Objectives 

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8/17/2022

HACCP Systems Validation

HACCP Systems

Validation Training

1

1

• Explain the two elements of validation

• Describe how validation documentation is a

form of supporting documentation

• Identify situations clearly representing

noncompliance with 9 CFR 417.5(a)(1) and

417.4(a)(1)

2

Validation

• The act or process of ensuring the HACCP

system is valid

• Valid: Well grounded or justifiable, relevant

and meaningful, logically correct

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IJ 

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8/17/2022

• HACCP Validation

Compliance Guideline

is available for industry

HACCP Validation Compliance Guideline

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4

HACCP Regulatory Requirements

9 CFR 417.4(a) 9 CFR 417.4(a)(1)

• “Every establishment shall • “Initial Validation. Upon completion of

validate the HACCP plan’s the hazard analysis and development of

adequacy in controlling the the HACCP plan, the establishment shall

food safety hazards conduct activities designed to determine

identified during the hazard that the HACCP plan is functioning as

analysis, and shall verify that intended. During this HACCP plan

the plan is being effectively validation period, the establishment shall

implemented.” repeatedly test the adequacy of the CCP’s,

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.” 5

HACCP Regulatory Requirements

9 CFR 417.5(a)(1)

• “The establishment shall

maintain the following records

documenting the

establishment’s HACCP plan: 

• The written hazard analysis

prescribed in 417.2(a) of this

part, including all supporting

documentation

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- - -

HACCP System

7

Initial Validation Timeframe

8/17/2022

• 9 CFR 304.3(b) and 381.22(b) require:

• New establishments to complete initial validation within 90

days under a conditional grant of inspection

• Establishments producing a new productto complete

validation of the new HACCP plan within 90 days after the

date the new product is produced for distribution in commerce

• In 90 calendar days, establishments may have varying

amounts of production:

• Large establishments could have 60 production days

• Small or Very Small establishments should have a minimum of

13 production days

Note: Small or Very Small establishments may make a

request to FSIS in writing for additional time. 

7

Statutory Authority for HACCP

FMIA PPIA EPIA

8

8

Statutory Authority for HACCP

• To enforce the HACCP and sanitation rules, we need to

show how an establishment’s failure to follow the

sanitary measures creates insanitary conditions that

could result in products that may be injurious to health.

• Example- If an establishmentfails to supporttheir

HACCP system, it could create insanitary conditions

because the establishment may not have addressed

conditions that could cause the productto be injurious

to health.

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10

HACCP

Records

HACCP Plan

Prerequisite Programs

Hazard Analysis

HACCP System

11

8/17/2022

Validation Requirements

10

Validation Requirements

Prerequisite programs not

Prerequisite programs that likely to be used to support

may support decisions in decisions in the hazard

the hazard analysis: analysis:

• Sanitation SOPs • Maintenance programs

• Purchase specifications • Facilities and grounds

programs • Antimicrobial interventions

• Pest control programs • Sanitary dressing programs

• Written recall plans • Allergen control programs

• Traceability programs

11

Validation of Prerequisite Programs

• Prerequisite programs support hazard

analysis decisions by preventing hazards

from being reasonably likely to occur.

• An effective HACCP system depends on:

• prerequisite programs being designed to prevent

hazards under actual plant conditions

• the establishment implementing prerequisite

programs as written

12

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Prerequisite Program Example

8/17/2022

Fresh Pork Hazard Analysis

Step Potential Hazard RLTO? Basis/

Justification

temperature control Raw meat Biological: No program (storage

storage Pathogen growth temperature ≤45°F and

time product is in

storage ≤5 days) will

The temperature control program must be validated. prevent pathogen

growth (Tompkin

paper).

13

Prerequisite Program Example

14

Critical Operational Parameters

• Critical operational • Examples of critical

parameters are the operational

specific conditions parameters:

that the intervention • Time

must meet in order for • Temperature

• Concentration it to be effective. • Humidity

• Dwell Time

• pH

• Contact Time

• Product Coverage

• Pressure

15 • Point of application

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5
Element 1:

Design)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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(

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8/17/2022

• Inadequate initial validation has

been linked to food safety problems

• In October 2007, frozen pot pies were

linked to an outbreak of Salmonellosis.

