Attachment_3.doc

ORA-WIDE PROCEDURE

Food and Drug Administration

Office of Regulatory Affairs Document Number:

FMD-76

Version #: 1.0

Title:

State Contracts – Evaluation of Inspectional Performance (FMD#-76) Date:

1/13/14

Sections included in this document

1. Purpose

2.

HYPERLINK \l "Scope"

Scope

3.

HYPERLINK \l "Guidelines"

Guidelines 4.

HYPERLINK \l "Background"

Background

5.

HYPERLINK \l "Procedures_Responsibilities"

Procedure/Responsibilities

6.

HYPERLINK \l "References_SupportingDocuments"

References/Supporting Documents

7. Definitions/Glossary

8. Records 9.

HYPERLINK \l "Attachments"

Attachments

Document and Change History

1. Purpose

The purpose of this FMD is to define: (1) procedures for conducting audits of contract inspections, (2) the required frequency of audits, (3) auditor training requirements, and (4) the records required to document the audits. Specific audit procedures and forms, data reporting instructions, and summary report forms of audit findings are included as appendices. This FMD does not modify the procedures for conducting joint audit inspections and joint inspections for contract monitoring and enforcement purposes.

2. Scope FMD-76 addresses the oversight of contract inspections in the following program areas:

· Food

· Feed establishment (includes GMP and BSE only inspections)

· Egg, tissue residue, medical device, and other inspection programs

This FMD does not address the training requirements and procedures for oversight of States performing inspections of mammography facilities certified by FDA under the Mammography Quality Standards Act of 1992 (MQSA). Those requirements are contained in the MQSA contractual agreements with the States and the FMD-144.

This FMD does not contain procedures for reviewing the quality of State documents. Districts are encouraged to conduct a quality assurance review of State documents as part of their quality assurance program.

3. Guidelines FMD-76 is the overarching document for oversight of the State contract audit program.

4. Background

The original FMD established procedures for joint inspections and independent audit inspections for the food, medicated feed (currently feed establishments), and interstate travel programs. In 1977, a revision expanded the audits, maintained the requirement for joint inspections, and added references to the diagnostic x-ray program. In 1982, a revision combined the general procedures for all current programs into one document. Guidance for auditing food sanitation and medicated feed contract inspections, and the procedures for auditing States performing inspections of mammography facilities certified by FDA under the Mammography Quality Standards Act of 1992 (MQSA) were added in 1999.

In June 2000, the Department of Health and Human Services, Office of Inspector General (OIG) published the results of its evaluation of FDA’s oversight of food firm inspections conducted by States through contracts. The report recommended that FDA take steps to address shortcomings in its system of oversight. In 2006, this FMD was revised to incorporate the OIG’s recommendations and to improve the oversight of food, feed establishment, and other inspections done under contract by the States. The procedures for auditing States performing MQSA inspections were removed since they are contained in the State contracts and the FMD-144.

The FMD was updated in 2012 to strengthen the processes for ensuring the audit rates are met and identifying and correcting systemic problems identified during the audits. This revision expanded the oversight of egg contract inspections and added procedures and computer automated forms to improve reporting and tracking of the required number of audits throughout the year.

5. Procedures/Responsibilities

5.1 Responsibilities

A. The Associate Commissioner of Regulatory Affairs (ACRA)

1. Ensures the Regional Food and Drug Directors (RFDDs) comply with the requirements of FMD-76.

2. Initiates actions to correct regional and National deficiencies.

B. FDA’s Office of Regulatory Affairs, Office of Partnerships (OP)

1. Primary oversight of the State contract inspection program.

C. Regional Food and Drug Directors (RFDDs)

1. Ensures the District Directors comply with the requirements of FMD-76.

2. Ensures the respective District Offices in the region have a standard operating procedure (SOP) for implementing and following the requirements in this FMD.

