State Implementation Agreement and Year End Evaluation 2023

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See bottom of page 7 for PRA statement

Appendix H

STATE IMPLEMENTATION AGREEMENT
And
YEAREND EVALUATION
Background
The Contract Inspection Audit Program (hereafter known as the Audit Program) is described in
FDA Field Management Directive No. 76 (FMD-76). The FMD-76 provides procedures for
auditing contract inspection programs. State agencies have the opportunity to assume
responsibility for auditing their human food and animal food contract inspections. The transition to
a state-based Audit Program occurs in two phases (Phase II and Phase III) after the Program
Division has completed Phase I of the Audit Program. Phases II and III are described in FMD-76.
This option does not apply to other contract inspection programs including egg and medical device.
Planned Resources
A. Funding
1. FDA/OP will provide funding for state inspectors to attend the audit courses.
2. FDA/OP will provide funding to the state agency for implementation of the Audit

Program.
B. Personnel
1. The Program Division or state agency will provide auditors to train and verify the

performance of state auditors assigned to audit human food and animal food contract
inspections.
2. The state agency will provide experienced (qualified) staff to be trained as auditors. This

could include supervisors, team leaders or inspectors.
Reporting
Refer to Appendix B.2 (Human Food) and C.2 (Animal Food) in FMD-76 for specific reporting
instructions.

APPENDIX H
STATE IMPLEMENTATION AGREEMENT
and
YEAREND EVALUATION
I. CONTACT INFORMATION

1. Program Division

2. Responsible FDA Division Contact

3. State Agency

4. Responsible State Agency Contact

II. CONTRACT INFORMATION

1. Period of Performance:

Start date

End date

2. Audit Phase:

Phase II

Phase III

3. Commodity:

Human Food

Animal Food

III. STATE BASED AUDIT PROGRAM
The state agency has provided the training required by the human food or animal food inspection contract and the FMD-76 to
the state inspectors designated as auditors for the Audit Program. Qualifications for auditors are stated in FMD-76. The
Program Division agrees that the state program is ready to implement the Audit Program.
Under this agreement, the FDA and the state agency will:
a. Follow the requirements in the FMD-76 and human food or animal food contract Statement of Work (SOW).
b. Develop a plan to train and verify the performance of state auditors assigned to audit contract inspections.
c. Develop an audit plan based on the firms assigned for inspection by the state agency to verify the performance of
state inspectors. The firm selection should be based on the inspection priorities listed in the “Statement of Work”
section of the contract and the contract obligation of the state.
d. Develop a plan for state inspectors who require remedial training to resume conducting inspections or audits under
FDA contract.
e. Complete Section VII, Yearend Evaluation, of this form for the contract performance period. Complete separate forms
for Human Food and Animal Food programs.
IV. PLANNED AND COMPLETED AUDITS
Planned
1. Total number of inspectors performing contract inspections
2. Total number of contract audits
3. Number of training audits for state auditor trainees completed by state and/or division
4. Number of initial verification audits for state auditor trainees completed by state
5. Number of verification audits for state auditors completed by state
6. Number of verification audits for state auditors completed by division
7. Number of contract audits completed by division
8. Number of contract audits completed by state agency
9. Number of joint inspections completed by division
10. Number of contract audits rated as acceptable
11. Number of contract audits rated as needs improvement
* To be completed by Program Division.

Completed*

V. HUMAN FOOOD STATE AUDITORS
List all state auditors. Identify the program area(s) in which the state auditors are trained to conduct audits by placing a
check mark in the appropriate box. Additional state auditors should be listed on the applicable Continuation Sheet.
If requested by the division, the state agency will provide records to verify the state auditors completed the training
requirements in FMD-76.
Human Food State Auditor

GMP*

LACF

Acidified
Food

Seafood
HACCP

*referenced as Food Inspections on the contract (includes Limited Scope PC and Modified Req)
VI. SIGNATURE SECTION
Signatures of Responsible Parties (To be signed prior to contract award and submitted with contract proposal)
For the State Agency - Director of state inspection program signs
Name:

Title:

Signature:

Date:

For the U.S. Food and Drug Administration – Program Division Director signs
Name:
Title:
Signature:

Date:

Juice
HACCP

V. ANIMAL FOOD STATE AUDITORS
List all state auditors. Identify the program area(s) in which the state auditors are trained to conduct audits by placing a
check mark in the appropriate box. Additional state auditors should be listed on the Continuation Sheet.
If requested by the Program Division, the state agency will provide records to verify the state auditors completed the
training requirements in FMD-76.

Animal Food State Auditor

BSE

Medicated
PC Animal Food Animal Food

VI. SIGNATURE SECTION
Signatures of Responsible Parties (To be signed prior to contract award and submitted with contract proposal)
For the State Agency - Director of state inspection program signs
Name:

Title:

Signature:

Date:

For the U.S. Food and Drug Administration – Program Division Director signs
Name:
Title:
Signature:

Date:

PCAF Part
507 CGMP

VII. YEAREND EVALUATION
This section will be completed by the program division. The state will be evaluated on its overall work performance during
the contract year, not the outcome of one contract audit. The program division and state agency should follow the
procedures in FMD-76 when program or performance deficiencies occur. An unacceptable audit will not cause a contract
to be altered or unpaid nor will payment for the contract inspection be withheld.
1. Evaluation (record strengths/weaknesses):

2. Date yearend evaluation was discussed between Program Division and state agency:
3. Names and titles of persons who participated in yearend evaluation:

V. HUMAN FOOD CONTINUATION SHEET
Human Food State Auditor

Additional Notes:

GMP

LACF

Acidified
Food

Seafood
HACCP

Juice
HACCP

V. ANIMAL FOOD CONTINUATION SHEET

Animal Food State Auditor

Additional Notes:

BSE

PCAGF Part
Medicated
PC Animal Food Animal Food 507 CGMP