Review of Establishment Data

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Review of Establishment Data Task 

FSIS Directive 5000.2 

Objectives 

Upon completion of this training module, Inspection Program Personnel (IPP) will

be able to:

1. Explain the purpose of the Review of Establishment Data task.

2. Identify the kinds of monitoring and testing records that are subject to IPP

review when performing the Review of Establishment Data task.

3. Describe how to assess the significance of information gathered during

the Review of Establishment Data task.

4. Explain how to follow up on questions or concerns identified when

performing the Review of Establishment Data task.

5. Explain how the Review of Establishment Data task is documented in

PHIS.

6. Describe what is done if establishment management refuses access to

records impacting its food safety system.

Introduction 

Establishments may conduct certain testing or monitoring activities that are not a

part of their HACCP plans or Sanitation SOPs. For example, establishments may 

perform testing or monitoring activities as a part of a prerequisite program or

conduct product testing to comply with certain specifications of its customers. 

Data generated by such activities may not even be referenced in a hazard

analysis. Nonetheless, these activities may provide information relevant to the

effectiveness of establishments’ food safety systems. In other words, the data

may raise questions or concerns about the adequacy of an establishment’s 

hazard analysis.

Whenever the results of testing and monitoring activities provide information

relevant to the adequacy of decisions made in a hazard analysis, FSIS considers 

records of these results to be supporting documentation for that hazard analysis. 

Such records must be maintained by the establishment and made available for

FSIS review. A prudent establishment will consider the significance of this 

information with respect to the overall effectiveness of its food safety system, and

respond to the results as necessary.

IPP should be aware of all monitoring and testing related to food safety 

conducted by an establishment, including monitoring and testing not referenced

in the hazard analysis and not included as components of the establishment’s 

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Sanitation SOPs or HACCP plan. FSIS Directive 5000.2 Rev. 2 specifies that at 

least once per week IPP are to review the results of any such monitoring and

testing. In this training module we discuss the methodology for reviewing such

data. The Review of Establishment Data task helps IPP gain a full understanding

of the establishment’s food safety system. Considering the significance of this 

information in the context of the establishment’s food safety system may identify

potential vulnerabilities that otherwise may not be recognized when performing

other HACCP and sanitation inspection tasks.

Records Subject to the Review of Establishment Data Task 

The Federal Meat Inspection Act (Section 642) and the Poultry Products 

Inspection Act (Section 460(b)) both establish the legal authority for requiring

establishments to maintain a broad range of records. In addition, the Acts provide

FSIS the authority to access any required records as necessary. FSIS has made

clear to the regulated industries that IPP have the authority to access all 

establishment records that could disclose the existence of an insanitary 

condition which needs to be addressed in an establishment’s HACCP plan, 

Sanitation SOPs, or prerequisite programs. 

The regulatory authority to have access to records, which may have some

bearing on the hazard analysis, derives directly from 9 CFR 417.5(a)(1), which

states that an establishment must maintain the written hazard analysis 

prescribed in 9 CFR 417.2(a) and all supporting documentation. Furthermore, 

establishments are required by 9 CFR 417.5(f) to make all records required by 9 

CFR 417 available for official review.

The purpose of a hazard analysis is to identify all relevant hazards and to

determine which are reasonably likely to occur in the production process (9 CFR 

417.2(a)(1)). A hazard analysis (and any documentation supporting the decisions

in that hazard analysis) is not intended to be a static document. At any time, 

additional information or data may call into question the adequacy of an

establishment’s hazard analysis. This information or data may not be specifically 

referenced in the hazard analysis or generated through implementation of the

establishment’s HACCP plan or Sanitation SOPs.

FSIS Directive 5000.2 specifies that IPP have access to any type of record

maintained by the establishment if the record relates to the establishment 

maintaining its food safety system. Establishments must decide what type and

frequency of testing is necessary to support the decisions made in its hazard

analysis. Thus, the establishment decides which testing programs are necessary 

to ensure food safety and which testing programs are unrelated to food safety.

However, the establishment would have to explain to IPP why certain test 

records are not related to food safety and do not impact the hazard 

analysis. If IPP learn of a testing program and have questions about whether

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records of that testing program should be included in the Review of 

Establishment Data task, they should seek guidance from their supervisors and

askFSIS.

NOTE: The Review of Establishment Data task targets records of monitoring and

testing results that bear on food safety, not product quality concerns. Certain 

regulatory product quality concerns would be verified through non-food safety,

other consumer protection (OCP) tasks instead of the Review of Establishment 

Data task.

