PRODUCT(S): Cold Pressed Almond Cranberry Energy Bar PAGE 8 of 16

PLANT NAME: Example ISSUE DATE 01/28/2016

ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015

Hazard Analysis
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 hazards, 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
(1) (2) (3) (4) (5) (6)
Ingredient/ Identify potential Are any Justify your decision for column 3 What preventive control Is the
Processing food safety potential measure(s) can be applied to preventive
Step hazards food safety significantly minimize or control
introduced, hazards prevent the food safety applied at
controlled or requiring a hazard? this step?
enhanced at this preventive Process including CCPs,
step control? Allergen, Sanitation, Supply‐
Yes No chain, other preventive control Yes No
Receive B None
Ingredients: C None
Corn syrup, P None
Canola oil
Receive B Salmonella X Untreated almonds have a history of Supply‐chain control – X
Ingredients: Salmonella issues Approved supplier 3rd party
Almonds audit and quarterly testing by
supplier
C Aflatoxin X Almonds have a history of potential Supply‐chain control – X
contamination with aflatoxin Quarterly testing by supplier
Undeclared X Almonds are tree nuts that are a Allergen control – Label review X
allergen – recognized food allergen and allergen cross‐contact
almond prevention
P Shell pieces X Pieces are removed at supplier during
sorting, including optical sorter.
Consumer complaint data do not
indicate an issue
Receive B Salmonella X A few cereal outbreaks have occurred, Supply‐chain control – X
Ingredients: but not with this specific type of process. Approved supplier 3rd party
Crisped rice Warrants supplier program at a reduced audit
level of concern.
C None
P None
Receive B Salmonella X Process to manufacture cranberries has
Ingredients: sufficient lethality. If present, Salmonella
Dried levels will decrease during storage
cranberries C Allergens X Cranberries are not a food allergen, but Allergen control – Subsequent X
ingredient has precautionary labeling for allergen labeling
other food allergens handled at supplier
facility
P None
Receive B None
Ingredients: C None
Vitamin/ P None
mineral pre‐
blend
Continued

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PRODUCT(S): Cold Pressed Almond Cranberry Energy Bar PAGE 9 of 16
PLANT NAME: Example ISSUE DATE 01/28/2016
ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015

(1) (2) (3) (4) (5) (6)

Ingredient/ Identify potential Are any Justify your decision for column 3 What preventive control Is the
Processing food safety potential measure(s) can be applied to preventive
Step hazards food safety significantly minimize or control
introduced, hazards prevent the food safety applied at
controlled or requiring a hazard? this step?
enhanced at this preventive Process including CCPs,
step control? Allergen, Sanitation, Supply‐
Yes No chain, other preventive control Yes No
Receive B None
Ingredients: C Undeclared X Soy is a recognized food allergen. All Allergen control – Subsequent X
Pan release allergen – soy products use this processing aid, so allergen labeling
agent cross‐contact is not relevant.
P None
Receive B None
Packaging C Undeclared X Printing errors have occurred and a Allergen control – Verify X
allergens correct allergen statement is essential allergen labeling
for safety. Packaging line operators
check the label number but not
necessarily the allergen information.
P None
Store B None
Ingredients C Undeclared X Ingredients with allergens are stored in
allergens the warehouse in segregated areas and
in sealed containers, easily managed by
general controls.
P None
Store B None
Packaging C None
P None
Measure B Environmental X Cross‐contamination possible if Sanitation controls ‐ Zoning, X
Ingredients pathogens such measuring environment not managed at dry environment
as Salmonella appropriate hygiene level.
C Food allergens X Materials containing allergens other Allergen controls – Proper X
from other than those on the label are handled in cleaning between allergens.
products the same environment. Use of dedicated tools, run
order of allergenic materials
P None
Mix and B Environmental X Cross‐contamination possible if Sanitation control ‐ Zoning, X
Warm Syrup pathogens such environment and employee practices maintaining dry environment
as Salmonella not managed at appropriate hygiene
level.
C None
P None
Cool Syrup B Environmental X Cross‐contamination possible if Sanitation control ‐ Zoning, X
pathogens such environment and employee practices maintaining dry environment
as Salmonella not managed at appropriate hygiene
level.
C None
P None
Continued

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Distribute after exercise for Chapter 8: Hazard Analysis and Preventive Controls Determination
PRODUCT(S): Cold Pressed Almond Cranberry Energy Bar PAGE 10 of 16
PLANT NAME: Example ISSUE DATE 01/28/2016
ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015

(1) (2) (3) (4) (5) (6)

