Brocoli, Zanahoria y Ensalada de Nueces: Diagrama de Flujo y Descripción del Proceso

PRODUCT(S): Broccoli, Carrot and Pecan Salad PAGE 1 of 19
PLANT NAME: Example ISSUE DATE 02/24/2016

ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
Selected Sections of a
Food Safety Plan

for
Broccoli, Carrot, Pecan Salad

Teaching Example
Reviewed by:___________________________ Plant Manager Date:
The information in this example is for training purposes only and does not represent any specific
operation. Many processing steps were omitted or combined to facilitate its use for class
exercises. Thus it is not complete and contains both required and optional information.
Because development of a Food Safety Plan is site specific, it is highly unlikely that this plan
can be used in a specific facility without significant modification. Conditions and specifications
used (e.g., validation information) are for illustrative purposes only and may not represent actual
process conditions.
FSPCA Training Model

For Exercise After Chapter 6: Preliminary Steps in Developing a Food Safety Plan
Table of Contents
Company Overview ....................................................................................................................... 3
Product Description....................................................................................................................... 3
Flow Diagram ................................................................................................................................ 4
Process Narrative ......................................................................................................................... 5
Receiving packaging ................................................................................................................. 5
Receiving shelf stable ingredients ............................................................................................. 5
Receiving refrigerated ingredients ............................................................................................. 5
Receiving frozen ingredients ..................................................................................................... 5
Packaging storage ..................................................................................................................... 5
Dry ingredient storage ............................................................................................................... 5
Refrigerated ingredient storage ................................................................................................. 5
Frozen ingredient storage ......................................................................................................... 5
Sort, wash, peel carrots ............................................................................................................. 5
Chop, rinse, dry carrots ............................................................................................................. 6
Mix all ingredients ...................................................................................................................... 6
Fill, weigh, label ......................................................................................................................... 6
Metal detection .......................................................................................................................... 6
Refrigerated finished product storage ....................................................................................... 6
Refrigerated product shipping ................................................................................................... 6
Hazard Analysis ............................................................................................................................ 7
Process Preventive Controls ....................................................................................................... 11
Allergen Preventive Controls ...................................................................................................... 14
Sanitation Preventive Controls .................................................................................................... 16
Hygienic Zoning & Environmental Monitoring ......................................................................... 16
Environmental Monitoring for Sanitation Preventive Control Verification ................................ 17
Supplier Verification Program for Preventive Controls ................................................................ 18

Company Overview
This company’s ~50 employees produce a variety of refrigerated salads, including:
 Broccoli, Carrot and Pecan Salad;
 Broccoli, Carrot and Raisin Salad; and
 Italian Vegetable Salad with Parmesan Cheese.
Product is produced 5 days a week, with one 9 hour production shift, followed by 4 hours for
sanitation. Cleaning and sanitizing of all processing equipment is conducted per a master
sanitation schedule, which also includes cleaning and sanitizing between production runs.
Municipal water, which is treated and tested per EPA requirements by the city, is used
throughout the facility.
This Food Safety Plan covers production of Broccoli, Carrot and Pecan Salad. Other products
have separate Food Safety Plans.
Product Description
Product Name(s) Broccoli, Carrot and Pecan Salad
Product Description, including Refrigerated, ready-to-eat salad, containing broccoli,
Important Food Safety carrots, pecans and salad dressing.
Characteristics pH <4.6,
water activity >0.95
Ingredients Fresh carrots, frozen (IQF) broccoli, and salad dressing
(water, soybean oil, high fructose corn syrup, vinegar,
cornstarch, eggs, salt, potassium sorbate, spice, dried
garlic)
Packaging Used 8 oz. plastic cup and snap on lid
Intended Use Ready-to-eat salad, appropriate for grab-and-go

applications. Sold through grocery stores, delis and
convenience stores.
Intended Consumers General public
Shelf Life 10 days after manufacture
Labeling Instructions Keep refrigerated.
Storage and Distribution Refrigerated (≤40°F) storage and distribution
Approved: Date:
Signature: F.S. Leader 6 January 2016
Print name: F.S. Leader

Flow Diagram
Receiving shelf Receiving
Receiving Receiving frozen
stable ingredients refrigerated
packaging [pecans, salad dressing] ingredients
[packaging material] ingredients [frozen broccoli florets]
[fresh whole carrots]
   
Dry ingredient Refrigerated Frozen ingredient
Packaging storage storage ingredient storage
[pecans] [fresh whole carrots, salad
storage
[frozen broccoli]
dressing]

Sort, wash, peel
carrots

Chop, rinse, dry
carrots

Mix all ingredients
[carrots, frozen broccoli,
pecans, salad dressing]

Fill, weigh, label

Metal detection

Refrigerated finished
product storage

Refrigerated product
shipping
NOTES:
Ambient salad dressing is moved to refrigerated
storage to help cooling. Not required for safety.
[Text in square brackets are for teaching purposes]

Process Narrative
Receiving packaging
Pre-labeled, 8 oz. flexible plastic cups with snap on lids are received in bulk. Specifications
require food grade material compatible for refrigerated food products. Packaging materials are
stored separate from ingredients, cleaning chemicals, etc.
Receiving shelf stable ingredients
Pecans: Bag-in-box roasted pecans are received from our sole source broker that offers
products only from suppliers complying with internationally recognized food safety and quality
schemes. The supplier provides a certificate of analysis for aflatoxin tests to verify compliance.
Salad dressing: Received as a shelf stable product in plastic containers from our sole source
broker. This ingredient contains egg which is an allergen and has a pH <4.6.
Receiving refrigerated ingredients
Fresh, topped carrots are received in totes from approved vendors/ growers who meet company
food safety and quality requirements. A Letter of Guarantee states that carrots are grown under
conditions that minimize contamination with vegetative pathogens and lead, and comply with
appropriate regulatory pesticide limits. All carrots are produced in the U.S.
Receiving frozen ingredients
Frozen, blanched individually quick frozen (IQF) broccoli florets are received from our sole
source broker. The broker’s Letter of Guarantee states that production processes and Good
Agricultural Practices for growing the broccoli are used. The product is imported.
Packaging storage
Cups and lids are stored in the dry storage room in the packaging area, arranged by product
code to avoid mixing of packaging. Packaging is used First-In-First-Out and partially used
shipping containers are closed during storage.
Dry ingredient storage
Pecans are stored in the dry ambient storage room in the ingredient area, arranged by
ingredient code number. Because pecans are a food allergen, containers are sealed and stored
in a specific location to avoid cross-contact.
Refrigerated ingredient storage
Carrots are stored in a segregated refrigerated storage away from other refrigerated ingredients
because they are raw and unwashed. They are used on a First-In-First-Out basis.
Salad dressing is refrigerated (≤40°F) upon receipt. Refrigeration is not necessary for safety, but
pre-chilling to ≤40°F aids in cooling the final product.
Frozen ingredient storage
After receipt, frozen broccoli florets are immediately taken to the frozen storage area and used
on a First-In-First-Out basis.
Sort, wash, peel carrots
On an as-needed basis, carrots are sorted by hand to remove gross soil, rot, small or large
carrots that do not meet product specification and foreign material. Defects are collected,
analyzed and trended. Relevant results are reported back to the broker/ grower. Sorted carrots
are mechanically washed to remove dirt and debris in antimicrobial treated water, currently

maintained at no less than 50 ppm free chlorine using a product labeled for washing and peeling
fruits and vegetables. Approved1 chemicals are used according to label instructions. Chlorine
levels in the wash water are monitored. Visual inspection verifies absence of foreign material
that could result in injury. Carrots are peeled with mechanical peeling equipment with
antimicrobial treated water (>50 ppm free chlorine). Care is taken to ensure that peeling
equipment is intact before and after each shift or batch.
Chop, rinse, dry carrots
The washed and peeled carrots are transferred to the vegetable preparation room where they
are mechanically chopped using a commercial knife blade vegetable chopper to a ¼ inch dice.
Chopping blades are checked to ensure they are intact before and after each shift. Once
chopped, the carrots are rinsed with single pass water and spin-dried to prevent the carrot juice
from bleeding throughout the finished product. Diced carrots are then held at production room
temperatures (45-50°F) for no longer than 2 hours.
Mix all ingredients
Chopped carrots, frozen broccoli florets, pecans and salad dressing are mixed using a ribbon
blender to gently blend to a uniform mixture. The finished salad is transferred manually with
scoops to totes, covered and transported to the filling area. A batch is blended in <15 minutes.
The blended product temperature is typically ≤40°F after mixing. Mixed product can be stored
in covered totes at ≤40°F for no longer than 24 hours before filling into final package. All work-
in-process (WIP) product is labeled with the appropriate product and allergen labeling, as well
as the date and time the product was filled into the tote.
Fill, weigh, label
Labels are matched to the specific description and product number as listed on the Daily
Production Schedule. 8 oz. pre-labeled cups that contain the pecan and egg allergen statement
are manually filled and weighed, and lids are applied to each container. Product pull date (10
days after production) is printed on each cup. The temperature of filled product is measured
periodically.
Metal detection
Packaged product is passed through a metal detector and then is transferred to refrigerated
storage (≤40°F)
Refrigerated finished product storage
Finished product is stored under refrigeration (≤40°F) until distributed.
Refrigerated product shipping
Product is shipped in refrigerated trucks to customers (convenience stores, office cafeterias,
quick serve restaurants and grocery stores) under refrigerated conditions (≤40°F).
1
“Approved” refers to meeting regulatory requirements, such as EPA registration or FDA listing of
chemical used.

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 food Do any Justify your decision for column 3 What preventive control Is the
Processing safety hazards potential measure(s) can be applied to preventive
Step introduced, controlled food safety significantly minimize or control
or enhanced at this hazards prevent the food safety applied at
step require a hazard? this step?
preventive Process including CCPs,
control? Allergen, Sanitation, Supply‐
Yes No chain, other preventive Yes No
control
Receiving B None
packaging C None
P None
Receiving B Vegetative X Raw tree nuts have a Supply-chain Control – X
shelf stable pathogens such history of potential Salmonella is controlled
ingredients as Salmonella contamination with by the supplier through
– pecans vegetative pathogens the roasting process
C Allergen – X Pecans are tree nuts, Allergen Control - X
pecan tree nut which could present a allergen cross-contact
source of cross-contact for prevention and allergen
other products that do not labeling at subsequent
contain pecans. steps
Aflatoxin X Pecans have a history of Supply-chain Control – X
potential contamination Aflatoxin is controlled by
with aflatoxin the supplier by removal
of moldy, discolored
pecans
P None
Receiving B None Industrially produced, shelf-
shelf stable stable salad dressing has a
ingredients high acid content that
– salad destroys vegetative
dressing pathogens
C Allergen – egg X Egg is an allergen, which Allergen Control - cross- X
could present a source of contact prevention and
cross-contact for other allergen labeling at
products that do not subsequent steps
contain egg.
P None
continued

For Exercise After Chapter 8: Hazard Analysis and Preventive Controls Determination
(1) (2) (3) (4) (5) (6)

control
Receiving– B Vegetative X Raw vegetables and soil Supply-chain Control - X
fresh whole pathogens such may contain pathogens that Production in
carrots as Salmonella can transfer through further accordance with the
and pathogenic handling and potentially Produce Safety rule
E. coli grow under abusive minimizes vegetative
conditions. Intact carrots do pathogens.
not support pathogen Subsequent process
growth. controls – antimicrobial
washing & peeling, short
post-chop process time,
finished product temp.
Sporeforming X While raw vegetables may
pathogens - C. contain C. botulinum, it will
botulinum not grow or produce toxin
on intact carrots or later
due to aerobic conditions
and competitive
microorganisms inherent to
the process.
C Pesticides X Ingredient is US-sourced.
FDA data rarely show
pesticide residues above
EPA tolerance levels or
unapproved pesticides
Lead X Lead can occur when Supply-chain Control - X
carrots are grown in a site selection addressed
former orchard that used in specifications
lead arsenate pesticide
P None
Receiving B Vegetative X Bacterial pathogens may Supply-chain Control - X
frozen, pathogens such occur on raw produce and Blanching and
blanched as Listeria recontamination can occur environmental sanitation
broccoli monocytogenes after blanching without controls
florets and Salmonella sanitation controls.
C Pesticides X FDA testing periodically Supply-chain Control - X
detects unapproved Pesticide control and
residues or levels above monitoring for broccoli
tolerance in produce from from countries without
certain countries.2 robust control programs
P None
2
FDA data suggests periodic detection of unapproved residues or levels above tolerance in imported
produce from certain countries. If sourced from US or other country with evidence that pesticide non-
compliance is rare, column 3 can be answered “No”. See carrot example.

