USDA Food Safety and Inspection Service 

-= US. Dm\RT'-E<T OF AGROl.Tl.RE 

• 

(-.(l~P-t', 

M11forcC'nw111 

IWC'Slis.?rnio 

nfllysis 

ffie<.'r 

Haza rd Ana lysis 

• 

Insert Photo

If Desired

2

7/15/2022

HACCP

EIAO Training

1

1

Performing the Assessment - HACCP

• Use Directive 5000.1 for policy guidance

• Answer the questions in the FSA Tool appropriate for the processing

category

• Assess design and implementation

2

HACCP-Hazard Analysis

• 9 CFR 417.2(a)(1): Each establishment must have a hazard analysis

conducted to determine the food safety hazards reasonably likely to

occur in the production process and identify preventive measures

the plant can apply to control those hazards.

• Consider all potential biological, chemical, and physical food safety

hazards, and determine the food safety hazards reasonably likely to

occur in its process.

• HA provides the basis for an establishment’s food safety system.

3

3

1
 

 

 

 

 

 

 

 

 

• 

• 

• 

4

5

7/15/2022

Hazard Analysis – 417.2(a)(1)

• HA involves: Hazard identification & evaluation.

• An adequate HA ensures the level of risk to the consumer is

acceptable.

• The HA must be supported according to 417.5(a)(1)

4

Hazard Identification

 Meat and Poultry Hazards and Controls Guide

https://www.fsis.usda.gov/guidelines/2018-0005

 FSIS Microbiological Hazards Guide

https://www.fsis.usda.gov/node/2253

 Appendices C & D of the HACCP Final Rule FR Notice

https://www.fsis.usda.gov/sites/default/files/media_file/2020-08/93-

016F_0.pdf

 FSIS HACCP Guidance

https://www.fsis.usda.gov/inspection/compliance-guidance/haccp

5

Evaluating Hazards

 Based on:

 Severity

 Likelihood

 Arbitrary decisions can lead to:

 CCPs unrelated to product safety

 No CCP for controlling a high-risk hazard

6

6

2
 

 

 

 

 

 

 

 

 

 

 

 

 

 

• 

• 

• 

7

8

7/15/2022

Hazard Analysis Decisions

 Reasonably Likely To Occur

 CCP somewhere in the process

 Support and validation for CCP

 Not Reasonably Likely To Occur

 Supporting documentation

 Prerequisite programs to prevent the hazard from occurring

7

Key Principle

Hazard Analysis

• If HA conducted incorrectly and does not identify significant hazards

- HACCP plan will be ineffective.

• Noncompliance with 417.2(a) because of an inadequate hazard

analysis can result in an inadequate system.

• Begin review of the HACCP system-Verify the design of the hazard

analysis.

• Assess whether appropriate hazards have been addressed.

• Use the questions from the Hazard Analysis and HACCP system

section of each tool.

8

Performing the Assessment - HACCP

• Let’s look at some of the questions from the FSA Tools in your

notebook that deal with the hazard analysis and HACCP system

9

9

3
 

 

 

 

 

 

 

 

 

 

 

 

 

• 

• 

• 

Supporting 

Documentation 

Workshop 

11

7/15/2022

Performing the Assessment - HACCP

10

10

Performing the Assessment -

Prerequisite Programs (PRP)

• PRPs are often used to support decisions in hazard analysis

• Decisions often involve these programs preventing a hazard

from being reasonably likely to occur (RLTO) or significant. 

• Example: Purchase specifications forincoming materials.

• Provide basic environmental and operating conditions

necessary for the production of safe & wholesome food.

• PRPs are the foundation for an effective HACCP system.

• PRPs frequently function facility wide.

11

Performing the Assessment -

Prerequisite Programs (PRP)

• PRPs may have unique names that do not incorporate the

actual term “prerequisite program”

• Examples

• Purchase Specification Program

• Allergen Control Program

• Temperature Control Program

12

12

4
 

 

 

 

 

 

 

 

 

 

 

• 

• D 

• 

14

7/15/2022

Prerequisite Program Examples

13

13

Performing the Assessment - PRPs

• Plant may determine a hazard is not significant because of

ongoing execution of a PRP.

• The EIAO will look closely at programs used in hazard

analysis decisions

• Determine if the design and implementation of the

programs actually support the decision

14

Prerequisite

Program

Records

Performing the Assessment -

Prerequisite Programs (PRP)

• PRPs cannot be used to directly control a hazard.

• Non-conformance with a PRP may not create a food safety

concern or call for product action.

• Non-conformance with the PRP may call into question

support for decisions in the HA.

15

15

5
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

• 

• 

• 

~ 

PR Program - ....... ontrol 

16

17

17

7/15/2022

Prerequisite vs. CCP?

A 

Prerequisite Program Critical Control Point 

• Cannot be used to directly • Directly control specific

control a hazard. hazards.

