# Appendix B.1

# Guidance for Completing the Contract Audit Form (FDA Form 3610)

# 

# I. Pre Inspection Assessment

1.  **Did the inspector review the state's establishment file for the
    previous inspection report and possible complaints or access other
    available resources in preparation for the inspection?**

## References:

-   State\'s Establishment Files

-   Applicable Compliance Programs Referenced in the Contract

## Examples of a "needs improvement" rating

a.  The inspector does not review the state's previous inspection report
    and follow-up on previously cited deficiencies.

b.  The inspector does not review a firm's response letter to the
    state's previous establishment inspection where corrective actions
    were promised.

c.  The inspector does not verify the firm's normal days of operation or
    seasonal hours.

d.  The inspector does not appropriately follow-up on a consumer
    complaint contained in the state\'s establishment file.

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2.  **Did the inspector have the appropriate equipment and forms to
    properly conduct the inspection?**

# [References:]{.underline}

-   Applicable Compliance Programs referenced in the contract

-   Applicable Inspection Guides

#### Examples of a "needs improvement" rating:

a.  During an inspection of a cream-filled pie manufacturer, the
    inspector does not have a calibrated thermometer available to
    accurately determine if the product is time/temperature abused.

b.  During an inspection of a cooked, ready-to-eat food processor, the
    inspector does not have a method to test the concentration of iodine
    sanitizer in the hand dip station.

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c.  The inspector does not have a flashlight available during an
    inspection to examine poorly lit raw material storage areas.

# 

# II. Inspection Observations and Performance

1.  **Was FDA jurisdiction established?**

> [References]{.underline}:

-   IOM 432 - Documenting Interstate Shipments

-   IOM 701 -- Statutory Authority

###  Examples of a "needs improvement" rating

a.  The inspector fails to confirm the interstate movement of the
    product or ingredients.

b.  The inspector conducts an inspection of a candy manufacturer. He/she
    fails to discover that the manufacturer has not shipped in
    interstate commerce in the past 24 months. This manufacturer has no
    ingredients or packaging components shipped interstate.

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2.  **Did the inspector select an appropriate product for the inspection
    and, if necessary, make appropriate adjustments based on what the
    firm was producing?**

> [References:]{.underline}

-   Applicable Compliance Program referenced in the contract

> [Examples of a "needs improvement" rating]{.underline}

a.  The inspector covers only a low-risk product, when the firm is also
    producing a high-risk product on the day of the inspection.

b.  The inspector does not cover a small ready-to-eat sandwich operation
    in a large frozen dinner processing plant.

c.  While inspecting a beverage bottling plant whose primary product is
    institutional-sized root beer syrup, the inspector ignores a bottled
    water processing operation at that site.

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3.  **Did the inspector assess the employee practices critical to the
    safe production and storage of food?**

> [Examples of a "needs improvement" rating]{.underline}:

a.  The inspector fails to evaluate the hygienic practices of employees
    working in a food processing area.

b.  The inspector is unaware of the need for employees processing
    cooked, ready-to-eat foods to first wash their hands prior to
    sanitizing each time they touch an unclean surface.

c.  A firm has a trash bin and a reclaim bin in the same area. The
    inspector notes this but does not evaluate practices sufficiently
    enough to identify an employee placing trash in the reclaim bin that
    subsequently re-enters the process flow.

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4.  **Did the inspector properly evaluate the likelihood that
    conditions, practices, components, and/or labeling could cause the
    product to be adulterated or misbranded?**

> [References:]{.underline}

-   Applicable Compliance Programs referenced in the contract

-   NLEA Inspection Guide

> [Examples of a "needs improvement" rating:]{.underline}

a.  The inspector fails to recognize when a firm's finished product
    labeling does not contain a sulfite declaration, even though the raw
    material does contain a sulfite declaration.

b.  The inspector fails to note the significance of "back hauling" raw
    eggs in a tanker used to carry pasteurized ice cream mix.

c.  During an inspection of a baby food manufacturer, the inspector
    observes a belt moving rapidly causing glass jars to rattle and
    notices shards of glass on the belt. The inspector fails to relate
    that observation to a recent increase in complaints about glass in
    baby food.

d.  The inspector fails to recognize the addition of an allergen during
    the production of a breaded product and fails to follow-up on the
    label review.

