danielle bauer vanilla ice cream food safety plan fall 2017 · vanilla ice cream product...
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1 | P a g e
Danielle Bauer
Vanilla Ice Cream Food Safety Plan
Fall 2017
2 | P a g e
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
3 | P a g e
Preventive Control for Human Foods: Flow Diagram Product or Process Name: Vanilla Ice Cream Flow Diagram – Bauer’s Ice Creamery Approved: _____________________________________ Date:_________________
4 | P a g e
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
5 | P a g e
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
Supply chain preventive
controls are in place to
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.
Supply chain preventive
controls are in place to
control hazard – Supplier
third party audits and
Allergen control – Allergen
labeling at subsequent
packaging receiving step
X
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Mycotoxin from
Aflatoxin
x
Letter of Guarantee
required on annual basis
Supply chain preventive
controls are in place to
control hazard – – Product
COA required with each
shipment and Supplier
third party audits and
Letter of Guarantee
required on annual basis
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
8 | P a g e
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
Process Control – Subsequent
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
Process Control – Subsequent
metal detection step
following packaging
x
9 | P a g e
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
x Pre-Operational Sanitation
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
x Pre-Operational Sanitation
Inspections prevent
contamination as
reasonably likely to occur
P Metal fragments x Metal on metal contact
could cause breakage and
introduction into product
Process Control – subsequent
metal detection step after
packaging
x
10 | P a g e
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
x Pre-Operational Sanitation
Inspections prevent
contamination as
reasonably likely to occur
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
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 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
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
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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
P Metal fragments x Metal on metal contact
could cause breakage and
introduction into product
Process Control – Subsequent
metal detection step after
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
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 None
P Metal fragments x Metal fragments may be
introduced in the process
during mixing
Process Control – Subsequent
metal detection step after
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
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 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
x Vegetative pathogens
including Listeria
monocytogenes 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 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
x Vegetative pathogens
including Listeria
monocytogenes 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
P
14 | P a g e
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.
15 | P a g e
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
What is going to be measured?
Product temperature inside the homogenizer
How will it be measured?
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.
Who will be responsible for monitoring?
Homogenizer operator or trained designee
16 | P a g e
and Staphylococcus
aureus
pasteurization
times and
temperatures; and
Attachment 1 for
pasteurizer
evaluation.
How frequently will it be measured?
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
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.
How will it be measured?
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.
Who will be responsible for monitoring?
Packing line operator or trained designee
How frequently will it be measured?
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_____________________________________________
17 | P a g e
Food Allergen Preventive Controls Form: PC for Human Foods
Product Name: Vanilla Ice Cream
Allergen
Control
Hazard(s) Criterion Monitoring Procedures
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
How will it be measured?
Visual check of one carton label from each pallet of product. Label must match
correct product formula and allergen declaration
Who will be responsible for monitoring?
Label coordinator or trained designee
How frequently will it be measured?
Each incoming shipment of pre-labeled cartons will be checked at receiving prior to
release into production.
Approved Date_____________________________________________
18 | P a g e
Sanitation Preventive Controls Form: PC for Human Foods
Product Name: Vanilla Ice Cream
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_____________________________________________
19 | P a g e
Process Preventive Controls Corrective Action and Verification Form: PC for Human Foods
Product Name: Vanilla Ice Cream
Process
Control Step
Hazard(s) Parameters,
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
How often are records reviewed by a PCQI for
calibration and verification testing?
All production records for PC B1 are reviewed within 7
working days of production
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.
What measures will be implemented to reduce the
likelihood of occurrence?
All operators will be trained by PCQI or QA
Manager on all PC SOPs annually to provide back
up for all employees.
How will the product be evaluated for safety?
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.
How will affected food be prevented from entering
commerce if it cannot be ensured that the product is
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.
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?
No environmental pathogen hazard is identified as
requiring a PC
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?
None
How often are records reviewed by a PCQI for
monitoring and CA?
All production records for PC B2 are reviewed within 7
working days of production
How often are records reviewed by a PCQI for
calibration and verification testing?
All production records for PC B2 are reviewed within 7
working days of production
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.
What measures will be implemented to reduce the
likelihood of occurrence?
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.
How will the product be evaluated for safety?
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
How will affected food be prevented from entering
commerce if it cannot be ensured that the product is
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
What equipment needs to be calibrated (or checked for
accuracy) for monitoring and verification, what is
frequency of calibration and who is responsible?
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
If appropriate, what product testing for a pathogen or
indicator organism or other hazard is being conducted,
including frequency and who is responsible?
None
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?
None
How often are records reviewed by a PCQI for
monitoring and CA?
All production records for PC P1 are reviewed within 7
working days of production
How often are records reviewed by a PCQI for
calibration and verification testing?
All production records for PC P1 are reviewed within 7
working days of production
Approved Date_____________________________________________
22 | P a g e
Allergen Preventive Controls Corrective Action and Verification Form: PC for Human Foods
Product Name: Vanilla Ice Cream
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
How will the product be evaluated for safety?
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
frequency of calibration and who is responsible?
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
How often are records reviewed by a PCQI for
monitoring and CA?
All production records for PC C1 are reviewed
within 7 working days of product receipt
How often are records reviewed by a PCQI for
calibration and verification testing?
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
Product Name: Vanilla Ice Cream
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.
How will the product be evaluated for safety?
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,
including frequency and who is responsible?
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
Product Name: Vanilla Ice Cream
Process
Control Step
Hazard(s) Parameters,
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
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
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
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 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 occurs/corrective action
is required
• PCQI reviews record within 7 days of
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:
• 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
• 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/corrective action
is required
• PCQI reviews record within 7 days of
production date
Approved Date_____________________________________________
27 | P a g e
Allergen Preventive Controls Recordkeeping Form: PC for Human Foods
Product Name: Vanilla Ice Cream
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
• 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
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____________________________________________
28 | P a g e
Sanitation Preventive Controls Recordkeeping Form: PC for Human Foods
Product Name: Vanilla Ice Cream
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
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 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
Product Name: Vanilla Ice Cream
Process
Control
Step
Hazard(s) Parameters,
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
How will it be measured?
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
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?
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.
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
environmental monitoring
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
How often are records
reviewed by a PCQI for
calibration and
verification testing?
All production records for
PC B1 are reviewed within
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
Hazard(s) Parameters,
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
How will it be measured?
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.
Who will be responsible
for monitoring?
Homogenizer operator or
trained designee
How frequently will it be
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.
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.
What measures will be
implemented to reduce the
likelihood of occurrence?
All operators will be trained
by PCQI or QA Manager on
all PC SOPs annually to
provide back up for all
employees.
How will the product be
evaluated for safety?
Continuous monitoring
system will be reviewed by
PCQI or QA Manager to
determine if product was held
at critical limit throughout the
homogenization hold time.
How will affected food be
prevented from entering
commerce if it cannot be
ensured that the product is
not adulterated?
All product back to the last
acceptable check will be
placed on hold for further
disposition by QA Manager or
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 wil 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?
None
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
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.
How often are records
reviewed by a PCQI for
monitoring and CA?
All production records for
PC B2 are reviewed within
7 working days of
production
How often are records
reviewed by a PCQI for
calibration and
verification testing?
All production records for
PC B2 are reviewed within
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
Hazard(s) Parameters,
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.
How will it be measured?
Continuous monitoring
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.
Who will be responsible
for monitoring?
Packing line operator or
trained designee
How frequently will it be
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.
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.
What measures will be
implemented to reduce the
likelihood of occurrence?
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.
How will the product be
evaluated for safety?
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
What equipment needs to
be calibrated (or checked
for accuracy) for
monitoring and
verification, what is
frequency of calibration
and who is responsible?
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
If appropriate, what
product testing for a
pathogen or indicator
organism or other hazard
is being conducted,
including frequency and
who is responsible?
None
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?
None
How often are records
reviewed by a PCQI for
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
How will affected food be
prevented from entering
commerce if it cannot be
ensured that the product is
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
All production records for
PC P1 are reviewed within
7 working days of
production
How often are records
reviewed by a PCQI for
calibration and
verification testing?
All production records for
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
Product Name: Vanilla Ice Cream
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
How will it be measured?
Visual check of carton label to
match product formula and
allergen declaration
Who will be responsible for
monitoring?
Label coordinator or trained
designee
How frequently will it be
measured?
All product labels will be
checked at receiving prior to
release into production
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
How will the product be
evaluated for safety?
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
What equipment needs to be
calibrated (or checked for
accuracy) for monitoring and
verification, what is
frequency of calibration and
who is responsible?
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
How often are records
reviewed by a PCQI for
monitoring and CA?
All production records for PC
C1 are reviewed within 7
working days of product receipt
How often are records
reviewed by a PCQI for
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
ensured that the product is
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
Product Name: Vanilla Ice Cream
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
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
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
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
verification testing?
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.”