danielle bauer vanilla ice cream food safety plan fall 2017 · vanilla ice cream product...

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Danielle Bauer

Vanilla Ice Cream Food Safety Plan

Fall 2017

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Product Characterization Form: PC for Human Foods

PLANT NAME

Bauer’s Ice Creamery ISSUE DATE

10/4/2017

PAGE

1

ADDRESS

1234 Moo Drive Louisville, KY USA

SUPERSEDES

PRODUCT CODE

9240VIC

Product Description Distribution, Consumers and Intended Use

Product Name(s)

Vanilla Ice Cream

Product Description, including

Important Food Safety

Characteristics

Frozen dairy product with natural vanilla flavoring

pH ~6.7

Ingredients

Cream, Skim Milk, Sugar, Natural Vanilla Flavor (Vanilla bean, alcohol),

Carrageenan, Vanilla Bean

Packaging Used

Pre-labeled paperboard carton with plastic film as primary packaging

Corrugated container as secondary packaging

Intended Use

Product is Ready-to-Eat and should be consumed frozen

Intended Consumers

General population

Shelf Life

≤ 365 days frozen

Labeling Instructions related to

Safety

Keep frozen, ≤ 10 ͦF

Storage and Distribution

Frozen ≤ 10 ͦF

Approved:

Signature:

Print name: Danielle Bauer

Date:

10/4/17

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Preventive Control for Human Foods: Flow Diagram Product or Process Name: Vanilla Ice Cream Flow Diagram – Bauer’s Ice Creamery Approved: _____________________________________ Date:_________________

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Hazard Analysis and Preventive Controls Form: PC for Human

Foods

PLANT NAME

Bauer’s Ice Creamery ISSUE DATE

11/13/17

PAGE

1

ADDRESS

1234 Moo Drive Louisville, KY USA

SUPERSEDES

PRODUCT CODE

9240VIC

Hazard identification (column 2) considers those that may be present in the food because the hazard occurs naturally, the

hazard may be unintentionally introduced, or the hazard may be intentionally introduced for economic gain.

B = Biological hazards including bacteria, viruses, parasites, and environmental pathogens

C = Chemical (including radiological) hazards, food allergens, substances such as pesticides and drug residues, natural

toxins, decomposition, and unapproved food or color additives

P = Physical hazards include potentially harmful extraneous matter that may cause choking, injury or other adverse health

effects

Hazard Analysis

(1)

Ingredient /

Processing

Step

(2)

Identify potential

food safety hazards

introduced,

controlled or

enhanced at this

step

(3)

Do any

potential

food safety

hazards

require a

preventive

control?

(4)

Justify your decision for

column 3

(5)

What preventive control

measure(s) can be applied to

significantly minimize or

prevent the food safety

hazard?

Process including CCPs,

Allergen, Sanitation, Supply-

chain, other preventive

control

(6)

Is the

preventive

control

applied at

this step?

Yes No Yes No

Receive

Refrigerated

Ingredients -

Pasteurized

Grade A Skim

Milk

B Presence of

vegetative

pathogens such

as: Bacillus

cereus,

Salmonella spp.

(particularly

Salmonella

typhimurium and

Salmonella

dublin), E.

coliO157:H7, L.

monocytogenes,

Campylobacter

spp., and

Staphylococcus

aureus

X

Vegetative pathogens are

not able to survive the

heat treatment of

pasteurization, however if

the process is not carried

out appropriately per the

supplier process, these

microorganisms may be

present in the product

received.

Process control –

Pasteurization occurs at

subsequent step

X

C Allergen

X

Milk is a major allergen

that must be labeled to

inform consumers. Cross

contact is of no concern as

all products in the

creamery contain milk.

Allergen control – Allergen

labeling control at

subsequent packaging

receiving step

X

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Drug Residues

Mycotoxin from

Aflatoxin

X

x

Supply chain preventive

controls are in place to

control hazard – Supplier

third party audits and

Letter of Guarantee

required on annual basis



control hazard – Product

COA required with each

shipment and Supplier

third party audits required

on annual basis

P Foreign material

such as wood or

plastic from the

supplier may be

introduced

during the

loading/transport

ation process

x SOPs are in place to utilize

screens to remove foreign

material prior to use. Past

history at the plant shows

this is not reasonably

likely to occur.

Receive

Refrigerated

Ingredients –

Cream

B Presence of

vegetative

pathogens such

as: Bacillus

cereus,

Salmonella spp.

(particularly

Salmonella

typhimurium and

Salmonella

dublin), E.

coliO157:H7, L.

monocytogenes

Campylobacter

spp. and

Staphylococcus

aureus

X Vegetative pathogens are

not able to survive the

heat treatment of

pasteurization, however if

the process is not carried

out appropriately per the

supplier process, these

microorganisms may be

present in the product

received

Process control –

Pasteurization occurs at

subsequent step

X

C Allergen

Drug Residues

X

X

Milk is a major allergen

that must be labeled to

inform consumers. Cross

contamination is of no

concern as all products in

the creamery contain milk.



control hazard – Supplier


Allergen control – Allergen

labeling at subsequent

packaging receiving step

X

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Mycotoxin from

Aflatoxin

x

Letter of Guarantee




control hazard – – Product

COA required with each

shipment and Supplier


Letter of Guarantee


P Foreign material

such as wood or

plastic from the

supplier may be

introduced

during the

loading/transpor

ation process

x SOPs are in place to utilize

screens to remove foreign

material prior to use. Past

history shows this is not

reasonably likely to occur

Receive Shelf

Stable

Ingredients -

Sugar

B None

P None

C None

Receive Shelf

Stable

Ingredients –

Natural

Vanilla Flavor

B None

C None

P None

Receive Shelf

Stable

Ingredients –

Vanilla Bean

B None

C None

P None

Receive Shelf

Stable

Ingredients –

Carrageenan

B Salmonella

enteritidis

x Supply chain preventive

control - COA required

with each shipment

C None

P None

Receiving

Packaging –

Pre-labeled

carton

B None

C1 Undeclared

allergens

X Labeled cartons must

declare milk allergen to

inform consumers of

potential hazard

Allergen control – Review

label to ensure allergens are

declared and information is

x

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correct prior to release into

production

P None

Receiving

Packaging –

Corrugated

container

B None

C None

P None

Receiving

Packaging –

Plastic Film

B None

C None

P None

Refrigerated

ingredient

storage

Pasteurized

Grade A

Skim Milk,

Cream

B Growth of

vegetative

pathogens such

as: Bacillus

cereus,

Salmonella spp.