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5.  **Did the inspector recognize significant violative conditions or
    practices, if present, and record findings consistent with state
    procedures?**

## Examples of a "needs improvement" rating:

a.  The inspector fails to recognize the presence of food residues and
    mold growth on food contact surfaces as a violation.

b.  The inspector does not recognize that employees handling cooked,
    ready-to-eat product with soiled hands is a deficiency.

c.  The inspector fails to recognize cumulative time/temp abuse that
    occurred during the cooling, holding and processing of a potentially
    hazardous food.

d.  The inspector fails to determine that the WD-40™, observed in the
    processing area, is being used to lubricate machine parts over food
    contact surfaces.

e.  The inspector fails to recognize that a firm's cooler dripping
    condensate on finished product provides an opportunity for cross
    contamination.

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6.  **Did the inspector demonstrate the ability to distinguish between
    significant versus insignificant observations and isolated incidents
    versus trends?**

> [References:]{.underline}

-   Applicable Compliance Programs referenced in the contract

> [Examples of a "needs improvement" rating:]{.underline}

a.  The inspector notes minor deficiencies such as chewing gum and nail
    polish while failing to note areas where cross contamination of
    cooked and raw product might occur.

b.  The inspector identifies record keeping deficiencies in records that
    are two months old. The inspector objects to these deficiencies
    without appropriately considering that the firm's weekly management
    review of the records has identified the deficiencies and that they
    have not been repeated within the last seven weeks.

c.  During an inspection of a ready-to-eat salad processor, the
    inspector places extensive emphasis on soiled non-food contact
    surfaces.

d.  During an inspection of a ready-to-eat trail mix manufacturer, the
    inspector observing the processing area notes only that an employee
    was wearing earrings and another was chewing gum. The inspector
    fails to observe employees touching soiled surfaces and then
    touching the product without washing and sanitizing their hands.

e.  During the inspection of a warehouse, the inspector places extensive
    emphasis on storing products away from the wall while not noticing
    that several pallets of rice are adulterated with moths.

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7.  **Did the inspector review and evaluate the appropriate records and
    procedures for this establishment's operation and effectively apply
    the information obtained from this review?**

## 

####  Examples of a "needs improvement" rating:

a.  During record review, the inspector fails to detect that cooking
    times routinely do not meet or exceed scheduled process and no
    corrective actions are documented.

b.  The inspector fails to detect possible evidence of record
    falsification such as inconsistencies among different types of
    records, unrealistically repetitive data, and inconsistencies in
    signatures or handwriting.

c.  Can teardown records are reviewed, but the inspector fails to note
    that teardown measurements were not done at appropriate intervals.

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8.  **Did the inspector collect adequate evidence and documentation in
    accordance with state procedures given the nature of the
    inspectional findings?**

######## Examples of a "needs improvement" rating

a.  The inspector fails to adequately document findings in accordance
    with state requirements when he/she encounters a violative firm.

b.  The inspector fails to collect samples of processed food in
    accordance with state requirements when necessary to document
    non-compliance with a state law.

c.  In an acidified food processing plant, the final product pH comes
    into question. The inspector does not collect a sample of the
    product as required by state procedures for pH analysis.

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9.  **Did the inspector verify correction of deficiencies identified
    during the previous state inspection?**

[Examples of a "needs improvement" rating:]{.underline}

a.  Although significant time-temperature abuse of coconut cream pies
    was identified during the previous inspection, the inspector does
    not determine whether these deficiencies have been corrected.

b.  The previous inspection of a firm listed a well that was not
    equipped with a sanitary seal. The manager informs the inspector
    during the current inspection that the well has been repaired and
    the lab results are acceptable. The inspector reviews these
    microbiological lab results, but does not go to the well to observe
    the sanitary seal or ask for repair receipts.

c.  The inspector fails to follow up on deficiencies from the previous
    inspection for cooked, ready-to-eat product because that product is
    not being made at the time of the inspection. The inspector does not
    review process records related to the product to determine if the
    firm took appropriate corrective actions.

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10. **Did the inspector act in a professional manner and demonstrate
    proper sanitary practices during the inspection?**

[Examples of a "needs improvement" rating:]{.underline}

a.  The inspector fails to wash and sanitize their hands before touching
    the product or product contact surfaces during the inspection.

b.  The inspector does not use the boot bath when entering in the
    firm\'s processing areas.

c.  The inspector fails to sanitize their thermometer prior to probing
    product.

d.  The inspector fails to wear protective clothing when entering an
    aseptic processing area.

e.  The inspector wears jewelry, which may jeopardize open product, into
    a firm's manufacturing or processing areas.

# II. A. Inspection Observation and Performance for 'HACCP-Required' Facilities 

# 

# \[Note: These four questions may be left blank if the firm is not 

#  required by regulations to have a HACCP plan.\]

1.  **Did the inspector use the "Fish and Fishery Products Hazards and
    Controls Guide" and the "Juice HACCP Hazards and Controls Guide", as
    appropriate, to identify and evaluate the hazards associated with
    the product and process?**

> [References:]{.underline}

-   Applicable Compliance Programs referenced in the contract

-   Code of Federal Regulations Parts 110, 123 & 1240

-   Fish and Fishery Products Hazards & Controls Guide (Guide)

-   HACCP Regulation for Fish & Fishery Products -- Questions and
    Answers

-   Code of Federal Regulations Part 120

> [Examples of a "needs improvement" rating:]{.underline}

a.  In a tuna processing plant, the inspector fails to identify
    histamine as a hazard inherent to the incoming raw material and
    fails to question its absence in the firm's HACCP plan. (Failure to
    identify a hazard reasonably likely to occur.)

b.  A firm is producing fresh, raw, refrigerated fish in cryovac
    packaging. The inspector is not aware that C. botulinum is a
    significant hazard.

c.  An inspector incorrectly identifies aquaculture drugs as a
    significant hazard for a secondary processor of a product that it
    receives from the primary processor. (Identification of a hazard not
    reasonably likely to occur.)

d.  The inspector fails to recognize that a batter tank is a likely CCP
    in a breaded shrimp processing operation. (Failure to recognize an
    appropriate CCP.)

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2.  **Did the inspector assess the firm's implementation of sanitation
    monitoring for the applicable eight key areas of sanitation?**

> [References:]{.underline}

-   Applicable Compliance Programs referenced in the contract

-   Code of Federal Regulations Parts 110, 123, and 1240

-   Fish and Fishery Products Hazards & Controls Guide (Guide)

-   HACCP Regulation for Fish & Fishery Products -- Questions and
    Answers

-   Code of Federal Regulations, Part 120

> [Examples of a "needs improvement" rating:]{.underline}

a.  The inspector insists on the need for the firm to perform medical
    check-ups for crabmeat pickers.

b.  The inspector is unaware of which of the eight areas of sanitation
    are relevant to the firms operations.

c.  The inspector fails to inquire about the firms SSOPs and monitoring
    practices.

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3.  **Did the inspector review firm's HACCP plan (or necessary process
    controls in the absence of a HACCP plan) and applicable monitoring,
    verification, and corrective action records, including those related
    to sanitation?**

> [References:]{.underline}

-   Applicable Compliance Programs referenced in the contract

-   Code of Federal Regulations Parts 110, 123, and 1240

-   Fish and Fishery Products Hazards & Controls Guide (Guide)

-   HACCP Regulation for Fish & Fishery Products -- Questions and
    Answers

-   Code of Federal Regulations, Part 120

> [Examples of a "needs improvement" rating:]{.underline}

a.  After conducting a brief walk through a crabmeat processor, the
    inspector relies on a review of the firm's records as the only means
    of evaluating whether the firm is implementing its HACCP plan. The
    inspector does not return to the crab picking room to observe
    whether the picking/packing critical limits are being met, whether
    the firm has the equipment to properly monitor the critical limits
    as specified in the plan, and whether the critical limits are, in
    fact, being monitored.

b.  The inspection reveals that the firm does not have a HACCP plan for
    a product for which one is needed. The inspector cites the lack of
    the HACCP plan but fails to observe the firm's processing operations
    to determine whether the necessary controls are in place, despite
    the absence of a plan.

c.  Although the inspector is told that the firm uses well water as its
    source for ice which comes into direct contact with the fish, the
    inspector does not verify that the firm has the water tested for
    coliforms to ensure its safety.

d.  The plant manager tells the inspector that pest control services are
    contracted out to another firm for biweekly monitoring/treatment,
    but the inspector does not ask to see documentation for such
    service.

e.  The inspector fails to accompany the firm's sanitarian on the his
    regular pre-operation inspection when there would be indications
    that sanitation and/or sanitation monitoring may be inadequate.

