HACCP Verification Task

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HACCP VERIFICATION TASK

Objectives

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

1. Identify the regulatory requirements verified with the HACCP verification task.

2. Explain how Inspection Program Personnel (IPP) is to perform the HACCP 

verification task.

3. Identify issues that represent noncompliance with an establishment’s HACCP 

plan and inadequacy of the HACCP system.

4. Identify the type of issues or concerns that are to be discussed with 

supervision before determining compliance and completing the HACCP 

verification task.

Introduction

According to the instructions delineated in FSIS PHIS Directive 5000.1, Chapter 

III, HACCP, IPP use two types of HACCP tasks – the Hazard Analysis 

Verification (HAV) task and HACCP verification task – for verifying that an 

establishment complies with the requirements of 9 CFR Part 417. As discussed 

earlier course, the HAV task addresses verifying the establishment’s hazard 

analysis, the establishment’s support for decisions made in the hazard analysis 

and HACCP plan including prerequisite programs, and the validation and 

reassessment regulatory requirements. The directive also provides instructions 

for performing the HACCP verification task which requires IPP to verify the 

monitoring, verification, recordkeeping, prerequisite program implementation 

(when applicable), corrective action, and pre-shipment review regulatory 

requirements. 

There are nine HACCP verification tasks. Each task represents a specific 

HACCP processing category.

 Slaughter

 Raw Product – Non-Intact

 Raw Product – Intact 

 Not Heat Treated – Shelf Stable

 Heat Treated – Shelf Stable

 Fully Cooked – Not Shelf Stable

 Heat Treated but Not Fully Cooked – Not Shelf Stable

 Product with Secondary Inhibitors – Not Shelf Stable
 

 

 

 
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As part of the HACCP recordkeeping requirements, IPP are to verify that the 

establishment completes the pre-shipment review before the product enters 

commerce. If IPP cannot complete the HACCP verification task in one day, they 

are to enter partial findings in PHIS but will not consider the task complete until 

all applicable mandatory regulatory requirements have been verified, including 

the pre-shipment review. PHIS will hold that task as incomplete in the inspector’s 

calendar until the inspector documents verification results for all mandatory 

regulatory requirements. 

Routine and Directed HACCP Verification Tasks

IPP are to perform the routine HACCP verification task for the applicable HACCP 

process category at the frequency in which they appear in the establishment’s

task list.

PHIS may also add a directed HACCP verification task to the establishment’s

task list in response to certain events or results (e.g. positive pathogen test 

results or a trend of food safety noncompliances) that suggest the establishment 

is either not implementing or maintaining control of its food safety system. 

IPP are to initiate a directed HACCP verification task as a necessary response

to finding noncompliance or as instructed by their immediate supervisor, FLS, 

DO, or Headquarters personnel. In these cases, the IPP are to add a directed 

instance of the routine HACCP verification task to their task calendar and 

perform the task. 

Performing the HACCP Verification Task

As mentioned earlier, PHIS adds HACCP verification tasks to the establishment’s 

task list based on the HACCP process categories specified in the establishment’s 

profile. IPP then add these tasks to their monthly calendar. To perform the 

HACCP verification task, IPP are to verify all applicable HACCP regulatory

requirements at each process step where a CCP is identified and verify 

implementation of any prerequisite programs that apply to the selected product 

by performing the following steps:

1. Select a product type within the specified HACCP process category and 

a specific production for the selected product type

If the establishment produces multiple types of products within the HACCP 

category, IPP are to ensure that they verify HACCP implementation for all 

product types produced in the establishment over the course of time. IPP are to 

select a product type that the establishment is currently producing. 

IPP are to select a specific production of the selected product type, such as the 

product produced during a specific period, a specific production lot, or other 
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designated product. IPP are to verify that the establishment has met all 

applicable HACCP regulatory requirements at each step and any prerequisite 

programs applicable to that specific production by following the instructions that 

follows throughout this section.

Specific production is a term that is used to refer to whatever method the 

establishment uses to group product, e.g., product produced during a specific 

period of time, a specific production lot, or other designated product. FSIS does 

not determine the method used to define specific production; this is an 

establishment’s responsibility. IPP will see a variety of different of methods used. 

For example, a poultry slaughter establishment might define all the birds from 

one house as a specific production; another might define it by all carcasses 

produced in one hour on one line.

Establishments might define all products from one formulation batch, one shift’s 

production or time period within a shift, product in one oven or smokehouse, or 

the product in one chiller as a specific production. It is important for IPP to 

understand the method used by the establishment to which they are assigned. 

IPP can determine this by asking establishment management. 

2. Review the HACCP plan for the selected product type: 

Before performing a HACCP verification task, IPP are to review the relevant 

HACCP plan to ensure they have full knowledge of its contents. They need to be 

familiar with the written procedures for monitoring and verification and their 

frequencies at each CCP in the HACCP plan. IPP are also to be familiar with any 

prerequisite programs or other control measures that the establishment uses to 

support that an identified food safety hazard is not reasonably likely to occur. 

They may also review the HACCP plan again if questions arise during the 

verification task. 

While reviewing the HACCP plan, IPP are to particularly note the most recent 

date when a responsible establishment representative signed the HACCP plan. 

If the date is recent, IPP are to pay close attention to the contents of the HACCP 

plan because a recent date on the HACCP plan may indicate that the 

establishment has recently revised the monitoring or verification procedures in 

the HACCP plan. 

Note: When IPP identify an addition to or modification of the CCPs in the 

HACCP plan, they are to note the changes and update the PHIS establishment 

profile to accurately reflect the revised content of the HACCP plan. IPP are to 

follow the instructions in FSIS Directive 5300.1 on how to update the HACCP 

information in the PHIS establishment profile. 

9 CFR 417.2(d) requires the establishment is to sign and date the HACCP plan 

upon initial acceptance, after any modifications, and after the annual 
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reassessment required by 9 CFR 417.4(a)(3). One or more of the following 

findings evidence that the establishment does not comply with 9 CFR 417.2(d): 

 Establishment management has not signed and dated the HACCP plan. 

 Establishment management has not signed and dated the HACCP plan at 

least once since January 1 of the previous calendar year. 

 Establishment management has modified the HACCP plan without 

updating the signature and date.

3-5. Verify that the monitoring, verification, and recordkeeping HACCP 

regulatory requirements have been met for all CCPs in the HACCP plan 

for that specific production

IPP verify HACCP implementation by verifying that the establishment has met 

the monitoring, verification, and recordkeeping HACCP regulatory requirements 

at each CCP. The instructions for verifying each of the HACCP regulatory 

requirements are discussed later in this section of training.

6. Verify the implementation of any prerequisite programs or other 

programs that apply to the specific production 

The implementation of the program and the records generated from the program 

must demonstrate that the relevant food safety hazard is not reasonably likely to 

occur on an ongoing basis. Instructions for verifying the implementation of 

prerequisite programs are discussed later in this section of training.

7. Verify that the corrective action HACCP regulatory requirement has been 

met 

When IPP perform the HACCP verification task and find a deviation from a 

critical limit or an unforeseen hazard associated with the specific production, they 

are required to verify that the corrective action regulatory requirements had been 

met. The instructions for verifying the HACCP corrective action regulatory 

requirements are discussed later in this section of training.

8. Verify that the pre-shipment review requirement for that specific 

production has been met

The HACCP verification task cannot be completed until the establishment 

performs the pre-shipment review for that specific production. Because the 

HACCP verification task is performed by verifying the HACCP regulatory 

requirements for a specific production, IPP are also determining whether the 

establishment’s HACCP system prevented the distribution of adulterated product.
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9. Consider any implications of noncompliance and document the HACCP 

verification task in PHIS

When IPP complete the HACCP verification task, they are to document their 

findings of compliance or noncompliance in PHIS. Noncompliance is the failure 

of an establishment to meet one or more HACCP regulatory requirements. In 

addition to documenting any findings of noncompliance, IPP are to consider all 

their findings in the context of the establishment’s food safety system.

HACCP Verification Task Example 1: The Raw Non-Intact HACCP verification 

task is on the IPP’s PHIS task calendar for today. The establishment has one 

HACCP plan in this processing category for ground beef patties. The IPP knows 

from previous experience that this establishment defines specific production as 

each day’s production, and that they generally perform pre-shipment review each 

morning on the previous day’s production. The HACCP plan identifies one CCP 

for chilling the finished patties and the establishment implements a temperature 

control program for processing rooms and coolers/freezers. The establishment is 

producing a lot of patties today. The IPP decides to use the review and 

observation and recordkeeping components to verify the four HACCP regulatory 

requirements at the CCP and the recordkeeping component for verifying the 

implementation of the temperature control program. He proceeds to the 

production floor to begin verifying that all of the HACCP requirements were met 

for the CCP by reviewing the current day’s HACCP records and prerequisite 

program records. After reviewing these records, he will observe the 

establishment employee performing the monitoring activity for today’s production 

lot. Since the establishment had not performed all of the verification activities 

when he reviewed the HACCP records, he knows that he will have to review the 

HACCP records again to verify the establishment meets the HACCP verification 

requirement and verify that the establishment conducted the pre-shipment review 

tomorrow before he can complete the task. 

HACCP Verification Task Example 2: The IPP has a Heat Treated – Shelf 

Stable HACCP verification task scheduled in her PHIS task calendar. The 

establishment has one HACCP plan for salami sticks in this processing category.

She knows from previous experience that this establishment defines specific 

production as each day’s production lot. The establishment performs preshipment review each day on the production lot that passes the final CCP, 

drying. This may take between 4-5 weeks. She proceeds to the HACCP office 

and determines that one production lot passed the drying CCP today and the 

pre-shipment review has been completed. She reads the HACCP plan to be 

familiar with the CCPs. She uses the recordkeeping component in this case 

because production is complete. She performed her verification and concluded

that all of the HACCP requirements were met for all of the CCPs in the HACCP

plan for this specific production, including the pre-shipment review. Then, she 

proceeds to enter her HACCP verification findings in PHIS and marks the task as 

completed.
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Workshop: HACCP Verification Task Methodology

Refer to the handout to complete the following questions.

1. What HACCP regulatory requirements are verified during the performance of 

the HACCP verification task? 

2. An establishment has one HACCP plan with two CCPs (identified as 1-2). 

Describe the steps in performing the HACCP verification task. 
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Verifying Compliance with the HACCP Regulatory Requirements

There are four regulatory requirements that the establishment must comply with 

during the day-to-day or ongoing operation of the HACCP system. The 

regulatory requirements are:

1. Monitoring

2. Verification

3. Recordkeeping 

4. Corrective Actions

Note: When establishments implement prerequisite programs or other 

supporting programs to support the decision that the hazard is not likely to 

occur, the implementation of the program is verified as part of the 

recordkeeping requirement. The pre-shipment review is also a recordkeeping 

requirement. Prerequisite programs or other supporting programs and the

pre-shipment review will be discussed in individual sections of the training 

even though they are part of the recordkeeping requirements.

IPP use HACCP verification tasks to verify that the establishment complies with 

these four regulatory requirements. 

This section covers how to verify regulatory compliance and make supportable 

decisions when performing the HACCP verification tasks. Below is a chart with 

the HACCP requirements, regulatory references, and the components utilized in 

verifying compliance. 
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Requirement Regulatory References Component

Monitoring 417.2(c)(4) Monitoring Requirement Rk 

R&O

Verification 417.2(c)(7) Verification Requirement 

417.4(a)(2)(i)(ii)(iii)Verification Activities

Rk

R&O

Recordkeeping 417.2(c)(6) Recordkeeping System Rk

417.5(a)(3) HACCP Records Rk 

417.5(b) Records Authenticity Rk

R&O

417.5(d) Computerized Records Rk

417.5(e)(1) and (2) Record Retention Rk

417.5(f) Official Review Rk

Prerequisite 

Program

Implementation

417.5(a)(1) Supporting Documentation Rk

R&O

Corrective 

Action

417.3(a) Deviation from a critical limit

417.3(b) Deviation not covered by a specified 

corrective action/unforeseen hazard 

Rk

R&O

Pre-Shipment 

Review

417.5(c) Pre-shipment Review Rk 

R&O (on occasion)
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Regulatory References for Verifying the HACCP Requirements

Monitoring

417.2(c)4 - List the procedures, and the frequency with which those procedures will be 

performed, that will be used to monitor each of the critical control points to ensure compliance 

with the critical limits;

Verification

417.2(c)(7) - List the verification procedures, and the frequency with which those procedures will 

be performed, that the establishment will use in accordance with Sec. 417.4 of this part.

417.4(a)2(i)(ii)(iii) - Ongoing verification activities -Ongoing verification activities include, but are 

not limited to: (i) The calibration of process-monitoring instruments; (ii) Direct observations of 

monitoring activities and corrective actions; and (iii) The review of records generated and 

maintained in accordance with Sec. 417.5(a)(3) of this part.

Recordkeeping

417.2(c)(6) Recordkeeping System - Provide for a recordkeeping system that documents the 

monitoring of the critical control points. The records shall contain the actual values and 

observations obtained during monitoring.

417.5(a)(3) HACCP Records - Records documenting the monitoring of CCP's and their critical 

limits, including the recording of actual times, temperatures, or other quantifiable values, as 

prescribed in the establishment's HACCP plan; the calibration of process-monitoring instruments; 

corrective actions, including all actions taken in response to a deviation; verification procedures 

and results; product code(s), product name or identity, or slaughter production lot. Each of these 

records shall include the date the record was made.

417.5(b) Records Authenticity - Each entry on a record maintained under the HACCP plan shall 

be made at the time the specific event occurs and include the date and time recorded, and shall 

be signed or initialed by the establishment employee making the entry.

417.5(d) Computerized Records - Records maintained on computers. The use of records 

maintained on computers is acceptable, provided that appropriate controls are implemented to 

ensure the integrity of the electronic data and signatures.

417.5(e)(1) and (2) Record Retention and Availability - (1) Establishments shall retain all records 

required by paragraph (a)(3) of this section as follows: for slaughter activities for at least one 

year; for refrigerated product, for at least one year; for frozen, preserved, or shelf-stable products, 

for at least two years. (2) Off-site storage of records required by paragraph (a)(3) of this section is 

permitted after six months, if such records can be retrieved and provided, on-site, within 24 hours 

of an FSIS employee's request.

417.5(f) Official Review - All records required by this part and all plans and procedures required 

by this part shall be available for official review and copying
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Prerequisite Program Implementation

417.5(a)(1) Supporting Documentation -(a) The establishment shall maintain the following 

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

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

Corrective Actions

417.3(a) - The written HACCP plan shall identify the corrective action to be followed in response 

to a deviation from a critical limit. The HACCP plan shall describe the corrective action to be 

taken, and assign responsibility for taking corrective action, to ensure:

(1) The cause of the deviation is identified and eliminated;

(2) The CCP will be under control after the corrective action is taken;

(3) Measures to prevent recurrence are established; and

(4) No product that is injurious to health or otherwise adulterated as a result of the deviation 

enters commerce.

417.3(b) - If a deviation not covered by a specified corrective action occurs, or if another 

unforeseen hazard arises, the establishment shall:

(1) Segregate and hold the affected product, at least until the requirements of paragraphs (b)(2) 

and (b)(3) of this section are met;

(2) Perform a review to determine the acceptability of the affected product for distribution;

(3) Take action, when necessary, with respect to the affected product to ensure that no product 

that is injurious to health or otherwise adulterated, as a result of the deviation, enters commerce;

(4) Perform or obtain reassessment by an individual trained in accordance with Sec. 417.7 of this 

part, to determine whether the newly identified deviation or other unforeseen hazard should be 

incorporated into the HACCP plan.

Pre-shipment Review

417.5(c) Pre-shipment Review - Prior to shipping product, the establishment shall review the 

records associated with the production of that product, documented in accordance with this 

section, to ensure completeness, including the determination that all critical limits were met and,

if appropriate, corrective actions were taken, including the proper disposition of product. Where 

practicable, this review shall be conducted, dated, and signed by an individual who did not 

produce the record(s), preferably by someone trained in accordance with Sec. 417.7 of this part, 

or the responsible establishment official.
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HACCP Verification Task Methodology

This thought process should be utilized when verifying all of the HACCP 

regulatory requirements. The following diagram illustrates the thought process.

Assess information

Determine compliance

Gather information 

1. Select a

product type 

and select a 

specific 

production 

2. Review 

the HACCP 

plan for the 

selected 

product type

For EACH CCP

3. Verify 

Monitoring

4. Verify 

Verification

5. Verify 

Recordkeeping

6. Verify any 

prerequisite 

programs that 

apply to the 

specific 

production

7. Verify 

Corrective 

Actions

8. Verify that the preshipment review has 

been performed

Using a logical thought 

process to arrive at a 

sound, supportable 

conclusion

9. Consider the implications of any 

noncompliance
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Monitoring 

The regulation that applies to monitoring is:

The establishment is required to develop and implement procedures to monitor 

each of the CCPs to ensure compliance with the critical limits (9 CFR 

417.2(c)(4)) 

IPP verify the monitoring requirement when performing the HACCP verification 

tasks. They can use either the recordkeeping or review and observation 

component, or both.

The thought process the IPP should use when verifying regulatory requirements 

includes:

 gathering information by asking questions;

 assessing the information; and 

 determining regulatory compliance.

Gather information by asking questions

When IPP verify HACCP implementation, they are to verify the regulatory 

requirements for monitoring by reviewing the HACCP plan, reviewing HACCP 

records, observing establishment employees performing monitoring activities, 

and taking measurements at CCPs. When verifying the monitoring requirements, 

IPP should seek answers to the following questions:

1. Does the HACCP plan list the monitoring procedures and frequencies 

that are used to monitor each of the critical control points to ensure 

compliance with the critical limits?

2. Are the monitoring procedures being performed as described in the 

HACCP plan?

3. Are the monitoring procedures being performed at the frequencies for 

the CCPs listed in the HACCP plan?

4. Are the critical limits met?

9 CFR 417.2(c)(4)—List the procedures, and the frequency with which 

those procedures will be performed, that will be used to monitor each 

of the critical control points to ensure compliance with the critical limits.
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Assess the information gathered

To answer these questions the IPP should:

 Review the HACCP plan 

 Review the HACCP monitoring records 

 Observe the establishment employees perform monitoring activities 

 Take measurements at critical control points

Now let’s review each of these activities in detail.

Reviewing the HACCP Plan

When reviewing the establishment’s HACCP plan for raw, ready-to-eat/not readyto-eat not shelf stable, or shelf stable processes, IPP will determine whether the 

HACCP plan includes the monitoring procedures and frequencies that are used 

to monitor each critical control point. It is very important for IPP to be familiar with 

the monitoring procedures and frequencies in the current HACCP plan. IPP 

should review the HACCP plan each time the monitoring requirement is verified 

since the establishment can modify the plan without notifying inspection. When 

reviewing the monitoring procedures and frequencies in the HACCP plan, the 

IPP should be able to visualize what is occurring at the CCP. If IPP do not 

understand how the establishment is performing the monitoring activity at the 

CCP, they are to seek clarification of the monitoring procedure from 

establishment management before continuing with the HACCP verification task. 

If the IPP cannot visualize what is occurring at the CCP, it could be an indication 

that the monitoring requirement is not being met. 

Monitoring Example 1: An IPP is performing the Slaughter HACCP verification 

task and verifying the monitoring requirements for the steam pasteurization CCP. 

She reviews the establishment’s HACCP plan and finds that it specifies 

monitoring personnel will observe and record the temperature as measured by 

the steam pasteurization cabinet gauges. The plan states that this monitoring 

procedure is to be performed hourly. Based upon her review of the plan, she 

decides the monitoring procedures and frequencies for this CCP are included in 

the HACCP plan.

Monitoring Example 2: An IPP is performing the Fully Cooked – Not Shelf 

Stable verification task and verifying the monitoring requirement for the metal 

detector CCP for the cubed breaded chicken product at the packing step. He 

reviews the HACCP plan, which specifies that monitoring personnel will observe 

the metal detector is properly functioning by passing the seeded sample through 

the metal detector and observing that the metal detector detects and rejects the 

seeded sample. The plan states that this monitoring procedure is to be 

performed hourly and results recorded. Based upon the IPP review of the plan, 
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he decided the monitoring procedures and frequencies for this CCP are included 

in the HACCP plan. 

Reviewing HACCP Monitoring Records

IPP may decide to use the recordkeeping component to verify the monitoring 

requirement to determine if the establishment is performing the monitoring 

procedures at the frequency specified in the HACCP plan.

Monitoring Example 3: An IPP is performing the Slaughter HACCP verification 

task and verifying the monitoring requirements for the steam pasteurization CCP. 

Reviewing the records, she finds that monitoring personnel have recorded 

temperatures hourly as per the HACCP plan for this CCP. She determines that 

the establishment is monitoring at the frequency stated for this CCP and is in 

compliance. She also verified that the critical limits were met. 

Note: When the establishment has a frequency of hourly listed for the monitoring 

activity, IPP should ask the establishment what hourly means. Hourly may mean 

on the clock hour (8:00 am, 9:00 am, etc) on the average (could be a few 

minutes before or after the clock hour) or once during the clock hour (could be 

almost 2 hour between the monitoring activities). Therefore, monitoring records 

with results a few minutes before or after the clock hour would be acceptable 

when the frequency is hourly on the average stated in the HACCP plan. 

Monitoring Example 4: An IPP is performing the Heat Treated – Shelf Stable 

HACCP verification task at a dry sausage establishment and verifying the 

monitoring requirements for the fermentation CCP, using the recordkeeping 

component. Reviewing yesterday’s records in the HACCP office, she finds that 

monitoring personnel have recorded the pH for 3 pieces of product from each 

smokehouse prior to initiating the cook cycle as per the HACCP plan for this 

CCP. All the recorded pH readings were below the required maximum pH. She 

determines that the establishment’s monitoring frequency for this CCP is in 

compliance and that the critical limit is met. 

Observing Establishment Employees 

IPP should observe an establishment employee performing HACCP monitoring 

activities in the process to determine whether the procedures are being carried 

out as written in the HACCP plan.

Monitoring Example 5: An IPP is performing the Slaughter HACCP verification 

task and verifying the monitoring requirements for the steam pasteurization CCP. 

She observes the establishment monitoring personnel as they visually observe 

the temperature gauge on the steam cabinet and document the temperature on 

the record for the steam pasteurization CCP. From her observation, she 
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determines that the establishment is in compliance with the monitoring procedure 

because it is performed as described in the HACCP plan. 

