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U.S. Department of Health and Human Services

Training and Continuing Education

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Audit Failure Reference Guide

 

Audit Failure reference guide 
Retail Food Level I Performance Audit For
State, Local & Tribal Food Safety Inspection Officers

Based on FDA’s Voluntary National Retail Food Program Standards
 Standard 2, Trained Regulatory Staff

Posted: April 26, 2007

After completing the training requirements in Standard 2, Trained Regulatory Staff, through the ORA U Retail Food Level I Curriculum http://www.fda.gov/ora/training/orau/state/RFCurric.htm or equivalent means, an individual’s newly acquired knowledge, skills and abilities may be assessed in the field with the following performance audit criteria and 10 elements of competency. The 10 elements of competency and criteria are derived from the Standard 2 “Assessment of Training Needs” (ATN) worksheet, which is utilized during trainee led joint inspections with the trainer/supervisor for training purposes. Demonstration of competency is required for each element for successful completion of the audit. This Reference Guide is designed to help clarify the competencies required for each element of the audit criteria.  When interpreting if each element is met, refer to the current editions of these references:

  • State and Local Codes as applicable
  • FDA Food Code as applicable

Note: Following each element (each question below) is a list of “examples of failure to perform”.  These examples are not intended to be all inclusive.  They are provided simply as a guide to help clarify the competencies required. 

Note: This is a voluntary audit “tool” being offered to those jurisdictions that may choose to use it. Management should delegate responsibilities (i.e. establishment selection, audit scheduling, concurrence of the audit, etc.) to first line supervisors.  Please provide any comments or questions to ORAU@fda.hhs.gov

Part I General Inspection Practices

  1. Did the Food Safety Inspection Officer (FSIO) demonstrate the use of risk-based inspection methodology to assess regulations related to practices essential to the safe storage, preparation and service of food, and obtain immediate corrective action for out of compliance practices? 

    Examples of failure to perform:

    • FSIO failed to verify approved food sources (e.g. Food from regulated food processing plants; Shellfish documentation; Game Animal Processing; Parasite destruction for certain species of fish intended for raw consumption; receiving temperatures).
    • FSIO failed to verify food safety practices for preventing cross-contamination of ready-to-eat food.
    • FSIO failed to verify food contact surfaces are clean and sanitized, protected from contamination from soiled cutting boards, utensils, aprons, etc., or raw animal foods.
    • FSIO failed to verify the restriction or exclusion of ill employees.
    • FSIO failed to verify no bare hand contact with ready-to-eat foods (or use of a pre-approved, alternative procedure).
    • FSIO failed to verify employee handwashing.
    • FSIO failed to verify cold holding temperatures of foods requiring time/temperature control for safety (TCS food) or when necessary, that procedures are in place to use time alone to control bacterial growth and toxin production.
    • FSIO failed to verify date marking of ready-to-eat foods requiring time/temperature control for food safety (TCS food) that are held for more than 24 hours.
    • FSIO failed to verify cooking temperatures to destroy bacteria and parasites.
    • FSIO failed to verify hot holding temperatures of TCS food or when necessary, that procedures were in place to use time alone to prevent the outgrowth of spore-forming bacteria. 
    • FSIO failed to verify cooling temperatures of TCS food to prevent the outgrowth of spore-forming or toxin-forming bacteria.
    • FSIO failed to verify reheating temperatures of TCS food for hot holding.
    • FSIO failed to verify the availability of a consumer advisory for foods of animal origin that are served raw or undercooked.
    • FSIO failed to identify those food processes and/or procedures that require a HACCP Plan per the jurisdiction’s regulations. 
    • The FSIO did not obtain immediate corrective action on employee practices and management procedures essential to the safe storage, preparation and service of food.
    • The FSIO did not verify critical limits and/or standard specified in their jurisdictions rules/regulations to the observation made.

  2. Did the FSIO demonstrate the use of necessary equipment and current applicable resource information? 

     

    Examples of failure to perform:

    • The FSIO failed to use equipment properly during the inspection.
    • The FSIO prepared for the inspection using out-dated reference materials and relied on information that has been superseded in current reference materials.
    • The FSIO did not review the establishment file (if available) for the previous inspection report or documents and complaints on file as applicable.

  3. Did the FSIO demonstrate knowledge of good retail practices and other applicable statutes, regulations and ordinances?  

