1. MFRPS Lesson Learned North Carolina
Jim Melvin
NCDA&CS
Food and Drug Protection Division

2. NCDA&CS MFRPS Timeline
Stop video at 0:50.

3. 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 agency’s counsel
A process to incorporate changes to State’s laws and regulations in order to maintain the state’s 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)
Owners/operators

4. 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
Ongoing classroom training that enhances skills and knowledge
Joint inspections with qualified trainers that provide hands on training and verification of techniques and skills.
Owners/operators

5. 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.
Owners/operators

6. 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
Owners/operators

7. 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.
Owners/operators

8. 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.
Owners/operators

9. 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
Owners/operators

10. 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.
Owners/operators

11. 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 Standard’s requirements.
Remaining Challenges
Capturing documentation required by Standard Seven
Owners/operators

12. 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
Owners/operators

13. 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
Owners/operators

14. NCDA&CS MFRPS Standard Ten
Current Status
ISO 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
Owners/operators

15. Questions?