HAV Methodology 

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The Hazard Analysis Verification (HAV) Task 

Objectives 

After completion of this module, the participant will be able to 

1. Identify the eight steps for performing the HAV task. 

2. Describe how IPP use the Meat and Poultry Hazards and Controls Guide while 

performing the HAV task. 

3. Identify the documents that are verified while performing the HAV task. 

4. Identify issues that represent noncompliance when performing HAV task. 

5. Describe the two elements of validation. 

6. Identify examples of scientific or technical documentation that establishments use to 

support their HACCP system. 

7. Identify the types of issues or concerns that are to be discussed with a supervisor 

before determining compliance and completing the HAV task. 

Reference 

FSIS Directive 5000.6 Rev. 2, Performance of the Hazard Analysis Verification (HAV) 

Task, June 2018 

Meat and Poultry Hazards and Controls Guide, March 2018 

FSIS Compliance Guideline: Hazard Analysis and Critical Control Point (HACCP) 

Systems Validation, April 2015 

The Hazard Analysis Verification (HAV) Task 

IPP verify that the development and implementation of the establishment’s food safety

system meets the five regulatory requirements (i.e., monitoring, verification, corrective 

actions, recordkeeping and reassessment) addressed in 9 CFR Part 417. The “food

safety system” can be defined as a systematic approach implemented to prevent food 

borne illness. It includes the development and implementation of a Hazard Analysis and 

Critical Control Point (HACCP) Plan in accordance with 9 CFR Part 417 and a 

Sanitation Standard Operating Procedure (SOP) in accordance with 9 CFR Part 416. It 

also includes any programs or procedures an establishment uses (e.g., prerequisite 

programs) to prevent food safety hazards from occurring and to support decisions in the 

hazard analysis. 

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The purpose of the HAV task is broader than simply to identify isolated noncompliance. 

IPP are also to consider what their findings show about the overall effectiveness of the 

establishment’s food safety system. If IPP have concerns about the ability of the 

establishment’s food safety system to produce safe products, they are to discuss those

concerns with their supervisor. Guidance and instructions for performing the HAV task 

are in FSIS Directive 5000.6 

The Hazard Analysis Verification (HAV) Task is a work method that provides IPP with 

a powerful approach to verifying compliance with certain requirements of 9 CFR 417, 

specifically those that pertain to certain foundational elements of an establishment’s 

HACCP system. These foundational elements are: 

 A flow chart and hazard analysis that matches the actual production processes in 

the establishment; 

 A hazard analysis in which the establishment accurately considers applicable 

food safety hazards given the nature of the process, product, and intended use of 

the product and determines whether each hazard is reasonably likely to occur; 

 Critical control points (CCPs) for hazards that are reasonably likely to occur in 

the process and documentation supporting those CCPs; 

 Documentation (prerequisite programs) supporting any decision that a food 

safety hazard is not reasonably likely to occur in the process; 

 Evidence supporting the validity of the HACCP system; and 

 Reassessment of the HACCP system annually and anytime changes occur that 

could affect the hazard analysis or HACCP plan. 

We refer to these elements of a HACCP system as foundational because each element 

is critical to the sound development and maintenance of a HACCP plan. If an 

establishment fails to meet a regulatory requirement associated with any one of these 

elements, the HACCP plan, and ultimately the HACCP system may be fundamentally 

flawed. Even if the HACCP plan is well executed, a HACCP system that is inadequate 

with respect to these foundational elements may result in the production of adulterated 

product. IPP are to consider the implications of their findings with respect to the overall 

effectiveness of the establishment’s food safety system.

The HAV methodology gives IPP an enhanced, step-by-step approach for reviewing 

these foundational elements of an establishment’s HACCP system. Use the HAV 

methodology along with the inspection verification thought process: gather information 

from the establishment, assess the significance of the information, and determine 

compliance. IPP gather information about the food safety system by considering the 

answers to questions based on the establishment’s HACCP process categories or 

product types. IPP assess that information as it compares to the regulatory 

requirements and as it affects food safety as a whole, and then they determine 

compliance. The questions that IPP consider are in FSIS Directive 5000.6 and in this 

handout. 

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Expectations of IPP Conducting the HAV Task 

The safety of meat and poultry products depends on establishments developing and 

implementing effective food safety systems. IPP are in the best position to identify 

concerns about the effectiveness of an establishment’s HACCP system because they

are familiar with the daily operations and actual conditions in the establishment. By 

identifying concerns about the hazard analysis, supporting documentation, or 

prerequisite programs, IPP are acting to protect the public health by preventing products 

that present a risk from entering commerce. 

Many establishments have developed unique and complicated HACCP systems. It is 

understandable and even expected that IPP involved in performing the HAV task will not 

always have the scientific, technical, or regulatory expertise necessary to determine the 

significance of their findings. When IPP have concerns about the establishment’s 

hazard analysis but are unable to determine whether their findings constitute 

noncompliance, they should discuss their concerns with their supervisor. 

IPP in slaughter establishments are to consult with their supervisor if they are uncertain 

about whether the available information supports a particular determination. 

Supervisors should be contacted immediately whenever IPP have reason to believe 

there are systematic problems with the establishment’s food safety system or that 

adulterated product may have been produced and shipped. 

Note that what is expected of IPP differs from what is expected of EIAOs. When 

conducting a comprehensive Food Safety Assessment, EIAOs determine the adequacy 

of an establishment’s hazard analysis and supporting documentation. However, the 

EIAO’s role involves more than the HAV methodology. EIAOs must comprehensively

investigate every detail of an establishment’s food safety system, and not only

determine whether specific findings represent compliance or noncompliance, but 

analyze the various kinds of food safety noncompliance in that establishment to arrive at 

a sound, supportable conclusion about the adequacy of that establishment's overall 

food safety system. IPP will identify obvious cases of noncompliance and other issues 

of concern that may require further consideration or investigation by an EIAO. 

Performing the HAV Task 

Once per quarter, IPP are to review the hazard analyses of one HACCP plan in 

accordance with the instructions below, paying particular attention to any changes that 

may have been made since the previous review of that hazard analysis; 

1. In establishments that have one HACCP plan that addresses a single process 

category, IPP are to conduct the HAV on that HACCP plan each quarter. 

2. In establishments that have one or more HACCP plans IPP are to select one 

HACCP plan to review using the priority rankings in Table 1 below. IPP are to 

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HAV Methodology 

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select a different HACCP plan each quarter until they have ensured that all the 

HACCP plans are verified. 

Table 1: HAV HACCP Category Priority Ranking 

Slaughter 

Raw/Non-Intact 

Raw/Intact 

Fully Cooked/Not Shelf Stable Post-lethality Exposed 

Not Heat Treated/Shelf Stable 

Heat Treated/Not Fully Cooked/Not Shelf Stable 

Secondary Inhibitors 

Heat Treated/Shelf Stable 

Fully Cooked/Not Shelf Stable Not Post-lethality Exposed 

Thermally Processed 

In establishments that have more than one HACCP plans in a processing category, IPP 

are to select one of the HACCP plans in that processing category for that quarter, then 

select a different HACCP plan in that category during the next quarterly routine task. 

For establishments with multiple IPP, the first level supervisor coordinates the work for 

only one HAV task to be performed per quarter, even if there are multiple shifts. The 

HAV task on the task list for the other shift(s) is marked as “not performed” using the 

justification “task assigned to another inspector.” All inspectors should have equal 

opportunity to perform the task. 

In the following situations, IPP are to verify that the establishment meets the regulatory 

requirements using a routine task if the task is still available on the establishment task 

list. If the HAV Task is no longer available because it was recently performed, IPP are 

to schedule a directed HAV task: 

1. Changes that could affect the hazard analysis or require altering the HACCP plan, 

such as an unforeseen hazard or a new or revised policy. 

2. Addition or removal of a critical control point (CCP) or other control measure based 

on the establishment’s determination related to whether a food safety hazard is 

reasonably likely to occur (RLTO). 

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HAV Methodology 

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HAV Task Steps 

When performing the HAV task, IPP use the recordkeeping component to review 

documentation, to verify that the establishment complies with the HACCP regulatory 

requirements. IPP may use the review and observation component when possible. For 

instance, IPP use the recordkeeping component to verify that the establishment has 

developed a flow chart and conducted a hazard analysis that addresses the relevant 

food safety hazards for the process, product, and intended use of the product in 

accordance with 9 CFR 417.2(a). IPP also use the recordkeeping component to verify 

that the establishment has developed a HACCP plan that has at least one CCP for each 

hazard that is reasonably likely to occur in the process and has support for the 

decisions made at that CCP in accordance with 9 CFR 417.2(c)(2) and 417.5(a)(2). 

When the establishment uses a prerequisite program (such as a Sanitation SOP, GMP, 

or purchase specifications) to support that an applicable hazard is not reasonably likely 

to occur, IPP use the recordkeeping component to verify that the establishment has the 

support for that decision in accordance with 9 CFR 417.5(a)(1). IPP use the review and 

observation component to verify the flow diagram represents the actual production 

process and verify that the establishment implements prerequisite programs effectively 

to support the decision that a hazard is not reasonably likely to occur in the process. 

These are just few examples demonstrating the use of both components. IPP are to 

contact their supervisor if the establishment does not make necessary records available 

for review as this may represent noncompliance with 9 CFR 417.5(f). 

IPP use the thought process and methodology summarized in the HAV Task Summary 

Table on the following pages and discussed in subsequent sections of this handout to 

gather and assess information while performing the HAV task. 

Note: If an establishment determines that no food safety hazards are reasonably likely 

to occur in the process, it is not required to develop CCPs or a HACCP plan. IPP will 

not perform HACCP verification tasks in this establishment. However, IPP will perform 

the HAV task on the hazard analysis specific to the product being produced without a 

HACCP plan, to verify that it has support for the decision that no hazards are 

reasonably likely to occur in the process. 

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HAV Task Summary Table 

Refer to Directive 5000.6 for additional information about each step. 

Step Description Verification Questions Regs 

1 Review flow chart and 

compare to production 

process. 

 Does the flow chart represent the actual 

production process? 417.2(a)(2) 

2 Review the hazard 

analysis and consider 

guidance in the FSIS 

Meat and Poultry 

Hazards and Controls 

Guide (HCG). 

 Does the flow chart or hazard analysis identify the 

intended use or consumers of the product? 

 Does the hazard analysis appear to consider the 

relevant food safety hazards for the 

establishment’s process, product, and intended

use? 

 For each hazard, does the establishment consider 

it RLTO or NRLTO? 

417.2(a)(2) 

417.2(a)(1) 

3 For each hazard the 

establishment 

considers RLTO, verify 

that the HACCP plan 

includes one or more 

CCPs to control it. If no 

hazards are reasonably 

likely to occur, skip to 

step 4. 

 Does the establishment have one or more CCPs 

to control the hazard in each product or process 

where it is reasonably likely to occur? 

 Does the establishment have information to 

support the CCPs, CLs, monitoring and verification 

procedures? 

