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  1. Field Management Directives

Appendix H Model Standard Agreement

ORA FIELD MANAGEMENT DIRECTIVE No. 76

Appendix H

Subject:
State Contracts-Evaluation of Inspectional Performance
Area:
State Program Management
Date:
8/22/6 Revised
 

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Appendix H

MODEL STANDARD AGREEMENT

STATE IMPLEMENTATION

CONTRACT INSPECTION AUDIT PROGRAM

between

{State Agency}

and

{District Office}

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 all contract inspection programs. Under the food contract inspection program, State agencies have the opportunity to assume responsibility for auditing their food contract inspections. The transition to a State-based Audit Program occurs in two phases (Phase II and Phase III) after the District has completed Phase I of the Audit Program. Phases I, II, and III are described in Section III of the FMD-76.

Phases II and III of the Audit Program are offered to the State agency as an elective under the “Statement of Work” of the food contract. If the State agency bids on the audit elective, this agreement must be signed by the District Director and the Director of the State inspection program. The signed agreement must be submitted with the State's contract proposal. Section IV of the FMD-76 and this agreement contain the requirements for implementing Phases II and III of the Audit Program.

Program Area

This agreement applies solely to the food contract inspection program.

Audit Obligation

During the contract performance period, 7 percent of the total number of food contract inspections must be audited. The minimum audit rate may be achieved through a combination of audits conducted by the District and the State agency.

Cooperating Agency Contacts

For the {District office}:
{Name, title, mailing address, telephone and fax numbers, and email address}

For the {State agency}:
{Name, title, mailing address, telephone and fax numbers, and email address}

State-based Audit Program

The District has trained a senior investigator to audit food contract inspections. Qualifications for auditors are stated in Section III, Part C of the FMD-76.

The State agency has provided the training required by the food inspection contract and the FMD-76 to the State inspectors designated as auditors for the Audit Program.

Under this agreement, the {District office} and the {State agency} will:

  1. Follow the requirements in the FMD-76.
    Note: The FMD-76 should be jointly reviewed by both parties.
  2. Develop a plan to train and verify the performance of the State inspectors assigned to audit contract inspections conducted by State inspectors.
  3. Develop an audit plan when the firms to be inspected are assigned to the State agency. The firm selection should be based on the inspection priorities listed in the “Statement of Work” section of the contract.
  4. Complete the contract inspection audit program evaluation form for the contract performance period.
  5. Develop a plan for State inspectors who require remedial training to resume conducting inspections or audits under FDA contract.
 

Phase II

In Phase II, the District will train and verify the performance of State inspectors assigned to audit contract inspections done by State inspectors. One FDA auditor should train only one State auditor trainee. If more than one State auditor trainee is present, the State supervisor will notify the FDA supervisor prior to the training audit. The FDA auditor will train and audit the State supervisor, team leader, or senior inspector to conduct the contract audit following these steps.

STEP 1: The FDA auditor will conduct a training audit. During this audit, the State auditor trainee will observe the FDA auditor auditing a State inspector. The FDA auditor will complete the FDA Form 3610. Additional observations about the audit should be recorded on the audit form, not in the FDA auditor's official diary.

STEP 2: The FDA auditor will conduct a verification audit. During this audit, the FDA auditor will observe the State auditor trainee conduct a contract audit. The State auditor trainee will complete the FDA Form 3610. The original audit form must be sent to the designated District person. The FDA auditor will refer to Appendix D of the FMD-76 for documenting the State auditor trainee's performance and any training he/she provided to the State auditor trainee. A copy of the memorandum will be sent to the State agency.

Only the State inspector, not the State auditor, will report his/her time in eSAF. The number of hours will be reported as an  audit not an inspection. At the time data is entered into eSAF, the State data entry user will change the Inspection Type field on the Add/Update Inspection Operation screen from State to Audit. The FDA investigator will report time following the instructions in the FMD-76, Appendix B.2.

The training and verification audits will be counted toward the audit obligation. The audit plan is summarized here.

