Appendix D Guidance for Conducting Joint Audit Inspections and Joint Inspections

 ORA FIELD MANAGEMENT DIRECTIVE No. 76
Appendix D

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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 inspection

    

   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, tissue residue and medical device and (2) as an option when a District doesn’t have a sufficient number of trained auditors.

    

   The FDA investigator should follow Appendix A. Instructions for Evaluating Contract Inspections for guidance on the roles and responsibilities of an auditor and an auditee. The evaluation is done by an FDA investigator accompanying the State inspector and observing his/her performance.

    

    Performance Factors

    

   The FDA investigator should discuss the performance factors with the State inspector prior the start of the evaluation. The State inspector’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

    

   The FDA investigator will prepare a memorandum to his/her supervisor to document the State inspector’s performance and any training he/she provided to the State inspector. A copy of the memorandum should be provided to the State agency.

    

   Any serious deficiencies in performance will be detailed in the memorandum with specific information sufficient to document the performance deficiency. Deficient performance is defined as not following program guidance and directives or not identifying adverse conditions (includes imminent health hazards) that would result in a violative inspectional classification. If a serious deficiency is documented, a copy of the memorandum is sent to the Division of Federal-State Relations, HFC-150.
   

    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. Joint inspections may be counted against 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.

    

    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.