417.2(c)(2) 

417.5(a)(2) 

4 For each hazard the 

establishment 

considers NRLTO, 

determine what 

evidence the 

establishment uses to 

support the decision, 

including prerequisite 

programs and other 

supporting 

programs(e.g. written 

programs, records, and 

employee activities) 

 Does the establishment prevent the hazard by 

implementing a prerequisite or other supporting 

program (SSOP, GMP, SOP, etc.)? – proceed to 

step 5. 

 Does the establishment support the decision 

with other documentation besides a prerequisite 

or other supporting program? –proceed to step 

6. 

 Does the written program appear to be designed 

to prevent the relevant hazard? 

 Do the records and your observations indicate 

the program is consistently being implemented 

as written? 

 Do the records and your observations indicate 

that the program continues to prevent the 

relevant hazard on an ongoing basis? 

417.5(a)(1) 

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HAV Task Summary Table (cont’d)

Refer to Directive 5000.6 for additional information about each step. 

Step Description Verification Questions Regs 

5 Review other 

supporting 

documentation 

 Does the establishment have copies of the 

documents referenced in the hazard analysis? 

 Do the documents appear to apply to the current 

establishment process? 

417.5(a)(1) 

6 Review establishment 

validation documents, 

including scientific 

supporting documents 

and validation data. 

 Does the establishment maintain documents to 

support the scientific or technical basis for the 

CCPs and prerequisite programs used to support 

decisions in the hazard analysis? 

 Does the establishment maintain in-plant 

validation data for the life of the plan? 

417.4(a)(1) 

7 Verify reassessment 

requirements. Check 

most recent signature 

date for each HACCP 

plan. 

 Has the establishment reassessed at least once in 

the most recent calendar year? 

 Has the establishment reassessed, if necessary, 

in response to any changes that could affect the 

hazard analysis? 

 Has the establishment reassessed, if necessary, 

in response to any unforeseen hazard? 

 Has the establishment documented the results of 

the reassessment? 

417.4(a)(3) 

417.3(b) 

417.4(a)(3) 

(ii) 

8 Document your findings 

in PHIS 

 No problems detected – document HAV task 

results in PHIS. 

 Clear case of noncompliance – document HAV 

task results and NR in PHIS and notify your 

supervisor. 

 Concerns about the establishment HACCP 

system – discuss situation with your supervisor for 

assistance in determining how to proceed. 

Document HAV task results in PHIS. 

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' 

r- - - - _ i _ - - - -1 

I I 

I I 

I I 

I I L----------~ 

1--------1 

I I 

I I 

I 

I 

I 

I L..--- ___ .J 

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02/21/2019 

Review establishment flowchart & compare 

to plant operation

Review Hazard 

Analysis (HA) and 

consider Hazards & 

Controls Guide

For each hazard, did the 

Est. decide it is RLTO?**

Repeat for each hazard

Review 

HACCP plan

Review 

support for 

decision that 

hazard is 

NRLTO** Verify that establishment has supporting 

documentation referenced in hazard 

analysis (417.5(a)(1))

Yes No

Start HAV

Hazard Analysis Verification 

Verify requirements 

of 417.2(a)(1) & 

417.2(a)(2) ** RLTO = Reasonably likely to occur

** NRLTO = Not reasonably likely to occur

Verify that HACCP 

plan has one or more CCPs to control 

hazard (417.2(c)(2)) Verify that prerequisite 

programs are written 

and implemented in a 

manner that supports 

the applicable decision (417.5(a)(1))

Verify decision documents for CCPs, 

CLs, and monitoring 

and verification 

procedures and 

frequencies 

(417.5(a)(2))

Document NR and 

other findings in PHIS

Consult with supervisor 

(if uncertain about ongoing noncompliance)

Was there any 

noncompliance? 

Done

No

Yes

Document 

findings in 

PHIS Est. resolves noncompliance (including corrective actions, if required)?

Yes

Close NR

Discuss at next 

weekly meeting No No

Verify validation 

requirement 

(417.4(a)(1))

Consult with 

supervisor (if 

uncertain about 

compliance)

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HAV Methodology 

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Step 1: Reviewing the Establishment’s Flow Chart 

9 CFR 417.2(a)(2): A flow chart describing the steps of each process and 

product flow in the establishment shall be prepared, and the intended use or 

consumers of the finished product shall be identified. 

The flow chart and hazard analysis are essential for the development of an accurate 

and effective HACCP Plan. Each step in the establishment’s process must be properly

identified before the establishment can conduct an adequate hazard analysis. It is 

essential that IPP accurately assess and verify that flow charts accurately represent the 

steps in each process and the flow of product through each process. This requires IPP 

to become familiar with the production steps and product flow within the establishment 

by observing operations. If they have questions about the process steps and product 

flow, they are to ask establishment management for assistance in understanding the 

production process, including how the establishment handles rework or returned 

products. 

FSIS developed the Meat and Poultry Hazards and Controls Guide (HCG) to help both 

FSIS and establishment personnel evaluate all aspects of an establishment’s HACCP

system for producing meat and poultry products. The HCG identifies common process 

steps that may be employed in each HACCP processing category. It lists the common 

biological, chemical and physical food safety hazards that have been traditionally 

associated with particular types of products or process steps, and cites some of the 

controls frequently used by processors to address these hazards. 

This HCG provides IPP with suggested general and process-specific verification 

questions needed to determine whether the establishment considered all the possible 

hazards for each process step and verify that the hazard analysis and the HACCP plan 

appropriately take into account the relevant food safety information. 

It is important to note that differences between the HCG and an establishment's hazard 

analysis are not, in themselves, sufficient to support a determination of noncompliance. 

However, IPP can use the HCG as a helpful reference when evaluating whether an 

establishment has considered the potential hazards associated with a particular 

production process. 

When verifying compliance with 9 CFR 417.2(a)(2), IPP should consider questions such 

as: 

1. Do the steps identified by the establishment reflect the actual production 

process? If not, it does not comply with 9 CFR 417.2(a)(2). 

2. Does the flow chart, or hazard analysis, identify the intended use or consumers 

of each product, and is the identified use consistent with the actual production? If 

not, noncompliance with 9 CFR 417.2(a)(2) exists. 

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IPP are to refer to the HCG as they consider an establishment’s flowchart. The HCG 

lists the process steps that are frequently associated with each HACCP processing 

category. IPP are to review the process steps in the Quick Reference Table for each 

processing category produced in the establishment. The establishment’s process may 

not include all the steps listed in the HCG, but the steps in the table will help IPP identify 

steps in the establishment’s process that are not in the flow chart. 

An establishment may have a single flow chart that shows an entire production process 

or it may have multiple flow charts. In some establishments, the flowchart will be part of 

the HACCP plan, while in others it will be a separate document. All of these approaches 

to presenting the information are acceptable. IPP are not to focus on the format or 

structure of the flow chart. They are to verify that the flow chart contains the required 

information for the entire production process. 

FSIS does not dictate the level of detail in the establishment flowchart. The 

establishment may incorporate several production steps into one step in a flow chart. 

However, the establishment must consider, and document, all the food safety hazards 

associated with all the activities embedded in that flow chart step to meet the 

requirements of 9 CFR 417.2(a). 

Compliance Example 1 

An establishment performs several different activities (cutting, needle tenderizing, 

injecting, and tumbling) when processing raw, non-intact products. The flow chart 

groups these activities in to the single step of “processing,” but the flow chart lists each

activity included in that step. Since the establishment listed the different activities 

associated with the step identified as “processing,” this would not represent

noncompliance with 9 CFR 417.2(a)(2). 

Compliance Example 2 

An establishment has a single flow chart that accurately reflects all steps and product 

flow for both its pork slaughter process and its raw, intact process (hot boning of 

carcasses). The single flow chart accurately represents the steps in both HACCP 

process categories; therefore, this would not represent noncompliance with 9 CFR 

417.2(a)(2). 

Compliance Example 3 

An establishment does not have a statement of intended use on its raw, intact process 

flow chart, but has included it with the written product description with its hazard 

analysis. Since the establishment has accurately identified the intended use or 

consumer, this would not represent noncompliance with 9 CFR 417.2(a)(2). 

Noncompliance with the Flow Chart: 

IPP are to document noncompliance with 9 CFR 417.2(a)(2), whenever findings clearly 

indicate one or more of the following: 

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HAV Methodology 

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 The establishment’s flow chart does not accurately represent all the steps in the

establishment’s production process.

 The establishment’s flow chart does not accurately describe product flow.

 The establishment’s flow chart (or hazard analysis) does not identify the intended

use or consumers for all finished products. 

Noncompliance Example: 

An IPP is conducting a HAV task in a portion control establishment that produces 

steaks, chops, and roasts for HRI use. While reviewing the flow chart he notes the 

establishment has no returned product step in its flow chart, but recalls observing 

several cases of frozen sirloin steaks being offloaded from food service truck the day 

before. At that time, a shipping supervisor had stated a restaurant was returning these 

steaks. The IPP determines that the establishment’s flow chart is not in compliance with

417.2(a)(2). 

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Step 2: Reviewing the Hazard Analysis 

9 CFR 417.2(a)(1): Every official establishment shall conduct, or have 

conducted for it, a hazard analysis to determine the food safety hazards 

reasonably likely to occur in the production process and identify the preventive 

measures the establishment can apply to control those hazards. The hazard 

analysis shall include food safety hazards that can occur before, during, and 

after entry into the establishment. A food safety hazard that is reasonably likely 

to occur is one for which a prudent establishment would establish controls 

because it historically has occurred or because there is a reasonable possibility 

that it will occur in the particular type of product being produced in the absence 

of those controls. 

IPP are to verify that the hazard analysis reflects all the steps in the flow chart and the 

establishment’s actual production processes. When performing the HAV task, IPP are 

to review the HA for all products produced under that HA, and verify the HA reflects all 

steps in the flow chart and actual processes. The Hazards and Controls Guide can be 

used to help verify relevant hazards were considered. 

There is no required format or specified structure of the hazard analysis. FSIS does 

not dictate the level of detail that must be in a hazard analysis, however IPP are to 

verify that the hazard analysis contains the required information for the entire production 

process. 

When a hazard is considered by the establishment to be reasonably likely to occur 

(RLTO) in the hazard analysis, IPP are to verify that the establishment has included one

or more CCPs to control that hazard. 

When a hazard is considered by the establishment to be not reasonably likely to occur 

(NRLTO), IPP are to verify that the establishment has supporting documentation for that

decision. This supporting information may be a program (prerequisite or other 

supporting program) that the establishment implements or some other documentation

that shows that the hazard is not reasonably likely to occur.

An establishment may determine that certain hazards are not reasonably likely to occur 

because of the intended use of the product. In these cases, IPP are to verify that the

establishment has documentation to support the intended use. This support might 

include labeling records, shipping invoices, letters of intent from receiving

establishments or other records that demonstrate how the establishment ensures that

products will be appropriate for their intended use. 

