state assessment observations tressa madden, mph, res cso/standards implementation staff fda...

State Assessment ObservationsTressa Madden, MPH, RES

CSO/Standards Implementation StaffFDA

Tuesday, March 11, 20149:00 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)

Example of PE Worksheet

Standard One

Full Conformance

(100%)

80-99% 60-79% 40-59% <39%

PE Conformance Rating

16 4 9 4 641 10 23 10 15

Total StatesPercentage (%)

Standard One

No. of YES 22 30 16 21 36No. of NO 15 6 16 10 4No. of NA 3 4 8 9 0

Documentation

1.a 1.b 2.a 2.b 3

Equivalent Authority & Regulations

Legal Authority & Regulations

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)

Standard Two

Full Conformance

(100%)

80-99% 60-79% 40-59% <39%


5 12 6 10 713 31 15 26 18


Standard Two

No. of YES 19 25 25 22 25 25 15 25 29 29 27 31No. of NO 21 14 12 17 12 13 18 14 11 11 13 9No. of NA 0 1 3 1 3 2 7 1 0 0 0 0

1.a 1.b 2.a 2.b 2.c 3.a 3.b 4.a 4.b 5.a 5.b 5.c

Continuing Education

Training Records and Documentation

State Training Plan Basic Food Insp. TrainingAdvanced Food Insp. Training

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

Standard Three

Full Conformance

(100%)

80-99% 60-79% 40-59% <39%


1 11 14 5 83 28 36 13 21


Standard Three

1.a 1.b 1.c 1.d 1.e 2.a 2.b 3.a 3.b 3.c 3.d 3.e 4.a 4.b 4.c 5.a 5.b 5.c 6.a 6.b

Risk Based Inspection System Inspection Protocol Recall System Consumer Complaint SystemFood Industry Complaint

Resolution SystemSelf Assessment

No. of YES 35 26 38 23 23 14 13 25 18 20 19 15 35 29 26 24 19 18 37 31No. of NO 4 11 1 16 16 25 26 14 21 19 20 24 4 10 13 15 20 21 2 8No. of NA 0 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0


• 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 SystemWritten procedures for sharing informationWritten procedures for removing productWritten procedures for performing recall checksWritten procedures for maintaining records

about recall information

Standard Four

Full Conformance

(100%)

80-99% 60-79% 40-59% <39%


4 4 2 2 2710 10 5 5 69


Standard Four

1.a 1.b 2.a 2.b 2.c 3.a 3.b 3.c 4.a 4.b 4.c 5.a 5.b 6.a 6.b

Field Inspection Audits Inspection Report Audits Sample Report AuditQuality Assurance

ProgramCorrective Action

PlanDocumentation

No. of YES 8 10 11 18 16 8 12 12 8 9 8 11 8 15 12No. of NO 30 28 28 21 23 31 27 27 30 27 27 28 31 24 27No. of NA 0 0 0 0 0 0 0 0 1 3 3 0 0 0 0


• Elements 4.2b &c, 4.3b & c, and 4.4b & c Implementation of the 3 Types of Audits– Field Inspection– Inspection Report– Sampling

Standard Five

Full Conformance

(100%)

80-99% 60-79% 40-59% <39%


6 16 7 5 515 41 18 13 13


Standard FiveSelf

Assessment

1.a 1.b 2.a 2.b 2.c 2.d 2.e 2.f 2.g 2.h 2.i 2.j 2.k 2.l 3 4.a 4.b 4.c 4.d 4.e

DocumentationFood-related Illness InvestigationState Program Contracts for

Support

28 22 23 34 33 20 32 32 19 27 19 28 29 29 39 28 24 25 17 3410 15 8 4 6 19 5 6 11 12 15 11 10 10 0 9 15 14 22 51 2 8 1 0 0 2 1 9 0 5 0 0 0 0 2 0 0 0 0


• 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

Standard Six

Full Conformance

(100%)

80-99% 60-79% 40-59% <39%


3 2 8 7 198 5 21 18 49


Standard Six

1.a 1.a.1 1.a.2 1.a.3 1.a.4 1.a.5 2.a 2.a.1 2.a.2 2.a.3

Compliance and Enforcement ProgramPerformance Review and Enforcement

Action

No. of YES 31 23 14 23 18 20 5 8 6 6No. of NO 8 16 25 16 21 19 34 31 33 33No. of NA 0 0 0 0 0 0 0 0 0 0


• 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

Standard Seven

Full Conformance

(100%)

80-99% 60-79% 40-59% <39%


25 9 3 2 064 23 8 5 0


Standard Seven

1.a 1.b 1.c 1.d 1.e 2.a 2.b

Communication and Information Exchange Documentation

No. of YES 39 38 38 37 34 31 33No. of NO 0 1 1 2 5 8 6No. of NA 0 0 0 0 0 0 0


• Element 7.2.a• Documentation of outreach activities

Standard Eight

Full Conformance

(100%)

80-99% 60-79% 40-59% <39%


8 11 12 4 321 28 31 10 8


Standard EightAdmin

Program Support

Program Resource Assessm

ent

Staffing Level

1 2 3 4.a 4.b

Equipment

No. of YES 30 32 24 34 14No. of NO 9 7 15 5 25No. of NA 0 0 0 0 0

Standard Nine

Full Conformance

(100%)

80-99% 60-79% 40-59% <39%


23 5 8 0 459 13 21 0 10


Standard Nine

1.a 1.a.1 1.a.2 1.b 2.a 2.b

System for Continuous

Improvements

System to conduct Program Self-Assessment

No. of YES 37 38 36 33 29 28No. of NO 3 2 4 7 11 12No. of NA 0 0 0 0 0 0


• 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

Standard Ten

Full Conformance

(100%)

80-99% 60-79% 40-59% <39%


12 16 6 3 231 41 15 8 5


Standard TenSelf

Assessment

1.a 1.b 1.c 1.d 1.e 2

Laboratory Services

No. of YES 35 37 30 16 14 34No. of NO 4 2 7 6 23 5No. of NA 0 0 2 17 2 0

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

Questions?

Contact Information

Tressa Madden

CSO/Standards Implementation Staff

FDA/ORA/OP

[email protected]

state assessment observations tressa madden, mph, res cso/standards implementation staff fda...

Documents

implementation slide

information slide

public slide

end of fy2013 slide

example of pe worksheet

emergency response event

b c implementation

pe data limitations