For contract performance period: {dates of contract year}
Total number of contract inspections ____
Total number of required audits ____
Number of training audits for State inspectors ____
Number of verification audits for State inspectors ____
Number of contract audits completed by {district office} ____
Number of contract audits completed by {State agency} ____
 

Phase III

In Phase III, the State agency assumes responsibility for auditing their food contract inspections at the rate stated in the Audit Obligation section of this agreement. The State auditor will complete the FDA Form 3610. The original audit forms will be submitted to the District contact person no later than five business days after the audit.

Only the State inspector, not the State auditor, will report his/her time in eSAF. The number of hours will be reported as an audit not an inspection. At the time data is entered into eSAF, the State data entry user will change the Inspection Type field on the Add/Update Inspection Operation screen from "State" to "Audit".

The audit plan is summarized here.

For contract performance period: {dates of contract year}
Total number of contract inspections ____
Total number of required audits ____
Number of training audits for State inspectors[1] ____
Number of verification audits for State inspectors ____
Number of contract audits completed by {district office} ____
Number of contract audits completed by {State agency} ____
Number of verification audits of State auditors [2] ____
Number of audits rated as acceptable ____
Number of audits rated as needs improvement ____

The State agency will maintain a quality assurance program that: (1) requires correcting performance deficiencies found during an inspection and (2) provides for re-training and re-verification of an auditor who fails to recognize deficient performance by an inspector. The State agency will audit its own auditors every 24 months considering the inspection priorities listed in the “Statement of Work” section of the food inspection contract. The State agency will follow the procedures for conducting a verification audit, which are found in Section IV, Phase II.B of the FMD-76.

Every 24 months, the District will select a representative sample of field audits in which the FDA auditor will evaluate the State auditor during an audit of a State inspector. The FDA auditor should give priority to auditing those State auditors trained and verified by the State agency. He/she will follow Appendix D of the FMD-76 to document the State auditor's performance and any training he/she provided to the State auditor. A copy of the memorandum will be sent to the State agency.

Planned Resources

  1. Funding

    1. FDA/DFSR will provide funding for State inspectors to attend the Food Contract Audit Course.
    2. FDA/DFSR will provide funding to the State agency for implementation of the Audit Program.

  2. Personnel

    1. The District will provide auditors to train and verify the performance of State inspectors assigned to audit food contract inspections.
    2. The State agency will provide State supervisors, team leaders, or senior inspectors to be trained as auditors.

Assessment Mechanisms

Refer to FMD-76, Section III, Part E for specific reporting instructions.

The District will:

  • maintain the original audit forms and
  • complete and send Worksheet E, and Appendix I of the FMD-76 to FDA/DFSR, HFC-150, Room 12-07, 5600 Fishers Lane, Rockville, Maryland 20857, Attention: Beverly Kent.

Conclusions and Recommendations

An unacceptable audit will not cause a contract to be altered or unpaid nor will payment for the contract inspection be withheld. The State will be evaluated on its overall work performance during the contract year, not the outcome of one contract audit. A single audit may give an indication of a problem but may not prove sufficient to determine its scope. If this occurs, it may indicate an area in the State's inspection program that may be improved.

The District should follow the procedures in FMD-76, Section III, Part F when performance deficiencies occur. The following conditions may indicate a need for action on the part of the District: (1) an audit of a food contract inspection is rated “needs improvement”, (2) a single performance factor is rated “needs improvement” in multiple audits, (3) the overall rating for the contract performance period is below 80 percent, or (4) performance deficiencies are found during a verification audit.

State inspectors who receive an overall audit rating of “needs improvement” shall receive remedial training. District and State agency managers will agree on the training needed to allow the State inspector or State auditor resume conduct inspections or audit under the FDA contract.

Signatures of Responsible Parties

For the U.S. Food and Drug Administration

{Name}
Director, {District office}

Signature ______________________________ Date _________________

For the {State agency}

{Name}
Director, {Office or Division}

Signature ______________________________ Date _________________

Attachment:
FMD-76

Endnotes:

[1] The State agency may conduct training and verification audits which will be counted toward the audit obligation.
[2] Phase III verification audits of State auditors conducted by the District for the 24-month evaluation of the State's implementation of the audit program may be counted against the total number of audits.
 
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