• May prevent a hazard from • Prevents, eliminates, or

being likely to occur. reduces a likely to occur

• Deviations from program hazard.

may not create direct food • Deviations from controls in a

safety concerns; BUT may HACCP plan cause food

call into question hazard safety concerns and

analysis decisions. generally require action on

affected product.

16

Performing the Assessment:

Inappropriate Use of PRPs

The EIAO will seek info such as:

• If criteria of the PRP are not met, are there questions about

the safety of the food?

• If criteria of the PRP are not met, does the establishment

implement corrective actions that meet 417.3?

• Is the only supportfor the PRP use historical info showing that

the program is the primary means of control? Performing the

Assessment: 

InappropriateUse of PRPs

If the answers is “yes” to such questions, then it is probable

that the program is being used to directly control the hazard

Performing the Assessment:

Inappropriate Use of PRPs

The EIAO will discuss such finding with the establishment and

inform them that they need to:

• Reassess its HACCP plan to reconsider use of the programs

and properly address the hazard.

Failure to reassess and properly use the programs may result in

the issuance of a NOIE NOIE

18

18

6
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

• 

• Reassess 

• 

19

20

7/15/2022

Performing the Assessment

Prerequisite Programs

The EIAO will review:

• Features of the written PRP

• Supporting documents

• Program data over a period of time

• Observe employees implementing the PRP

The standard of performance for prerequisite programs records

is different from the expectations of HACCP records

19

Performing the Assessment

Prerequisite Programs

• A single instance of nonconformance may not represent

noncompliance, if decisions in the HA are still supported. 

• PRP Records must continue to support the not reasonably likely

to occur hazard analysis decision.

• If EIAO determines the prerequisite program is ineffective or not

being executed as designed and there are no food safety

concerns.

• The establishment will need to reassess the hazard analysis to

20

determine whether there is continued support for the decisions.

Evaluating Sampling that is part of a

Prerequisite Program

 FSIS website resources to help EIAOs evaluate sampling and

testing done by an establishment:

 Foodborne Pathogen Test Kits Validated by Independent

Organizations

https://www.fsis.usda.gov/guidelines/2019-0008

 FSIS Guidance for Evaluating Test Kit Performance

https://www.fsis.usda.gov/guidelines/2010-0004

 Establishment Guidance for Selecting a Lab

https://www.fsis.usda.gov/guidelines/2013-0009

 AskFSIS

21

7

21
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

• 

• 

• 

22

23

7/15/2022

Prerequisite Programs - Example

 Raw ground beef operation has a PR program based on purchase

specifications

 The EIAO will review the records from the program to verify that it

supports the decision made in the hazard analysis that E. coli

O157:H7 is not likely to occur.

22

Prerequisite Programs - Example

 Establishment producing post-lethality exposed RTE products has

product or environmental testing in a PR program

 The EIAO will review the program, results, and decision documents

to verify it is science based.

 Assess the total system to verify design of the testing and

implementation effectively addresses Listeria.

23

Prerequisite Programs

 Example of Regulatory Thought Process:

 Ineffective PR Program

 Hazard likely to occur(?)

 No supportfor NRLTO decision in HA: 417.5(a)(1) noncompliance

 HA Inadequate (hazard unaccounted for): 417.2(a)(1)

 HACCP system not valid (lack of support): 417.4

 Inadequate HACCP system: 417.6

 The EIAO should analyze the information and document a

supportable agency position related to the plants’ use of

prerequisite programs. 

24

8

24
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

• 

• 

• 

25

26

7/15/2022

Performing the Assessment - HACCP

• Monitoring: Assess the design and frequency of monitoring

procedures. 

• Review the HACCP plan, supporting documentation and at least 60

days of records

• Now turn to the HACCP Tools portion of your notebook and look at

some questions dealing with monitoring

25

Performing the Assessment - HACCP

• Verification: Review the HACCP plan and at least 60 days of

verification records

• Determine whether verification procedures comply with requirements

• Look at the design and implementation of the procedures

• Now turn to the HACCP tools portion of your notebook and look at

some questions dealing with verification.

26

Performing the Assessment - HACCP

• Recordkeeping: From the 60 days of records, summarize what

happened related to safe and wholesome product production.

• Review supporting documentation

• Randomly select 13 production days from the 60 days

• Assess whether the HACCP System design is implemented and whether

it meets regulatory requirements.

• If an establishment has operated less than 13 days in last 60 days, 

review minimum 13 days.

Note: Only review more records if larger food safety issue is observed.

27

27

9
 

 

 

 

 

 

 

 

 

 

 

 

 

 

• 

• 

• 

29

7/15/2022

Recordkeeping

Now turn to the HACCP Tools portion

of your notebook and look at some

questions dealing with recordkeeping

28

28

Corrective Actions

Corrective Actions (CA): Review the HACCP plan and at least 60 days of

records.

• Assess design of CA and determine if they meet 417.3 requirements.

• If no CA taken in that timeframe attempt to find the last instance where

CA was taken.