• Consumers were not cooking the

products in the microwave adequately.

• The cooking instructions on not readyto-eat products must be validated when

consumer cooking is used to support

decisions in the hazard analysis.

Case Example of Inadequate Validation

Company A

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Two Elements of Initial Validation

Element 1:

Scientific or

Technical

Support

(Design)

Element 2:

Initial in plant

Validation Data

(Execution)

• Theoretical support

• scientific or technical support

for decisions made in

designing the HACCP system

• use 417.5(a)(1)

• Initial In-plant validation

• evidence from the HACCP

plan shows it achieves the

parameters and results

expected from the supporting

documents

• use 417.4(a)(1) 17

Element 1: Scientific Support

Element 1:

Scientific or

Technical

Support

(Design)

• To meet the first element of initial

validation:

• Gather scientific support that:

• Closely matches the actual process

• Shows the establishment’s process will

prevent, reduce, or eliminate the

hazard identified in the hazard analysis

• Identify the critical operational parameters

from the scientific support relevant to the

establishment's process.

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FSIS Cooking Guideline for 

Meat and Poulby Products 

(Revised Appendix A) 

December, 2021 

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Element 1: Scientific Support

8/17/2022

• The scientific support should identify: 

• The specific hazard

• The expected level of hazard reduction/prevention

• All critical operational parameters

• The processing steps where the reduction or

prevention should occur

• How these processing steps can be monitored

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Element 1: Scientific Support

What if the biological hazards in the scientific support don’t match

the hazard analysis?

• Appendix A may be used to support lethality

temperatures to control Salmonella and

other pathogens such as E. coli O157:H7 and

Lm.

• Interventions validated to control E. coli

O157:H7 should be effective in controlling

non-O157 STEC.

• Data from indicator organisms may be used.

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Element 1: Examples of Scientific Support

• Published Processing

Guidelines (FSIS Compliance

Guidelines)

• Best Practice Guidelines

• Peer-reviewed Scientific

Data/Information

• Challenge or Inoculated Pack

Study

• Pathogen Modeling Program

• Regulatory Performance

Standards

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8/17/2022

Element 1: Examples of Scientific Support

Hazard

Critical Operational

Parameters

Level of Prevention

22

Hazard

Log

Reduction

Critical Operational Parameters (time, temperature, product type)

Process

Step

Element 1: Examples of Scientific Support

23

Element 1: Examples of Scientific Support

Table 3. Antimicrobial effectiveness of several food-safe compounds used to

eliminate meatborne pathogens from experimentally inoculated beef surfaces.

Log

reduction

Antimicrobial type and concentration. Other critical operational parameters not shown (distance of spray to carcass

surface, carcass coverage, application method and pressure, contacttime, temperature.)

Hazard

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Diameter of product studied –

Impermeable

glass “casing” of

product studied

Element 1: Noncompliance

8/17/2022

Element 1 Noncompliance is cited using 417.5(a)(1)

Examples:

• An establishment references a peer reviewed journal article,

but can’t produce the article upon request

• A process that is validated for a specific log reduction of a

pathogen in a non-meat or poultry product is being used as

sole supporting documentation

• Documentation in the form of a No Objection Letter without

additional support

• Processing authority’s opinion without any reference to

established scientific principles or peer-reviewed data 25

Element 1: Inadequate Scientific Validation

Case Example: Scientific support did not match the process

– March 2011- recalled Lebanon bologn

was associated with a foodborne illne

outbreak of E. coli O157:H7.

– The establishment had not properly

validated their process.

Semi-permeable

casing of actual – There were differences in the diameter product produced and type of casing material on the

product studied versus the actual

product that likely led to a lower

reduction in foodborne pathogens. Diameter of product produced – 26 52 to 119 mm

27 mm

Element 2: In plant Validation Data

Element 2:

Initial in plant

Validation Data

(Execution)

• To meet the second element of initial

validation:

• Implement parameters consistent with

those in the scientific support

• Collect in-plant data showing the

establishment can meet the parameters

for at least one product from each HACCP

category

• Analyze the data to determine whether

the parameters are being implemented

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-

-

-

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Element 2: In plant Validation Data

8/17/2022

• The establishment should

implement: 

• the same parameters or

• support the effectiveness of

any difference in the

parameters

• The establishment should

incorporate:

• all of the parameters into

the critical limits of a CCP or

• some parameters could be

measured as part of a

prerequisite program.