Monitoring Example 6: While performing the Heat Treated – Shelf Stable 

HACCP verification task at a dry sausage establishment, the IPP decides to 

perform the review and observation component as part of her verification of the 

monitoring requirements for the fermentation CCP. The HACCP plan states that 

the pH of three pieces from each smokehouse will be measured at the 

completion of the fermentation cycle. The IPP observes the establishment 

monitoring personnel as they prepare each sample and use the pH meter to 

determine the pH for the three pieces of product from one smokehouse and 

document the results on the Fermentation records. From her observation, she 

determines that the establishment is in compliance with the monitoring 

requirement because the monitoring activity is performed as described in the 

HACCP plan.

Taking Measurements at Critical Control Points

IPP should occasionally take measurements at certain critical control points in 

the process (i.e., perform a hands-on – review component) to verify that product 

meets the critical limit. When IPP take measurements to verify that product 

meets the critical limit, they are to use the calibrated instrument that the 

establishment uses for the monitoring or verification activities. 

Note: IPP should not take independent measurements using complex equipment

such as pH meters, water activity, etc. In this case, the IPP should observe 

establishment employees taking the measurements and recording the results.

IPP should have access to the procedures/method of operating and calibrating 

these process-monitoring instruments.

Monitoring Example 7: Continuing with the Slaughter HACCP verification task, 

from example 5 above, the IPP proceeds to the temperature gauges on the 

steam pasteurization cabinet and observes the temperature reading. She then 

compares her temperature reading with the temperature reading that was 

recorded by the establishment monitoring personnel. She determines that the 

establishment is in compliance because her temperature reading is within the 

critical limits and compares with the temperature reading that was recorded by 

establishment monitoring personnel.

Monitoring Example 8: An IPP is performing the Fully Cooked-Not Shelf Stable 

HACCP verification task at a hot dog operation, she proceeds to the smokehouse 

and takes 3 temperature readings, with the hand held thermometer provided by 

the establishment, as described in the HACCP plan. She then compares her 

temperature readings with the three temperature readings that were recorded by 

the smokehouse operator. She determines that the establishment is in 

compliance because her temperature readings are within the critical limits and 
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her readings compare with the temperature readings recorded by establishment 

monitoring personnel.

Determine compliance

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

the monitoring requirement, he/she must determine regulatory compliance. 

Based on reviewing the monitoring records or based on observing the 

establishment performing the monitoring procedures, IPP must determine 

whether the monitoring procedures described in the HACCP plan are being 

performed in the manner and at the frequencies specified in the HACCP plan. If 

the IPP finds that the establishment has met all regulatory requirements, then 

there is no regulatory noncompliance. If the IPP finds that the establishment has 

not met all regulatory requirements, there is noncompliance. 

Noncompliance with the Monitoring Requirement

One or more of the following findings evidence that the establishment does not 

comply with 9 CFR 417.2(c)(4): 

 The HACCP plan does not include a written monitoring procedure to 

ensure that product meets the critical limit at each CCP. 

 The establishment employee is not conducting the monitoring procedures 

as written in the HACCP plan.

 The establishment employees do not implement the monitoring 

procedures at the frequencies specified in the HACCP plan.

 The IPP takes a measurement at a CCP and finds that the critical limit is 

not met.

 IPP observe a deviation from the critical limit that was not detected by the 

establishment monitoring procedure. This finding includes any time IPP 

observe the deviation in product that has already passed the CCP, 

product that is at the point of the CCP that would not be selected for 

monitoring by the establishment, or product that was selected for 

monitoring but the deviation was not detected by the establishment. 

The following are examples of noncompliance with the monitoring requirement.

Monitoring Noncompliance Example 1: The HACCP plan specifies that 

monitoring personnel will select three samples from different locations of each 

batch of product, blend/emulsify the sample, and measure the pH. While 

performing verification for the monitoring requirement, the IPP observes that the 
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monitor took one sample. The establishment is not conducting the 

monitoring procedures as specified in the HACCP plan.

Monitoring Noncompliance Example 2: The HACCP plan specifies that the 

concentration of the organic acid beef carcass rinse will be monitored hourly by 

establishment personnel and recorded in the Pathogen Reduction Logbook. The 

IPP reviews the logbook and finds that the monitoring checks were recorded 

every 2 hours. Upon further inquiry, she determines that the monitoring checks 

were actually being performed every 2 hours. The establishment is not 

performing the monitoring procedures at the frequencies specified in the 

HACCP plan.

Monitoring Noncompliance Example 3: The HACCP plan specifies that the 

temperature inside the post lethality steam tunnel will be maintained at a 

minimum of 180oF at the center of the tunnel. The IPP observes the temperature 

gauge on the side of the equipment and finds that it reads 177oF. The critical 

limit for the CCP is not met.

Monitoring Noncompliance Example 4: An IPP is performing the poultry 

Slaughter HACCP verification task and verifying the establishment compliance 

with the monitoring requirements. The IPP proceeds to the establishment’s 

management office and reviews the HACCP plan. The IPP finds that the 

establishment incorporated a chilling procedure into its HACCP plan and 

specifies that trisodium phosphate (TSP) will be used as a prechill antimicrobial 

spray, chlorine will be added to the chiller water and the post chill carcasses 

internal temperature will be measure. The critical limits values for those 3 CCPs 

consecutively are 9% concentration, 20 ppm concentration, and less than 40 F. 

All critical limits will be monitored hourly. The IPP reviews all the 3 CCPs 

monitoring records and finds that the monitoring checks for the chlorine 

concentration were not recorded in the past 3 hours. The IPP determines that the 

establishment is not performing the monitoring procedures at the 

frequencies specified in the HACCP plan.

Note: On August 21, 2014 FSIS published a final rule to modernize poultry 

slaughter inspection that removed the prescriptive time and temperature 

parameters from the chilling regulatory requirements for all establishments

producing ready to cook poultry (RTC) except for ratites. Establishments are 

required to incorporate procedure for chilling poultry into their HACCP system, 

e.g., HACCP plan or Sanitation SOP or other prerequisite program (9 CFR 

381.66 (b)(3)).

If IPP find a monitoring noncompliance, they are to take a regulatory control 

action, if necessary, to prevent adulterated product from entering commerce. In 

addition, IPP are to consider whether the noncompliance may have resulted in 

adulterated product entering commerce. If they find that adulterated product may 

have entered commerce, IPP are to notify DO personnel through supervisory 
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channels immediately (refer to FSIS PHIS Directive 5000.1, Part II, Section X –

Subpart B III.B.3). 

Note: As per 9 CFR part 418 (Recalls), official establishments are required to 

prepare and maintain procedures for the recall of all meat and poultry products 

produced and shipped by the establishment. In addition, the establishments are 

to notify FSIS (i.e., the District Office) within 24 hours if the establishment 

believes or has reason to believe that an adulterated or misbranded product 

received by or originating from the establishment has entered into commerce.

IPP will document the HACCP verification task results in PHIS including any 

noncompliance. 
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Workshop: Monitoring 

Refer to the handout to complete the following questions.

1. An IPP is assigned to a small goat slaughter establishment and is performing 

the Slaughter HACCP Verification task. He is verifying the monitoring 

requirement for the slaughter food safety standard (zero tolerance for fecal, 

ingesta, and milk) CCP. Review the HACCP plan and answer the following 

questions.

Goat Slaughter HACCP Plan

Process 

Step

CCP 

Number

CCP 

Description

Critical 

Limits

Monitoring Procedures

Carcass

Trim zero 

tolerance

1B No visible 

contamination

No visible 

feces, milk, 

or ingesta

Every carcass will be visually 

examined by the carcass

trimmer for visible feces, ingesta, 

or milk

a. If the IPP decides to perform the recordkeeping component in verifying the 

monitoring requirement, what monitoring requirement question would he 

seek the answer to when reviewing the HACCP plan? What would the 

answer to the question be?

b. Review the record below and answer the questions. In reviewing the 

monitoring records for the recordkeeping component, what questions 

would the IPP seek the answer to? 

Slaughter 

Number

Feces, ingesta, milk 

present? (Y or N)*

Performed 

by

Date: 2-8-12

Time

Corrective Actions 

and/or Comments

1 N TDM 0840

2 N TDM 0915

3 N TDM 0955

4 N TDM 1035

5 N TDM 1140

6 N TDM 1229

7 N TDM 1320

8 N TDM 1405

9 N TDM 1455

* N indicates no feces, ingesta or milk present. Y indicates feces, ingesta or 

milk was observed. If so, described in comments.
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c. Where would he perform the recordkeeping component? 

d. If he decides to perform the review and observation component, how 

would he proceed?

2. Case Study - The following is the monitoring procedure for the preevisceration wash as written in a pork slaughter HACCP plan:

QC evaluates 10% of carcasses for visible contaminants. QC 

monitors washing and antimicrobial equipment to ensure proper 

adjustment. Concentration of antimicrobial is tested.

Does this monitoring procedure comply with 417.2(c)(4)? Explain your 

answer.

3. At Establishment P42, the Fully Cooked-Not Shelf Stable HACCP verification 

task is scheduled on the PHIS task calendar. The IPP verifies the monitoring 

requirement while performing the review and observation component of the 

Fully Cooked-Not Shelf Stable HACCP verification task. The IPP reviews the 

HACCP plan and sees that the monitoring procedure for CCP-3 is to check 

the cooked internal temperature of turkey bologna. The plan states that the 

smokehouse operator will check the internal temperature using a hand-held 

digital thermometer of 1 piece of product from 3 locations on each rack of 

product (top, middle, and bottom) in every smokehouse of product. The 

critical limit is 160°F or higher. The smokehouse operator will document all 3 

readings on the Smokehouse Record. 

a) The IPP goes to the smokehouse area and discovers that the 

smokehouse operator is ready to conduct a monitoring check on the 

product the IPP planned to check. What does the IPP expect to see? 
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b) The IPP decides to take an internal product temperature. What does the 

IPP do?

c) The IPP looks at the smokehouse record. What is the IPP looking for?

4. An IPP is performing the Heat Treated Shelf Stable HACCP verification task 

and has decided to verify the monitoring requirement. He reviews the 

HACCP plan.

HACCP plan: Beef Sticks, Heat Treated, Shelf-stable

CCP # Critical 

Limits

Monitoring Procedures & 

Frequencies

HACCP Records

2. Lethality ≥158°F Select 3 beef sticks at the specified 

cold spot, measure the internal 

temperature with a thermocouple 

thermometer and record the lowest 

temperature.

Lethality log

Corrective action 

log

Calibration log

What do you determine regarding compliance?
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Verification

Verification activities are tools that the establishment uses to ascertain that the 

HACCP plan is being followed correctly.

The regulations that apply to verification procedures and frequencies are:

The establishment is required to develop and implement procedures to verify the 

ongoing effective implementation of the HACCP plan (9 CFR 417.2(c)(7) and 

417.4(a)(2)). The verification procedures provide for the calibration of process 

monitoring instruments, direct observation of monitoring activities and corrective 

actions, and review of HACCP records unless one or more activity is not 

applicable in a particular establishment. The verification procedures may also 

include other activities the establishment develops to verify the effective 

implementation of the HACCP plan (e.g. microbial sampling of products). 

The verification procedures may be particular to each CCP or may apply more 

broadly across all CCPs. For example, an establishment may use thermometers 

to monitor several different CCPs. It would not be necessary to have a specific 

thermometer calibration procedure for each CCP. The establishment could have 

a single thermometer calibration procedure that covers the HACCP plan as a 

whole. 

IPP verify the verification requirement by performing the HACCP verification 

tasks. They can use either the recordkeeping, or review and observation 

component, or both.

The thought process the IPP should use when verifying regulatory requirements 

should include:

 gathering information by asking questions;

 assessing the information; and

 determining regulatory compliance.

9 CFR 417.2(c)(7)—List the verification procedures, and the frequency with 

which those procedures will be performed, that the establishment will use in 

accordance with §417.4 of this part.

9 CFR 417.4(a)(2)(i)(ii)(iii)—Ongoing verification activities include, but are not 

limited to: (i) the calibration of process-monitoring instruments; (ii) direct 

observations of monitoring activities and corrective actions; and (iii) the review 

of records generated and maintained in accordance with §417.5(a)(3) of this 

part.
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Gather information by asking questions

IPP verify the regulatory requirements for verification by reviewing the HACCP 

plan, reviewing HACCP records, and observing establishment employees 

performing verification activities. When verifying the verification requirement, the 

IPP should seek answers to the following questions.

1. Does the HACCP plan contain verification procedures and frequencies 

for the calibration of the process-monitoring instruments?

2. Does the HACCP plan contain verification procedures and frequencies 

for direct observations of monitoring activities and corrective actions?

It is important that the establishment implement corrective actions that 

meet the requirements of 9 CFR 417.3(a) each time that a deviation from 

a critical limit occurs, and the requirements of 9 CFR 417.3(b) each time 

an unforeseen hazard occurs. Since the establishment cannot predict 

when a deviation from a critical limit or an unforeseen hazard will occur, it 

would be counterproductive to require that it have specific procedures and 

frequencies in its HACCP plan for directly observing corrective actions. It 

is necessary, however, for an establishment to directly observe corrective 

actions frequently enough to verify that these actions are being performed 

in a manner that meets the regulatory requirements. Under the regulations 

(417.4(a)(2)(ii)), the establishment is to document these direct 

observations of corrective actions in the same manner that it documents 

other verifications. 

3. Does the HACCP plan list verification procedures and frequencies for 

the review of records generated and maintained in accordance with 9 

CFR 417.5(a)(3)?

4. Does the HACCP plan list product sampling as a verification activity?

5. Are process-monitoring instrument calibration activities conducted as 

per the HACCP plan?

6. Are verification activities conducted as per the HACCP plan?

7. Are records generated in accordance with 9 CFR 417.5(a)(3) being 

reviewed by the establishment as specified in the HACCP plan?

Assess information

When assessing the information, the IPP should do the following.

 Review the HACCP plan
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 Review HACCP records

 Observe establishment employees performing verification activities

Now let’s review each of these activities in detail.

Reviewing the HACCP Plan

When reviewing the HACCP plan, IPP are to determine whether it includes 

verification procedures such as direct observation procedures and frequencies, 

records review procedures and frequencies, and process monitoring instrument 

calibration procedures and frequencies. All three verification activities do not 

have to occur at each CCP, but all three should be addressed in the HACCP 

plan. However, if the verification activity is applicable at a CCP and it is not 

being addressed in the HACCP plan the establishment must have support in 

accordance with 417.5(a)(2) for not performing the verification activity. The IPP 

should review the HACCP plan each time the verification requirement is verified 

since the establishment can modify the plan without notifying inspection 

personnel. 

Verification Example 1: An IPP is performing the Slaughter HACCP verification 

task in a poultry slaughter operation and verifying the establishment verification 

requirements for the chilling CCP. He reviews the establishment’s HACCP plan

and finds that it specifies verification personnel will review the temperature 

records and observe the monitoring procedures at this CCP once per shift. It also 

specifies that maintenance personnel will verify the accuracy of the temperature 

recording charts once per shift by taking an independent temperature check. 

Based upon his review of the HACCP plan, he determines that the establishment 

is in compliance with 417.2(c)(7) and 417.4(a)(2)(i)(ii)(iii). 

Verification Example 2: An IPP is performing the Heat Treated – Shelf Stable 

HACCP verification task in a beef jerky operation. She reviews the

establishment’s HACCP plan and finds that it specifies quality control personnel 

will review the water activity records and observe the monitoring procedures at 

this CCP once per shift. It also specifies that quality control personnel will verify 

the accuracy of the water activity measuring equipment once per shift by 

performing a calibration check procedure. Based upon her review of the HACCP 

plan, she determines that the establishment is in compliance with 417.2(c)(7) and 

417.4(a)(2)(i)(ii)(iii). 

It is important to point out here that some HACCP plans might not contain all 

three verification activities that are found in 417.4(a)(2)(i)(ii)(iii). If an 

establishment has a CCP that is monitored without the use of process monitoring 

equipment, there would be no need for process monitoring equipment calibration 

verification procedures. If the monitoring procedure involves automatic 

monitoring devices and does not require any human action to accomplish the 
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monitoring of the critical limit, then direct observation of the automatic portion of 

the monitoring procedure is not required. 

If an establishment only has one employee, it would not be possible for that 

person to conduct a direct observation of the monitoring activity. In this situation, 

the HACCP plan would not need to list a direct observation of the monitoring 

activities. 

Verification Example 3: An IPP is performing the Slaughter HACCP verification 

task in a very small sheep and goat slaughter operation and verifying the 

establishment verification requirements for the contamination (feces/ingesta/milk) 

CCP. She reviews the establishment’s HACCP plan and finds that it does not 

provide for direct observation of monitoring procedures. She determines that the 

establishment only has one employee working on the slaughter floor and it would 

be impossible for direct observation of monitoring to take place. There is no 

noncompliance in this instance. 

Reviewing HACCP Verification Records

IPP should review the verification records to determine if the establishment is 

performing the verification procedures at the frequencies specified in the HACCP 

plan for raw processes.

Verification Example 4: An IPP is performing the Raw-Intact HACCP 

verification task in a poultry cut-up operation and verifying the verification 

requirements for the finished product storage CCP. He reviews the 

establishment’s HACCP plan and finds one of the verification procedures 

specifies the HACCP Coordinator will observe maintenance personnel perform 

the monitoring check once per shift. He reviews several recent room temperature 

logs and observe that the HACCP Coordinator has recorded results for the 

verification procedure for each shift. He determines that this requirement is in 

compliance because the verification procedures are being performed at the 

frequency specified in the HACCP plan.

Verification Example 5: An IPP is performing the Heat Treated – Shelf Stable 

HACCP verification task in a dry sausage operation and verifying the 

establishment’s verification activities for the addition of an antimicrobial agent at 

the formulation CCP, using the recordkeeping component. He reviews the 

establishment’s HACCP plan and finds that one of the verification procedures 

specifies the HACCP Coordinator will observe production personnel weighing 

and adding the antimicrobial agent to a batch of sausage once per shift. He 

reviews several recent formulation logs and observe that the HACCP Coordinator 

has recorded results for the verification procedure for each shift. The IPP 

determine that this requirement is in compliance because this verification 

procedure is being performed at the frequency specified in the HACCP plan. He 

realizes that this is just one of the verification activities.
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Observing Establishment Employees 

IPP should observe an establishment employee performing the verification 

activities listed in the plan to determine if the procedures are being carried out as 

written in the HACCP plan. 

Verification Example 6: Continuing with the Raw-Intact HACCP verification task 

at the poultry cut-up establishment, the IPP reviews of the establishment’s 

HACCP plan revealed that the other verification procedure specified is that the 

HACCP Coordinator will check the accuracy of the finished product storage 

temperature monitoring equipment daily, and adjust as necessary. He proceeds 

to the HACCP office, and observe the thermometers being checked for accuracy, 

and results being recorded on the thermometer calibration log. He determines 

that this requirement is in compliance because the verification procedure is being 

carried out as written in the HACCP plan.

Verification Example 7: As part of the Heat Treated –Shelf Stable HACCP 

verification task, the IPP decides to observe the direct observation verification 

procedure. She notices that the HACCP Coordinator is in the packaging area, 

and watches while he observes the packaging personnel performing the 

monitoring check at the post lethality treatment CCP, and records the result. The 

IPP determine that the direct observation verification procedure requirements are 

met.

Note: On-going verification activities should be designed for the establishment 

verifier to directly observe the establishment employee conducting the monitoring 

activity. An establishment verifier conducting the same activity as the monitor 

does not meet the regulatory requirement for the direct observation verification 

activity described in §417.4(a)(2)(ii). However, the establishment can choose to 

perform additional verification activities such as taking additional (hands-on) 

measurements at a CCP.

Product sampling is considered a verification activity if the establishment 

incorporates product sampling into the HACCP plan. It may be used to verify a 

CCP or it may be used as an overall verification of the HACCP system and not 

be associated with any one CCP. For example, some establishments may 

include their E. coli O157:H7 testing programs (beef trimmings or ground beef 

products), or Lm testing programs (RTE products that are post-lethality exposed 

to the environment), or Salmonella testing program (beef jerky products) in the 

HACCP plan. When that is the case, the IPP must verify the testing program is 

in compliance with the verification requirement (417.4(a)(2)). The establishment 

may perform end-product sampling. If the establishment does end-product 

sampling, the verification is not necessarily associated with a single CCP, but it 

could be an overall verification of all the CCPs from the specific HACCP plan. If 

the product sampling is part of the verification of the HACCP plan, the IPP should 

observe the establishment employee collecting samples and following all the 
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procedures identified in the plan as part of the HACCP verification task when 

verifying §417.4(a)(2). If the establishment received positive results, the IPP 

should verify the corrective action requirements of 9 CFR 417.3(a) are met.

Verification Example 8: An IPP is performing the Raw Non-Intact HACCP 

verification task in a raw ground beef operation and verifying the establishment 

verification requirements for the finished ground beef temperature CCP. She 

reviews the establishment’s HACCP plan and finds one of the verification 

procedures specifies the establishment will conduct finished product testing for E. 

coli O157:H7 daily. She observes the HACCP Coordinator take the samples from 

the finished ground beef. She observes the production lot control procedures. 

She reviews several days’ records in the laboratory-testing log and finds negative 

test results were recorded for each day. She determines that the establishment is 

in compliance because the verification procedures are being performed as 

described, and at the frequency stated. 

As mentioned previously, all three of the on-going verification activities must be 

in the HACCP plan, when applicable. All three of the on-going verification 

activities must be performed at each CCP when applicable, unless the 

establishment can provide justification (support) for not performing the ongoing verification activities as required by 417.5(a)(2).

Determine compliance

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

the verification requirement, he/she must determine regulatory compliance. If the 

IPP finds that the establishment has met all regulatory requirements, then there 

is no regulatory noncompliance. If the IPP finds that the establishment has not 

met all regulatory requirements, there is noncompliance. 

Noncompliance with the Verification Requirement

The following are examples of noncompliance with the verification requirement 

(417.4(a)(2):

 The HACCP plan does not include written verification procedures and 

frequencies for calibration of any process monitoring instruments used to 

monitor the CCPs (also noncompliance with 417.2(c)(7)). Calibration 

methods should be in accordance with accepted procedures or 

manufacturer instructions. 

 The HACCP plan does not include written verification procedures and 

frequencies for direct observation of monitoring activities (also 

noncompliance with 417.2(c)(7)). 
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 The HACCP plan does not include written verification procedures and 

frequencies for review of records (also noncompliance with 417.2(c)(7)). 

 Establishment employees do not implement the verification procedures at 

the frequencies specified in the HACCP plan. 

 The HACCP plan does not include written description of additional 

verification procedures (if any) and frequencies the establishment uses to 

verify the effective implementation of the HACCP plan (e.g. 

microbiological sampling) (also noncompliance with 417.2(c)(7)). 

