food safety plan for broccoli, carrot, pecan salad · food safety plan for broccoli, carrot, pecan...
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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
FSPCA Training Model For Exercise After Chapter 6: Preliminary Steps in Developing a Food Safety Plan
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.
PRODUCT(S): Broccoli, Carrot and Pecan Salad PAGE 2 of 19 PLANT NAME: Example ISSUE DATE 02/24/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model For Exercise After Chapter 6: Preliminary Steps in Developing a Food Safety Plan
TableofContentsCompany 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
PRODUCT(S): Broccoli, Carrot and Pecan Salad PAGE 3 of 19 PLANT NAME: Example ISSUE DATE 02/24/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model For Exercise After Chapter 6: Preliminary Steps in Developing a Food Safety Plan
CompanyOverviewThis 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.
ProductDescriptionProduct Name(s) Broccoli, Carrot and Pecan Salad Product Description, including Important Food Safety Characteristics
Refrigerated, ready-to-eat salad, containing broccoli, carrots, pecans and salad dressing. 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:
Signature: F.S. Leader Print name: F.S. Leader
Date: 6 January 2016
PRODUCT(S): Broccoli, Carrot and Pecan Salad PAGE 4 of 19 PLANT NAME: Example ISSUE DATE 02/24/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model For Exercise After Chapter 6: Preliminary Steps in Developing a Food Safety Plan
FlowDiagramReceiving packaging
[packaging material]
Receiving shelf stable ingredients [pecans, salad dressing]
Receiving refrigerated ingredients
[fresh whole carrots]
Receiving frozen
ingredients [frozen broccoli florets]
Packaging storage
Dry ingredient storage [pecans]
Refrigerated ingredient storage
[fresh whole carrots, salad dressing]
Frozen ingredient
storage [frozen broccoli]
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]
PRODUCT(S): Broccoli, Carrot and Pecan Salad PAGE 5 of 19 PLANT NAME: Example ISSUE DATE 02/24/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model For Exercise After Chapter 6: Preliminary Steps in Developing a Food Safety Plan
ProcessNarrativeReceiving 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
PRODUCT(S): Broccoli, Carrot and Pecan Salad PAGE 6 of 19 PLANT NAME: Example ISSUE DATE 02/24/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model For Exercise After Chapter 6: Preliminary Steps in Developing a Food Safety Plan
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.
PRODUCT(S): Broccoli, Carrot and Pecan Salad PAGE 7 of 19 PLANT NAME: Example ISSUE DATE 02/24/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model For Exercise After Chapter 8: Hazard Analysis and Preventive Controls Determination
HazardAnalysisHazard 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)
Ingredient/ Processing
Step
(2) Identify potential food
safety hazards introduced, controlled
or enhanced at this step
(3) Do any
potential food safety
hazards require a
preventive control?
(4) Justify your decision for column 3
(5) What preventive control
measure(s) can be applied to significantly minimize or prevent the food safety
hazard? Process including CCPs,
Allergen, Sanitation, Supply‐chain, other preventive
control
(6) Is the
preventive control
applied at this step?
Yes No Yes No
Receiving packaging
B None C None P None
Receiving shelf stable ingredients – pecans
B Vegetative pathogens such as Salmonella
X Raw tree nuts have a history of potential contamination with vegetative pathogens
Supply-chain Control – Salmonella is controlled by the supplier through the roasting process
X
C Allergen – pecan tree nut
X Pecans are tree nuts, which could present a source of cross-contact for other products that do not contain pecans.
Allergen Control - allergen cross-contact prevention and allergen labeling at subsequent steps
X
Aflatoxin X Pecans have a history of potential contamination with aflatoxin
Supply-chain Control – Aflatoxin is controlled by the supplier by removal of moldy, discolored pecans
X
P None Receiving shelf stable ingredients – salad dressing
B None Industrially produced, shelf-stable salad dressing has a high acid content that destroys vegetative pathogens
C Allergen – egg X Egg is an allergen, which could present a source of cross-contact for other products that do not contain egg.
Allergen Control - cross-contact prevention and allergen labeling at subsequent steps
X
P None
continued
PRODUCT(S): Broccoli, Carrot and Pecan Salad PAGE 8 of 19 PLANT NAME: Example ISSUE DATE 02/24/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model For Exercise After Chapter 8: Hazard Analysis and Preventive Controls Determination
(1) Ingredient/ Processing
Step
(2) Identify potential food
safety hazards introduced, controlled
or enhanced at this step
(3) Do any
potential food safety
hazards require a
preventive control?
(4) Justify your decision for column 3
(5) What preventive control
measure(s) can be applied to significantly minimize or prevent the food safety
hazard? Process including CCPs,
Allergen, Sanitation, Supply‐chain, other preventive
control
(6) Is the
preventive control
applied at this step?
Yes No Yes No
Receiving–fresh whole carrots
B Vegetative pathogens such as Salmonella and pathogenic E. coli
X Raw vegetables and soil may contain pathogens that can transfer through further handling and potentially grow under abusive conditions. Intact carrots do not support pathogen growth.
Supply-chain Control - Production in accordance with the Produce Safety rule minimizes vegetative pathogens. Subsequent process controls – antimicrobial washing & peeling, short post-chop process time, finished product temp.
X
Sporeforming pathogens - C. botulinum
X While raw vegetables may contain C. botulinum, it will 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 carrots are grown in a former orchard that used lead arsenate pesticide
Supply-chain Control - site selection addressed in specifications
X
P None Receiving frozen, blanched broccoli florets
B Vegetative pathogens such as Listeria monocytogenes and Salmonella
X Bacterial pathogens may occur on raw produce and recontamination can occur after blanching without sanitation controls.
Supply-chain Control - Blanching and environmental sanitation controls
X
C Pesticides X FDA testing periodically detects unapproved residues or levels above tolerance in produce from certain countries.2
Supply-chain Control - Pesticide control and monitoring for broccoli from countries without robust control programs
X
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.
PRODUCT(S): Broccoli, Carrot and Pecan Salad PAGE 9 of 19 PLANT NAME: Example ISSUE DATE 02/24/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model For Exercise After Chapter 8: Hazard Analysis and Preventive Controls Determination
(1) Ingredient/ Processing
Step
(2) Identify potential food
safety hazards introduced, controlled
or enhanced at this step
(3) Do any
potential food safety
hazards require a
preventive control?
(4) Justify your decision for column 3
(5) What preventive control
measure(s) can be applied to significantly minimize or prevent the food safety
hazard? Process including CCPs,
Allergen, Sanitation, Supply‐chain, other preventive
control
(6) Is the
preventive control
applied at this step?
Yes No Yes No
Storage – Packaging and dry ingredients [pecans]
B None C Allergen cross-
contact during storage
X Only unopened or resealed containers of allergenic ingredients are stored in the dry storage area making cross-contact unlikely.
P None Refrigerated ingredient storage [fresh carrots, salad dressing]
B None These refrigerated ingredients do not support pathogen growth.
C Allergen cross-contact during storage
X Only closed containers of allergenic ingredients are stored in this storage area
P None Frozen ingredient storage [blanched broccoli]
B None Pathogen growth does not occur in frozen storage
C None P None
Sort, wash, peel carrots
B Vegetative pathogens such as Salmonella, STEC
X Wash water may spread contamination, if present, to all carrots. Growth is not likely with short process time.
Process Control – Antimicrobial (chlorine) in wash water
X
C None P Metal X Metal on metal wear in
peeling equipment Metal detection at a later step
X
Chop, rinse, dry carrots
B Environmental pathogens such as Listeria monocytogenes
X Environmental contamination
Sanitation Control – zoning and environmental sanitation
X
C None P Metal X The potential for metal
contamination from chopper exists; fragments could result in injury.
Metal detection at a later step
X
continued
PRODUCT(S): Broccoli, Carrot and Pecan Salad PAGE 10 of 19 PLANT NAME: Example ISSUE DATE 02/24/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model For Exercise After Chapter 8: Hazard Analysis and Preventive Controls Determination
(1) Ingredient/ Processing
Step
(2) Identify potential food
safety hazards introduced, controlled
or enhanced at this step
(3) Do any
potential food safety
hazards require a
preventive control?
(4) Justify your decision for column 3
(5) What preventive control
measure(s) can be applied to significantly minimize or prevent the food safety
hazard? Process including CCPs,
Allergen, Sanitation, Supply‐chain, other preventive
control
(6) Is the
preventive control
applied at this step?
Yes No Yes No
Mix all ingredients [carrots, frozen broccoli, pecans, salad dressing]
B Environmental pathogens such as L. monocytogenes
X Recontamination may occur if environmental control is not in place. Process time is too short for growth to occur.
Sanitation Control – zoning and environmental sanitation
X
C Allergens from other products; e.g., Italian Vegetable Salad
X This product could be exposed to milk allergen from other products if not controlled
Allergen Control and Sanitation Control – prevent allergen cross-contact
X
P None Fill, weigh, label
B Vegetative and sporeforming pathogen growth
X Short process time - pathogens unlikely to grow
Product recontamination with environmental pathogens such as L. mono
X Recontamination may occur if equipment cleaning and employee practices are not proper
Sanitation Control – zoning and environmental sanitation
X
C Undeclared allergens – egg, pecan
X Product contains egg and pecan allergens
Allergen Control – declaration on label
X
P None Metal detection
B None C None P Metal X Chopping carrots and other
metal-on-metal contact may periodically produce metal hazards
Process Control – metal detection
X
Refrigerated finished product storage
B Vegetative and sporeforming pathogen growth
X Pathogens can grow if product is time and temperature abused
Process Control – product storage temperature prior to shipment
X
C None P None
Refrigerated product shipping
B Vegetative and sporeforming pathogen growth
X Pathogens can grow if product is time and temperature abused
Process Control – product and shipping vehicle temperature
X
C None P None
PRODUCT(S): Broccoli, Carrot and Pecan Salad PAGE 11 of 19 PLANT NAME: Example ISSUE DATE 02/24/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model For Exercise After Chapter 9: Process Preventive Controls
ProcessPreventiveControls
Process Control(s)
Hazard(s) Critical Limits Monitoring
Corrective Action
Verification Record-keeping
Procedures What How Frequency Who
Wash, carrots Vegetative pathogens such as Salmonella and pathogenic E. coli
Free chlorine in wash water at end of batch run is ≥10 ppm, pH 7.5 maximum
Wash water Initial chlorine level in water is ≥50 ppm
Chlorine and pH test strips match color
Each batch Wash operator
If chlorine or pH level is not correct, then
1) adjust and conduct training as needed to prevent recurrence
2) segregate carrots to the last good check, reprocess or discard;
3) identify root cause and correct.