• Answer questions in the tools

Now turn to the HACCP

Tools portion of your notebook

and look at some questions

dealing with corrective

actions. 29

Performing the Assessment - HACCP

Reassessment:

• Review at least 60 days of records

• Determine if reassessment should have occurred

• Review reassessment decisions and any actions taken as a

result

• Verify annual requirement is met

• Verify reassessment documentation

30

30

10
 

 

 

 

 

 

 

 

 

 

·re are no changes a 

• 

• 

• 

re are no c anges a

31

32

7/15/2022

Performing the Assessment - HACCP

• Requires documentation of all reassessments

• Requires documentation of reasons for changes or no

changes

• Reassessment: 417.4(a)(3)(ii)

• For annual reassessment if the h

reason is not required

31

Reassessment

Now turn to the HACCP Tools portion of your notebook and

look at some questions dealing with reassessment.

32

FSA Tools

Performing the Assessment

Analyze, formulate and document a supportable Agency

position about whether regulatory requirements have been

met for:

• Monitoring

• Verification

• Corrective Action

• Reassessment

• Recordkeeping

33

33

11
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

• 

• 

• 

34

35

7/15/2022

Performing the Assessment - Validation

Now let’s review the validation requirements and key points

to look for in the assessment.

34

Performing the Assessment - Validation 417.4(a)(1)

When a HACCP plan is implemented, the establishment

must:

• Conduct activities designed to determine that the HACCP

plan is functioning as intended

• Repeatedly test CCPs, CLs, monitoring, recordkeeping,

corrective action

• Review records to ensure properfunctioning of the HACCP

system

35

Performing the Assessment - Validation

Initial validation = first 90 days

• 9CFR 304.3(b) and 381.22(b)

Validation has 2 parts:

• Scientific or technical supportfor the HACCP system

• In-plant demonstration proving the HACCP system can

perform as expected

36

36

12
 

 

 

 

 

 

 

 

 

 

 

 

 

 

• 

• 

-==::.-:-=-:--==.=-:- --=,.,.,. 

• 

37

7/15/2022

Part 1 Scientific or Technical Support

• Historical data

• Scientific journal articles

• Plant generated data

• Other regulatory requirements

• Pathogen modeling program

• Processing authority

• Agency Issuances

37

Historical Data as Support

• Records must be available

• Verify historical records reflect current establishment

operations

38

38

Scientific Documents as Support

• Conditions in the study are representative of those in the

establishment’s process.

• Document describes how and why the data supportthe conclusion.

• Scientific Support Characteristics:

• Identify hazard and pathogen

• Level of reduction

• Identify critical parameters

• Sufficient relationship to hazard

• Implemented in the establishment as documented

• Otherwise additional research data needed 39

39

13
 

 

 

 

 

 

 

 

 

I 

•• 

• 

I 

I 

-

40

41

7/15/2022

Plant Generated Data as Support

• Challenge studies

• Pathogen modeling programs

• Microbiological test results

• Frequency of sampling

• Sample selection

• Sampling method

• Sample handling

• Analytical method

40

Other Regulations as Support

• May use regulations or other agency issuances to

support a NRLTO decision

• Must follow or have additional support

41

Part 2 Initial In-Plant Validation

• In-plant observations

• Measurements

• Microbiological test results

• Other information demonstrating control measures can be

implemented to achieve the intended food safety objective

42

42

14
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

• 

• 

• 

43

44

7/15/2022

Initial In-Plant Validation Characteristics

• Based on critical parameters identified in scientific support

• Intensified data collection during first 90 days “repeatedly

testing” NOT recreating entire scientific support.

• EIAO may see microbial before/after testing used to

demonstrate log reductions documented in scientific support

• Indicators and pathogen of concern

• Not required by regulation

• No deliberate introduction of pathogens allowed

43

In-plant Validation Data Uses

• “Repeatedly testing” data often used as supporting documentation for

frequencies.

• Establish a baseline of performance.

• Data can show which critical parameters are most important and give

the first signs the system is “out of control”. 

• Scientific support documentation and 90-day initial validation data

become records under 9 CFR 417.5(a)(1) supporting documentation

44

Validation & Validation Updates

• 9 CFR 417.4(a)(1): Includes review of HACCP system records.

• 9 CFR 417.1 HACCP System Defined: The HACCP plan in operation

including the HACCP plan itself.

• Entire system must be validated- Including any interventions or

processes used to support decisions in the hazard analysis.

• FR Docket No. FSIS–2009–0019

• Clarification of Requirements for Validation

• Compliance Guideline updated April 2015

45

45

15
 

 

• 

• 

46

47

7/15/2022

Validation

Now turn to the HACCP Tools portion of your notebook and

look at some questions dealing with validation.

FSA Tools

46

Validation Workshop

47

Questions?

48

48

16
 

 

• 

49

7/15/2022

Methods Group Exercise II

• Look at the Hazard Analysis for pepperoni

• Discuss any concerns

• Report out

49

17