 Establishment employees do not implement the verification procedures as 

written in the HACCP plan.

 The establishment verification employee does not actually observe the 

monitoring employee performing the monitoring procedure during the 

direct observation verification procedure. 

 The verification results indicate that the establishment is not implementing 

the HACCP plan as written, and the establishment has not corrected the 

situation. 

The following are examples of noncompliance with the verification requirement.

Verification Noncompliance Example 1: The HACCP plan, which has one 

CCP at the product storage area, specifies that the verification procedure is that 

the QC supervisor will calibrate thermometers daily and that the QC supervisor 

will review the finished product room temperature logs daily. The IPP observes 

that there is no direct observation verification procedure listed for this HACCP 

plan. She recalls that the regulations require that all three verifications must be 

listed in the HACCP plan when they are applicable. One verification procedure, 

the direct observation, is missing. The HACCP plan does not, at a minimum, 

list records review verification procedures; direct observation verification 

procedures; or calibration of process instruments verification procedures.

Verification Noncompliance Example 2: A beef jerky HACCP plan specifies 

that the verification procedure for the cooking/drying CCP is that QC will check 

the accuracy of the time, temperature and humidity monitoring equipment and 

have them calibrated if necessary. QC will observe the cooking room operator 

performing the monitoring check daily; and that QC will review the cooking logs 

daily. The IPP observes that there is no frequency listed for the calibration check 

of equipment. The HACCP plan does not list the frequencies at which the 

calibration verification procedure will be performed.

Verification Noncompliance Example 3: The HACCP plan specifies that one of 

the verification procedures for the cooking CCP is that the QC supervisor will 
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observe the plant employee performing the monitoring check. The IPP observe 

that the QC supervisor performs a monitoring check and records it on the 

cooking log as a direct observation verification procedure. He observes that the 

QC supervisor did not perform a direct observation of the establishment 

employee performing the monitoring check as described in the HACCP plan. The 

establishment is not performing the direct observation verification 

procedures as specified in the HACCP plan.

Verification Noncompliance Example 4: The HACCP plan specifies that one of 

the verification procedures for the metal detection CCP is that the QC supervisor 

will review the metal detection logs daily. The IPP’s review of the records reveals 

that there is no documentation of this verification procedure for the last three 

days of production. The establishment is not performing the records review 

verification procedures as specified in the HACCP plan. 

Verification Noncompliance Example 5: The HACCP plan specifies that one of 

the verification procedures for the product temperature CCP is that the QC 

supervisor will verify the accuracy and calibrate, if needed all hand held 

thermometers daily. The IPP observes that the QC supervisor verifies the 

accuracy of only about half of the thermometers. When the IPP asks, he is 

provided the explanation that "we have learned that checking every other 

thermometer is sufficient." The establishment is not performing the process 

monitoring verification procedures as specified in the HACCP plan.

Verification Noncompliance Example 6: The HACCP plan specifies that one of 

the verification procedures is that finished product will be sampled and tested for 

Listeria monocytogenes once per day. When the IPP reviews the microbiology 

testing records, he observes that there are only results for two samples a week. 

When he asks about these results, he is told that the financial department 

required QC to cut back on the number of samples sent to outside labs. The 

establishment is not performing one or more of the verification procedures 

listed in the HACCP plan at the frequencies specified in the HACCP plan.

Noncompliance with the verification requirement is documented in PHIS as part 

of the HACCP verification task. If IPP find a verification noncompliance, they are 

to consider whether the noncompliance may have resulted in adulterated product 

entering commerce. For example, if the verification results show that 

establishment employees have not been implementing the monitoring procedure 

correctly, is there sufficient information to determine whether the product met the 

critical limit? If the establishment cannot demonstrate that the product met the 

critical limit, IPP are to take a regulatory control action on any affected product to 

prevent it from entering commerce. If adulterated product may have entered 

commerce, IPP are to contact their supervisor immediately to discuss the issue. 

IPP document the HACCP verification task results in PHIS including any 

noncompliance. 
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Workshop: Verification 

Refer to the handout to complete the following questions.

1. Answer the following questions:

a. What are the 3 verification activities that the HACCP regulations specify?

b. Must all three occur at each CCP in the HACCP plan? Please explain your 

answer.

c. Would an establishment be in compliance if the same establishment 

employee performed all three of the verification activities at one CCP?

2. Describe in your own words the difference between FSIS inspection 

verification and the establishment’s verification procedures. 
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3. An IPP is performing the Raw-Intact HACCP verification task in a poultryboning operation and verifying the establishment verification requirements for 

the chilling CCP. While performing the task, she reviews the establishment's 

HACCP plan:

a. Does the HACCP plan contain procedures and frequencies for the 

calibration of the process-monitoring instruments? 

If yes, what is the procedure? 

If yes, what is the frequency?

HACCP plan: raw boneless skinless chicken breasts

CCP # Critical 

Limits

Monitoring 

Procedures 

& 

Frequencies

HACCP 

Records

Verification Procedures & 

Frequencies

Corrective 

Actions

2

Chilling

Product 

temperature 

not to 

exceed 40 

degrees F 

QC 

personnel 

will record 

temperature 

every 4 

hours

Product 

Temperature 

Log

Corrective 

Action Log

Thermometer 

Calibration 

Log

HACCP Coordinator will 

review the Product 

Temperature Log and 

observe QC personnel 

performing monitoring once 

per shift

Daily, the QC will check the 

accuracy of all 

thermometers used for 

monitoring devices for 

accuracy by immersion in 

slush ice, 

All thermometers found to 

be inaccurate will be 

calibrated using immersion 

in slush ice and reevaluated

HACCP Coordinator will

review the Corrective 

Action Log (if applicable) 

and the Thermometer 

Calibration Log once per 

week.

Corrective 

actions shall 

meet all 

requirements 

of Part 

417.3(a)
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b. Does the HACCP plan contain procedures and frequencies for direct 

observation of monitoring activities and corrective actions?

If yes, what is the procedure? 

If yes, what is the frequency?

c. Does the HACCP plan list procedures and frequencies for the review of 

records generated and maintained in accordance with 9 CFR 417.5(a)(3)?

If yes, what is the procedure? 

If yes, what is the frequency?

d. How would the IPP determine whether process-monitoring calibration 

activities were being conducted as per the HACCP plan?

If the IPP performs the review and observation component:

If the IPP performs the recordkeeping component:

e. How would the IPP determine whether direct observation verification 

activities were being conducted as per the HACCP plan?

If the IPP performs the review and observation component:

If the IPP performs the recordkeeping component:
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f. How would the IPP determine if records generated in accordance with 9 

CFR 417.5(a)(3) were being reviewed by the establishment?

If the IPP performs the review and observation component:

If the IPP performs the recordkeeping component:

She requests the Thermometer Calibration Logs and the Product 

Temperature Logs.

Thermometer Calibration Log Calibrate to 32o F in slush ice water

Thermometer 

ID #

Temperature Adjustment 

Required?

Date Time Initials

A1 32 No 1-2-12 5:23 am NM

A2 32 No 1-2-12 5:25 am NM

Product Temperature Log Critical limit 40°F or below 

 

Date: 1-2-12

Time Temperature Initials Comments Verification

6:20 am 36 NM

7:30 am 38 NM Direct observation, results as per 

HACCP plan JP 7:30 am, 1-2-12

g. What do you conclude from the records?

She proceeds to the storage cooler and observes the HACCP coordinator 

watching the QC personnel perform monitoring, recording the monitoring 

check, reviewing the Product Temperature Log, and signing the record. 

h. What is your determination regarding compliance based on what she has 

seen?
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4. As part of the Secondary Inhibitors-Not Shelf Stable HACCP verification task, 

the IPP reviews the HACCP plan to verify that it contains on-going verification 

procedures and frequencies.

HACCP Plan for fermented semi-dry sausages

CCP #1 –

Biological

Critical Limit Monitoring Procedures 

and Frequency

Verification 

Procedures and 

Frequency

Fermentation 

(pH and 

temperature)

Achieve a pH of 5.2 

or less within 12 

hours from the start 

of the fermentation 

process for S. 

aureus control, to 

prevent C. 

botulinum and C. 

perfringens growth,

and to suppress the 

growth of Listeria 

monocytogenes

during the shelf life

Room temperature 

not to exceed 90°F 

Production foremen will 

enter the start and finish 

time for the fermentation 

process on the 

fermentation log. QC 

will select three samples 

from different locations 

of each batch of 

product, blend or 

emulsify the sample, 

and measure the pH 

using a pH meter. The 

highest result will be 

recorded on the pH log. 

Production foreman will 

observe the room 

temperature recording 

chart once per shift and 

enter the result on the 

fermentation log.

QC supervisor will 

review fermentation 

and pH logs and 

observe QC selecting 

samples, measuring 

pH and recording the 

result and the 

production foremen 

recording results. 

Maintenance 

personnel will check 

the accuracy of the 

recording chart 

thermometer probe 

and chart, and 

calibrate as needed. 

a. How does the IPP proceed with performing the Secondary Inhibitors-Not 

Shelf Stable HACCP verification task? 

b. What questions will the IPP ask when verifying the verification 

requirement? Is there noncompliance?
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Recordkeeping 

IPP verify the recordkeeping requirements when performing HACCP verification 

tasks. IPP verify recordkeeping requirements by reviewing the following:

 The HACCP plan 

 HACCP records 

IPP may use the recordkeeping and review and observation components to verify 

the establishment complies with the recordkeeping regulations. In most 

instances, they only use the recordkeeping component of the HACCP verification 

task when they are verifying the recordkeeping requirements. IPP must use the 

review and observation component to verify that establishment employees make 

an entry on the record at the time the specific event occurs (record authenticity). 

There are several regulations that pertain to HACCP recordkeeping practices.

The table below summarizes the recordkeeping regulatory requirements. 

HACCP Recordkeeping Requirements

Now let’s go into more detail about each requirement as they relate to HACCP 

plans. These regulations will be covered in Sections A-F as follows.

Regulatory Recordkeeping Requirement

Recordkeeping system

417.2(c)(6)

HACCP Records

417.5(a)(3)

Record Authenticity

417.5(b)

Computerized Records

417.5(d)

Record Retention 

417.5(e)(1) and (2)

Official Review of Records/Plans

417.5(f)
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A. Recordkeeping System

The regulatory requirement for a recordkeeping system is:

9 CFR 417.2(c)(6)—Provide for a recordkeeping system that documents the 

monitoring of the critical control points. The records shall contain the actual values 

and observations obtained during monitoring.

IPP verify this requirement using the recordkeeping component while performing 

the HACCP verification task.

Gather information by asking questions

In performing the tasks, IPP should seek the answer to the following questions:

1. Does the HACCP plan set out a recordkeeping system that documents 

the monitoring of the CCP?

2. Do the records contain actual values and observations obtained during 

monitoring?

Assess the information

To verify that the establishment is in compliance with this regulation, IPP should 

review the following:

 HACCP plan 

 HACCP monitoring records

Reviewing the HACCP Plan for the Recordkeeping System Requirement

In reviewing the HACCP plan for compliance with 417.2(c)(6), IPP should verify 

that it lists the records that will be used to document the monitoring of critical 

control points. 

Recordkeeping Example 1:

HACCP plan: raw boneless skinless chicken breasts

CCP # Critical 

Limits

Monitoring 

Procedures & 

Frequencies

HACCP 

Records

Verification Procedures & 

Frequencies

Corrective 

Actions

2

Chilling

Product 

temperature 

not to 

exceed 40 

degrees F 

QC personnel 

will record 

temperature 

every 4 hours

Product 

Temperature 

Log

Thermometer 

Calibration log

HACCP Coordinator will 

review the Product 

Temperature Log and observe 

QC personnel performing 

monitoring once per shift

Corrective 

actions shall 

meet all 

requirements 

of Part 

417.3(a)
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The establishment’s HACCP plan identifies the “Product Temperature Log” as 

the record that the establishment uses to document product temperatures taken 

at the chilling step. The establishment is in compliance with 9 CFR 417.2(c)(6) 

because it has a recordkeeping system for documenting the monitoring activities 

at the CCP.

Reviewing HACCP Records for the Recordkeeping System Requirement

When reviewing the HACCP records for compliance with 417.2(c)(6), IPP should 

verify that it contains the actual values and observations that were obtained 

during the monitoring of critical control points.

Recordkeeping Example 2: The IPP is verifying the recordkeeping requirement 

while performing the Fully Cooked-Not Shelf Stable HACCP verification task at 

an egg roll operation. The IPP reviews the HACCP plan to verify that it provides 

for a recordkeeping system that documents the monitoring of critical control 

points and the IPP finds the following records listed for the cooking CCP: Egg 

Roll Temperature Record and Oil Temperature Chart. The IPP also reviews 

some Egg Roll Temperature Records and observes that monitoring personnel 

have recorded the time, product identification, temperatures, and initials. The 

record is dated to correspond with the day of the monitoring. Based upon the IPP 

review, the IPP determines that the establishment is in compliance with this part 

of the recordkeeping requirements of 417.2(c)(6) at this CCP. 

Recordkeeping Example 3: An IPP is performing the HACCP verification task to 

verify the establishment recordkeeping requirements for the only CCP, product 

storage. He reviewed the establishment’s HACCP plan and found that it lists the 

records used to document the monitoring of the critical control points, including 

the room temperature log, calibration log, and the corrective action log. He also 

found the monitoring procedure specifies that maintenance personnel observe 

the product storage area thermometer every two hours, and record results on the 

room temperature log. He reviewed the room temperature logs and observed that 

the maintenance personnel have recorded actual temperatures and times on the 

form, and initialed each result. Based upon his review, he determined that the 

establishment is in compliance with this part of the recordkeeping requirements 

of 417.2(c)(6) at this CCP. 

Determine Compliance

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

recordkeeping system requirement, they must determine regulatory compliance. 

If they find that the establishment has met all regulatory requirements for 

§417.2(c)(6), then there is no regulatory noncompliance. If they find that the 

establishment has not met all §417.2(c)(6) regulatory requirements, there is 

noncompliance. More information about making compliance determinations is 

provided in another section of the training.
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Noncompliance with the Recordkeeping System Requirement

The following are examples of noncompliance with 417.2(c)(6).

Noncompliance Example 1: An IPP is reviewing the HACCP monitoring log for 

the stabilization CCP in a sliced turkey bologna establishment and finds that 

monitoring personnel are placing a check mark on Chilling Log instead of the 

actual thermometer reading as specified in the HACCP plan. The monitoring 

personnel are not recording actual values as required in 417.2(c)(6).

Noncompliance Example 2: An IPP is reviewing the HACCP plan for a very 

small swine slaughter establishment and he notices that there is a CCP for 

finished product storage but the plan does not provide for any records for 

documenting the monitoring of cooler temperatures. The HACCP plan does not 

provide for a recordkeeping system that documents the monitoring of the 

CCP.

B. HACCP Records Requirement

The regulatory requirement for HACCP records is:

9 CFR 417.5(a)(3)—The establishment shall maintain: Records documenting the 

monitoring of CCP and their critical limits, including the recording of actual times, 

temperatures, or other quantifiable values, as prescribed in the establishment’s 

HACCP plan; the calibration of process-monitoring instruments; corrective actions, 

including all actions taken in response to a deviation; verification procedures and 

results; product code(s), product name or identity, or slaughter production lot. Each 

of these records shall include the date the record was made.

IPP will verify compliance with this regulation by performing the HACCP 

verification task. IPP will use the recordkeeping component to verify this 

regulation. 

The thought process IPP should use when verifying regulatory requirements 

includes:

 gathering information by asking questions;

 assessing the information; and 

 determining regulatory compliance.

This thought process should be utilized when verifying all of the regulatory 

requirements. 

Gather information by asking questions

When reviewing HACCP records for compliance with 417.5(a)(3), IPP should 

seek the answer to the following questions:
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1. Do the records document the monitoring of CCP and their critical 

limits?

2. Do the records include actual times, temperatures, or other quantifiable 

values, as prescribed in the establishment’s HACCP plan?

3. Do the monitoring, verification, and corrective action records include 

product codes, product name or identity, or slaughter production lot, 

and the date each record was made?

4. Are the verification procedures and results of those procedures 

documented? 

5. Is the time recorded when the verification activity was performed?

6. Does the record contain the date the record was made?

7. Are the process-monitoring calibration procedures and results being 

recorded?

Assess the information

To answer these questions, IPP should review:

 HACCP records that document monitoring and verification procedures for 

CCP and their critical limits

 Documentation of corrective actions taken in response to a deviation from 

a critical limit, a deviation not covered by a critical limit, or an unforeseen 

hazard. 

When reviewing the HACCP records for compliance with 417.5(a)(3), IPP will 

verify that the records document the monitoring of CCP and their critical limits, 

including the recording of actual times, temperatures, or other quantifiable 

values, as prescribed in the establishment’s HACCP plan and verification 

procedures and results.

Recordkeeping Example 4: An IPP is performing the Slaughter HACCP 

verification task in a pork slaughter operation and as part of the task, he is 

verifying all requirements for all CCPs for a specific production. As part of his 

review, he examines all HACCP records produced. While verifying the 

recordkeeping requirement in 417.5(a)(3) for the pre-evisceration carcass rinse 

CCP. He reviews the HACCP records for this CCP and finds that the monitoring 

and verification personnel have made the following entries: 
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Antimicrobial Intervention Log

Date Lot No. Time Solution

Conc.

Pressure Corrective

Actions

Monitored 

by

Verified by

*

2-1-2012 1 0730 2.2% 30psi

-

TDM PP

*direct observation verification-results as per HACCP plan

Based upon his records review, he determines that the establishment is in 

compliance with this part of the recordkeeping requirements of 417.5(a)(3). 

In addition, he will verify that monitoring and corrective action records include 

product codes, product name or identity, or production lot, and the date the 

record was made. 

Recordkeeping Example 5: An IPP is performing the Raw Non-Intact HACCP 

verification task in a raw pork sausage operation and as part of the task, he is 

verifying all requirements for all CCPs for a specific production. As part of his 

review, he examines all HACCP records produced. He observes that each of the 

records includes actual values, the production code and the product name, 

where applicable, and that each record includes the date. Based on his review, 

he decides that the establishment is in compliance with this part of the 

recordkeeping requirement.

The IPP will also verify that process monitoring calibration procedures and 

results are recorded if that is part of the HACCP plan.

Recordkeeping Example 6: The IPP is performing the Heat Treated-Not Fully 

Cooked-Not Shelf Stable HACCP verification task in a smoked bacon operation 

and is verifying the recordkeeping requirement 417.5(a)(3) at the cooling CCP. 

The IPP selects the process-monitoring calibration records to review and finds 

that the establishment personnel have made the following entries: 

Thermometer Calibration Log

Calibrate to 32o F in slush ice water

Date Time Area Thermometer

ID

Personal 

Thermometer

Reading

Adjustment 

Required

Initials Comments

2-1-2012 0800

Belly

Chilling 2A 32 No TDM

Based upon her records review, she determines that the establishment is in 

compliance with this part of the recordkeeping requirements for the cooling 

CCP. She would then proceed to verify the other recordkeeping requirements.

Determine Compliance

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

HACCP records requirement, they must determine regulatory compliance. If they 

find that the establishment has met all regulatory requirements for §417.5(a)(3), 

then there is no regulatory noncompliance. If they find that the establishment has 
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not met all regulatory requirements for §417.5(a)(3), there is noncompliance. 

More information about making compliance determinations is provided in another 

section of the training.

Noncompliance with the HACCP Records Requirement

One or more of the following findings evidence that the establishment does not 

comply with 9 CFR 417.5(a)(3): 

 Establishment monitoring records do not document all monitoring activities 

or do not include actual times, temperatures, or other quantifiable values. 

 Establishment verification records do not document all verification 

activities or do not include the results of verification procedures. 

 Establishment corrective action records do not document all corrective 

actions performed by the establishment. 

Note: When IPP observe that records are missing, they are to carefully 

consider whether the record is missing because the establishment 

employee failed to perform the specified activity or because the employee 

failed to make the appropriate record entry. If they determine that the 

employee failed to perform the specified procedure (monitoring, 

verification, or corrective action), they are to document noncompliance 

with the applicable regulation (9 CFR 417.2(c)(4), 417.4(a), or 417.3, 

respectively) rather than 9 CFR 417.5(a)(3).When a deviation from a 

critical limit occurs, the establishment must implement the corrective 

actions specified in the HACCP plan. The regulation that applies to the 

corrective actions will be discussed in a later section.

 Establishment HACCP records (including pre-shipment review) do not 

include product names, product codes, or other identifying information 

sufficient to demonstrate which specific production is covered by a 

particular record. 

The following are examples of noncompliance with 417.5(a)(3):

Noncompliance Example 3: An IPP is reviewing the monitoring records for the 

poultry TSP antimicrobial spray CCP and he finds there is no record of a 

monitoring procedure being performed in the last 3 hours. The HACCP plan 

specifies that monitoring at this CCP will take place on an hourly basis. He asks 

the establishment about these missing records. They provide a signed statement 

from the monitor stating that the monitoring took place, and that the results were 

within critical limits, but that the monitor neglected to write this on the record at 

the time it was done. The IPP concludes that the monitoring took place but it was 
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not recorded. The records do not have the monitoring results recorded.

Noncompliance Example 4: An IPP is reviewing the poultry chiller CCP 

monitoring records and finds that the temperatures have been recorded on the

monitoring log but no times are recorded. Upon further investigation, she was 

provided evidence that the monitoring checks were performed at the proper 

times. The records do not include the actual times that monitoring is 

performed.

Noncompliance Example 5: An IPP is reviewing the monitoring records for the 

carcass wash CCP in a poultry establishment and he finds that the chlorine 

monitoring results are recorded simply as “O.K.” instead of the actual value in 

ppm as described in the HACCP plan. The records do not include the actual 

values as required.

Noncompliance Example 6: An IPP is reviewing the HACCP records for the 

finished product storage CCP in a small sheep slaughter operation and she 

notices that the product temperature log does not record the lot number or 

product ID as is specified in the HACCP plan. The monitoring entries do not 

include the product identification or code.

Noncompliance Example 7: An IPP is reviewing the verification records for the 

fermentation CCP in a large semi-dry sausage operation and he notices that the 

verification results are being recorded once per day. The HACCP plan lists the 

frequency of this verification as twice per shift. The establishment provides other 

written evidence that the verification procedures were performed. The 

verification procedures and results are not being recorded 

Noncompliance Example 8: An IPP is reviewing the corrective actions for the 

fecal CCP in a poultry slaughter operation and he notices the establishment 

monitoring procedure at 0700 had a fecal finding and the following procedure at 

0710 also had a fecal finding. He looks at the corrective action log and finds no 

record of any corrective actions. He requests more information and the 

establishment provides satisfactory evidence that the corrective actions were 

performed but not recorded. The corrective actions taken in response to a 

deviation from a critical limit are not recorded.