Daily review of Wash Water Chlorine log
Perform accuracy check on both pH and chlorine strips for each new lot of strips with standard solutions
Review of corrective action log
Review of verification records
Wash Water log showing both chlorine and pH values
Corrective action records
Verification records
Validation report that shows chlorine wash water is effective
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.
PRODUCT(S): Broccoli, Carrot and Pecan Salad PAGE 12 of 19 PLANT NAME: Example ISSUE DATE 02/24/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model For Exercise After Chapter 9: Process Preventive Controls
Process Control(s)
Hazard(s) Critical Limits Monitoring
Corrective Action
Verification Record-keeping
Procedures What How Frequency Who
Refrigerated finished product storage
Vegetative and spore-forming pathogen growth
Cooler maintained at ≤40°F
Cooler temperature
Digital time and temperature data logger with a continuous chart recorder
Continuous, with visual check of recorded data once per day
Production employee
If cooler temperature is >40°F, place product in alternative cooler.
If product temperature is >40°F, measure upstream product and component temperatures to determine potential issues.
Hold and evaluate based on total time and temperature exposure - release or reject as appropriate. Find root cause and fix cooler. Retrain if appropriate.
Check recorder and dial thermometer for accuracy and to ensure that they are operating properly before putting into use; check daily at the beginning of operations. Calibrate recorder annually. Calibrate dial thermometer when accuracy check indicates need.
Review monitoring, corrective action, and verification records within one week of preparation
Recording refrigeration charts and visual check records
Product temperature log
Thermometer accuracy checks and calibration records.
Product temperature ≤40°F
Product internal temperature when it enters the cooler
Dial thermometer
First product in and every 2 hours until the end of shift
Production employee
PRODUCT(S): Broccoli, Carrot and Pecan Salad PAGE 13 of 19 PLANT NAME: Example ISSUE DATE 02/24/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model For Exercise After Chapter 9: Process Preventive Controls
Process Control(s)
Hazard(s) Critical Limits Monitoring
Corrective Action
Verification Record-keeping
Procedures What How Frequency Who
Refrigerated product shipping
Vegetative and spore-forming pathogen growth
Product and shipping vehicle temperature must be ≤40°F.
Temperature in refrigerated truck
Recording thermometer on truck compared to temperature of our own thermometer.
Every load before loading
Shipping clerk
If truck temperature is >40°F before loading, then
1) close truck and wait until temperature is ≤40°F before loading.
2) identify root cause;
3) conduct training as needed to prevent recurrence
Check thermometer for accuracy daily at the beginning of operations. Calibrate annually.
Review monitoring, and associated corrective action, and verification records within one week of preparation
Shipping truck temperature log
Thermometer calibration records.
PRODUCT(S): Broccoli, Carrot and Pecan Salad PAGE 14 of 19 PLANT NAME: Example ISSUE DATE 02/24/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model For Exercise After Chapter 10: Food Allergen Preventive Controls
AllergenPreventiveControls
Allergen Controls
Hazard(s) Criterion Monitoring Corrective
Action Verification Records
What How Frequency Who
Fill, weigh, label
Undeclared Allergens – pecans and eggs
Correct labels applied to finished product
Label on finished product matches product number and declares pecans and egg
Visual inspection of finished product label
At the beginning and the end of each packaging run, and each new case of containers
Packaging line worker
If label is incorrect, then
1) segregate product, inspect back to the last good check, re-label or discard product;
2) identify root cause;
3) conduct training as needed to prevent recurrence
QA manager reviews Packing Room Log within one week and compares to past information to identify any trends.
Weekly review of associated verification records corrective action records, if any
Allergen Label Check log
Corrective Action records
Verification records
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
PRODUCT(S): Broccoli, Carrot and Pecan Salad PAGE 15 of 19 PLANT NAME: Example ISSUE DATE 02/24/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model For Exercise After Chapter 10: Food Allergen Preventive Controls
Production Line Allergen Assessment
Product Name Production
Line
Intentional Allergens
Eg
g
Milk
So
y
Wh
eat
Tre
e N
ut
(m
arke
t na
me)
Pea
nu
t
Fis
h
(m
arke
t na
me)
Sh
ellf
ish
(m
arke
t na
me)
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.
PRODUCT(S): Broccoli, Carrot and Pecan Salad PAGE 16 of 19 PLANT NAME: Example ISSUE DATE 02/24/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model For Exercise After Chapter 11: Sanitation Preventive Controls
SanitationPreventiveControlsNOTE: 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).
Entry Office Break Room
Men’s Locker Room
Women’s Locker Room
Maintenance Mechanical
Hall
Shipping/ Receiving
Ambient Storage
Frozen Storage
Refrigerated Storage
Carrot Prep Mixing ingredients
Fill, weigh, label
Metal detection
Hall
KEY: Non-manufacturing Transition Basic GMP
Primary pathogen control area – 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
PRODUCT(S): Broccoli, Carrot and Pecan Salad PAGE 17 of 19 PLANT NAME: Example ISSUE DATE 02/24/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model 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)
PRODUCT(S): Broccoli, Carrot and Pecan Salad PAGE 18 of 19 PLANT NAME: Example ISSUE DATE 02/24/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model For Exercise After Chapter 12: Supply-chain Preventive Controls
Supply‐chainPreventiveControlsProgram
DeterminationofVerificationProcedures–AuditsVerification 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
Material or Other
Ingredient
Hazard(s) Requiring a
Supply-chain-applied Control
Preventive Control Applied
by Supplier Verification Activities
Verification Procedures
Acceptance Criteria
Pecans Vegetative pathogens such as Salmonella
The supplier roasts pecans to inactivate vegetative pathogens
3rd party audit See above See above
Aflatoxin The supplier sorts pecans to remove damaged nuts and conducts aflatoxin testing (using a valid method listed on their results report) to verify their control procedures.
A certificate of analysis for each lot of shelled pecans is used to verify supplier control.
For each lot received, trained receiving personnel review the supplier certificate of analysis for aflatoxin
< 15 ppb aflatoxin average maximum for sub-samples with no individual reading > 25 ppb
Fresh carrots
Vegetative pathogens such as Salmonella and pathogenic E. coli
Produce Safety rule compliance minimizes lead and vegetative pathogens
3rd party audit See above See above
Lead Frozen broccoli
Vegetative pathogens such as L. monocytogenes and Salmonella
Blanching and environmental sanitation controls
3rd party audit See above See above
Pesticides (for product sourced from countries without robust control programs)
Pesticide control and monitoring
Sampled and sent for pesticide screen, quarterly
Quality technician takes and submits samples per procedure XYZ. Quality manager verifies that results comply with acceptance criteria
Residues comply with regulatory requirements following procedure XYZ
PRODUCT(S): Broccoli, Carrot and Pecan Salad PAGE 19 of 19 PLANT NAME: Example ISSUE DATE 02/24/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model For Exercise After Chapter 12: Supply-chain Preventive Controls
Approved Suppliers for Ingredients Requiring a Supply-chain-applied Control Ingredient (requiring supply-chain-applied control)
Approved Supplier
Date of Approval
Hazard(s) requiring supply-chain-applied control
Verification method
Verification records
Pecans Nuts2U Co., Cropville, USA
10/22/2013 Salmonella Copy of 3rd party audit by a qualified auditor obtained from supplier to verify Salmonella control
Copy of audit kept in Supplier Verification File
Aflatoxin Supplier’s Certificate of Analysis (COA) with each shipment to verify aflatoxin control
COA and incoming goods log, corrective records
Fresh carrots WeeGrower Inc., Rabbiton, USA
9/15/2011 Vegetative pathogens such as Salmonella and pathogenic E. coli
Copy of 3rd party audit by a qualified auditor obtained from supplier
Copy of audit kept in Supplier Verification File
Frozen broccoli FreezRFood, Bordertown, NotUSA
8/8/2012 Vegetative pathogens such as L. monocytogenes and Salmonella
Copy of 3rd party audit by a qualified auditor obtained from supplier
Copy of audit kept in Supplier Verification File
Pesticides (for product sourced from countries without robust control programs)
Internal sample and test
Lab test results kept 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 PLANT NAME: Example ISSUE DATE 01/28/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model
For exercise after Chapter 6: Preliminary Steps in Developing a Food Safety Plan
Selected Sections of a
Food Safety Plan for
Cold Pressed Energy Bar
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.
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.
PRODUCT(S): Cold Pressed Almond Cranberry Energy Bar PAGE 2 of 16 PLANT NAME: Example ISSUE DATE 01/28/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model
For exercise after Chapter 6: Preliminary Steps in Developing a Food Safety Plan
TableofContentsCompany Overview ....................................................................................................................... 3
Product Description ....................................................................................................................... 3
Flow Diagram ................................................................................................................................ 4
Process Narrative ......................................................................................................................... 5
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
Allergen Preventive Controls ...................................................................................................... 13
Ingredient Allergen Identification ............................................................................................. 13
Production Line Allergen Assessment ..................................................................................... 13
Allergen Label Verification Listing ........................................................................................... 13
Allergen Preventive Control Chart ........................................................................................... 14
Sanitation Preventive Controls .................................................................................................... 15
Zoning and Related GMP Controls ......................................................................................... 15
Cleaning and Sanitation .......................................................................................................... 15
Microbiological Verification of Sanitation Practices ................................................................. 15
Supply-chain Preventive Controls Program ................................................................................ 16
PRODUCT(S): Cold Pressed Almond Cranberry Energy Bar PAGE 3 of 16 PLANT NAME: Example ISSUE DATE 01/28/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model
For exercise after Chapter 6: Preliminary Steps in Developing a Food Safety Plan
CompanyOverviewThis 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.
ProductDescriptionProduct Name(s) Almond, Cranberry Energy Bar
Product Description, including Important Food Safety Characteristics
This product is a ready to eat energy bar packed in a pouch for on-the-go eating. The low water activity makes the product shelf 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:
Signature: F.S. Leader Print name: F.S. Leader
Date: 05 January 2016
PRODUCT(S): Cold Pressed Almond Cranberry Energy Bar PAGE 4 of 16 PLANT NAME: Example ISSUE DATE 01/28/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model
For exercise after Chapter 6: Preliminary Steps in Developing a Food Safety Plan
FlowDiagram
Receive Ingredients Receive Packaging
Store Ingredients Store Packaging
Measure Ingredients
Mix and Warm Syrup [canola oil, corn syrup] (195 to 205oF 15
minutes )
Mix Dry Ingredients [almonds, crisped rice, dried cranberries, vitamin/mineral
pre‐blend]
Cool Syrup (120 to 130oF)
Blend Ingredients Rework
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
PRODUCT(S): Cold Pressed Almond Cranberry Energy Bar PAGE 5 of 16 PLANT NAME: Example ISSUE DATE 01/28/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model
For exercise after Chapter 6: Preliminary Steps in Developing a Food Safety Plan
ProcessNarrativeIngredients 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.
PRODUCT(S): Cold Pressed Almond Cranberry Energy Bar PAGE 6 of 16 PLANT NAME: Example ISSUE DATE 01/28/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model
For exercise after Chapter 6: Preliminary Steps in Developing a Food Safety Plan
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
PRODUCT(S): Cold Pressed Almond Cranberry Energy Bar PAGE 7 of 16 PLANT NAME: Example ISSUE DATE 01/28/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model
For exercise after Chapter 6: Preliminary Steps in Developing a Food Safety Plan
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.
PRODUCT(S): Cold Pressed Almond Cranberry Energy Bar PAGE 8 of 16 PLANT NAME: Example ISSUE DATE 01/28/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model
Distribute after exercise for Chapter 8: Hazard Analysis and Preventive Controls Determination
HazardAnalysisHazard 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) Ingredient/ Processing
Step
(2) Identify potential
food safety hazards
introduced, controlled or
enhanced at this step
(3) Are any
potential food safety
hazards requiring a preventive
control?
(4) Justify your decision for column 3
(5) What preventive control
measure(s) can be applied to significantly minimize or prevent the food safety
hazard? Process including CCPs,
Allergen, Sanitation, Supply‐chain, other preventive control
(6) Is the
preventive control
applied at this step?
Yes No Yes No
Receive Ingredients: Corn syrup, Canola oil
B None
C None
P None
Receive Ingredients: Almonds
B Salmonella X Untreated almonds have a history of Salmonella issues
Supply‐chain control – Approved supplier 3rd party audit and quarterly testing by supplier
X
C Aflatoxin X Almonds have a history of potential contamination with aflatoxin
Supply‐chain control – Quarterly testing by supplier
X
Undeclared allergen – almond
X Almonds are tree nuts that are a recognized food allergen
Allergen control – Label review and allergen cross‐contact prevention
X
P Shell pieces X Pieces are removed at supplier during sorting, including optical sorter. Consumer complaint data do not indicate an issue
Receive Ingredients: Crisped rice
B Salmonella X A few cereal outbreaks have occurred, but not with this specific type of process. Warrants supplier program at a reduced level of concern.
Supply‐chain control – Approved supplier 3rd party audit
X
C None
P None
Receive Ingredients: Dried cranberries
B Salmonella X Process to manufacture cranberries has sufficient lethality. If present, Salmonella levels will decrease during storage
C Allergens X Cranberries are not a food allergen, but ingredient has precautionary labeling for other food allergens handled at supplier facility
Allergen control – Subsequent allergen labeling
X
P None
Receive Ingredients: Vitamin/ mineral pre‐blend
B None
C None
P None
Continued
PRODUCT(S): Cold Pressed Almond Cranberry Energy Bar PAGE 9 of 16 PLANT NAME: Example ISSUE DATE 01/28/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model
Distribute after exercise for Chapter 8: Hazard Analysis and Preventive Controls Determination
(1) Ingredient/ Processing
Step
(2) Identify potential
food safety hazards
introduced, controlled or
enhanced at this step
(3) Are any
potential food safety
hazards requiring a preventive
control?
(4) Justify your decision for column 3
(5) What preventive control
measure(s) can be applied to significantly minimize or prevent the food safety
hazard? Process including CCPs,
Allergen, Sanitation, Supply‐chain, other preventive control
(6) Is the
preventive control
applied at this step?
Yes No Yes No
Receive Ingredients: Pan release agent
B None
C Undeclared allergen – soy
X Soy is a recognized food allergen. All products use this processing aid, so cross‐contact is not relevant.
Allergen control – Subsequent allergen labeling
X
P None
Receive Packaging
B None
C Undeclared allergens
X Printing errors have occurred and a correct allergen statement is essential for safety. Packaging line operators check the label number but not necessarily the allergen information.
Allergen control – Verify allergen labeling
X
P None
Store Ingredients
B None
C Undeclared allergens
X Ingredients with allergens are stored in the warehouse in segregated areas and in sealed containers, easily managed by general controls.
P None
Store Packaging
B None
C None
P None
Measure Ingredients
B Environmental pathogens such as Salmonella
X Cross‐contamination possible if measuring environment not managed at appropriate hygiene level.
Sanitation controls ‐ Zoning, dry environment
X
C Food allergens from other products
X Materials containing allergens other than those on the label are handled in the same environment.
Allergen controls – Proper cleaning between allergens. Use of dedicated tools, run order of allergenic materials
X
P None
Mix and Warm Syrup
B Environmental pathogens such as Salmonella
X Cross‐contamination possible if environment and employee practices not managed at appropriate hygiene level.
Sanitation control ‐ Zoning, maintaining dry environment
X
C None
P None
Cool Syrup B Environmental pathogens such as Salmonella
X Cross‐contamination possible if environment and employee practices not managed at appropriate hygiene level.
Sanitation control ‐ Zoning, maintaining dry environment
X
C None
P None
Continued
PRODUCT(S): Cold Pressed Almond Cranberry Energy Bar PAGE 10 of 16 PLANT NAME: Example ISSUE DATE 01/28/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model
Distribute after exercise for Chapter 8: Hazard Analysis and Preventive Controls Determination
(1) Ingredient/ Processing
Step
(2) Identify potential
food safety hazards
introduced, controlled or
enhanced at this step
(3) Are any
potential food safety
hazards requiring a preventive
control?
(4) Justify your decision for column 3
(5) What preventive control
measure(s) can be applied to significantly minimize or prevent the food safety
hazard? Process including CCPs,
Allergen, Sanitation, Supply‐chain, other preventive control
(6) Is the
preventive control
applied at this step?
Yes No Yes No
Mix Dry Ingredients
B Environmental pathogens such as Salmonella
X Cross‐contamination possible if environment and employee practices not managed at appropriate hygiene level.
Sanitation controls – Zoning , maintaining dry environment
X
C Food allergens from other products
X Materials containing allergens other than those on the label are handled in the same environment.
Allergen controls – Proper cleaning between allergens. Use of dedicated tools, run order of allergenic materials
X
P Metal X Metal‐on‐metal contact occurs in equipment
Subsequent metal detection X
Blend All Ingredients
B Environmental pathogens such as Salmonella
X Cross‐contamination possible if environment and employee practices not managed at appropriate hygiene level.
Sanitation control ‐ Zoning, maintaining dry environment
X
C Food allergens from other products
X Materials containing allergens other than those on the label are handled in the same environment.
Allergen controls – Proper cleaning between allergens. Use of dedicated tools, run order of allergenic materials
X
P Metal X Poorly maintained or improperly operated mixer could generate foreign bodies. Preventive maintenance reduces occurrence
Other control – Preventive maintenance
X
Spray Pans B Environmental pathogens such as Salmonella
X Cross‐contamination possible if environment and employee practices not managed at appropriate hygiene level.
Sanitation control – Zoning, maintaining dry environment
X
C Food allergens from other products
X Materials containing allergens other than those on the label are handled in the same environment.
Allergen controls – Proper cleaning between allergens. Use of dedicated tools, run order of allergenic materials
X
P None
Form/ Press B Environmental pathogens such as Salmonella
X Cross‐contamination possible if environment and employee practices not managed
Sanitation control – Zoning, maintaining dry environment
X
C Food allergens from other products
X Materials containing allergens other than those on the label are handled in the same environment.
Allergen controls – Proper cleaning between allergens. Use of dedicated tools, run order of allergenic materials
X
P Metal X Poorly maintained or improperly use pressing equipment could generate metal fragments. Preventive maintenance reduces occurrence
Subsequent metal detection X
Continued
PRODUCT(S): Cold Pressed Almond Cranberry Energy Bar PAGE 11 of 16 PLANT NAME: Example ISSUE DATE 01/28/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model
Distribute after exercise for Chapter 8: Hazard Analysis and Preventive Controls Determination
(1) Ingredient/ Processing
Step
(2) Identify potential
food safety hazards
introduced, controlled or
enhanced at this step
(3) Are any
potential food safety
hazards requiring a preventive
control?
(4) Justify your decision for column 3
(5) What preventive control
measure(s) can be applied to significantly minimize or prevent the food safety
hazard? Process including CCPs,
Allergen, Sanitation, Supply‐chain, other preventive control
(6) Is the
preventive control
applied at this step?
Yes No Yes No
Setting B Environmental pathogens such as Salmonella
X Cross‐contamination possible if environment and employee practices not managed at appropriate hygiene level.
Sanitation control – Zoning, maintaining dry environment
X
C Food allergens from other products
X Materials containing allergens other than those on the label are handled in the same environment.
Allergen controls – Proper cleaning between allergens. Use of dedicated tools, run order of allergenic materials
X
P None
Cutting B Environmental pathogens such as Salmonella
X Cross‐contamination possible if environment and employee practices not managed
Sanitation control – Zoning, maintaining dry environment
X
C Food allergens from other products
X Materials containing allergens other than those on the label are handled in the same environment.
Allergen controls – Proper cleaning between allergens. Use of dedicated tools, run order of allergenic materials
X
P Metal X Poorly maintained or improperly used cutting equipment could generate metal fragments.
Subsequent metal detection X
Rework B Environmental pathogens such as Salmonella
X Cross‐contamination possible if processing environment and employee practices not managed at appropriate hygiene level.
Sanitation control – Zoning, maintaining dry environment and equipment, proper drying after allergen changeover
X
C Food allergens from other products
X Materials containing allergens other than those on the label are handled in the same environment.
Allergen controls – Use of dedicated storage containers, rework use matrix run order of allergenic materials, proper cleaning of tools and equipment between allergens, employee GMP
X
P None
Metal Detection
B None
C None
P Metal inclusion X Metal may be present from previous operations
Process control – metal detector
X
Wrap, Case B Environmental pathogens such as Salmonella
X Cross‐contamination possible if processing environment and employee practices not managed at appropriate hygiene level.
Sanitation preventive control – Zoning, maintaining dry environment and equipment, proper drying after allergen changeover
X
C Undeclared allergens – almond, soy
X The product contains almonds and soy which are food allergens. The wrapper has the labeling
Allergen Control – verification appropriate label used
X
P None
Store, Ship B None
C None
P None
PRODUCT(S): Cold Pressed Almond Cranberry Energy Bar PAGE 12 of 16 PLANT NAME: Example ISSUE DATE 01/28/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model
Distribute after exercise for Chapter 9: Process Preventive Controls
ProcessPreventiveControls
Process control(s)
Hazard(s) Critical limits
Monitoring Corrective Action
Verification Records What How Frequency Who
Metal detection
Metal 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.
PRODUCT(S): Cold Pressed Almond Cranberry Energy Bar PAGE 13 of 16 PLANT NAME: Example ISSUE DATE 01/28/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model
Distribute after exercise for Chapter 10: Food Allergen Preventive Controls
AllergenPreventiveControlsIngredient Allergen Identification
Raw Material Name Supplier
Allergens in Ingredient Formulation
Allergens in Precautionary Labeling Eg
g
Milk
Soy
Wh
eat
Tre
e N
ut
(mar
ket
nam
e)
Pe
anu
t
Fish
(mar
ket
nam
e)
She
llfis
h
(mar
ket
nam
e)
Blanched almonds
BIG Almond Company Almond
None
Dried cranberries Fruit & Nut Ltd.
Packed in a facility that also produces peanuts, tree nuts, soy and milk
Corn syrup G. Narich Sweetners, Inc.
None
Crisped rice A. Cereal Company
None
Pan release agent My Distributor X None
Vitamin/ Mineral Pre‐blend
CarGen Nutritionals
None
Production Line Allergen Assessment
Product Name Production
Line
Intentional Allergens
Egg
Milk
Soy
Wh
eat
Tre
e N
ut
(mar
ket
nam
e)
Pe
anu
t
Fish
(mar
ket
nam
e)
She
llfis
h
(mar
ket
nam
e)
Almond Cranberry Bar 1 and 2 X Almond
Chocolate Covered Peanut Bar 1 and 2 X X X
Sunflower Seed Raisin Bar 1 X
Scheduling Implications: Standard practice is to run the Sunflower Seed Raisin Bar in the beginning of the shift to reduce the potential for allergen cross-contact.
Allergen Cleaning Implications: (Required) A full allergen clean is required AFTER production of Chocolate Covered Peanut Bar and Almond Cranberry Bar because they contain unique allergens (see table)
Allergen Label Verification Listing Product Allergen Statement Label Number Almond Cranberry Bar
Contains: Almond, soy Manufactured on equipment that also handles peanuts, other tree nuts, and milk
AC123
Chocolate Covered Peanut Bar
Contains: Peanut, milk, soy Manufactured on equipment that also handles tree nuts
CP456
Sunflower Seed Raisin Bar
Contains: Soy Manufactured in a facility that also handles peanuts, tree nuts and milk
SSR789
PRODUCT(S): Cold Pressed Almond Cranberry Energy Bar PAGE 14 of 16 PLANT NAME: Example ISSUE DATE 01/28/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model
Distribute after exercise for Chapter 10: Food Allergen Preventive Controls
Allergen Preventive Control Chart
Allergen control Hazard(s) Criteria Monitoring
Corrective Action Verification Records What How Frequency Who
Receiving packaging (labeled wrapper)
Undeclared allergens – almonds, soy lecithin
Precautionary labeling: Manufactured on equipment that also handles peanuts, other tree nuts, and milk
Product label declares allergens present in the formula and has precautionary labeling from ingredients
Ingredient listing and allergen declaration matches product
Visual exam of wrapper label to match product formula per SOP 14‐264
Each receipt before release to production
Label specialist
If label is incorrect, reject labels and return to supplier or destroy. Identify root cause and conduct training as needed or discuss with supplier how to prevent recurrence
QA manager or designee reviews and initials records within 7 working days and compares results with past results to identify any trends
Allergen Label Verification Listing
Allergen Label Verification at Receipt Log
Corrective action records
Verification records
Wrap, Case (labeled wrapper)
Undeclared allergens – almonds, soy lecithin and Precautionary labeling
Label number matches product
Confirm that packaging used matches the product number
Visual inspection of the wrapper stock to match the product number
Beginning and end of run and when label stock is changed
Line operator
If label is incorrect, segregate product, inspect back to the last good check, relabel or destroy; identify root cause and conduct training as needed to prevent recurrence
Allergen Label Verification Listing
Allergen Label Verification on Line Log
Corrective action records
Verification records
Allergen change over procedures, including clean following the use of other allergenic material on equipment
Cross‐contact with allergens not present in the recipe
No residual allergenic material from previous production
Application of effective cleaning; visual inspection prior to start‐up
Procedures as outlined in Allergen Change Over Procedures – SOP 14‐456
After products containing allergenic materials not in this recipe are handled on the line
Sanitation manager
Re‐clean line Hygiene audit; ATP swabs
Sanitation log
Corrections records
Verification records
PRODUCT(S): Cold Pressed Almond Cranberry Energy Bar PAGE 15 of 16 PLANT NAME: Example ISSUE DATE 01/28/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model
Distribute after exercise for Chapter 11: Sanitation Preventive Controls
SanitationPreventiveControlsZoning 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
PRODUCT(S): Cold Pressed Almond Cranberry Energy Bar PAGE 16 of 16 PLANT NAME: Example ISSUE DATE 01/28/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model
Distribute after exercise for Chapter 12: Supply-chain Controls
Supply‐chain‐appliedPreventiveControlsProgramThe 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 and location
B.I.G. Almond Company, Nuttown, USA A. Cereal Company, Grainbelt, USA
Approval Date 10/08/2010 9/9/2009
Hazard requiring a Supply-chain-applied Control
Salmonella Aflatoxin Salmonella
Preventive Controls Applied by the Supplier
Propylene oxide treatment required for California almonds in North America achieves a minimum 4-log reduction of Salmonella
Sorting to remove moldy nuts that may contain aflatoxin
The crisping process provides sufficient heat to kill Salmonella. Zoning and dry cleaning used to prevent recontamination.
Type(s) of Supplier Verification
3rd party audit of approved supplier and quarterly certificates of analysis (COA)
3rd party audit of approved supplier
Verification Procedure(s)
A copy of a 3rd party audit is requested from the supplier annually. The audit 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 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.
NA
Salmonella not detected in 5 25g samples per lot
Aflatoxin < 10 ppm for lots received
Records – ingredient or hazard specific
Quarterly COAs Salmonella
Quarterly COAs for aflatoxin
See list below
– 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
PRODUCT(S): Fettuccini Marinara with Broccoli, Ready to Cook PAGE 1 of 17 PLANT NAME: FSPCA Exercise Version ISSUE DATE 2/25/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 2/24/2016
FSPCA Training Model For Exercise After Chapter 6: Preliminary Steps in Developing a Food Safety Plan
Selected Sections of a
Food Safety Plan
for Fettuccini Marinara with Broccoli
Ready to Cook
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. 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.
PRODUCT(S): Fettuccini Marinara with Broccoli, Ready to Cook PAGE 2 of 17 PLANT NAME: FSPCA Exercise Version ISSUE DATE 2/25/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 2/24/2016
FSPCA Training Model For Exercise After Chapter 6: Preliminary Steps in Developing a Food Safety Plan
TableofContentsCompany Overview ....................................................................................................................... 3
Product Description ....................................................................................................................... 3
Flow Diagram ................................................................................................................................ 4
Process Narrative ......................................................................................................................... 5
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
Allergen Preventive Controls ...................................................................................................... 12
Undeclared Allergens –Wheat or milk ..................................................................................... 12
Sanitation Preventive Controls .................................................................................................... 14
Hygienic Zoning/ Environmental Monitoring ............................................................................ 14
Environmental Monitoring for Sanitation Preventive Control Verification ................................ 15
Supplier Program for Preventive Controls .................................................................................. 16
Spices ...................................................................................................................................... 16
Pasta ....................................................................................................................................... 16
PRODUCT(S): Fettuccini Marinara with Broccoli, Ready to Cook PAGE 3 of 17 PLANT NAME: FSPCA Exercise Version ISSUE DATE 2/25/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 2/24/2016
FSPCA Training Model For Exercise After Chapter 6: Preliminary Steps in Developing a Food Safety Plan
CompanyOverviewThis 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.
ProductDescriptionProduct Name(s) Fettuccini Marinara with Broccoli Meal
Product Description, including Important Food Safety Characteristics
Fettuccini Marinara with Broccoli is a frozen, ready-to-cook meal packed in a plastic tray and sealed with a transparent 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)
Intended Consumers
General public
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:
Signature: F.S. Leader Print name: F.S. Leader
Date: 23 February 2016
PRODUCT(S): Fettuccini Marinara with Broccoli, Ready to Cook PAGE 4 of 17 PLANT NAME: FSPCA Exercise Version ISSUE DATE 2/25/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 2/24/2016
FSPCA Training Model For Exercise After Chapter 6: Preliminary Steps in Developing a Food Safety Plan
FlowDiagram
Receiving packaging
[trays, film, carton, case]
Receiving shelf stable
ingredients [pasta, salt, sauce, spices]
Receiving frozen
ingredients [frozen broccoli]
Receiving refrigerated
ingredients [Romano cheese]
Packaging
storage
Shelf stable ingredient storage
Frozen ingredient
storage
Refrigerated ingredient storage
Open cans [sauce]
Cook pasta, drain
[water, salt, pasta] Water
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
PRODUCT(S): Fettuccini Marinara with Broccoli, Ready to Cook PAGE 5 of 17 PLANT NAME: FSPCA Exercise Version ISSUE DATE 2/25/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 2/24/2016
FSPCA Training Model For Exercise After Chapter 6: Preliminary Steps in Developing a Food Safety Plan
ProcessNarrative
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.
PRODUCT(S): Fettuccini Marinara with Broccoli, Ready to Cook PAGE 6 of 17 PLANT NAME: FSPCA Exercise Version ISSUE DATE 2/25/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 2/24/2016
FSPCA Training Model For Exercise After Chapter 6: Preliminary Steps in Developing a Food Safety Plan
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).
PRODUCT(S): Fettuccini Marinara with Broccoli, Ready to Cook PAGE 7 of 17 PLANT NAME: FSPCA Exercise Version ISSUE DATE 2/25/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 2/24/2016
FSPCA Training Model
For Exercise After Chapter 8: Hazard Analysis and Preventive Controls Determination
HazardAnalysisHazard 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)
Ingredient/ Processing Step
(2) Identify potential food
safety hazards introduced, controlled
or enhanced at this step
(3) Do any
potential food safety
hazards require a
preventive control?
(4) Justify your decision for column 3
(5) What preventive control
measure(s) can be applied to significantly minimize
or prevent the food safety hazard?
Process including CCPs, Allergen, Sanitation, Supply‐chain, other preventive control
(6) Is the
preventive control
applied at this step?
Yes No Yes No
Receiving packaging
B None C Undeclared
allergens X Labels on cartons must declare
allergens present in the product and print errors have occurred
Allergen Control for label review by qualified individual
X
P None Receiving shelf stable ingredients – pasta
B Sporeforming pathogens such as B. cereus
X B. cereus spores may be present in dry pasta and outbreaks due to growth after hydration have occurred. Levels present at receiving are not hazardous and will not change as long as the pasta is dry.
Subsequent cooling step prevents B. cereus growth and toxin formation in rehydrated pasta.
X
Vegetative pathogens such as Salmonella
X Salmonella may be present in pasta at a very low frequency and subsequent cooking is more than adequate to destroy it
Staphylococcus aureus enterotoxin
X S. aureus can form heat stable toxin during pasta production at the supplier without preventive control.
Supply-chain Control is essential to prevent S. aureus enterotoxin prior to receipt.
X
C Allergen – wheat X Wheat is an allergen and could contribute to cross-contact for other products that do not contain wheat.
Allergen Control for cross-contact prevention and allergen labeling at a later step
X
P None Receiving shelf stable ingredients – salt
B None C None P None
Receiving shelf stable ingredients – tomato sauce
B None Low pH, shelf-stable product is not likely to have biological hazards
C None P None
PRODUCT(S): Fettuccini Marinara with Broccoli, Ready to Cook PAGE 8 of 17 PLANT NAME: FSPCA Exercise Version ISSUE DATE 2/25/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 2/24/2016
FSPCA Training Model
For Exercise After Chapter 8: Hazard Analysis and Preventive Controls Determination
(1) Ingredient/
Processing Step
(2) Identify potential food
safety hazards introduced, controlled
or enhanced at this step
(3) Do any
potential food safety
hazards require a
preventive control?
(4) Justify your decision for column 3
(5) What preventive control
measure(s) can be applied to significantly minimize
or prevent the food safety hazard?
Process including CCPs, Allergen, Sanitation, Supply‐chain, other preventive control
(6) Is the
preventive control
applied at this step?
Yes No Yes No
Receiving shelf stable ingredients – spices (pepper, garlic)
B Vegetative pathogens (Salmonella)
X Salmonella has been known to occasionally contaminate spices. Treated spices are used so this is unlikely.
Supply-chain Control – pathogen reduction treatment for these ingredients
X
Pathogenic sporeformers (C. perfringens, B. cereus)
X C. perfringens and B. cereus spores may be in spices but cannot grow in the dry spice or in the sauce during processing time, especially given the acid pH of the tomato sauce.
C None P None
Receiving frozen ingredients – broccoli
B Vegetative pathogens such as L. monocytogenes, Salmonella
X Bacterial pathogens may be present in raw produce. Supplier determined that their blanching process is adequate to destroy vegetative pathogens, but recontamination can occur if sanitation controls are not in place. Freezing prevents growth.
Supply-chain Control – Blanching and environmental sanitation controls reduce vegetative pathogens and freezing prevents pathogen growth.
X
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 refrigerated Romano cheese
B Vegetative pathogens such as Salmonella, Staphylococcus aureus and pathogenic E. coli
X Processing and fermentation practices influence the potential for pathogen presence and growth, which must be controlled by the supplier
Supply-chain Control – processing and fermentation procedures to control hazards
X
C Allergens X Cheese is a source of milk allergens and could contribute to cross-contact for other products that do not contain milk.
Allergen Control for cross-contact prevention and allergen labeling at a later step
X
P None Packaging storage
B None C Allergen cross-
contact during storage
X Plant- specific GMPs allow only sealed containers of allergenic ingredients in dry storage, thus cross-contact unlikely
P None Continued
PRODUCT(S): Fettuccini Marinara with Broccoli, Ready to Cook PAGE 9 of 17 PLANT NAME: FSPCA Exercise Version ISSUE DATE 2/25/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 2/24/2016
FSPCA Training Model
For Exercise After Chapter 8: Hazard Analysis and Preventive Controls Determination
(1) Ingredient/
Processing Step
(2) Identify potential food
safety hazards introduced, controlled
or enhanced at this step
(3) Do any
potential food safety
hazards require a
preventive control?
(4) Justify your decision for column 3
(5) What preventive control
measure(s) can be applied to significantly minimize
or prevent the food safety hazard?
Process including CCPs, Allergen, Sanitation, Supply‐chain, other preventive control
(6) Is the
preventive control
applied at this step?
Yes No Yes No
Shelf stable ingredient storage [pasta, sauce, salt, spices]
B None C Allergen cross-
contact during storage
X Plant-specific GMPs allow only sealed containers of allergenic ingredients in dry storage, thus cross-contact unlikely
P None Frozen ingredient storage [broccoli]
B None C None P None
Refrigerated ingredient storage [cheese]
B None C Allergen cross-
contact during storage
X Only closed containers of allergenic ingredients are stored in this storage area.
P None Open cans [sauce]
B None C None P Metal shavings X Preventive maintenance is
applied, however metal shavings are observed from time to time
Process control – subsequent metal detection
X
Cook pasta, drain
B None Validation data demonstrated 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
EPA requirements by the city
C None P None
Cool pasta, drain
B Sporeforming pathogens such as B. cereus
X Spores may survive cooking. Growth and toxin production could occur during slow cooling.
Process Control – Time and temperature control for cooling pasta
X
C Allergen X Kettles used only for cooking wheat pasta, which prevents cross-contact to other foods
P None Continued
PRODUCT(S): Fettuccini Marinara with Broccoli, Ready to Cook PAGE 10 of 17 PLANT NAME: FSPCA Exercise Version ISSUE DATE 2/25/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 2/24/2016
FSPCA Training Model
For Exercise After Chapter 8: Hazard Analysis and Preventive Controls Determination
(1) Ingredient/
Processing Step
(2) Identify potential food
safety hazards introduced, controlled
or enhanced at this step
(3) Do any
potential food safety
hazards require a
preventive control?
(4) Justify your decision for column 3
(5) What preventive control
measure(s) can be applied to significantly minimize
or prevent the food safety hazard?
Process including CCPs, Allergen, Sanitation, Supply‐chain, other preventive control
(6) Is the
preventive control
applied at this step?
Yes No Yes No
Mix all ingredients
B Environmental pathogens such as L. mono.
X Recontamination may occur if environmental control is not in place
Sanitation controls verified by environmental monitoring1, 2
X
C None P Metal X Mixing metal on metal contact
may periodically produce metal hazards.
Process Control – metal detection at a later step
X
Fill, heat seal film, weigh
B Environmental pathogens such as L. mono.
X Recontamination may occur if environmental control is not in place
Sanitation Controls verified by environmental monitoring
X
C None P None
Metal detection
B None C None P Metal X Opening cans and mixing metal
on metal contact may periodically produce metal hazards.
Process Control – metal detection
X
Freezing B Growth of environmental pathogens and pathogenic sporeformers
X Product is frozen in under 1 hour and pathogens won't grow in frozen product. As per SOPs, freezer is cleaned and maintained to be in sanitary condition.
C None P None
Label/carton B None C Undeclared
Allergens –wheat, milk
X Product contains wheat and milk allergens
Allergen Control – declaration on label
X
P None Frozen product storage
B None C None P None
Frozen product shipping
B None C None 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
PRODUCT(S): Fettuccini Marinara with Broccoli, Ready to Cook PAGE 11 of 17 PLANT NAME: FSPCA Exercise Version ISSUE DATE 2/25/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 2/24/2016
FSPCA Training Model For Exercise After Chapter 9: Process Preventive Controls
ProcessControlsProcess
Control(s) Hazard(s) Critical
Limits Monitoring Corrective Action Verification Records
What How Frequency Who
Cool pasta, drain
Growth of spore-formers such as B. cereus
Chill pasta to 50°F or less within 4 hours or less
Pasta temperature and time
Recording thermometer that is placed directly in pasta
Every batch
Cook or designee
If temperature is not achieved in the specified time, then 1) add more cold water or ice to achieve temperature;
2) segregate product, evaluate product, rework or discard as appropriate,
2) identify root cause;
3) conduct training to prevent recurrence
Daily review of Pasta Cooling log by Supervisor.
Accuracy of thermometer checked weekly by QA Tech. Quarterly thermometer calibration
Pasta cooling log Thermometer calibration records Verification records Validation report for determining critical limit cooling parameters 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.
PRODUCT(S): Fettuccini Marinara with Broccoli, Ready to Cook PAGE 12 of 17 PLANT NAME: FSPCA Exercise Version ISSUE DATE 2/25/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 2/24/2016
FSPCA Training Model For Exercise After Chapter 10: Food Allergen Preventive Controls
AllergenPreventiveControls
Allergen Controls
Hazard(s) Criteria Monitoring Corrective Action Verification Records
What How Frequency Who
Receiving packaging
Undeclared allergen - Wheat or milk
Presence of allergens in formulation on labels received
Label matches product number and declares milk and wheat
Visual inspection to product specification
Each receipt before release to production
Label coordinator
If allergen statement is incorrect:
1) segregate and block packaging stock;
2) Contact supplier for return, identification of root cause, and delivery of new labels
QA manager reviews and initials records weekly and compares results with past information to determine any trends.
Allergen label receiving inspection log
Corrective action records
Verification records
Label/ carton step allergen labeling
Undeclared Allergens –Wheat or milk
Correct labels applied to finished product using labeled cartons
Label matches product number
Visual inspection of one finished product sample to ensure proper allergen labeling information on label
At the beginning and end of each packaging run, and each new case of containers
Packaging line worker
If label is incorrect:
1) segregate product, inspect back to the last good check, re-package in cartons with correct label, or discard product;
2) identify root cause;
3) conduct training as appropriate
QA manager reviews and initials records weekly and compares results with past testing to determine any trends.
Allergen Label Check log
Verification records
Corrective action records
Allergen Label Verification Listing Products Allergen Statement Fettuccini Marinara with Broccoli Contains: Wheat, milk
Shrimp and Angel Hair Pasta Contains: Wheat, shrimp
Pasta Primavera Contains: Wheat
PRODUCT(S): Fettuccini Marinara with Broccoli, Ready to Cook PAGE 13 of 17 PLANT NAME: FSPCA Exercise Version ISSUE DATE 2/25/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 2/24/2016
FSPCA Training Model For Exercise After Chapter 10: Food Allergen Preventive Controls
Production Line Allergen Assessment
Product Name Production
Line
Intentional Allergens
Eg
g
Milk
So
y
Wh
eat
Tre
e N
ut
(m
arke
t na
me)
Pea
nu
t
Fis
h
(m
arke
t na
me)
Sh
ellf
ish
(m
arke
t na
me)
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.
PRODUCT(S): Fettuccini Marinara with Broccoli, Ready to Cook PAGE 14 of 17 PLANT NAME: FSPCA Exercise Version ISSUE DATE 2/25/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 2/24/2016
FSPCA Training Model For Exercise After Chapter 11: Sanitation Preventive Controls
SanitationPreventiveControlsNOTE: 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)
Frequency: During production
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. 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 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.
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 one week
PRODUCT(S): Fettuccini Marinara with Broccoli, Ready to Cook PAGE 15 of 17 PLANT NAME: FSPCA Exercise Version ISSUE DATE 2/25/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 2/24/2016
FSPCA Training Model 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” 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.
PRODUCT(S): Fettuccini Marinara with Broccoli, Ready to Cook PAGE 16 of 17 PLANT NAME: FSPCA Exercise Version ISSUE DATE 2/25/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 2/24/2016
FSPCA Training Model For Exercise After Chapter 12: Supply-chain Preventive Controls
Supply‐chain‐appliedPreventiveControlsProgramDetermination of Verification Procedures
SpicesHazards 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.
PastaHazards 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.
RomanocheeseHazards requiring a supply-chain-applied control: Hazard analysis determined that vegetative 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.
Verification activities: Same as for Spices.
Verification procedures: Same as for Spices.
Records: Same as for Spices.
FrozenbroccoliHazards requiring a supply-chain-applied control: Hazard analysis determined that vegetative 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.
Verification activities: Same as for Spices.
Verification procedures: Same as for Spices.
Records: Same as for Spices.
PRODUCT(S): Fettuccini Marinara with Broccoli, Ready to Cook PAGE 17 of 17 PLANT NAME: FSPCA Exercise Version ISSUE DATE 2/25/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 2/24/2016
FSPCA Training Model For Exercise After Chapter 12: Supply-chain Preventive Controls
Approved Suppliers for Ingredients Requiring a Supply-chain-applied Control Ingredient (requiring supply-chain-applied control)
Approved Supplier
Hazard(s) requiring supply-chain-applied control
Date of Approval
Verification method
Verification records
Spices Spicetown Co., Port, USA
Vegetative pathogens such as Salmonella
10/08/2010 Copy of 3rd party audit by a qualified auditor obtained from supplier
Copy of audit kept in Supplier Verification file Incoming goods log
Pasta MajorCo, Wheaton, USA
Staphylococcus aureus
9/9/2009
Romano cheese
Big Cheese Co., Cheesytown, USA
Vegetative pathogens such as Salmonella, S. aureus and pathogenic E. coli
1/21/2009
Frozen broccoli
USGrown Co., Farmvalley, USA
Vegetative pathogens, such as L. monocytogenes and Salmonella
2/22/2009
Receiving Procedure for Ingredients Requiring a Supply-chain-applied Control
For each shipment received, the receiving clerk:
verifies that the product is from an approved supplier
documents the above in the incoming goods log.
PRODUCT(S): Peanut Butter PAGE 1 of 16 PLANT NAME: Example ISSUE DATE 2/24/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model For Exercise After Chapter 6: Preliminary Steps in Developing a Food Safety Plan
Selected Sections of a
Food Safety Plan
for Peanut Butter
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. 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.
PRODUCT(S): Peanut Butter PAGE 2 of 16 PLANT NAME: Example ISSUE DATE 2/24/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model For Exercise After Chapter 6: Preliminary Steps in Developing a Food Safety Plan
TableofContentsCompany 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
PRODUCT(S): Peanut Butter PAGE 3 of 16 PLANT NAME: Example ISSUE DATE 2/24/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model For Exercise After Chapter 6: Preliminary Steps in Developing a Food Safety Plan
CompanyOverviewThis 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.
ProductDescriptionProduct Name(s) Peanut Butter – Creamy, Chunky and Extra Chunky
Product Description, including Important Food Safety Characteristics
Peanut butter with varying sizes of peanut particulates depending on the variety. 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
Intended Consumers
General public
Shelf Life
Nine months ambient, unopened
Labeling Instructions
Contains peanuts
Storage and Distribution
Ambient
Approved:
Signature: F.S. Leader Print name: F.S. Leader
Date: 8 August 2015
PRODUCT(S): Peanut Butter PAGE 4 of 16 PLANT NAME: Example ISSUE DATE 2/24/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model For Exercise After Chapter 6: Preliminary Steps in Developing a Food Safety Plan
FlowDiagram
Receiving packaging material
(jars, lids, labels)
Receiving shelf stable ingredients
(Sugar, vegetable oil, salt)
Raw peanut receiving
Packaging storage Non-peanut ingredient
storage (sugar, vegetable oil, salt)
Raw peanut storage (ambient < 70%RH)
Raw peanut cleaning
Roasting1 (300oF / 25 min dry)
Cooling
Mix all ingredients
(peanut paste, sugar, vegetable oil, salt)
Grinding
Cleaning jars
(invert and flush with filtered air)
Fill, weigh, seal
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.
PRODUCT(S): Peanut Butter PAGE 5 of 16 PLANT NAME: Example ISSUE DATE 2/24/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model For Exercise After Chapter 6: Preliminary Steps in Developing a Food Safety Plan
ProcessNarrative
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.
Receiving shelf stable ingredients 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.
Receiving shelf stable ingredients 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.
PRODUCT(S): Peanut Butter PAGE 6 of 16 PLANT NAME: Example ISSUE DATE 2/24/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model For Exercise After Chapter 6: Preliminary Steps in Developing a Food Safety Plan
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.
PRODUCT(S): Peanut Butter PAGE 7 of 16 PLANT NAME: Example ISSUE DATE 2/24/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model For Exercise After Chapter 8: Hazard Analysis and Preventive Controls Determination
HazardAnalysisHazard identification (column 2) considers those that may be present in the food because the hazard occurs naturally, the hazard may be unintentionally introduced, or the hazard may be intentionally introduced for economic gain.
B = Biological hazards including bacteria, viruses, parasites, and environmental pathogens C = Chemical (including radiological) hazards, food allergens, substances such as pesticides and drug residues,
natural toxins, decomposition, and unapproved food or color additives P = Physical hazards include potentially harmful extraneous matter that may cause choking, injury or other
adverse health effects (1)
Ingredient/ Processing
Step
(2) Identify potential
food safety hazards introduced,
controlled or enhanced at this step
(3) Do any
potential food safety hazards
require a preventive
control?
(4) Justify your decision for column 3
(5) What preventive control
measure(s) can be applied to significantly minimize or prevent the food safety
hazard? Process including CCPs, Allergen, Sanitation, Supply‐chain, other
preventive control
(6) Is the
preventive control
applied at this step?
Yes No Yes No
Receiving packaging- jars and lids
B None C None P None
Receiving packaging - labels
B None C Undeclared
allergen (peanut) X Product contains peanut as an
ingredient Allergen control –Label review upon receipt for correct allergen information
X
P None Receiving non-peanut ingredients – salt, sugar, oil
B None C None P None
Receiving raw peanuts
B Non-sporeforming pathogens such as Salmonella
X Raw peanuts have a history of contamination with vegetative pathogens from the environment or harvesting
Process control – Subsequent roasting destroys Salmonella
X
C Aflatoxin X Aflatoxin may be present due to growth of Aspergillus flavus during growth, harvesting or storage.
Supply-chain Control - Verification of supplier Certificate of Analysis
X
Unapproved pesticide
X Unapproved pesticides may be present in imported peanuts but are less likely in domestically sourced peanuts. Domestic peanuts are used
P Foreign material e.g., wood, metal, plastic, stones
X Grinding and milling would reduce the size to a non-hazardous nature. Supplier controls these to prevent adulteration and potential equipment damage.
Packaging storage
B None C None P None
Non-peanut ingredient storage
B None C None P None
continued
PRODUCT(S): Peanut Butter PAGE 8 of 16 PLANT NAME: Example ISSUE DATE 2/24/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model For Exercise After Chapter 8: Hazard Analysis and Preventive Controls Determination
(1) Ingredient/ Processing
Step
(2) Identify potential
food safety hazards introduced,
controlled or enhanced at this step
(3) Do any
potential food safety hazards
require a preventive
control?
(4) Justify your decision for column 3
(5) What preventive control
measure(s) can be applied to significantly minimize or prevent the food safety
hazard? Process including CCPs, Allergen, Sanitation, Supply‐chain, other
preventive control
(6) Is the
preventive control
applied at this step?
Yes No Yes No
Raw peanut storage
B None C Aflatoxin X The dry conditions and short
storage time prevents production of aflatoxin
P None Raw peanut cleaning
B Environmental pathogens such as Salmonella
X Raw peanuts nuts may contain Salmonella than can contaminate the environment
Sanitation control – Hygienic zoning needed to contain potential Salmonella in this pre-roast area
X
C None P Foreign material;
e.g., wood, metal, plastic, , stones
X Grinding and milling would reduce the size to a non-hazardous nature or material would damage equipment to prevent processing
Roasting B Non-sporeforming pathogens such as Salmonella
X Non-sporeforming pathogens may be present in the raw peanuts
Process control – Roasting step destroys Salmonella by thermal treatment
X
C None P Foreign material -
metal X Data from subsequent metal
detection demonstrates that metal fragments originating from the roasting rarely occur due in part to preventive maintenance
Cooling B Environmental pathogens such as Salmonella
X Salmonella harbored in the environment could contaminate exposed product in cooling
Sanitation control – Zoning and dry cleaning procedures
X
C None
P None Grinding B Environmental
pathogens such as Salmonella
X Salmonella harbored in the environment could contaminate exposed product
Sanitation control – Zoning and dry cleaning procedures
X
C None P Foreign material -
metal X Metal fragments could be
generated during the grinding process
Process control – Metal detection at later step
X
Mixing all ingredients
B Environmental pathogens such as Salmonella
X Salmonella harbored in the environment could contaminate exposed product
Sanitation control – Zoning and dry cleaning procedures
X
C None P Foreign material -
metal X Metal fragments could be
generated during the mixing process. Preventive maintenance reduces the occurrence.
Process control – Metal detection at later step
X
continued
PRODUCT(S): Peanut Butter PAGE 9 of 16 PLANT NAME: Example ISSUE DATE 2/24/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model For Exercise After Chapter 8: Hazard Analysis and Preventive Controls Determination
(1) Ingredient/ Processing
Step
(2) Identify potential
food safety hazards introduced,
controlled or enhanced at this step
(3) Do any
potential food safety hazards
require a preventive
control?
(4) Justify your decision for column 3
(5) What preventive control
measure(s) can be applied to significantly minimize or prevent the food safety
hazard? Process including CCPs, Allergen, Sanitation, Supply‐chain, other
preventive control
(6) Is the
preventive control
applied at this step?
Yes No Yes No
Cleaning jars
B Environmental pathogens such as Salmonella
X Air filter that traps Salmonella is in place and on a preventive 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, seal
B Environmental pathogens such as Salmonella
X Salmonella harbored in the environment could contaminate exposed product
Sanitation control – Zoning and dry cleaning procedures
X
C Undeclared milk allergen from chocolate spread product
X Chocolate spread, which is also produced in the facility, contains milk, which is a food allergen.
Allergen control –Dedicated filler for milk-containing products to prevent cross-contact
X
P None Label, code B None
C Undeclared allergen - peanut
X It is essential that the correct label is on the package to inform allergic consumers
Allergen control – Allergen label verification
X
P None Metal detection
B None C None P Foreign material -
metal X Metal could be present in the raw
materials, generated from equipment or introduced by employees
Process control – metal detection
X
Casing B None C None P None
Dry storage B None C None P None
Shipping B None C None P None
PRODUCT(S): Peanut Butter PAGE 10 of 16 PLANT NAME: Example ISSUE DATE 2/24/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model For Exercise After Chapter 9: Process Preventive Controls
ProcessPreventiveControls
Process Control(s) Hazard(s)
Critical Limits
Monitoring
Corrective Action Verification Records What How Frequency Who
Roasting Non-sporeforming pathogens such as Salmonella
Minimum roast time: 25 minutes
Length of roast cycle
Measure time-in to time-out with stop watch and metal test unit run through oven
Beginning of shift and after any adjustment
Roaster operator
If roasting is interrupted, product is held and evaluated to determine if it can be re-processed.
If a processing parameter was not met, reprocess batch using alternate validated process; identify root cause and determine actions needed to address it; conduct training as needed to prevent recurrence.
Also segregate and evaluate product, rework or discard as appropriate.
Operator verifies the roaster bed depth, temperature and roasting time are accurate and operating properly during the processing run once each day during morning shift.
QA manager reviews and initials records within a week of preparation and compares performance with past results to determine trends.
Maintenance manager ensures that roaster and monitoring equipment are calibrated.
Finished product tested for Enterobacteriaceae once every 2 weeks. Salmonella is analyzed if hygiene Enterobacteriaceae counts are found out of specification.
Roasting log, including time, temperature and depth records.
Recording device calibration records.
Corrective action logs.
Validation study establishing roasting parameters
Bed depth ≤2 inches
Bed depth leveling bar height
Leveling bar height is set at 2 inches high at oven inlet
Check at startup and end of day
Oven temperature minimum 300oF Note: to achieve 5 log reduction of Salmonella
Oven air temperature
Recording thermometer at the coldest locations (i.e., inlet and outlet of oven)
Continuous with visual check of recorded data at start-up and once per day at each location
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.
PRODUCT(S): Peanut Butter PAGE 11 of 16 PLANT NAME: Example ISSUE DATE 2/24/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model For Exercise After Chapter 10: Food Allergen Preventive Controls
AllergenPreventiveControls
Allergen Declaration on Packaged Product
Allergen Controls
Hazard(s) Criterion Monitoring Corrective
Action Verification Records
What How Frequency Who
Receiving packaging material - Labels
Undeclared allergen (peanuts)
Correct ingredient and allergen information is printed on the label
Presence of peanut in ingredient list and “contains” statement on label
Visual inspection to ensure all allergens in the formula are on the label
Each batch of printed labels before release to production
Label coordinator
Reject label, request replacement with correct information from label printer.
Label coordinator verifies declared allergens match current formula monthly and each formula change. Preventive Controls Qualified Individual or designee reviews records within 7 working days.
Product label review form. Ingredient formula Corrective action records
Label verification – Label, code step
Undeclared allergen (peanuts)
Correct labels are loaded into labelling equipment
Correct label is loaded onto labelling equipment
Visual inspection
Each time labels are loaded onto machine
Operator Return material to warehouse, request correct labelling.
Verify label review procedure
Review records to evaluate trends
Allergen label check log
Production deviation log
Allergen Label Verification Listing Products Allergen Statement
Plain, Chunky, and Extra Chunky Contains: Peanut
Peanut Butter Chocolate Swirl Contains: Peanut, milk
PRODUCT(S): Peanut Butter PAGE 12 of 16 PLANT NAME: Example ISSUE DATE 2/24/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model For Exercise After Chapter 10: Food Allergen Preventive Controls
Production Line Allergen Assessment
Product Name Production
Line
Intentional Allergens
Eg
g
Milk
So
y
Wh
eat
Tre
e N
ut
(m
arke
t na
me)
Pea
nu
t
Fis
h
(m
arke
t na
me)
Sh
ellf
ish
(m
arke
t na
me)
Plain, Chunky and Extra Chunky Peanut Butter 1 X Peanut Butter Chocolate Swirl 1
(same line but different filler head)
X Unique allergen
X
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
Allergen Controls Hazard(s) Criterion
Monitoring Corrective
Action Verification Records What How Frequency Who Dedicated
filler for milk-containing products to
prevent cross-contact
Undeclared milk
allergen from
chocolate spread product
Peanut-dedicated filler
is in place
Only peanut – dedicated filler is used for peanut
only products
Visual observation
that the correct filler is in place
Beginning of shift and
at each formula change
Line operator Segregate all product back to last good
check. Discard or rework into
peanut chocolate swirl
product. Replace
correct filler. Determine why
wrong filler was used and
retrain.
QA manager reviews and initials
records within a week of
preparation
Review records to evaluate trends
Filler check log
Corrective action records
PRODUCT(S): Peanut Butter PAGE 13 of 16 PLANT NAME: Example ISSUE DATE 2/24/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model For Exercise After Chapter 11: Sanitation Preventive Controls
SanitationPreventiveControlsNOTE: 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.
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
Packaging storage
Cleaning jars
Fill, weigh, seal
Label, code
Metal detection
Casing
Receiving for non‐peanut raw materials
Non‐peanut ingredient
storage
Mix ingredients
Grinding Cooling
Hall
Finished product storage
Receiving for raw peanuts
Raw peanut storage
Raw peanut cleaning
Roasting Shipping
Hallway
Maintenance MechanicalMen’s locker
room
Women’s locker room
Small utensil
washingOffice
Raw peanut area, Basic GMP, Primary pathogen control area – CONTROLLED ACCESSNon‐GMP area
PRODUCT(S): Peanut Butter PAGE 14 of 16 PLANT NAME: Example ISSUE DATE 2/24/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model For Exercise After Chapter 11: Sanitation Preventive Controls
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
PRODUCT(S): Peanut Butter PAGE 15 of 16 PLANT NAME: Example ISSUE DATE 2/24/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model 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 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.
Laboratory: Wee Beasties Laboratory (987 Critter Drive, Yourtown, USA) conducts the analysis 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 result sheet identifies the specific method number used.
Interpretation of results:
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.
PRODUCT(S): Peanut Butter PAGE 16 of 16 PLANT NAME: Example ISSUE DATE 2/24/2016 ADDRESS: 123 Xyz Street, USA SUPERSEDES 10/22/2015
FSPCA Training Model For Exercise After Chapter 12: Supply-chain Preventive Controls
Supply‐chainPreventiveControlsProgram
Determination of Verification Procedures
Hazards requiring a supply-chain-applied control: Hazard analysis determined that 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.
Approved Suppliers for Ingredients Requiring a Supply-chain-applied Control Ingredient (requiring supply-chain-applied control)
Approved Supplier
Hazard(s) requiring supply-chain-applied control
Date of Approval
Verification method
Verification records
Shelled peanuts
Nuts2U Co., Cropville, USA
Aflatoxin 10/08/2010 Supplier’s Certificate of Analysis (COA) with each shipment
COA and incoming goods log, corrective records
Receiving procedures: For each shipment received, the receiving clerk:
verifies that the product is from an approved supplier
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 PLANT NAME: Example ISSUE DATE 2/24/2016 ADDRESS: 123 ABC Street, USA SUPERSEDES 10/20//2015
FSPCA Training Model
For Exercise After Chapter 6: Preliminary Steps in Developing a Food Safety Plan
Selected Sections of a
Food Safety Plan for
Ground Black Pepper
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. 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.
PRODUCT(S) Ground Black Pepper PAGE 2 of 12 PLANT NAME: Example ISSUE DATE 2/24/2016 ADDRESS: 123 ABC Street, USA SUPERSEDES 10/20//2015
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 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
Sanitation Preventive Controls .................................................................................................... 10
- 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
PRODUCT(S) Ground Black Pepper PAGE 3 of 12 PLANT NAME: Example ISSUE DATE 2/24/2016 ADDRESS: 123 ABC Street, USA SUPERSEDES 10/20//2015
FSPCA Training Model
For Exercise After Chapter 6: Preliminary Steps In Developing a Food Safety Plan
CompanyOverviewThis 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.
ProductDescriptionProduct Name(s) Ground Black Pepper
Product Description, including Important Food Safety Characteristics
Dried ground black pepper
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 Intended Consumers General public Shelf Life ~ 2 years ambient Labeling Instructions None Storage and Distribution Dried, ambient temperature Approved:
Signature: F.S. Leader Print name: F.S. Leader
Date: 10/8/2015
PRODUCT(S) Ground Black Pepper PAGE 4 of 12 PLANT NAME: Example ISSUE DATE 2/24/2016 ADDRESS: 123 ABC Street, USA SUPERSEDES 10/20//2015
FSPCA Training Model
For Exercise After Chapter 6: Preliminary Steps In Developing a Food Safety Plan
FlowDiagram
Receiving Shelf Stable Ingredients
Receiving Packaging
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.
PRODUCT(S) Ground Black Pepper PAGE 5 of 12 PLANT NAME: Example ISSUE DATE 2/24/2016 ADDRESS: 123 ABC Street, USA SUPERSEDES 10/20//2015
FSPCA Training Model
For Exercise After Chapter 6: Preliminary Steps In Developing a Food Safety Plan
ProcessNarrativeIngredients 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.
PRODUCT(S) Ground Black Pepper PAGE 6 of 12 PLANT NAME: Example ISSUE DATE 2/24/2016 ADDRESS: 123 ABC Street, USA SUPERSEDES 10/20//2015
FSPCA Training Model
For Exercise After Chapter 8: Hazard Analysis and Preventive Controls Determination
HazardAnalysisHazard 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) Ingredient/ Processing
Step
(2) Identify potential
food safety hazards introduced,
controlled or enhanced at this
step
(3) Do any
potential food safety
hazards require a
preventive control?
(4) Justify your decision for column 3
(5) What preventive control
measure(s) can be applied to significantly minimize or
prevent the food safety hazard? Process including CCPs,
Allergen, Sanitation, Supply‐chain, other preventive control
(6) Is the
preventive control
applied at this step?
Yes No Yes No
Receiving shelf stable ingredients – peppercorns
B Vegetative bacteria such as Salmonella and pathogenic E. coli
X Salmonella and pathogenic E. coli recalls and outbreak history
Process Control: Subsequent inactivation step
X
C Pesticides X Imported product Supply‐chain Control: Verification of supplier Certificates of Analysis for pesticide residues
X
P Foreign material (e.g., stones, wire etc.)
X Unavoidable foreign material is associated with the growing and harvesting environment. Subsequent grinding eliminates potential physical hazards, but presents potential adulteration issues. Metal may damage grinding equipment.
Receiving packaging
B None
C None
P None
Ingredient storage
B None
C None
P None
Packaging storage
B None
C None
P None
Cleaning B None
C None
P Foreign material
X Addresses potential adulteration but not safety ‐ see above for receiving peppercorns
continued
PRODUCT(S) Ground Black Pepper PAGE 7 of 12 PLANT NAME: Example ISSUE DATE 2/24/2016 ADDRESS: 123 ABC Street, USA SUPERSEDES 10/20//2015
FSPCA Training Model
For Exercise After Chapter 8: Hazard Analysis and Preventive Controls Determination
(1) Ingredient/ Processing
Step
(2) Identify potential
food safety hazards introduced,
controlled or enhanced at this
step
(3) Do any
potential food safety
hazards require a
preventive control?
(4) Justify your decision for column 3
(5) What preventive control
measure(s) can be applied to significantly minimize or
prevent the food safety hazard? Process including CCPs,
Allergen, Sanitation, Supply‐chain, other preventive control
(6) Is the
preventive control
applied at this step?
Yes No Yes No
Pathogen destruction
B Vegetative pathogens such as Salmonella and pathogenic E. coli
X History of outbreaks and recalls show these organisms may be present
Process Control: Heat treatment for pathogen reduction
X
C None
P None
Grinding B Environmental pathogens such as Salmonella
X Post pasteurization contamination, cross contamination
Sanitation Control: Zoning and dry sanitation
X
C None
P Metal X Equipment failure can potentially introduce metal
Process Control: Subsequent metal detection
X
Metal detection
B None C None P Metal X Potential equipment failure at
grinding step Process Control: Metal detection
X
Packaging B Environmental pathogens such as Salmonella
X Post pasteurization contamination, cross contamination
Sanitation Control: Zoning and dry sanitation
X
C Undeclared allergens
X Other products packed contain allergens
Allergen Control: prevent allergen cross‐contact
X
P None
Storage B None
C None
P None
Shipping B None
C None
P None
PRODUCT(S) Ground Black Pepper PAGE 8 of 12 PLANT NAME: Example ISSUE DATE 2/24/2016 ADDRESS: 123 ABC Street, USA SUPERSEDES 10/20//2015
FSPCA Training Model
For Exercise After Chapter 9: Process Preventive Controls
ProcessPreventiveControls
Process Control(s)
Hazard(s) Critical Limits Monitoring Corrective Action
Verification Activities
Records
What How Frequency Who
Pathogen Destruction
Vegetative pathogens such as Salmonella and pathogenic E. coli
XF for Y1 minutes as a heat treatment for peppercorns
Review time and temperature on recording chart to meet parameters listed under critical limits
Chart recorder
After initial temperature is reached, conduct continuous monitoring by visual check of recording instrument chart during each run.
Pathogen destruction equipment operator
If parameters are not met then reprocess.
Determine the root cause of processing failure and correct to prevent recurrence.
Calibrate equipment once per month
QA manager or designee reviews and initials records daily Quarterly generic E. coli and Salmonella testing
Pathogen Destruction Processor Log
Recording device calibration records
Corrective actions
Validation study by American Spice Trade Association demonstrating that the time/ temperature exposure for peppercorns heat is sufficient for a 5-log inactivation. Copy of report is in the plan.
Metal Detection
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.
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.
PRODUCT(S) Ground Black Pepper PAGE 9 of 12 PLANT NAME: Example ISSUE DATE 2/24/2016 ADDRESS: 123 ABC Street, USA SUPERSEDES 10/20//2015
FSPCA Training Model
For Exercise After Chapter 10: Food Allergen Preventive Controls
AllergenPreventiveControlsAllergen Cross-contact Prevention
Production Line Allergen Assessment
Product Name Productio
n Line
Intentional Allergens
Eg
g
Milk
So
y
Wh
eat
Tre
e N
ut
(m
arke
t na
me)
Pea
nu
t
Fis
h
(m
arke
t na
me )
S
hel
lfis
h
(mar
ket
nam
e )
Ground black pepper 1
Green, white and black peppercorn mix
1
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.
PRODUCT(S) Ground Black Pepper PAGE 10 of 12 PLANT NAME: Example ISSUE DATE 2/24/2016 ADDRESS: 123 ABC Street, USA SUPERSEDES 10/20//2015
FSPCA Training Model
For Exercise After Chapter 11: Sanitation Preventive Controls
SanitationPreventiveControlsAllergen 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
PRODUCT(S) Ground Black Pepper PAGE 11 of 12 PLANT NAME: Example ISSUE DATE 2/24/2016 ADDRESS: 123 ABC Street, USA SUPERSEDES 10/20//2015
FSPCA Training Model
For Exercise After Chapter 11: Sanitation Preventive Controls
Hygienic Zoning/ Environmental Monitoring Purpose: Hygienic zoning in post-pathogen destruction area is important to minimize the potential of re-contamination with environmental pathogens.
Frequency: During production
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.
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 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.
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 preventive controls and records review within one week.
PRODUCT(S) Ground Black Pepper PAGE 12 of 12 PLANT NAME: Example ISSUE DATE 2/24/2016 ADDRESS: 123 ABC Street, USA SUPERSEDES 10/20//2015
FSPCA Training Model
For Exercise After Chapter 12: Supply-chain Preventive Controls
Supply‐chain‐appliedControlsHazards requiring a supply-chain-applied control: Hazard analysis determined that 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.
Approved Suppliers for Ingredients Requiring a Supply-chain-applied Control Ingredient (requiring supply-chain-applied control)
Approved Supplier
Hazard(s) requiring supply-chain-applied control
Date of Approval
Verification method
Verification records
Black peppercorns
Spice4U Co., Port, USA
Pesticides 10/08/2010 Supplier’s Certificate of Analysis (COA) quarterly
COA, Pesticide Screen Log, 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.
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