff FDA Tuesday, March 11, 2014 9:00 am – 10:00 am
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
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
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
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
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)
Standard One • 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)
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
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
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
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
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
Breakout Session Focus • Element 7.2.a • Documentation of outreach activities
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
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
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
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
Contact Information Tressa Madden CSO/Standards Implementation Staff FDA/ORA/OP Tressa.madden@fda.hhs.gov