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

control
Storage – B None
Packaging C Allergen cross- X Only unopened or resealed
and dry contact during containers of allergenic
ingredients storage ingredients are stored in
[pecans] the dry storage area
making cross-contact
unlikely.
P None
Refrigerated B None These refrigerated
ingredient ingredients do not support
storage pathogen growth.
[fresh C Allergen cross- X Only closed containers of
carrots, contact during allergenic ingredients are
salad storage stored in this storage area
dressing] P None
Frozen B None Pathogen growth does not
ingredient occur in frozen storage
storage C None
[blanched P None
broccoli]
Sort, wash, B Vegetative X Wash water may spread Process Control – X
peel carrots pathogens such contamination, if present, to Antimicrobial (chlorine)
as Salmonella, all carrots. Growth is not in wash water
STEC likely with short process
time.
C None
P Metal X Metal on metal wear in Metal detection at a X
peeling equipment later step
Chop, rinse, B Environmental X Environmental Sanitation Control – X
dry carrots pathogens such contamination zoning and
as Listeria environmental sanitation
monocytogenes
C None
P Metal X The potential for metal Metal detection at a X
contamination from later step
chopper exists; fragments
could result in injury.
continued

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

control
Mix all B Environmental X Recontamination may Sanitation Control – X
ingredients pathogens such occur if environmental zoning and
[carrots, as L. control is not in place. environmental sanitation
frozen monocytogenes Process time is too short
broccoli, for growth to occur.
pecans, C Allergens from X This product could be Allergen Control and X
salad other products; exposed to milk allergen Sanitation Control –
dressing] e.g., Italian from other products if not prevent allergen cross-
Vegetable Salad controlled contact
P None
Fill, weigh, B Vegetative and X Short process time -
label sporeforming pathogens unlikely to grow
pathogen
growth
Product X Recontamination may Sanitation Control – X
recontamination occur if equipment cleaning zoning and
with and employee practices are environmental sanitation
environmental not proper
pathogens such
as L. mono
C Undeclared X Product contains egg and Allergen Control – X
allergens – egg, pecan allergens declaration on label
pecan
P None
Metal B None
detection C None
P Metal X Chopping carrots and other Process Control – metal X
metal-on-metal contact detection
may periodically produce
metal hazards
Refrigerated B Vegetative and X Pathogens can grow if Process Control – X
finished sporeforming product is time and product storage
product pathogen temperature abused temperature prior to
storage growth shipment
C None
P None
Refrigerated B Vegetative and X Pathogens can grow if Process Control – X
product sporeforming product is time and product and shipping
shipping pathogen temperature abused vehicle temperature
growth
C None
P None

Process Preventive Controls
Monitoring Record-
Process Corrective
Hazard(s) Critical Limits Verification keeping
Control(s) What How Frequency Who Action
Procedures
Wash, carrots Vegetative Free chlorine in wash Wash water Chlorine and pH Each batch Wash If chlorine or pH Daily review of Wash Water
pathogens water at end of batch Initial chlorine test strips match operator level is not Wash Water log showing
such as run is ≥10 ppm, pH 7.5 level in water is color correct, then Chlorine log both chlorine
Salmonella maximum ≥50 ppm 1) adjust and Perform and pH values
and conduct training accuracy check Corrective
pathogenic E. as needed to on both pH and action records
coli prevent chlorine strips
recurrence for each new lot Verification
of strips with records
2) segregate
carrots to the standard Validation
last good check, solutions report that
reprocess or shows
discard; chlorine wash
Review of
water is
3) identify root corrective action
effective
cause and log
correct.
Review of
verification
records
Metal detection
See Food Safety Plan in curriculum for an example

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

For Exercise After Chapter 9: Process Preventive Controls
Monitoring Record-
Process Corrective
Procedures
Refrigerated Vegetative Cooler maintained at Cooler Digital time and Continuous, Production If cooler Check recorder Recording
finished and spore- ≤40°F temperature temperature with visual employee temperature is and dial refrigeration
product storage forming data logger with check of >40°F, place thermometer for charts and
pathogen a continuous recorded product in accuracy and to visual check
growth chart recorder data once alternative ensure that they records
per day cooler. are operating Product
If product properly before temperature
temperature is putting into use; log
>40°F, measure check daily at
Thermometer
upstream the beginning of
accuracy
product and operations.
checks and
Product temperature Product internal Dial First Production component Calibrate
calibration
≤40°F temperature thermometer product in employee temperatures to recorder
records.
when it enters and every 2 determine annually.
the cooler hours until potential issues. Calibrate dial
the end of thermometer
Hold and
shift when accuracy
evaluate based
check indicates
on total time and
need.
temperature
exposure - Review
release or reject monitoring,
as appropriate. corrective
Find root cause action, and
and fix cooler. verification
Retrain if records within
appropriate. one week of
preparation

Monitoring Record-
Process Corrective
Procedures
Refrigerated Vegetative Product and shipping Temperature in Recording Every load Shipping If truck Check Shipping truck
product and spore- vehicle temperature refrigerated thermometer on before clerk temperature is thermometer for temperature
shipping forming must be ≤40°F. truck truck compared loading >40°F before accuracy daily at log
pathogen to temperature loading, then the beginning of Thermometer
growth of our own 1) close truck operations. calibration
thermometer. and wait until Calibrate records.
temperature is annually.
≤40°F before Review
loading. monitoring, and
associated
2) identify root corrective
cause; action, and
3) conduct verification
training as records within
needed to one week of
prevent preparation
recurrence

Allergen Preventive Controls
Monitoring
Allergen Corrective
Hazard(s) Criterion Verification Records
Controls What How Frequency Who Action
Fill, weigh, Undeclared Correct labels Label on Visual At the Packaging If label is QA manager Allergen Label
label Allergens – applied to finished finished inspection of beginning and line worker incorrect, then reviews Packing Check log
pecans and product product finished the end of 1) segregate Room Log within Corrective
eggs matches product label each product, one week and Action records
product packaging inspect back to compares to past
number and run, and each the last good information to Verification
declares new case of check, re-label identify any records
pecans and containers or discard trends.
egg product; Weekly review of
associated
2) identify root verification
cause; records corrective
action records, if
3) conduct any
training as
needed to
prevent
recurrence
Allergen Label Verification Listing

Products Allergen Statement
Broccoli, Carrot and Pecan Salad Contains: Pecans, egg
Broccoli, Carrot and Raisin Salad Contains: Egg
Italian Vegetable Salad with Parmesan Cheese Contains: Milk, egg

For Exercise After Chapter 10: Food Allergen Preventive Controls
Production Line Allergen Assessment

Intentional Allergens
Shellfish
Tree Nut
(market
(market
(market
Peanut
Wheat
name)
name)
name)
Fish
Milk
Egg
Soy
Production
Product Name Line
Broccoli, Carrot and Pecan Salad 1 X Pecan
Unique
allergen
Broccoli, Carrot and Raisin Salad 1 X
Italian Vegetable Salad with Parmesan Cheese 1 X X
Unique
allergen
Scheduling Implications: Broccoli, Carrot and Raisin Salad does not contain allergens present in other products. Standard practice is to run this product
first to facilitate change overs.
Allergen Cleaning Implications: A complete allergen clean is required after Broccoli, Carrot and Pecan Salad and Italian Vegetable Salad with Parmesan
Cheese to avoid allergen cross-contact.

Sanitation Preventive Controls

NOTE: See Food Safety Plan in curriculum for an example of potential wording for cleaning and
sanitation procedures. Parameters can vary depending on the product, equipment, etc.
Hygienic Zoning & Environmental Monitoring

Purpose: Hygienic zoning in is important to minimize the potential of re-contamination with
environmental pathogens. Verification is by environmental monitoring (see Environmental Monitoring
for Sanitation Preventive Control Verification).
Men’s Women’s
Break
Entry Office Locker Locker Maintenance Mechanical
Room
Room Room
Hall
Ambient Frozen Refrigerated Carrot Prep Mixing Fill, weigh, Metal
Shipping/
Storage Storage Storage ingredients label detection
Receiving
Hall
Basic Primary pathogen control area –
KEY: Non-manufacturing Transition
GMP CONTROLLED ACCESS
Frequency: During production

Who: Employees and other individuals entering the Mixing and Fill areas (in pink above)
Procedure: Employees entering the Assembly and Fill areas must (in the order listed):
1. Take a clean, blue smock from the rack outside the production area and put them on. Smocks
must cover outer clothing that would be above the processing line.
2. Take blue shoe covers from the box by the entry and put them on over shoes.
3. Take a blue hairnet from the box by the entry and put it on. Ensure that all loose hair is
captured. Men with facial hair should also apply beard nets.
4. Wash hands just before entering the area following the procedures posted by the sink. Apply a
clean pair of gloves.
5. When exiting the room deposit smocks, shoe covers and hair nets in the receptacles provided.
DO NOT reuse disposable items after entering uncontrolled areas.
Maintenance workers and visitors must follow the above when entering this area. Traffic in this area is
minimized during production.
Monitoring: For hygienic zoning, the sanitation supervisor visually observes the presence of the
properly smocked employees, before start up and after lunch break, and every 2 hours.
Corrections: Employee is instructed to gown properly.
Records: Daily Hygienic Zoning Record, Environmental Monitoring Sampling Record and lab results
Verification: Environmental monitoring for verification of sanitation control and records review within
7 working days

For Exercise After Chapter 11: Sanitation Preventive Controls
Environmental Monitoring for Sanitation Preventive Control Verification

Purpose: Environmental monitoring is conducted to verify the effectiveness of sanitation and hygienic
zoning procedures in the Mixing and Fill, weigh, label areas to control environmental
pathogens such as L. monocytogenes.
Sample identification: Based on observation when sampling, “worst case” areas are sampled; e.g.,
standing water or product residue, around table legs, crevasses major traffic areas. Record the
specific location sampled.
Sampling procedure: Every other week, sponge swabs are collected during production at least 3
hours after production starts. Sampling time is not uniform to avoid bias of results. Samples
are shipped to the laboratory using the sampling kit provided by the laboratory. Samples are
refrigerated and shipped in an insulated cooler with a gel pack with next day delivery. Samples
are NOT frozen.
The following number of samples collected each time.
 3 in Assembly area
 3 in Fill, weigh, label area
 1 in the hallway at the entry of the assembly area
 3 other samples based on observed conditions
Laboratory: Wee Beasties Laboratory (987 Critter Drive, Yourtown, USA) conducts the analysis
using XYZ3 procedures. Analysis is started within 48 hours of sampling.
Test conducted: For routine samples, the contract lab composites sponges from the same area to
run as one test for Listeria species. Investigation samples must be run individually. The test
result sheet identifies the specific method number used.
Interpretation of results:
Acton for a negative result – Continue routine operations
Corrective action for a positive result:
1. If a composite is positive, the positive areas are re-sampled within a day of notification and
prior to implementing intensive sanitation procedures. Additional samples (number depends on
size of area) are taken in other potential problem areas in an attempt to identify a site of
contamination. All samples are run individually, without compositing.
2. Intensive sanitation procedures are implemented after sampling is complete.
3. Production can continue after sanitation is complete and product can be shipped.
4. If all re-samples are negative, resume the normal sampling frequency.
5. If one or more re-samples are positive, perform corrective action investigation to resolve the
issue. Implement a hold and finished product testing procedure per the Product Testing for
Verification corrective action protocol.
3
XYZ would be a scientifically valid method, such as AOAC, ISO, FDA, etc. The procedure must be validated
for compositing (FDA BAM is not as of 10/22/2015)
Supply‐chain Preventive Controls Program

Determination of Verification Procedures – Audits
Verification activities: A 3rd party supplier audit by a qualified auditor is used to verify supply- chain
control of the hazards listed in the table below. Additional verification activities may be conducted as
identified in the table below.
Verification procedures: A copy of a 3rd party audit is requested from each supplier listed below on
an annual basis. The audit date, auditor qualifications, audit procedures and audit results are
reviewed. Follow up discussion with the supplier takes place, as necessary, to verify that any
corrective actions mentioned in a report have been completed, with records maintained for this
activity.
Records: A copy of audit reports and verification of corrective actions taken by the supplier are
maintained on file by the Food Safety Team Leader.
Other Verification Procedures
Raw Hazard(s)
Material or Requiring a Preventive
Other Supply-chain- Control Applied Verification Verification Acceptance
Ingredient applied Control by Supplier Activities Procedures Criteria
Pecans Vegetative The supplier 3rd party audit See above See above
pathogens such as roasts pecans to
Salmonella inactivate
vegetative
pathogens
Aflatoxin The supplier sorts A certificate of For each lot received, < 15 ppb
pecans to remove analysis for trained receiving aflatoxin
damaged nuts each lot of personnel review the average
and conducts shelled pecans supplier certificate of maximum for
aflatoxin testing is used to verify analysis for aflatoxin sub-samples
(using a valid supplier control. with no
method listed on individual
their results reading > 25
report) to verify ppb
their control
procedures.
Fresh Vegetative Produce Safety 3rd party audit See above See above
carrots pathogens such as rule compliance
Salmonella and minimizes lead
pathogenic E. coli and vegetative
Lead pathogens
Frozen Vegetative Blanching and 3rd party audit See above See above
broccoli pathogens such as environmental
L. monocytogenes sanitation
and Salmonella controls
Pesticides (for Pesticide control Sampled and Quality technician Residues
product sourced and monitoring sent for takes and submits comply with
from countries pesticide samples per regulatory
without robust screen, procedure XYZ. requirements
control programs) quarterly Quality manager following
verifies that results procedure
comply with XYZ
acceptance criteria
For Exercise After Chapter 12: Supply-chain Preventive Controls
Approved Suppliers for Ingredients Requiring a Supply-chain-applied Control

Ingredient Approved Date of Hazard(s) requiring supply- Verification Verification
(requiring Supplier Approval chain-applied control method records
supply-chain-
applied control)
Pecans Nuts2U Co., 10/22/2013 Salmonella Copy of 3rd Copy of

Cropville, party audit by a audit kept in
USA qualified auditor Supplier
obtained from Verification
supplier to verify File
Salmonella
control
Aflatoxin Supplier’s COA and
Certificate of incoming
Analysis (COA) goods log,
with each corrective
shipment to records
verify aflatoxin
control
Fresh carrots WeeGrower 9/15/2011 Vegetative pathogens such as Copy of 3rd Copy of
Inc., Salmonella and pathogenic E. party audit by a audit kept in
Rabbiton, coli qualified auditor Supplier
USA obtained from Verification
supplier File
Frozen broccoli FreezRFood, 8/8/2012 Vegetative pathogens such as Copy of 3rd Copy of
Bordertown, L. monocytogenes and party audit by a audit kept in
NotUSA Salmonella qualified auditor Supplier
obtained from Verification
supplier File
Pesticides (for product Internal sample Lab test
sourced from countries without and test results kept
robust control programs) in supplier
file
Receiving procedures: For each shipment received, the receiving clerk uses the receiving
database to identify required documentation then:
 verifies that the product is from an approved supplier
 verifies that each lot in the shipment is accompanied by a COA, if appropriate
 reviews each COA against acceptance criteria above, as appropriate
 documents the above in the Incoming Goods Log.

