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  1. Field Management Directives

Appendix D Guidance for Conducting Joint Audit Inspections and Joint Inspections

ORA FIELD MANAGEMENT DIRECTIVE No. 76

Appendix D

Subject:
State Contracts-Evaluation of Inspectional Performance
Area:
State Program Management
Date:
1/24/14 Revised
 

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Appendix D
Guidance for Conducting Joint Audit Inspections and Joint Inspections

This appendix: (1) defines the joint audit inspection and joint inspection and (2) provides guidance on when the inspections should be used.

1. Joint Audit Inspections and Verification Audits for State Auditors (for food contracts only)

Joint audit inspections are used: (1) to assess the quality of contract inspections for those inspection programs that are not covered under the Contract Inspection Audit Program, for example, egg, tissue residue, and medical device and (2) to assess the performance of State auditors conducting audits of food contract inspections.

The qualified auditor should follow Appendix A. Instructions for Evaluating Contract Inspections for guidance on the roles and responsibilities of an auditor and an auditee. The JAI is done by an FDA investigator observing a State inspector conducting an inspection of a firm in one of the program areas mentioned in (1) above. The verification audit is done by a qualified FDA or State auditor observing a State qualified auditor performing an audit of a State inspector conducting a food contract inspection.

Performance Factors:

The qualified auditor should discuss the performance factors with the State inspector or State auditor prior the start of the evaluation. The State inspector or State auditor's performance should be evaluated using the performance factors listed here.

  1. Understands the program objective and regulatory authorities.
  2. Has necessary knowledge (training), skills, and abilities to conduct the inspection.
  3. Covers critical areas during the inspection.
  4. Selects an appropriate product for inspection.
  5. Recognizes significant violative conditions or practices.
  6. Notifies firm's management when an immediate corrective action is required.
  7. Explains inspection findings accurately and clearly to firm managers.

Performance Documentation:

A memorandum will be used to document the State inspector or State auditor's performance.

For joint audit inspections:

The FDA auditor will prepare the memorandum for supervisory review. The District will send a copy of the memorandum to the State agency no later than 20 business days after the audit is completed. 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.

For verification audits for State auditors:

The FDA or State auditor will prepare the memorandum for supervisory review.

FDA will send a copy of the memorandum to the State agency no later than 20 business days after the audit is completed.

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

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

Data Reporting:

Joint audit inspections are reported as investigation operations, operation code 13. Investigation time should be reported against the PAC for the appropriate compliance program, for example, PAC 71R800, a tissue residue short-term assignment, may be used to report time for tissue residue contract inspection audit. Only one coversheet should be prepared per inspection with both FDA and State inspection time recorded.

2. Joint inspections

A joint inspection is an inspection conducted jointly by FDA and State personnel for the purposes of training or enforcement. A joint inspection may be used to provide training to a State inspector during an inspection of a firm contracted to the State. This joint inspection may be counted against the required number of audits. 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.

Data Reporting:

Joint inspections are reported as inspection operations, operation code 12. The inspection time should be reported against the PAC for the appropriate compliance program.

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