D. District Directors (DDs)

1. Ensure the required numbers of audits are completed.

2. Ensures documented program and performance deficiencies are corrected.

3. Ensures adequate staff is assigned to meet the responsibilities of the Audit Program.

E. FDA Auditor

1. Conduct audits of State inspectors performing contract inspections.

2. Train and verify the performance of State Auditors.

3. Submit audit reports to the district.

F. State Auditor (Phase II and III only)

1. Conduct audits of State inspectors performing contract inspections.

2. Train and verify the performance of State Auditors.

3. Submit audit reports to the District for review through the State agency.

G. State Contract Liaisons/Monitors, or designee

1. Manage Contract Inspection Audit Program at the district level.

2. Work with management at District and State agency to:

a. Assign audits to FDA employees.

b. Ensure the required numbers of audits are completed.

c. Document and ensure correction of individual and program performance deficiencies

d. Ensure required documentation, including audit reports, are completed, maintained, and distributed, as needed.

5.2 Overview

FDA must audit contract inspections to ensure the quality of inspections purchased through contracts with States is adequate and complies with the contract requirements. The Contract Inspection Audit Program (hereafter known as the Audit Program) is a standardized system of formal audits conducted by qualified FDA and State auditors at a minimum frequency or audit rate. Implementation of the Audit Program is described here.

There are three phases of auditing.

1. Phase I: the District is responsible for conducting the minimum number of contract audits.

2. Phase II: the District and State agency share responsibility for conducting the minimum number of contract audits to meet the audit rate.

3. Phase III: the State agency assumes full responsibility for conducting the minimum number of contract audits to meet the audit rate.

NOTE: Phases II and III apply to the food contracts only. Appendix H (State Implementation Agreement and Yearend Evaluation) must be submitted with the food contract proposal. Section 5.12 provides guidance for implementing Phases II and III of the Audit Program.

5.3 Auditor Qualifications

Contract audits are conducted by FDA and State auditors who have completed the required training courses relevant to the inspection programs listed in this section and any additional training courses listed in the related contract. The auditors must have experience in conducting inspections in the program area and should have an understanding of the relevant FDA compliance program and regulations. Additional qualifications for State Auditors are listed in Section 5.12.

5.3.1 Food Contract Auditor Training Requirements

1. FD320 - FDA State Food Contract Audit Course

2. Contract inspections that require a State inspector to complete specific training courses shall be audited by FDA and State auditors who have completed the same course requirements listed here.

a. Low-Acid Canned Food and Acidified Food

· FD202 – Conducting Acidified Food Inspections

· FD304 (formerly FD203) – Low-Acid Canned Food Inspections

b. Seafood HACCP

· FD249 – Conducting Seafood Inspections

c. Juice HACCP

· FD219 – Juice HACCP and Conducting Juice Inspections

5.3.2 Feed Establishment Contract Auditor Training Requirements

1. VM212 - FDA BSE/Feed Establishment Contract Audit Course

2. Contract inspections that require a State inspector to complete specific training courses shall be audited by FDA auditors who have completed the same course requirements listed here.

a. BSE01- Bovine Spongiform Encephalopathy (BSE)

(FDA web-based course)

b. BSE02 - BSE Inspectional Approach (FDA web-based course)

c. VM206 - Medicated Feeds Inspection

3. Knowledge of Compliance Programs and forms, including completing the REPORT OF INSPECTION FOR COMPLIANCE WITH 21 CFR §589.2000 and §589.2001.

5.4 Audit Rates

5.4.1 Minimum Audit Rates

The minimum audit rates to be accomplished each contract year by inspection program are shown in Table 1. All State inspectors must be audited during the contract period of performance if the required number of audits exceeds the number of State inspectors. State inspectors may be audited more than once per contract period of performance in order to meet the minimum audit rate. In split-district States, the required number of audits is prorated based on the number of firms covered by the State in each District’s territory.

Table 1: Audit Rate for Contract Inspection Programs

Food

7 percent of contract inspections

Feed establishment

5 percent of contract inspections

OP emails a status reminder to the Senior Advisor to theOP, RFDDs, and DDs at the end of the second quarter of the contract period of performance if less than 25 percent of the required audits of a State’s food or feed contract inspections have been completed.

5.4.2 Audit Selection

District and the State agency managers develop an audit schedule when assigning the firms to be inspected under contract by the State agency. Firm selection should be based on the inspection priorities listed in the “Statement of Work” section of the contract and the contractual obligation of the contractor including, for food contracts only, the State’s implementation of the contract audit program.