PRODUCT(S): Cold Pressed Almond Cranberry Energy Bar PAGE 1 of 16
Food Safety Plan

for
Cold Pressed Energy Bar

Teaching Example
Reviewed by:___________________________ Plant Manager Date: __________________
exercises. Thus it is not complete and contains both required and optional information.
Because development of a Food Safety Plan is site specific, it is highly unlikely that this plan can
be used in a specific facility without significant modification. Conditions and specifications used
(e.g., validation information) are for illustrative purposes only and may not represent actual
process conditions.
NOTE: This example refers to Standard Operating Procedures (SOP) to illustrate that separate
procedures can be used to provide more detail. The details of these SOPs are not included in this
teaching example, but would be subject to regulatory review.

For exercise after Chapter 6: Preliminary Steps in Developing a Food Safety Plan
Table of Contents
Flow Diagram ................................................................................................................................ 4
Ingredients and Packaging Materials ........................................................................................ 5
Receive Ingredients ................................................................................................................... 5
Receive Packaging.................................................................................................................... 5
Store Ingredients ....................................................................................................................... 5
Store Packaging ........................................................................................................................ 6
Measure Ingredients .................................................................................................................. 6
Mix and Warm Syrup ................................................................................................................. 6
Cool Syrup ................................................................................................................................. 6
Mix Dry Ingredients ................................................................................................................... 6
Blend All Ingredients ................................................................................................................. 6
Pan Release Spray ................................................................................................................... 6
Form/Press ................................................................................................................................ 6
Setting ....................................................................................................................................... 6
Cutting ....................................................................................................................................... 6
Rework ...................................................................................................................................... 6
Metal Detection ......................................................................................................................... 6
Wrap, Case ............................................................................................................................... 7
Store, Ship................................................................................................................................. 7
Hazard Analysis ............................................................................................................................ 8
Process Preventive Controls ....................................................................................................... 12
Ingredient Allergen Identification ............................................................................................. 13
Production Line Allergen Assessment ..................................................................................... 13
Allergen Label Verification Listing ........................................................................................... 13
Allergen Preventive Control Chart ........................................................................................... 14
Zoning and Related GMP Controls ......................................................................................... 15
Cleaning and Sanitation .......................................................................................................... 15
Microbiological Verification of Sanitation Practices ................................................................. 15
Supply-chain Preventive Controls Program ................................................................................ 16

Company Overview
This example company is a small firm that makes a variety of ready-to-eat energy bars. The
cold pressed products are manufactured through the preparation of a binding syrup that is
combined with a dry ingredient mix. The mass is formed/pressed and allowed to set prior to
cutting and packaging in foiled bags. They do not receive any kill step during processing. The
following products are produced in the facility using some of the same equipment:
 Almond, Cranberry Bar (described in this plan)
 Chocolate Covered Peanut Bar (described in a separate plan)
 Sunflower Seed, Raisin Bar (described in a separate plan)
Product is made 5 days a week in one 8 hour production shift, followed by 4 hours for sanitation.
Dry cleaning is used in production areas, with select small pieces of equipment being cleaned in
a separate wet washing room. Water is treated and tested per EPA requirements by the city. An
integrated pest control program is also in place.
Product Description
Product Name(s) Almond, Cranberry Energy Bar
Product Description, including This product is a ready to eat energy bar packed in a pouch for
Important Food Safety on-the-go eating. The low water activity makes the product shelf
Characteristics stable. Processing involves dry mixing and forming with no
process lethality step.
Water activity ≤0.65

Ingredients Corn syrup, blanched/slivered almonds, crisped rice, dried
cranberries, canola oil, pan release agent (soy lecithin), vitamin
and mineral pre-blend
Packaging Used Metalized polyethylene film, individual retail package with label
Intended Use Ready-to-eat bars
Intended Consumers General consumption
Shelf Life One year
Labeling Instructions None
Storage and Distribution Ambient, not to exceed 90°F
Approved: Date:
Signature: F.S. Leader 05 January 2016

Flow Diagram
Receive Ingredients Receive Packaging

 
Store Ingredients Store Packaging

Measure Ingredients

Mix and Warm Syrup Mix Dry Ingredients
[canola oil, corn syrup] [almonds, crisped rice, dried
(195 to 205oF 15 cranberries, vitamin/mineral
minutes ) pre‐blend]
 
Cool Syrup
 Blend Ingredients  Rework
(120 to 130oF)

Spray Pans

[pan release spray] Form/Press

Setting

Cutting

Metal Detection

Wrap, Case

Store, Ship
Gray area indicates primary pathogen control area
Verified by: P. I. Model Date: January 5, 2016

Process Narrative
Ingredients and Packaging Materials
Ingredients and packaging materials are purchased from approved suppliers that comply with
internationally recognized food safety and quality systems. Suppliers that provide ingredients
and raw materials that have a history of the presence of significant hazards for which we do not
have an effective control in our facility are evaluated through an on-site audit (trusted third party
audit) and are included in a supplier verification program. For each ingredient, the same brand
is used consistently to minimize variation. Ingredients are stored according to manufacturers’
recommendations when specified.
Receive Ingredients
Corn syrup – Received in 5 gallon plastic containers
Canola oil – Received in 5 gallon plastic containers
Almonds, blanched and slivered – Received in 20 lb. bags. Specifications require
blanching after shelling and sorting for defects and mold. Prior to blanching, shelled
almonds are treated with propylene oxide (PPO) to achieve the minimum 4-log reduction
of Salmonella required for California almonds in North America. Screening and testing
for aflatoxin is also conducted. Quarterly, Certificates of Analysis (COA) for Salmonella,
Enterobacteriaceae and aflatoxin conformance to specifications accompany shipments.
Crisped rice – Received in 22 lb. bag-in-box. Ingredients include rice flour, corn flour,
sugar and salt.
Dried cranberries – Received in 25 lb. cases. Ingredients include cranberries, sugar and
sunflower oil. Packaged in the same facility as peanuts, tree nuts, soy, and milk
products.
Vitamin/ mineral pre-blend – Vitamins (A, B-mix, C, E) and minerals (Ca, Mg, K, Zn)
received in 1 lb. plastic sealed bags, with 10 bags in a box. Certificates of analysis
accompany each shipment, confirming levels of vitamins and minerals.
Pan release agent – contains soy lecithin – received in spray cans
Receive Packaging
Corrugated shippers and pre-printed metalized film are received in bulk at the factory.
Specifications require food grade material for metalized film. Suppliers provide a Certificate of
Conformance that packaging materials and inks meet food safety and regulatory requirements.
Appropriate allergen label information is included in the specification and reviews are conducted
for each receipt, including listing almonds and soy lecithin on the ingredient statement, followed
by “Contains Almond, Soy” and “May Contain” peanuts, tree nuts and milk on the precautionary
statement.
Store Ingredients
All ingredients are stored in the dry storage room (temperature kept below 75°F) in the
ingredient area, arranged by ingredient code number. All containers are sealed to avoid cross-
contact and cross-contamination during storage. Ingredients that contain allergens are labelled
and stored in specific locations with like allergenic ingredients.

Store Packaging
Cartons and trays are stored in the dry storage room adjacent to the packaging area. Unused
trays are covered during storage between uses. Plastic wrap is stored in sealed containers to
protect from contamination. Packaging is used First-In-First-Out.
Measure Ingredients
Ingredients are measured and staged in a dedicated room. The hygiene level of the room is
consistent with the requirements of exposed product manufacturing areas. Allergenic materials
are weighed on dedicated equipment into dedicated containers using color coded tools
dedicated to the allergen. Employees change smocks and gloves before and after handling an
allergenic material.
Mix and Warm Syrup
Corn syrup and canola oil are added to a jacketed mixer and warmed to 195 to 205°F and
blended for 20 minutes to ensure even distribution. Warming facilitates more uniform blending
and is not intended to be a kill step in these low water activity ingredients.
Cool Syrup
The syrup is cooled to 120-130°F and held in the mixer until needed.
Mix Dry Ingredients
Almonds, crisped rice, dried cranberries, and the vitamin/mineral pre-blend are added to a mixer
and blended for 30 minutes to ensure even distribution.
Blend All Ingredients
Mixed dry ingredients are gradually added to the syrup mixer. Rework is added at this step.
Spray Pans
Pans that have been cleaned and dried are sprayed by hand with a processing aid containing
soy lecithin.
Form/Press
The blended mass is dispensed onto pans. The mixture is formed and pressed with rollers to
ensure consistent spreading and density.
Setting
Pans are moved to setting area where they are cooled to ambient temperature around 70°F.
Cutting
Sheets are cut mechanically in two successive cutting operations, vertically and horizontally
(rotary blade, reciprocal blade).
Rework
Rework may be generated from the mixing operation, blending operation or after cutting of
sheets. Rework is collected in clean and dry containers, which are labelled with the product
name, relevant allergens, and date rework was generated. Allowable rework use is calculated
based upon the composition of the rework. Rework is used according to a rework/allergen
matrix to ensure that no undeclared allergens are introduced into products. Potential rework
material is discarded approximately monthly to break the rework “chain,” which simplifies
traceability.
Metal Detection
Cut bars are passed through a calibrated metal detector on the conveyor. Bars that are kicked
off during this operation are passed through a more sensitive metal detector. Rejected bars are

inspected and sent to waste. The performance of the metal detector is verified once an hour
using metal detectable wands containing 1.5 mm ferrous and 2.0 mm stainless steel.
Wrap, Case
The identity of wrapping material is confirmed for each batch placed on the line to ensure that it
is the correct material and contains relevant allergen declaration information. Trays containing
cut bars are flipped onto wrappers and bars are individually heat sealed and cut. Lot information
is printed onto each sealed package. Bars are transferred by hand into cases, with 24
bars/case. Product and lot information is printed on each case. Cases are transferred by hand
to pallets, which are sealed in plastic.
Store, Ship
Pallets are transferred by fork lift to the warehouse where they are stored under ambient
condition at < 70% RH until shipping.

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.
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


Distribute after exercise for Chapter 8: Hazard Analysis and Preventive Controls Determination
(1) (2) (3) (4) (5) (6)

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
level.
C None
P None
Continued


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

Mix Dry B Environmental X Cross‐contamination possible if Sanitation controls – Zoning , X
Ingredients pathogens such environment and employee practices maintaining dry environment
level.
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
level.
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
level.
P None
Form/ Press B Environmental X Cross‐contamination possible if Sanitation control – Zoning, X
as Salmonella not managed
P Metal X Poorly maintained or improperly use Subsequent metal detection X
pressing equipment could generate
metal fragments. Preventive
maintenance reduces occurrence
Continued

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

Setting B Environmental X Cross‐contamination possible if Sanitation control – Zoning, X
level.
P None
Cutting B Environmental X Cross‐contamination possible if Sanitation control – Zoning, X
as Salmonella not managed
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


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.