Noncompliance Example 9: An IPP is reviewing the chilling records for the 

stabilization CCP in a turkey bologna operation and she finds that the calibration 

for the temperature-recording device had not been documented for the shift. The 

HACCP plan specifies that the calibration will be performed and recorded prior to 

the startup of every shift. She requests more information and the establishment 

provides her with evidence that the calibration was performed. The results of 

calibration of process monitoring instruments are not recorded. 
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IPP document the HACCP verification task results in PHIS including any 

noncompliance 

C. Records Authenticity

The regulatory requirement for record authenticity is:

9 CFR 417.5(b)—Each entry on a record maintained under the HACCP plan shall 

be made at the time the specific event occurs and include the date and time 

recorded, and shall be signed or initialed by the establishment employee making 

the entry.

IPP will verify compliance with this regulation by performing the HACCP 

verification task. They are going to use the recordkeeping and the review and 

observation components.

The thought process IPP should use when verifying regulatory requirements 

includes:

 gathering information by asking questions;

 assessing the information; and 

 determining regulatory compliance.

This thought process should be utilized when verifying all of the regulatory 

requirements. 

Gather information by asking questions

When verifying that the establishment is in compliance with this requirement, IPP 

should seek the answer to these questions:

1. Was each entry on the record made at the time the event occurred?

2. Does each entry include the time?

3. Was each entry on the record signed or initialed by the establishment 

employee making the entry?

4. Does each record include the date?

Assess the information

IPP will review: HACCP records documenting monitoring, verification activities, 

and corrective action.

When reviewing the HACCP records for compliance with 417.5(b), IPP should 

verify that each record entry is made at the time the event occurred and includes 
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the time as part of the entry. In addition, they should verify that the record was 

signed and initialed by the establishment employee making the entry. 

Recordkeeping Example 7: The IPP is performing the Heat Treated-Not Fully 

Cooked-Not Shelf Stable HACCP verification task in a smoked pork chop 

operation and is verifying the recordkeeping requirements for the cooling 

(stabilization) CCP. While reviewing the establishment’s HACCP plan, he sees 

that the verification procedure states that QC personnel will observe the monitor 

conduct the monitoring activities twice per shift. He looks at the chilling record 

being completed on the shift and QC has made one direct observation entry. The 

entry includes the time that the direct observation was performed; the monitoring 

was being conducted as per the HACCP plan, and initials of the verifier. The 

monitoring entries on the form included product ID, time, actual temperatures, 

initials, and date the data was recorded. He notices that the verifier is in the area 

so he remains in the area and observes that the QC employee performs the 

second monitoring direct observation verification and records the results at the 

time of the verification. He determines that this part of the recordkeeping 

requirement is in compliance because the entries are made at the time the event 

occurs, each entry includes the time, the form includes the date, and each entry 

is initialed.

Determine Compliance

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

HACCP record authenticity requirement, they must determine regulatory 

compliance. If they find that the establishment has met all regulatory 

requirements for §417.5(b), then there is no regulatory noncompliance. If they 

find that the establishment has not met all regulatory requirements for §417.5(b), 

there is noncompliance. More information about making compliance 

determinations is provided in another section of the training.

Noncompliance with HACCP Record Authenticity

One or more of the following findings evidence that the establishment does not 

comply with 9 CFR 417.5(b): 

 Establishment employees do not make entries in HACCP records at the 

time that specific events occur. 

Note: Some establishments may choose to record HACCP results on 

“scratch paper” or a “note pad” and then transfer the results to a clean 

record at a later time (significantly after the event occurred). This practice 

is allowed, but the initial “scratch paper or note pad” record needs to meet 

HACCP recordkeeping requirements and must be retained as an official 

HACCP record. Scratch paper or note pad used during a monitoring 

procedure is not a HACCP record when the data is transcribed to the 
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HACCP record immediately when the employee finishes taking the 

measurements.

 Establishment records do not clearly state the date and time when each 

entry was made

Note: The establishment may elect not to enter a date or time for every 

separate entry in the HACCP record when they make several entries at 

the same time or on the same date. This practice is acceptable as long as 

the IPP is able to determine the time and date when each entry was 

made. For example, an establishment may place a single date at the top 

of a record to cover all entries made during that day. 

 Establishment employees do not sign or initial their entries in HACCP 

records. 

The following is an example of noncompliance with 417.5(b):

Noncompliance Example 10: The HACCP plan has a monitoring procedure for 

checking temperature of incoming trimmings by checking 2 combos from each 

truck with a long-stem thermometer. An IPP observes this record:

Incoming trimmings log Critical limit = 38 F or lower Date: 2-8-12 

Truck ID Truck 

condition 

Combo ID Source Tracking # Temp Time Monitor initials

138 A -981 Bexel 380001 34 4:56 am JP

138 A -982 Bexel 380002 34 5:05 am JP

8526 B -020 Donfort 380003 36 7:20 am GM

8526 B -021 Donfort 380004 

He observes the next truck unloaded. The establishment employee “GM” 

performs the monitoring procedure on the combo bins, and does not enter the 

results on the form until much later in the day. He determines that there is a 

recordkeeping noncompliance. One entry on the record does not contain the 

time the event occurred or the temperature. The records do not include the 

signature or initials of the person performing the activity. Results are not 

being recorded when the events occur. 

IPP document the HACCP verification task results in PHIS including any 

noncompliance. 
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D. Computerized Records

The regulatory requirement for computerized records is:

9 CFR 417.5(d)—Records maintained on computers. The use of records 

maintained on computers is acceptable, provided that appropriate controls are 

implemented to ensure the integrity of the electronic data and signatures.

Electronic signatures are different from the digitized signature used for signing 

a credit card purchase. An electronic signature, or digital signature, uses 

computer technology to ensure the security of records or messages. The person 

making the record or message uses an electronic “code” to identify himself or 

herself. The computer, using an electronic “key,” de-codes the record or 

message. This endorses the identity of the user.

IPP will verify compliance with this regulation by performing the HACCP 

verification task using the recordkeeping component.

The thought process IPP should use when verifying regulatory requirements 

includes:

 gathering information by asking questions;

 assessing the information; and 

 determining regulatory compliance.

This thought process should be utilized when verifying all of the regulatory 

requirements. 

Gather information by asking questions

When verifying this requirement, IPP should seek the answer to this question:

Are appropriate controls provided to ensure integrity of electronic data and 

signatures?

Assess the information

To obtain answers to this question, IPP would review the computerized 

recordkeeping system.

Recordkeeping Example 8: An establishment enters all HACCP activity results 

into hand-held computer devices. Network access is for QA employees only. 

Each employee has a unique login name and password that is kept secure. 

Passwords are changed periodically. Once an entry is made, it is saved as readonly, and cannot be changed. 
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Determine Compliance

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

computerized records requirement, they must determine regulatory compliance. 

If they find that the establishment has met all regulatory requirements for 

§417.5(d), then there is no regulatory noncompliance. If they find that the 

establishment has not met all regulatory requirements for §417.5(d), there is 

noncompliance. More information about making compliance determinations is 

provided in another section of the training.

Noncompliance with the Computerized HACCP Records Requirement

The following are examples of noncompliance with 417.5(d):

Noncompliance Example 11: The establishment uses a computer-based 

system to monitor and record the temperatures in all processing rooms, coolers, 

and chillers. The IPP requests information about the controls that the 

establishment has in place to ensure the integrity of the record. The 

establishment manager provides him with a record showing that all of the 

establishment’s employees can access the records without any restriction. The 

IPP asks the establishment manager if the establishment has any controls in 

place to ensure that record integrity is not compromised and the establishment 

manager replies, “No one will do anything to the records that will never happen”. 

The establishment does not have controls in place to ensure the integrity 

of the electronic records.

Noncompliance Example 12: The establishment uses a computer-based 

system to monitor and record the temperatures in all processing rooms, coolers, 

and chillers. The IPP observes that on a warm day a processing room employee 

adjusts the computer settings so that the alarm will not keep going off. The IPP 

observes that the passwords are prominently posted near the computer station. 

The establishment has controls to ensure the integrity of the electronic 

records but is not following those controls. The passwords are not kept 

secure. 

IPP document the HACCP verification task results in PHIS including any 

noncompliance. 
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E. Record Retention 

The regulatory requirements for record retention and off-site storage of records 

are:

9 CFR 417.5(e)(1) and (2)—Record retention. (1) Establishments shall retain all 

records required by paragraph (a)(3) of this section as follows: for slaughter 

activities for at least one year; for refrigerated products, for at least one year; for 

frozen, preserved, or shelf-stable products, for at least two years. (2) Off-site 

storage of records required by paragraph (a)(3) of this section is permitted after six 

months, if such records can be retrieved and provided, on-site, within 24 hours of 

an FSIS employee’s request.

IPP will verify compliance with this regulation by performing the HACCP 

verification task using the recordkeeping component.

The thought process IPP should use when verifying regulatory requirements 

includes:

 gathering information by asking questions;

 assessing the information; and 

 determining regulatory compliance.

This thought process should be utilized when verifying all of the regulatory 

requirements. 

Gather information by asking questions

IPP should seek the answer to the following questions.

1. Are the records being maintained for the required amount of time, i.e., 

1 year for slaughter and refrigerated products and 2 years for frozen 

products?

2. Are the records kept on-site for 6 months?

3. If the records are stored off-site after 6 months, can they be retrieved 

within 24 hours?

Note: Only the HACCP records set out in 9 CFR 417.5(a)(3) may be stored offsite after 6 months. Prerequisite program records and other supporting 

documentation must be maintained and stored at the establishment.

Assess the information

IPP should verify that the records are being maintained the required amount of 

time by reviewing HACCP records. 
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If IPP suspect that records stored off-site are not being maintained for the 

required amount of time, they should contact the Frontline Supervisor for 

instructions. IPP might request records stored off-site one time to ensure they 

can be provided, but it would not be necessary for the IPP to routinely request 

records that are stored off-site to verify this requirement.

Recordkeeping Example 9: On January 10, 2012 at 1:30 pm, the IPP 

performed the Heat Treated-Not Fully Cooked-Not Shelf Stable HACCP 

verification task in a small bacon processing establishment. The establishment 

has 2 critical control points: CCP 1 to monitor the critical limit of the amount of 

sodium nitrite added to the formulation, and CCP 2 for the storage temperature of 

final product. As part of the procedure, the IPP verified the establishment’s 

compliance with the records maintenance requirements. She asked the 

establishment to provide her with CCP 1 and CCP 2 monitoring, verification, and 

corrective action records for February 6th of 2011 and November 10th of 2011. 

The establishment provided her with November’s records and informed her that 

February’s records are stored off-site. February’s records were provided to the 

IPP on January 11th at 8.00 am. 

Determine Compliance

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

records retention and availability requirement, they must determine regulatory 

compliance. If they find that the establishment has met all regulatory 

requirements for §417.5(e)(1) and (2), then there is no regulatory noncompliance. 

If they find that the establishment has not met all regulatory requirements for 

§417.5(e)(1) and (2), there is noncompliance. More information about making 

compliance determinations is provided in another section of the training.

Noncompliance with Records Retention and Availability

One or more of the following findings evidence that the establishment does not 

comply with 9 CFR 417.5(e)(1) and (2): 

 HACCP records are not kept on-site for 6 months

 HACCP records are not maintained for the required amount of time 

 A HACCP record stored off-site cannot be retrieved within 24 hours of the 

CSI request.

The following are examples of noncompliance with 417.5(e)(1) and (2):

Noncompliance Example 13: In October, the IPP asks the establishment to 

provide a sample of the fecal CCP monitoring log records from last January. 

They give him a folder that contains February’s records. He asks the 
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establishment about January’s records and they tell him they had to clean out the 

files because they were getting too full. The establishment cannot produce 

January’s records. The establishment is not maintaining records for the 

required length of time. 

Noncompliance Example 14: In October, the IPP is reviewing the establishment 

HACCP records for the Lm sampling component of the post-lethality treatment 

CCP in a large deli product establishment. She suspects the establishment is not 

maintaining testing records on-site. She discusses this with her frontline 

supervisor and then she asks the establishment for the records from May. They 

tell the IPP that they can give her the records for the past month but they will 

have to retrieve any other month’s records from the corporate headquarters 500 

miles away. The records are not being maintained on-site for 6 months.

Noncompliance Example 15: An IPP is newly assigned to a large deli product 

establishment and is performing records maintenance verification as part of the 

Fully Cooked-Not shelf Stable HACCP verification task. He wonders about 

whether the establishment is able to retrieve records stored off-site and 

discusses this with his supervisor. He decides to ask the establishment to 

provide a sample of records from 7 months in the past. Management tells him 

that after 6 months they store them at corporate headquarters. He requests that 

the establishment retrieve 2 days of records from corporate headquarters. He 

receives the records 5 days later. The establishment cannot retrieve the 

records within 24 hours when stored off-site 

F. Official Review Records

The regulatory requirement for making establishment records available to IPP 

upon request for official review is:

9 CFR 417.5(f) Official Review—All records required by this part and all plans 

and procedures required by this part shall be available for official review and 

copying.

IPP will verify compliance with this regulation by performing the HACCP 

verification task using the recordkeeping component.

The thought process IPP should use when verifying regulatory requirements 

includes:

 gathering information by asking questions;

 assessing the information; and 

 determining regulatory compliance.

This thought process should be utilized when verifying all of the regulatory 

requirements. 
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Inspection Methods 18-52

Gather information by asking questions

When verifying this requirement IPP should seek the answer to this question:

Are all records, plans, and procedures required by Part 417 available for 

official review?

Assess the information

To obtain the answer to this question, IPP would request HACCP records, 

HACCP plans, hazard analyses, and supporting documentation including 

prerequisite programs and records from the establishment.

Some establishments keep their HACCP plans, HACCP records, and other 

official records in secured areas (locked cabinets or offices). In these cases, IICs 

are to work with establishment management to develop a method for an 

establishment employee to provide access to the secured area upon request. 

IPP are to follow any such established procedure when requesting access to 

records. IPP only request those records normally required to perform their 

verification duties. They are not to test the establishment by requesting additional 

records. 

IPP are to contact their supervisor if the establishment will not make HACCP 

plans, HACCP records, or supporting documents available for review. 

Recordkeeping Example 10: A relief IPP assigned to a large poultry slaughter 

establishment is verifying the establishment’s compliance with making records 

available for official review as part of the Slaughter HACCP verification task. He 

asks the establishment manager to provide him with the HACCP plan, hazard 

analysis and support documentation records. The establishment manager 

informs the IPP that they keep all HACCP records in a lock cabinet in his office. 

The establishment manager opens the locked cabinet and gives the IPP access 

to the records. The IPP determines that the establishment is in compliance with 9 

CFR 417.5(f) of the recordkeeping requirements. 

Determine Compliance

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

availability records requirement, they must determine regulatory compliance. If 

they find that the establishment has met all regulatory requirements for §417.5(f), 

then there is no regulatory noncompliance. If they find that the establishment has 

not met all regulatory requirements for §417.5(f), there is noncompliance. More 

information about making compliance determinations is provided in another 

section of the training.
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Noncompliance with Official Review of Records

The following are examples of noncompliance with 417.5(f)

Noncompliance Example 16: An IPP is assigned to 2nd shift in a large smoked 

pork chop processing establishment. While he was performing the Heat TreatedNot Fully Cooked-Not Shelf Stable HACCP verification task, he needed to access 

the establishment monitoring records to verify the monitoring requirement for the 

cooling (stabilization) CCP. The IPP asked the smokehouse supervisor to 

provide him with the monitoring records. The smokehouse supervisor informed 

him that all of the monitoring records were locked in the HACCP manager’s 

office. The manager is available only during the day shift. This is 

noncompliance with 417.5(f) because the records are not available for 

official review. 

Noncompliance Example 17: An IPP was performing the Slaughter HACCP 

verification task. As part of her verification activities, she needed to review the 

HACCP plan. The establishment uses a computer-based system to electronically 

store the HACCP plan, hazard analysis, support documentation and all HACCP 

system records. When the IPP asked the establishment owner to provide her 

with access to the records, he stated that “we have very high-security computer 

systems the only person who can access the system is Mr. John Hunt who is sick 

today”. This is a noncompliance with 417.5(f) because the records are not 

available for official review.

IPP document the HACCP verification task results in PHIS including any 

noncompliance. 

Records Misrepresentation

A HACCP system will not work unless consistent, reliable records are generated 

during the plan’s operation. The availability of well-maintained records that 

contain objective, relevant data, reflecting actual operating conditions benefits

both industry and regulatory officials. The legitimacy of these records is 

extremely important.

FSIS views recordkeeping as a serious matter with potentially grave implications 

if records are falsified or not properly maintained. When enforcement action is 

required, it is important to distinguish between unintentional (one time or 

sporadic) errors or isolated cases of sloppy recordkeeping, and errors that reveal 

a pattern of noncompliance with the procedure or plan, willful errors or omissions, 

or intentional misinformation. As IPP become familiar with establishment 

records, and how they appear under ordinary circumstances, they should be able 

to distinguish between unintentional and willful errors, omissions, and intentional 

misrepresentation. 
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When deliberate misrepresentation of records is suspected, IPP should not

discuss the situation with an establishment employee. They should notify the IIC 

and document the findings in a memorandum to the files—not on an NR. The IIC 

should use a secure method (email or a telephone off-premises if necessary) to 

inform the District Office. FSIS does not consider the telephone in the 

Government office and cellular phones to be secure. The District Manager will 

provide instructions for further action. If the IIC is not available, the inspector 

should use a secure method to notify the District Office and follow the District 

Manager’s instructions.

Note: IPP are to follow their chain of command when reporting record 

misrepresentation to the District Office.
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Inspection Methods 18-55

Workshop: Recordkeeping

Refer to the handout to complete the following questions.

1. What recordkeeping requirement must be verified using the review and 

observation component? 

2. Case Study. An IPP is verifying the recordkeeping requirement at the preevisceration antimicrobial rinse CCP as part of the Slaughter HACCP 

verification task. He reviews the monitoring record for the CCP, which follows.

Pathogen Reduction Log

Date Lot No. Time Solution

Conc. (%)

Pressure

(psi)

Corrective

Actions

Monitored 

by

Verified 

by

*

2-1-2012 1 0730 OK OK - TDM PP

*direct observation verification-results as per HACCP plan

a. Are there any noncompliances in this record? Please explain and cite the 

relevant regulation.

b. What should he do next? 

3. How soon, after the monitoring and verification activities, do the results have 

to be recorded on the establishment records? What is the regulatory 

reference for this? 
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Inspection Methods 18-56

4. Evaluate the record below.

Thermometer Calibration Log

Calibrate to 32° F while in slush ice water

Date Tim

e

Dept. Thermomete

r

ID

Personal 

Thermomete

r

Reading

Adjustmen

t 

Required?

(Yes or 

No)

Initial

s

Comment

s

2/15/201

2

PM Carcas

s 

Cooler

2B 32°F No TDM

a. Is there any noncompliance with recordkeeping requirements here? 

b. If so, what is the regulatory reference? 

5. Case Study. An IPP is verifying the recordkeeping requirement as part of a 

Slaughter HACCP verification task and has decided to review the poultry 

reprocessing slaughter food safety standard CCP. According to the HACCP plan, 

the frequency for monitoring is hourly and the frequency for direct observation 

and record review verifications is daily. The shift runs from 0600-1430 with a 30-

minute lunch from 1100-1130. The critical limit for the CCP is zero. Evaluate the 

following record.

Reprocessing Log

Time Product 

ID

Results of 

Inspection

Monitor 

Initials

Verification 

procedure and 

results

Corrective Actions or Comments

0645 Lot 1 0 BK

0750 Lot 1 0 BK

0840 Lot 2 1 CH 1⁄2 inch smear of green fecal 

material

0955 Lot 2 0 BK

1330 Lot 3 0 CH

1430 Lot 4 0 CH

a. Do you see any obvious noncompliance with this record? If so, list what it is 

and give the regulatory references?
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Inspection Methods 18-57

b. Based on what you have observed, could there be more noncompliance? If 

so, list what it is and give the regulatory references?

c. What should the IPP do next, if anything? 

6. While performing the recordkeeping component of the Heated Treated-Not 

Fully Cooked-Not Shelf Stable HACCP verification task at a smoked pork 

chop establishment, the IPP is verifying the record retention requirement. The 

establishment has been producing this product for two years. The QC 

Manager gives the IPP a thick file and says that it contains all the HACCP 

records that the establishment has for these products. The IPP looks at 

yesterday‘s record (January 29, 2012), which is on top. The IPP looks through 

the records in the folder and notes that the oldest date is for June 30, 2011. Is 

there noncompliance?
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Supporting Documentation- Prerequisite Programs and Other 

Supporting Programs

The regulatory requirement that addresses the use of prerequisite programs to 

support decisions in the hazards analysis is: 

9 CFR 417.5(a)—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 verify this requirement using both the review and observation and the 

recordkeeping components while performing the HACCP verification task.

The establishment is required to maintain documentation to support the decisions 

in the hazard analysis 9 CFR 417.5(a) (1). If the establishment uses prerequisite 

programs or other measures to support a decision that a particular hazard is not 

reasonably likely to occur, the records of the ongoing implementation of 

those prerequisite programs or measures is part of the supporting 

documentation required by 9 CFR 417.5(a)(1). 

9 CFR 417.5(f) requires that all records required under 9 CFR 417 be available 

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

supervisor if the establishment will not make prerequisite programs, prerequisite 

program records, or other supporting documents available for review. 

The thought process IPP should use when verifying regulatory requirements 

includes:

 gathering information by asking questions;

 assessing the information; and 

 determining regulatory compliance.

This thought process should be utilized when verifying all of the regulatory 

requirements. 

Prerequisite Program, GMPs or SOPs

Based on the regulatory requirements of 9 CFR 417.2(a)(2) and 9 CFR 

417.5(a)(1), FSIS believes that the results of testing and monitoring activities 

related to the production of product are subject to FSIS review and must be 

available to FSIS personnel upon request, including records from a prerequisite 

program. IPP should be aware of all monitoring and testing conducted by the 

establishment and should ask establishment management to share the data that 

is generated by this monitoring and testing. IPP review this data while performing 

the HACCP verification task and Review Establishment Data task (refer to FSIS 

Directive 5000.2) when verifying the requirement for supporting documentation. 
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When reviewing records, results, and supporting documentation associated with 

testing, monitoring, and verification activities that are from procedures or 

prerequisite programs outside the HACCP plan, IPP should determine if the 

records generated from these programs continue to support the decisions made 

in the establishment’s hazard analysis that the hazard is not reasonably likely to 

occur in the process. They should also verify that if there is information in the 

records that requires the establishment to reevaluate or reassess its HACCP

plan, the establishment has conducted the reassessment. 