Obviously, IPP should question why the results of any testing for pathogens 

conducted to meet purchase specifications or for other purposes would not affect 

the hazard analysis. It is not unusual, though, for many establishments to

conduct testing of non-product contact surfaces or finished product for generic 

microbes such as aerobic plate counts (APCs), generic coliform bacteria, or other

non-pathogenic microbes. Establishments may use such testing to provide

information about product quality (e.g., shelf life) or to meet certain customer

purchase specifications. Generally, such test results can also have implications 

for food safety. For example, if non-pathogen test results are used to ensure that 

the production process controls the overall level of microbes in the product, such

test results may affect the hazard analysis, because the production process may 

be modified in response to microbial levels. In these situations, the test results 

should be made available to IPP for review. If purchase specifications call for

testing of non-pathogens and the results are for information purposes only, those

results would not affect the hazard analysis and generally would not have to be

made available to IPP for review. 

EXAMPLE 1: 

One of the establishment’s customers requires the establishment to conduct 

quantitative aerobic plate counts (APCs) on product contact surfaces during

operations. The customer requires that the APC quantitative level not exceed a

specified limit as an indication of the sanitary condition under which the product

is produced. The establishment does not reference this testing program in its 

hazard analysis, and it is not a component of its HACCP plan or Sanitation

SOPs. However, the results of this testing should be made available to IPP and

included in their Review of Establishment Data task, because the establishment

would be making a determination as to whether to adjust its process controls 

based on the results of the testing. This determination bears directly on the

establishment’s hazard analysis even if this testing program is not referenced in

the hazard analysis. Alternatively, if the customer had not set a limit for the APC

results that would cause rejection of the product, the testing would not bear on

the determination of whether there is an insanitary condition and would not be

subject to the Review of Establishment Data task.

For some tests, there may be no established industry-wide standards for what 

represents acceptable vs. unacceptable. ATP bioluminescence testing to assess 

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the cleanliness of surfaces is one example. Even when there are no industry 

standards for a particular test, if the test results are related to decisions in the

food safety system, these results must be available to IPP for review. When

reviewing the results of tests for which there are no industry standards, IPP

would verify that an establishment is responding appropriately to its results based

on the establishment’s standards.

The types of records subject to the Review of Establishment Data task are not

limited to records of microbial testing. For example, some establishments may 

include metal detection in their process to meet some customer purchase

specification. The establishment’s hazard analysis may reference preventive

maintenance programs and visual checks for metal contamination as support for

metal being not reasonably likely to occur, but not include the customer-required

metal detection program as additional support. Nonetheless, the metal detection

program has implications for food safety in such an establishment, and records 

associated with the metal detection program should be made available to IPP for

review.

In addition to the results of any monitoring or test results, IPP also have access

to any written procedures associated with those results. This would include

information such as the methods of sample collection and analysis or the

procedure for conducting some monitoring activity.

Performing the PHIS Review of Establishment Data Task 

At least once a week IPP should schedule and perform the PHIS Review of 

Establishment Data task. IPP review the results of any testing that the

establishment has performed that may have an impact on the establishment’s 

hazard analysis.

NOTE: Prior to the implementation of PHIS, reviews of establishment data were

done during the performance of a HACCP 01 procedure. With the

implementation of PHIS the HACCP 01 methodology was discontinued, and

these reviews were defined as a specific PHIS task, the Review of Establishment 

Data task. FSIS Directive 5000.2 will be updated (from Revision 2 to Revision 3)

to reflect this change.

Gathering Information 

When reviewing such monitoring and test results, inspection program personnel

are to consider questions such as:

1. Is there documentation that supports the frequency of the testing that the

establishment employs?

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2. If the establishment uses the testing to reflect the effects of a prerequisite

program do the results support the decision-making for the design of the

program?

3. At what point in the process does the testing occur?

4. Does the establishment use the test results in a manner that checks the

proper execution of some activity at the point in the process where the

testing occurs?

5. Do the results indicate that a food safety concern may be developing?

6. Is the establishment reacting to the situation? If so, what is it doing?

7. Do results indicate that a potential food safety concern is decreasing?

8. If pathogen or indicator organism positive results have decreased, does 

the establishment plan to reduce testing frequencies? If so, how it will

ensure that such modifications to its testing program will not affect the

likelihood of finding pathogens?

9. Are there operational results that correlate with the testing results? For

example, does a reduction in microbial counts coincide with a new

cleaning regimen, or conversely, has there been an increase in microbial

counts during a time when the establishment failed to adequately 

implement some Sanitation SOP activities?

Assessing Information 

A negative response to any of the questions above does not automatically mean

there is a noncompliance or inadequate hazard analysis. IPP are to consider all

available information in order to make any determination as to whether there is a

basis for concern about how the establishment is implementing its system, or

about how it is reacting to the results of its testing. However, IPP are not to write

a noncompliance record on the basis of their review of these records. IPP should

keep in mind that the Agency’s policy is to encourage establishments to do

testing and to address any problems that exist.

At weekly meetings with establishment management (see FSIS PHIS Directive

5000.1 & FSIS Directive 5010.1, Rev. 1), inspection program personnel are to

raise any questions they have regarding any tests results that may have an

impact on the establishment’s hazard analysis. When necessary, inspection

program personnel are to raise concerns, through supervisory channels, to the

District Office.