Implementing Critical Operating Parameters

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Incomplete Coverage of Antimicrobial Sprays

Element 2: In plant Validation Data

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Element 2: In plant Validation Data

• Initial in-plant validation data should be collected for:

• at least one product from each HACCP process category

• all CCPs and prerequisite programs used to support

decisions in the food safety system

• product within each HACCP process category that

represents the worst-case

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-

-

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Element 2: In plant Validation Data

8/17/2022

• Microbiological data collection is encouraged (but not

required) for initial in-plant validation, if the

establishment:

1. Has adequate scientific supporting documentation (the

first element of initial validation)

2. Is following the same parameters in the scientific support

3. Can demonstrate that it can meet the critical 

parameters during operation (the second element of

initial validation)

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Element 2: In plant Validation Data

Example- No Microbiological Data Is Needed

• An establishment may only need initial in-plant validation

data for the critical operational parameters when:

• Using the Tompkin paper to support a storage temperature

CCP for raw meat of ≤45°F and

• Time product is in storage is ≤5 days

• In-plant validation data gathered should demonstrate:

• Ambient air storage temperature does not exceed 45°F

• Productis not held in storage for more than 5 days and

• Correlationbetween the product temperature and the

ambient storage temperature.

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Element 2: In plant Validation Data

• In-plant microbiological data is needed when:

• the process does notfollow the same parameters in the

supporting documentation, or

• the scientific support does not contain microbiological

data

• In either case, the establishment should demonstrate:

• the modified critical operational parameters are being

met, and

• the intervention’s effectiveness under actual in-plant

conditions (e.g., through microbiological data).

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Element 2: In plant Validation Data

8/17/2022

Example- Microbiological Data Is Needed

• A poultry establishment uses an intervention that

has been validated to reduce Salmonella.

• The pathogen of concern is Campylobacter, but

they can’t find literature documenting the

intervention’s effectiveness on Campylobacter.

• The establishment should gather in-plant

microbiological data along with data on the critical

operational parameters. 

34

Example: Storage Temperature Control Program

Product Hazard Process

Critical

Operational

Parameters

InitialValidation

Scientificor Technical Support In-PlantValidation Data

Post-lethality Biological -Listeria Packaging -Time Packaging Tompkin Paper. Table 2. In plant records for 90

exposed ready- monocytogenes and Temperature room http://www.meathaccp.wisc.edu/M day period

to-eat meats GMP’s temperature ≤

50°F.

Product

remains in

packaging< 5

hours priorto

refrigerated

storage.

odel_Haccp_Plans/assets/raw_gro

und/TompkinPaper.pdf.

demonstrating ambient

air temperature in the

assembly room does not

exceed 50°F and that

productis not held during

packaging for more than

5 hours. In plantrecords

for 90 day period

demonstrating a

correlation between

producttemperature and

ambient temperature.

35

Example: Storage Temperature Control Program

36

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8/17/2022

Example: Antimicrobial Intervention

Product Hazard Process Critical Operational Parameters

Initial Validation

Scientific Support Initial In-Plant Data

Beef Carcass Biological –

E. coli

O157:H7,

Salmonella

Typhimurium

Chemical -

excessive

levels of lactic 

acid

Physical -

none

Lactic Acid

Spray

2% lactic acid applied within 12

inches of carcass surface and

entire carcass covered using a

stainless steel spray tank fitted

with a pressure gauge and air

compressor.

Each side of beef should be

sprayed for at least 1 minute

and sprayed from top to bottom

and sufficient lactic acid is 

applied such that some of it

drips off.

Note: The entire carcass is 

sprayed with lactic acid

following washing each side of

beef from top to bottom for at

least 2 minutes with hot water

and allowing a 5 minute drip

time after the hot water wash.

Antimicrobial Spray 

Treatments 

for Red Meat Carcasses 

Processed in

Very Small Meat

Establishments.

Pennsylvania State

University. 2005.

Technical support from

the manufacturer with

instructions on mixing

the lactic acid with

water to achieve a

concentration that is 

safe and suitable in

accordance with:

FSIS Directive 7120.1

In plant monitoring records for 90

day period recorded on Hot

Water and Drip Time Monitoring

Check Sheet (including

parameters for the time the

carcass is sprayed with hot

water, carcass coverage, method

application (from top to bottom

and spray nozzle within 12 inches 

of carcass), and drip time.

Records of lactic acid

concentration. Trial Reports run

under specified lactic acid critical

parameters demonstrating

complete carcass coverage,

sufficient amount (lactic acid

drips off carcass), contact time,

method of application (spray 

nozzle within 12 inches of

carcass and from top to bottom).

37

Example: Antimicrobial Intervention

38

Example: Antimicrobial Intervention

39

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•Frequency:

•W th n the f rst 90 days

of new/rev sed HACCP

system

•Purpose:

•To ensure the HACCP

system funct ons as

ntended

•Repeated y test

parameters to show

they are mp emented

and effect ve n

prevent ng or contro ng

the hazards

•Frequency

•After n t a va dat on

(day 91 and onward)

•Purpose:

•To ensure the HACCP

system cont nues to

funct on as ntended

•Conduct ongo ng

ver f cat on act v t es

(ca brat on d rect

observat on and rev ew

of records) and other

checks such as test ng

91 and onward)

•Purpos

•To ensur

em con

n as nt

ongo n

act v t

rect

rev ew

of er

chec g

•Frequency

•Annua y and whenever

changes occur that affect

the hazard ana ys s or

HACCP p an

•Purpose:

•To determ ne whether

the HACCP system as

des gned and executed s

st adequate

•Rev ew of HACCP

records to ensure the

HACCP system as

des gned and executed s

st adequate

41

8/17/2022

Yes! Best Practice

 Contact

time

 Concentration

(not shown)

 Method of application

 Pressure

Gauge

Are All of the Critical Operational Parameters Being Met?

Example: Antimicrobial Intervention

40

40

Element 2: Noncompliance

Element 2 Noncompliance is cited using 417.4(a)(1)

Examples:

• The establishment does not maintain in-plant validation data for at least

one product in each HACCP process category.

• In-plant validation records show the HACCP system does not control a

food safety hazard.

• Prerequisite programs or CCPs do not incorporate the parameters from

the scientific references and there is no additional support data.

• The establishment had a validated process on file but did not

follow the process as described.

• The establishment references time and temperature values from

Appendix A, but fails to reach the required values 41

What is the Difference Between Initial Validation and Ongoing

Verification?

Initial

Validation

i i i

i

i

i

l

i l

i i

i lli

•Frequency:

•Within the first 90 days

of new/revised HACCP

system

•Purpose:

•To ensure the HACCP

system functions as

intended

•Repeatedly test

parameters to show

they are implemented

and effective in

preventing or controlling

the hazards

Ongoing

Verification

i i i l li i

i

i i

i

i i i i i i

li i , i

i , i

i

•Frequency

•After initial validation

(day

e:

e the HACCP

syst tinues to

functio i ended

•Conduct i g

verification i i ies

(calibration, di

observation, and i

records) and oth

ks such as testin

Reassessment

ll

l i

l

i

i i

ill

i

i i

ill

•Frequency

•Annually and whenever

changes occur that affect

the hazard analysis or

HACCP plan

•Purpose:

•To determine whether

the HACCP system as

designed and executed is

still adequate

•Review of HACCP

records to ensure the

HACCP system as

designed and executed is

still adequate

If reassessment results in no changes

If reassessment results in changes to the HACCP system

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Summary

8/17/2022

• Initial validation includes data that shows the entire HACCP

system is functioning as intended. 

• There are two elements to initial validation:

• Element 1: Scientific Support Documentation (Design)

• Element 2: Initial in-plant Demonstration Data (Execution)

• Initial Validation is within the first 90 days

• Usually, initial in-plant validation data will consist of data

related to critical operational parameters (not

microbiological data).

43

What questions do you have?

44

Questions

45

Workshop

45

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