    Examples of failure to perform:

    • The FSIO did not provide identification to the person in charge and state the purpose of the inspection.
    • The FSIO incorrectly assessed the Compliance status of other regulations (Good Retail Practices).
    • The FSIO did not verify out of compliance observations identified during previous inspections.
    • The FSIO incorrectly cited the rule/regulation for each out of compliance observation. 

  4. Part II Sample Collection and Evidence Development 

     

  5. Did the inspector demonstrate an ability to properly collect evidence as applicable in order to document violations and support potential regulatory actions? 

     

    Examples of failure to perform:

    • FSIO failed to document a regulatory finding or objectionable condition with photographs, as appropriate.   
    • FSIO failed to use an aseptic food sample collection consistent with criteria established by laboratory serving the jurisdiction.
    • FSIO failed to use an aseptic water sample collection method consistent with criteria established by the laboratory serving the jurisdiction.
  6. Part III oral Communication 
  7. Did the FSIO demonstrate an ability to clearly and adequately engage in dialogue with the person in charge/employees to obtain information relevant to the inspection?

     

    Examples of failure to perform:

    • The FSIO failed to use effective communication and conflict resolution techniques to overcome inspection barriers.
    • The FSIO could not effectively explain the rationale for citing a violation. 
    • The FSIO failed to use available means (e.g. interpreter, drawings, demonstrations, diagrams) to overcome language or communication barriers.
    • The FSIO failed to ask open-ended questions.

  8. Did the FSIO demonstrate ability to communicate deficiencies and corrective actions with responsible persons? 

     

    Examples of failure to perform:

    • The FSIO did not discuss observations with responsible persons as the observations were observed or at any time prior to the exit interview as appropriate.
    • The FSIO discussed deficiencies with subordinate employees but not with those persons with responsibility and authority to correct.
    • The FSIO failed to conduct the exit interview explaining out of compliance observations and identifying corrective actions and timelines for all noted violations. 

  9. Did the FSIO respond appropriately to relevant questions and comments?  

     

    Examples of failure to perform:

    • The FSIO fabricated an answer to a question or comment, rather than admit that he/she did not know.
    • In responding to questions, the FSIO assumed the role of an authoritative consultant. 
    • The FSIO failed to provide the operator with accurate answers to inspection related questions.
    • The FSIO did not follow department policy with regard to disclosure of confidential information.     
  10. Part IV Written Communication
  11. Did the FSIO properly complete appropriate inspection forms?  

     

    Examples of failure to perform:

    • The FSIO did not possess the necessary forms and administrative materials 
    • The FSIO did not sign the inspection report.
    • The FSIO wrote the wrong establishment name on the report.
    • The FSIO failed to complete inspection forms per the jurisdictions administrative procedures (e.g. observations, corrective actions, public health reason, applicable code reference, compliance dates).

  12. Did the FSIO present all proper forms to the appropriate person(s)? 

     

    Examples of failure to perform:

    • The FSIO issued forms to someone other than the owner/operator or agent in charge.
    • The FSIO did not issue a receipt for a sample(s) collected, when required.
    • The FSIO failed to present the inspection report and (when necessary), cross-reference documents, to the person in charge.   
    • The FSIO failed to include with the inspection report, any (when necessary) cross-reference documents, compliance or regulatory documents (e.g. exhibits, attachments, sample forms, embargo forms, destruction forms, suspension notices) identified or cross referenced in written statements. 
  13. Part V Professionalism
  14. Did the FSIO demonstrate the following attributes?     

     

    1. Open-mindedness
    2. Ethical behavior
    3. Diplomacy
    4. Tactfulness
    5. Consideration

    Examples of failure to perform:

    • After the conclusion of an inspection, the FSIO solicited, or accepted, a gift from responsible persons.
    • When facility management requested the FSIO to remove personal jewelry to conform to their procedures, the inspector refused.
    • The FSIO failed to follow the firm’s safety procedures & polices. 
    • The inspector displayed abusive and/or threatening behavior during the inspection.
    • The FSIO did not have a professional appearance that was consistent with the jurisdictions policy (e.g. clean outer clothing, hair restraint).
    • The FSIO failed to demonstrate proper sanitary practices as expected from a food service employee.
    • The FSIO failed to report findings.