The types of contract inspections conducted by an inspector must be considered when scheduling an audit. If a State inspector conducts contract inspections in more than one program area, the State or District must rotate the audits to ensure the State inspector is audited conducting a contract inspection in all applicable program areas.

A training or verification audit is counted as one audit, because a single contract audit is being performed during a training or verification audit of a State auditor.

Districts may schedule joint inspections as needed for training purposes. District approved joint inspections count toward audit rate.

5.4.3 Audit Rate Reduction

In limited circumstances, the audit rate may be adjusted. OP will consider the number and type of contract inspections, the number of State inspectors conducting the contract inspections, and previous individual and program performance when evaluating audit rate reduction requests.

The audit reduction is not based on the number of FDA or State auditors. Audit reductions will not be given when a District or State agency fails to conduct the required audits.

The District must submit Appendix I, Request for Audit Reduction, to OP via email to ContractAudits@fda.hhs.gov, during the first quarter of the contract period of performance. Submit a separate form for each program if an audit reduction is being requested in both feed and food.

5.5 Procedures

This section describes the references, rate of audit, performance documentation, performance factors, and timeframes for submitting performance documents for all contract inspection programs.

5.5.1 Food

Rate of Audit

7 percent of the total number of contract inspections

For 36-month verification audits of State auditors

The FDA or State auditor will prepare a memorandum to document the State auditor’s performance.

Performance factors are found in Appendix B.

For 36-month verification audits of State auditors

Follow guidance in Appendix D.

When the State agency conducts the audit, it will send the original audit form or memorandum for the verification audit to the District no later than 20 business days after the audit is completed.

If a contract audit is rated as “needs improvement,” the District or State agency should notify the other party no later than 10 business days after the audit is completed.

If a verification audit is unacceptable, the District or the State agency should notify the other party no later than 10 business days after the audit is completed.

5.5.2 Feed Establishment

Performance Documentation

Performance Factors

Performance factors are found in Appendix C.

If an audit is rated as “needs improvement,” the District should notify the State agency no later than 10 business days after the audit is completed.

5.5.3 Egg, Tissue Residue, Medical Device, and Other Inspection Programs

The FDA auditor will prepare a memorandum to document the State inspector’s performance.

Performance factors are found in Appendix D.

If the joint audit inspection is unacceptable, the District should notify the State agency no later than 10 business days after the audit is completed.

5.6 Reporting Audit Findings

The District reports the audit findings for each quarter. All audit results must be reported, even when more than the required numbers are performed.

5.6.1 Food and Feed contracts

The District completes Workbooks E and F (Appendices E and F) and emails them to the State agency and the OP audit mailbox ContractAudits@fda.hhs.gov no later than 20 business days after the end of each quarter of the contract period of performance. Workbooks E and F are used: (1) to calculate an overall rating for the contract period of performance and (2) to evaluate the audit ratings for a single performance factor. The District, State agency, and OP use the rating and evaluation to identify specific aspects of the State’s inspection program that require improvement.

5.6.2 Egg, tissue residue, medical device, and other inspection programs Appendix G, Audit Summary for Other Inspection Programs, is emailed to the OP audit mailbox ContractAudits@fda.hhs.gov no later than 20 business days after the end of the contract period of performance.

5.7 Audit Rate Deficiencies

The District and State agency must take action when the minimum audit rate is not met. A memorandum approved by the DD and RFDD must be emailed to the Director, Contracts and Grants, OP (CGS) no later than 20 business days after the end of the contract period of performance. The memorandum should have the following information:

· the number of inspections awarded in the contract and the number of inspections for each type of inspection

· the number of audits completed for each type of inspection

· the number of audits not completed

· detailed reasons for not completing the required number of audits

· detailed recommendations for solving issues that caused the required number of audits not to be met

· detailed proposal for meeting the required number of audits for the next contract period of performance

In Phase I, the District prepares the memorandum.

In Phase II, the District and State agency work together to prepare the memorandum. The District also documents how to increase oversight of the program and, if necessary, implement action to assume increased responsibility for completing the audits. The Director, OP reviews the memorandum and discusses the need to adjust the State agency’s implementation phase with the DD and the Director of the State food program.