Verifying prerequisite programs

 

When an establishment references a prerequisite program in its hazard analysis 

as supporting documentation that a food safety hazard is not likely to occur, 

verify that the establishment:

1. has written procedures that set out the design of the prerequisite program;

Note: There is no regulatory requirement that the prerequisite program 

has to be written. However, if the program is not written, the establishment

would probably not be able to support the decision the hazard is not 

reasonably likely to occur. (Exceptions: If the establishment addresses the 

removal, segregation and disposal of SRMs using a prerequisite program, 

the measures it implements to segregate and dispose of them must be 

written as stated in 9 CFR 310.22). If the establishment uses the 

Sanitation SOP to support a decision that a hazard is not reasonably likely 

to occur, the procedure will be in the written Sanitation SOP.

2. is executing the program as designed, and

3. has evidence that the program is being executed as designed and 

continues to support decisions made in the hazard analysis (e.g., 

information on suppliers’ interventions, test results from suppliers, results 

from its own testing, or documents regarding the on-going effectiveness of 

the program).

Unlike with HACCP plans, IPP do not verify compliance with specific regulatory 

requirements for such activities as monitoring, verification, and recordkeeping. 

For instance, there are no specific regulations that address monitoring activities 

or recordkeeping practices for prerequisite programs. Hence, an occasional 

missed measurement, or failures to initial entries on records, failures to enter the 

time on records, or a missing entry on the record would not represent 

noncompliance or would not necessarily mean the prerequisite program is not 

being implemented effectively. Minor deviations from executing the prerequisite 

program usually would not create a food safety concern or necessitate action on 

the product, whereas deviations from the critical limit in a HACCP plan would 

cause food safety concerns and generally require action on the affected product. 
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By means of records review and observations, and discussions with the 

establishment at the weekly meeting, IPP should focus on: 

1. the overall program to verify that the establishment:

a. implements the procedures as set out in the program’s design?

b. maintains records to support the implementation of the program, including 

verification records and results from outside auditors?

 c. evaluates the implementation of the program?

d. has a means to correct implementation problems?

2. any problems that indicate that the prerequisite program may no longer be 

supporting the decision made in the hazard analysis that a hazard is not likely 

to occur, and consider questions such as:

a. are elements of the program not being implemented?

b. are adjustments made to the programs when necessary?

c. do the same implementation problems continue to reoccur?

d. are there numerous or recurrent mistakes made in the implementation of 

the program?

Gather information by asking questions 

IPP are to verify that establishment employees are implementing the procedures 

in the prerequisite program and the records generated by the prerequisite 

program continue to demonstrate that the relevant hazard is not reasonably likely 

to occur. IPP should seek the answer to the following questions:

1. Is the establishment implementing the procedures in the program as 

written?

2. Does the establishment maintain records to support the 

implementation of the program including verification records and 

results from outside auditors?

 

3. Do the records show that the prerequisite program continues to 

support the decision that the relevant hazard is not reasonably likely to 

occur on an ongoing basis?
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Assess the information

To answer these questions, IPP should: 

 Review the establishment’s hazard analysis,

 Review the records generated by the prerequisite program, and

 Observe establishment employees implementing the procedures in the 

prerequisite program.

Now let’s review each of these activities in detail.

Reviewing the Hazard Analysis

When reviewing the hazard analysis, IPP determine if the establishment uses a 

prerequisite program or other supporting program to support a decision that a 

particular hazard is not reasonably likely to occur. 

Prerequisite Program Example 1: An IPP is reviewing the hazard analysis in a 

raw ground beef patty operation during the performance of the Raw Non-Intact 

HACCP verification task. She observes that at the receiving step the 

establishment has identified that there is a physical food safety hazard, “foreign 

material,” but determined that it was not reasonably likely to occur, on the basis 

that “establishment records show that there has been no incidence of foreign 

materials in products received in the establishment.” She decides to request the 

supporting documentation for this decision. The establishment provides a copy of 

a procedure for physical examination of raw materials at receiving.

Prerequisite Program Example 2: An IPP is reviewing the hazard analysis in a 

raw ground beef patty operation during the performance of the Raw Non-Intact 

HACCP verification task. He observes at the raw material storage step that the 

establishment is implementing a temperature control prerequisite program to 

maintain the internal product temperature below 42°F to support that the hazard 

of pathogen growth is not reasonably likely to occur. He decides to request the 

supporting documentation for this decision. The establishment provides a copy of 

the procedures for measuring product temperature and recording results.

Prerequisite Program Example 3: An IPP is reviewing the hazard analysis in a 

poultry slaughter operation during the performance of the slaughter HACCP 

verification task. She observes at the carcass chilling step that the establishment 

is implementing a carcass chilling prerequisite program to support that the 

hazard of pathogen growth is not reasonably likely to occur. She decides to 

request the supporting documentation for this decision. The establishment 

provides a copy of the chilling procedures and all related records.
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Reviewing Prerequisite Program Records

For each prerequisite program or other program the establishment uses to 

support a decision that a hazard is not reasonably likely to occur, IPP are to 

review the records generated by the program for the specific production selected 

to determine if they continue to support the decision that that the relevant hazard 

is not reasonably likely to occur on an ongoing basis. 

Prerequisite Program Example 1a: Continuing with the example 1 above, the 

IPP requests completed raw material examination records for the trimmings that 

were used in the specific production she has selected. She reviews the records 

and finds there are no entries that would represent a foreign material hazard. 

She determines that the establishment in compliance with 9 CFR 417.5(a)(1) 

because it is implementing the program in a manner that supports the hazard 

analysis decision and the records generated from the program show that the 

relevant hazard is not reasonably likely to occur on an ongoing basis. 

Prerequisite Program Example 2a: Continuing with example 2 above, the IPP 

knows that a specific production is an 8-hour shift’s production and the 

temperature control procedure states that the internal temperature of product will 

be measured at the grinding step three times a day. He decides to review internal 

product temperature record that is on a table next to the grinder for the day’s 

shift. He notices that the establishment employee did not record a time for the 

second temperature measurement as specified in the written program. The 

temperature result is 39°F. He realizes that this minor failure to follow the 

program would not represent a failure to support the hazard analysis because the 

temperature result is less than 42°F.

Note: IPP should discuss the less-than-perfect implementation of prerequisite 

programs or other supporting programs with establishment management at the 

weekly meeting. The establishment’s response should be documented in the 

Memorandum of Interview (MOI) the IPP gives to the establishment. 

Observing Establishment Employees 

For each prerequisite program or other program the establishment uses to 

support a decision that a hazard is not reasonably likely to occur, IPP are to 

observe an establishment employee performing the procedures listed in the 

program to determine if the procedures are being carried out as written in the 

program. 

Prerequisite Program Example 2b: Continuing with example 2a above, the IPP 

is in the production room and notices that an establishment employee is going to 

take the last product temperature of the shift at the grinding step. He stops to 

observe the employee taking the measurement. The establishment employee 

measures the product temperature as written in the program and documents the 
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Inspection Methods 18-63

result. The IPP decides to observe the temperature result that the employee 

recorded. The product temperature result is 40°F and the time of the 

measurement is recorded. Based on these observations, he determines that the 

establishment in compliance with 9 CFR 417.5(a)(1) because it is implementing 

the program in a manner that supports the hazard analysis decision and the 

records generated from the program show that relevant hazard is not reasonably 

likely to occur on an ongoing basis. 

Determine Compliance

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

supporting documentation requirement, they must determine regulatory 

compliance. There are three possible outcomes when verifying whether the 

on-going implementation of a prerequisite program and the records generated 

from the program continue to support the decision that a particular hazard is not 

reasonably likely to occur.

1. Compliance

2. Noncompliance

3. Inability to determine compliance because more information is needed

If IPP find that the establishment has met all verification regulatory requirements, 

then there is no regulatory noncompliance. If they find that the establishment has 

clearly not met all supporting documentation regulatory requirements, there is 

noncompliance. 

When IPP determine that there is not enough information available to determine 

whether the establishment complies with 9 CFR §417.5(a) (1), they should notify 

establishment management. This provides the establishment with an opportunity 

to support the decisions made, or to reassess the hazard analysis and make 

decisions that it can support. After allowing the establishment the opportunity to 

provide additional support, if IPP are still uncertain whether the implementation of 

the prerequisite program and the records generated from a prerequisite program 

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

their supervisor. 

If IPP have concerns about the design of the procedures or programs an 

establishment is using to support decisions in the hazard analysis, they should 

contact the Policy Development Division (PDD) or an EIAO through supervisory

channels. EIAOs conduct comprehensive food safety assessments in 

establishments to verify that the design of the food safety systems in operation 

meet regulatory requirements.
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Noncompliance with the Supporting Documentation Requirement When 

Using a Prerequisite Program or Other Supporting Program

One or more of the following findings evidence that the establishment has not 

met the requirement of 9 CFR 417.5(a) (1): 

 The establishment employees are not implementing the procedures in the 

prerequisite program sufficiently to continue to support that the relevant 

hazard is not reasonably likely to occur. 

 The prerequisite program records indicate consistent or repeated failures 

to implement the procedures that are used to support the decision in the 

hazard analysis that the relevant hazard is not reasonably likely to occur. 

 The prerequisite program records do not demonstrate that the program 

continues to support the decision in the hazard analysis that the relevant 

hazard is not reasonably likely to occur. 

The following are examples of noncompliance with the supporting documentation 

requirement.

Noncompliance Example 1: An IPP is performing a Slaughter HACCP 

verification task in an establishment that slaughters 30 months of age and older 

cattle. While performing the task, he observes spinal cord on a carcass that 

passed through the establishment’s spinal cord removal step. The establishment 

has a prerequisite program for SRMs removal to support their decision in the

Hazard analysis that SRMs are not reasonably likely to occur, the program 

states that all spinal cords must be removed at the spinal cord removal step, you 

had a meeting with the establishment’s manager yesterday about their less than

perfect implementation of the SRMs removal prerequisite program multiple times 

over the last few weeks. The finding would represent noncompliance with 9 

CFR 310.22(c) and (e) because the establishment has failed to implement its 

procedures for removal of SRMs. This finding would call into question the 

establishment’s decision SRM is not reasonably likely to occur. The IPP 

decided to discuss this noncompliance with his supervisor to identify further 

enforcement actions.

Noncompliance Example 2: An IPP is performing the Slaughter HACCP 

verification task to verify that an establishment is in compliance with 9 CFR 

417.5(a)(1). She reviews the hazard analysis and finds that the establishment 

implements a prerequisite program for the specified risk materials to support that 

the hazard of SRM is not reasonably likely to occur. The prerequisite program 

states that all of the specified risk materials will be removed from the carcasses 

at different SRM removal stations. This procedure is implemented throughout the 

processing steps to ensure the absence of all of the SRM from edible products 

before boxing. 
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The establishment will have 5 SRM removal stations.

 Station one (located in the kill floor next to the head inspection area): the 

establishment’s trained employee will remove the palatine and the lingual 

tonsils from the head and the tongue. 

 Station two (located in the auger room): the establishment’s trained employee 

will remove the brain by a suction apparatus and dispose the skull in the 

marked SRM containers.

 Station three (located in the kill floor after the viscera inspection): The entire 

intestine including the distal ileum will be condemned and disposed in the

marked SRM containers.

 Station four (located on the kill floor before the final trim rail): the spinal cord 

will be removed entirely by specified marked tools (orange handle).

 Station five (located in the boning room): the vertebral column will be 

removed by specified marked tools (orange handle) and disposed of in the 

marked SRM containers. 

All SRM will be destroyed through denaturing with a formula consisting of one 

part FD&C No. 3 green coloring, 40 part water, 40 parts liquid detergent, and 40 

parts oil of citronella.

The establishment employees who are assigned to the SRM stations will be 

trained on the SRM removal procedure (the procedure is attached to the 

prerequisite program file). 

The establishment will maintain daily records to document the implementation 

and the monitoring of the procedures for the removal, segregation, disposition of 

the SRM, and any corrective actions taken.

The QC supervisors will monitor the effectiveness of the SRM removal at all of 

the SRM removal stations twice per day (per station), and log the monitoring 

time, and sign. This information will be documented on the prerequisite program 

record Form A.

The establishment will maintain daily records to document the absence of SRM 

from the edible products. This will be done by the QC supervisor who will 

randomly check 20 hanging carcasses in the cooler and open, examine 4 boxes 

of finished products. This check will be done twice per day. The first check 

should be done before 11.30 am, and the second check should be done after 

11.30 am and before 2.30 pm. This information will be documented on the 

prerequisite program record Form B.
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If the QC supervisor observes any errors in implementing the program or 

observes any identifiable SRM on edible product, all corrective action steps 

should be followed (a copy of the corrective action steps is attached to the 

prerequisite program file).

The IPP asked the establishment manger to provide her with all prerequisite 

program records for the past 5 days. The manager provided her with the 

following records informing her that these are all the records that he has.

The IPP asked the establishment manager if he has the rest of the prerequisite 

program records, he replied, “These are all of the records I have.” The IPP 

subsequently went to the kill floor and found that the establishment had 5 SRM 

stations, but 2 stations did not have any employees on location. This finding 

would call into question the establishment’s decision SRM is not 

reasonably likely to occur. 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 SRM would 

not be a hazard reasonably likely to occur and 9 CFR 310.22(c)and (e)

Pre requisite program form A

Date Station 

#

Time finding Corrective 

actions

signature

01-01-2012 1 6 am No finding N/A JOHN SMITH

01-01-2012 1 11.30 am

01-01-2012 2 6.30 am

01-01-2012 2 12.30 pm

01-01-2012 3 7.00 am No finding JOHN SMITH

01-01-2012 3 1.00 pm

01-01-2012 4 7.30 am

01-01-2012 4 1.30 am

01-01-2012 5 8.00 am

01-01-2012 5 2.00 pm No finding JOHN SMITH

Pre requisite program form A

Date Station 

#

Time finding Corrective 

actions

signature

01-05-2012 1 6 am No finding N/A JOHN SMITH

01-05-2012 1 11.30 am

01-05-2012 2 6.30 am

01-05-2012 2 12.30 pm

01-05-2012 3 7.00 am No finding N/A JOHN SMITH

01-05-2012 3 1.00 pm

01-05-2012 4 7.30 am

01-05-2012 4 1.30 am

01-05-2012 5 8.00 am

01-05-2012 5 2.00 pm
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Inspection Methods 18-67

because the establishment has failed to implement its procedures for 

removal of SRMs. The IPP decided to discuss this noncompliance with her 

supervisor to identify further enforcement actions.

Noncompliance Example 3: An IPP is reviewing the hazard analysis in a small 

fully cooked ham operation, during the performance of the Fully Cooked-Not 

Shelf Stable HACCP verification task. He observes at the raw material storage 

step that the establishment is implementing a temperature control prerequisite 

program to maintain the internal product temperature below 42°F to support that 

the hazard of pathogen growth is not reasonably likely to occur. The IPP asked 

the establishment manager to provide him with all prerequisite program records 

for the past 5 days, which includes the day the specific production was produced. 

While reviewing the records the IPP finds that the temperature results for the last 

three days are missing. The IPP asked the establishment manager if the 

temperatures were taken for those days according to the prerequisite program 

procedures, he replied, “The establishment employee that is responsible for 

implementing the prerequisite program was out sick and I didn’t have another 

employee to perform this program”. The IPP asked the establishment manager to 

provide him with the records from the last 15 days. After reviewing the records 

and discussing the issue with the establishment manager, the IPP finds that the 

establishment did not follow the temperature control program 10 days out of the 

last 15 days. 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 pathogen growth 

would not be a hazard reasonably likely to occur. This finding would call 

into question the establishment’s decision that the hazard of pathogen 

growth is not reasonably likely to occur. The IPP decided to discuss this 

noncompliance with his supervisor to identify further enforcement actions.

IPP document the HACCP verification task results in PHIS including any 

noncompliance. 
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Workshop: Supporting Documentation- Prerequisite Programs 

and Other Supporting Programs

Refer to the handout to complete the following questions.

1. An IPP is performing the Raw Non-Intact HACCP verification task, he reviews 

the hazard analysis and finds that the establishment implements a 

prerequisite program for metal detection to support the decision they made in 

the hazard analysis that the physical hazard/metal (broken needles) is not 

reasonably likely to occur. He reviews the metal detection program and finds 

that the establishment maintains a daily record of the metal detection results. 

He asks the establishment manager to provide him with the prerequisite 

program record for the day the specific production was produced. The 

establishment manager could not produce the record. Thus, the IPP asks him 

for the metal detection records from the previous 4 working days. The 

establishment manager could only provide the IPP with a record from one day 

stating, “These are all of the records I have”. 

a. Is there any noncompliance with the support documentation 

recordkeeping requirements in this scenario?

b. What should he do next?
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2. An IPP is performing the Raw Intact HACCP verification task, she reviews the 

hazard analysis and finds that the establishment implements a prerequisite 

program for product temperature control to support the decision they made in 

the hazard analysis that the growth of pathogens is not reasonably likely to 

occur. The temperature control program indicates that 2 internal product 

temperatures are taken daily. She asks the establishment manager to provide 

her with the prerequisite program record for the day the specific production 

was produced. She sees that only one measurement is documented on the 

record instead of two results.

a. Is there any noncompliance with the support documentation 

recordkeeping requirements at this point?

b. What should she do next?
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Corrective Actions 

Before we elaborate on the corrective action requirements, let’s review the 

difference between a deviation from a critical limit and a HACCP noncompliance.

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

determined by the establishment for a CCP. If a deviation from a critical limit 

occurs, an establishment is required to take corrective actions in accordance with 

9 CFR 417.3. 

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

requirements of 9 CFR parts 417. If a HACCP noncompliance occurs, an 

establishment is expected to take immediate and further planned actions to bring 

itself back into compliance with regulations. 

When IPP verify HACCP implementation, they are to verify that establishments 

meet the corrective action requirements whenever an event occurs that requires 

corrective action. For instance, whenever IPP determine through their own 

observations or through the review establishment records (e.g. monitoring 

records) that a deviation from a critical limit or other unforeseen hazard has 

occurred, they are to verify that the establishment implements corrective actions 

that meet the regulatory requirements. IPP verify that corrective action 

requirements are met while performing the HACCP verification task. If necessary, 

IPP are to initiate a directed HACCP verification task to document their 

verification of corrective action requirements when a routine HACCP verification 

task is not available (e.g., all of the routine tasks have either been scheduled or 

already performed for the month). 

Note: IPP may not be able to verify corrective action requirements during a 

routine HACCP verification task if no corrective action is required for that specific 

production. 

A. Corrective Actions in Response to a Deviation from a Critical Limit

When a deviation from a critical limit occurs, the establishment must implement 

the corrective actions specified in the HACCP plan. The regulation that applies to 

corrective actions taken in response to a deviation from a critical limit is:

9 CFR Part 417.3(a)—The written HACCP plan shall identify the corrective action 

to be followed in response to a deviation from a critical limit. The HACCP plan 

shall describe the corrective action to be taken, and assign responsibility for taking 

corrective action, to ensure: (1) The cause of the deviation is identified and 

eliminated; (2) The CCP will be under control after the corrective action is taken; 

(3) Measures to prevent recurrence are established; and (4) No product that is 

injurious to health or otherwise adulterated as a result of the deviation enters 

commerce.
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The thought process that IPP should use when verifying regulatory requirements 

includes:

 gathering information by asking questions;

 assessing the information; and 

 determining regulatory compliance.

This thought process should be utilized when verifying all of the regulatory 

requirements. 

Gather information by asking questions

To verify compliance with the corrective action regulatory requirements, IPP 

should seek the answer to the following questions:

1. Did the establishment identify and eliminate the cause of the 

deviation? 

2. Did the corrective actions ensure that the CCP is brought under 

control?

3. Were measures implemented to prevent recurrence of the deviation?

4. Did the actions ensure that no product that is injurious to health or 

otherwise adulterated, as a result of the deviation, enters commerce?

Assess the information

When seeking answer to these questions, the IPP should:

 Observe the establishment executing the corrective actions. 

 Review the corrective action records associated with the deviation from 

the critical limit. 

 Compare the establishment’s recorded corrective actions to the regulatory 

requirements listed in 9 CFR 417.3(a) to determine whether the corrective 

actions taken by the establishment in response to the deviation from the 

critical limit meet the requirements. 

Now let’s have a look at each of these in more detail.

Observing the Establishment Execute Corrective Actions

In observing the establishment executing corrective actions, the IPP should verify 

that the appropriate affected product has been identified.
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Corrective Action Example 1, Part 1: Upon arrival at a raw ground beef patty 

operation establishment on an IPP patrol assignment at 10:30 am, the IPP is 

notified by the establishment management that there has been a deviation of the 

metal detection critical limit. He thanks the establishment manager for voluntarily 

notifying him about this situation. He knows that he must verify that the corrective 

action requirements are met, and realizes he could do this by performing the 

review and observation component of the Raw Non-intact HACCP verification 

task. He reviews the establishment’s HACCP plan and finds that the monitoring 

procedure is that the packaging line supervisor will check the metal detector 

using a seeded sample every two hours to determine that the metal detector is 

functioning, that results are recorded on the metal detection control log, and that 

corrective actions are recorded on the corrective action log. He finds that the 

corrective actions are “all parts of 417.3 will be met.” He proceeds to the 

production area and reviews the metal detection control log, and finds the 

deviation noted at the 10:04 am monitoring check. The form notes that the 

equipment failed to detect the seeded sample. He notes that the form states that 

at the 8:00 check the equipment was operating properly. He observes that the 

establishment has product identified and segregated. He inspects the amount 

and the codes of segregated product and compares them to the codes on the 

monitoring record. He asks the packaging line supervisor about the segregation 

of product and is informed that all products produced after the 8:00 am check has 

been identified and segregated. He determines that the establishment has 

segregated the appropriate affected product.

Note: IPP are to verify that the establishment applies corrective actions to all 

product affected by the deviation. IPP must consider how the establishment 

defined the affected product and verify that additional products are not implicated 

by the deviation hazard. IPP must consider any available information about the 

establishment process that could indicate whether additional product was 

affected. These sources of information may include:

 Other establishment HACCP monitoring or verification records, 

 SSOP records, 

 Establishment testing results, and 

 The records of any related prerequisite programs. 