Ingredient/ Identify potential Are any Justify your decision for column 3 What preventive control Is the
Processing food safety potential measure(s) can be applied to preventive
Step hazards food safety significantly minimize or control
introduced, hazards prevent the food safety applied at
controlled or requiring a hazard? this step?
enhanced at this preventive Process including CCPs,
step control? Allergen, Sanitation, Supply‐
Yes No chain, other preventive control Yes No
Mix Dry B Environmental X Cross‐contamination possible if Sanitation controls – Zoning , X
Ingredients pathogens such environment and employee practices maintaining dry environment
as Salmonella not managed at appropriate hygiene
level.
C Food allergens X Materials containing allergens other Allergen controls – Proper X
from other than those on the label are handled in cleaning between allergens.
products the same environment. Use of dedicated tools, run
order of allergenic materials
P Metal X Metal‐on‐metal contact occurs in Subsequent metal detection X
equipment
Blend All B Environmental X Cross‐contamination possible if Sanitation control ‐ Zoning, X
Ingredients pathogens such environment and employee practices maintaining dry environment
as Salmonella not managed at appropriate hygiene
level.
C Food allergens X Materials containing allergens other Allergen controls – Proper X
from other than those on the label are handled in cleaning between allergens.
products the same environment. Use of dedicated tools, run
order of allergenic materials
P Metal X Poorly maintained or improperly Other control – Preventive X
operated mixer could generate foreign maintenance
bodies. Preventive maintenance reduces
occurrence
Spray Pans B Environmental X Cross‐contamination possible if Sanitation control – Zoning, X
pathogens such environment and employee practices maintaining dry environment
as Salmonella not managed at appropriate hygiene
level.
C Food allergens X Materials containing allergens other Allergen controls – Proper X
from other than those on the label are handled in cleaning between allergens.
products the same environment. Use of dedicated tools, run
order of allergenic materials
P None
Form/ Press B Environmental X Cross‐contamination possible if Sanitation control – Zoning, X
pathogens such environment and employee practices maintaining dry environment
as Salmonella not managed
C Food allergens X Materials containing allergens other Allergen controls – Proper X
from other than those on the label are handled in cleaning between allergens.
products the same environment. Use of dedicated tools, run
order of allergenic materials
P Metal X Poorly maintained or improperly use Subsequent metal detection X
pressing equipment could generate
metal fragments. Preventive
maintenance reduces occurrence
Continued

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Distribute after exercise for Chapter 8: Hazard Analysis and Preventive Controls Determination
PRODUCT(S): Cold Pressed Almond Cranberry Energy Bar PAGE 11 of 16
PLANT NAME: Example ISSUE DATE 01/28/2016
ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015

(1) (2) (3) (4) (5) (6)

Ingredient/ Identify potential Are any Justify your decision for column 3 What preventive control Is the
Processing food safety potential measure(s) can be applied to preventive
Step hazards food safety significantly minimize or control
introduced, hazards prevent the food safety applied at
controlled or requiring a hazard? this step?
enhanced at this preventive Process including CCPs,
step control? Allergen, Sanitation, Supply‐
Yes No chain, other preventive control Yes No
Setting B Environmental X Cross‐contamination possible if Sanitation control – Zoning, X
pathogens such environment and employee practices maintaining dry environment
as Salmonella not managed at appropriate hygiene
level.
C Food allergens X Materials containing allergens other Allergen controls – Proper X
from other than those on the label are handled in cleaning between allergens.
products the same environment. Use of dedicated tools, run
order of allergenic materials
P None
Cutting B Environmental X Cross‐contamination possible if Sanitation control – Zoning, X
pathogens such environment and employee practices maintaining dry environment
as Salmonella not managed
C Food allergens X Materials containing allergens other Allergen controls – Proper X
from other than those on the label are handled in cleaning between allergens.
products the same environment. Use of dedicated tools, run
order of allergenic materials
P Metal X Poorly maintained or improperly used Subsequent metal detection X
cutting equipment could generate metal
fragments.
Rework B Environmental X Cross‐contamination possible if Sanitation control – Zoning, X
pathogens such processing environment and employee maintaining dry environment
as Salmonella practices not managed at appropriate and equipment, proper drying
hygiene level. after allergen changeover
C Food allergens X Materials containing allergens other Allergen controls – Use of X
from other than those on the label are handled in dedicated storage containers,
products the same environment. rework use matrix run order of
allergenic materials, proper
cleaning of tools and
equipment between allergens,
employee GMP
P None
Metal B None
Detection C None
P Metal inclusion X Metal may be present from previous Process control – metal X
operations detector
Wrap, Case B Environmental X Cross‐contamination possible if Sanitation preventive control – X
pathogens such processing environment and employee Zoning, maintaining dry
as Salmonella practices not managed at appropriate environment and equipment,
hygiene level. proper drying after allergen
changeover
C Undeclared X The product contains almonds and soy Allergen Control – verification X
allergens – which are food allergens. The wrapper appropriate label used
almond, soy has the labeling
P None
Store, Ship B None
C None
P None

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PRODUCT(S): Cold Pressed Almond Cranberry Energy Bar PAGE 12 of 16
PLANT NAME: Example ISSUE DATE 01/28/2016
ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015

Process Preventive Controls

Process Critical Monitoring Corrective
Hazard(s) Verification Records
control(s) limits What How Frequency Who Action

Metal Metal
detection inclusion

See the Food Safety Plan in the

curriculum for an example of
potential wording for metal
detection. Parameters can vary
depending on the product,
packaging, detection system, etc.

