Jim Melvin NCDA&CS Food and Drug Protection Division
[email protected] MFRPS Lesson Learned North Carolina
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NCDA&CS MFRPS Timeline
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NCDA&CS MFRPS Standard One Current Status Legal authority
to perform inspections and investigations, gather evidence, collect
samples, and take enforcement actions Adoption by reference of the
current FD&C Act, Title 21 Code of Federal Regulations (CFR) or
other Federal laws. A legal review by the State agencys counsel A
process to incorporate changes to States laws and regulations in
order to maintain the states regulatory base equivalency Remaining
Challenges Resources for the adoption of 21 CFR 112 and 117 (21 CFR
115 and 118 took 2 years to navigate through the rule making
process)
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NCDA&CS MFRPS Standard Two Current Status A fully
documented and implemented training Plan Documented through
policies and procedures Records maintained as hard copy and in an
online database. Coursework for the inspector training that
encompasses: Basic Level Education for all inspectors validated by
joint inspections with qualified trainers. Advanced Training for
inspectors that perform complex or advance technique inspections
validated by joint inspections with qualified trainers. Continuing
Education training that enhances the skills and knowledge of the
inspection staff oOngoing classroom training that enhances skills
and knowledge oJoint inspections with qualified trainers that
provide hands on training and verification of techniques and
skills.
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NCDA&CS MFRPS Standard Two Remaining Challenges NCDA&CS
online training database is cumbersome to use and will be replaced.
Getting all of staff through FD180 and FD152 (non issue) DHRD has
worked with States to make classes available. Both Technical
Trainer(s) have retired over the last three months.
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NCDA&CS MFRPS Standard Three Current Status Risk-based
inspection program Food Firms data system that maintains the
current firm inventory Documented inspectional policies and
procedures Initiating Pilot Program for Online Establishment
Inspection Report system based on FDA EIR Food recall system that
shares information with affected government agencies with
documentation of events. Online consumer and industry complaint
tracking system
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NCDA&CS MFRPS Standard Three Remaining Challenges
Implementation of inspectional procedure based on FDA Job Task
Analysis. Complete implementation of the online EIR system using
the Food Firms Database.
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NCDA&CS MFRPS Standard Four Current Status Implemented
audit program which covers the three following inspectional program
functions: (Phase III) Field Inspections (17 per year)
Establishment Inspection Reports (75+ per year) Sample Reports (75+
per year) Implemented corrective action process Remaining
Challenges Lead auditor and trainer/auditor retired Revision of
procedure for EIR audits for new online system.
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NCDA&CS MFRPS Standard Five Current Status Implemented
system to conduct illness or injury investigations Implemented RRT
Implemented communication processes with FDA and other State,
Federal and Local authorities Laboratory capabilities that provide
support for investigations of illness, injury, or outbreaks
Remaining Challenges Development of forward leaning preventive
system to minimum effect of food emergencies
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NCDA&CS MFRPS Standard Six Current Status Implemented risk
based enforcement strategy with established timeline for
progressive regulatory actions A compliance information system that
track firms with critical and chronic compliance history Remaining
Challenges Automating the trigger systems within the database for
critical and chronic offenders Audit process of the Compliance
system equal to the processes for the inspectional staff.
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NCDA&CS MFRPS Standard Seven Current Status Staff
participates in activities include the sponsoring or actively
participating in meetings such as task forces, advisory boards, or
advisory committees Online activity tracking program conforms to
Standards requirements. Remaining Challenges Capturing
documentation required by Standard Seven
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NCDA&CS MFRPS Standard Eight Current Status Implemented
systems that ensure that staff, equipment, and funding are managed
to accomplish the elements detailed in the MFRP Standards.
Remaining Challenges Continued funding of program Expanding firm
base without expansion of staff (more firms, no additional staff)
Funding to implement FSMA
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NCDA&CS MFRPS Standard Nine Current Status Ongoing
assessment of program and corrective action in non conformities or
implementation gaps Completed 60 month PAVA Remaining Challenges
Unknown FDA Program requirements and funding
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NCDA&CS MFRPS Standard Ten Current Status ISO 17025 primary
servicing lab Relationships established with all servicing
laboratories defined through written contracts, agreements, MOUs or
customer supplier agreements. Remaining Challenges Maintaining
existing capacities and relationships