In Phase III, the Director of the State food program prepares the memorandum and sends it to the DD. The DD forwards it to the RFDD with a cover letter having the following content:

· support of the memorandum submitted by the State food program

· summary of discussions held between District and State food program to prevent program deficiencies from reoccurring

· district's proposal for increasing oversight of the audit program to ensure the required number of audits are met in the next contract period of performance

5.8 Performance Deficiencies

5.8.1 Individual Performance Deficiencies

When there is an individual performance deficiency, the District or State agency notifies the other party no later than 10 business days after the audit is completed.

An individual performance deficiency occurs when:

· a contract audit is rated “needs improvement”

· performance deficiencies are found during a verification audit of a State auditor conducted by the District (applies to food contracts only)

· a joint audit inspection of an inspector conducting an egg, tissue residue, medical device, or other inspections done under contract is unacceptable

5.8.2 Program Performance Deficiencies

When there is a program performance deficiency, the District or State agency notifies the other party no later than 10 business days after the end of the contract period of performance.

A program performance deficiency occurs when:

· a single performance factor rated as “needs improvement” occurs in four or more audits. If fewer than four audits are conducted, a performance deficiency may be considered for a single performance factor rated as “needs improvement” at the discretion of the District and the State agency

· the overall audit performance rating is below 90 percent

5.8.3 Documenting and Correcting Performance Deficiencies

The District or State agency follows these steps to address individual or program performance deficiencies:

· provide a copy of the performance documents (audit form, memorandum, or yearend summaries) to the State agency

· develop a plan to correct the deficiencies. The plan must address (1) the possible causes for the individual or program performance deficiency and (2) the corrective actions that will improve performance

· complete the Appendix J, Corrective Action Plan for Program and Individual Performance Deficiencies

The District or State agency follows these additional steps to address individual performance deficiencies identified during audits:

· the District and State agency discuss the deficiencies identified during the audit. The State inspector or State auditor discontinues conducting or auditing that type of inspection, respectively, until remedial training is completed. The State may be required to absorb the cost of the training.

· State inspectors receiving an overall rating of “needs improvement” must complete remedial training in deficient areas. The District and State agency managers agree on the remedial training needed to allow the State inspector or State auditor to resume conducting or auditing contract inspections, respectively. The remedial training should directly address the deficiencies noted during the audit.

· After remedial training is completed, the State agency conducts an internal audit of the State inspector or State auditor while conducting or auditing a non-contract inspection, respectively. The internal audit should evaluate the effectiveness of the remedial training.

· the District audits the State inspector or State auditor while conducting or auditing a contract inspection, respectively, once remedial training and the internal audit has been completed.

5.9 Process for Contract Modifications for Program and Performance Deficiencies

The District immediately notifies the Contracting Officer Representative (COR), listed in the SOW, of any individual or program performance deficiencies that may affect a contractual requirement. The District provides the COR with additional notification of all follow-up actions and copies of any written correspondence to the State agency.

If the District proposes a change to the contract, the DD emails a recommendation to change the contract to the RFDD, who in turn emails the memorandum to the Director, CGS no later than 10 business days after the end of the contract period of performance.

The recommendation must contain the following information:

· documentation of the problem. Attach copies of pertinent State inspection reports and FDA audit reports

· a description of the steps taken by the State agency and the District to correct the problem

· copies of correspondence such as emails between the District and State agency documenting efforts to address and correct the problem

· an assessment by the District of the cause of the problem and suggested changes to the contract

The Director, CGS and the COR review the District’s proposal to determine if the recommended action is appropriate and complies with contracting regulations and procedures. The Director, CGS discusses with the District any potential action to be taken. OP requests the Office of Acquisitions and Grant Services (OAGS) send an official notification of any action to the contractor. Any actions pursued under this section are done in accordance with the guidance provided in the SOW regarding alteration of the contract and payment for work conducted under the contract.