Distribute after exercise for Chapter 9: Process Preventive Controls

Ingredient Allergen Identification
Allergens in Ingredient Formulation
Tree Nut
Shellfish
Peanut
Allergens in Precautionary
Wheat
(market
(market
(market
name)
name)
name)
Fish
Milk
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

(market name)
(market name)
Tree Nut
Shellfish
Wheat
Peanut
(market
Milk
Soy
Fish
name)
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)

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

Distribute after exercise for Chapter 10: Food Allergen Preventive Controls
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

Distribute after exercise for Chapter 10: Food Allergen 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

Distribute after exercise for Chapter 11: Sanitation Preventive Controls
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 moldyThe 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

Distribute after exercise for Chapter 12: Supply-chain Controls
PRODUCT(S): Fettuccini Marinara with Broccoli, Ready to Cook PAGE 1 of 17
PLANT NAME: FSPCA Exercise Version ISSUE DATE 2/25/2016


Food Safety Plan
for
Fettuccini Marinara with Broccoli
Ready to Cook

Teaching Example
exercises. It is not complete and contains both required and optional information.
can be used in a specific facility without significant modification. Conditions and specifications
used (e.g., validation information) are for illustrative purposes only and may not represent actual
process conditions.


Table of Contents
Flow Diagram ................................................................................................................................ 4
Receiving Ingredients and Packaging: ...................................................................................... 5
Storing Ingredients and Packaging: .......................................................................................... 5
Cook pasta ................................................................................................................................ 5
Cool, drain pasta ....................................................................................................................... 6
Mix all ingredients ...................................................................................................................... 6
Fill, weigh, label ......................................................................................................................... 6
Metal detection: ......................................................................................................................... 6
Freezing .................................................................................................................................... 6
Cartoning ................................................................................................................................... 6
Frozen finished product storage ................................................................................................ 6
Frozen product shipping ............................................................................................................ 6
Hazard Analysis ............................................................................................................................ 7
Process Controls......................................................................................................................... 11
Undeclared Allergens –Wheat or milk ..................................................................................... 12
Hygienic Zoning/ Environmental Monitoring ............................................................................ 14
Environmental Monitoring for Sanitation Preventive Control Verification ................................ 15
Supplier Program for Preventive Controls .................................................................................. 16
Spices...................................................................................................................................... 16
Pasta ....................................................................................................................................... 16

Company Overview
This example company is a small firm that makes a variety of frozen entrees that are intended
to be cooked prior to consumption. Products include:
 Fettuccini Marinara with Broccoli,
 Shrimp and Angel Hair Pasta
 and Pasta Primavera.
Product is made 5 days a week in one 8 hour production shift, followed by 4 hours for sanitation.
An integrated pest control program is also in place.
This Food Safety Plan covers production of Fettuccini Marinara with Broccoli, but parts of it
(e.g., pasta cooking) apply to other products as well.
Product Description
Product Name(s) Fettuccini Marinara with Broccoli Meal
Product Description, including Fettuccini Marinara with Broccoli is a frozen, ready-to-cook
Important Food Safety meal packed in a plastic tray and sealed with a transparent
Characteristics film. The frozen product is placed in a box and
warehoused, distributed and retailed frozen.
Ingredients Cooked enriched pasta (wheat), Marinara sauce (tomato

sauce, spices), Romano cheese, salt, spices and broccoli.
Packaging Used 8" plastic tray with clear film overwrap inside pre-printed
carton. 10 ounces serving size.
Intended Use Fully cook before serving (NRTE- not ready to eat)
Shelf Life 1 to 2 years frozen
Labeling Instructions Keep frozen. Microwave cooking instructions. Allergen

labeling.
Storage and Distribution Frozen storage and retail distribution
Approved: Date:
Signature: F.S. Leader 23 February 2016

Flow Diagram
Receiving Receiving shelf stable Receiving frozen Receiving refrigerated
packaging ingredients ingredients ingredients
[trays, film, carton,
[pasta, salt, sauce, spices] [frozen broccoli] [Romano cheese]
case]
   
Packaging Shelf stable ingredient Frozen ingredient Refrigerated ingredient
storage storage storage storage

Open
Cook pasta, drain  Water
cans [water, salt, pasta]
[sauce]

Cool pasta, drain
[pasta, water]

Mix all ingredients
[sauce, spices, cheese, frozen
broccoli, pasta]

Fill, heat seal film,
weigh

Metal detection

Freezing

Label/carton

Frozen product
storage

Frozen product
shipping

Process Narrative
Receiving Ingredients and Packaging:
Ingredients and raw materials are purchased from a broker that offers products only from
suppliers complying with internationally recognized food safety and quality schemes. Ingredients
are stored appropriately according to manufacturers’ requirements.
 Receiving packaging: Pre-labeled cartons, 10oz. plastic trays, heat sealable film, and
cases are received in bulk. Labeled cartons are reviewed for conformance with product
allergen requirements and ingredients. Specifications require food grade material
compatible for frozen food and microwavable products.
 Receiving shelf stable ingredients:
o Wheat pasta: Received dry from sole source broker.
o Salt: Received in bags from sole source broker. Specifications require food grade
salt.
o Tomato sauce: Received as a shelf stable product in metal #10 cans from sole
source broker.
o Spices (pepper and garlic powder): Received from sole source broker. Specifications
require the garlic powder and pepper to undergo microbial reduction treatments for
vegetative pathogens.
 Receiving refrigerated ingredients: Shredded, aged Romano cheese received from
sole source broker in bags.
 Receiving frozen ingredients:
o Individually quick frozen, blanched broccoli is received from sole source broker. For
this ingredient, the broker’s letter of guarantee states that the supplier complies with
21 CFR part 117, that is subpart B, GMPs; subpart C, Hazard Analysis and Risk-
based Preventive controls; and subpart G, Supply-chain program were followed. The
supplier also obtained an audit to verify that the farm followed the requirements
outlined in 21 CFR part 112 (Produce Rule) for growing and harvesting the broccoli.
Storing Ingredients and Packaging:
 Packaging storage: Cartons, trays, film and cases are stored in the dry storage room in
the packaging area, arranged by product code to avoid mixing of packaging. Packaging
is used First-In-First-Out and partially used carton cases are closed during storage.
 Dry ingredient storage: Tomato sauce, pasta, salt, and spices are stored in the dry
storage room in the ingredient area, arranged by ingredient code number. All containers
are sealed to avoid food allergen cross-contact and cross-contamination during storage.
Ingredients containing food allergens are identified and stored in specific locations with
like allergenic ingredients, unless allergen cross-contact is not foreseeable.
 Frozen ingredient storage: After receipt, frozen broccoli and ice are taken to the frozen
storage area (≤0°F) and used on a First-In-First-Out basis. Broccoli in not thawed before
use.
 Refrigerated ingredient storage: Cheese is stored in a cooler that is kept at ≤40°F and
used on a First-In-First-Out basis.
Open cans: Sauce cans are opened using a mechanical can opener. Periodically, metal
shavings have been observed. Preventive maintenance is used to examine and adjust the can
openers on a periodic basis.
Water: Water is treated and tested per EPA requirements by the city and used as needed.
Cook pasta, drain: Salt is added to water in a steam jacketed kettle and is brought to boiling.
The pasta is added to boiling water and cooked for at least 15 minutes to achieve acceptable
product quality. Product temperature exceeds 165°F in this processing time. Only pasta is
processed in the pasta cook area. The kettle is drained; cooked pasta is retained in the kettle.
Cool pasta, drain: Potable cold water is used to cool the drained pasta. Cold water
temperatures are 50-55°F depending on the season. Pasta is cooled by running cold water
through it. Generally the pasta is cooled to the cold water temperature in <30 minutes from the
time the boiling water was drained, but this depends on the cooling water temperature and the
time it takes for staff to begin the cooling process. Cooled pasta is drained and transferred to
the area where it is mixed with other ingredients.
Mix all ingredients: Dry ingredients are blended with tomato sauce and cheese to distribute
spices just prior to adding cooked pasta and frozen broccoli using a blender to gently blend to a
uniform mixture. A batch of cooled, drained pasta is mixed with other ingredients in <30 minutes
after delivery to the mixing area or sticking will occur. The blended ingredient temperature is
typically below ambient after mixing.
Fill, heat seal film, weigh: 10 oz. trays are filled, a film is heat sealed to close the tray and
trays are weighed.
Metal detection: Sealed trays are passed through a metal detector.
Freezing: Packaged product passes through a freezer tunnel. Product temperature is ≤0°F in
20 minutes.
Label/Carton: Frozen, sealed trays are placed in labeled cardboard cartons and are boxed in
cases – 12 per case. Carton has ingredient and allergen information that declare the wheat and
milk allergens. Labels on cartons are matched to the specific description and product number as
listed on the Daily Production Schedule.
Frozen product storage: Finished product is transferred to frozen storage (≤0°F).
Frozen product shipping: Product is shipped in freezer trucks to customers (convenience
stores, office cafeterias, quick serve restaurants and grocery stores) under frozen conditions
(≤0°F).

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.
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)
Processing Step safety hazards potential measure(s) can be applied preventive
introduced, controlled food safety to significantly minimize control
or enhanced at this hazards or prevent the food safety applied at
control? Allergen, Sanitation,
Yes No Supply‐chain, other Yes No
preventive control
Receiving B None
packaging C Undeclared X Labels on cartons must declare Allergen Control for X
allergens allergens present in the product label review by
and print errors have occurred qualified individual
P None
Receiving B Sporeforming X B. cereus spores may be present Subsequent cooling X
shelf stable pathogens such in dry pasta and outbreaks due step prevents B.
ingredients – as B. cereus to growth after hydration have cereus growth and
pasta occurred. Levels present at toxin formation in
receiving are not hazardous and rehydrated pasta.
will not change as long as the
pasta is dry.
Vegetative X Salmonella may be present in
pathogens such pasta at a very low frequency
as Salmonella and subsequent cooking is more
than adequate to destroy it
Staphylococcus X S. aureus can form heat stable Supply-chain Control X
aureus toxin during pasta production at is essential to prevent
enterotoxin the supplier without preventive S. aureus enterotoxin
control. prior to receipt.
C Allergen – wheat X Wheat is an allergen and could Allergen Control for X
contribute to cross-contact for cross-contact
other products that do not prevention and
contain wheat. allergen labeling at a
later step
P None
Receiving B None
shelf stable C None
ingredients – P None
salt
Receiving B None Low pH, shelf-stable product is
shelf stable not likely to have biological
ingredients – hazards
tomato C None
sauce P None

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

preventive control
Receiving B Vegetative X Salmonella has been known to Supply-chain Control X
shelf stable pathogens occasionally contaminate spices. – pathogen reduction
ingredients – (Salmonella) Treated spices are used so this treatment for these
spices is unlikely. ingredients
(pepper, Pathogenic X C. perfringens and B. cereus
garlic) sporeformers (C. spores may be in spices but
perfringens, B. cannot grow in the dry spice or in
cereus) the sauce during processing
time, especially given the acid
pH of the tomato sauce.
C None
P None
Receiving B Vegetative X Bacterial pathogens may be Supply-chain Control X
frozen pathogens such present in raw produce. Supplier – Blanching and
ingredients – as L. determined that their blanching environmental
broccoli monocytogenes, process is adequate to destroy sanitation controls
Salmonella vegetative pathogens, but reduce vegetative
recontamination can occur if pathogens and
sanitation controls are not in freezing prevents
place. Freezing prevents growth. pathogen growth.
C Pesticides X Ingredient is US-sourced and
FDA data show that unapproved
pesticides or residues above
EPA tolerance levels are rare.
P None
Receiving B Vegetative X Processing and fermentation Supply-chain Control X
refrigerated pathogens such practices influence the potential – processing and
Romano as Salmonella, for pathogen presence and fermentation
cheese Staphylococcus growth, which must be controlled procedures to control
aureus and by the supplier hazards
pathogenic E.
coli
C Allergens X Cheese is a source of milk Allergen Control for X
allergens and could contribute to cross-contact
cross-contact for other products prevention and
that do not contain milk. allergen labeling at a
later step
P None
Packaging B None
storage C Allergen cross- X Plant- specific GMPs allow only
contact during sealed containers of allergenic
storage ingredients in dry storage, thus
cross-contact unlikely
P None
Continued

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

preventive control
Shelf stable B None
ingredient C Allergen cross- X Plant-specific GMPs allow only
storage contact during sealed containers of allergenic
[pasta, storage ingredients in dry storage, thus
sauce, salt, cross-contact unlikely
spices] P None
Frozen B None
ingredient C None
storage P None
[broccoli]
Refrigerated B None
ingredient C Allergen cross- X Only closed containers of
storage contact during allergenic ingredients are stored
[cheese] storage in this storage area.
P None
Open cans B None
[sauce] C None
P Metal shavings X Preventive maintenance is Process control – X
applied, however metal shavings subsequent metal
are observed from time to time detection
Cook pasta, B None Validation data demonstrated
drain that for pasta, temperatures
achieved during the cooking
process (boiling water for ≥15
minutes) to achieve a palatable
texture far exceed those needed
to destroy vegetative pathogens.
C Allergen – wheat X Kettles used only for cooking
wheat pasta, which prevents
cross-contact to other foods
prepared in facility.
P None
Water B None Water is treated and tested per
C None EPA requirements by the city
P None
Cool pasta, B Sporeforming X Spores may survive cooking. Process Control – X
drain pathogens such Growth and toxin production Time and
as B. cereus could occur during slow cooling. temperature control
for cooling pasta
C Allergen X Kettles used only for cooking
wheat pasta, which prevents
cross-contact to other foods
P None
Continued

