HACCP Regulatory Process 

10/11/2017 

HACCP REGULATORY PROCESS 

Objectives 

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

1. Define the term “HACCP system”.

2. Identify the components of a “HACCP plan in operation”. 

3. Describe the four components that are part of the HACCP regulatory process. 

4. Identify the two HACCP inspection tasks that IPP perform to verify the 

HACCP regulatory requirements. 

5. Describe the two verification components used when performing HACCP 

inspection tasks. 

Overview of the Regulatory Process 

An establishment’s food safety system consists of the HACCP plans, a Sanitation 

SOP and other programs, measures, and procedures that it implements to 

prevent, eliminate, or otherwise control identified food safety hazards in the 

products it produces. Inspection Program Personnel (IPP) allow the application 

marks of inspection to products when they are able to find that the products are 

not adulterated. A fundamental step in producing products that are not 

adulterated is to produce the product in accordance with the elements of a valid 

HACCP system. The HACCP system, referenced in 9 CFR 417.4, is defined in 9 

CFR 417.1 as “the HACCP plan in operation, including the HACCP plan itself”. 

The HACCP plan in operation includes the: 

 hazard analysis, 

 HACCP plan, 

 supporting documentation including prerequisite programs used to make 

decisions in the hazard analysis, and 

 HACCP records generated on an ongoing basis. 

IPP must focus on the overall effectiveness of the establishment’s HACCP 

system. Hands-on sensory inspection to determine whether individual product 

units are wholesome is important but is not the best method of assessing the 

ongoing effectiveness of the establishment’s HACCP system. Sensory 

inspection may not identify all products that may be unsafe or unwholesome. By 

verifying that an establishment is implementing an effective HACCP system, 

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FSIS can best ensure that the establishment is producing wholesome, 

unadulterated products. 

The diagram on the next page shows the HACCP Regulatory Process. It 

includes the following four components: 

 Inspection Methodology 

 Performing HACCP inspection tasks 

 Verifying specific HACCP regulatory requirements during the 

performance of the HACCP inspection task 

 Decision-making (GAD) 

 Gathering information, making observations, reviewing documentation, 

assessing the gathered information and arriving at a supportable 

compliance or noncompliance determination. 

 Documentation 

 Entering HACCP inspection task results (observations and 

determinations) in PHIS 

 Documenting noncompliance on a Noncompliance Record 

 Associating noncompliance from the same cause 

 Enforcement 

 Following the Rules of Practice (ROP) 

 Providing the establishment with due process 

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HACCP Regulatory Process 

Inspection Regulatory 

Methodology Decision-making Documentation Enforcement 

5. Inadequate 

System? 

3. 

Noncompliance 

Found? 

6. Complete 

NR 

Yes 

No 

Yes 

7. Complete 

NR 

4. Stop 

8. Follow 

ROP 

No 

2. Perform HACCP 

verification Task 

1. Perform 

HAV 

Task 

9. Notify 

District 

Office 

through 

supervisory 

channels 

10. District 

Office will 

determine 

appropriate 

enforcement 

action based 

on the ROP 

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FSIS Responsibilities 

FSIS responsibilities for verifying an establishment food safety system are 

outlined in FSIS Directive 5000.1 and 5000.6. You are responsible for 

understanding and properly performing the HACCP inspection tasks in the Public 

Health Information System (PHIS) as described in these Directives. The 

information in the Directives follows the regulatory process. These Directives are 

the foundation for this training course. 

IPP verify HACCP regulatory requirements by performing the HACCP inspection 

tasks that appear on the establishment’s task list. The HACCP inspection tasks 

appear on the establishment’s inspection task list as routine tasks according to

the specific HACCP process categories (listed in 9 CFR 417.2(b)) entered in the 

establishment profile in PHIS. IPP may initiate directed HACCP inspection tasks 

when they observe HACCP regulatory noncompliance or are instructed to do so 

by their supervisor. 

Example: If an establishment slaughters, fabricates and grinds meat, there will 

be HACCP verification tasks for the raw HACCP category of Slaughter, Raw 

Intact, and Raw Non-Intact on the task list. Each task in PHIS directs IPP to the 

applicable policy documents and provides instructions to help them understand 

how to verify HACCP requirements for the particular HACCP process or product 

type. 

HACCP Inspection Tasks (Blocks 1 and 2 on the Regulatory 

Process Diagram) 

IPP perform two HACCP inspection tasks to verify that establishments 

are complying with 9 CFR Part 417. The Hazard Analysis 

Verification (HAV) task directs the IPP to review the establishment’s

hazard analysis for one HACCP plan, the HACCP plan, and any Perform HAV or prerequisite programs or other documentation used to support the HACCP decision that a food safety hazard is not reasonably likely to occur in verification task the process. The HACCP verification task focuses the attention of 

the IPP on the execution or implementation of the establishment’s 

HACCP plans, prerequisite programs and other supporting programs, 

i.e., implementation of the establishment’s HACCP system. IPP 

perform a HACCP verification task for each of the HACCP process 

categories listed in the establishment’s profile. Both of the HACCP

verification tasks can be performed as a routine or directed task. Each 

HACCP task has two verification components: 

 A recordkeeping component, and 

 A review and observation component 

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IPP use either component or a combination of the components to verify 

regulatory compliance. For example, an IPP may decide to review monitoring 

records at one CCP and take a measurement, or observe the establishment 

taking a measurement at another CCP to verify that the monitoring requirement 

is met. Similarly, an IPP may observe something while reviewing monitoring 

records for a CCP that prompts him or her to perform a review or observation at 

that CCP. 

How to Perform the Two Components 

Recordkeeping Component 

To perform the recordkeeping (Rk) component, the IPP will gather information 

by looking at establishment records associated with the HACCP system. 

Depending on the HACCP verification task, these records might include the 

hazard analysis, records of any prerequisite or supporting programs, the HACCP 

plans, or HACCP records that document monitoring, verification, corrective 

actions, and reassessment activities. For example, the IPP may review HACCP 

records to determine if the establishment recorded its test results or 

measurements at the required frequency, if all required data was recorded, if the 

data is accurate, if critical limits have been met, and if corrective action was 

taken when necessary. When the IPP performs the recordkeeping component, 

he or she is only reviewing records. Typically, this review would take place where 

the records are maintained and may not be at the physical location of the CCP. 

Regulation 9 CFR 417.5(f) requires the establishment to make all such records 

available for official review. Some establishments, however, control access to 

their food safety records. In such situations, the IPP needs to work with the 

establishment to develop a mechanism to allow him or her access to food safety 

records within a reasonable time of a request. If the establishment does not 

provide access to the records needed to perform the verification tasks, the IPP is 

to document noncompliance with 417.5(f) and bring the matter to the attention of 

his or her immediate supervisor. 

Example 1: The IPP is performing a HACCP verification task and is verifying the 

monitoring regulatory requirement. He decides to perform the recordkeeping 

component and reviews the monitoring records generated for the chilling CCP 

listed in the HACCP plan. He looks at the frequency of the temperature entries 

and the actual recorded temperature values and then compares the recorded 

temperatures to the critical limit for this step. 

Review and Observation Component 

To perform the review and observation (R&O) component, IPP gather 

information by directly observing the establishment employees performing 

procedures or activities as stated in the HACCP plan or prerequisite program 

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(observation), taking measurements to see if the values they obtained match 

those recorded by the establishment (review), or observing the product or 

conditions within the establishment. 

Note: When taking a measurement, IPP are to use the calibrated instrument that 

the establishment uses for the monitoring or verification activities and use the 

procedures as described in the HACCP plan. 

Example 2: The IPP is performing a HACCP verification task and verifying the 

monitoring requirement, which in this case, is a product temperature check. She 

decides to perform both parts of the review and observation component. She 

directly observes the establishment employee carry out the product temperature 

check. Then, she takes a product temperature measurement, and compares the 

result that she obtained to the one just recorded by the establishment employee. 

Regulatory Decision-Making- A Thought Process 

When IPP perform both of the HACCP inspection tasks, they need to use the 

regulatory thought process described below. 

Gather, Assess, and Determine or GAD 

IPP are to gather all available information to help them determine regulatory 

compliance by: 

 Reviewing establishment hazard analyzes, HACCP plans, prerequisite 

programs and other supporting documentation 

 Reviewing establishment records documenting the implementation of 

HACCP plans, prerequisite programs and other supporting programs or 

procedures 

 Observing establishment employees implementing each HACCP plan, 

prerequisite program or other supporting program or procedure, and 

 Observe product and occasionally take measurements as specified in the 

establishment HACCP plans, prerequisite programs, or other supporting 

programs or procedures. 

Note: 9 CFR 417.5(f) requires that all records required under Part 417 be 

available for official review by FSIS inspection personnel. IPP are to contact their 

supervisor if an establishment refuses to make necessary records available for 

review. 

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IPP are to assess the significance and meaning of information gathered by: 

 Comparing the information gathered to HACCP regulatory requirements 

 Considering what each piece of information, either taken separately or 

with other findings, says about how the HACCP system is functioning to 

ensure that products are not adulterated 

 Considering the information in the context of past findings to identify any 

patterns or trends, e.g., Is this an isolated or recurring problem? Are 

conditions getting worse? Is the establishment responding effectively and 

in a timely manner to problems? 

IPP are to determine whether the information supports a finding of regulatory 

compliance by considering the following questions: 

 Has adulterated product been produced or shipped? 

 Is the HACCP system effectively controlling the relevant food safety 

hazards? 

 Has the establishment failed to meet one or more HACCP regulatory 

requirements? 

HACCP noncompliance is the failure to meet any of the HACCP regulatory 

requirements of 9 CFR Part 417. If a HACCP noncompliance occurs, the 

establishment is expected to take immediate and further planned actions. 

Before IPP determine whether or not they should document the failure to meet 

the HACCP regulatory requirements as a noncompliance, they should consider 

the following questions: 

1. Has the establishment already identified the failure to meet regulatory 

requirements or deviation from a critical limit? 

Note: A deviation from a critical limit is the failure to meet the applicable 

value established for the CCP. 

2. If product is involved, has the establishment ensured product safety? 

3. Has the establishment taken immediate and further planned actions to 

correct the failure to meet regulatory requirements, or has it taken 

corrective actions to address the deviation in accordance with 9 CFR 

417.3? 

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4. Is a trend developing (i.e., has the establishment carried out the actions in 

1 through 3 above for similar situations)? 

Note: When answering these questions, it may be necessary for the IPP to 

gather additional information, e.g., records. 

If the answer is “yes” to questions 1, 2, and 3 and “no” to question 4, then 

there is no noncompliance because the establishment has already identified and 

addressed the situation. IPP document compliance with the applicable 

regulations in PHIS, and no other action is necessary. Because the 

establishment’s response provided the further planned actions and preventive 

measures for the noncompliance or deviation, not writing an NR does not 

adversely affect an IPP’s ability to track developing trends. However, an

establishment’s failure to follow through on further planned actions and 

preventive measures could lead to recurring noncompliances and would warrant 

NRs in recurring situations. 

If the answer is “no” to questions 1, or 2, or 3, or “yes” to question 4, then a 

noncompliance exists. IPP document noncompliance in PHIS and generate an 

NR. 

Examples of Determining if HACCP Noncompliance should be Documented 

The following are examples of situations that require IPP to determine if they 

should document HACCP noncompliance. For purposes of consistency, all the 

examples below use the HACCP monitoring regulatory requirement. The 

methodology applies to problems with the HACCP verification, recordkeeping, 

and corrective actions requirements as well. 

Example 1: While performing a Raw Intact HACCP verification task, using 

recordkeeping component, the IPP finds that an establishment employee missed 

a 9:00 a.m. monitoring check. She then finds that the establishment found the 

error during its records verification, demonstrated product safety with other 

records, and took immediate measures for the noncompliance by re-training the 

employee. Also, the IPP looked at previous NR and determined that the 

establishment had not missed a monitoring check in over three months. In this 

situation no NR is necessary even though there was a missed monitoring check. 

However, if the IPP found that adequate preventive measures were not in place, 

and that the missed monitoring check and correction had occurred several times, 

she may determine that a trend for monitoring noncompliance has developed. In 

this case, she would issue an NR, verify the establishment brings itself back into 

regulatory compliance and discuss this trend with establishment management 

during the weekly meeting. 

Example 2: While performing a Raw Non-Intact HACCP verification task using 

the recordkeeping component, the IPP finds that an establishment employee 

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missed a 9:00 a.m. monitoring check and finds no indication that the 

establishment identified the missed monitoring check. He writes a 

noncompliance. He continues to verify and finds that the product was shipped 

without a pre-shipment review. In this situation, on the same NR the IPP would 

write another noncompliance that explains his findings. Next, the IPP would 

determine whether the establishment can provide other documentation that 

establishes product safety. If the establishment cannot demonstrate product 

safety, he would take action in accordance with the Rules of Practice, 9 CFR Part 

500. 

Example 3: While performing a HACCP verification task using the recordkeeping 

component, the IPP observes that an establishment employee recorded a 

deviation from a critical limit on the monitoring record. She verifies that the 

corrective actions taken by the establishment meet the requirements of 417.3(a). 

There is no regulatory noncompliance, and an NR is not necessary. 

Example 4: While performing a Raw Non-Intact HACCP verification task records 

review for a single lot of product, the IPP sees in the records that an 

establishment employee missed a monitoring check at 10:00 a.m. and had a 

deviation from a critical limit at 11:00 a.m. He continues to review the records 

and finds that at pre-shipment review the establishment identified the deviation 

and took the proper 417.3 corrective and preventive measures but failed to 

address the monitoring error. In this situation, the IPP would write a 

noncompliance for the monitoring error and determine whether the establishment 

can demonstrate product safety relevant to the missed monitoring check. If so, 

no other action is necessary. If the establishment cannot support product safety, 

he should take action in accordance with the Rules of Practice, 9 CFR Part 500. 

Note: If IPP are uncertain whether the information supports a particular 

compliance determination, they are to discuss the issue with their supervisor. 

Once a sound determination has been made, IPP are to document their 

determination in accordance with FSIS Directive 5000.1. 

Noncompliance as it Relates to the HACCP System 

While any issue of noncompliance is important and must be properly 

documented, the purpose of the HACCP verification tasks is more than just to 

identify isolated instances of noncompliance. IPP must also consider what their 

findings, whether positive, negative, or inconclusive, suggest about the overall 

effectiveness of the establishment’s HACCP system. When IPP have concerns 

about the ability of the establishment’s HACCP system to produce safe products,

they are to discuss those concerns with their supervisor. 

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It is important that IPP consider each piece of information in the context of 

the HACCP system and the potential for product adulteration. The following 

questions will help IPP to consider the significance of each finding for the 

HACCP system: 

 Is this piece of information part of a pattern? For example, suppose 

the establishment skipped a measurement for a prerequisite program. Is 

this an isolated incident or has the establishment regularly failed to 

implement their prerequisite programs? 

 Is there other information to indicate that the HACCP system is 

working or is not working? For example, an establishment’s prerequisite

program specifies product will be received with supplier certificates of 

analysis (COA) and periodically tested. If the establishment failed to 

receive a COA for a particular product, how did they respond on whether 

or not to use the product? 

 Does the information seem to agree with the other available 

information about the food safety system? For example, the 

establishment uses a prerequisite program to prevent a hazard in 

incoming products, and the records appear to show that a particular 

hazard is being prevented. However, the establishment’s testing of

finished product for the particular hazard finds positive results. 

 Do these results support each other or is there an apparent 

contradiction? For example, an establishment that uses a prerequisite 

program to prevent E. coli O157:H7 in incoming beef has certificates of 

analysis and verification test results on incoming trim that appear to 

indicate that the hazard is not reasonably likely to occur, but the 

establishment gets a positive test result on a finished product lot. The 

finished product test result calls into question the effectiveness of the 

prerequisite program as means of supporting the decision that E. coli 

O157:H7 is not reasonably likely to occur. 

In the upcoming training modules, we will focus on verifying that 

establishment’s food safety system is in compliance with the HACCP 

regulatory requirements in 9 CFR Part 417. We will demonstrate the IPP’s

responsibilities within the HACCP regulatory process. For instance, you 

will learn how the IPP verifies regulatory compliance and makes 

supportable decisions when performing the HAV task and HACCP 

verification task. Several workshops will reinforce the PHIS documentation 

concepts you learned earlier in the course. A more detailed discussion on 

enforcement will occur near the end of the course to reinforce the 

overview of enforcement actions that was provided during the Rules of 

Practice module. 

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HACCP Regulatory Process Workshop 

Refer to the handout and to FSIS Directive 5000.1 to complete the following 

questions. 

1. According to 9 CFR 417.1 the HACCP System is defined as: 

2. The HACCP plan in operation includes the: 

3. List the 4 components of the HACCP regulatory process and give a short 

explanation of each component. 

4. What are the two components that may be used to verify the HACCP 

regulatory requirements when IPP perform HACCP verification tasks? 

5. Explain how to perform the recordkeeping component and the review and 

observation component. 

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