Questions that IPP are to ask regarding the hazard analysis include, but are not limited 

to, the following: 

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1. Does the hazard analysis reflect all the steps in the flow chart and the actual 

production process? If not, it does not comply with 9 CFR 417.2(a)(1). 

2. Has the establishment determined whether certain hazards are not reasonably likely 

(NRLTO) to occur because of the intended use of the product? 

a. If so, does the establishment have documentation (e.g., labeling records, 

shipping invoices, letter of intent from receiving establishments or other 

records) to support the intended use? 

b. If not, the establishment does not comply with 9 CFR 417.2(a)(2). 

IPP are to consider general questions such as those provided below and those found in 

the HCG when evaluating the hazard analysis: 

1. Has the establishment addressed this process step in the hazard analysis? 

2. Does the establishment have a prerequisite program that addresses this step? 

3. Has the establishment identified any hazards associated with this step? 

4. Is this process step a CCP? 

5. Is the establishment following all procedures identified in the hazard analysis? 

6. Does the establishment maintain records associated with this step? 

7. Do the establishment’s records contain information that indicates that a

reassessment of the hazard analysis or HACCP plan is necessary? 

8. Are the records made available to FSIS? 

For each food safety hazard identified in the hazard analysis, IPP are to ask the 

following questions: 

1. Does the establishment consider the identified food safety hazard to be 

reasonably not likely to occur (NRLTO) in the production process? If so, does 

the establishment maintain support (such as a prerequisite program or other 

supporting documentation) for this decision? If not, noncompliance with 9 CFR 

417.5(a)(1) exists. 

2. Does the establishment consider the identified food safety hazard to be 

reasonably likely to occur (RLTO) in the production process? If so, does the 

establishment include one or more CCPs to control the hazard in the HACCP 

plan associated with that product? If not, noncompliance with 9 CFR 417.5(a)(1) 

exists. 

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Based on the establishment’s hazard analysis, information in the HCG, and their 

knowledge of the actual establishment process, IPP are to assess whether the 

establishment’s hazard analysis complies with 9 CFR 417.2(a). 

Be aware that specific pathogens of concern are associated with the production of 

certain products (e.g., E. coli O157:H7 in a ground beef operation or Listeria 

monocytogenes in ready-to-eat products). If an establishment determines that 

biological hazards are RLTO in that specific process, the establishment may simply 

state “pathogens” in the hazard analysis and HACCP plan. However, the supporting 

documents and decision-making documents associated with the selection and 

development of the CCPs and CLs must be sufficient to demonstrate food safety 

hazards are controlled. The supporting documents must also demonstrate which 

pathogens were considered when the hazard analysis was conducted. The support 

should make evident that the HACCP system is sound and effective in controlling the 

pathogens of concern. If IPP have concerns about the supporting documentation, they 

are to seek input from their immediate supervisor or request the assistance of an EIAO. 

Compliance Example 

The IPP reviews a hazard analysis and determines that all the steps in the flow chart 

that appropriately reflect all steps in the production process are also included in the 

hazard analysis. She uses the HCG and the general and specific questions as an aid to 

verify whether the establishment has identified the logical food safety hazards at each 

step. She reviews the establishment’s decisions for whether a hazard is reasonably 

likely to occur or not and the basis for the decision. For hazards deemed reasonably 

likely to occur, she verifies the establishment has identified critical control point(s). 

A poultry establishment that produces ready-to-eat (RTE) cooked boneless skinless 

chicken fillets determined that a biological hazard (Salmonella) was reasonably likely to 

occur on raw poultry at the receiving step but stated that the receiving step was not a 

CCP because the biological hazard would be controlled at a step later in the process. 

The establishment identified that Salmonella would be controlled at the cooking step, 

and used the FSIS Salmonella Compliance Guidelines for Small and Very Small Meat 

and Poultry Establishments that Produce Ready-to-Eat (RTE) Products and Appendix A 

for the support of this CCP. Based on the HCG and her knowledge of pathogens, this 

appears logical. 

For all other process steps, logical hazards and controls were considered. Based on 

the information gathered, she determined that the hazard analysis meets the 

requirements of 417.2(a)(1). 

Noncompliance with the Hazard Analysis 

IPP are to document noncompliance with 9 CFR 417.2(a), whenever findings clearly 

indicate one or more of the following: 

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 The hazard analysis does not reflect all the steps in the flow chart and the actual 

production processes. It does not comply with 9 CFR 417.2(a)(1). 

 The hazard analysis does not consider the relevant food safety hazards at each 

step in the production process. It does not comply with 9 CFR 417.2(a)(1). 

 The establishment determined that certain hazards are not reasonably likely to 

occur (NRLTO) because of the intended use of the product but does not have 

documentation (e.g., labeling records, shipping invoices, letter of intent from 

receiving establishments or other records) to support the intended use. It does 

not comply with 9 CFR 417.2(a)(2). 

 The establishment failed to consider whether a hazard was reasonably likely to 

occur (RLTO) or not reasonably likely to occur (NRLTO). It does not comply with 

9 CFR 417.2(a)(1). 

 The hazard analysis identifies a hazard reasonably likely to occur (RLTO) but 

doesn’t have an associated CCP.

If IPP are uncertain whether the establishment has considered the appropriate hazards 

at each process step, they are to contact their supervisors for assistance in order to 

determine if noncompliance with 9 CFR 417.2(a) exists. 

Noncompliance Example 

After verifying the flow chart matched the establishment’s actual process flow, the IPP 

determines that the establishment is receiving returned products. However, the 

establishment failed to conduct the hazard analysis for the returned products step. The 

IPP determines that the establishment is not in compliance with 417.2(a)(1). 

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HAV Methodology 

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Step 3: Reviewing Support for the Critical Control Points and Critical 

Limits 

9 CFR 417.5(a)(2): The written HACCP plan, including decision making 

documents associated with the selection and development of CCPs and critical 

limits, and documents supporting both the monitoring and verification 

procedures selected and the frequency of those procedures. 

9 CFR 417.5(a)(2) requires the establishment to maintain the following types of 

supporting documentation for the HACCP plan: 

1. Decision making documents associated with the selection and development of 

CCPs and critical limits; 

2. Documents supporting the selection of monitoring procedures and their 

frequencies; and 

3. Documents supporting the selection of verification procedures and their 

frequencies. 

IPP are to review establishment records to verify that the establishment has evidence to 

support the development of all CCPs, critical limits, and monitoring and verification 

procedures as required by 9 CFR 417.5(a)(2). These supporting documents must be 

applicable to the establishment’s actual process, and support the relevant establishment 

programs or interventions. IPP are to pay particular attention to verifying that the 

establishment has supporting documentation for any CCPs that have been added or 

modified since the last review. 

Some examples of supporting documentation that an establishment might use to 

support decisions made in the HACCP plan include: 

 Scientific journal articles 

 Regulations 

 Pathogen modeling program results 

 Processing authority documents 

 Challenge studies/Research 

 In-plant (historical) data 

 Agency guidance documents 

 Decision-making documents 

When performing the HAV task, CSIs are to verify that the establishment maintains 

these types of supporting documents for each CCP. These documents are also 

examples of supporting documentation the establishment may have on file to meet the 

validation requirements to be discussed in Step 6. 

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HAV Methodology 

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Scientific journal articles - Journal articles can be used to support a critical limit. IPP 

should consider what the critical parameters are in the journal article, and if the 

establishment is meeting all of the critical parameters. If they do not, IPP should look 

for additional support. Consider the date of the article and if the article has been peer 

reviewed. Look for whether the article relates to the process, product type and 

characteristics. 

Regulations - There are specific regulations that outline prescribed regulatory 

procedures with applicable regulatory targets for chilling and storing product, such as 

9 CFR 318.23—time and temperatures for heat processing uncured meat patties. 

Establishments may use regulations to support their critical limits. 

Pathogen Modeling Program (PMP) - These are software programs that use several 

factors to estimate microbial growth, lethality, or survival of microbes in broths or foods. 

A PMP cannot stand alone as the only support for food safety unless the program has 

been validated for the specific type of product produced. Parameters used in the PMP 

should match the product characteristics. 

Processing Authority (PA) - PA recommendations should be relevant to the process 

and product they are supporting. This documentation should reference scientific 

principles or peer-reviewed data in addition to the processing authority’s opinion to

ensure that the decision is science-based. IPP should ask their supervisor or utilize 

askFSIS to help evaluate such recommendations and data. PAs may evaluate heating 

or cooling deviations and make decisions about product disposition and safety. 

Challenge Studies - These studies are typically conducted in a laboratory. A certain 

number of microorganisms are added to the product as part of such a study, and they 

are counted again after control measures have been applied. A challenge study may be 

used to support that a new process can produce a safe product. The challenge study 

should identify the hazard or target organism, indicate the log reduction/increase, 

specify the actual processing conditions, and list product characteristics. 

In-plant data - If a process is not implemented exactly as the scientific paper outlines it, 

then in-plant generated data can be used to supplement the support. For example, if an 

establishment is introducing a new technology, applying standard technology in an 

unusual way, or lacking data generated from a new technology, in-plant data may be 

needed or used as additional support. This data should be considered on a case-bycase basis. 

Agency compliance guidance documents - These are published by FSIS and are 

designed to assist establishments in complying with regulatory requirements. Guidance 

documents are not regulations. The establishment can use them as support and 

assistance in helping them achieve compliance. 

Decision-making documents - These documents record the hazard analysis thought 

process the establishment used, or rationale for decisions made. 

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HAV Methodology 

02/21/2019 

Job Aid for Considering Supporting Documentation 

Important Note: These are just examples and should not be considered a comprehensive listing. 

All Processes 

Systems 

Examples of Supporting Documentation 

Receive Raw 

Materials 

LOG (Letter of Guarantee); COA (Certificate of Analysis); Product 

temperature controls; Microbial Testing + 

Receive Packaging 

Materials and NonMeat Ingredients 

LOG to show free of hazards; Storage to prevent contamination; 

Temperature controls + 

Allergen controls 

Store Raw Materials Temperature controls; Sanitation; Maintain package integrity+; Store raw 

meat at 41 ̊F or below;

Example: FDA Food Code states ‘Red meat, which is a potentially

hazardous food, must be stored at 41 ̊F or below.’ ++ 

Thawing frozen meat Temperature controls during thawing; Specifically surface temperatures + 

Example: In potable, flowing water at 70°F, chicken thawed to an internal ++ temperature of 40°F in 5 hours showed no increase in Salmonella. 