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

preventive control
Mix all B Environmental X Recontamination may occur if Sanitation controls X
ingredients pathogens such environmental control is not in verified by
as L. mono. place environmental
monitoring1, 2
C None
P Metal X Mixing metal on metal contact Process Control – X
may periodically produce metal metal detection at a
hazards. later step
Fill, heat seal B Environmental X Recontamination may occur if Sanitation Controls X
film, weigh pathogens such environmental control is not in verified by
as L. mono. place environmental
monitoring
C None
P None
Metal B None
detection C None
P Metal X Opening cans and mixing metal Process Control – X
on metal contact may metal detection
periodically produce metal
hazards.
Freezing B Growth of X Product is frozen in under 1 hour
environmental and pathogens won't grow in
pathogens and frozen product. As per SOPs,
pathogenic freezer is cleaned and
sporeformers maintained to be in sanitary
condition.
C None
P None
Label/carton B None
C Undeclared X Product contains wheat and milk Allergen Control – X
Allergens – allergens declaration on label
wheat, milk
P None
Frozen B None
product C None
storage P None
Frozen B None
product C None
shipping P None
1
Sanitation Controls to include equipment cleaning, zoning and employee practices to prevent cross
contamination.
2
Some facilities may conclude that a preventive control is not needed because the product is not ready-
to-eat

Process Controls
Process Hazard(s) Critical Monitoring Corrective Action Verification Records
Control(s) Limits
Cool Growth of Chill pasta Pasta Recording Every Cook or If temperature is not Daily review of Pasta cooling
pasta, spore- to 50°F or temperature thermometer batch designee achieved in the Pasta Cooling log
drain formers less within 4 and time that is specified time, then log by
such as B. hours or placed 1) add more cold Supervisor. Thermometer
cereus less directly in water or ice to calibration
pasta achieve Accuracy of records
temperature; thermometer
checked Verification
2) segregate
weekly by QA records
product, evaluate
Tech.
product, rework or
discard as Validation
Quarterly report for
appropriate,
thermometer determining
2) identify root calibration critical limit
cause;
cooling
3) conduct training parameters
to prevent
recurrence Corrective
action log
Metal
detection
See Food Safety Plan in curriculum for an example
of potential wording for metal detection. Parameters
can vary depending on the product, packaging,
detection system, etc.

Allergen Hazard(s) Criteria Monitoring Corrective Action Verification Records

Controls
Receiving Undeclared Presence of Label Visual Each receipt Label If allergen statement is QA manager reviews Allergen label
packaging allergen - allergens in matches inspection to before coordinator incorrect: and initials records receiving
Wheat or milk formulation on product product release to 1) segregate and block weekly and compares inspection log
labels received number specification production packaging stock; results with past
and information to Corrective action
2) Contact supplier for return, records
declares determine any trends.
identification of root cause, and
milk and
delivery of new labels Verification
wheat
records
Label/ Undeclared Correct labels Label Visual At the Packaging If label is incorrect: QA manager reviews Allergen Label
carton Allergens – applied to matches inspection beginning line worker 1) segregate product, and initials records Check log
step Wheat or finished product of one and end of inspect back to the last good weekly and Verification
allergen milk product using number finished each check, re-package in compares results records
labeling labeled product packaging cartons with correct label, or with past testing to
Corrective
cartons sample to run, and discard product; determine any
action records
ensure each new trends.
proper case of 2) identify root cause;
allergen containers
labeling 3) conduct training as
information appropriate
on label

Fettuccini Marinara with Broccoli Contains: Wheat, milk
Shrimp and Angel Hair Pasta Contains: Wheat, shrimp
Pasta Primavera Contains: Wheat


Shellfish
Tree Nut
(market
(market
(market
Peanut
Wheat
name)
name)
name)
Fish
Milk
Egg
Soy
Production
Product Name Line
Fettuccini Marinara with Broccoli 1 X X
Shrimp and Angel Hair Pasta 1 X Shrimp
Unique
allergen
Pasta Primavera 1 X X
Scheduling Implications: Shrimp and Angel Hair Pasta contains a unique allergen (shrimp) and does not contain the milk allergen present in other
products.
Allergen Cleaning Implications: Fettuccini Marinara with Broccoli and Pasta Primavera can be run in any order. An allergen cleaning is required before
and after any Shrimp and Angel Hair Pasta run.


NOTE: See Food Safety Plan in curriculum for an example of potential wording for cleaning and
sanitation procedures to prevent allergen cross-contact from seafood containing product. Parameters
can vary depending on the product, equipment, etc.
Hygienic Zoning/ Environmental Monitoring
Purpose: Hygienic zoning in is important to minimize the potential of re-contamination with environmental
pathogens. Verification is by environmental monitoring. (See Environmental Monitoring for Sanitation Preventive
Control Verification)

Who: Employees and other individuals entering the Mixing and Fill areas (in pink above)
Procedure: Employees entering the Mixing and Fill areas must (in the order listed):
1. Take a clean, blue smock from the rack outside the production area and put them on. Smocks
must cover outer clothing that would be above the processing line.
3. Take a blue hairnet from the box by the entry and put it on. Ensure that all loose hair is
captured. Men with facial hair should also apply beard nets.
4. Wash hands just before entering the area following the procedures posted by the sink. Apply a
clean pair of gloves.
5. When exiting the room deposit smocks, shoe covers and hair nets in the receptacles provided.
DO NOT reuse disposable items after entering uncontrolled areas.
Maintenance workers and visitors must use follow the above procedures but use white foot covers
and clean white smocks when entering this area. Traffic in this area is minimized during production.
Monitoring: The sanitation supervisor visually observes the presence of the properly smocked
employees, before start up and after lunch break, and every 2 hours.
Records: Daily Hygienic Zoning Record, Environmental Monitoring Sampling Record and lab results
Verification: Environmental monitoring for verification of sanitation control and records review within
one week

Purpose: Environmental monitoring is conducted to verify the effectiveness of sanitation and hygienic
zoning procedures in the “Mixing” and “Fill” areas to control environmental pathogens such as
L. monocytogenes.
Sample identification: Based on observation when sampling, “worst case” areas are sampled; e.g.,
standing water or product residue, around table legs, crevasses major traffic areas. Record the
specific location sampled.
Sampling procedure: Every other week, sponge swabs are collected during production at least 3
hours after production starts. Sampling time is not uniform to avoid bias of results. Samples
are shipped to the laboratory using the sampling kit provided by the laboratory. Samples are
refrigerated and shipped in an insulated cooler with a gel pack with next day delivery. Samples
are NOT frozen.
The following number of samples collected each time.
 3 in Assembly area
 3 in Fill, weigh, label area
 1 in the hallway at the entry of the assembly area
 3 other samples based on observed conditions
using XYZ3 procedures. Analysis is started within 48 hours of sampling.
Test conducted: For routine samples, the contract lab composites sponges from the same area to
run as one test for Listeria species. Investigation samples must be run individually. The test
Acton for a negative result – Continue routine operations
Corrective action for a positive result:
1. If a composite is positive, the positive areas are re-sampled within a day of notification and
prior to implementing intensive sanitation procedures. Additional samples (number depends on
size of area) are taken in other potential problem areas in an attempt to identify a site of
contamination. All samples are run individually, without compositing.
2. Intensive sanitation procedures are implemented after sampling is complete.
3. Production can continue after sanitation is complete and product can be shipped.
4. If all re-samples are negative, resume the normal sampling frequency.
5. If one or more re-samples are positive, perform corrective action investigation to resolve the
issue. Implement a hold and finished product testing procedure per the Product Testing for
Verification corrective action protocol.
3
XYZ would be a scientifically valid method, such as AOAC, ISO, FDA, etc.

Supply‐chain‐applied Preventive Controls Program

Determination of Verification Procedures
Spices
Hazards requiring a supply-chain-applied control: Hazard analysis determined that vegetative
pathogens, such as Salmonella, are hazards requiring a preventive control for spices because our
process does not have a kill step.
Preventive controls applied by the supplier: The spice treatment process should kill the
vegetative pathogens.
Verification activities: A 3rd party supplier audit by a qualified auditor is used to verify control of
the identified hazards by the supplier.
Verification procedures: A copy of a 3rd party audit is requested from the supplier on an annual
basis. The audit date, auditor qualifications, audit procedures and audit results are reviewed.
Follow up discussion 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.
Records: A copy of the audit report and verification of corrective actions taken by the supplier are
maintained in the Supplier Verification file.
Pasta
Hazards requiring a supply-chain-applied control: Hazard analysis determined that
Staphylococcus aureus can form heat stable toxin during pasta production at the supplier without
preventive control.
Preventive controls applied by the supplier: The supplier must be aware of the potential hazard
and manage processing conditions to prevent toxin production by S. aureus.
Verification activities: Same as for Spices.
Verification procedures: Same as for Spices.
Records: Same as for Spices.
Romano cheese
pathogens such as Salmonella, Staphylococcus aureus and pathogenic E. coli are hazards
requiring a preventive control during cheese manufacture by the supplier.
Preventive controls applied by the supplier: The supplier must be aware of the potential hazard
and manage processing conditions to prevent toxin production by S. aureus and occurrence of
Salmonella and pathogenic E. coli.
Frozen broccoli
pathogens, such as L. monocytogenes and Salmonella, are hazards requiring a preventive control
for frozen broccoli because our process does not have a kill step.
Preventive controls applied by the supplier: Blanching reduces vegetative pathogens, freezing
prevents pathogen growth and environmental sanitation minimizes recontamination of the broccoli.


Ingredient Approved Hazard(s) requiring Date of Verification Verification
(requiring Supplier supply-chain- Approval method records
supply-chain- applied control
applied control)
Spices Spicetown Vegetative 10/08/2010 Copy of 3rd Copy of
Co., Port, pathogens such as party audit by audit kept
USA Salmonella a qualified in Supplier
Pasta MajorCo, Staphylococcus 9/9/2009 auditor Verification
Wheaton, aureus obtained from file
USA supplier Incoming
Romano Big Cheese Vegetative 1/21/2009 goods log
cheese Co., pathogens such as
Cheesytown, Salmonella, S.
USA aureus and
pathogenic E. coli
Frozen USGrown Vegetative 2/22/2009
broccoli Co., pathogens, such
Farmvalley, as L.
USA monocytogenes
and Salmonella
Receiving Procedure for Ingredients Requiring a Supply-chain-applied Control

For each shipment received, the receiving clerk:
 documents the above in the incoming goods log.

PRODUCT(S): Peanut Butter PAGE 1 of 16

Food Safety Plan
for
Peanut Butter

Teaching Example
operation. Many processing steps were omitted or combined to facilitate its use for class exercises. It is
not complete and contains both required and optional information.
Because development of a Food Safety Plan is site specific, it is highly unlikely that this plan can be
used in a specific facility without significant modification. Conditions and specifications used (e.g.,
validation information) are for illustrative purposes only and may not represent actual process
conditions.


