Current MFRPS State Implementation Status

Transcription

1 Current MFRPS State Implementation Status Timothy Weigner Staff Director U.S. FDA Office of Regulatory Affairs, Office of Partnerships, Standards Implementation Staff February 3, 201 9:15 9:5 am

2 Implementation Status Determination: Methodology, Scope and Limitations Who s Involved Determining, Measuring, and Reporting Implementation Determination of State s implementation/conformance of the MFPRS Audit Staff

3 Additional Resources for MFRPS Progress Determination Mid-year and year-end deliverables and report reviews FDA District Offices Office of Regulatory Science (lab accreditation) Office of Operations/Audit Staff scheduled assessments and audits

4 SIS MFRPS Evaluation and Trends Analysis OP/SIS Program Element (PE) worksheets (tool) to assist evaluating State program MFRPS implementation/progress Measures: Yes (meets) No (gap(s) identified) NA (not applicable) Metric database allows for trends analysis by: Individual program standards Individual program element State progress over a period of time

5 Example of OP/SIS Program Element Worksheet (Std 3)

6 Example of OP/SIS Program Element Data Analysis by Program Standard on a National Level Evaluation by State Program Evaluation by Program Element

7 Additional Use of the Data Focus on continuous improvements Identification of gaps to redirect national resources and training Continue to refine metrics and improve ways to analyze data

8 No. of States What Does the Data Reveal? State Implementation Progress of the MFPRS ( ): No. of Standards in Significant (>0%) to Full Implementation (0%) FY13 FY1 FY15

9 No. of States State Implementation Progress of MFRPS Standard 1 Regulatory Foundation (n = 0) <0% 0-59% 0-79% 0-99% 0% Percentage of Program Element Implementation of Standard 1 FY13 FY1 FY15

10 No. of States State Implementation Progress of MFRPS Standard 2 Training Program (n = 0) FY13 FY1 FY < 0% 0-59% 0-79% 0-99% 0% Percentage of Program Element Implementation of Standard 2

11 Challenging Program Elements: Standard 2 Training Program Each inspector completes a minimum of ten joint inspections or audit inspections with a qualified trainer (2.3.a) Improvement from 5% to 7% Each inspector completes a minimum of three joint inspections with a qualified trainer of food plants representing (2.3.b) (Advanced Level) Improvement from 53% to 5% Each inspector conducting manufactured food inspections receives 3 contact hours of classroom training continuing education every 3 months (2.3.c) Improvement from % to 7%

12 No. of States State Implementation Progress of MFRPS Standard 3 Inspection Program (n = 0) FY13 FY1 FY < 0% 0-59% 0-79% 0-99% 0% Percentage of Program Element Implementation of Standard 3 1

13 Challenging Program Elements: Standard 3 Inspection Program FY1, 1 of the 20 program elements had an implementation status of < 70% FY15 improvements Only 2 program elements had an implementation status of < 70 The state program has written policies and procedures for inspecting food plants that require inspectors to: (items listed in section 3.3.b.1-22) Improvement from 3% to % The State program has written procedures for identifying and maintaining records about essential recall information. (3.3.c. and 3.5) Improvement from 53% to %

14 No. of States State Implementation Progress of MFRPS Standard Audit Program (n = 0) FY13 FY1 FY15 0 < 0% 0-59% 0-79% 0-99% 0% Percentage of Program Element Implementation of Standard

15 Program Elements: Standard Audit Program (FY15) Quality Assurance Program Field Inspection Audits Inspection Report Audits Sample Report Audit Corrective Action Plan Documentation Program Element 1.a 1.b 2.a 2.b 2.c 3.a 3.b 3.c.a.b.c 5.a 5.b.a.b No. of YES No. of NO No. of NA Percentage Yes Percentage No Percentage NA

16 No. of States State Implementation Progress of MFRPS Standard 5 Food-Related Illness & Outbreak Response (n = 0) FY13 FY1 FY < 0% 0-59% 0-79% 0-99% 0% Percentage of Program Element Implementation of Standard 5

17 Challenging Program Elements: Standard 5 FY1, of the 20 program elements had an implementation status of < 70% FY15 improvements Only 3 program elements had an implementation status of < 70 Coordinate traceback and trace-forward of food implicated in an illness, injury, or outbreak (5.3.d) Improvement from 5% to 0% Established criteria and written procedures for the release of investigation information (5.3.i and 5.5) Improvement from 3% to 5% Written agreement that identifies and describe sources of supplemental laboratory capacity and expertise including laboratory support (5.5) Improvement from 55% to 0%

18 No. of States State Implementation Progress of MFRPS Standard Compliance & Enforcement Program (n = 0) FY FY1 FY15 0 < 0% 0-59% 0-79% 0-99% 0% Percentage of Program Element Implementation of Standard

19 Program Elements: Standard Compliance & Enforcement Program (FY15) Program Element Compliance and Enforcement Program Performance Review and Enforcement Action 1.a 1.a.1 1.a.2 1.a.3 1.a. 1.a.5 2.a 2.a.1 2.a.2 2.a.3 No. of YES No. of NO No. of NA Percentage Yes Percentage No Percentage NA

20 No. of States State Implementation Progress of MFRPS Standard 7 Industry & Community Relations (n = 0) < 0% 0-59% 0-79% 0-99% 0% Percentage of Program Element Implementation of Standard 7 FY13 FY1 FY15

21 No. of States State Implementation Progress of MFRPS Standard Program Resources (n = 0) FY13 FY FY15 0 < 0% 0-59% 0-79% 0-99% 0% Percentage of Program Element Implementation of Standard

22 No. of States State Implementation Progress of MFRPS Standard 9 Program Assessment (n = 0) < 0% 0-59% 0-79% 0-99% 0% Percentage of Program Element Implementation of Standard 9 FY13 FY1 FY15

23 No. of States State Implementation Progress of MFRPS Standard Laboratory Support (n = 0) < 0% 0-59% 0-79% 0-99% 0% FY13 FY1 FY15 Percentage of Program Element Implementation of Standard

24 Summary Data reflects great progress by the states Root cause analysis changes in strategic plans Trend data is now part of state reports Continuous improvements/coordination within FDA stakeholders What s next with the 201 MFRPS?

25 Questions

26 Contact Information Timothy Weigner Staff Director U.S. FDA Office of Regulatory Affairs, Office of Partnerships, Standards Implementation Staff