Documenting the Review of Establishment Data Task 

As part of documenting the weekly Memorandum of Interview (MOI), IPP are to

indicate that they conducted the Review of Establishment Data task, and that 

they discussed, if indicated, any concerns with the establishment at the weekly 

meeting. In the MOI, IPP are to:

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1. Briefly list what tests results they reviewed and for what time period

2. Describe the specific concerns, if any, that they discussed with the

establishment

3. State how the establishment responded

Anytime IPP have concerns about how an establishment responds to what was 

discussed at the weekly meeting, or questions about whether a particular type of 

data is available to the Agency, they are to raise those concerns or questions 

through supervisory channels. Frontline Supervisors will periodically review the

documentation above and raise any concerns with the in-plant team and, as 

necessary, the District Office. Based on the concerns raised by IPP through

supervisory channels, District Offices may determine that an Enforcement 

Investigation Analysis Officer needs to conduct a food safety assessment to

assess factors such as what the tests results reveal about food safety, and

whether the design of testing, procedures or prerequisite programs are

adequately supported by the decisions made in the hazard analysis.

Once IPP have conducted the Review of Establishment Data task, discussed any

concerns with plant management, and included the items above in the MOI, they 

are to indicate within PHIS that the inspection task has been completed.

Refusal of Access to Records 

Inspection program personnel have reported that establishments have refused to

give them access to the results of equipment swab tests, microbiological testing

of marinade solutions that are to be reused, and Salmonella testing. 

Establishments have refused to give access to these testing results on the

grounds that the results are trade secrets, the testing is done for customers who

do not want the results shared with the Agency, and the Agency is only entitled

access to records upon which the establishment affirmatively relies.

The argument that the testing is a trade secret does not provide a basis not to

share the information with FSIS. FSIS has authority and responsibility to protect 

trade secret information under the Freedom of Information Act. Such authority is 

meaningless unless the Agency has access to such information. The fact that a

customer does not want the information shared with the Agency is irrelevant. The

Agency’s HACCP regulations have the force and effect of law and thus must be

followed by the establishment.

If the Inspection Program Personnel have questions about whether a particular

type of data is available to the Agency, they are to advise their supervisor of the

situation. As indicated above, an establishment is obligated to provide access to

HACCP plans and other establishment data by 9 CFR 417.5(f). If an

establishment refuses to provide access to its HACCP plan or other supporting

documentation for review and recording of information into PHIS, IPP are to

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record a noncompliance, citing 9 CFR 417.5(f). IPP are then to discuss this

noncompliance with establishment management at the next weekly meeting, and

document that fact and any establishment response in the MOI. If the

establishment continues in its refusal, IPP are to immediately contact their

Frontline Supervisor, who will in turn inform the District Manager (DM) of the

establishment's refusal. The DM, or designee, will contact establishment 

management and discuss the issue. If the establishment continues to refuse, the

DM will instruct IPP to take an official control action by withholding inspection as 

defined under 9 CFR 500.1(b). The DM will then document the incident in a letter

to the establishment, officially informing it that FSIS has withheld inspection

under 9 CFR 500.3(a)(6) because the establishment has interfered with an FSIS

inspector performing his inspection duties. The DM will lift the withholding action

when the establishment has provided its HACCP plan and supporting

documentation to IPP.

EXAMPLE 2: 

You are assigned to a large sliced deli meat establishment. While performing the

Preoperational Review & Observation task in the post-lethality slicing and

packaging room you observe QA personnel collecting environmental swabs in

the area. Later, you proceed to the on-site microbiology laboratory to ask about 

the environmental swab sample collection observed earlier. The microbiologist 

explains that a customer requires quantitative tests for Aerobic Plate Counts as 

an indicator of adequate sanitation. He points to APC plates resting by the colony 

counter and incubator, and indicates that is what he’s working on now. You

request the APC records. The microbiologist states that you will have to see the

plant manager about that. By this time, you must return to the inspection office to

retrieve your agenda for the weekly meeting with plant management, which

begins in a few minutes. You also decide to take a copy of FSIS Directive 5000.2

to the meeting. During the meeting, you provide a copy of the directive to the

plant manager and summarize the directive’s purpose. You discuss the observed

environmental swabbing and discussion with the microbiologist today. You again

request to review the APC test results. The manager informs you that these

records are not subject to FSIS review because they were created solely to meet

a client’s purchase specifications and are not associated with the establishment’s 

HACCP plan. You advise the manager that the records are subject to review by 

FSIS because the results reflect sanitary conditions within the post-lethality 

processing environment and would have bearing on decisions made in the

hazard analysis at the slicing and packaging step of the process. You further

explain that these records represent a form of supporting documentation required

by 9 CFR 417.5(a)(1); therefore access must be granted in order to be in

compliance with 9 CFR 417.5(f). The manager agrees to provide the APC 

records and sends the HACCP coordinator to retrieve the records from the

microbiology lab so that you can review them and ask any additional questions 

during the meeting.

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