Table of Contents
Company Overview ...................................................................................................................................3
Product Description...................................................................................................................................3
Flow Diagram ............................................................................................................................................4
Process Narrative .....................................................................................................................................5
Receiving packaging material ...............................................................................................................5
Receiving shelf stable ingredients .........................................................................................................5
Packaging storage.................................................................................................................................5
Non-peanut ingredient storage ..............................................................................................................5
Raw peanut storage ..............................................................................................................................5
Raw peanut cleaning .............................................................................................................................5
Roasting ................................................................................................................................................5
Cooling ..................................................................................................................................................5
Grinding .................................................................................................................................................6
Mixing all ingredients .............................................................................................................................6
Cleaning jars .........................................................................................................................................6
Fill, weigh, seal ......................................................................................................................................6
Label, code ............................................................................................................................................6
Metal detection ......................................................................................................................................6
Casing ...................................................................................................................................................6
Dry storage ............................................................................................................................................6
Shipping ................................................................................................................................................6
Hazard Analysis ........................................................................................................................................7
Process Preventive Controls ...................................................................................................................10
Allergen Preventive Controls ..................................................................................................................11
Allergen Declaration on Packaged Product .........................................................................................11
Allergen Scheduling Implications ........................................................................................................12
Sanitation Preventive Controls ................................................................................................................13
Hygienic Zoning...................................................................................................................................13
Environmental Monitoring for Sanitation Preventive Control Verification ............................................15
Supply-chain Preventive Controls Program ............................................................................................16
Determination of Verification Procedures ............................................................................................16
Approved Suppliers for Ingredients Requiring a Supply-chain-applied Control ..................................16

Company Overview
This example company is a small firm that makes a variety of peanut butter products, including creamy,
chunky and extra chunky peanut butter, and peanut butter with chocolate swirl spread.
 Product is made 5 days a week in one 8 hour production shift, followed by 4 hours for sanitation. A
sanitary facility program is in place, with dry cleaning procedures enforced in most production areas
of the facility to minimize establishment of environmental pathogens. A separate wet-washing room
is used for washing, drying and sanitizing small equipment.
 Regular and frequent roof integrity inspections are conducted because the root cause of a previous
Salmonella contamination event was traced to water infiltration into the facility through a roof leak.
 Water is treated and tested per EPA requirements by the city. An integrated pest control program is
also in place.
This Food Safety Plan covers production of peanut butter products except for the Peanut Butter
Chocolate Swirl product, which has a separate Food Safety Plan.
Product Description
Product Name(s) Peanut Butter – Creamy, Chunky and Extra Chunky
Product Description, including Peanut butter with varying sizes of peanut particulates
Important Food Safety depending on the variety.
Characteristics aw < 0.35
pH about 6.3
Ingredients Peanuts, sugar, hydrogenated vegetable oil and salt
Packaging Used Plastic container, paper / foil induction lid-stock, plastic

closure. The headspace of jars is flushed with nitrogen (N2)
prior to sealing to delay organoleptic deterioration.
Intended Use The product is ready-to-eat
Shelf Life Nine months ambient, unopened
Labeling Instructions Contains peanuts
Storage and Distribution Ambient
Approved: Date:
Signature: F.S. Leader 8 August 2015

Flow Diagram
Receiving packaging Receiving shelf stable
material ingredients Raw peanut receiving
(jars, lids, labels) (Sugar, vegetable oil, salt)
  
Non-peanut ingredient
Packaging storage Raw peanut storage
storage (ambient < 70%RH)
(sugar, vegetable oil, salt)

Raw peanut cleaning

Roasting1
(300oF / 25 min dry)

Cooling

Mix all ingredients
(peanut paste, sugar, vegetable oil,  Grinding
salt)

Cleaning jars
(invert and flush with filtered  Fill, weigh, seal
air)

Label, code

Metal detection

Casing

Dry storage

Shipping

1
Typically, a blanch step occurs after roasting. The blanch step is omitted from this model for simplicity.

Process Narrative
Receiving packaging material
Corrugated shippers, shrink film, plastic containers, plastic lids and labels are received
individually cased. Specifications require food grade material for packaging material that is
compatible with ambient storage of food products. Vendors provide a certificate of conformance
that packaging materials and inks meet food safety and regulatory requirements.
Sugar and salt are received in 50 lb. bags. Hydrogenated vegetable oil (rapeseed and refined
soy) are received in 5 gallon plastic pails. Nitrogen is received in gas cylinders and a certificate
of analysis (COA) is provided to ensure it is food grade.
Shelled peanuts are received on trucks from several sheller locations. Each sheller is required
to submit a COA for aflatoxin and indicating the product meets edible grade standards. The
aflatoxin specification is <15 parts per billion (ppb) average maximum for subsamples with no
individual reading >25 ppb. Control of extraneous material (shells, stems, skins, stones, plastic
metal, etc.) in peanuts is a primary responsibility of suppliers, who have systems to sort and
inspect peanuts prior to shipment.
Packaging storage
Corrugate, shrink film, plastic containers, plastic lids and labels are stored in a dry storage area
and segregated from raw food material. Packaging is used on a First-In-First-Out basis.
Non-peanut ingredient storage
Sugar, hydrogenated vegetable oil and salt are received and stored at ambient conditions in an
area separate from raw peanuts. These materials are used on a First-In-First-Out basis.
Raw peanut storage
Raw peanuts are stored in a segregated area at ambient temperature and <70% relative
humidity. Raw peanuts are used on a First-In-First-Out basis.
Raw peanut cleaning
Prior to roasting, shelled raw peanuts are visually inspected and passed over a vibratory
conveyor to remove residual foreign material, including sticks, rocks or metal pieces. A HEPA-
filtered air stream is used to remove light extraneous material such as shell fragments.
Roasting2
Peanuts are conveyed through a roaster in a continuous process that applies forced heated air
uniformly from above and below the peanut bed. The bed is kept at an even depth of two inches
through the use of a leveling device. The peanuts are exposed to minimum of 300oF for 25
minutes. Air velocity and circulation are maintained to ensure adequate time and temperature in
all areas of the oven including “cold spots.” A process validation study performed on this specific
process equipment demonstrated that these conditions provide a minimum 5-log reduction of
Salmonella. The bed depth, time and temperature are all monitored during peanut roasting.
Cooling
Roasted peanuts are cooled under ambient conditions prior to grinding.
2
Typically, a blanch step occurs after roasting. The blanch step is omitted from this model for simplicity.

Grinding
Peanuts are conveyed across a magnet to a grinder where the peanuts are coarse ground to a
paste consistency.
Mixing all ingredients
The peanut paste is pump-conveyed to a mixer to which sugar, salt and oil are added. The
batch is mixed until ingredients are adequately dispersed.
Cleaning jars
Inverted jars are blown with HEPA-filtered, de-ionized air to remove foreign material prior to
filling.
Fill, weigh, seal
Peanut butter is dispensed into cleaned jars to the appropriate fill weight. Nitrogen is injected
into the headspace after filling, thin foil induction seal (compatible with metal detection) and the
plastic caps are applied. NOTE: The swirl product uses a different filler head that incorporates
the chocolate into the product at this step.
Label, code
Immediately after the capping, the lot identifier code is printed on each jar and labels are
applied. Labels are checked prior to adding to the labeler to ensure the correct label is used.
The label contains an allergen declaration statement that this product contains peanuts.
Metal detection
The product is passed through a metal detector. Rejected product is examined to isolate metal,
determine its source, and direct corrective action.
Casing
Jars are placed by hand into corrugate cases, with 12 jars per case. Cases are sealed and
coded with lot information.
Dry storage
Finished product is stored ambient warehouses until distributed.
Shipping
Product is shipped in ambient trucks to customers.

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.
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
(1) (2) (3) (4) (5) (6)
Ingredient/ Identify potential Do any Justify your decision for column 3 What preventive control Is the
Processing food safety hazards potential food measure(s) can be applied to preventive
Step introduced, safety hazards significantly minimize or control
controlled or require a prevent the food safety applied at
enhanced at this step preventive hazard? this step?
control? Process including CCPs, Allergen,
Yes No Sanitation, Supply‐chain, other Yes No
preventive control
Receiving B None
packaging- C None
jars and lids P None
Receiving B None
packaging - C Undeclared X Product contains peanut as an Allergen control –Label X
labels allergen (peanut) ingredient review upon receipt for
correct allergen information
P None
Receiving B None
non-peanut C None
ingredients P None
– salt,
sugar, oil
Receiving B Non- X Raw peanuts have a history of Process control – X
raw peanuts sporeforming contamination with vegetative Subsequent roasting
pathogens such pathogens from the environment or destroys Salmonella
as Salmonella harvesting
C Aflatoxin X Aflatoxin may be present due to Supply-chain Control - X
growth of Aspergillus flavus during Verification of supplier
growth, harvesting or storage. Certificate of Analysis
Unapproved X Unapproved pesticides may be
pesticide present in imported peanuts but
are less likely in domestically
sourced peanuts. Domestic
peanuts are used
P Foreign material X Grinding and milling would reduce
e.g., wood, metal, the size to a non-hazardous
plastic, stones nature. Supplier controls these to
prevent adulteration and potential
equipment damage.
Packaging B None
storage C None
P None
Non-peanut B None
ingredient C None
storage P None
continued

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

preventive control
Raw peanut B None
storage C Aflatoxin X The dry conditions and short
storage time prevents production
of aflatoxin
P None
Raw peanut B Environmental X Raw peanuts nuts may contain Sanitation control – Hygienic X
cleaning pathogens such Salmonella than can contaminate zoning needed to contain
as Salmonella the environment potential Salmonella in this
pre-roast area
C None
P Foreign material; X Grinding and milling would reduce
e.g., wood, metal, the size to a non-hazardous nature
plastic, , stones or material would damage
equipment to prevent processing
Roasting B Non- X Non-sporeforming pathogens may Process control – Roasting X
sporeforming be present in the raw peanuts step destroys Salmonella by
pathogens such thermal treatment
as Salmonella
C None
P Foreign material - X Data from subsequent metal
metal detection demonstrates that metal
fragments originating from the
roasting rarely occur due in part to
preventive maintenance
Cooling B Environmental X Salmonella harbored in the Sanitation control – Zoning X
pathogens such environment could contaminate and dry cleaning procedures
as Salmonella exposed product in cooling
C None
P None
Grinding B Environmental X Salmonella harbored in the Sanitation control – Zoning X
pathogens such environment could contaminate and dry cleaning procedures
as Salmonella exposed product
C None
P Foreign material - X Metal fragments could be Process control – Metal X
metal generated during the grinding detection at later step
process
Mixing all B Environmental X Salmonella harbored in the Sanitation control – Zoning X
ingredients pathogens such environment could contaminate and dry cleaning procedures
C None
P Foreign material - X Metal fragments could be Process control – Metal X
metal generated during the mixing detection at later step
process. Preventive maintenance
reduces the occurrence.
continued

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

preventive control
Cleaning B Environmental X Air filter that traps Salmonella is in
jars pathogens such place and on a preventive
as Salmonella maintenance program, which
eliminates the potential for
contaminated air being used.
C None
P None Cleaning of jars has not detected
any hazards using current
packaging material
Fill, weigh,B Environmental X Salmonella harbored in the Sanitation control – Zoning X
seal pathogens such environment could contaminate and dry cleaning procedures
C Undeclared milk X Chocolate spread, which is also Allergen control –Dedicated X
allergen from produced in the facility, contains filler for milk-containing
chocolate spread milk, which is a food allergen. products to prevent cross-
product contact
P None
Label, code B None
C Undeclared X It is essential that the correct label Allergen control – Allergen X
allergen - peanut is on the package to inform allergic label verification
consumers
P None
Metal B None
detection C None
P Foreign material - X Metal could be present in the raw Process control – metal X
metal materials, generated from detection
equipment or introduced by
employees
Casing B None
C None
P None
Dry storage B None
C None
P None
Shipping B None
C None
P None


Monitoring
Process Critical
Control(s) Hazard(s) Limits What How Frequency Who Corrective Action Verification Records
Roasting Non- Minimum Length of Measure time-Beginning of Roaster If roasting is Operator verifies the Roasting log,
sporeforming roast time: roast cycle in to time-out
shift and after operator interrupted, product roaster bed depth, including time,
pathogens 25 minutes with stop any is held and temperature and roasting temperature
such as watch and adjustment evaluated to time are accurate and and depth
Salmonella metal test unit determine if it can operating properly during records.
run through be re-processed. the processing run once Recording
oven If a processing each day during morning device
parameter was not shift. calibration
met, reprocess QA manager reviews and records.
Bed depth Bed depth Leveling bar Check at
batch using initials records within a Corrective
≤2 inches leveling bar height is set at startup and
alternate validated week of preparation and action logs.
height 2 inches high end of day
process; identify compares performance
at oven inlet Validation
root cause and with past results to
study
determine actions determine trends.
establishing
needed to address Maintenance manager
Oven Oven air Recording Continuous roasting
it; conduct training ensures that roaster and parameters
temperature temperature thermometer with visual
as needed to monitoring equipment are
minimum at the coldest check of
prevent recurrence. calibrated.
300oF locations (i.e., recorded data
inlet and outlet at start-up and Also segregate and Finished product tested for
Note: to of oven) once per day evaluate product, Enterobacteriaceae once
achieve 5 at each rework or discard every 2 weeks. Salmonella
log location as appropriate. is analyzed if hygiene
reduction of Enterobacteriaceae counts
Salmonella are found out of
specification.
Metal
Detection See Food Safety Plan in curriculum for an example for potential wording
for metal detection. Parameters can vary depending on the product,
packaging, detection system, etc.