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PRODUCT(S): Cold Pressed Almond Cranberry Energy Bar PAGE 13 of 16
PLANT NAME: Example ISSUE DATE 01/28/2016
ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015

Allergen Preventive Controls

Ingredient Allergen Identification
Allergens in Ingredient Formulation

Tree Nut

Shellfish
Allergens in Precautionary

Peanut
(market

(market

(market
Wheat

name)

name)

name)
Milk

Fish
Soy
Egg
Raw Material Labeling
Name Supplier

Blanched BIG Almond None

almonds Company Almond

Dried cranberries Fruit & Nut Ltd. Packed in a facility that also
produces peanuts, tree
nuts, soy and milk
Corn syrup G. Narich None
Sweetners, Inc.
Crisped rice A. Cereal None
Company
Pan release agent My Distributor X None
Vitamin/ Mineral CarGen None
Pre‐blend Nutritionals

Production Line Allergen Assessment

Intentional Allergens

(market name)

(market name)
Tree Nut

Shellfish
Wheat

Peanut
(market
name)
Milk

Fish
Soy
Egg

Production
Product Name Line
Almond Cranberry Bar 1 and 2 X Almond

Chocolate Covered Peanut Bar 1 and 2 X X X

Sunflower Seed Raisin Bar 1 X

Scheduling Implications:
Standard practice is to run the Sunflower Seed Raisin Bar in the beginning of the shift to reduce the
potential for allergen cross-contact.

Allergen Cleaning Implications: (Required)

A full allergen clean is required AFTER production of Chocolate Covered Peanut Bar and Almond
Cranberry Bar because they contain unique allergens (see table)

Allergen Label Verification Listing

Product Allergen Statement Label Number
Almond Cranberry Contains: Almond, soy AC123
Bar Manufactured on equipment that also handles peanuts, other
tree nuts, and milk
Chocolate Covered Contains: Peanut, milk, soy CP456
Peanut Bar Manufactured on equipment that also handles tree nuts
Sunflower Seed Contains: Soy SSR789
Raisin Bar Manufactured in a facility that also handles peanuts, tree nuts
and milk

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 PRODUCT(S): Cold Pressed Almond Cranberry Energy Bar PAGE 14 of 16
PLANT NAME: Example ISSUE DATE 01/28/2016
ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015

Allergen Preventive Control Chart

Monitoring
Allergen control Hazard(s) Criteria Corrective Action Verification Records
What How Frequency Who

Receiving packaging Undeclared Product label Ingredient Visual exam of Each receipt Label If label is QA manager or Allergen Label
(labeled wrapper) allergens – declares listing and wrapper label to before release specialist incorrect, reject designee reviews Verification
almonds, soy allergens present allergen match product to production labels and return and initials Listing
lecithin in the formula declaration formula per SOP to supplier or records within 7
Allergen Label
and has matches 14‐264 destroy. Identify working days and
Precautionary Verification at
precautionary product root cause and compares results
labeling: Receipt Log
labeling from conduct training with past results
Manufactured on ingredients as needed or to identify any Corrective action
equipment that discuss with trends records
also handles supplier how to
peanuts, other prevent Verification
tree nuts, and recurrence records
milk

Wrap, Case (labeled Undeclared Label number Confirm that Visual inspection Beginning and Line If label is Allergen Label
wrapper) allergens – matches product packaging used of the wrapper end of run and operator incorrect, Verification
almonds, soy matches the stock to match when label segregate product, Listing
lecithin and product number the product stock is changed inspect back to
Allergen Label
Precautionary number the last good
Verification on
labeling check, relabel or
Line Log
destroy; identify
root cause and Corrective action
conduct training records
as needed to
prevent Verification
recurrence records
Allergen change Cross‐contact No residual Application of Procedures as After products Sanitation Re‐clean line Hygiene audit; Sanitation log
over procedures, with allergens allergenic effective outlined in containing manager ATP swabs
Corrections
including clean not present in material from cleaning; visual Allergen Change allergenic
records
following the use of the recipe previous inspection prior Over Procedures materials not in
other allergenic production to start‐up – SOP 14‐456 this recipe are Verification
material on handled on the records
equipment line

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PRODUCT(S): Cold Pressed Almond Cranberry Energy Bar PAGE 15 of 16
PLANT NAME: Example ISSUE DATE 01/28/2016
ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015