Formulation Allergen Controls (clean up, progressive scheduling, & color-coding); 

Control of nitrate/nitrites; Temperature controls + 

Mixing/Grinding Temperature controls during processing 

Physical contamination: use most sensitive detection technique available +; 

Monitoring equipment should be sensitive enough to detect contamination 

as small as 1/32” (0.8mm); A visible inspection is prudent in addition to

metal detection or x-ray machines; Hard or sharp objects 7-25mm represent 

a potential physical hazard, but objects < 7mm could also be a potential 

physical hazard for certain populations (children). ++ 

Rework Cross-contamination of lots; Records to support distinction between 

lot/specific productions; Microbial testing + 

Returned Product Condition of product; Package Integrity + 

Animal 

Receiving/Feed 

Control 

Feed withdrawal and holding animals (beef/pork) 2 to 6 hours prior to 

slaughter has been shown to reduce the incidence of ruptured viscera and 

cross-contamination. ++ 

Residue controls Slaughter establishments may request LOGs and copies of relevant animal 

treatment records. + 

Best Practices: animals identified for trace back, producers notified in writing 

when there’s a positive/residue violation, require suppliers to participate in

residue avoidance program, conduct live animal testing 

Residue Violators listing: www.fsis.usda.gov/Science/Chemistry/index.asp 

+++ 

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HAV Methodology 

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Job Aid for Considering Supporting Documentation (cont’d)

All Processes 

Systems 

Examples of Supporting Documentation 

Hide removal/ Steam vacuuming beef carcasses at 162°F, followed by a hot water spray of 

evisceration 203°F, at 24 psi, and/or an 11 second spray of 2% lactic acid at 131°F; 

Fecal contamination will be removed by steam vacuuming when 

accompanied by either or both of the hot water or lactic acid treatments. E. 

coli, Enterobacteriaceae, and total and thermotolerant coliforms were 

consistently reduced to less than 1.0 log. ++ 

Carcass Wash/ - Assure that time, temperature, pressure, dwell time, and other parameters 

Antimicrobial are consistent with supporting documents. 

Interventions - Rinse beef carcasses with low pressure (10 psi) followed by high pressure 

(250 psi) 95°F water, then spray the area with a fine mist of 131 ̊F 2% 

acetic acid for 11 seconds; The addition of the 2% acetic acid treatment 

with the water wash, reduced E. coli, and S. typhimurium count 2.4 to 5.1 

log units inside the contaminated area and to < 0.5 log units outside the 

initial contamination area to below detection level more effectively than 

just the water wash, or trimming. ++ 

- Spraying pork carcasses with 2% lactic acid solution reduced S. ++ typhimurium by 2.25 log units. 

+ - Lactic acid spray: concentration, time/temperature dwell time, pressure ; 

Lactic acid (livestock carcasses, offal, and variety meats prior to 

fabrication up to a 5% lactic acid solution; Beef heads and tongues 2.0-

2.8% solution applied to brushes in a washer cabinet system used to 

clean beef heads and tongues. 

- Organic Acids (lactic, acetic, citric acid) As part of a carcass wash applied 

pre-chill up to 2.5% solution FSIS Notice 49-94 

Scalding Pork 

Carcasses 

Scalding in water to 145°F; E. coli, Salmonella and Campylobacter are killed 

at 145°F instantaneous. ++ 

Poultry Scalding Counter-current scalders; multistage tanks; maintain water pH at either 

above or below 6.5-7.5 to preclude the growth of Salmonella 

Poultry Dip/Rinse - Chlorine, chlorine dioxide, acidifed sodium chlorite (500-1200ppm to 

achieve pH of 2.3-2.9; 21 CFR 173.325), TSP, Inspexx 100 (peroxyacetic 

acid), lactic acid 

- Sodium hypochlorite Reprocessing contaminated poultry carcasses 20 

ppm calculated as free available chlorine 

Note: Agency guidance has allowed the use of up to 50 ppm calculated as 

free available chlorine (9 CFR 381.91)++++ 

SRM controls 9 CFR 310.22 - recordkeeping requirements -

www.fsis.usda.gov/PDF/9CFR_310.22.pdf 

E. coli Prerequisites Validated interventions; Certificates of Analysis; Microbial testing of product 

by supplier and processor; 3rd party audits 

References: +Meat and Poultry Hazards and Controls Guide; FSIS 

++Supporting Document Materials for HACCP Decisions, Folk and Knipe, The Ohio State University 

+++FSIS training ++++FSIS Directive 7120.1 

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HAV Methodology 

02/21/2019 

Compliance Example 1 

An establishment has an antimicrobial intervention CCP in the beef slaughter process at 

the carcass wash location that identifies minimum concentration as the critical limit. The 

establishment maintains the following supporting documents to meet the requirement of 

9 CFR 417.5(a)(2): 

 A decision-making document that describes how establishment management 

selected the CCP based on a particular scientific article that addresses the 

establishment’s particular hazard and product. 

 A copy of the referenced scientific article. 

 A document from the test kit manufacturer that describes a method for monitoring 

the concentration of the antimicrobial solution to support the establishment’s 

monitoring procedure. 

 A written decision document to monitor the critical limit once per day because the 

establishment mixes the antimicrobial solution daily. 

 A written decision memo stating that the establishment will verify that it maintains 

the necessary minimum concentration of antimicrobial weekly because historical 

records show consistent control of this CCP. 

Compliance Example 2 

The IPP reviews the hazard analysis and HACCP plan for a beef slaughter operation. 

The IPP finds that at the receiving step the establishment has identified that there is a 

biological food safety hazard, “presence of Salmonella spp. and E. coli O157:H7 

microorganisms on the live animal and in the intestinal tract” that is reasonably likely to

occur. Later steps in the process, evisceration and final wash, are identified as the 

points (CCPs) to reduce the prevalence of these pathogens in the finished product. The 

HACCP plan indicates that a steam-vacuum sanitizer is utilized to remove visible fecal 

contamination after the carcass is eviscerated. The steam vacuum delivers a 

continuous stream of 7 to 10 PSI water at a temperature between 179.6° F and 185° F 

at the inside of the nozzle. The static vacuum for the system is a minimum of 7 inches of 

mercury. The IPP decides to request the supporting documentation for these critical 

parameters. The establishment provides a copy of a scientific article. The article 

addresses the effectiveness of steam-vacuum sanitizing for reducing E. coli O157:H7 

on beef carcass surface tissue that has been inoculated with E. coli O157:H7. The 

same operating parameters for the steam vacuum that the establishment is using in the 

HACCP plan are identified in the materials and methods section of the paper. The 

abstract and results and discussion sections of the article state that the steam-vacuum 

sanitizer reduced aerobic plate counts associated with bovine fecal contamination 2.5 

log10 cfu/cm2 on beef carcass short plates and on the same beef carcass short plates 

inoculated with E. coli O157:H7 in feces there was a 5.5 log10 cfu/cm2 reduction after 

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HAV Methodology 

02/21/2019 

steam-vacuum treatment. The IPP concludes that the article is relevant to the process, 

identifies the hazard, level of pathogen reduction achieved, and supports the 

establishment’s critical limits in the HACCP plan. Based upon the review, the IPP 

determines that the establishment is in compliance with 417.5(a)(2). 

Compliance Example 3 

The IPP reviews the hazard analysis and HACCP plan for a young chicken slaughter 

operation. The IPP finds that at the carcass chilling step the establishment has identified 

that there is a biological food safety hazard, “growth of Salmonella spp and 

Campylobacter can result in higher prevalence of these pathogens in the final product.”

A time and temperature combination is listed at the chilling step in the HACCP plan. 

Carcasses and major portions of carcasses are chilled immediately after processing to 

an internal temperature of 40°F or less within 4 hours. The IPP decides to request the 

supporting documentation for these critical limits. The establishment provides a copy of 

FSIS Compliance Guide - Modernization of Poultry Slaughter Inspection: Chilling 

Requirements. It has the same temperature values listed for chilling poultry carcasses. 

Based upon the review, the IPP determines that the establishment is in compliance with 

9 CFR 417.5(a)(2). 

Compliance Example 4 

An IPP reviews the HACCP plan, hazard analysis, and supporting documentation for 

the steam pasteurization CCP in a beef slaughter operation to verify that it meets the 

requirement in 417.5(a)(2). They find that the supporting documents describe the 

rationale for the location and critical limits of the CCP. The supporting documentation 

includes scientific articles by researchers at various institutions supporting the location 

and the critical limits for the steam pasteurization CCP. The establishment also has 

documents supporting the monitoring and verification procedures and frequencies. 

Based upon the review, the IPP determines that the establishment is in compliance with 

417.5(a)(2). 

After the IPP has gathered and assessed all available information pertaining to the 

supporting documentation requirement, he or she must determine regulatory 

compliance. If he or she finds that the establishment has met all regulatory 

requirements for §417.5(a)(2), then there is no regulatory noncompliance. If he or she 

finds that the establishment has not met all regulatory requirements for §417.5(a) (2), 

there is noncompliance. 

Noncompliance with the HACCP Plan and Its Supporting Documentation 

IPP are to document noncompliance with 9 CFR 417.5(a)(2), whenever findings clearly 

indicate the establishment does not have documentation to support the development of 

CCPs, critical limits, or monitoring and verification procedures. IPP are not tasked with 

determining the adequacy of the supporting documentation, however, if they have 

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HAV Methodology 

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concerns about the documentation, they are to discuss the issue with their supervisor 

prior to making a compliance determination. 

Noncompliance Example 1 

A IPP is reviewing the HACCP plan for a large beef slaughter establishment and finds 

that it has a CCP for E. coli O157:H7 at the steam pasteurization step prior to chilling. 

The verification procedures specify that maintenance will calibrate the temperature 

recording device once a week prior to operations. She asks the establishment for 

documentation supporting this frequency of calibrating the temperature recording 

device, and they produce some technical documents from the manufacturer that states 

the temperature recording device should be calibrated daily. The establishment has no 

documentation supporting the verification procedure and frequency; therefore, it is not in 

compliance with 417.5(a)(2). 

Noncompliance Example 2 

The HACCP plan has a monitoring procedure for checking the finished product chilling 

medium by hand thermometer at the beginning of each shift. The establishment is not 

able to provide any supporting documentation for this procedure or frequency. The 

establishment has no documentation supporting the monitoring procedures and 

frequencies; therefore, it is not in compliance with 417.5(a)(2). 

Noncompliance Example 3 

The hazard analysis has identified that Salmonella is reasonably likely to occur, and a 

CCP was established to control this hazard. The establishment provides as supporting 

documentation for its critical limit some charts from a microbial pathogen computer 

modeling program. Upon examination, the IPP observes that the parameters used in the 

predictive model do not match the ones used by the establishment in its process. The 

establishment has documentation, but the documentation does not support what the 

establishment is trying to support. The IPP discusses the finding with his supervisor and 

they determine the establishment is not in compliance with 417.5(a)(2). 

Inspection Methods 20-23 
 

 

 

 

 

HAV Methodology 

02/21/2019 

Workshop: HAV Task—Supporting Documentation 

Case Study. While performing the HAV Task, an IPP is reviewing the HACCP plan for a 

large beef slaughter establishment. They find that the establishment has a CCP for 

control of E. coli O157:H7 at the hot water carcass rinse prior to chilling. The critical limit 

for the hot water wash is 140o F. The IPP asks the establishment for scientific support 

for this temperature. The establishment provides him with a scientific study paper from 

researchers at a major university that supports the use of hot water washes with a 

minimum of 165o F as a method to effectively reduce the numbers of E. coli O157:H7. 

The IPP then asks the establishment for supporting documents for the 140o F critical 

limit at the CCP. The establishment tells him that the critical limit was put at 140o F 

because that was the maximum output temperature for the establishment boiler. 

Is this a noncompliance? Explain your answer and cite the relevant regulation. 

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HAV Methodology 

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Step 4: Reviewing NRLTO Decisions Including Prerequisite Programs 

9 CFR 417.5(a)(1): The establishment shall maintain the following records 

documenting the establishment’s HACCP plan: (1) The written hazard analysis 

prescribed in §417.2(a) of this part, including all supporting documentation. 

Prerequisite Programs 

As establishments make decisions in their hazard analysis, they must decide if potential 

hazards are or are not reasonably likely to occur. For not reasonably likely to occur 

(NRLTO) hazards, they must have documentation that supports that decision. The 

implementation of a prerequisite program may be used to prevent a hazard from 

occurring, therefore making it the supporting documentation for the NRLTO decision. 

In other words, prerequisite program’s purpose is not to control a food safety hazard 

that was identified in the hazard analysis as being RLTO, but instead, its purpose is to 

prevent the hazard from becoming RLTO. An establishment can determine, through its 

hazard analysis, that a food safety hazard is NRLTO because data collected from the 

implementation of a prerequisite program supports that that program is preventing the 

hazard from occurring. 

When a prerequisite program is used to support decisions in the hazard analysis, it is 

supporting documentation in accordance with 9 CFR 417.5(a)(1), and any records 

associated with the prerequisite program must be available for FSIS review. 

When reviewing records associated with NRLTO decisions, IPP should consider these 

criteria: 

1. Is the program written, and if so, does it describe procedures implemented by the 

establishment to support that a hazard is not reasonably likely to occur? 

2. Does the program describes records that the establishment keeps to show the 

program is implemented as written? 

3. Does the establishment maintain records showing that the implementation of the 

prerequisite continually supports that a hazard is prevented from becoming 

RLTO? 

4. Does the program describe activities the establishment conducts if it fails to 

implement the program, or if it finds that implementation of the program failed to 

prevent a hazard from becoming RLTO? 

If an establishment’s prerequisite program is not designed in the manner defined by 

these criteria, it is likely that the establishment has not met the requirements of 9 CFR 

417.5(a)(1). IPP are to contact their supervisor for assistance if they have concerns 

about whether the prerequisite program is designed to prevent the relevant hazard. 

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NOTE: Establishments are not required to maintain records for prerequisite programs. 

In situations where the prerequisite program does not generate records, IPP are to 

determine compliance by observing whether the establishment implements the 

prerequisite program sufficient to prevent the hazard from being RLTO. 

Verifying NRLTO Decisions and Implementation of Prerequisite Programs 

The regulations in 9 CFR 417 do not include specific requirements (e.g., monitoring, 

recordkeeping, corrective actions) for prerequisite programs. However, without 

maintaining some level of documentation that demonstrates that the prerequisite 

program has been implemented effectively and serves its intended purpose, it may be 

difficult for establishments to support a decision that a food safety hazard is NRLTO or 

to comply with the requirements of 9 CFR 417.5(a)(1). 

Based on the information they gather from the records review and observations, IPP are 

to consider whether the establishment is implementing the prerequisite program or other 

control measures in a manner that supports the relevant hazard analysis decisions. 

In general, the failure to comply with one aspect of the prerequisite program may not 

result in direct product contamination or adulteration; however, the safety of the product 

or the adequacy of the food safety system may need further evaluation by a supervisor 

or EIAO. 

Compliance Example 1 

An establishment implements a prerequisite program to maintain raw product coolers 

below 35°F to prevent the hazard of pathogen growth from being reasonably likely to 

occur. On 3 separate days last week, the employee recording the cooler temperature 

records did not record his initials as specified in the written program. This minor failure 

to follow the program would not represent a failure to support the hazard analysis, as 

long as there is no reason to believe that the 35°F temperature was not maintained. 

Therefore, the establishment is in compliance with 9 CFR 417.5(a)(1). 

Noncompliance 

Repeated failure to implement procedures in a prerequisite program, or evidence that 

the program is not effectively preventing the hazard, is an indication that the 

establishment does not have adequate support for the relevant decisions in its hazard 

analysis. Failure to support hazard analysis decisions is cause for IPP to document 

noncompliance with 9 CFR 417.5(a)(1) and may be grounds for an enforcement action. 

Noncompliance Example 1 

An establishment implements a prerequisite program to support that the hazard of E. 

coli O157:H7 is not reasonably likely to occur in received beef trimmings. The 

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prerequisite program states that a production supervisor will verify receipt of a certificate 

of analysis (COA) for each lot of trimmings before grinding. It also states that the 

establishment will sample and test a lot of its finished ground product for E. coli 

O157:H7 quarterly. While performing the HAV task, the IPP notes that the 

establishment has not received a COA for the lot of trimmings they are presently 

grinding. The IPP asks the establishment for evidence to support product safety for the 

lot in question, and the establishment cannot provide any other evidence to support 

product safety of the lot. This finding calls into question the establishment’s decision

that E. coli O157:H7 is not reasonably likely to occur. Therefore, the finding would 

represent noncompliance with 9 CFR 417.5(a)(1) because the establishment does not 

have the records specified in the prerequisite program to support that the hazard of E. 

coli O157:H7 was not reasonably likely to occur. 

Noncompliance Example 2 

At the product receiving step, an establishment that further processed raw poultry 

determined the potential hazard of contamination with pathogens was not reasonably 

likely to occur based on its Product Receiving SOP. The written SOP specified the 

shipping manager or a designee would visually inspect and check temperatures on 

incoming product. Product was to be returned to suppliers if there was any evidence of 

contamination or temperature abuse. When performing the HAV task, the IPP reviewed 

the prerequisite program records and discovered that establishment employees had 

failed to document results of visual inspection and temperature checks on 10 loads of 

incoming product over the previous 4 weeks. The IPP determined that the 

establishment had failed to maintain adequate supporting documentation for these 

decisions in its hazard analysis because this was not an isolated incident; the 

establishment was regularly failing to implement the procedures specified in its 

prerequisite program. 

If IPP are uncertain whether the implementation and records of a prerequisite program 

support the hazard analysis decisions, they are to discuss the issue with their 

supervisor. 

Inspection Methods 20-27 
 

 

 

HAV Methodology 

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Workshop: HAV Task—

Reviewing NRLTO Decisions Including Prerequisite Programs 

While conducting an HAV task, an IPP noted that in its hazard analysis, a poultry 

slaughter establishment referenced a chlorination system to prevent pathogens 

(Salmonella & Campylobacter) from occurring in its poultry chiller water reuse (a.k.a. 

“red water”). This system depended on control of both the free available (residual) 

chlorine and pH levels through the addition of chlorine and carbon dioxide to the red 

water. The inspector reviewed the prerequisite program, which specified the following: 

Chlorine 

Residual pH Procedure Frequency Actions 

1-5 ppm 5.5 –

6.0 

 Sample red water 

at inflow to chiller 

 Determine chlorine 

and pH levels with 

handheld 

colorimeter 

QA will test 

chlorine and pH 

every hour of 

production 

 Record results on 

Red Water Check 

form 

 Contact 

maintenance if 

chlorine or pH are 

out of range so 

adjustments can be 

made 

1. Is the program written and does it describe procedures that the establishment will 

implement to show the hazard is not reasonably likely to occur? 

2. Does the program describe records that the establishment will keep to 

demonstrate that the program is being implemented as written? 

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3. What will the establishment do if there is a failure to implement the program or 

meet the critical operating parameters? 

4. Who could the IPP talk to about the program and these parameters to ensure 

they are adequate? 

5. What documents might the IPP ask for to determine compliance? 

The IPP noted the establishment had failed to document a chlorine test result on three 

scattered production days over the past month. All other results recorded for those 

production days indicated that the establishment had been maintaining the chlorine and 

pH levels within the specified operating parameters. 

6. Does it appear that the establishment is continuing to support the decision in the 

hazard analysis that the hazards, Salmonella and Campylobacter, are not 

reasonably likely to occur? 

7. Is the establishment in compliance? What regulation has been verified? 

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Step 5: Reviewing Other Supporting Documentation 

9 CFR 417.5(a)(1): The establishment shall maintain the following records 

documenting the establishment’s HACCP plan: (1) The written hazard analysis 

prescribed in §417.2(a) of this part, including all supporting documentation. 

IPP are to verify that the establishment maintains copies of all the documents 

referenced in the hazard analysis that are designated as support for the decisions 

regarding the prevention or elimination of food safety hazards or their reduction to an 

acceptable level. In many cases, this supporting documentation will take the form of 

scientific documents, establishment historical records, or other establishment-generated 

data. IPP are to verify that the establishment maintains the documents referenced in the 

hazard analysis to support the relevant decision regarding a hazard being not 

reasonably likely to occur. 

When verifying compliance with 9 CFR 417.5(a)(1), IPP should consider questions such 

as: 

1. If establishment records or data are being used, does the establishment include 

a decision document that explains why the data or records support its decision? 

2. If a scientific document is being used, is the establishment following the criteria 

addressed in the document? 

3. If multiple records are being used to support a single outcome (e.g., multiple 

slaughter interventions used to support a specific log reduction), does the 

establishment provide a decision document that explains how the documents 

support the outcome? 

Compliance Example 

Recall from a previous example (in Step 4) that an IPP was reviewing an 

establishment’s support for its NRLTO decision at the product packaging material 

receiving step. The support was based in part on letters of guaranty from its packaging 

material suppliers. Next, the IPP requested the letters of guaranty from the QA 

manager. While reviewing the letters of guaranty, the inspector took notes on suppliers, 

types of packaging material, and the shipments of packaging material covered by a 

particular letter of guaranty based on information in the receiving logs. The inspector 

then went to the area where packaging materials were stored and verified that all 

packaging materials could be associated with a particular letter of guaranty. She 

concluded that the establishment was in compliance with 381.144(b), and with respect 

to this particular decision in its hazard analysis, also in compliance with 417.5(a)(1). 

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Noncompliance with Other Supporting Documentation 

IPP are to document noncompliance with 9 CFR 417.5(a)(1) when the establishment 

does not maintain copies of the documents referenced in the hazard analysis. If IPP 

have concerns that the documents referenced in the hazard analysis do not support the 

relevant decisions, they are to discuss the issue with their supervisors. 

Noncompliance Example 

An IPP is performing a HAV task and notes in the hazard analysis that SRMs are 

deemed not reasonably likely to occur at the receiving step of a raw intact process 

because the establishment obtains supplier certificates with each shipment that state 

carcasses and primal parts are derived from cattle that are less than 30 months of age. 

He asks the establishment for the certificates from the previous 2 weeks of production 

so he can review them. Establishment management informs you that their supplier 

neglected to send them. The establishment had received 12 shipments of carcasses 

and primal parts during this period. 

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Step 6: Verify Establishment HACCP System Validation Documents 

9 CFR 417.4(a): Every establishment shall validate the HACCP plan’s adequacy

in controlling the food safety hazards identified during the hazard analysis, and 

shall verify that the plan is being effectively implemented. 

9 CFR 417.4(a)(1): Initial validation. Upon completion of the hazard analysis 

and development of the HACCP plan, the establishment shall conduct activities 

designed to determine that the HACCP plan is functioning as intended. During 

this HACCP plan validation period, the establishment shall repeatedly test the 

adequacy of the CCP, critical limits, monitoring and recordkeeping procedures, 

and corrective actions set forth in the HACCP plan. Validation also 

encompasses reviews of the records themselves, routinely generated by the 

HACCP system, in the context of other validation activities. 

Establishments are required to validate the adequacy of their HACCP systems in 

controlling the food safety hazards identified in its hazard analysis. 

Establishments are required to assemble the two elements of supporting documentation 

to demonstrate a HACCP system is validated: 

1. The scientific or technical support for the HACCP system design (design), and 

2. The in-plant implementation (validation) data (execution). 

When verifying that establishments meet validation requirements, IPP are to review the 

scientific and technical support and the documents associated with the effectiveness of 

the HACCP plan in operation in-plant (i.e., in-plant validation data). IPP are to verify that 

the establishment maintains both types of validation documents. 

Verifying Scientific and Technical Support 

The following are examples of scientific or technical support for a HACCP system: 

 Scientific journal articles 

 Regulations 

 Pathogen modeling program results 

 Processing authority documents 

 Challenge studies/Research 

 In-plant (historical) data 

 Agency guidance documents 

 Decision-making documents 

The scientific and technical support establishes a documented basis for the HACCP 

system. This consists of having scientific and technical documentation demonstrating 

that the designed process can control the identified hazards. The documentation should 

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identify the hazard, the level of hazard prevention or control to be achieved, all critical 

parameters or conditions, the processing steps that will achieve the specified 

prevention, reduction or control, and the way these processing steps will be monitored. 

In other words, these documents support how the HACCP system works in theory. 

The supporting documentation must be complete, available for review and related to the 

process, product and hazard identified in the hazard analysis. Critical operational 

parameters are those parameters of an intervention that must be met in order for the 

intervention to operate effectively and as intended. Examples of critical operational 

parameters include: time, temperature, pressure, water activity, humidity, etc. 

IPP review the establishment’s scientific or technical support and verify the 

establishment maintains references and copies of relevant portions of text from the 

scientific or technical support to address the effectiveness of the CCPs and prerequisite 

programs that support decisions in the hazard analysis. 

Examples which may warrant IPP to have a discussion with their supervisor might 

include: 

1. The scientific or technical support documentation is for a product that is different 

from the product that the establishment produces. In general, the establishment 

should be using scientific or technical support that is related to the product 

produced or provide support for why research with a different product applies to 

the product in question. For example, a documentation that shows a process 

achieves a 5-log reduction of E. coli O157:H7 in apple cider would not be 

sufficient scientific support for the reduction of E. coli O157:H7 in a beef product 

without additional justification. In addition, documentation that shows a process 

achieves a 1-log reduction in Salmonella in poultry would not be sufficient 

scientific support for the reduction of Salmonella in beef without additional 

justification. 

2. The scientific or technical support documentation contains expert opinion from a 

processing authority without any reference to scientific principles or peerreviewed data. The documentation should contain reference to scientific 

principles or peer-reviewed data in addition to the processing authority’s opinion

to ensure that the decision is science-based. 

3. The scientific or technical support documentation specifies the log reduction or 

prevention achieved by the process but does not include information on the 

critical operational parameters, such as pH, pressure, contact time, temperature, 

or relative humidity, critical to achieving that reduction. That information should 

be included in order for the process to be considered validated, and so that the 

establishment can implement the process consistent with the support. 

4. The establishment’s CCPs, prerequisite programs, or other programs do not 

incorporate the critical operational parameters described in the supporting 

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HAV Methodology 

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documentation, and the establishment does not maintain additional data to 

support the adequacy of the measures that incorporate different parameters. 

Establishments should be using the same critical operational parameters as 

those in the scientific or technical support. However, some minor differences may 

be acceptable, and establishments may be able to provide additional data to 

support different parameters. 

Verifying Initial In-Plant Demonstration 

The initial in-plant demonstration takes place during the initial 90 days of operation 

under that HACCP system according to 9 CFR 304.3(b) and 381.22(b). It involves 

collecting data that proves the system can perform as expected in the establishment’s 

process with its own equipment, employees, environment, etc. 

Establishments must collect in-plant data to demonstrate that they are able to routinely 

implement and meet the critical operational parameters and/or CCPs for the controls, 

interventions, or other procedures in their HACCP systems. This data would include 

observations, measurements, or other information that demonstrates the establishment 

can successfully implement these parameters in its process. The establishment is to 

maintain the initial in-plant demonstration records for the life of the HACCP system to 

meet the requirements of 9 CFR 417.5(a)(1) and 9 CFR 417.5(a)(2). 

The initial in-plant validation data includes the in-plant observations, measurements, 

microbiological test results, or other information demonstrating that the control 

measures, as written into a HACCP system, can be implemented within a particular 

establishment, and that when they are, they achieve the intended food safety 

objectives. 

IPP review the records that document initial in-plant validation and verify that the 

establishment maintains its in-plant validation data for the life of the HACCP system. 

Establishments must maintain the original in-plant validation data for the life of the 

HACCP system. In addition, if establishments make changes to the HACCP system and 

determine as part of reassessment, that in-plant validation data should be gathered to 

demonstrate the modified system is being implemented effectively, that new data is to 

be kept for the life of the HACCP system. 

Validation Example 1 

An establishment utilizes an antimicrobial carcass spray intervention. Supporting 

scientific documentation for this intervention provides critical parameters of water 

pressure at the nozzle, water temperature at the carcass surface, whole carcass 

coverage, and a water/carcass contact time. The establishment would be expected to 

have data showing that those parameters are actually being achieved in the process. It 

is crucial that measurements for collecting the data be designed to actually measure the 

correct parameter. For instance, the water temperature measured at a holding tank or at 

the nozzle may not be the actual water temperature at point of contact with a carcass so 

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the measurements for this parameter must be indicative of carcass surface 

temperature. 

Validation Example 2 

A small cattle slaughter establishment has a CCP for antimicrobial carcass treatment 

with lactic acid. The establishment’s supporting document for this CCP and critical limit 

is a journal article. The IPP verifies that the journal article supports the critical 

parameters of the intervention and that the establishment is able to consistently meet 

those parameters. Records reflecting the first 90 days implementation of this CCP are 

available and show that the critical parameters are consistently met. 

Validation Example 3 

An establishment uses the following supporting documentation and conducts the inplant demonstration as validation for their beef carcass, lactic acid spray process: 

Product: Beef Carcass Process: Lactic Acid Spray 

Hazard: E. coli O157:H7, Salmonella Typhimurium 

Scientific Supporting Documentation: 

Antimicrobial Spray Treatments for Red Meat Carcasses Processed in Very Small Meat 

Establishments. Pennsylvania State University. 2005. http://extension.psu.edu/foodsafety/resources-contacts/small-and-very-small-meatprocessors/resources/antimicrobial-spray/intervention-booklet-2005.pdf/view. 

Critical Operational Parameters: 

2% lactic acid applied within 12 inches of carcass surface and entire carcass covered

using a stainless steel spray tank fitted with a pressure gauge and air compressor.

Each side of beef should be sprayed for at least 1 minute and sprayed from top to

bottom and sufficient lactic acid is applied such that some of it drips off. 

Note: The entire carcass is sprayed with lactic acid following washing each side of beef 

from top to bottom for at least 2 minutes with hot water and allowing a 5 minute drip

time after the hot water wash. 

Initial In-Plant Documentation: 

In plant monitoring records for 90 day period recorded on Hot Water and Drip Time

Monitoring Check Sheet (including parameters for the time the carcass is sprayed with

hot water, carcass coverage, method application (from top to bottom and spray nozzle 

within 12 inches of carcass), and drip time.

Records of lactic acid concentration. Trial Reports run under specified lactic acid critical 

parameters demonstrating complete carcass coverage, sufficient amount (lactic acid 

drips off carcass), contact time, method of application (spray nozzle within 12 inches of 

carcass and from top to bottom).

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If, while reviewing the in-plant validation data, IPP have a concern about a technical 

aspect of the documentation, they are to contact their supervisor. The following are 

examples of issues IPP may identify regarding in-plant validation data that could 

warrant a discussion with their supervisor: 

1. The in-plant validation data was collected from HACCP records or other data 

collected or maintained by the establishment as part of its HACCP system, and the 

records do not include all critical operational parameters. IPP are to be aware that 

establishments that did not keep their in-plant validation data from when their 

HACCP systems were first implemented were given time by FSIS (until January 4, 

2016 at large establishments and April 4, 2016 at small and very small 

establishments) to collect in-plant validation data from HACCP records, provided 

the data included all critical operational parameters, or the establishment provided 

additional support that all critical operational parameters are being implemented. 

An establishment may use data from records generated as part of the HACCP 

system in place of their original in-plant validation data provided it has support for 

its monitoring procedures and frequencies per 9 CFR 417.5(a)(2) and there is no 

evidence that the monitoring procedures and frequencies are insufficient to monitor 

the CLs and identify deviations. IPP are also to be aware that although FSIS 

recommends establishments gather in-plant validation data at an increased 

frequency compared to the frequency listed in the HACCP plan or prerequisite 

program, there is no requirement that an establishment do so. 

2. The documentation does not contain in-plant validation data for at least one 

product per HACCP category and the establishment does not have support for why 

less data is sufficient. 9 CFR 417.2(b)(1) contains a list of HACCP processing 

categories. Depending on the HACCP category, products, and the frequency with 

which they are produced, establishments may be able to support collecting in-plant 

validation data for at least one product in some but not all the HACCP categories 

used. 

3. The documentation contains in-plant validation data from fewer than the total 

number of production days the establishment operated within its 90-calendar day 

validation period. For large establishments, 90 calendar days equates to 

approximately 60 production days. For small and very small establishments, 90-

calendar days may equate to a minimum level of records from 13 production days. 

IPP are to be aware that establishments may be able to provide support for why 

gathering records from less days than the total number of production days it 

operated, within a 90calendar day period, is sufficient (e.g., by providing a written 

justification that explains how the records it did gather demonstrate the system is 

validated). 

IPP are to contact their supervisor for assistance if they have any concerns regarding 

the establishment’s scientific or technical support or in-plant validation data not covered 

in this notice. 

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HAV Methodology 

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Noncompliance 

If the establishment does not make documents or data available to IPP to demonstrate 

both parts of validation, there is noncompliance with 9 CFR 417.5(a)(1). 

If the establishment does not maintain documents to support the scientific or technical 

basis for the CCPs and prerequisite programs used to support decisions in the hazard 

analysis there is noncompliance with 9 CFR 417.5(a)(1). When determining 

noncompliance, IPP are to be aware: 

1. The establishment must have scientific or technical support for CCPs and 

prerequisite programs that support decisions in the hazard analysis because 

these programs are considered part of the HACCP system and, therefore, must 

be validated. 

2. Establishments may use more than one scientific or technical support document 

to support the effectiveness of an intervention in its HACCP system. 

If the establishment does not maintain validation data, there is noncompliance with 9 

CFR 417.4(a)(1). When determining noncompliance, IPP are to be aware that FSIS 

does not require establishments to collect in-plant microbiological data provided that the 

establishment has adequate scientific or technical support, is following the parameters 

in the scientific or technical support, and has in-plant validation data demonstrating that 

it can meet the critical parameters during operation. 

If IPP have concerns about the adequacy of the establishment’s validation records, they

are to discuss the issue with their supervisor. 

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HAV Methodology 

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Step 7: Verifying the Reassessment Requirements 

9 CFR 417.4(a)(3)(i) Reassessment of the HACCP plan. Every establishment 

shall reassess the adequacy of the HACCP plan at least annually and whenever 

any changes occur that could affect the hazard analysis or alter the HACCP 

plan. Such changes may include, but are not limited to, changes in: raw 

materials or source of raw materials; product formulation; slaughter or 

processing methods or systems; production volume; personnel; packaging; 

finished product distribution systems; or, the intended use or consumers of the 

finished product. The reassessment shall be performed by an individual trained 

in accordance with Sec. 417.7 of this part. The HACCP plan shall be modified 

immediately whenever a reassessment reveals that the plan no longer meets 

the requirements of Sec. 417.2(c) of this part. 

(ii) Each establishment must make a record of each reassessment required by 

paragraph (a)(3)(i) of this section and must document the reasons for any 

changes to the HACCP plan based on the reassessment, or the reasons for not 

changing the HACCP plan based on the reassessment. For annual 

reassessments, if the establishment determines that no changes are needed to 

its HACCP plan, it is not required to document the basis for this determination. 

9 CFR 417.7(a) Only an individual who has met the requirements of paragraph 

(b) of this section, but who need not be an employee of the establishment shall 

be permitted to perform the following functions: 

(1) Development of the HACCP plan, in accordance with section 417.2(b) of 

this part, which could include adapting a generic model that is appropriate for 

the specific product, and 

(2) Reassessment and modification of the HACCP plan, in accordance with 

section 417.3 of this part. 

(b) The individual performing the functions listed in paragraph (a) of this section 

shall have successfully completed course of instruction in the application of the 

seven HACCP principles to meat and poultry product processing including a 

segment on the development of a HACCP plan for a specific product and on 

record review. 

A reassessment of the HACCP system and/or HACCP plan must be conducted under 

the following conditions: 

1. At least annually 

2. Whenever changes occur that could affect the hazard analysis or require 

modification of the HACCP plan 

3. As part of the corrective actions when an unforeseen hazard has occurred, or 

4. When otherwise directed by the Agency based on the regulations, such as a 

Federal Register notice 

IPP are to review establishment records and ask establishment management about 

reassessments conducted since the previous HAV task. IPP are also to consider 

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HAV Methodology 

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whether there have been any changes within the establishment that could affect the 

hazard analysis (including prerequisite programs) or present the need to modify the 

HACCP plan, including violative sample results for residues or pathogens. IPP are also 

to consider whether any unforeseen hazards have occurred since the last HAV task that 

would have required reassessment. 

In an establishment that has a HACCP plan, reassessment of the food safety system, 

including the hazard analysis and any prerequisite programs is required at least 

annually, and whenever any changes occur that could affect the hazard analysis or alter 

the HACCP plan (9 CFR 417.4(a)(3)). 

The establishment can reassess its HACCP plan, or plans, any time during the calendar 

year to meet the annual reassessment requirement. This requirement does not expect 

the establishment to reassess every 12 months. 

The establishment must reassess the adequacy of the HACCP plan whenever a change 

occurs that could affect the hazard analysis or alter the HACCP plan. The 

establishment is required to 1) document this reassessment and 2) document the 

rationale for the decision to change or not to change the plan. 

The occurrence of unforeseen hazards may also reflect changes that could affect the 

hazard analysis or alter the HACCP plan (9 CFR 417.4(a)(3)), therefore establishments 

must reassess the hazard analysis and any applicable prerequisite programs when an 

unforeseen hazard occurs as part of complying with the corrective action requirement 

specified by 9 CFR 417.3(b)(4). 

The individual who performs a reassessment or makes modifications to the HACCP 

plan must have successfully completed a training course in the application of the 

seven HACCP principles to meat or poultry product processing. However, there is no 

requirement for the establishment to provide documentation of training. IPP are to 

accept oral statements that establishment employees have been trained in accordance 

with 9 CFR 417.7. 

While performing the HAV task, IPP verify compliance with §417.4(a)(3), §417.7, and 

§417.3(b) by: 

 Reviewing reassessment records 

 Reviewing the HACCP plan, 

 Asking establishment management about reassessments conducted since the 

previous HAV task, and 

 Asking establishment management whether the individual performing any 

reassessments or making modifications to the HACCP plan have been trained. 

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HAV Methodology 

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Compliance Example 

On 1-28-2018, an IPP is performing the HAV task in a turkey slaughter operation. She 

reviews the HACCP plan and verifies that the annual reassessment was last performed 

and signed off on 4-1-2017. She learned in her HACCP training that the establishment 

reassessment requirement is based upon the calendar year and not upon a 12-month 

period. The person who signed the plan has been identified as someone who completed 

a HACCP training course meeting the requirements in §417.7. She determines that the 

establishment is in compliance with the annual reassessment and training requirements 

since reassessment was performed in 2017 and the person that reassessed the plan 

was HACCP trained. 

Noncompliance with Reassessment of the HACCP Plan and Establishment 

Training 

One or more of the following findings are evidence of noncompliance: 

1. Changes that could affect the hazard analysis or HACCP plan or unforeseen 

hazards have occurred, but the establishment has not performed a 

reassessment; or if the reassessment was performed but not documented. 

Document noncompliance with 9 CFR 417.4(a)(3)(ii). 

2. The establishment did not perform a reassessment at least once in the previous 

calendar year (i.e. the 12-month period ending on the previous December 31st); 

or if the reassessment was performed but not documented. Document 

noncompliance with 9CFR 417.4(a)(3)(ii). 

3. The reassessment was not performed by an individual trained in accordance with 

the regulations. Document noncompliance with 9 CFR 417.7. 

Noncompliance Example 1 

On 2-2-2016, the IPP is performing the HAV task and is reviewing the HACCP plan to 

verify it meets the annual reassessment and training requirements. The HACCP plan is 

signed and dated 11-11-2014. She questions the HACCP coordinator and determines 

that the last reassessment was in November of 2014. The annual reassessment 

requirement was not met. 

Noncompliance Example 2 

A large beef slaughter establishment received a positive E. coli O157:H7 test result from 

their own sampling. The hazard analysis stated that STEC were not reasonably likely to 

occur, and the establishment made no changes to its hazard analysis or its HACCP 

plan. The establishment failed to perform the reassessment as a result of this change. 

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Reassessment of the Hazard Analysis 

9 CFR 417.4(b)--Reassessment of the hazard analysis. Any establishment that 

does not have a HACCP plan because a hazard analysis has revealed no food 

safety hazards that are reasonably likely to occur shall reassess the adequacy of 

the hazard analysis whenever a change occurs that could reasonably affect 

whether a food safety hazard exists. Such changes may include, but are not 

limited to, changes in: raw materials or source of raw materials, product 

formulation, slaughter or processing methods or systems, production volume, 

personnel, packaging, finished product distribution systems, or the intended use 

or consumers of the finished product. 

Some establishments do not have a HACCP plan because they have determined that 

no hazards were reasonably likely to occur. They must reassess their HACCP system 

whenever any changes occur that could reasonably affect whether a food safety hazard 

is reasonably likely to occur. 

Unlike the requirement for a HACCP plan, there is no annual reassessment requirement 

for the hazard analysis in these establishments. 

Noncompliance with Reassessment of the Hazard Analysis and Establishment 

Training 

If an establishment does not have a HACCP plan because the hazard analysis shows 

that no food safety hazards are reasonably likely to occur, the following is evidence that 

the establishment does not comply with 9 CFR 417.4(b): 

Changes that could affect the hazard analysis have occurred but the establishment has 

not performed a reassessment. 

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HAV Methodology 

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Workshop: HAV Task—Reassessment 

1. On 1-15-2018, an IPP is performing a scheduled HAV task in a turkey slaughter 

operation and elects to include verification of the annual reassessment as part of the 

task. He reviews the HACCP plan and finds that the annual reassessment was last 

performed and signed on 1-1-2017. 

What would be the last date this plan would be in compliance with the regulatory 

requirement for reassessment? 

2. An IPP is performing the HAV task at a raw ground beef patty operation. She 

observes employees adding dry seasoning ingredients at the mixer. She is familiar 

with this establishment, and this is the first time that she has observed any non-meat 

ingredients being used. She goes to the HACCP office and reviews the HACCP 

plan. She finds no documentation that this change to the product formula has 

triggered a reassessment. 

a. What should she do next? 

b. Why would she do that? 

c. Is there a HACCP noncompliance? If so, what regulations should be cited on the 

noncompliance (NR)? 

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Step 8: Documenting HAV Task Results in PHIS 

IPP are to use PHIS to document the results of HAV tasks. PHIS is designed to capture 

information about the regulatory requirements verified and whether there was 

compliance or noncompliance with each regulatory requirement. Therefore, IPP will 

document findings of regulatory compliance and findings of noncompliance when 

conducting the HAV task. When documenting the performance of the HAV, the 

Questionnaire tab will be available in PHIS. IPP are to complete the questionnaire each 

time they perform the HAV. 

Compliance Determination 

If IPP do not identify any issues of noncompliance, and find no evidence of potential 

problems in the food safety system, they are to document the results of the HAV task in 

PHIS, including specifying compliance with each of the regulatory requirements verified. 

If IPP are unable to determine whether their findings represent regulatory compliance, 

they are to discuss the issue with their supervisor before making a determination. 

Noncompliance Determination 

Anytime IPP find noncompliance, they are to document the noncompliance in PHIS in 

accordance with FSIS Directive 5000.1, Verifying an Establishment’s Food Safety

System. IPP are to discuss noncompliance found while performing the HAV task with 

their supervisor, as needed, to determine if additional action may be necessary. 

When documenting noncompliance identified with the HAV task, IPP are to describe 

why the findings led them to a determination of noncompliance. For example, a single 

failure to make a temperature entry on prerequisite program record for received product 

is not, in itself, sufficient to support noncompliance. However, failure to complete the 

temperature log multiple times over the course of a production week, or inspection 

findings that received product exceeded the specified temperature in even one instance, 

may be sufficient to determine that this prerequisite program does not support the 

establishment’s decision that a hazard will be prevented by the prerequisite program. 