(particularly

Salmonella

typhimurium and

Salmonella

dublin), E.

coliO157:H7, L.

monocytogenes

Campylobacter

spp. and

Staphylococcus

aureus

x Pre-requisite programs

ensure proper cooler

temperatures daily

through SOPs

C Ammonia

contamination

from refrigerant

system

x Continuous monitoring

system and daily SSOPs

prevent likely

contamination

P None

Ambient Dry

Ingredient

Storage

Sugar,

Natural

Vanilla Flavor,

Vanilla Bean,

Carrageenan

B None

C None

P None

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Packaging

Storage

Labeled

Paperboard

Carton,

Corrugated

container,

Plastic Film

B None

C None

P None

Dry

Ingredient

Batching

B Contamination

with vegetative

pathogens such

as Listeria

monocytogenes,

Samonella spp.

and

Staphylococcus

aureus

x Pathogens may be

introduced into open

product from the

environment or poor

employee practices

Process Control – Subsequent

pasteurization step

x

C None

P None

Mix with heat

Milk, Cream,

Sugar,

Carrageenan

B Contamination

with vegetative

pathogens such

as Salmonella

spp.

(particularly

Salmonella

typhimurium

and Salmonella

dublin), E.

coliO157:H7, L.

monocytogenes,

Campylobacter

spp., and

Staphylococcus

aureus

x Pathogens may be

introduced into open

product from the

environment or become

introduced from raw

materials


pasteurization step

x

C Cleaning and

sanitizing

residues

x Pre-Operational Sanitation

Inspections prevent the

likelihood of

contamination

P Metal fragments x Mixing equipment may

break from metal on

metal contact and

introduce metal into

product


metal detection step

following packaging

x

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Pasteurize B1 Survival of

vegetative

pathogens such

as: Bacillus

cereus,

Salmonella spp.

(particularly

Salmonella

typhimurium

and Salmonella

dublin), E.

coliO157:H7, L.

monocytogenes,

Campylobacter

spp., and

Staphylococcus

aureus

x Pathogens may survive if

the product mix does not

meet time and

temperature

requirements

Process Control –

Vat Pasteurization for ≥30

minutes at ≥155F (69C)

x

C Cleaning and

sanitizing

residues


Inspections prevent the

likelihood of

contamination

P Metal fragments x Metal on metal contact

could cause breakage and

introduction into product

Process Control – subsequent

metal detection step after

packaging

x

Homeogenize B2 Growth of

vegetative

pathogens such

as: Bacillus

cereus,

Salmonella spp.

(particularly

Salmonella

typhimurium

and Salmonella

dublin), E.

coliO157:H7, L.

monocytogenes,

Campylobacter

spp., and

Staphylococcus

aureus

x Pathogen growth may

occur if product

temperature drops below

the pasteurization

temperature

Process Control – Monitor

mix to ensure product

remains at pasteurization

temperatures 155F (69C)

x

C Cleaning and

sanitizing

residues


Inspections prevent

contamination as





Process Control – subsequent


packaging

x

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Aging Vats B Contamination

with vegetative

pathogens such

as Salmonella

spp.

(particularly

Salmonella

typhimurium

and Salmonella

dublin), E.

coliO157:H7,

Listeria

monocytogenes

x Vegetative pathogens may

be introduced into a RTE

food product after

pasteurization due to poor

sanitation or employee

hygiene

Sanitation Control –

Cleaning/sanitizing SSOPs in

place to control microbial

growth. Compliance to cGMPs

control risk of contamination

from employees. . A monthly

environmental monitoring

program is in place to seek

out and identify

environmental pathogens

such as Listeria

monocytogenes

x

C Cleaning and

sanitizing

residues


Inspections prevent

contamination as


P None

Flavoring

Natural

Vanilla Flavor,

Vanilla Beans

B Contamination

with vegetative

pathogens such

as Salmonella

spp.

(particularly

Salmonella

typhimurium

and Salmonella

dublin), E.

coliO157:H7List

eria

monocytogenes



food product after



hygiene









out and identify


such as Listeria

monocytogenes

x

C None

P None

Freezer B Contamination

with vegetative

pathogens such

as Salmonella

spp.

(particularly

Salmonella

typhimurium

and Salmonella

dublin), E.

coliO157:H7,

Listeria

monocytogenes

x Vegetative pathogens

may be introduced into a

RTE food product after



hygiene









out and identify


such as Listeria

monocytogenes

x

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C2 Ammonia

contamination

from refrigerant

system

x A break or leak in the

refrigerant system could

cause product

contamination

Sanitation Control – Check

refrigerant system pressure

gauge before and after each

batch

x






packaging

x

In-line Metal

Detector

B Contamination

with vegetative

pathogens such

as Salmonella

spp.

(particularly

Salmonella

typhimurium

and Salmonella

dublin), E.

coliO157:H7

Listeria

monocytogenes



food product after



hygiene









out and identify


such as Listeria

monocytogenes

x

C None

P Metal fragments x Metal fragments may be

introduced in the process

during mixing



packaging

x

Fill into

prelabeled

carton,

weight, label,

date code

B Contamination

with vegetative

pathogens such

as Salmonella

spp.

(particularly

Salmonella

typhimurium

and Salmonella

dublin), E.

coliO157:H7

Listeria

monocytogenes


may be introduced into a

RTE food product after



hygiene









out and identify


such as Listeria

monocytogenes

x

C Milk allergen

labeling

X Carton label must contain

milk allergen information

to inform consumers

Allergen Control –Verify

labels list milk allergen upon

receipt of product

x

P None

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Hardening B None

C None

P None

Metal

Detection

B None

C None

P1 Metal fragments x Metal fragments may be

introduced at any point in

the process due to broken

equipment or breach in

employee SOPs. Metal

fragments ≥7 mm or ≤25

mm are considered

hazardous in finished

product.

Process Control – Metal

detection

x

Final product

packaging

into

corrugated

container

B None

C None

P None

Frozen

Storage

B Growth of

pathogens such

as : Salmonella

spp.

(particularly

Salmonella

typhimurium

and Salmonella

dublin), E.

coliO157:H7

Listeria

monoctyogenes

if product

temperatures

were to rise

x Pre-requisite cGMP

programs ensure proper

freezer temperatures are

maintained through SOPs

C Ammonia

contamination

from refrigerant

system

x Continuous monitoring

system and sanitation

validation processes

prevent likely

contamination

P None

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Addition of

Rework

B Contamination

with vegetative

pathogens such

as Listeria

monocytogenes,

Salmonella spp.

(particularly

Salmonella

typhimurium and

Salmonella

dublin), E.

coliO157:H7and

Staphylococcus

aureus


including Listeria

monocytogenes may be

introduced into a RTE food

product after



hygiene






from employees. A monthly



out and identify


such as Listeria

monocytogenes

x

C None

P None

Returned

Product

B Contamination

with vegetative

pathogens such

as Listeria

monocytogenes,

Salmonella spp.

(particularly

Salmonella

typhimurium and

Salmonella

dublin), E.

coliO157:H7 and

Staphylococcus

aureus


including Listeria

monocytogenes may be

introduced into a RTE food

product after



hygiene






from employees. A monthly



out and identify


such as Listeria

monocytogenes

x

C

P

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Justification for Preventive Controls – Vanilla Ice Cream

Process Preventive Controls:

• PC B1 - Pasteurization

Although the dairy ingredients used in the ice cream produced at this facility are purchased as

pasteurized products, there is the possibility that the supplier’s process could fail, rendering the

product unsafe to consumers. Raw material suppliers may not alert Bauer’s Ice Creamery of a

problem before production or release to the consumer occurs. The pasteurization process

preventive control ensures Bauer’s Ice Creamery kills all potential pathogens from raw

ingredients.

• PC B2 – Homogenization

Once the product has finished pasteurizing for the prescribed time and temperature, the product

must be maintained at this temperature until the product is cooled in the aging vats. Product that

drops below the pasteurization temperature may allow for growth of potential pathogens. There

are no subsequent lethality steps after this step.

• PC P1 – Metal Detection

Metal contamination in product can seriously harm an unsuspecting consumer. Stainless steel

equipment is used throughout the ice cream production process which allows the potential to

introduce metal into the product. While regular maintenance and sanitation SOPs are in place to

inspect and replace broken equipment, it is reasonably likely to assume that metal fragments

could enter the product throughout the production process.

Allergen Preventive Controls:

• PC C1 – Undeclared allergens

Allergens are a chemical hazard that can cause serious harm or death to consumers. FDA

regulatory requirements mandate that food products must declare any of the eight major allergens

on product labels. Recalls due to undeclared allergens made up 36% of recalls in 2009-2013.

Recalls can be detrimental to businesses. Milk is a major allergen and is present in ice cream.

Sanitation Preventive Controls:

• PC C2 – Ammonia contamination

Ammonia is used in the refrigerant system for cooling and freezing ice cream. Ammonia causes

severe illness in humans. Damage to the ammonia system in this equipment could cause direct

product contamination. A small leak could potentially go unnoticed without regular inspection,

causing consumers to become seriously ill.

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Process Preventive Controls Form: PC for Human Foods

Product Name: Vanilla Ice Cream

Process

Control Step

Hazard(s) Parameters,

Values or Critical

Limits

Monitoring Procedures

B1-

Pasteurize

Survival of

vegetative

pathogens such as:

Bacillus cereus,

Salmonella spp.

(particularly

Salmonella

typhimurium and

Salmonella dublin),

E. coliO157:H7, L.

monocytogenes,

Campylobacter spp.,

and Staphylococcus

aureus

Vat Pasteurization

for ≥30 minutes at

≥155F (69C)

PMO, Part 1,

Definition S;

Attachment 4 for

acceptable

pasteurization

times and

temperatures; and

Attachment 1 for

pasteurizer

evaluation.

What is going to be measured?

Product temperature and time in vat pasteurization system

How will it be measured?

Continuous monitoring system will measure product temperature throughout the process and an

alarm will sound if critical temperature limit is not reached, or the temperature drops. Pasteurizer

operator or trained designee will record temperature of product sample using a calibrated

thermometer. The Pasteurizer operator or trained designee will use a stopwatch to measure and

record the time product has been in the vat pasteurizer, from the time the product reaches 155F to

the end of the process.

Who will be responsible for monitoring?

Pasteurization operator or trained designee

How frequently will it be measured?

Product temperature will be continuously monitored throughout the pasteurization process using a

calibrated continuous temperature monitoring system. Pasteurizer operator or trained designee will

record the product temperature at the start of the holding period and at the end of the holding period

using a calibrated thermometer. The pasteurization time will be measured once at the end of the 30-

minute pasteurization period.

B2-

Homogenize

Growth of

vegetative

pathogens such as:

Bacillus cereus

Salmonella spp.

(particularly

Salmonella

typhimurium and

Salmonella dublin),

E. coliO157:H7, L.

monocytogenes,

Campylobacter spp.,

Monitor mix

temperature to

ensure product

remains at

pasteurization

temperatures

≥ 155F (69C)

PMO, Part 1,

Definition S;

Attachment 4 for

acceptable


Product temperature inside the homogenizer


Continuous monitoring system will measure product temperature throughout the process and alarm

will sound if critical temperature limit drops. Product temperature will be recorded from a product

sample using a calibrated thermometer by the homogenizer operator or trained designee.


Homogenizer operator or trained designee

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and Staphylococcus

aureus

pasteurization

times and

temperatures; and

Attachment 1 for

pasteurizer

evaluation.


The product temperature will be recorded by homogenizer operator or trained designee at the start of

the process, every thirty minutes (+/- 10 minutes) during production thereafter, and at the end of the

process.

P1- Metal

detection

Metal fragments

may be introduced

at any point in the

process due to

broken equipment or

breach in employee

SOPs. Metal

fragments ≥7 mm or

≤25 mm are

considered

hazardous in

finished product.

Metal detector

detects:

≥2 mm ferrous, ≥2

mm nonferrous, ≥2

mm stainless steel

FDA Compliance

Policy Guide

555.425 Foods -

Adulteration

Involving Foreign

Objects


The ability of metal detector to reject the 2 mm ferrous, 2 mm nonferrous, and 2 mm stainless steel

standards.


Continuous monitoring using a functional metal detector able to detect 2 mm ferrous, 2 mm

nonferrous, and 2 mm stainless steel standards. The packing line operator or trained designee will

verify the metal detector is functional using standard seeded wands through the detectors with

positive rejection. Each metal test standard must be passed through the metal detectors with positive

rejection twice.


Packing line operator or trained designee


Line operator or trained designee will verify the equipment is functioning properly at start-up of

production, hourly during production, and at the end of production.

Approved Date_____________________________________________

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Food Allergen Preventive Controls Form: PC for Human Foods


Allergen

Control

Hazard(s) Criterion Monitoring Procedures

C1 –

Receiving

Packaging –

Pre-labeled

carton

Undeclared

allergens

Labeled cartons

must declare milk

allergen


Ingredient listing and allergen warning contains milk allergen information


Visual check of one carton label from each pallet of product. Label must match

correct product formula and allergen declaration


Label coordinator or trained designee


Each incoming shipment of pre-labeled cartons will be checked at receiving prior to

release into production.

Approved Date_____________________________________________

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Sanitation Preventive Controls Form: PC for Human Foods


Location

Purpose Frequency Sanitation Procedures

C2-

Ice cream

freezer

Inspect refrigerant

system pressure

gauge to ensure no

product has been

contaminated with

ammonia and to

prevent any affected

product from entering

commerce

Prior to start of

production, at the

end of production,

and any breaks in

production

Who will be responsible?

Sanitation operator or trained designee

What is the Procedure?

Sanitation operator or trained designee will perform visual inspection of the

pressure gauge to ensure specifications are met.

How will it be monitored?

Sanitation operator or trained designee will record the pressure reading on the

appropriate form.

Approved Date_____________________________________________

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Process Preventive Controls Corrective Action and Verification Form: PC for Human Foods


Process

Control Step


Values or

Critical Limits

Corrective Action Verification Procedures

B1-

Pasteurize

Survival of

vegetative

pathogens such as:

Bacillus cereus

Salmonella spp.

(particularly

Salmonella

typhimurium and

Salmonella dublin),

E. coliO157:H7, L.

monocytogenes,

Campylobacter

spp., and

Staphylococcus

aureus

Vat

Pasteurization for

≥30 minutes at

≥155F (69C)

PMO, Part 1,

Definition S;

Attachment 4 for

acceptable

pasteurization

times and

temperatures;

and Attachment 1

for pasteurizer

evaluation

What caused the deviation and how will the cause

(not the product) be corrected?

Equipment malfunction caused product temperature

to drop below 155F during the 30-minute hold

period. The root cause was determined to be the

thermometer had drifted out of calibration during

production due to excess product buildup that had

not been adequately removed in the sanitation

process. In turn, the alarm system did not alert the

operator of a problem. The thermometer will be

cleaned according to SSOPs and verified against

NIST standard prior to use in production.

What measures will be implemented to reduce the

likelihood of occurrence?

Sanitation operators will be retrained by PCQI or

trained designee on the proper cleaning procedures

and frequencies for the continuous monitoring

system.

How will the product be evaluated for safety?

Product will be re-pasteurized and monitored at 5-

minute intervals by pasteurizer operator or trained

designee using calibrated hand-held thermometers to

ensure consistent product temperature

How will affected food be prevented from entering

commerce if it cannot be ensured that the product is

not adulterated?

All product from the batch will be placed on hold

and reworked if possible, or destroyed if QA

manager or trained designee deems unsafe.

What equipment needs to be calibrated (or checked for

accuracy) for monitoring and verification, what is

frequency of calibration and who is responsible?

The continuous monitoring temperature system and

hand-held thermometers used by operators must be

calibrated annually. Operator or trained designee will

check for accuracy daily during production against a

calibrated NIST standard

If appropriate, what product testing for a pathogen or

indicator organism or other hazard is being conducted,

including frequency and who is responsible?

Pathogen testing for E. coliO157:H7, L. monocytogenes,

and Salmonella spp. is performed on a quarterly basis.

The principal microbiologist or trained designee will be

responsible for testing using BAM standards.

If product is RTE and there is an environmental pathogen

hazard requiring a PC, what environmental monitoring is

conducted, including frequency and who is responsible?

No environmental pathogen hazard is identified as

requiring a PC

How often are records reviewed by a PCQI for

monitoring and CA?

All production records for PC B1 are reviewed within 7

working days of production


calibration and verification testing?



20 | P a g e

B2-

Homogenize

Growth of

vegetative

pathogens such as:

Bacillus cereus

Salmonella spp.

(particularly

Salmonella

typhimurium and

Salmonella dublin),

E. coliO157:H7, L.

monocytogenes,

Campylobacter

spp., and

Staphylococcus

aureus

Monitor mix

temperature to

ensure product

remains at

pasteurization

temperatures

≥ 155F (69C)

PMO, Part 1,

Definition S;

Attachment 4 for

acceptable

pasteurization

times and

temperatures;

and Attachment 1

for pasteurizer

evaluation.

What caused the deviation and how will the cause be

corrected?

Operator did not monitor product temperature as

required by the Food Safety Plan Process Preventive

Controls. Operator will be trained by PCQI or QA

Manager to contact supervisor prior to leaving

his/her work station.



All operators will be trained by PCQI or QA

Manager on all PC SOPs annually to provide back

up for all employees.


Continuous monitoring system will be reviewed by

PCQI or QA Manager to to determine if product was

held at critical limit throughout the homogenization

hold time.



not adulterated?

All product back to the last acceptable check will be

placed on hold for further disposition by QA

Manager or trained designee. If possible, product

will be re-pasteurized. Any product that cannot be

reworked will be destroyed.




The continuous monitoring temperature system and

hand-held thermometers used by operators must be

calibrated annually. Operator or trained designee will

check for accuracy daily during production against a





No environmental pathogen hazard is identified as

requiring a PC




None


monitoring and CA?







21 | P a g e

P1- Metal

detection

Metal fragments

may be introduced

at any point in the

process due to

broken equipment

or breach in

employee SOPs.

Metal fragments ≥7

mm or ≤25 mm are

considered

hazardous in

finished product.

Metal detector

detects:

≥2 mm ferrous,

≥2 mm

nonferrous, ≥2

mm stainless

steel

FDA Compliance

Policy Guide

555.425 Foods -

Adulteration

Involving

Foreign Objects

What caused the deviation and how will the cause be

corrected?

Packing operator found metal detector did not

positively reject metal standards at hourly

production check. The packing operator shall

immediately stop the line and place all product on

hold until the last acceptable check. Maintenance

will perform any adjustments needed and the

equipment will be verified to perform properly before

use.



Frequency of checks will be increased to every 30

minutes during production shifts by packing operator

or trained designee until an official calibration is

performed. Calibration by the equipment

manufacturer will be required after a corrective

action incident.


The packing operator will place all product on hold

until the last acceptable hourly production check.

PCQI or QA Manager will reanalyze product

through a functioning metal detector



not adulterated?

All product between acceptable checks will be placed

on hold and reevaluated using a functional metal

detector as described above. If product does not pass

check, the product will be destroyed




Metal detector is calibrated annually by equipment

manufacturer. Operator or trained designee will perform

accuracy checks of the machine at the start of

production, hourly during production, and at the end of

production each day




None




None


monitoring and CA?

All production records for PC P1 are reviewed within 7




All production records for PC P1 are reviewed within 7


Approved Date_____________________________________________

22 | P a g e

Allergen Preventive Controls Corrective Action and Verification Form: PC for Human Foods


Process

Control Step

Hazard(s) Criterion Corrective Action Verification Procedures

C1 –

Receiving

Packaging –

Pre-labeled

carton

Undeclared

allergens

Labeled cartons

must declare

milk allergen

What caused the deviation and how will the

cause (not the product) be corrected?

Packaging supplier shipped product out of FIFO

rotation and released older product that no

longer contained the correct information. Label

coordinator or trained designee will address

issue with supplier and require root cause and

corrective action report into the incident.

Product will be rejected and will not enter

facility.

What measures will be implemented to reduce

the likelihood of occurrence?

Supplier will be required to destroy all

discontinued product or artwork to eliminate

possibility of shipping outdated packaging


Packaging is not received if the appropriate

allergen declarations are not present on the

label.

How will affected food be prevented from

entering commerce if it cannot be ensured that

the product is not adulterated?

Packaging is not received if the appropriate

allergen declarations are not present on the label

to prevent the possibility of use in production.

What equipment needs to be calibrated (or checked

for accuracy) for monitoring and verification, what is


None

If appropriate, what product testing for an allergen

hazard is being conducted, including frequency and

who is responsible?

None. All products produced at the facility contain

milk allergen


monitoring and CA?

All production records for PC C1 are reviewed

within 7 working days of product receipt



All production records for PC C1 are reviewed

within 7 working days of product receipt

Approved Date_____________________________________________

23 | P a g e

Sanitation Preventive Controls Corrective Action and Verification Form: PC for Human Foods


Location

Purpose Corrective Action Verification Procedures

C2-

Ice cream freezer

Inspect

refrigerant

system pressure

gauge to ensure

no product has

been

contaminated

with ammonia

and to prevent

any affected

product from

entering

commerce

What caused the deviation and how will the cause (not the

product) be corrected?

Corrosion of metal in the equipment caused a fracture that

allowed ammonia to leak into product. The fracture was not

found by the sanitation operator during the last inspection.

Maintenance will need to repair the damage and the freezer will

not be used.

What measures will be implemented to reduce the likelihood of

occurrence?

Sanitation operators will be required to verify their findings

with Sanitation manager prior to start-up of production.


All product in the system will be placed on hold and destroyed

for ammonia contamination

How will affected food be prevented from entering commerce if

it cannot be ensured that the product is not adulterated?

Product will be destroyed due to ammonia contamination

If product is RTE and there is an environmental pathogen hazard

requiring a PC, what environmental monitoring is conducted,


No environmental monitoring PC identified

Other environmental monitoring procedures, including frequency

and who is responsible?

Environmental swab testing for Listeria monocytogenes and

Salmonella spp. is performed on a rotating monthly basis. Sites

are identified throughout the plant for Zones 1, 2, 3, and 4. The

principal microbiologist or trained designee is responsible for

conducting the tests using appropriate SSOPs.

How often are records reviewed by a PCQI for monitoring and

CA?

All records for PC C2 are reviewed within 7 working days of

production

How often are records reviewed by a PCQI for calibration and

verification testing?

All records for PC C2 are reviewed within 7 working days of

production

Approved Date_____________________________________________

24 | P a g e

Process Preventive Controls Recordkeeping Form: PC for Human Foods


Process

Control Step


Values or

Critical Limits

Name of Records Name of Position Title of the Responsible

Person for Filling Out Each Record

B1-

Pasteurize

Survival of

vegetative

pathogens such

as: Bacillus

cereus,

Salmonella spp.

(particularly

Salmonella

typhimurium and

Salmonella

dublin), E.

coliO157:H7, L.

monocytogenes,

Campylobacter

spp., and

Staphylococcus

aureus

Vat

Pasteurization

for ≥30 minutes

at ≥155F (69C)

PMO, Part 1,

Definition S;

Attachment 4

for acceptable

pasteurization

times and

temperatures;

and Attachment

1 for

pasteurizer

evaluation

Pasteurizer Operator Training Record

Pasteurization PC B1 Record

Pasteurizer Thermometer Check Record

PC B1 Corrective Action Record

Quarterly Pathogen Testing Report

Pasteurizer Operator Training Record:

• PCQI or QA Manager completes for each

new operator prior to first equipment

operation and after each corrective action

incident related to operator error

Pasteurization PC B1 Record:

• Pasteurization operator or trained designee is

responsible for recording temperature at start

and end of batch process

• QA Manager or trained designee is

responsible for verification of PC through

operator observation twice per production

shift

• Daily production record is reviewed by

PCQI within 7 days of production date

Pasteurizer Thermometer Check Record

• Pasteurizer operator verifies both hand-held

thermometer and continuous monitoring

thermometer against a calibrated NIST

standard at the start of each production day

• PCQI reviews record within 7 days

verification date


• QA Manager or trained QA designee will

provide disposition for product that did not

meet critical limits and will complete record

at each corrective action incident

• PCQI completes observation verification

each time deviation occurs/corrective action

is required

• PCQI reviews record within 7 days of

production date

25 | P a g e

Quarterly Pathogen Testing Report

• Principal microbiologist or trained QA

designee will record results of sample testing

on a quarterly basis

• PCQI reviews records within 7 days of

completed testing.

B2-

Homogenize

Growth of

vegetative

pathogens such

as: Bacillus

cereus,

Salmonella spp.

(particularly

Salmonella

typhimurium and

Salmonella

dublin), E.

coliO157:H7, L.

monocytogenes,

Campylobacter

spp., and

Staphylococcus

aureus

Monitor mix

temperature to

ensure product

remains at

pasteurization

temperatures

≥ 155F (69C)

PMO, Part 1,

Definition S;

Attachment 4

for acceptable

pasteurization

times and

temperatures;

and Attachment

1 for

pasteurizer

evaluation.

Homogenizer Operator Training Record

Homogenizer PC B2 Record

Homogenizer Thermometer Check Record


Homogenizer Operator Training Record:





Homogenizer PC B2 Record:

• Homogenizer operator or trained designee is

responsible for recording temperature at start

of the process, every thirty minutes (+/- 10

minutes) during production thereafter, and at

the end of the process.




shift



Homogenizer Thermometer Check Record

• Homogenizer operator verifies thermometer

against a calibrated NIST standard at the

start of each production day

• PCQI reviews record within 7 days

verification date








is required


production date

26 | P a g e

P1- Metal

detection

Metal fragments

may be introduced

at any point in the

process due to

broken equipment

or breach in

employee SOPs.

Metal fragments ≥7

mm or ≤25 mm are

considered

hazardous in

finished product.

Metal detector

detects:

≥2 mm ferrous,

≥2 mm

nonferrous, ≥2

mm stainless

steel

FDA Compliance

Policy Guide

555.425 Foods -

Adulteration

Involving

Foreign Objects

On-Line Metal Detector Operator Training Record

Metal Detection PC P1 Record

PC P1 Corrective Action Record

On-Line Metal Detector Operator Training Record:





Metal Detection PC P1 Record:

• Packing line operator or trained designee is

responsible for verifying equipment is

properly functioning at start-up of

production, hourly during production, and at

the end of production




shift



PC P1 Corrective Action Record







is required


production date

Approved Date_____________________________________________

27 | P a g e

Allergen Preventive Controls Recordkeeping Form: PC for Human Foods


Process

Control Step

Hazard(s) Criterion Name of Records Name of Position Title of the Responsible

Person for Filling Out Each Record

C1 –

Receiving

Packaging –

Pre-labeled

carton

Undeclared

allergens

Labeled cartons

must declare

milk allergen

Label Receiving for Allergens Training Form

Incoming Packaging Materials –Labels Log

PC C1 Corrective Action Form

Label Receiving for Allergens Training Form:

• PCQI or QA Manager completes for

each new operator prior to first

equipment operation and after each

corrective action incident related to

operator error

Incoming Packaging Materials –Labels Log:

• Label coordinator or trained designee

will perform visual check of correct

allergens and complete log for all

incoming labels


responsible for verification of PC

through operator observation twice per

production shift


receiving date

PC C1 Corrective Action Form:

• QA Manager or trained QA designee

will provide disposition for product that

did not meet criterion and will

complete record at each corrective

action incident

• PCQI completes observation

verification each time deviation

occurs/corrective action is required


production date

Approved Date____________________________________________

28 | P a g e

Sanitation Preventive Controls Recordkeeping Form: PC for Human Foods


Location

Purpose Name of Records Name of Position Title of the Responsible Person for Filling Out

Each Record

C2-

Ice cream

freezer

Inspect refrigerant

system pressure

gauge to ensure no

product has been

contaminated with

ammonia and to

prevent any

affected product

from entering

commerce

Ammonia Systems Training Form

Ice Cream Freezer Equipment Monitoring

Record


Environmental Monitoring Monthly Report

Ammonia Systems Training Form:

• PCQI or QA Manager completes for each new operator prior to

first equipment operation and after each corrective action


Ice Cream Freezer Equipment Monitoring Record

• Sanitation operator or trained designee completes form prior to

start of production, at the end of production, and any breaks in

production

• QA Manager or trained designee is responsible for verification

of PC through operator observation twice per production shift

• Daily production record is reviewed by PCQI within 7 days of

production date


• QA Manager or trained QA designee will provide disposition

for affected product and will complete record at each corrective

action incident

• PCQI completes observation verification each time deviation

occurs/corrective action is required

• PCQI reviews record within 7 days of production date

Environmental Monitoring Monthly Report

• Principal microbiologist or trained QA designee will complete

rotating environmental testing on a monthly basis

• PCQI reviews records within 7 days of completed monthly testing

Approved Date_____________________________________________

29 | P a g e

Process Preventive Controls Summary Form: PC for Human Foods


Process

Control

Step


Values or

Critical Limits

Monitoring Procedures Corrective Action Verification Records Record

Responsibility

B1-

Pasteurize

Survival of

vegetative

pathogens such

as: Bacillus

cereus,

Salmonella

spp.

(particularly

Salmonella

typhimurium

and Salmonella

dublin), E.

coliO157:H7,

L.

monocytogenes

,

Campylobacter

spp., and

Staphylococcus

aureus

Vat

Pasteurization for

≥30 minutes at

≥155F (69C)

PMO, Part 1,

Definition S;

Attachment 4 for

acceptable

pasteurization

times and

temperatures;

and Attachment 1

for pasteurizer

evaluation

What is going to be

measured?

Product temperature and

time in vat pasteurization

system


Continuous monitoring

system will measure

product temperature

throughout the process and

alarm will sound if critical

temperature limit is not

reached. Pasteurizer

operator or trained designee

will record temperature of

product sample using a

calibrated thermometer.

The Pasteurizer operator or

trained designee will use a

stopwatch to measure and

record the time product has

been in pasteurizer.

Who will be responsible

for monitoring?

Pasteurization operator or

trained designee

How frequently will it be

measured?

Product temperature will be

continuously monitored

throughout the

pasteurization process using

a calibrated continuous

What caused the deviation

and how will the cause (not

the product) be corrected?

Equipment malfunction

caused product temperature to

drop below 155F during the

30-minute hold period. The

root cause was determined to

be the thermometer had

drifted out of calibration

during production due to

excess product buildup that

had not been adequately

removed in the sanitation

process. In turn, the alarm

system did not alert the

operator of a problem. The

thermometer will be cleaned

according to SSOPs and

verified against NIST

standard prior to use in

production.

What measures will be

implemented to reduce the


Sanitation operators will be

retrained by PCQI or trained

designee on the proper

cleaning procedures and

frequencies for the continuous

monitoring system.

How will the product be

evaluated for safety?

What equipment needs to

be calibrated (or checked

for accuracy) for

monitoring and

verification, what is

frequency of calibration


The continuous monitoring

temperature system and

hand-held thermometers

used by operators must be

calibrated annually.

Operator or trained

designee will check for

accuracy daily during

production against a


If appropriate, what

product testing for a

pathogen or indicator

organism or other hazard

is being conducted,

including frequency and

who is responsible?

Pathogen testing for E.

coliO157:H7, L.

monocytogenes, and

Salmonella spp. is

performed on a quarterly

basis. The principal

microbiologist or trained

designee will be

responsible for testing.

Pasteurizer

Operator

Training

Record

Pasteurization

PC B1 Record

Pasteurizer

Thermometer

Check Record

PC B1

Corrective

Action

Record

Quarterly

Pathogen

Testing

Report

Pasteurizer

Operator Training

Record:

• PCQI or QA

Manager completes

for each new operator

prior to first

equipment operation

and after each

corrective action

incident related to

operator error

Pasteurization PC

B1 Record:

• Pasteurization

operator or trained

designee is

responsible for

recording

temperature at start

and end of batch

process

• QA Manager or

trained designee is

responsible for

verification of PC

through operator

observation twice per

production shift

• Daily production

record is reviewed by

PCQI within 7 days

of production date

30 | P a g e

temperature monitoring

system. Operator will

record the product

temperature at the start of

the holding period and at

the end of the holding

period using calibrated

thermometer. The

pasteurization time will be

measured once at the end of

the 30 minute

pasteurization period and

recorded.

Product will be re-pasteurized

and monitored at 5-minute

intervals by pasteurizer

operator or trained designee

using calibrated hand-held

thermometers to ensure

consistent product

temperature

How will affected food be

prevented from entering

commerce if it cannot be

ensured that the product is

not adulterated?

All product from the batch

will be placed on hold and

reworked if possible, or

destroyed if QA manager or

trained designee deems

unsafe.

If product is RTE and

there is an environmental

pathogen hazard

requiring a PC, what


is conducted, including

frequency and who is

responsible?

None

How often are records

reviewed by a PCQI for

monitoring and CA?

All production records for

PC B1 are reviewed within

7 working days of

production



calibration and




7 working days of

production

Pasteurizer

Thermometer

Check Record

• Pasteurizer operator

verifies both hand-

held thermometer and

continuous

monitoring

thermometer against

a calibrated NIST

standard at the start

of each production

day

• PCQI reviews

record within 7 days

verification date

PC B1 Corrective

Action Record

• QA Manager or

trained QA designee

will provide

disposition for

product that did not

meet critical limits

and will complete

record at each

corrective action

incident

• PCQI completes

observation

verification each time

deviation

occurs/corrective

action is required

• PCQI reviews

record within 7 days

of production date

Quarterly Pathogen

Testing Report

Principal

microbiologist or

trained QA designee

31 | P a g e

will record results of

sample testing on a

quarterly basis

PCQI reviews

records within 7 days

of completed testing.

32 | P a g e

Process

Control

Step


Values or

Critical Limits

Monitoring Procedures Corrective Action Verification Records Record Responsibility

B2-

Homogen-

ize

Growth of

vegetative

pathogens such

as:

Bacillus

cereus,

Salmonella

spp.

(particularly

Salmonella

typhimurium

and Salmonella

dublin), E.

coliO157:H7,

L.

monocytogenes

,

Campylobacter

spp., and

Staphylococcus

aureus

Monitor mix

temperature to

ensure product

remains at

pasteurization

temperatures

≥ 155F (69C)

PMO, Part 1,

Definition S;

Attachment 4 for

acceptable

pasteurization

times and

temperatures;

and Attachment 1

for pasteurizer

evaluation

What is going to be

measured?

Product temperature inside

the homogenizer



system will measure

product temperature

throughout the process and

alarm will sound if critical

temperature limit drops.

Product temperature will be

recorded from a product

sample using a calibrated

thermometer.


for monitoring?

Homogenizer operator or

trained designee


measured?

The product temperature

will be recorded by

operator at the start of the

process, every thirty

minutes (+/- 10 minutes)

during production

thereafter, and at the end of

the process.


and how will the cause be

corrected?

Operator did not monitor

product temperature as

required by the Food Safety

Plan Process Preventive

Controls. Operator will be

trained by PCQI or QA

Manager to contact supervisor

prior to leaving his/her work

station.




All operators will be trained

by PCQI or QA Manager on

all PC SOPs annually to

provide back up for all

employees.




system will be reviewed by

PCQI or QA Manager to

determine if product was held

at critical limit throughout the

homogenization hold time.





not adulterated?

All product back to the last

acceptable check will be

placed on hold for further

disposition by QA Manager or



for accuracy) for

monitoring and




The continuous monitoring

temperature system and

hand-held thermometers

used by operators must be

calibrated annually.

Operator or trained

designee wil check for

accuracy daily during

production against a






is being conducted,


who is responsible?

None



pathogen hazard





responsible?

No environmental pathogen

hazard is identified as

requiring a PC

Homogenizer

Operator

Training

Record

Homogenizer

PC B2 Record

Homogenizer

Thermometer

Check Record

PC B2

Corrective

Action

Record

Homogenizer

Operator Training

Record:

• PCQI or QA

Manager

completes for

each new

operator prior to

first equipment

operation and

after each

corrective action

incident related

to operator error

Homogenizer PC B2

Record:

• Homogenizer

operator or

trained designee

is responsible

for recording

temperature at

start of the

process, every

thirty minutes

(+/- 10 minutes)

during

production

thereafter, and at

the end of the

process.

• QA Manager or

trained designee

is responsible

for verification

of PC through

operator

observation

33 | P a g e

trained designee. If possible,

product will be re-pasteurized.

Any product that cannot be

reworked will be destroyed.



monitoring and CA?



7 working days of

production



calibration and




7 working days of

production

twice per

production shift

• Daily

production

record is

reviewed by

PCQI within 7

days of

production date

Homogenizer

Thermometer

Check Record

• Homogenizer

operator verifies

thermometer

against a

calibrated NIST

standard at the

start of each

production day

• PCQI reviews

record within 7

days verification

date

PC B2 Corrective

Action Record

• QA Manager or

trained QA

designee will

provide

disposition for

product that did

not meet critical

limits and will

complete record

at each

corrective action

incident

• PCQI completes

observation

verification each

time deviation

34 | P a g e

occurs/correctiv

e action is

required

• PCQI reviews

record within 7

days of

production date

35 | P a g e

Process

Control

Step


Values or

Critical Limits

Monitoring Procedures Corrective Action Verification Records Record Responsibility

P1- Metal

detection

Metal

fragments may

be introduced

at any point in

the process due

to broken

equipment or

breach in

employee

SOPs

No metal

fragments in

finished product

≥7 mm or ≤25

mm

Metal detector

detects:

≥2 mm ferrous,

≥2 mm

nonferrous, ≥2

mm stainless steel

FDA Compliance

Policy Guide

555.425 Foods -

Adulteration

Involving Foreign

Objects

What is going to be

measured?

The ability of metal

detector to reject the 2 mm

ferrous, 2 mm nonferrous,

and 2 mm stainless steel

standards.



using functional metal

detector able to detect 2

mm ferrous, 2 mm

nonferrous, and 2 mm

stainless steel standards.

Operators will verify the

metal detector is functional

using standard seeded

wands through the detectors

with positive rejection.

Each metal test standard

must be passed through the

metal detectors with

positive rejection twice.


for monitoring?

Packing line operator or

trained designee


measured?

Packing line operator or

trained designee will verify

the equipment is

functioning properly at

start-up of production,

hourly during production,

and at the end of

production.


and how will the cause be

corrected?

Packing operator found metal

detector did not positively

reject metal standards at

hourly production check. The

packing operator shall

immediately stop the line and

place all product on hold until

the last acceptable check.

Maintenance will perform any

adjustments needed and the

equipment will be verified to

perform properly before use.




Frequency of checks will be

increased to every 30 minutes

during production shifts by

packing operator or trained

designee until an official

calibration is performed.

Calibration by the equipment

manufacturer will be required

after a corrective action

incident.



The packing operator will

place all product on hold until

the last acceptable hourly

production check. PCQI or

QA Manager will reanalyze

product through a functioning

metal detector



for accuracy) for

monitoring and




Metal detector is calibrated

annually by equipment

manufacturer. Operator or

trained designee will

perform accuracy checks of

the machine at the start of

production, hourly during

production, and at the end

of production each day





is being conducted,


who is responsible?

None



pathogen hazard





responsible?

None



monitoring and CA?

On-Line

Metal

Detector

Operator

Training

Record

Metal

Detection PC

P1 Record

PC P1

Corrective

Action

Record

On-Line Metal

Detector Operator

Training Record:

• PCQI or QA

Manager

completes for

each new

operator prior to

first equipment

operation and

after each

corrective action

incident related

to operator error

Metal Detection PC

P1 Record:

• Packing line

operator or

trained designee

is responsible

for verifying

equipment is

properly

functioning at

start-up of

production,

hourly during

production, and

at the end of

production

• QA Manager or

trained designee

is responsible

for verification

of PC through

operator

observation

twice per

production shift

36 | P a g e





not adulterated?

All product between

acceptable checks will be

placed on hold and

reevaluated using a functional

metal detector as described

above. If product does not

pass check, the product will

be destroyed


PC P1 are reviewed within

7 working days of

production



calibration and



PC P1 are reviewed within

7 working days of

production

• Daily

production

record is

reviewed by

PCQI within 7

days of

production date

PC P1 Corrective

Action Record

• QA Manager or

trained QA

designee will

provide

disposition for

product that did

not meet critical

limits and will

complete record

at each

corrective action

incident

• PCQI completes

observation

verification each

time deviation

occurs/correctiv

e action is

required

• PCQI reviews

record within 7

days of

production date

Approved Date_____________________________________________

37 | P a g e

Allergen Preventive Controls Summary Form: PC for Human Foods


Allergen

Control

Hazard(s) Criterion or

Parameter Monitoring Procedures Corrective Action Verification Records Record Responsibility

C1 –

Receiving

Packaging

– Pre-

labeled

carton

Undeclared

allergens

Labeled

cartons must

declare milk

allergen

What is going to be

measured?

Ingredient listing and allergen

warning contains milk

allergen information


Visual check of carton label to

match product formula and

allergen declaration

Who will be responsible for

monitoring?

Label coordinator or trained

designee


measured?

All product labels will be

checked at receiving prior to

release into production


and how will the cause (not

the product) be corrected?

Packaging supplier shipped

product out of FIFO rotation

and released older product

that no longer contained the

correct information. Label

coordinator or trained

designee will address issue

with supplier and require

root cause and corrective

action report into the

incident. Product will be

rejected and will not enter

facility.




Supplier will be required to

destroy all discontinued

product or artwork to

eliminate possibility of

shipping outdated packaging



Packaging is not received if

the appropriate allergen

declarations are not present

on the label.




What equipment needs to be

calibrated (or checked for

accuracy) for monitoring and


frequency of calibration and

who is responsible?

None

If appropriate, what product

testing for an allergen hazard

is being conducted, including


responsible?

None. All products produced at

the facility contain milk

allergen



monitoring and CA?

All production records for PC

C1 are reviewed within 7

working days of product receipt



calibration and verification

testing?

All production records for PC

C1 are reviewed within 7

working days of product receipt

Label Receiving

for Allergens

Training Form

Incoming

Packaging

Materials –

Labels Log

PC C1

Corrective

Action Form

Label Receiving for

Allergens Training

Form:

• PCQI or QA

Manager

completes for each

new operator prior

to first equipment

operation and after

each corrective

action incident

related to operator

error

Incoming Packaging

Materials –Labels

Log:

• Label coordinator

or trained designee

will perform visual

check of correct

allergens and

complete log for

all incoming labels

• QA Manager or

trained designee is

responsible for

verification of PC

through operator

observation twice

per production

shift

• PCQI reviews

record within 7

days of receiving

date

38 | P a g e


not adulterated?

Packaging is not received if

the appropriate allergen

declarations are not present

on the label.

PC C1 Corrective

Action Form:

• QA Manager or

trained QA

designee will

provide disposition

for product that did

not meet criterion

and will complete

record at each

corrective action

incident

• PCQI completes

observation

verification each

time deviation

occurs/corrective

action is required

• PCQI reviews

record within 7

days of production

date

Approved Date_____________________________________________

39 | P a g e

Sanitation Preventive Controls Form Summary: PC for Human Foods


Location

Purpose Frequency Sanitation Procedures Corrective Action Verification Procedures Records Record Responsibility

C2-

Ice

cream

freezer

Inspect

equipment

using

refrigerant

system to

ensure no

product

has been

contamina

ted with

ammonia

and to

prevent

any

affected

product

from

entering

commerce

Prior to start of

production, at

the end of

production, and

any breaks in

production

Who will be

responsible?

Sanitation operator or

trained designee

What is the

Procedure?

Check the ammonia

system for leakage or

damage at pre-

determined locations on

equipment

How will it be

monitored?

Sanitation operator will

perform a visual

inspection to ensure the

ammonia system was

not disrupted causing

leakage into product

What caused the

deviation and how

will the cause (not the

product) be

corrected?

Corrosion of metal in

the equipment caused

a fracture that allowed

ammonia to leak into

product. The fracture

was not found by the

sanitation operator

during the last

inspection.

Maintenance will need

to repair the damage

and the freezer will not

be used.

What measures will

be implemented to

reduce the likelihood

of occurrence?

Sanitation operators

will be required to

verify their findings

with Sanitation

manager prior to start-

up of production.

How will the product

be evaluated for

safety?

All product in the

system will be placed

on hold and destroyed

for ammonia

contamination



pathogen hazard





responsible?

No environmental

monitoring PC identified

Other environmental

monitoring procedures,


who is responsible?

Environmental swab testing

for Listeria monocytogenes

and Salmonella spp. is

performed on a rotating

monthly basis. Sites are

identified throughout the

plant for Zones 1, 2, 3, and

4. The principal

microbiologist or trained

designee is responsible for

conducting the tests using

appropriate SSOPs



monitoring and CA?

All records for PC C2 are

reviewed within 7 working

days of production



Ammonia

Systems

Training Form

Ice Cream

Freezer

Equipment

Monitoring

Record

PC C2

Corrective

Action Form

Environmental

Monitoring

Monthly Report

Ammonia Systems

Training Form:

• PCQI or QA

Manager completes

for each new

operator prior to first

equipment operation

and after each

corrective action

incident related to

operator error

Ice Cream Freezer

Equipment Monitoring

Record:

• Sanitation operator

or trained designee

completes form prior

to start of production,

at the end of

production, and any

breaks in production

• QA Manager or

trained designee is

responsible for

verification of PC

through operator

observation twice per

production shift

• Daily production

record is reviewed by

PCQI within 7 days

of production date

PC C2 Corrective Action

Form

• QA Manager or

trained QA designee

40 | P a g e

How will affected

food be prevented

from entering

commerce if it cannot

be ensured that the

product is not

adulterated?

Product will be

destroyed due to

ammonia

contamination

calibration and


All records for PC C2 are

reviewed within 7 working

days of production

will provide

disposition for

affected product and

will complete record

at each corrective

action incident

• PCQI completes

observation

verification each

time deviation

occurs/corrective

action is required

• PCQI reviews record

within 7 days of

production date

Environmental

Monitoring Monthly

Report

• Principal

microbiologist or

trained QA

designee will

complete rotating

environmental

testing on a monthly

basis

• PCQI reviews

records within 7

days of completed

monthly testing

Approved Date_____________________________________________

41 | P a g e

References

Food and Drug Administration. Hazard Analysis and Risk-Based Preventive Controls for Human Food:

Draft Guidance for Industry. 2016.

Food and Environmental Hygiene Department HKSAR. “Microbiological Risk Assessment of Ice-

Cream.” September 2001.

International Food Safety and Quality Network. “Metal Detection Discussion.” June 4, 2009.

Junchao Lu, Xiao-Hui Pua, Chi-Te Liu, Che-Lang Chang, Kuan-Chen Cheng, The implementation of

HACCP management system in a chocolate ice cream plant, In Journal of Food and Drug Analysis,

Volume 22, Issue 3, 2014, Pages 391-398, https://doi.org/10.1016/j.jfda.2013.09.049.

http://www.sciencedirect.com/science/article/pii/S1021949813001257

"Microbiology Handbook Dairy Products 3rd edition." Food Engineering & Ingredients, Feb.-Mar. 2009,

p. 19. General OneFile,

go.galegroup.com/ps/i.do?p=ITOF&sw=w&u=ksu&v=2.1&id=GALE%7CA208693023&it=r&asid=f31e

d178567e3a96c1082077fea82cac. Accessed 5 Oct. 2017.

U.S. Department of Health and Human Services Public Health Service Food and Drug Administration.

Grade “A” Pasteurized Milk Ordinance. Revision 2015

Wilkin, E., Brouillette, R., Carver, J. (2015). “Control of Listeria Monoctyogenes: Guidance for US Dairy

Industry.”

https://doi.org/10.1016/j.jfda.2013.09.049

http://www.sciencedirect.com/science/article/pii/S1021949813001257

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