5.10 Dispute Resolution

The District and the State agency must make every effort to resolve disputes about audit findings and overall audit ratings. If, however, the District and State agency are unable to resolve a dispute, both parties send a written summary of the situation and a proposed resolution to the Director, OP. All related documents, including the FDA audit reports and State inspection reports, shall be included. The Director, OP reviews the reports and works with the District and the State agency to arrive at a resolution. If the State agency fails to respond, the disposition of the contract may be effected.

5.11 Reporting National Audit Findings

The OP conducts a comprehensive review and analysis of the audit data and the documents associated with the audits for all inspection programs covered in this FMD. OP prepares a written report that summarizes the audit findings and accomplishments and describes program and performance deficiencies and corrective actions. The Director, OP will provide the written report to the Associate Commissioner for Regulatory Affairs (ACRA), and other designated managers.

After the audit completion data is reviewed by the ACRA, it will be posted on www.FDA.gov.

5.12 State Implementation of the Audit Program: Phases II and III Section 5.12 ONLY applies to food contracts.

5.12.1 Contract

Full implementation of the Audit Program occurs when the State agency assumes responsibility for auditing their food contract inspections. This process begins in Phase II and is completed in Phase III. Phases II and III of the Audit Program are offered to the State agency as an elective under the Food Contract SOW. If the State agency bids on the audit option, the Appendix H, State Implementation Agreement and Yearend Evaluation, is signed by the District and the State agency and must be submitted with the State’s contract proposal.

At the end of the contract performance period, the agreement is updated by the District to include a yearend evaluation and a summation of the number of audits completed. The updated agreement is emailed to the State agency and to the OP audit mailbox ContractAudits@fda.hhs.gov no later than 20 business days after the end of the contract period of performance.

5.12.2 Training and Verification

The District and State agency develop a plan to accomplish the training and verification audits for those State inspectors who have completed the training requirements in Section 5.3.1 and the SOW. If requested by the District, the State agency will provide records to verify that State auditors have completed the prerequisite training requirements.

In addition, the State auditor must complete one training audit and one verification audit for each type of inspection that the auditor will be responsible for auditing. For example, to conduct audits for GMP and seafood HACCP (SFD), the State auditor must complete at least one training and one verification audit for GMP and one training and one verification audit for SFD.

FDA auditors train and verify the performance of State auditor trainees. States with one qualified auditor may conduct the training and verification audits for other State auditor trainees. States with two qualified State auditors may conduct verification audits of State auditors following the Phase III audit procedures (See 5.12.3). The contract audits completed during the training and verification audits will be counted towards the audit obligation.

One auditor should train only one State auditor trainee during a contract inspection. The State supervisor or additional State inspectors are not permitted to accompany the auditor during a training or verification audit.

A. During the training audit, the State auditor trainee observes the FDA or State auditor conducting a contract inspection audit. The auditor, not the trainee, completes Form FDA 3610.

B. During the verification audit, the FDA or State auditor observes the State auditor trainee conducting a contract audit. The State auditor trainee completes Form FDA 3610. The original audit forms are submitted to the District contact person no later than 20 business days after the audit. The auditor follows the guidelines in Appendix D to document the State auditor trainee’s performance during the verification audit. A copy of the memorandum is sent to the State agency when FDA conducts the audit, and vice versa.

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.”

5.12.3 Phase III

Phase III occurs when the State agency assumes full responsibility of auditing their food contract inspections. The State agency must have a quality assurance program (QAP) that requires correcting performance deficiencies found during an inspection or an audit. The QAP should describe the remedial training process and an internal audit of an auditor who fails to recognize: (1) deficient performance by an auditor or inspector or (2) inspector’s performance that should be rated as “needs improvement”, as discussed in Section 5.8 of this FMD.

All State auditors are listed in Appendix H, Section V. The State agency must audit its own auditors every 36 months considering the inspection priorities listed in the food contract SOW and the inspections performed under contract. To meet this requirement, the State agency must have a minimum of two qualified State auditors. If during the contract year the State agency is unable to retain a qualified auditor for contracted specialized inspections or a minimum of two auditors, it stays in Phase III for the remainder of the contract year. The State agency is moved to Phase II the following contract year and remains in Phase II until they have a minimum of two qualified auditors or a qualified auditor for contracted specialized inspections. If the change in implementation was due to the loss of a qualified auditor for contracted specialized inspections, the State agency may renegotiate their contract to exclude the specialized inspections.