Therefore, IPP need to precisely describe the facts of a case in such a way as to show 

how they arrived at a decision of noncompliance. 

If IPP have questions regarding whether or not the establishment is implementing the 

prerequisite program as described, or does not maintain sufficient records to support 

their decision, IPP may wish to discuss their concerns with their supervisor. The 

supervisor may determine that it is necessary to request the assistance of an EIAO, 

who may conclude that the prerequisite program is not capable of supporting the 

decisions made in the hazard analysis. 

If it is determined that the implementation of the prerequisite program no longer 

supports the decisions made in the hazard analysis, IPP are to do the following: 

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1. Document the noncompliance on an Noncompliance Record (NR) citing 9 CFR 

417.5(a)(1) 

2. Verify that the establishment conducts the following activities: 

a. Reassesses its hazard analysis as required in 9 CFR 417.4(b) because the 

decisions made in the hazard analysis may no longer be supported as per 9 

CFR 417.5(a)(1); and 

b. Provides data supporting the decisions made during this reassessment as 

required in 9 CFR 417.5(a)(1) 

If IPP determine that the failure to implement a prerequisite program results in a hazard 

being RLTO or that an unforeseen hazard has occurred, they are to: 

1. Describe those findings in a noncompliance citing 9 CFR 417.5(a)(1); 

2. Verify that the establishment performs and documents corrective actions in 

accordance with 9 CFR 417.3(b), including controlling the affected product; 

3. Retain affected product if the establishment does not have other information to 

demonstrate that the product is not adulterated; and 

4. Seek guidance through supervisory channels regarding what additional actions 

may be necessary. 

Before the HAV task can be completed, IPP must (1) verify that the establishment takes 

necessary actions to return to compliance with the applicable regulatory requirement(s) 

and (2) record in PHIS that the establishment has brought itself back into compliance. 

The HAV inspection task cannot be marked as completed in PHIS until the IPP has 

documented the establishment’s return to compliance.

If IPP are unable to determine whether their findings represent regulatory 

noncompliance, they are to discuss those findings with their supervisor before making a 

determination. In some cases, it may be necessary to request policy and technical 

guidance through askFSIS. IPP may have findings that do not rise to the level of 

noncompliance but warrant discussion with establishment management. These issues 

should be discussed as they arise or in weekly meetings with establishment 

management. IPP are to document these discussions in an MOI in PHIS, and provide 

establishment management with a copy of the MOI. 

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HAV Methodology 

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Supervisory Responsibilities 

If IPP have a question or concern they should seek assistance from their supervisor. 

The supervisor plays a key role in ensuring that decisions made by IPP are consistent 

with FSIS statutory authority and Agency policy, and that IPP duties are performed 

according to the directive. If IPP have obtained additional information from askFSIS or 

other resources, supervisors should be actively engaged with reviewing the information 

and assisting in the process of making compliance determinations. If IPP have 

concerns with prerequisite programs or scientific support for the hazard analysis or the 

in-plant validation data, supervisors need to address these questions and concerns. If 

needed, the supervisor is to ask the DO to assign an EIAO to review the prerequisite 

program or scientific support. Supervisors are to keep track of when HAV tasks are 

scheduled by their IPP to ensure that these tasks are performed in a timely and 

complete manner and ensure IPP understand and apply the Gather, Assess, and 

Determine (GAD) thought process. 

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Workshop: HAV Task 

Refer to the handout and the HAV Task Summary Table to complete the following 

questions. 

1. When should IPP perform the HAV task? 

2. Review the flow diagram, product description, hazard analysis, and HACCP plan on 

the following pages, and answer the following questions: 

a. How did the establishment address biological hazards at receiving? 

(circle the answer on the form and mark “a”)

b. How did the establishment address physical hazards at receiving? 

(circle the answer on the form and mark “b”)

c. How did the establishment address biological hazards at storage? 

(circle the answer on the form and mark “c”)

3. What decisions in the hazard analysis would the IPP request supporting 

documentation for, if any? Please explain your answer? 

4. Are all steps in the flow diagram addressed in the hazard analysis? If not, please 

explain. 

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HAV Methodology 

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5. Are all hazards identified as reasonably likely to occur addressed by a CCP 

somewhere in the process? If not please explain. 

6. How does the establishment monitor temperature at storage? 

7. Is the use of terms like “microbial growth” or “growth of pathogens” sufficient to

identify microbiological hazards? 

8. What decision in the HACCP Plan would the IPP request supporting documentation 

for, if any? 

Inspection Methods 20-47 
 

 

 

,-----------------------------------~ I I 

I 

I 

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Raw ground beef patties 

Process flow diagram 

Product Description: 

Receiving Trimmings & 

Packaging Materials 

Storage 

Grind 

Mix 

Patty formation 

Freezing 

Metal Detection 

Packaging 

Distribution 

Process category: Raw ground 

Product: Frozen ground beef 

patties 

Name: Ground beef patties 6 per 

pound 

Type of package: 10 pounds per 

box, in plastic bag with paper 

liners separating layers 

Length of shelf life: 3-6 months if 

maintained frozen as 

recommended on label; 5 days if 

thawed and held refrigerated 

Intended use: Fast food restaurant 

Labeling instructions: Keep frozen, 

safe food handling label 

Note: No rework used in this 

process 

Example: for training use only 

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HAV Methodology 

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Hazard Analysis: Raw ground beef patties 

Process Food Safety Is Justification What control Is step a 

Step Hazards hazard 

likely 

to 

occur? 

for decision measures can be 

applied to prevent 

the significant 

hazards? 

critical 

control 

point? 

Receiving 

trimmings 

& 

Packing 

materials 

Biological: 

Pathogens 

E. coli 

O157:H7 and 

Salmonella 

Chemical: 

non-food 

grade 

No 

No 

E. coli 

O157:H7 or 

Salmonella 

may be 

present on 

trimmings 

received 

Letters of 

guarantee 

Purchase 

specifications for 

certification from all 

suppliers that 

trimmings are from 

carcasses that 

received validated 

interventions 

effective to eliminate 

or reduce E. coli 

O157:H7 to an 

undetectable level & 

negative 

microbiological test 

results for E. coli 

O157:H7 required 

from suppliers 

No 

Physical: 

foreign 

material 

No Establishment 

records show 

that there has 

been no 

incidence of 

foreign 

material in 

products in 

past several 

years 

No 

Inspection Methods 20-49 
 

 

 

 

,-----------------------------------~ I I 

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HAV Methodology 

02/21/2019 

Hazard Analysis: Raw ground beef patties (Continued) 

Process 

Step 

Storage 

Food Safety 

Hazards 

Biological: 

Growth of 

pathogens 

Is 

hazard 

likely 

to 

occur? 

Yes 

Justification 

for decision 

E. coli 

O157:H7 or 

Salmonella 

may grow if 

not maintained 

at proper 

refrigeration 

temperatures 

What control 

measures can be 

applied to prevent 

the significant 

hazards? 

Maintain product 

temperature at or 

below a level 

sufficient to prevent 

growth 

Is step a 

critical 

control 

point? 

Yes 

Chemical: 

none 

Physical: none 

Grind Biological: 

none 

Chemical: 

none 

Physical: Yes 

metal 

Contamination 

Past history 

indicates that 

metal 

contamination 

has occurred 

during 

grinding 

Proper maintenance 

of equipment, routine 

examination during 

cleaning, metal 

detector later in 

process 

No 

Example: for training use only 

Inspection Methods 20-50 
 

 

 

 

 

HAV Methodology 

02/21/2019 

Hazard Analysis: Raw ground beef patties (Continued) 

Process Food Safety Is Justification What control Is step a 

Step Hazards hazard 

likely 

to 

occur? 

for decision measures can be 

applied to prevent 

the significant 

hazards? 

critical 

control 

point? 

Mix Biological: 

none 

Chemical: 

none 

Physical: none 

Patty 

formation 

Biological: 

none 

Chemical: 

none 

Physical: 

metal 

contamination 

Yes Past history 

indicates that 

metal 

contamination 

has occurred 

during patty 

formation 

Proper maintenance 

of equipment, routine 

examination during 

cleaning, metal 

detector later in 

process 

No 

Freezing Biological: 

none 

Chemical: 

none 

Physical: none 

Metal Biological: Past history Functioning metal Yes 

Detection none 

Chemical: 

none 

Physical: none 

indicates that 

metal 

contamination 

has occurred 

in previous 

process steps 

detection equipment 

to identify and reject 

contaminated product 

Packaging Biological: 

none 

Chemical: 

none 

Physical: none 

Inspection Methods 20-51 
 

 

 

 

 

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HAV Methodology 

02/21/2019 

HACCP Plan: Raw ground beef patties 

CCP Critical 

Limits 

Monitoring 

Procedures 

and 

Frequencies 

HACCP 

Records 

Verification 

Procedures & 

Frequencies 

Corrective 

Actions 

# 1 Product QC personnel Product HACCP Corrective 

Temp temperature will record Temperature Coordinator will actions shall 

control ≤44 ° F temperature of Log verify accuracy of meet all 

at product the Product requirements 

storage exiting grinder 

every hour 

Corrective 

Action Log 

Thermometer 

Calibration 

Log 

Temperature Log 

once per shift and 

observe QC 

personnel 

performing 

monitoring. 

HACCP 

Coordinator will 

verify temperature 

of raw materials 

cooler and freezer 

daily. 

QC check all 

thermometers used 

for monitoring 

devices for 

accuracy by 

immersion in slush 

ice, and will verify 

to within 2 degrees 

F daily. 

All thermometers 

found to be 

inaccurate will be 

calibrated using 

immersion in slush 

ice and reevaluated 

of Part 

417.3 (a) 

Example: for training use only 

Inspection Methods 20-52 
 

 

 

 

 

,-----------------------------------~ I I 

I I 

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HAV Methodology 

02/21/2019 

HACCP Plan: Raw ground beef patties (Continued) 

CCP Critical 

Limits 

Monitoring 

Procedures 

and 

Frequencies 

HACCP 

Records 

Verification 

Procedures & 

Frequencies 

Corrective 

Actions 

# 2 Functional Packaging line Metal QC personnel will Corrective 

Metal Metal supervisor will Detection Log verify that the metal actions shall 

Detector Detector check the 

metal detector 

using a 

seeded 

sample every 

two hours to 

determine 

limits are not 

exceeded 

Corrective 

Action Log 

detector is 

functioning as 

intended by running 

the seeded sample 

(2 mm) through the 

metal detector 

twice per shift. 

Functioning metal 

detector must 

identify and remove 

the seeded sample. 

HACCP 

Coordinator will 

verify accuracy of 

the Metal Detection 

Log and observe 

packaging line 

supervisor 

performing 

monitoring once per 

shift. 

Maintenance 

personnel will 

perform calibration 

procedure once per 

shift. 

meet all 

requirements 

of Part 

417.3 (a) 

Example: for training use only 

Inspection Methods 20-53