He would observe the execution of corrective actions to verify that the cause of 

the deviation has been identified and eliminated.

Corrective Action Example 1, Part 2: Continuing with the above example, the 

IPP continues to observe the establishment’s actions in the production area. He 

observes that production has stopped. Maintenance employees are working on 

the metal detector, which is then removed from the area. The packaging line 

supervisor reports to him that the unit is malfunctioning, and that it will not be 

used until it is repaired. Later, the establishment informs him that the cause of 

the deviation was that water got into the machine during cleanup. They establish 
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a new SOP for removing the machine from the area during wet cleanup. Based 

on these observations, he determines that the establishment has identified and 

eliminated the cause of the deviation.

He would observe the execution of corrective actions to verify that the CCP is 

under control upon completion.

Corrective Action Example 1, Part 3: Continuing with the above example, the 

IPP continues to observe the establishment’s actions in the production area. The 

establishment brings in a replacement unit for the metal detector. The packaging 

line supervisor checks the replacement unit with the seeded sample, and the 

equipment responds appropriately. The IPP observes production resume. The 

packaging line supervisor notifies him that they will perform the monitoring 

checks at an increased frequency of once per hour for one week. Based on these 

observations, he determines that the establishment has the CCP under control.

He would observe the execution of corrective actions to verify that the 

establishment prevents product that is injurious to health or otherwise 

adulterated, as a result of this deviation, from entering commerce.

Corrective Action Example 1, Part 4: Continuing with the above example, the 

IPP returns to the production area. He observes a monitoring check on the metal 

detector. Next, he observes as the establishment begins to run the segregated 

product through the metal detector. No metal is detected, and the packaging line 

supervisor releases the segregated product. Based on these observations, he 

determines that the establishment has prevented product that is injurious to 

health or otherwise adulterated, as a result of this deviation, from entering 

commerce.

He would observe the execution of corrective actions to verify that preventive 

measures are established.

Corrective Action Example 1, Part 5: Continuing with the above example, it is 

now about two weeks since the deviation. The IPP reviews the establishment’s 

HACCP plan and finds that a verification procedure has been added, “make an 

observation that the machine has been placed in a dry room during cleanup”. He 

goes to the production area. He notices that the original metal detector, the one 

that malfunctioned, is back in place. He observes that the metal detector appears 

to be working. He reviews the monitoring records and observes that the 

monitoring had been done at the increased frequency for one week, as 

proposed. Later, he observes that the machine is removed to a dry room during 

cleanup. Based on these observations, he determines that the establishment has 

established preventive measures.
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Corrective Action Example 2, Part 1 - The IPP arrives at an establishment, 

which produces roast beef and is notified that an internal product temperature 

deviation occurred at the cooling CCP. The IPP begins the corrective action 

verification by reviewing the HACCP plan.

CCP Critical 

Limit 

Monitoring Verification Records Corrective 

Action 

CCP 3 

Cooling 

Product 

internal 

temperature 

reduced 

from 130°F 

to 80°F in 

less than 

1.5 hours 

and from 

80°F to 40°F 

in less than 

5 hours. 

Product 

internal 

temperature 

will be 

monitored 

continuously 

throughout 

process 

using 

recording 

chart 

temperature 

probes. The 

two pieces 

of product 

that are 

monitored 

will be 

visually 

selected by 

QC to 

represent 

largest 

pieces in the 

lot. 

Daily, QC 

Supervisor 

will review 

cooling 

temperature. 

chart 

Cooling 

temperature 

chart 

Calibration 

log 

Corrective 

action log 

All parts of 

417.3 will 

be met 

Next, the IPP reviews the cooling temperature chart. The first part of the critical 

limit was met, but the product took 6 hours to reduce from 80°F to 40°F. The IPP 

observes that the product has been moved to the storage cooler, and is held and 

segregated by QC. 

Note: IPP are to verify that the establishment applies corrective actions to all 

product affected by the deviation. IPP must consider how the establishment 

defined the affected product and verify that additional products are not implicated 

by the deviation hazard. IPP must consider any available information about the 

establishment process that could indicate whether additional product was 

affected. These sources of information may include: 

 Other establishment HACCP monitoring or verification records, 

 SSOP records, 
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 Establishment testing results, and 

 The records of any related prerequisite programs. 

The IPP would observe the execution of corrective actions to verify that the 

cause of the deviation has been identified and eliminated.

Corrective Action Example 2, Part 2 - verifying 417.3(a)(1): Continuing, the IPP 

observes that maintenance employees are working on the cooling unit. The 

maintenance supervisor reports that one of the motors burned out, and is being 

replaced. The IPP determines that the establishment has identified and 

eliminated the cause of the deviation. 

The IPP would observe the execution of corrective actions to verify that the CCP 

is under control upon completion.

Corrective Action Example 2, Part 3 - verifying 417.3(a) (2): Continuing, the 

IPP observes that the cooler unit is returned to production. The QC Supervisor 

reports QC will observe the cooler temperature every hour through a complete 

cooling cycle, in addition to product temperature. The IPP determines that the 

CCP is under control. 

The IPP would observe the execution of corrective actions to verify that 

preventive measures are established.

Corrective Action Example 2, Part 4 - verifying 417.3(a)(3): Continuing, the QC 

Supervisor reports that the HACCP plan is being modified to include a verification 

procedure for checking the cooler temperatures. The IPP reviews the HACCP 

plan. Verification has been modified to include: “Once per cooling cycle, QC will 

check cooler temperature.” Additionally, the QC Supervisor informs the IPP that a 

new maintenance SOP has been established, to check cooler unit operation 

monthly. The IPP determines that the establishment has established preventive 

measures. 

The IPP would observe the execution of corrective actions to verify that the 

establishment prevents product that is injurious to health or otherwise 

adulterated, as a result of this deviation, from entering commerce. Additionally, in 

reviewing the corrective action records, the IPP should compare the 

establishment‘s recorded corrective actions with the requirements of 417.3(a).

Corrective Action Example 2, Part 5 - verifying 417.3(a)(4): Continuing with 

example 2, the establishment has held and segregated the affected product, and 

provided a processing authority with its cooling data points (time/temperature 

combinations) for the deviation. The processing authority has plotted the data 

into a pathogen-modeling program and used other scientific literature to 

determine that there would be no outgrowth of Clostridium botulinum and no 

more than one log increase in Clostridium perfringens, based on the cooling 
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curve that the product experienced. The report from the processing authority, 

which indicates that the product is safe for distribution, is attached to the 

corrective action log. The IPP determines that the establishment has prevented 

product that is injurious to health or otherwise adulterated, as a result of this 

deviation, from entering commerce. The IPP determines that the requirements for 

417.3(a) have been met. The IPP verifies all the regulatory requirements at all 

CCPs for that specific production, determines that the establishment has carried 

out the pre-shipment review for that particular specific production, and records 

the results in PHIS as a directed Fully Cooked-Not Shelf Stable HACCP 

verification task. 

Note: Though this procedure would probably be entered as a directed HACCP 

Verification task, it is possible that the IPP could have already has a routine 

HACCP verification task in progress on this specific production. In that case, the 

entry would be made in the in-progress routine HACCP verification task.

Reviewing the Corrective Action Records

In reviewing the corrective action records, the IPP should compare the 

establishment’s recorded corrective actions with the requirements of 417.3(a).

Corrective Action Example 1, Part 6: Continuing with example 1, the IPP 

reviews the establishment’s corrective action log for this deviation. He compares 

the recorded corrective actions with what he has observed, and with the 

requirements of 417.3(a), and finds that all requirements were met The 

establishment identified and eliminated the cause of the deviation, the CCP was 

under control after the corrective action was taken, measures to prevent 

recurrence were established, and no product that is injurious to health or 

otherwise adulterated, as a result of the deviation, entered commerce. The IPP 

observes the record that shows the proposed maintenance repairs were 

performed. He determines that this requirement is met.

Determine Compliance

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

corrective action requirement, they must determine regulatory compliance. If 

they find that the establishment has met all corrective action regulatory 

requirements in 9 CFR 417.3(a), then there is no regulatory noncompliance. 

When IPP document compliance with the corrective action requirement, they are 

to briefly describe their observations that support a finding of compliance as 

described in FSIS PHIS Directive 5000.1. If they find that the establishment has 

not met all corrective action regulatory requirements, there is noncompliance. 

More information about making compliance determinations is provided in another 

section of the training.
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Noncompliance with the Corrective Action Requirements 

One or more of the following findings evidence that the establishment does not 

comply with 9 CFR 417.3(a): 

 The establishment does not implement a corrective action specified in the 

HACCP plan in response to a deviation from a critical limit. 

 The establishment’s corrective action does not identify and eliminate the 

cause of the deviation. 

 The establishment’s corrective action does not result in the CCP coming 

back under control. 

 The establishment’s corrective action does not prevent adulterated 

product from entering commerce. 

 The establishment’s corrective action does not prevent recurrence of the 

deviation. 

The following are examples of noncompliance with 417.3(a):

Noncompliance Example 1, Part 1: An IPP is reviewing monitoring records for 

the TSP CCP in a poultry slaughter operation and he finds that at 0800 the 

recorded TSP concentration was below the critical limit of 8%. She proceeds to 

verify that corrective actions were taken as required in 417.3(a) by reviewing an 

excerpt from the entries in the corrective action log, which reads as follows: 

“TSP concentration control dial was increased to 9% at 0805. Chlorine in the 

chiller was increased from 20 to 40 ppm and the post-chill chlorinated rinse 

cabinets were turned on at 0810.” These actions are consistent with the 

corrective actions regulations but she finds no documentation and observes no 

evidence that the establishment attempted to identify the cause of the 

deviation from the critical limit.

Noncompliance Example 1, Part 2: Continuing from the example above, the 

establishment later documents that the deviation from the critical limit was due to 

a defect in the electronic apparatus that controls the TSP concentration. She 

finds no record and no evidence that the establishment took any actions to repair 

or replace the electronic device. The establishment identified the cause of the 

deviation from the critical limit but did not take appropriate actions to 

eliminate the cause. 

Noncompliance Example 1, Part 3: Continuing the example above, she reviews 

the corrective action records again and finds that there was no follow-up 

measurement to verify that the TSP concentration was above the critical limit of 

8% after the electronic control was turned up to 9%. The establishment did not 

implement appropriate measures to ensure the CCP was under control 
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after the actions were taken.

Noncompliance Example 1, Part 4: Continuing the example above, if the 

establishment had not implemented the measures of increasing the chiller 

chlorination and turning on the chlorinated rinse cabinets, it could be assumed 

that the establishment did not take measures to ensure that no product 

injurious to health or otherwise adulterated enters commerce.

Noncompliance Example 2, Part 1: An IPP is reviewing monitoring records for 

the post-packaged pasteurization CCP in a sliced turkey bologna operation and 

she finds that at 0800 the recorded pasteurization temperature was below the 

minimum critical limit of 475oF. She proceeds to verify that corrective actions 

were taken as required in 417.3(a) by reviewing an excerpt from the entries in the 

corrective action log, which reads as follows: 

“The air temperature was increased to 575oF at 0805”. She finds no 

documentation and observes no evidence that the establishment attempted to 

identify the cause of the deviation from the critical limit. 

Noncompliance Example 2, Part 2: Continuing with this example, the 

establishment later documents that the deviation from the critical limit was due to 

a defect in the electronic device that controls the oven air temperature. The IPP 

finds no record and no evidence that the establishment took any actions to repair 

or replace the electronic device. The establishment identified the cause of the 

deviation from the critical limit but did not take appropriate actions to 

eliminate the cause. 

Noncompliance Example 2, Part 3: Continuing with this example, she reviews 

the corrective action records again and finds that there was no follow-up 

measurement to verify that the air temperature was above the critical limit of 

475oF after the electronic control was turned up to 575oF. The establishment 

did not implement appropriate measures to ensure the CCP was under 

control after the actions were taken. 

Noncompliance Example 2, Part 4: Continuing with this example, the 

establishment had not identified the affected product that went through the 

process while the temperature was below 475oF and did not reprocess the 

affected product after increasing the air temperature to 575oF. The 

establishment did not take measures to ensure that no product injurious to 

health or otherwise adulterated enters commerce.

Note: Remember; anytime there is a deviation from a critical limit, the IPP will 

verify that the corrective actions taken by the establishment meet the 

requirements of the regulation. In addition, the IPP will verify the establishment‘s 

support when product is retreated with critical operating parameters different 

from the ones stated in the HACCP plan and determine whether they are 
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effective in controlling or preventing the relevant hazard. For instance, in the 

noncompliance example above, there is a potential issue with increased bacterial 

resistance to heat if the original heat treatment did not destroy the target 

microorganism. 

IPP are to take regulatory control action to prevent adulterated product from 

entering commerce when it becomes apparent that the establishment intends to 

release product but cannot demonstrate that it is not adulterated. For example, if 

the establishment signs the pre-shipment review before performing necessary 

corrective actions. Once the establishment has signed pre-shipment review, 

FSIS considers the product to be in commerce. IPP are to retain the affected 

product before it leaves the establishment if they find evidence that the 

establishment‘s intended actions would result in adulterated product entering 

commerce.

IPP document the HACCP verification task results in PHIS including any 

noncompliance. 

B. Corrective Actions in Response to a Deviation Not Covered by a 

Specific Corrective Action, or an Unforeseen Hazard

The regulation that applies when a deviation not covered by a specific corrective 

action or an unforeseen hazard occurs is:

9 CFR 417.3(b)—If a deviation not covered by a specified corrective action occurs, 

or if another unforeseen hazard arises, the establishment shall: (1) Segregate and 

hold the affected product, at least until the requirements of paragraphs (b)(2) and 

(b)(3) of this section are met; (2) Perform a review to determine the acceptability 

of the affected product for distribution; (3) Take action, when necessary, with 

respect to the affected product to ensure that no product that is injurious to health 

or otherwise adulterated, as a result of the deviation, enters commerce; (4) 

Perform or obtain reassessment by an individual trained in accordance with §417.7 

of this part, to determine whether the newly identified deviation or other unforeseen 

hazard should be incorporated into the HACCP plan.

The thought process IPP should use when verifying regulatory requirements 

includes:

 gathering information by asking questions;

 assessing the information; and 

 determining regulatory compliance.

This thought process should be utilized when verifying all of the regulatory 

requirements. 

Gather information by asking questions
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IPP should answer the following questions to determine whether the corrective 

action requirements have been met:

1. Did the establishment segregate and hold all affected product?

2. Did the establishment perform a review to determine the acceptability 

of the affected product for distribution?

3. Did the establishment take necessary action with respect to the 

affected product to ensure that no product that is injurious to health, or 

otherwise adulterated as a result of the deviation, enters commerce?

4. Was a reassessment conducted to determine whether the newly 

identified deviation or other unforeseen hazard should be incorporated 

into the HACCP plan?

Assess the information

When seeking answer to these questions, the IPP should:

 Review the corrective action records associated with the deviation not 

covered by a specific corrective action or unforeseen hazard and observe 

the establishment executing the corrective actions. 

 Compare the establishment’s recorded corrective actions to the regulatory 

requirements listed in 9 CFR 417.3(b) (1) and (2) (3)(4) to determine 

whether the corrective actions taken in response to the deviation from the 

critical limit meets all of these requirements.

 Observe the establishment segregating and holding the affected product 

to verify that the establishment segregated and held all affected product.

 Observe the establishment evaluating the affected product to verify that 

only acceptable product is released.

 Review the corrective action records; determine if a reassessment was 

performed. 

Now let’s look at each of these in more detail.

Reviewing the Corrective Action Records

In reviewing the corrective action records, the IPP should compare the 

establishment’s recorded corrective actions with the requirements of 417.3(b).
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Corrective Action Example 3, Part 1: An IPP is performing the Slaughter 

HACCP verification task in a poultry slaughter establishment. She finds that an 

event has occurred earlier in the shift, in which the establishment monitoring 

personnel found metal shavings on the carcasses exiting from the chill system. 

The establishment decided that the metal would constitute a food safety hazard. 

The establishment has no CCP for metal contaminants in the chill system. She 

reviews the corrective action log dated 2-1-2012 and finds the following entry for 

this incident: 

All carcasses exiting the chill system held by QA in vats and placed in the cooler. 

Carcasses were visually examined by production personnel for the presence of 

metal. Metal shavings were removed from affected carcasses. All carcasses will 

be deboned and resulting product run through a metal detector system. The 

HACCP plan will be reassessed by 2-3-2012. Based upon her review of the 

records, she determines that the recorded actions meet the requirements of 

417.3(b).

Observing the Establishment Execute Corrective Actions

She would observe the establishment executing corrective actions to verify that 

all affected product is segregated and held.

Corrective Action Example 3, Part 2: Continuing from the previous example in 

which there were metal shavings on the product, the IPP verifies that the 

establishment segregates and holds the affected product by going to the chiller 

and the cooler to observe the product. At the chiller, she finds no product exiting 

the chiller since operations ceased an hour earlier. She finds the affected product 

held by a QA tag and segregated in the cooler. Based upon her observations, 

she determines that the establishment has adequately held and segregated 

affected product.

She would observe the establishment evaluating the affected product to verify 

that only acceptable product is released.

Corrective Action Example 3, Part 3: Continuing from the previous example in 

which there were metal shavings on the product, the IPP observes the 

establishment examine and remove the metal contaminants, debone the 

carcasses, and run the boneless product through a metal detector. Upon 

completion of the establishment’s corrective actions, she inspects several 

samples of boneless product and finds no trace of metal contamination. Based 

upon her observations the establishment took necessary measures to ensure 

that only acceptable product was released.
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Determine if a Reassessment was Performed and Documented

IPP verify that establishments perform a reassessment when an unforeseen 

hazard occurs (9 CFR 417.3(b)(4)), provide supporting documentation for 

decisions made during the reassessment (9 CFR 417.5(a)(1)), and make a 

record of the reassessment by documenting 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 (9 CFR 417.4(a)(3)(ii)) while 

performing the directed HACCP verification task.

Note: IPP are to verify the reassessment requirement as part of the HAV task. 

However, if during the performance of the HACCP verification task, IPP discover 

that the establishment performed a reassessment that is not documented in 

accordance with 9 CFR 417.4(a)(3)(ii), IPP are to document the noncompliance 

under the HACCP verification task being performed if a HAV task is not being 

performed. 

Corrective Action Example 4: During a Raw Non-intact HACCP verification 

task and while reviewing the establishment’s HACCP plan for raw ground beef, 

the IPP observes a notation that the HACCP plan has been reassessed, and 

updates made. She further observes that the establishment has added a CCP at 

receiving that reads, “E. coli O157:H7 in raw beef trimmings”. The critical limit is 

that suppliers must provide certification that products have been subjected to a 

validated antimicrobial carcass treatment. She decides to investigate further and 

asks for more information, and any supporting documentation, from 

establishment management. She learns that this reassessment was conducted 

as a result of an unforeseen hazard. She is shown a laboratory test result that 

the establishment conducted on finished product, which came back positive for 

E. coli O157:H7. 

This is the first positive result for this organism. The corrective action log shows 

that all corrective actions were met, and product was diverted for cooking. The 

IPP was shown a record documenting the reassessment, which states that 

because of the positive result the establishment determined that E. coli O157:H7 

was now considered “reasonably likely to occur” and therefore this update was 

made to the hazard analysis and the HACCP plan was modified. The IPP 

determines that the establishment has met its requirement to perform 

reassessment when an unforeseen hazard arises and to determine whether the 

unforeseen hazard should be incorporated into the HACCP plan. She determines 

that the establishment is in compliance with 9 CFR 417.3(b) and 417.4(a)(3)(ii).

Note: She would also verify the support for the decisions in the HACCP plan 

during the directed HACCP verification task performed as a result of the 

unforeseen hazard, e.g., the documentation the establishment receives from its 

supplier stating what antimicrobial treatment is applied to the trimmings that are 

received, and the specified reduction in the number of pathogens achieved, 
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documentation for the selection and placement of the CCP and the support for 

monitoring and verification procedures and frequencies at the receiving CCP, etc.

Determine Compliance

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

corrective action requirement, they must determine regulatory compliance. If 

they find that the establishment has met all corrective action regulatory 

requirements in 9 CFR 417.3(b), then there is no regulatory noncompliance. 

When IPP document compliance with the corrective action requirement, they are 

to briefly describe their observations that support a finding of compliance as 

described in FSIS PHIS Directive 5000.1. If they find that the establishment has 

not met all regulatory requirements for corrective action, there is noncompliance. 

More information about making compliance determinations is provided in another 

section of the training.

Noncompliance with the Corrective Action Requirements

One or more of the following findings evidence that the establishment does not 

comply with 9 CFR 417.3(b): 

 An unforeseen hazard occurs or there is a deviation not covered by a 

specified corrective action and the establishment fails to take the 

corrective actions required by 9 CFR 417.3(b). 

 The establishment’s corrective action does not segregate and hold all 

affected product. 

 The establishment does not perform a review to determine the 

acceptability of the affected product. 

 The establishment’s corrective action does not prevent adulterated 

product from entering commerce. 

 The establishment does not reassess the relevant HACCP plan to 

determine whether to address the unforeseen hazard 

The following are examples of noncompliance with 417.3(b):

Noncompliance Example 1, Part 1: Continuing from our above example in 

which metal shavings were found on carcasses coming out of the poultry chiller, 

if the IPP found product in the cooler with metal shavings that the establishment 

had not held, she would conclude that all affected product was not held. 

Noncompliance Example 1, Part 2: If the personnel collecting the birds coming 

out of the chill system had misunderstood which chiller was affected and held 
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product from the wrong chill system, the establishment would have held product 

but it would not be the affected product.

Noncompliance Example 1, Part 3: If the establishment did not thoroughly 

examine the product and pass the deboned product through a metal detector, the 

establishment did not evaluate the product to determine whether it was 

acceptable for distribution.

Noncompliance Example 1, Part 4: If the establishment found metal in the 

product after corrective actions were completed and did not hold the product, the 

establishment did not take necessary action to ensure that no product 

injurious to health enters commerce.

Noncompliance Example 1, Part 5: If the establishment did not perform a 

HACCP plan reassessment after the unforeseen hazard event, it would not be 

in compliance with 417.3(b).

Noncompliance Example 2: An IPP is performing the Raw Non-Intact HACCP 

verification task in a small beef grinding operation and he is verifying the 

establishment recordkeeping requirements for all CCPs. He reviews a recent 

corrective action log that documents a large fecal smear observed on the 

boneless bull meat chucks as they were being prepared for grinding. Currently, 

the establishment does not have a CCP for visual observation of raw materials. 

Under preventive measures on the corrective action log, “none needed” is 

recorded. He asks whether they considered this an unforeseen hazard, and 

whether they performed a reassessment of the hazard analysis and HACCP 

plan. The QC manager replies, “No, because this was the only time we’ve 

observed this.” A deviation not covered by a specific corrective action or an 

unforeseen hazard occurred, and a reassessment was not conducted.

Noncompliance Example 3: The establishment’s test result for a lot of cooked 

sliced chicken was positive for Lm. The IPP found that half the product with this 

lot number was not held by the establishment. The establishment did not hold 

the affected product. 

Noncompliance Example 4: The personnel handling the Lm positive fully 

cooked sliced ham had misunderstood which operation line was affected and 

held product from the wrong operation line. The establishment held product but 

it was not the affected product. 

Noncompliance Example 5: The establishment did not destroy or rework a lot of 

hot dogs that passed over an Lm contaminated food contact surface and the 

product was not in the cooler. The establishment did not evaluate the product 

to determine whether it was acceptable for distribution. 
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Noncompliance Example 6: The establishment found the hot dog packaging 

conveyor belt to be positive for Lm after corrective actions were completed and 

did not hold the product. The establishment did not take necessary action to 

ensure that no product injurious to health enters commerce. 

Noncompliance Example 7: If the establishment did not perform a HACCP 

plan reassessment after the unforeseen hazard event, it would not be in 

compliance with 417.3(b).

IPP document the HACCP verification task results in PHIS including any 

noncompliance. 
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Workshop: Corrective Action

Refer to the handout to complete the following questions.

1. An IPP is reviewing a HACCP record and observes that a result of 3% is 

recorded as a monitoring check. The critical limit at this CCP is “at least 6%.” 

a. At this point in the review, is this a deviation from a critical limit and/or a 

HACCP noncompliance?

b. Continuing with the above, if the establishment’s records indicate that all 

corrective actions met the requirements of 417.3(a), is there a HACCP 

noncompliance?

2. The HACCP plan specifies that the CCP for product temperature will be 

monitored by checking product at three locations in the cooler each hour, and 

recording all results. An IPP reviews the temperature log and observes that 

at each monitoring check there are only two temperatures recorded. All 

results are within critical limits.

a. Based only on the information given, is this a deviation from a critical limit, 

an unforeseen hazard, or a HACCP noncompliance? 

b. Would the IPP expect to see all corrective actions in section 417.3(a) 

taken for this situation? Please explain. 

3. An IPP is making observations in the poultry boning room, when she 

observes that there is a commotion among employees at the automatic breast 

deboning equipment. Investigating, she observes that a full set of viscera has 

been hung up on the equipment, and intestinal contents are spread all over. 

The employees shut off the line. Because she reviewed the HACCP plan this 

morning, she realizes that there is no CCP that addresses this situation. 

a. Which regulation would apply in this situation?
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b. At this point, is there a HACCP noncompliance?

c. What should the IPP do next?

The IPP observes the employees gather all of the chicken breasts from the 

area, put them into inedible containers, and begin cleaning up. She returns to 

her other duties, and later she goes to the QA office and asks for 

documentation of the actions taken.

d. Do the establishment’s recorded corrective actions meet all of the 

corrective action regulatory requirements?

e. What else should the IPP do in this situation?

HACCP CORRECTIVE ACTION OR UNFORESEEN HAZARD REPORT XYZ Corporation

Date: 1-2-2012

Product and amount affected: 397 lbs chicken breasts

Describe the unforeseen hazard, including cause: 

At 8:30 am viscera present in box of breasts got onto equipment causing major 

contamination. We stopped the line, disposed of product and did a full cleanup AB 8:50 am.

Describe how the affected product was segregated and held:

All product from line or near line disposed of as inedible AB 8:50 am.

Describe how the product was reviewed to determine acceptability for distribution:

In addition, we did a visual inspection of all product that we had not yet run from that lot, and 

reinspected a sample of the product already produced. No other defects found AB 9:15 am.

Describe measures taken to prevent a reoccurrence and/or to eliminate the cause:

Production employees were instructed to observe dumping of raw materials more closely. 

We have contacted the supplying establishment and their written reply attached. The next 

load of product from that supplier will be given 100 % reinspection before us e CD 2:00 pm.

State whether HACCP plan reassessed, conclusions, and any changes:

Yes, hazard analysis done, no changes to the HACCP plan. A new SOP for supplier 

certification/acceptability added for purchasing/receiving CD 3:00 pm 1-3-12.

Adel Brezil 1-3-12 Craig Darrow 1-3-12

Plant Management, date QA Manager, date

Example: For 

Training Use Only
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4. An IPP has recently rotated assignments and his new patrol includes a pork 

fabrication operation. Today’s schedule includes the Raw Non-Intact HACCP 

verification task. He observes that there is a metal detector in use on the pork 

cuts before they enter the tenderizer injector. He reviews the HACCP plan 

and hazard analysis, and he sees that the hazard analysis identifies metal, 

but finds it is not likely to occur. The HACCP plan does not have a CCP for 

metal detection. 

What might the IPP conclude at this point? 

Later that day, he learns that the metal detector has rejected product. He 

reviews the corrective action log.

a. What regulation applies to this situation? 

b. Did the establishment meet corrective action requirements? 

c. Is there a HACCP noncompliance? 

d. What else should the IPP do? 

HACCP CORRECTIVE ACTION OR UNFORESEEN HAZARD REPORT IJK Corporation

Date: 3-2-12

Product and amount affected: 25 lb boneless pork loin

Describe the unforeseen hazard, including cause: 

At 9:00 am the metal detector rejected product, which was carefully examined by QC, what 

looks like a syringe needle was found EF 10:05 am. 

Describe how the affected product was segregated and held:

We disposed of the piece as inedible EF 10:05 am

Describe how the product was reviewed to determine acceptability for distribution:

All product from that same load was run back through the metal detector but nothing else 

was found EF 1:00 pm. 

Describe measures taken to prevent a reoccurrence and/or to eliminate the cause:

We have contacted the supplying establishment XYZ and notified them that if it happens 

again we will no longer purchase from that supplier GH 11:00 am.

State whether HACCP plan reassessed, conclusions, and any changes:

Yes. Established a new CCP for metal detection. See new version of HACCP plan, dated 

3-2-12 GH 1:00 pm.

Eric Fazoli 3-2-12 Gerry Harroldson 3-2-12

Plant Management, date QA Manager, date

Example: For Training 

Use Only
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5. Read each of the following statements and then summarize in your own 

words what the HACCP noncompliance is. What regulation would you cite on 

the NR?

a. The HACCP plan lists a monitoring procedure for the temperature of the 

hot water pasteurization spray as “visual checking the temperature gauge 

three times per shift.” The critical limit is 180o F or above. The IPP 

reviews the monitoring log. 

Hot Water Pasteurization Spray, critical limit 180o F or above Date: 1-2-12

Time Temp Monitor Comments

6:45 am 182 OP

9:30 am 175 OP

12:00 183 OP

The IPP asks the monitor whether any corrective actions were done after 

the second check and the reply is “none.” She asks for the associated 

corrective action log and is told that there is none. What is the 

noncompliance and the regulatory reference?

b. The HACCP plan has a monitoring procedure for measuring internal 

product temperature of fresh pork sausage chubs. The IPP reviews the 

temperature log and observe a deviation recorded. He reviews the 

associated corrective action log and finds that the establishment recorded 

the cause of the deviation, eliminated the cause, and ensured that the 

CCP was in control before continuing production. His review also reveals 

that the establishment implemented an effective preventive measure. The 

corrective action report does not contain any record of what was done with 

the product that was produced while the critical limit was out of control. He 

reviews shipping records and observes that the product has been 

distributed. The establishment cannot produce any further records to 

demonstrate the safety of this product. What is the noncompliance and 

the regulatory reference?
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6. The results of a sample of sliced turkey ham the establishment sent to the lab 

for analysis was positive for Salmonella. The sampled lot of product was 

placed on hold pending laboratory analysis. The establishment evaluated the 

product for acceptability for distribution and determined to recook it. It 

performed a reassessment of the HACCP plan. That is the information the IPP 

observed recorded in the corrective action log as part of a directed Fully 

Cooked-Not Shelf Stable HACCP verification task he or she performed as a 

result of learning about the positive result. Does this meet the requirements of 

417.3(b)? Explain your answer. 
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Pre-Shipment Review Requirement

The regulatory requirement for pre-shipment review is:

9 CFR 417.5(c)--Prior to shipping product, the establishment shall review the 

records associated with the production of that product, documented in accordance 

with this section, to ensure completeness, including the determination that all 

critical limits were met and, if appropriate, corrective actions were taken, including 

the proper disposition of product. Where practicable, this review shall be 

conducted, dated, and signed by an individual who did not produce the record(s), 

preferably by someone trained in accordance with §417.7 of this part, or the 

responsible establishment official.

The purpose of a pre-shipment review is to ensure that adulterated product is not 

released into commerce. Therefore, the establishment must review the records 

associated with the production of specific product to ensure completeness, 

including the determination that all critical limits were met, and if appropriate, 

corrective actions were taken, including proper disposition of the product. To 

meet 9 CFR 417.5(c), the establishment’s pre-shipment review must include the 

review of all records, including any prerequisite program and disposition records,

used to determine whether the product is safe and not adulterated.

Establishments have a lot of flexibility in how they conduct the pre-shipment 

review. For instance, establishments can perform the review of their records in 

stages and by multiple employees. They are not required to gather all the 

records together and review them all at once prior to shipping the product in 

commerce. The establishment has the responsibility to evaluate its production 

and recordkeeping systems to determine how the review of the applicable 

records will be accomplished during the pre-shipment review procedure.

Note: When IPP have submitted a finished product sample to an FSIS lab to be 

tested for an adulterant, the establishment cannot complete the pre-shipment 

review until negative results are received. In addition, the establishment would 

not meet 9 CFR 417.5(c) if it completed the pre-shipment review before receiving 

test results for adulterants from samples it has submitted to its own lab. The 

establishment could review all the applicable records that are available, hold or 

control the product until acceptable test results are received from its lab, then 

perform the final review and release the product. 

There is no regulatory requirement for an establishment to conduct a preshipment review when the product moves from one process category to another 

in same establishment, e.g., carcasses from the slaughter process moving to 

further processing (cut-up or boning).

FSIS considers product to be “produced and shipped” when the establishment 

completes the pre-shipment review even if the product is still at the 
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establishment. Verifying that the establishment has completed the pre-shipment 

review enables IPP to know whether the company has taken full and final 

responsibility for applying its HACCP system controls to the product that it has 

produced. 

When IPP verify the establishment’s implementation of its HACCP system, they 

are to review the records for the specific production to verify that the 

establishment has conducted the pre-shipment review in accordance with 9 CFR 

417.5(c). Occasionally, when IPP perform the HACCP verification task, they are 

to observe the establishment employee performing the pre-shipment review 

procedure using the review and observation component of the task. The 

inspector in charge (IIC) determines how often (the frequency) IPP are to verify 9 

CFR 417.5(c) using review and observation in a multiple inspector establishment. 

The front line supervisor (FLS) determines how often IPP use review and 

observation to verify 9 CFR 417.5(c) in a single inspector assignment.

IPP should understand that the pre-shipment review can be accomplished if the 

product is at a location other than the producing establishment, as long as the 

review of appropriate documents and compliance with 9 CFR 417.5(c) occurs 

before the product leaves the control of the producing establishment. 

The thought process that IPP should use when verifying regulatory requirements 

includes:

 gathering information 

 assessing the information; and 

 Determining regulatory compliance.

This thought process should be utilized when verifying all of the regulatory 

requirements. 

Gather information by asking questions

IPP should seek the answer to the following questions:

1. Has the establishment reviewed all the records associated with the

production of the product, including any prerequisite program records 

that are part of the HACCP system, prior to shipment?

Note: Some prerequisite programs may not apply to a specific 

production. In addition, most procedures in the Sanitation SOP are not 

associated with a specific lot of product. If a prerequisite program or 

the Sanitation SOP procedure is not product specific and does not 

have a bearing on whether product is adulterated, the establishment 

does not need to review the records associated with program or 

Sanitation SOP as part of pre-shipment review. However, if the 

prerequisite program or Sanitation SOP procedure is associated with a 
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specific lot of product (e.g., test results for adulterants) establishments 

need to review the prerequisite program and Sanitation SOP records 

when conducting pre-shipment review. IPP are to be aware of the 

establishment’s HACCP system associated with the production of a 

specific product so that they can understand which programs are part 

of the HACCP system and which bear on the determination whether 

product is adulterated

2. Has the pre-shipment review been signed and dated by an 

establishment employee?

Assess the information

To answer these questions, the IPP should review the pre-shipment review 

records. 

Pre-shipment Review Compliance Example: An IPP is performing the 

Slaughter HACCP verification task in a poultry slaughter establishment, and 

verifying the establishment’s compliance with the pre-shipment review 

requirement. The IPP has already observed that the establishment performs preshipment review by looking at and signing and dating each CCP record and 

prerequisite program records associated with a shift’s production. The 

establishment has two CCPs (final wash and carcass chilling) and 3 prerequisite 

programs: chiller chlorine program, antimicrobial online reprocessing program, 

and a salmonella testing program. The IPP reviews the Sanova antimicrobial 

rinse CCP log and the chilling CCP log from yesterday’s shift and finds that all 

the results were entered, no corrective action was needed, and the 

establishment’s QC supervisor had signed and dated at the bottom of the record. 

He also reviews the 3 prerequisite program records and finds the same results 

Based on his observations; he determines that the establishment is in 

compliance with 9 CFR 417.5(c).

Determine Compliance

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

pre-shipment review requirement, they must determine regulatory compliance. If 

the IPP finds that the establishment has met all pre-shipment review regulatory 

requirements in 9 CFR 417.5(c), then there is no regulatory noncompliance. If the 

IPP finds that the establishment has not met all regulatory requirements for preshipment review, there is noncompliance. More information about making 

compliance determinations is provided in another section of the training.

Noncompliance examples with Pre-Shipment Review Requirement 417.5(c)

One or more of the following findings evidence that the establishment does not 

comply with 9 CFR 417.5(c): 
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 The establishment ships product in commerce without performing a preshipment review. 

 The establishment transports product to another location prior to preshipment review and cannot demonstrate that it maintains control of the 

product. 

 An establishment employee does not sign and date the pre-shipment 

review. 

 An establishment employee does not review the appropriate HACCP 

records associated with the production covered by the pre-shipment 

review. The appropriate HACCP records typically include the records of 

any monitoring activities, verification activities, corrective actions and 

records from prerequisite programs that are part of the HACCP system 

that were created during the production period covered by the preshipment review. 

If IPP find that the establishment employees failed to review a prerequisite 

program or SSOP record associated with the production of a specific product 

during the pre-shipment review and electronically or manually signed and dated

the pre-shipment review, they are to issue an NR citing both 9 CFR 417.5 (a)(1) 

and 417.5(c) as the regulations with which the establishment failed to comply.

IPP are to determine noncompliance with 9 CFR 417.5(a) (3) if the pre-shipment 

review records do not identify the specific production to which they apply (e.g., 

product codes, lot codes, product name, and production periods)

The following are examples of noncompliance with 417.5(c).

Noncompliance Example 1: The IPP is performing the Slaughter HACCP 

verification task on a specific production of turkey carcasses that has left the 

control of the establishment. She requests the pre-shipment review records for 

this production, which the establishment is not able to provide. The 

establishment shipped the product without conducting a pre-shipment 

review. The IPP determines that there is noncompliance with 417.5(c) and 

documents the noncompliance in PHIS.

Noncompliance Example 2: An IPP is performing the Slaughter HACCP 

verification task in a beef slaughter establishment, and verifying the 

establishment’s compliance with the pre-shipment review requirement using the 

review and observation component of the task. The establishment has two CCPs 

(zero tolerance and final wash), and a prerequisite program for specified risk 

materials (SRMs). The IPP observed the establishment employee review the 

CCP records then signed and dated the pre-shipment review record without 

reviewing the prerequisite program record. The IPP determines that there is 
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noncompliance with 417.5(c) AND 417.5(a)(1) and documents the 

noncompliance in PHIS.

IPP document the HACCP verification task results in PHIS including any 

noncompliance. 

Note: If a noncompliance trend is occurring because an establishment does not

review its prerequisite programs as part of the pre-shipment review, IPP are to 

discuss the issue with their immediate supervisor and determine whether a 

further review is necessary by an Enforcement Investigation and Analysis Officer.
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Workshop: Pre-shipment Review

Refer to the handout to complete the following questions.

1. The establishment must accomplish the pre-shipment review prior to the 

specific production leaving the physical premises. True or False?

2. An IPP is assigned to a very small beef slaughter establishment that stores a 

wide variety of finished products (raw and cooked) for several months in the 

freezer. The HACCP plan includes a CCP for cold storage of finished

products after processing. The establishment monitors the CCP daily and 

documents the results. The pre-shipment review form is then signed and 

dated, and any product in the freezer is clear to be shipped that day. 

Does this fulfill the regulatory requirements for pre-shipment review? Why or 

why not?
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Summary – Verifying the HACCP Regulatory Requirements 

Table 1 below summarizes the Steps that IPP perform during the HACCP 

verification task. Table 2 and Table 3 on the following pages provide a quick 

reference for the questions that IPP should seek answers to when verifying each 

of the HACCP Implementation regulatory requirements. 

Table 1

HACCP Verification Task Summary 

Step 1: Select Product 

Type and Specific

Production

Select product type within the process category Ensure all product types within 

process category are verified over 

time.

Select product type that the est. is 

currently producing.

Select specific production.

Verify all HACCP regulatory requirements at 

each CCP by following Steps 3-9

Step 2: Review the 

HACCP Plan for the 

Selected Product Type

Understand the monitoring and verification 

procedures and frequencies

Note the most recent signature date (must be 

entered into PHIS)

417.2(d)

Note changes to the HACCP plan and update the 

establishment profile 

Step 3: Verify Monitoring Per Directive 5000.1 417.2(c)(4)

Step 4: Verify Verification Per Directive 5000.1 417.2(c)(7), 417.4(a)(2)(i)(ii)(iii)

Step 5: Verify 

Recordkeeping

Per Directive 5000.1 417.2(c)(6), 417.5(a)(3), 417.5(b), 

417.5(d), 417.5(e)(1), 417.5(e)(2),

417.5(f)-Note: contact supervisor 

if records are not made available

Step 6: Verify 

Implementation of 

Prerequisite program 

(PRP)/Other Control 

Measures Used to 

Support Hazards Not 

Reasonably Likely to 

Occur (NRLTO)

Per Directive 5000.1 417.5(a)(1)

Review PRP records for the specific production,

Observe program implementation,

Verify implemented as written, and

Verify records continue to support decision that 

hazard is NRLTO

Contact supervisor if records are 

not made available per 417.5(f)

Consider whether implemented in a manner that 

supports the Hazard Analysis decisions

Contact supervisor if uncertain whether 

implementation or records support the decision in 

the Hazard Analysis

Step 7: Verify Corrective 

Action (CA)

Per Directive 5000.1

Initiate a directed HACCP verification task to 

verify CA when no routine HACCP verification 

task is available

417.5(c), 417.3(a), 417.3(b)

Step 8: Verify Preshipment Review

Per Directive 5000.1 417.5(c)

Step 9: Consider the 

Implications of any 

noncompliance

Document findings of compliance and 

noncompliance.

Associate any previous noncompliances.

Use systems based thinking per Directive 5000.1

417.6

If IPP find that adulterated product may have entered commerce, they are to notify the DO 

personnel through supervisory channels immediately.
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Table 2—Monitoring, Verification, and Recordkeeping Requirements

Step 3

Monitoring

Step 4

Verification 

Step 5

Recordkeeping 

9CFR 417.2(c)(4)

1. Does the 

HACCP plan list 

the monitoring 

procedures and 

frequencies that 

are used to monitor 

each of the CCP to 

ensure compliance 

with the critical 

limits?

2. Are the 

monitoring 

procedures being 

performed as 

described in the 

HACCP plan?

3. Are the 

monitoring 

procedures being 

performed at the 

frequencies for the 

CCP listed in the 

HACCP plan?

4. Are the CL met?

9CFR 417.2(c)(7)

417.4(a)(2)(i)(ii)(iii)

1. Does the HACCP plan 

contain procedures and 

frequencies for the 

calibration of the processmonitoring instruments?

2. Does the HACCP plan 

contain procedures and 

frequencies for direct 

observations of monitoring 

activities & corrective 

actions?

3. Does the HACCP plan list 

procedures and frequencies 

for the review of records 

generated and maintained in 

accordance with 9 CFR 

417.5(a)(3)?

4. Does the HACCP plan list 

product sampling as a 

verification activity?

5. Are process-monitoring 

instrument calibration 

activities conducted as per

the HACCP plan?

6. Are direct observation 

verification activities 

conducted as per the 

HACCP plan?

7. Are records generated in 

accordance with 9 CFR 

417.5(a)(3) being reviewed 

by the establishment?

Recordkeeping Requirement – 9CFR 417.2(c)(6)

1. Does the HACCP plan set out a recordkeeping system that 

documents the monitoring of the CCP?

2. Do the records contain actual values & observations 

obtained during monitoring?

HACCP Records Requirement – 9CFR 417.5(a)(3)

1. Do the records document the monitoring of CCP and critical 

limits?

2. Do the records include actual times, temperatures, or other 

quantifiable values, as prescribed in the establishment’s 

HACCP plan?

3. Do the monitoring, verification, and corrective action 

records include product codes, product name or identity, or 

slaughter production lot, and the date each record was made?

4. Are verification procedures and results documented? 

5. Is the time recorded when the verification activity was 

performed?

6. Does the record contain the date the record was made?

7. Are process-monitoring calibration procedures & results 

recorded?

Records Authenticity Requirement – 9CFR 417.5(b)

1. Was each entry on the record made at the time the event 

occurred?

2. Does each entry include the time?

3. Was each entry on the record signed or initialed by the 

establishment employee making the entry?

4. Does each record include the date?

Computerized Records Requirement – 9CFR 417.5(d)

Are appropriate controls provided to ensure integrity of 

electronic data and signatures?

Record Retention and Availability Requirement – 9CFR 

417.5(e)(1) and (2)

1. Are the records being maintained for the required amount of 

time, i.e., one year for slaughter and refrigerated products and 

two years for frozen, preserved, or shelf-stable products?

2. Are the records kept on-site for 6 months?

3. If the records are stored off-site, can they be retrieved in 24 

hours?

Official Review of Records – 9 CFR 417.5(f)

Are all records, plans, and procedures required by Part 417 

available for official review?
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Table 3- Prerequisite Program Implementation, Corrective Action, Preshipment Review Requirements, and System Thinking

Step 6

Prerequisite Program 

Implementation

Step 7

Corrective Actions 

Step 8

Pre-shipment Review

Supporting Documentation 

Requirement – 9 CFR 

417.5(a)1

1. Is the establishment 

implementing the procedures in 

the program as written?

2. Does the establishment 

maintain records to support the 

implementation of the program, 

including verification records 

and results from outside 

auditors?

3.Do the records show that the 

prerequisite program continues 

to support the decision that the 

relevant hazard is not 

reasonably likely to occur on an 

ongoing basis

Corrective actions in response to a 

deviation from a critical limit – 9 CFR 

417.3(a)

1. Did the establishment identify and 

eliminate the cause of the deviation? 

2. Did the corrective actions ensure that 

the CCP is brought under control?

3. Were measures implemented to 

prevent recurrence of the deviation?

4. Did the actions ensure that no 

product that is injurious to health or 

otherwise adulterated, as a result of the 

deviation, enters commerce?

Corrective Actions in Response to a 

Deviation Not Covered by a Specific 

Corrective Action or an Unforeseen 

Hazard – 9CFR 417.3(b)

1. Did the establishment segregate and 

hold all affected product?

2. Did the establishment perform a 

review to determine the acceptability of 

the affected product for distribution?

3. Did the establishment take necessary 

action with respect to the affected 

product to ensure that no product that is 

injurious to health, or otherwise 

adulterated as a result of the deviation, 

enters commerce?

4. Was a reassessment conducted to 

determine whether the newly identified 

deviation or other unforeseen hazard 

should be incorporated into the HACCP 

plan?

Pre-shipment Review 

Requirement – 417.5(c)

1. Has the establishment 

reviewed the records 

associated with the production 

of the product, prior to 

shipment?

2. Has the pre-shipment 

review been signed and dated 

by an establishment 

employee?

Step 9

Consider the Implications 

of any noncompliance

and 

Document

1. Is there a pattern of 

repeated failure to implement 

the HACCP procedures as 

written?

2. .Is there reason to believe 

that the establishment’s food 

safety system is not effectively 

preventing or controlling the 

applicable food safety 

hazards?

3. Has product been prepared, 

packed, or held under 

insanitary conditions where it 

may have become 

contaminated with filth or 

rendered injurious to health?

4. Has the establishment 

produced adulterated products 

or shipped adulterated 

products in commerce?

Note: The Corrective Action requirement is verified at each occurrence. For example, 

when the IPP is performing the HACCP verification task and the IPP notices that the 

establishment had a deviation from a critical limit, the IPP would verify that the corrective 

action requirements had been met.
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FSIS Verification

The IPP performs the HACCP verification task by verifying all requirements at all 

CCPs for a specific production, including the pre-shipment review. The 

HACCP implementation requirements verified at each CCP include monitoring, 

verification, recordkeeping, and corrective action. Furthermore, when 

establishments implement prerequisite programs or other supporting program to 

support the decision that a hazard is not reasonably likely to occur, they are 

verified as part of the recordkeeping requirement. The pre-shipment review is 

also part of the recordkeeping requirement. The IPP may use either component 

or both components when performing the HACCP verification task. 

To perform the HACCP verification task, the IPP will:

1. Select the product type and specific production; review the HACCP plan for 

the selected product type 

2. Verify that all four HACCP implementation requirements have been met for all 

CCPs in the HACCP plan for that specific production. The IPP must 

understand what the establishment has defined as their specific production 

that will be shipped. 

3. Verify the pre-shipment review requirement for that specific production is met. 

The IPP must observe at least once how the establishment meets the 

requirements in §417.5(c) prior to being able to properly perform the HACCP 

verification task.

4. Observe the records reviewed by the establishment during its defined preshipment review process to determine if all the relevant records reviewed 

associated with that specific production meet the regulatory requirements. 

Corrective Actions are verified as part of the HACCP verification task at each

occurrence. 

Example: The IPP is performing the Secondary Inhibitors-Not Shelf Stable 

HACCP verification task and proceeds to verify all the requirements at all the 

CCPs for a lot of Westphalian hams. The establishment has three CCPs, one at 

drying, one at smoking, and one at storage. The IPP seeks to answer the 

questions in Table 2 and 3 to ensure that all the HACCP regulatory requirements 

have been met for all the CCPs. The establishment has a prerequisite program at 

the receiving step to inhibit growth of pathogen. The IPP decides to use the 

recordkeeping component at the drying and smoking CCPs. For the storage 

temperature CCP, the IPP decides to use the review and observation component 

since there has been some inconsistency in the cooler temperatures lately. The 

IPP proceeds to check the records of the prerequisite program at the receiving 

step to see if the operational parameters have been met. After that, the IPP goes 
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to the storage area to take a temperature measurement and compare it to the 

continuous recording thermometer (process monitoring instrument). The IPP also 

checks the records at this CCP to verify that the results meet the regulatory 

requirements. There have been no corrective actions associated with this lot of 

product so the IPP cannot verify this requirement. Later in the shift, the IPP goes 

to the QA office to check records to determine whether the establishment has 

carried out the pre-shipment review for that particular lot.

Implications of any Noncompliance in PHIS – HAV and HACCP 

Verification Tasks

As discussed throughout this module, IPP are to verify HACCP regulatory 

requirements by performing the HACCP verification tasks that appear on the 

establishment’s task list. The HACCP verification tasks will appear on the 

establishment’s inspection task list according to the specific HACCP process 

categories (listed in 9 CFR 417.2(b)) entered in the establishment profile in PHIS. 

IPP are also to initiate directed HACCP verification tasks when they observe 

noncompliance (sometimes referred to as stumble-on situation) or are instructed 

to do so by their supervisor. 

When IPP complete the HACCP verification task, they are to document their 

findings of compliance or noncompliance in accordance with FSIS PHIS Directive 

5000.1 – Chapter V. If IPP cannot complete the whole HACCP verification task in 

one day, they are to enter partial findings in PHIS and then complete the task 

later. 

In addition to documenting any findings of noncompliance, IPP are to consider all 

their findings in the context of the establishment’s food safety system. IPP are to 

think about the broader implications of their findings regardless of whether they 

identify specific regulatory noncompliance. Documenting individual regulatory 

noncompliances is important, but to protect public health, IPP are also to identify 

those establishments where vulnerabilities in the food safety system may result 

in increased food safety risks. 

IPP are to consider the following questions: 

1. Are there potential shortcomings in the establishment’s decisions 

regarding hazards that are reasonably likely to occur in its production 

process? 

2. Is there a pattern of repeated failure to implement the HACCP procedures 

as written? 
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3. Is there reason to believe that the establishment’s food safety system is 

not effectively preventing or controlling the applicable food safety 

hazards?

4. Has product been prepared, packed, or held under insanitary conditions 

where it may have become contaminated with filth or rendered injurious to 

health? 

5. Has the establishment produced adulterated products or shipped 

adulterated products in commerce? 

6. Do the establishment’s records show any pattern or trend of increasing 

microbial levels or provide any other indication of an increasing potential 

for failure of the food safety system or product adulteration? 

IPP also consider whether their findings indicate systemic or ongoing problems 

with the establishment’s food safety system, and whether those problems could 

result in the establishment producing adulterated or misbranded products. If IPP 

have concerns that there may be systemic problems with the establishment’s 

food safety system, or there is reason to believe that product may have become 

adulterated, IPP are to bring the issues to the attention of their supervisor 

immediately.
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Food Safety Systems Thinking Workshop

General Instructions

Work through this workshop as a group. Select a group leader. The leader 

should monitor the time and focus of the group, and ensure the discussion 

involves each member of the group. Answer the workshop questions. 

Description of the Establishment’s Production Process and Scenario

You are Phyllis Isaacs, the GS-12 PHV IIC, assigned to Novosibar Poultry INC, 

which is a 4-line SIS (Streamline Inspection System) poultry slaughter and 

processing establishment. The establishment slaughters on two shifts and 

processes approximately 260,000 young chickens a day. The chickens have an 

average weight of 4.5 lbs. The establishment implements a prerequisite program

for on-line reprocessing and uses a post evisceration Syntrx antimicrobial rinse 

prior to the chiller. 

In addition to whole birds and giblets, the establishment produces tray packs of 

wings, drums, thighs, chicken breasts, and tenders. After packaging, the boxed 

product is shipped under refrigeration to wholesale and retail outlets. 

Shortly after operations started, an inspector on line 2 requests that you look at a 

couple of birds she had the helper take off the line. You notice a couple of small 

black specks on the legs of the carcasses. After you question this inspector, and 

all of the other on-line inspectors, you observe some carcasses and determine 

that the presence of the black specks is infrequent occurrence, isolated to line 

two, and that the bird washers further down the line seem to be removing the 

specks. 

1. At this point, what do you conclude from your findings?

Several hours later, one of the GS-08 floor inspectors informs you that he found 

"several small smearable black specks" on four of the ten birds from line 2 while 

performing a pre-chill Finished Products Standard (FPS) test. He determined that 

this substance appeared to be falling off of the rails and onto the carcasses. He 

also informs you that the FPS test passed and therefore the establishment did 

not seem to be worried about the black specks. Moments later, the other GS-08 

floor inspector informs you that the line inspectors on line 2 had informed her that 

"the birds were covered with a powdery black substance" and that they wanted to 

see you.
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You proceed to the slaughter floor to investigate the line inspectors’ concern. You 

observe several carcasses and determine that approximately 45% of them have 

varying degrees of a powdery, smearable black substance on them. You look up 

at the rails and notice a build-up of this same substance on the rails and the 

chain’s trolley wheels.

2. Based on your findings, are there components of the establishment’s food 

safety system that you think need to be evaluated/reviewed/verified? Is so, 

what components and why would you want to review or verify them?

3. Would you take any action based on the above findings? If so, what type of 

action? If there is regulatory support for your action, please identify the 

regulations. 

At this point, you review the establishment’s FPS and SSOP records:

 The pre-chill and post-chill FPS records show higher than normal levels of 

extraneous material. 

 Today’s pre-operational SSOP record document the sanitation crew’s, effort 

to reduce some minor rust build-up on the line 2 rail by foaming it with an 

approved cleaner, rinsing it with water and then having the maintenance 

department apply an approved oil lubricant to the rail. 

 Today’s operational SSOP record has two entries that state that there has a 

problem with a black powdery build-up on the rails and trolley wheels and that 

"this same substance was falling onto the carcasses.” The record also states 

that the establishment “wiped the rails with rags soaked in a lubricant” during 

breaks in production. The last entry indicated that the establishment planned 

to perform a more thorough wiping of the rail at lunch (which was still 
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approximately two hours away at that point). The records also indicated that 

any affected product was appropriately reconditioned.

After completing your records review, you inspect some product in the cut-up 

department. You observe this same black substance on chicken parts being 

placed into plastic trays going to the cooler, labeled and ready to ship. 

4. At this point, what do you conclude from your findings? 

5. Would you take any additional action based on these findings? If so, what 

type of action? If there is regulatory support for your action, please identify the 

regulations. 

6. Could the contamination of product with a lubricant be considered a food 

safety hazard? 

7. How could the establishment support that the lubricant is not a food safety 

hazard?
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9 CFR Part 417--Hazard Analysis and Critical Control Point 

(HACCP) Systems

Sections:

417.1 Definitions.

417.2 Hazard Analysis and HACCP plan.

417.3 Corrective actions.

417.4 Validation, Verification, Reassessment.

417.5 Records.

417.6 Inadequate HACCP Systems.

417.7 Training.

417.8 Agency verification.

Sec. 417.1 Definitions.

For purposes of this part, the following definitions shall apply:

Corrective action - Procedures to be followed when a deviation occurs.

Critical control point - A point, step, or procedure in a food process at which 

control can be applied and, as a result, a food safety hazard can be prevented, 

eliminated, or reduced to acceptable levels.

Critical limit- The maximum or minimum value to which a physical, biological, or 

chemical hazard must be controlled at a critical control point to prevent, 

eliminate, or reduce to an acceptable level the occurrence of the identified food 

safety hazard.

Food safety hazard- Any biological, chemical, or physical property that may 

cause a food to be unsafe for human consumption.

HACCP System- The HACCP plan in operation, including the HACCP plan itself.

Hazard - SEE Food Safety Hazard.

Preventive measure - Physical, chemical, or other means that can be used to 

control an identified food safety hazard.

Process-monitoring instrument - An instrument or device used to indicate 

conditions during processing at a critical control point.

Responsible establishment official-The individual with overall authority on-site or 

a higher level official of the establishment.

Sec. 417.2 Hazard Analysis and HACCP Plan.

(a) Hazard analysis. (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 
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occur in the particular type of product being processed, in the absence of those 

controls. 

 (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. 

 (3) Food safety hazards might be expected to arise from the following:

 (i) Natural toxins;

 (ii) Microbiological contamination;

 (iii) Chemical contamination;

 (iv) Pesticides;

 (v) Drug residues;

 (vi) Zoonotic diseases;

 (vii) Decomposition;

 (viii) Parasites;

 (ix) Unapproved use of direct or indirect food or color additives; and

 (x) Physical hazards.

(b) The HACCP plan. (1) Every establishment shall develop and implement a 

written HACCP plan covering each product produced by that establishment 

whenever a hazard analysis reveals one or more food safety hazards that are 

reasonably likely to occur, based on the hazard analysis conducted in 

accordance with paragraph (a) of this section, including products in the following 

processing categories:

 (i) Slaughter--all species.

 (ii) Raw product--ground.

 (iii) Raw product--not ground.

 (iv) Thermally processed--commercially sterile.

 (v) Not heat treated--shelf-stable.

 (vi) Heat treated--shelf-stable.

 (vii) Fully cooked--not shelf-stable.

 (viii) Heat treated but not fully cooked--not shelf-stable.

 (ix) Product with secondary inhibitors--not shelf-stable.

 (2) A single HACCP plan may encompass multiple products within a single 

processing category identified in this paragraph, if the food safety hazards, 

critical control points, critical limits, and procedures required to be identified and 

performed in paragraph (c) of this section are essentially the same, provided that 

any required features of the plan that are unique to a specific product are clearly 

delineated in the plan and are observed in practice.

 (3) HACCP plans for thermally processed/commercially sterile products do not 

have to address the food safety hazards associated with microbiological 

contamination if the product is produced in accordance with the requirements of 

part 318, subpart G, or part 381, subpart X, of this chapter.

(c) The contents of the HACCP plan. The HACCP plan shall, at a minimum:

 (1) List the food safety hazards identified in accordance with paragraph (a) of 

this section, which must be controlled for each process.

 (2) List the critical control points for each of the identified food safety hazards, 

including, as appropriate:
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 (i) Critical control points designed to control food safety hazards that could be 

introduced in the establishment, and

 (ii) Critical control points designed to control food safety hazards introduced 

outside the establishment, including food safety hazards that occur before, 

during, and after entry into the establishment;

 (3) List the critical limits that must be met at each of the critical control points. 

Critical limits shall, at a minimum, be designed to ensure that applicable targets 

or performance standards established by FSIS, and any other requirement set 

forth in this chapter 

pertaining to the specific process or product, are met;

 (4) List the procedures, and the frequency with which those procedures will be 

performed, that will be used to monitor each of the critical control points to 

ensure compliance with the critical limits;

 (5) Include all corrective actions that have been developed in accordance with 

Sec. 417.3(a) of this part, to be followed in response to any deviation from a 

critical limit at a critical control point; and

 (6) Provide for a recordkeeping system that documents the monitoring of the 

critical control points. The records shall contain the actual values and 

observations obtained during monitoring.

 (7) List the verification procedures, and the frequency with which those 

procedures will be performed, that the establishment will use in accordance with 

Sec. 417.4 of this part.

(d) Signing and dating the HACCP plan. (1) The HACCP plan shall be signed 

and dated by the responsible establishment individual. This signature shall 

signify that the establishment accepts and will implement the HACCP plan.

 (2) The HACCP plan shall be dated and signed:

 (i) Upon initial acceptance;

 (ii) Upon any modification; and

 (iii) At least annually, upon reassessment, as required under Sec. 417.4(a)(3) 

of this part.

(e) Pursuant to 21 U.S.C. 456, 463, 608, and 621, the failure of an establishment 

to develop and implement a HACCP plan that complies with this section, or to 

operate in accordance with the requirements of this part, may render the 

products produced under those conditions adulterated.

Sec. 417.3 Corrective actions.

 

(a) The written HACCP plan shall identify the corrective action to be followed in 

response to a deviation from a critical limit. The HACCP plan shall describe the 

corrective action to be taken, and assign responsibility for taking corrective 

action, to ensure:

 (1) The cause of the deviation is identified and eliminated;

 (2) The CCP will be under control after the corrective action is taken;

 (3) Measures to prevent recurrence are established; and

 (4) No product that is injurious to health or otherwise adulterated as a result of 

the deviation enters commerce.
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(b) If a deviation not covered by a specified corrective action occurs, or if another 

unforeseen hazard arises, the establishment shall:

 (1) Segregate and hold the affected product, at least until the requirements of 

paragraphs (b)(2) and (b)(3) of this section are met;

 (2) Perform a review to determine the acceptability of the affected product for 

distribution;

 (3) Take action, when necessary, with respect to the affected product to 

ensure that no product that is injurious to health or otherwise adulterated, as a 

result of the deviation, enters commerce;

 (4) Perform or obtain reassessment by an individual trained in accordance with 

Sec. 417.7 of this part, to determine whether the newly identified deviation or 

other unforeseen hazard should be incorporated into the HACCP plan.

(c) All corrective actions taken in accordance with this section shall be 

documented in records that are subject to verification in accordance with Sec. 

417.4(a)(2)(iii) and the recordkeeping requirements of Sec. 417.5 of this part.

Sec. 417.4 Validation, Verification, Reassessment.

 

(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.

 (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 CCPs, 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.

 (2) Ongoing verification activities. Ongoing verification activities include, but 

are not limited to:

 (i) The calibration of process-monitoring instruments;

 (ii) Direct observations of monitoring activities and corrective actions; and

 (iii) The review of records generated and maintained in accordance with Sec. 

417.5(a)(3) of this part.

 (3) Reassessment of the HACCP plan. (i) 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.
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(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.

(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; packaging; finished product 

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

Sec. 417.5 Records.

 

(a) The establishment shall maintain the following records documenting the 

establishment's HACCP plan:

 (1) The written hazard analysis prescribed in Sec. 417.2(a) of this part, 

including all supporting documentation;

 (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.

 (3) Records documenting the monitoring of CCPs and their critical limits, 

including the recording of actual times, temperatures, or other quantifiable 

values, as prescribed in the establishment's HACCP plan; the calibration of 

process-monitoring instruments; corrective actions, including all actions taken in 

response to a deviation; verification procedures and results; product code(s), 

product name or identity, or slaughter production lot. Each of these records shall 

include the date the record was made.

(b) Each entry on a record maintained under the HACCP plan shall be made at 

the time the specific event occurs and includes the date and time recorded, and 

shall be signed or initialed by the establishment employee making the entry.

(c) Prior to shipping product, the establishment shall review the records 

associated with the production of that product, documented in accordance with

this section, to ensure completeness, including the determination that all critical 

limits were met and, if appropriate, corrective actions were taken, including the 

proper disposition of product. Where practicable, this review shall be conducted, 

dated, and signed by an individual who did not produce the record(s), preferably 

by someone trained in accordance with Sec. 417.7 of this part, or the responsible 

establishment official.

(d) Records maintained on computers. The use of records maintained on 

computers is acceptable, provided that appropriate controls are implemented to 

ensure the integrity of the electronic data and signatures.
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(e) Record retention. (1) Establishments shall retain all records required by 

paragraph (a)(3) of this section as follows: for slaughter activities for at least one 

year; for refrigerated product, for at least one year; for frozen, preserved, or 

shelf-stable products, for at least two years.

 (2) Off-site storage of records required by paragraph (a)(3) of this section is 

permitted after six months, if such records can be retrieved and provided, on-site, 

within 24 hours of an FSIS employee's request.

(f) Official review. All records required by this part and all plans and procedures 

required by this part shall be available for official review and copying.

Sec. 417.6 Inadequate HACCP Systems.

 

A HACCP system may be found to be inadequate if:

(a) The HACCP plan in operation does not meet the requirements set forth in this 

part;

(b) Establishment personnel are not performing tasks specified in the HACCP 

plan;

(c) The establishment fails to take corrective actions, as required by Sec. 417.3 

of this part;

(d) HACCP records are not being maintained as required in Sec. 417.5 of this 

part; or

(e) Adulterated product is produced or shipped.

Sec. 417.7 Training.

(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 Sec. 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 

Sec. 417.3 of this part.

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

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

seven HACCP principles to meat or poultry product processing, including a 

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

record review.

Sec. 417.8 Agency verification.

FSIS will verify the adequacy of the HACCP plan(s) by determining that each 

HACCP plan meets the requirements of this part and all other applicable 

regulations. Such verification may include:

 (a) Reviewing the HACCP plan;

 (b) Reviewing the CCP records;
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 (c) Reviewing and determining the adequacy of corrective actions taken when 

a deviation occurs;

 (d) Reviewing the critical limits;

 (e) Reviewing other records pertaining to the HACCP plan or system;

 (f) Direct observation or measurement at a CCP;

 (g) Sample collection and analysis to determine the product meets all safety 

standards; and

 (h) On-site observations and record review.

9 CFR PART 418—RECALLS

Sections:

418.1 [Reserved]

418.2 Notification.

418.3 Preparation and maintenance of written recall procedures.

418.4 Records.

Authority: 7 U.S.C. 450; 21 U.S.C. 451–470, 601–695; 7 CFR 2.18, 2.53.

§ 418.1 [Reserved]

§ 418.2 Notification. 

Each official establishment must promptly notify the local FSIS District Office 

within 24 hours of learning or determining that an adulterated or misbranded 

meat, meat food, poultry, or poultry product received by or originating from the 

official establishment has entered commerce, if the official establishment 

believes or has reason to believe that this has happened. The official 

establishment must inform the District Office of the type, amount, origin, and 

destination of the adulterated or misbranded product.

§ 418.3 Preparation and maintenance of written recall procedures.

Each official establishment must prepare and maintain written procedures for the 

recall of any meat, meat food, poultry, or poultry product produced and shipped 

by the official establishment. These written procedures must specify how the 

official establishment will decide whether to conduct a product recall, and how 

the establishment will effect the recall, should it decide that one is necessary.

§ 418.4 Records.

All records, including records documenting procedures required by this part, must 

be available for official review and copying.