Sanitation Preventive Controls

Zoning and Related GMP Controls
The ingredient measurement room and processing areas are maintained at a higher hygiene
level than receiving, storage, and shipping areas, as specified in SOP 15-123 – High Hygiene
Sanitation Procedures.
As specified in SOP 15-456 – Employee Hygiene in High Hygiene Areas, employees must put
on smocks that do not have pockets, change into factory shoes, put on protective equipment
(hair net, beard net), and wash their hands before entering ingredient measurement and
production areas.
Rework is covered and stored in a room adjacent to the processing area, and maintained at the
same hygiene level as the processing area (See SOP 15-789 – Rework Procedures).
Equipment and utensils that are cleaned out-of-place are cleaned and sanitized in a wash room
adjacent to the processing areas. Clean equipment is dried and stored on racks in an area
adjacent to the processing area. The cleaning and sanitation crew have a dedicated room to
store cleaning equipment.
Cleaning and Sanitation
The warehouse and loading areas are dry cleaned. Ingredient measurement room, production
areas and rework storage rooms are maintained dry during production. Lines and equipment are
wet cleaned and sanitized when changing over from a product containing a different allergen.
Equipment is completely dried prior to production. See these Standard Operating Procedures
for details:
SOP 16-454 – Dry Cleaning
SOP 16-455 – Controlled Wet Cleaning
SOP 14-456 – Allergen Change Over
Microbiological Verification of Sanitation Practices
A Salmonella environmental monitoring program is in place to verify that controls are sufficient
to prevent the presence and harborage of Salmonella in the environment and equipment. The
program includes an evaluation of Enterobacteriaceae levels as an additional verification that
conditions do not exist that could lead to the presence and harborage of Salmonella.
Enterobacteriaceae environmental monitoring occurs weekly and Salmonella monitoring occurs
monthly.
Additional environmental monitoring is conducted in the event of special circumstances,
including maintenance in the ingredient measurement room and processing areas; leaks that
introduce water into the ingredient measurement room and processing areas (other than normal
controlled wet cleaning); or audit findings suggesting sanitation controls may be inadequate.
See:
SOP 15-282: Environmental Monitoring Verification Procedures
SOP 15-283 Environmental Monitoring for Special Circumstances

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PRODUCT(S): Cold Pressed Almond Cranberry Energy Bar PAGE 16 of 16
PLANT NAME: Example ISSUE DATE 01/28/2016
ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015

Supply‐chain‐applied Preventive Controls Program

The following suppliers provide ingredients or raw materials requiring a supply-chain-applied control
because we do not have an effective control in our facility. Each of these approved suppliers is evaluated
through an on-site third party audit conducted by a qualified auditor. Additional verification activities are
also conducted as noted below. The supplier approval process is documented in SOP 16-321.

Raw Material or
Ingredient Almonds Crisped Rice
Approved Supplier B.I.G. Almond Company, Nuttown, USA A. Cereal Company,
and location Grainbelt, USA
Approval Date 10/08/2010 9/9/2009

Hazard requiring a Supply- Salmonella Aflatoxin Salmonella

chain-applied Control
Preventive Controls Propylene oxide treatment Sorting to remove moldy The crisping process
Applied by the required for California nuts that may contain provides sufficient heat
Supplier almonds in North America aflatoxin to kill Salmonella.
achieves a minimum 4-log Zoning and dry
reduction of Salmonella cleaning used to
prevent
recontamination.
Type(s) of Supplier 3rd party audit of approved supplier and 3rd party audit of
Verification quarterly certificates of analysis (COA) approved supplier
Verification A copy of a 3rd party audit is requested from the supplier annually. The audit
Procedure(s) date, auditor qualifications, audit procedures and audit results are reviewed by
our Quality Assurance Manager. Follow up with the supplier takes place, as
necessary, to verify that any corrective actions mentioned in the report have
been completed, with records maintained for this activity.
For each shipment received, the incoming goods technician verifies that the
material is from the approved supplier location using the Bill of Lading,
documents the check in the incoming goods log and files the Bill of Lading.
Certificates of Analysis NA
The incoming goods technician:
visually checks the COA for compliance with
specification (see below),
documents the check in the incoming goods log and
files the COA with supplier records.
If the COA is not provided in the required timeframe, the
lot is put on hold and a COA is requested.
The lot is rejected if no COA is provided for the lot.
Salmonella not detected in Aflatoxin < 10 ppm for lots
5 25g samples per lot received
Records Quarterly COAs Quarterly COAs for See list below
– ingredient or hazard Salmonella aflatoxin
specific
– required for all A copy of the audit report and verification of corrective actions taken by the
supplier maintained on file by the Quality Assurance Manager
Incoming Goods Log
Bill of Lading verifying each shipment came from an approved supplier
Corrective action records

FSPCA Training Model

Distribute after exercise for Chapter 12: Supply-chain Controls