FDA also conducts a minimum of one audit of each State auditor every 36 months. The FDA auditor evaluates the State auditor’s performance over a representative sample of audits of contract inspections, giving priority to auditing those State auditors trained and verified by the State agency.

Both audits by the State and FDA follow the procedures in Sections 5.5.1 and 5.12.2 of the FMD-76 for conducting and documenting a verification audit.

5.13 Quality Assurance

Within the first quarter of the following contract year, the Quality System Manager (QSM), or person designated by the DD, conducts an internal audit of the previous contract year to ensure the District followed the requirements in this FMD and applicable SOP. The internal audit findings will be provided to the DD. All nonconformances must be documented and addressed according to QMS procedures.

6. References/ Supporting Documents

All references and supporting documents are included in Section 5, Procedure/ Responsibilities, Section 9, Attachments, and/ or the contract SOW. Additional resources may be found online at www.fda.gov. Users are responsible for ensuring that they are using the most up-to-date version of the referenced documents.

7. Definitions/ Glossary The types of audits relevant to the oversight of contract inspections are defined here.

1. Audit Performance Rating is the comprehensive assessment of all audits conducted in a contract program during a single period of performance. The Performance rating is calculated based on the rating of all individual performance factors as follows: Total Acceptable/ (Total Acceptable + Total Needs Improvement) * 100. The Audit Performance Rating is expressed as a percentage. The Audit Performance Rating must be greater than or equal to 90percent.

2. Contract audit is an evaluation of a contract inspection in which a qualified auditor accompanies a State inspector to document the inspector’s performance. FDA investigators or State inspectors are qualified to conduct a contract audit after all the requirements for the specific inspection program listed in Sections 5.3 have been successfully completed.

3. Joint audit inspection is an audit conducted by an FDA investigator accompanying a State inspector and observing his/her performance. A joint audit inspection is used to assess the quality of contract inspections for egg, tissue residue, medical device, and other industries that are not covered by an FDA audit course. Appendix D provides guidelines for conducting and reporting joint audit inspections.

4. Joint inspection is an inspection conducted jointly by District and State personnel for training. Joint inspections may be counted towards the required number of audits when used to train state inspectors. Training may be necessary when a new contract is negotiated, new industries are added to an existing contract, or remedial training is needed. If authorized in the contract, the State agency may count the joint inspection as a contract inspection. Appendix D provides additional guidelines for conducting and reporting joint inspections

5. Overall Audit Rating is the comprehensive assessment for an individual audit (see Appendices B and C). If three or less items are marked “needs improvement,” the overall rating is “acceptable.” If four or more items are marked “needs improvement,” the overall rating is “needs improvement.”

6. Training audit is an audit in which a State auditor trainee accompanies an FDA or State auditor and the State inspector during a contract inspection. Its purpose is to teach the State auditor trainee how to conduct an audit by observing an audit of a State inspector. The State auditor trainee must also meet the auditor qualifications in Sections 5.3, 5.12, and in the food inspection contract SOW.

7. Verification audit is an audit conducted by an FDA or State auditor to verify the ability of the State auditor trainee or State auditor to audit the inspection performance of a State inspector conducting a contract inspection. Appendix D provides guidance for conducting and reporting verification audits.

8. Records

Records must be maintained and distributed in accordance with Section 5 (Procedure/ Responsibilities) and other applicable requirements.

9. Attachments

Document History/Change History

(D,I, R, C)

Beverly Kent, OP OIG Working Group Barbara Cassens, Acting Director OP

- D: Draft, I: Initial, R: Revision, C: Cancel 1.0 Previous versions of this document exist and are archived, however version numbering was not included. This is the first version in the new format.

� “other inspection programs” are inspection programs not specifically named in this FMD.

� includes low-acid canned foods and acidified foods, seafood HACCP, and juice HACCP inspections, where appropriate.

� includes BSE only inspections and inspections at licensed and non-licensed feed mill inspections.