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4.  **Did the inspector recognize deficiencies in the firm's monitoring
    and sanitation procedures through in-plant observations?**

> [References:]{.underline}

-   Applicable Compliance Programs referenced in the contract

-   Code of Federal Regulations Parts 110, 123, and 1240

-   Fish and Fishery Products Hazards & Controls Guide (Guide)

-   HACCP Regulation for Fish & Fishery Products -- Questions and
    Answers

-   Code of Federal Regulations, Part 120

> [Examples of a "needs improvement" rating:]{.underline}

a.  The inspector fails to recognize cumulative time/temperature abuse
    during cooling, holding and picking of cooked crabs substantially in
    excess of that allowed under the firm's HACCP plan.

b.  The inspector fails to recognize that a firm's finished product
    labeling does not contain a sulfite declaration even though the raw
    material does contain a sulfite declaration.

c.  The inspector fails to recognize that the presence of product
    residues and mold growth on processing equipment immediately prior
    to processing is evidence of the firm's failure to adequately
    monitor that area of sanitation.

d.  The inspector does not recognize that food-contact surfaces are
    being sanitized with a product that is not approved for that use.

# 

# III. Oral and Written Communication

1.  **Did the inspector identify himself/herself and make appropriate
    introductions, which includes explaining the purpose and scope of
    the inspection?**

###  Examples of a "needs improvement" rating:

a.  The inspector fails to explain why he/she is at the facility and
    what products he/she will be covering.

b.  The inspector enters through the back door and begins examining a
    storage area without making his/her presence known to anyone in the
    firm.

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2.  **Did the inspector use suitable interviewing techniques?**

### 

###  Examples of a "needs improvement" rating:

### The inspector is non-specific in his/her requests for information, causing the firm to provide unnecessary paperwork that is irrelevant to the inspection.

### 

### The inspector's requests contain jargon that is unfamiliar to the firm causing confusion in their efforts to meet his/her requests.

### During the inspector\'s interview of the plant manager concerning the firm\'s sanitation program, the plant manager\'s responses are evasive. The inspector does not ask follow-up questions to obtain the necessary information, leaving the questions only partially answered.

### 

### While obtaining information from the firm\'s management and process personnel, the inspector fails to follow up on discrepancies between statements made by the two parties.

3.  **Did the inspector explain findings clearly and adequately
    throughout the inspection?**

> [Examples of a "needs improvement" rating:]{.underline}

a.  The inspector does not conduct a discussion of the observations at
    the conclusion of the inspection.

b.  The inspector does not discuss a significant deficiency observed in
    the bean storage/conveyor system before he/she proceeds to the soak
    tank room in a cannery although the general manager is present at
    the time.

c.  The inspector's discussion of the deficiencies at the conclusion of
    the inspection is vague. It is unclear to management the
    significance of the observations and that corrective action should
    be taken by the firm.

d.  The inspector does not discuss a significant deficiency observed
    during the inspection at the conclusion of the inspection.

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4.  **Did the inspector alert the firm's appropriate management when an
    immediate corrective action was necessary?**

> [Examples of a "needs improvement" rating]{.underline}

a.  The inspector fails to advise appropriate management that products
    containing undeclared FD&C Yellow #5 are being packaged, and that
    shipment of the product could result in a health hazard.

b.  The inspector fails to advise appropriate management of his/her
    findings after witnessing direct contamination of raw carrots with
    blood dripping from boxes of boneless beef.

c.  After witnessing direct product contamination with a toxic chemical,
    the inspector immediately notifies an employee performing production
    area clean up of the problem.

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5.  **Did the inspector answer questions and provide information in an
    appropriate manner?**

> [Examples of a "needs improvement" rating:]{.underline}

a.  The inspector reveals specific information about a pending
    compliance action against a competitor.

b.  The inspector provides information to a firm about a competitor's
    exclusive process.

c.  The inspector makes up an answer to a policy question, which may
    lead the firm to take an inappropriate corrective action.

d.  The inspector dictates an inappropriate corrective action for a
    deficiency.

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6.  **Did the inspector write his/her findings accurately, clearly, and
    concisely on the state form/document left with the firm?**

##### [References:]{.underline}

-   Applicable Compliance Programs referenced in the contract

> [Examples of a "needs improvement" rating]{.underline}:

##### 

a.  The inspector fails to write on the list of findings that the firm
    has a significant process deviation.

b.  The inspector fails to write on the list of findings that he/she
    observed fresh rodent pellets in bags of rice.

c.  The list of findings shows that the "Firm did not control hazards"
    with no further explanation.