Allergen Declaration on Packaged Product
Monitoring
Allergen Corrective
Hazard(s) Criterion Verification Records
Controls What How Frequency Who Action
Receiving Undeclared Correct Presence of Visual Each Label Reject label, Label coordinator Product label
packaging allergen ingredient and peanut in inspection to batch of coordinator request verifies declared review form.
material - (peanuts) allergen ingredient ensure all printed replacement allergens match Ingredient
Labels information is list and allergens in labels with correct current formula formula
printed on the “contains” the formula are before information monthly and each Corrective
label statement on on the label release to from label formula change. action records
label production printer. Preventive
Controls
Qualified Individual
or designee
reviews records
within 7 working
days.
Label Undeclared Correct labels Correct label Visual Each time Operator Return Verify label review Allergen label
verification – allergen are loaded into is loaded inspection labels are material to procedure check log
Label, code (peanuts) labelling onto loaded warehouse,
step equipment labelling onto request correct Review records to Production
equipment machine labelling. evaluate trends deviation log

Plain, Chunky, and Extra Chunky Contains: Peanut
Peanut Butter Chocolate Swirl Contains: Peanut, milk


Shellfish
Tree Nut
(market
(market
(market
Peanut
Wheat
name)
name)
name)
Fish
Milk
Egg
Soy
Production
Product Name Line
Plain, Chunky and Extra Chunky Peanut Butter 1 X
Peanut Butter Chocolate Swirl 1 X X
(same line Unique
but different allergen
filler head)
Scheduling Implications: Plain, Chunky and Extra Chunky flavors can be run in any order, depending on demand. Do NOT use the Peanut Butter
Chocolate Swirl filler for these products 1) to prevent cross-contact with milk allergen in the chocolate and 2) to avoid the swirl pattern in the filled container.
Standard practice is to run the Peanut Butter Chocolate Swirl in the end of the shift and use the filler* dedicated to the chocolate swirl product.
Allergen Cleaning Implications: Dry cleaning procedures must be used in all production areas. If peanut-only filler head is mistakenly used for Peanut
Butter Chocolate Swirl product, dismantle filler and remove parts for wet washing in the isolated wet wash room.
Allergen Scheduling Implications

Monitoring
Allergen Corrective
Controls Hazard(s) Criterion What How Frequency Who Action Verification Records
Dedicated Undeclared Peanut- Only peanut Visual Beginning Line operator Segregate all QA manager Filler check log
filler for milk- milk dedicated filler – dedicated observation of shift and product back reviews and initials Corrective
containing allergen is in place filler is used that the correct at each to last good records within a action records
products to from for peanut filler is in place formula check. Discard week of
prevent chocolate only change or rework into preparation
cross-contact spread products peanut
product chocolate swirl Review records to
product. evaluate trends
Replace
correct filler.
Determine why
wrong filler
was used and
retrain.


NOTE: See Food Safety Plan in curriculum for an example of potential wording for cleaning and sanitation procedures.
Parameters can vary depending on the product, equipment, etc. Dry cleaning would be appropriate in this plan.
Hygienic Zoning
Purpose: Hygienic zoning is important to minimize the potential of re-contamination with
environmental pathogens. The Flow Diagram highlights areas managed as zones and the basic
plant layout below illustrates raw peanut and primary pathogen control areas. Two primary
preventive controls are used for hygienic zoning: 1) air flow control and 2) dedicated personnel in
sensitive areas.
Packaging Cleaning Fill, weigh, Label, Metal

Casing
storage jars seal code detection
Receiving for Non‐peanut Finished

Mix
non‐peanut ingredient Grinding Cooling product
ingredients
raw materials storage storage
Hall
Receiving for Raw peanut Raw peanut

Roasting Shipping
raw peanuts storage cleaning
Hallway
Women’s Small
Men’s locker
Maintenance Mechanical locker utensil Office
room
room washing
Raw peanut area,  Basic GMP, Primary pathogen control area – CONTROLLED ACCESS

Non‐GMP area
1. Air flow control

A positive air balance (i.e., air flows out of the area) is maintained between primary pathogen
control processing areas and other areas of the factory. A negative air balance (i.e., air flows
in) is maintained between raw peanut handling and other areas of the factory, and air flow
direction is verified.
Frequency: Weekly and when plant changes occur
Procedure: The system was set up during installation by a competent heating, ventilation and
air conditioning (HVAC) technician.
Monitoring: Air flow test using procedure XYZ at entrances, exits, and air handling vents.
Corrections: If airflow is not flowing in the correct direction:
a. Correct air flow
b. Increase environmental monitoring in area where flow is in the wrong direction.
c. Review environmental monitoring data. Assess risk, determine if action against
product is needed, document rational for actions.
Verification: 1) Environmental monitoring and 2) records review within 7 working days
Records: Weekly Air Flow Record, Environmental Monitoring Sampling Record, lab results
2. Dedicated personnel in sensitive areas

The post-roasting areas of the factory are physically segregated from areas where raw
peanuts are handled. Processing areas where ingredients and products are exposed (primary
pathogen control areas above) are managed at a higher hygiene level than raw peanut,
warehouse and receiving areas.
Frequency: During production and cleaning
Who: Employees and other individuals entering primary pathogen control or raw peanut areas
Procedure:
Primary pathogen control area
Employees entering primary pathogen control areas must (in the order listed):
1. Take a clean, blue smock from the rack outside the production area and put it on.
2. Take the correct size clean rubber boots from the shelves along the wall outside
the controlled area and put them on over shoes.
3. Take a blue hairnet from the box by the entry and put it on. Ensure that all loose
hair is captured. Men with facial hair should also apply beard nets.
4. Wash hands just before entering the controlled area following the procedures
posted by the sink. Apply a clean pair of gloves.
5. When exiting the room deposit smocks and boots in the receptacles provided. DO
NOT return them to the clean smock and shoe cover receptacle.
Maintenance workers and visitors must follow the above but use foot covers and clean
smocks when entering this area. Traffic in this area is minimized during production.
Raw peanut zone:
Raw peanuts are received separately from other ingredients and other raw materials.
Raw peanuts are stored in a dedicated, segregated area. A negative air balance (i.e.,
air flows in) is maintained between raw peanut handling and other areas of the factory.
Personnel involved in the processing of raw peanuts are dedicated to this activity.
These personnel do not enter other processing areas of the factory. Employees
working in raw peanut areas wear grey smocks and dedicated footwear.
Monitoring: The sanitation supervisor visually observes the presence of the properly
smocked employees, before start up and after lunch break, and every 2 hours.
Corrections: Employee is instructed to gown properly. If raw peanut boots or smocks are
worn outside of the raw peanut area, areas visited by the employee are sanitized following dry
sanitizing procedures.
Verification: 1) Environmental monitoring and 2) records review within 7 working days
Records: Daily Hygienic Zoning Record, Environmental Monitoring Sampling Record and lab
results


Purpose: Environmental monitoring is conducted to verify the effectiveness of sanitation and
hygienic zoning procedures in the primary pathogen control zones to control
environmental pathogens such as Salmonella.
Sample identification: Based on observation when sampling, “worst case” areas are sampled;
e.g., signs of moisture, product accumulation areas, crevasses, major traffic areas.
Routine sampling sites include non-food contact surfaces and environmental surfaces.
Record the specific location sampled.
Sampling procedure: The primary pathogen control area is tested monthly for the presence of
Salmonella. Ten (10) stick swabs, sponge swabs, or accumulated product are collected
during production at least 3 hours after production starts. Sampling time is not uniform to
avoid bias of results. Samples are shipped to the laboratory using the sampling kit
provided by the laboratory. Samples are refrigerated and shipped in an insulated cooler
with a gel pack with next day delivery. Samples are NOT frozen.
using validated procedures identified on their report. Analysis is started within 48 hours of
sampling. The lab notifies the facility by phone any positive result is observed.
Test conducted: All samples are tested individually for Salmonella without compositing. The test
Records are reviewed within 7 working days of creation. If Salmonella spp. are found in routine
testing, corrective actions are applied.
1. If a routine (non-food-contact-surface) sample is positive, the positive area is re-sampled
within a day of notification and prior to implementing intensive sanitation procedures.
Additional samples (number depends on size of area) are taken in other potential problem
areas in an attempt to identify a site of contamination. Food contact surfaces are also
included in re-sampling, focusing around positive sites.
2. Intensive dry cleaning sanitation procedures are implemented after sampling is complete.
3. Production may continue after sanitation is complete, but product is placed on hold until
environmental re-sample results are reported to be negative.
4. If all re-samples are negative, resume the normal sampling frequency and release product.
5. If one or more non-food-contact surface re-samples are positive, perform corrective action
investigation to resolve the issue. Implement a hold and finished product testing procedure
per the Product Testing for Verification corrective action protocol.
6. If one or more food contact surface re-samples are positive, product is considered to be
contaminated with Salmonella. Destroy or divert product to a process that inactivates
Salmonella. Halt production and initiate investigation to determine and correct root causes.
Perform reanalysis of relevant parts of the Food Safety Plan to prevent recurrence.

Supply‐chain Preventive Controls Program

Determination of Verification Procedures
aflatoxin requires a supply-chain-applied control for peanuts. Our process does not reduce
aflatoxin.
Preventive controls applied by the supplier: An approved supplier sorts peanuts to remove
damaged kernels and conducts aflatoxin testing (using a valid method listed on their results
report) to verify their control procedures.
Verification activities: A certificate of analysis for each lot of shelled peanuts is used to verify
supplier control.
Verification procedures: For each lot received, trained receiving personnel:
 review the supplier certificate of analysis for aflatoxin to verify that the following
parameters are met:
o < 15 ppb aflatoxin average maximum for sub-samples with no individual
reading > 25 ppb
 inspect incoming lots for mold.
Records: Certificate of Analysis for each lot, incoming goods log, and verification of corrective
actions taken by the supplier are maintained on file by the Food Safety Team Leader.
applied control)
Shelled Nuts2U Co., Aflatoxin 10/08/2010 Supplier’s COA and

peanuts Cropville, Certificate of incoming
USA Analysis goods log,
(COA) with corrective
each shipment records
Receiving procedures: For each shipment received, the receiving clerk:

 reviews each COA against acceptance criteria above
 verifies that each lot in the shipment is accompanied by a COA
 verifies that no mold is observed per procedure #XYZ
 documents the above in the incoming goods log.

PRODUCT(S) Ground Black Pepper PAGE 1 of 12
ADDRESS: 123 ABC Street, USA SUPERSEDES 10/20//2015
Food Safety Plan
for
Ground Black Pepper

Teaching Example
The information in this example is for training purposes only and does not represent any
specific operation. Many processing steps were omitted or combined to facilitate its use for
class exercises. It is not complete and contains both required and optional
information.
can be used in a specific facility without significant modification. Conditions and
specifications used (e.g., validation information) are for illustrative purposes only and may
not represent actual process conditions.

Table of Contents
Flow Diagram ................................................................................................................................ 4
- Receiving shelf stable ingredients: ............................................................................................ 5
- Receiving packaging:................................................................................................................. 5
- Ingredient storage: ..................................................................................................................... 5
- Packaging storage: .................................................................................................................... 5
- Cleaning:.................................................................................................................................... 5
- Pathogen destruction: ................................................................................................................ 5
- Grinding: .................................................................................................................................... 5
- Metal detection: ......................................................................................................................... 5
- Packaging: ................................................................................................................................. 5
- Storage: ..................................................................................................................................... 5
- Shipping: .................................................................................................................................... 5
Hazard Analysis ............................................................................................................................ 6
Process Preventive Controls ......................................................................................................... 8
Allergen Preventive Controls ........................................................................................................ 9
- Allergen Cross-contact Prevention ............................................................................................ 9
- Allergen Cleaning of Filler........................................................................................................ 10
- Hygienic Zoning/ Environmental Monitoring ............................................................................ 11
Supply-chain-applied Controls .................................................................................................... 12
- Approved Suppliers for Ingredients Requiring a Supply-chain-applied Control ....................... 12

For Exercise After Chapter 6: Preliminary Steps In Developing a Food Safety Plan
Company Overview
This example company is a small firm that makes a variety of spices that may be single spices
or blends. They are assumed to be ready-to-eat because they may be used as is or in cooked
products. Products include ground black pepper, black pepper rub (which includes whey
protein, sugar and salt); and green, white and black peppercorn mix. The black pepper rub is
blended in a separate room to prevent cross-contact issues. The only potential concern for
allergen cross-contact is at filling.
Product is made 5 days a week in one 8 hour production shift, followed by 2 hours for
sanitation. A sanitary facility program is in place, with dry cleaning procedures enforced in most
production areas of the facility to minimize establishment of environmental pathogens. A
separate wet-washing room is used for washing, drying and sanitizing small equipment. Water
is treated and tested per EPA requirements by the city. An integrated pest control program is
also in place. The company follows guidance from the American Spice Trade Association for
production of safe and clean spices.
This Food Safety Plan covers production of ground black pepper. Other products have separate
Food Safety Plans.
Product Description
Product Name(s) Ground Black Pepper
Product Description, including Dried ground black pepper
Important Food Safety
Characteristics
Ingredients Black peppercorns
Packaging Used Food grade steel container with plastic lid

Intended Use The product is considered ready-to-eat. It is used to flavor
prepared foods or used as part of a recipe
Shelf Life ~ 2 years ambient
Labeling Instructions None
Storage and Distribution Dried, ambient temperature
Approved: Date:
Signature: F.S. Leader 10/8/2015

Flow Diagram
Receiving Shelf Stable Receiving Packaging
Ingredients
 
Ingredient Storage Packaging Storage

Cleaning

Pathogen Destruction

Grinding

Metal Detection

Packaging

Storage

Shipping
Verified by: Date_____________
NOTE: Several more steps are

usually included in a real process.
This process is for teaching-
purposes only.