Uncontrolled when printed on: 11/25/2013 For the most current and official copy, check QMiS or InsideFDA.gov

_1416302406.unknown

_1428476680.unknown

_1428476703.unknown

_1439202635.unknown

_1447487258.pdf

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 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 FMD-76.

Planned Resources

a. Funding

1. FDA/OP will provide funding for State inspectors to attend the FD320 Food Contract Audit Course.

2. FDA/OP will provide funding to the State agency for implementation of the Audit Program.

b. Personnel

1. The District or State agency will provide auditors to train and verify the performance of State auditors assigned to audit food contract inspections.

2. The State agency will provide State supervisors, team leaders, or senior inspectors to be trained as auditors.

Reporting

Refer to Appendix B.2 in the FMD-76 for specific reporting instructions.

LISA.BELLOWS

Typewritten Text

APPENDIX H

STATE IMPLEMENTATION AGREEMENT

and

YEAREND EVALUATION

I. CONTACT INFORMATION

1. District Office:

2. District Contact:

3. State Agency:

4. State Agency Contact:

II. CONTRACT INFORMATION

1. Period of Performance: start date: end date:

2. Audit Phase: Phase II Phase III

III. STATE BASED AUDIT PROGRAM

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. Qualifications for auditors are stated in FMD-76. The District 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 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.

IV. PLANNED AND COMPLETED AUDITS

Planned Completed*

1. Total number of contract inspections

2. Total number of contract audits

3. Number of training audits for State auditor trainees completed by State and/or District

4. Number of verification audits for State auditor trainees completed by State and/or District

5. Number of verification audits for State auditors completed by State

6. Number of verification audits for State auditors completed by District

7. Number of contract audits completed by District

8. Number of contract audits completed by State agency

9. Number of joint inspections completed by District

10. Number of contract audits rated as acceptable

11. Number of contract audits rated as needs improvement

* To be completed by District.

V. 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 District, the State agency will provide records to verify the State auditors completed the training requirements in FMD-76.

State Auditor GMP LACF Acidified Food

Seafood

HACCP

Juice

VI. SIGNATURE SECTION

Signatures of Responsible Parties (To be signed prior to contract award and submitted with contract proposal)

For the State Agency:

Name: Title:

Signature: Date:

For the U.S. Food and Drug Administration:

Name: Title:

Signature: Date:

VII. YEAREND EVALUATION

This section will be completed by the District. The State will be evaluated on its overall work performance during the contract year, not the outcome of one contract audit. The District 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 District and State agency:

3. Names and titles of persons who participated in yearend evaluation:

CONTINUATION SHEET

State Auditor GMP LACF Acidified Food

Seafood

Juice

Additional Notes:

HNarrative 8-28-13

Appendix H form

PRINT:

RESET:

1:

District Office: [ ]

Evaluation:

2 District Contact:

3:

State Agency: [ ]

Names and titles of person who participated in yearend evaluation::

4 State Agency Contact:

Start Date:

End Date:

Phase: Off

1 planned:

1 completed:

2 planned:

2 completed:

3 planned:

3 completed:

4 planned:

4 completed:

5 planned:

5 completed:

6 planned:

6 completed:

7 planned:

7 completed:

8 planned:

8 completed:

9 planned:

9 completed:

10 acceptable:

11 needs improvement:

State AuditorRow1:

Check Box2: Off

Check Box3: Off

Check Box4: Off

Check Box5: Off

Check Box6: Off

State AuditorRow2:

Check Box7: Off

Check Box8: Off

Check Box9: Off

Check Box10: Off

Check Box11: Off

State AuditorRow3:

Check Box12: Off

Check Box13: Off

Check Box14: Off

Check Box15: Off

Check Box16: Off

State AuditorRow4:

Check Box17: Off

Check Box18: Off

Check Box19: Off

Check Box20: Off

Check Box21: Off

State AuditorRow5:

Check Box22: Off

Check Box23: Off

Check Box24: Off

Check Box25: Off

Check Box26: Off

State AuditorRow6:

Check Box27: Off

Check Box28: Off

Check Box29: Off

Check Box30: Off

Check Box31: Off

State AuditorRow7:

Check Box32: Off

Check Box33: Off

Check Box34: Off

Check Box35: Off

Check Box36: Off

State AuditorRow8:

Check Box37: Off

Check Box38: Off

Check Box39: Off

Check Box40: Off

Check Box41: Off

State AuditorRow9:

Check Box42: Off

Check Box43: Off

Check Box44: Off

Check Box45: Off

Check Box46: Off

State AuditorRow10:

Check Box47: Off

Check Box48: Off

Check Box49: Off

Check Box50: Off

Check Box51: Off

State AuditorRow11:

Check Box52: Off

Check Box53: Off

Check Box54: Off

Check Box55: Off

Check Box56: Off

State AuditorRow12:

Check Box57: Off

Check Box58: Off

Check Box59: Off

Check Box60: Off

Check Box61: Off

State AuditorRow13:

Check Box62: Off

Check Box63: Off

Check Box64: Off

Check Box65: Off

Check Box66: Off

State AuditorRow14:

Check Box67: Off

Check Box68: Off

Check Box69: Off

Check Box70: Off

Check Box71: Off

Name:

Title:

Signature:

Date:

Name_2:

Title_2:

Signature_2:

Date_2:

2 Date yearend evaluation was discussed between District and State agency:

State AuditorRow1_2:

Check Box76: Off

Check Box77: Off

Check Box78: Off

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Check Box80: Off

State AuditorRow2_2:

Check Box81: Off

Check Box82: Off

Check Box83: Off

Check Box84: Off

Check Box85: Off

State AuditorRow3_2:

Check Box86: Off

Check Box87: Off

Check Box88: Off

Check Box89: Off

Check Box90: Off

State AuditorRow4_2:

Check Box91: Off

Check Box92: Off

Check Box93: Off

Check Box94: Off

Check Box95: Off

State AuditorRow5_2:

Check Box96: Off

Check Box97: Off

Check Box98: Off

Check Box99: Off

Check Box100: Off

State AuditorRow6_2:

Check Box101: Off

Check Box102: Off

Check Box103: Off

Check Box104: Off

Check Box105: Off

State AuditorRow7_2:

Check Box106: Off

Check Box107: Off

Check Box108: Off

Check Box109: Off

Check Box110: Off

State AuditorRow8_2:

Check Box111: Off

Check Box112: Off

Check Box113: Off

Check Box114: Off

Check Box115: Off

State AuditorRow9_2:

Check Box116: Off

Check Box117: Off

Check Box118: Off

Check Box119: Off

Check Box120: Off

State AuditorRow10_2:

Check Box121: Off

Check Box122: Off

Check Box123: Off

Check Box124: Off

Check Box125: Off

State AuditorRow11_2:

Check Box126: Off

Check Box127: Off

Check Box128: Off

Check Box129: Off

Check Box130: Off

State AuditorRow12_2:

Check Box131: Off

Check Box132: Off

Check Box133: Off

Check Box134: Off

Check Box135: Off

State AuditorRow13_2:

Check Box136: Off

Check Box137: Off

Check Box138: Off

Check Box139: Off

Check Box140: Off

State AuditorRow14_2:

Check Box141: Off

Check Box142: Off

Check Box143: Off

Check Box144: Off

Check Box145: Off

State AuditorRow15:

Check Box146: Off

Check Box147: Off

Check Box148: Off

Check Box149: Off

Check Box150: Off

State AuditorRow16:

Check Box151: Off

Check Box152: Off

Check Box153: Off

Check Box154: Off

Check Box155: Off

State AuditorRow17:

Check Box156: Off

Check Box157: Off

Check Box158: Off

Check Box159: Off

Check Box160: Off

State AuditorRow18:

Check Box161: Off

Check Box162: Off

Check Box163: Off

Check Box164: Off

Check Box165: Off

State AuditorRow19:

Check Box166: Off

Check Box167: Off

Check Box168: Off

Check Box169: Off

Check Box170: Off

State AuditorRow20:

Check Box171: Off

Check Box172: Off

Check Box173: Off

Check Box174: Off

Check Box175: Off

State AuditorRow21:

Check Box176: Off

Check Box177: Off

Check Box178: Off

Check Box179: Off

Check Box180: Off

Additional Notes:

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