Process Narrative
Ingredients and raw materials are purchased from reputable suppliers that comply with
internationally recognized food safety and quality systems. For each ingredient the same brand
is used consistently to minimize variation. Ingredients are stored according to manufacturers’
recommendations when specified.
Receiving shelf stable ingredients:
Black Peppercorns are typically received in 50 pound bags with appropriate labeling and coding
to ensure adequate traceability.
Receiving packaging:
Food grade steel containers and plastic lids are received in a bulk shipment on pallets.
Specifications require food grade material for packages that is compatible with dried storage of
food products.
Ingredient storage:
Dried black peppercorns are stored in the dry ambient storage room dedicated for ingredients,
arranged by ingredient code number. All containers are sealed to avoid contamination during
storage.
Packaging storage:
Containers and lids are stored in dry ambient storage segregated from ingredients. Packages
are stored in covered containers to protect from contamination.
Cleaning:
As received, peppercorns may be contaminated with dust, dirt, stones, metal and other foreign
material. The peppercorns are cleaned by passing over sieves of varying sizes and magnets to
separate foreign material and provide uniform peppercorn size. Unusual findings of foreign
material and extraneous vegetative material are investigated. A library of “unusual findings”
photographs are maintained for training purposes and may include wire, extraneous vegetative
material, rodent droppings or other filth, etc. Many of these represent potential adulteration
issues, which are addressed by contacting the supplier and potential delisting as an approved
supplier. No allergen containing materials are passed over these devices.
Pathogen destruction:
A validated heat treatment method is used for pathogen destruction. Testing post-process for
Salmonella is conducted daily to verify efficacy.
Grinding:
Material is ground according to product specifications to achieve correct particle size for food
application and appearance. Grinding occurs on a mill line utilizing roller mills and sifter screens.
Screen size is selected to obtain desired particle size.
Metal detection:
Finished product passes through an in line metal detector prior to packaging since the product is
packaged in a metal can. Rejected material is diverted prior to filling in the metal container. All
rejected product is examined for the presence of metal.
Packaging:
Ground black pepper is packaged in a metal tin with a plastic lid and coded with the appropriate
lot and day code designation. The finished product is cased and coded.
Storage:
Finished product is stored ambient and dry until distributed.
Shipping:
Product is shipped in ambient trucks to customers.

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.
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)
Processing food safety hazards potential measure(s) can be applied to preventive
Step introduced, food safety significantly minimize or control
controlled or hazards prevent the food safety hazard? applied at
enhanced at this require a Process including CCPs, this step?
step preventive Allergen, Sanitation, Supply‐
control? chain, other preventive control
Yes No Yes No
Receiving B Vegetative X Salmonella and pathogenic E. Process Control: Subsequent X
shelf stable bacteria such as coli recalls and outbreak history inactivation step
ingredients – Salmonella and
peppercorns pathogenic E.
coli
C Pesticides X Imported product Supply‐chain Control: X
Verification of supplier
Certificates of Analysis for
pesticide residues
P Foreign X Unavoidable foreign material is
material (e.g., associated with the growing and
stones, wire harvesting environment.
etc.) Subsequent grinding eliminates
potential physical hazards, but
presents potential adulteration
issues. Metal may damage
grinding equipment.
Receiving B None
packaging C None
P None
Ingredient B None
storage C None
P None
Packaging B None
storage C None
P None
Cleaning B None
C None
P Foreign X Addresses potential
material adulteration but not safety ‐ see
above for receiving peppercorns
continued


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

Processing food safety hazards potential measure(s) can be applied to preventive
Step introduced, food safety significantly minimize or control
controlled or hazards prevent the food safety hazard? applied at
enhanced at this require a Process including CCPs, this step?
step preventive Allergen, Sanitation, Supply‐
control? chain, other preventive control
Yes No Yes No
Pathogen B Vegetative X History of outbreaks and recalls Process Control: Heat X
destruction pathogens such show these organisms may be treatment for pathogen
as Salmonella present reduction
and pathogenic
E. coli
C None
P None
Grinding B Environmental X Post pasteurization Sanitation Control: Zoning X
pathogens such contamination, cross and dry sanitation
as Salmonella contamination
C None
P Metal X Equipment failure can Process Control: Subsequent X
potentially introduce metal metal detection
Metal B None
detection C None
P Metal X Potential equipment failure at Process Control: Metal X
grinding step detection
Packaging B Environmental X Post pasteurization Sanitation Control: Zoning X
pathogens such contamination, cross and dry sanitation
as Salmonella contamination
C Undeclared X Other products packed contain Allergen Control: prevent X
allergens allergens allergen cross‐contact
P None
Storage B None
C None
P None
Shipping B None
C None
P None

Process Hazard(s) Critical Limits Monitoring Corrective Verification Records

Control(s) Action Activities
Pathogen Vegetative XF for Y1 Review time Chart After initial Pathogen If parameters Calibrate Pathogen
Destruction pathogens minutes as a and recorder temperature is destruction are not met equipment Destruction
such as heat treatment temperature reached, equipment then once per Processor Log
Salmonella for peppercorns on recording conduct operator reprocess. month
Recording
and chart to continuous Determine the device
pathogenic E. meet monitoring by root cause of QA
calibration
coli parameters visual check of processing manager or
records
listed under recording failure and designee
critical limits instrument correct to reviews and Corrective actions
chart during prevent initials
each run. Validation study
recurrence. records
by American
daily
Spice Trade
Quarterly
Association
generic E.
demonstrating
coli and
that the time/
Salmonella
temperature
testing
exposure for
peppercorns heat
is sufficient for a
5-log inactivation.
Copy of report is
in the plan.
Metal See Food Safety Plan in curriculum for an example for potential wording for metal detection.
Detection Parameters can vary depending on the product, packaging, detection system, etc.
1
An actual plan would insert specific temperature and time. No specific numbers are used in this model to prevent misapplication of parameters that may not apply
to a specific product.


Allergen Cross-contact Prevention
Shellfish
Tree Nut
(market
(market
(market
Peanut
Wheat
name)
name)
name)
Fish
Milk
Egg
Soy
Productio
Product Name n Line
Ground black pepper 1
Green, white and black 1
peppercorn mix
Black pepper rub 1 X
Unique
allergen
Scheduling Implications: Black pepper rub is the only product that contains a food allergen (milk
from whey protein). This product is run at the end of the day. A capital request has been submitted to
obtain a dedicated filler for this product to minimize the risk of allergen cross-contact.
Allergen Cleaning Implications: Dry cleaning procedures must be used in all production areas. The filler
head is completely dismantled after the Black Pepper Rub product is run for through cleaning using
alcohol wipes to ensure that there is no visible residue. Swabs have been taken to validate the
effectiveness of this cleaning method to remove milk protein to non-detectable levels on a routine basis.
The cleaning crew is trained on this procedure, including its importance.


Allergen Cleaning of Filler
Purpose: Remove the food allergen, milk, from the filler head to prevent potential allergic
reaction in sensitive individuals and to prevent mis-labeling of product.
Frequency: After each run of Black Pepper Rub
Who: Sanitation crew
Procedure:
1. Completely dismantle filler chute following dismantling photograph and take parts to the
cleaning area.
2. Wet wash parts that can be exposed to water (refer to photo2)
3. Use food contact surface grade alcohol wipes to wipe down parts that cannot be
exposed to water until there is no visual reside (refer to photo)
4. Allow filler parts to dry completely!
5. Reassemble dry filler parts prior to production
Monitoring: Visually observe the filler parts prior to reassembly of the filler to ensure they are
both clean and dry.
Corrections: If the filler head is not properly clean (e.g., visible residue or wet), the employee is
instructed on how to properly clean the parts and the importance of doing so to prevent potential
allergic reactions.
Records: Allergen cleaning log
Verification: Visual inspection of the parts prior to assembly by the sanitation supervisor.
Allergen cleaning log is reviewed within one week.
2
Photo not provided for training but would be useful for the cleaning team to ensure consistent results

Hygienic Zoning/ Environmental Monitoring

Purpose: Hygienic zoning in post-pathogen destruction area is important to minimize the
potential of re-contamination with environmental pathogens.

Who: Employees and other individuals entering the Post Pathogen Destruction area (in
pink or light shading above)
Procedure: Employees entering the Post Pathogen Destruction area must (in the order
listed):
1. Take a clean, blue smock from the rack outside the production area and put them
on. Smocks must cover outer clothing that would be above the processing line.
3. Take a blue hairnet from the box by the entry and put it on. Ensure that all loose
hair is captured. Men with facial hair should also apply beard nets.
4. Wash hands just before entering the area following the procedures posted by the
sink. Apply a clean pair of gloves.
5. When exiting the room deposit smocks, shoe covers and hair nets in the
receptacles provided. DO NOT reuse disposable items after entering
uncontrolled areas.
Maintenance workers and visitors must follow the procedures above but use white foot
covers and clean white smocks when entering this area. Traffic in this area is minimized
during production.
Monitoring: The sanitation supervisor visually observes the presence of the properly
smocked employees, before start up and after lunch break, and every 2 hours.
Records: Daily Hygienic Zoning Record, Environmental Monitoring Sampling Record
and lab results.
Verification: Environmental monitoring for verification of sanitation preventive controls
and records review within one week.

Supply‐chain‐applied Controls
pesticides require a supply-chain-applied control for raw black peppercorns. Our process
does not reduce pesticides.
Preventive controls applied by the supplier: The supplier sources pepper from producers
that use good agricultural practices and apply only approved pesticides. Periodic pesticide
screening is conducted by the supplier to verify compliance.
Verification activities: The supplier sends Certificates of Analysis (COA) for pesticide
residues for our review to verify supplier control for these hazards, minimum quarterly.
Verification procedures: The Quality Supervisor:
 verifies that copies of COAs received from the supplier for pesticide residues comply
with regulatory requirements following procedure XYZ
 verifies that quarterly submission of COA requirements have been met
 enters the date of the results of the review into the Pesticide Screen Log
Records: COA copies for pesticides, Pesticide Screen Log, Incoming Goods Log, Approved
Supplier List, and verification of corrective actions taken by the supplier are maintained on
file by the Quality Manager.
applied control)
Black Spice4U Pesticides 10/08/2010 Supplier’s COA,

peppercorns Co., Port, Certificate of Pesticide
USA Analysis Screen
(COA) Log,
quarterly Incoming
Goods
Log,
corrective
records
Receiving procedures: For each shipment received, the receiving clerk verifies that the
product is from an approved supplier and documents this in the Incoming Goods Log.


Brocoli, Zanahoria y Ensalada de Nueces: Diagrama de Flujo y Descripción del Proceso

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Brocoli, Zanahoria y Ensalada de Nueces: Diagrama de Flujo y Descripción del Proceso

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PRODUCT(S): Broccoli, Carrot and Pecan Salad PAGE 1 of 19

PLANT NAME: Example ISSUE DATE 02/24/2016

Food Safety Plan

Reviewed by:___________________________ Plant Manager Date:

FSPCA Training Model

FSPCA Training Model

Packaging Used 8 oz. plastic cup and snap on lid

Intended Use Ready-to-eat salad, appropriate for grab-and-go

Intended Consumers General public

Shelf Life 10 days after manufacture

Labeling Instructions Keep refrigerated.

Storage and Distribution Refrigerated (≤40°F) storage and distribution

FSPCA Training Model

[Text in square brackets are for teaching purposes]

FSPCA Training Model

FSPCA Training Model

FSPCA Training Model

FSPCA Training Model

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

FSPCA Training Model

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

FSPCA Training Model

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

FSPCA Training Model

Process Preventive Controls

See Food Safety Plan in curriculum for an example

FSPCA Training Model

FSPCA Training Model

FSPCA Training Model

Allergen Preventive Controls

Allergen Label Verification Listing

Broccoli, Carrot and Pecan Salad Contains: Pecans, egg

Broccoli, Carrot and Raisin Salad Contains: Egg

Italian Vegetable Salad with Parmesan Cheese Contains: Milk, egg

FSPCA Training Model

Production Line Allergen Assessment

FSPCA Training Model

Sanitation Preventive Controls

Hygienic Zoning & Environmental Monitoring

Frequency: During production

FSPCA Training Model

Environmental Monitoring for Sanitation Preventive Control Verification

Supply‐chain Preventive Controls Program

Approved Suppliers for Ingredients Requiring a Supply-chain-applied Control

Pecans Nuts2U Co., 10/22/2013 Salmonella Copy of 3rd Copy of

FSPCA Training Model

Food Safety Plan

Reviewed by:___________________________ Plant Manager Date: __________________

FSPCA Training Model

FSPCA Training Model

Water activity ≤0.65

Intended Use Ready-to-eat bars

Intended Consumers General consumption

Shelf Life One year

Labeling Instructions None

Storage and Distribution Ambient, not to exceed 90°F

FSPCA Training Model

Receive Ingredients Receive Packaging

Gray area indicates primary pathogen control area

Verified by: P. I. Model Date: January 5, 2016

FSPCA Training Model

FSPCA Training Model

Reviewed by:_________ Plant Manager Date: