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Shakshouka Inspired Breakfast Crepe
Frozen Breakfast for the On-the-Go Consumer
Danielle Bauer
May 9th, 2018
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Executive Summary
The current frozen breakfast marketplace is awash with repeated offerings of meat and egg
sandwiches. There are limited choices available for the health-conscious consumer, and even fewer
options for new and exciting world cuisines. Thus, an opportunity for a vegetable-based choice
from the Mediterranean region was identified. This product will fill the needs of busy moms and
millennial consumers and allow them to get the nutrition they crave in a portable crepe.
A Shakshouka-inspired crepe was developed from traditional Middle-Eastern breakfast
food recipes, and includes a ½ serving of vegetables, one whole egg, and is an excellent source of
protein. The product will be distributed and sold at retail in the frozen state in the frozen breakfast
aisle. Consumers can heat and serve the product and consume while on the go. Crepes Around the
World! is the intended brand name for the product and allows the potential for endless line
extension opportunities.
The crepe will be produced in three main component parts: vegetable, crepe, and egg. Each
line will be specifically tailored to each. Blanching of vegetables is a key step to control enzymes
in the kale and bell peppers. Each component will be cooked to food safe temperatures as defined
in the FDA Food Code to control food safety hazards. All components will come together after
thermal processing to be assembled automatically. Finally, each crepe will be hand rolled and
placed into the portable cone before freezing and further packaging. This process was chosen to
mimic the benchtop process as closely as possible to ensure a positive consumer experience.
The product will be guaranteed for six months shelf-life at frozen temperatures. Important
quality aspects include both controls during processing and after the final product is complete.
Line tests will include crepe batter viscosity, diameter, and bake color. The Shakshouka vegetable
mixture will be monitored for pH and Brix. Finished product tests include a complete sensory
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evaluation and comparison to Gold Standard. All tests ensure consistent product quality, time after
time, and helps to build a repeat customer base.
Financial considerations include fixed and variable costs for the product. A complete
analysis was completed along with ingredient and packaging costs to determine the number of
units required to be sold to ensure a profit. Projections of 200,000 units sold annually at a price of
$6.07 estimate a profit margin of 23.0% and return on investment of 62.7%. Successful marketing
campaigns will be critical in helping build the success of the brand and sell the product.
Based on consumer market research, focus panels, and the financial analysis, the
Shakshouka-inspired crepe has the potential for success in the marketplace. The product will fill
the needs of busy, health-conscious consumers all while opening up the door to new ethnic cuisine.
The potential for line extensions with recipes from other cultures will help build the brand and
consumer following. This product a great starting point to break into the market.
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Market Screening
Breakfast may be considered the most important meal of the day by traditional standards,
but a 2015 survey from Technomic found that only 80% of consumers eat breakfast sometimes
throughout the week and only 26% of consumers report eating breakfast every morning (Atchley
2015). What is the root cause of these statistics? The answer may not surprise you: minimal time
in the morning for busy consumers. Technomic reports that 37% of consumers are unable to
consume breakfast due to lack of time, and 20% do not eat breakfast at home (Atchley 2015).
Today, people are looking for quick and portable options for their weekday morning and 33% of
consumers age 18-34 even eat their breakfast while commuting to work or school (Doris 2018).
In our current non-stop culture, consumers require breakfast choices that can keep up with their
busy schedule. At the same time, they expect fresh, healthy ingredients and clean label products.
Many of the current popular trends in the food industry also apply to the breakfast segment.
Consumers are looking for convenient, healthy options, plant-based products, and new ethnic
cuisines (Doris 2018). As consumers become more accepting of new cuisines and are willing to
venture outside of their comfort zone, product developers can offer new and exciting choices
(Doris 2018). Many consumers try new dishes prepared at restaurants. As chefs move to adopt
new trends and expose the population to new ingredients and flavors, this helps to open the market
for food manufacturers at retail.
The overall market of the frozen food category has struggled in recent years, with IRI
reporting flat results in the dinner category (Garrison 2018). However, the breakfast category,
including both entrees and handheld items posted sales and unit gains (Garrison 2018). Options
featuring health benefits are a leading trend in the breakfast category, and are an expectation of
many consumers (Garrison 2018).
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A local market research screening found current trends in the frozen breakfast category
to include many health claims. Protein claims were a leading claim found on products, including
“Excellent source of protein” and “Good source of protein.” Brands also boasted claims of
“Natural” and “No artificial colors or flavors”. A great deal of breakfast products contained egg
and many held claims of “Cage-free eggs” or “No Antibiotics Ever”. A theme present throughout
the breakfast industry was offerings that were labeled as convenient and portable. Flavor trends
observed included mostly “traditional” breakfast, such as eggs, sausage or bacon, and cheese.
There was also a wide assortment of breakfast burritos containing egg and sausage. It was found
the only ethnic offering in the local selection was Mexican, which has long been established in
American food culture. This presents an opening for new and different ethnic trends to be
introduced alongside the current options.
Most Americans are not eating enough fruits and vegetables. In fact, the United States
Centers for Disease Control and Prevention reports that in 2015 just 12.2% of Americans ate the
recommended amount of 1.5-2 cups of fruits per day (Food Processing Hartman 2018).
Alarmingly, the numbers for vegetables are even lower. The CDC reports that just 9.3% ate the
recommended daily intake of 2-3 cups of vegetables per day (Hartman 2018). Fortunately, Food
Processing Magazine reports that the demand for fresh produce is growing as more studies reveal
the importance of fruits and vegetables to human health (Hartman 2018).
Based on the literature review of food trends today, food claims observed in the
marketplace, and an overwhelming interest in health and fitness, a need within the retail frozen
breakfast section was identified for new and exciting ethnic products. Considering consumer
demand for portable and healthy options and acceptance of plant-based products, a vegetable-filled
Mediterranean inspired crepe was formulated. The Mediterranean diet is known for its health
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benefits and has become increasingly popular in the United States. A portable frozen breakfast
crepe filled with vegetables, egg, and cheese inspired by flavors of the Middle East was created to
fill this gap in the market. The product is intended to provide consumers with a delicious option
they can feel good about eating, all while tasting flavors from a different culture.
A patent search was conducted to ensure no intellectual property infringement. A few
patents were found that describe methods for producing a similar product but were determined to
be different than the specific product developed. Patent ES2263740T3, held by Unilver NV was
the most similar. Because this patent covers crepes featuring two sauces separated by an edible
layer, it was determined the product was not infringing upon the design (Univlever NV US Patent
ES2263740T3 2006). In addition, a trademark search was conducted to confirm the product name
was not in use by another company or individual. The intended brand name of Crepes Around the
World! is free for use.
Product Description
The traditional Middle Eastern breakfast dish Shakshouka was the inspiration for the
flavors featured in the frozen crepe product. Shakshouka is a dish originating from Syria, Lebanon,
and Jordan and consists primarily of bell peppers and tomatoes with fried eggs and served with
bread (Moine 2014). The developed product features tomatoes, bell peppers, onions, and garlic
alongside simple scrambled eggs and mozzarella cheese. All of this is wrapped in a whole grain
crepe formulated with kale. While pancakes and waffles are pervasive in the grocery store freezer,
the crepe is not as well represented and offers a sense of a gourmet selection. The product offers a
half-serving of vegetables, whole grains, and a whole egg that makes each serving an excellent
source of protein. Crepes Around the World! brand offers a virtually endless array of options that
allows for easy line extension of the product. Utilization of flavors from different cultures,
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different flour sources for added health benefits or for a gluten-free option, and even the
opportunity for a dessert lineup are possible. The product has great market potential for capturing
key attributes consumers are looking for in the marketplace today.
The target audience for this portable filled crepe is the general public, specifically those
who are busy and have little time to prepare food in the morning. Those consumers are typically
of working age 18-60. Within this demographic, working mothers/single parents concerned for the
health of themselves and their children, as well as millennials, those age 22-37 interested in
healthy, and trending new flavors will be the target consumer.
The product is intended to be distributed and sold frozen and displayed in the frozen
breakfast section of a retail grocery store. Consumers should store the product frozen and prepare
the product in the microwave directly before consumption. Instructions to heat the benchtop
prototype are to heat using the defrost cycle for 5 minutes and regular cycle for 2 minutes (this
heat time is expected to be improved with industrial freezing and processing methods). After the
product has cooled, it can be consumed on the go with the convenient packaging provided.
Formulation and Functionary
The product was formulated with clean label objectives in mind to align with customer
expectations of a healthy diet. The benchtop product formulation will be used to compare against
production samples. To improve the texture and quality of the eggs during processing and over the
duration of storage, it is recommended to use Xanthan gum in the scrambled egg component to
restrict syneresis and ice crystal growth (Zaritzky and others 2000). Ingredient and formula
information is summarized in Table 1.
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Table 1. Formula and description for each ingredient and component of Shakshouka-inspired filled
crepe
Ingredient Formula
(%w/w)
Function Specification Supplier
Crepe
Whole Milk 35.312 Rich flavor, moisture,
tenderizer
Grade A Pasteurized Whole
Milk, 3.25% Milkfat
Berkeley Farms
Liquid Egg,
whole 29.97
Binder, emulsifier Pasteurized liquid egg Cargill Kitchen
Solutions: Sunny
Fresh
Whole
wheat flour 21.365
Gluten formation,
structure
Whole wheat enriched flour,
Fine mill texture
Archer Daniels
Midland Milling
Kale,
chopped
green
5.935
Natural green color for
crepe, appearance,
health
Chopped green kale, US No. 1 Taylor Farms
Butter 4.451 Mouthfeel; rich, moist
texture
Land O Lakes Bulk Grade AA
Unsalted Butter
Land O Lakes
Water 2.378 Grind kale Municipal water
Salt 0.59 Tenderizer, flavor Fine flake, iodized salt Cargill: Alberger
TOTAL 100.000
Shakshouka
Filling
Tomato 50.472 Vegetable; flavor, health
benefits, label claim
Petite diced tomatoes in juice,
US Grade A
Neil Jones Food
Company: San
Benito
Bell pepper 29.535 Vegetable; flavor health
benefits, label claim
Red, orange whole peppers, US
No. 1
The Horton Fruit
Company
Onion, diced
yellow
15.105 Vegetable; health
benefits, label claim
½” Diced yellow onion, US No.
1
Taylor Farms
Olive oil 1.658 Cooking medium, heat
transfer
Extra virgin olive oil Cargill
Garlic 1.412 Flavor Minced, dehydrated Sensient Natural
Ingredients
Sugar 0.737 Flavor, water g Granulated, white sugar Cargill
Sriracha 0.737 Flavor – spice Orange-red color, low-heat spicy
flavor
Ventura Foods
Salt 0.123 Flavor – spice Fine flake, iodized salt Cargill
Pepper 0.123 Flavor – spice Speckled dark brown color McCormick
Parsley
flakes
0.098 Appearance Dried, bright kelly green color Sensient Natural
Ingredients
TOTAL 100.000
Scrambled
Egg
Liquid Egg,
whole
82.644 Protein source Pasteurized liquid egg Cargill Kitchen
Solutions: Sunny
Fresh
Whole Milk 14.463 Fat source, adds rich
mouthfeel
Grade A Pasteurized Whole
Milk, 3.25% Milkfat
Berkeley Farms
Butter 2.893 Cooking medium.
Mouthfeel: smooth and
full
Land O Lakes Bulk Grade AA
Unsalted Butter
Land O Lakes
TOTAL 100.000
Cheese Mozzarella Flavor, protein source Shredded Schreiber
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Process Description
The process to produce the product is divided into component steps: receiving of raw
ingredients, thermal processing of each product component, assembly, freezing, packaging, and
frozen storage prior to distribution. The processes and equipment have been chosen to replicate
the benchtop process as much as possible. Multiple unit operations are involved for each product
component.
Receiving of raw materials is the first step in any food processing plant. There will be three
types of receiving: refrigerated ingredients, dry ingredients, and packaging. Each ingredient will
be appropriately inspected, labeled, and stored per the specific temperature requirements or needs
of production. COAs must be compared to specification for each ingredient prior to acceptance. If
a product does not meet the specification, it will be rejected or placed on hold for further
disposition. Packaging will be inspected upon receipt to confirm the correct labeling of allergen
information on each batch and recorded on the incoming packaging log. Packaging will be rejected
if allergen listing is not present. Fresh vegetable ingredients will undergo additional QA product
checks to ensure high quality raw material is accepted for use.
Prior to use in production, fresh vegetables must be washed, chopped, and prepared. Bell
peppers will be washed, chopped to ¼” pieces and blanched. Kale will be washed, blanched and
blended with water for 3-5 minutes to create a liquid ingredient for use in the crepe. Blanching
inactivates enzymes that may cause enzymatic browning or other chemical degradation during
frozen storage.
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The crepe product will be produced by mixing the batter and then depositing onto a
contact cooker for cooking. First, lesser ingredients of the formulation will be pre-weighed and
larger ingredients will be dosed in through pipes
or added in bulk by hand. A paddle blender will
be used for mixing, considering the low to
medium viscosity of the resulting crepe batter
(Fellows 2017). Mixing combines ingredients
and dissolves dry ingredients in the liquid to
create a batter. First, the eggs, milk, and salt will
be added and mixed for 5-6 minutes. Flour will
be added slowly and mixed thoroughly before
the melted butter and kale are added as a final step
(Holmberg 2012). Total mix time is 10-12 minutes. Quality assurance will test the viscosity of the
batter to ensure the specification is met prior to depositing on the link for cooking. A contact
cooker will be used to evenly cook the product and reduce yield loss (Fellows 2017). The crepes
will be cooked for 2-3 minutes to a temperature of 158-165F.
The Shakshouka vegetable mixture will be prepared separately
by sautéing in olive oil using a Bratt pan to simulate the results
achieved by pan sautéing in the benchtop setting. Onion and bell
peppers are first added by hand from bulk containers to the heated
olive oil in the pan and allowed to cook 10 minutes until
vegetables are soft. Next, garlic is added and cooked for 1
minute. Finally, diced and drained tomatoes, sugar, and sriracha sauce are added to the pan and
Fig. 1 Paddle mixer for mixing crepe batter
PM Industries (nd) Paddle blender.
Fig 2. Bratt pan for vegetable
processing
Fellows, PJ. (2016) Bratt pan
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mixed by the operator to ensure even cooking and blending. Parsley flakes are added as the final
step. The mixture is cooked for an additional 20-25 minutes until slightly thickened and pulpy and
the temperature reaches 135-140F (Moine 2014, FDA Food Code 2017). Once finished, the
mixture is pumped to the filling line to fill the crepe prior to freezing.
The scrambled eggs will be prepared from pasteurized
liquid egg product. The paddle blender will be used to mix the egg
with milk for a mixing time of 5-7 minutes to incorporate air into
the eggs and ensure a fluffy, rich product. The mixture is then
pumped over to the electric griddle that will cook the batch to a
temperature of 158F-165F for 5-10 minutes. Butter will be used as
cooking medium for heat transfer. The cooked, scrambled egg will
then be transported to a conveyer belt to move the product to the assembly area to fill the crepes.
Once all components are prepared, it’s time to fill the crepes. Each crepe will move on an
assembly line that first deposits the shredded mozzarella cheese in an even layer on the crepe. The
crepe then is filled with scrambled egg released by another depositor. Finally, the Shakshouka
vegetable mixture is deposited onto the crepe by a pumping system depositor. Once all components
have been filled into the crepe, the product moves into the rolling station. Each crepe must be hand
rolled by line operators to ensure a proper fold. Each crepe is then loaded into a paper cone by
hand and is individually wrapped in plastic via a horizontal form, fill and seal packaging machine
(Kennedy 2000).
Fig 3. Electric griddle for egg processing
Source: Uniworld Fooservice Equipment.
(nd) Electric griddle
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The crepes enter the freezer and are chilled to a minimum internal temperature of -12.8C
for 1 hour. Freezing time and temperature was determined from guidelines referenced by Kennedy
in Managing Frozen Foods and are based on the product radius
of 2.5 cm, initial freezing point of vegetables at -2.8C, and
freezer capabilities of 0.5-3.0 cm/hour (2000). A spiral freezer,
such as the Strafrost Helix Freezer will be used to ensure even
chilling and lower air speeds to ensure the delicate crepe is
not damaged and has the capability to freeze both packaged
and unpackaged food (Starfrost). Fast freezing is essential
to produce small ice crystals and ensure the best quality product (Fellows 2017). This type of
freezer is a mechanical refrigerator that uses compressed refrigerant and cooled air to remove heat
from foods (Fellows 2017).
After freezing two crepes are loaded per box. The box moves through an in-line metal
detector to ensure no metal has contaminated the product at any point throughout the process.
Packaging is again verified for the correct allergen labeling Boxes are automatically filled into
tertiary packaging, sealed, and palletized by hand. After the product has been packaged, each pallet
moves into frozen storage or is loaded directly onto a truck at frozen temperatures for transport to
retail. Figure 5 illustrates the process.
Fig. 4 Spiral freezer
Starfrost Freezing and Chilling Systems
(2017) Spiral freezer and chiller
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Process Flow Diagram
Figure 5. Description of production process of frozen filled crepe
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Package Selection
The package of any food item is intended to protect, preserve, and present information
(George 2000). A major focus of packaging for frozen foods is to preserve quality through barrier
properties that restrict transfer rates of moisture and gases in the product (George 2000). It is also
critical that the packaging chosen can withstand a wide range of temperatures, specifically those
expected to be experienced during storage, distribution, and at the consumer level (George 2000).
Quality deterioration of this product is attributed mainly to enzymatic activity and protein
denaturation and the packaging chosen is intended to reduce deterioration to preserve high quality
characteristics. The crepe will be immediately packaged in a paper cone for easy portability. This
paper will be coated in with varnish to provide a moisture barrier to the product (George 2000).
High density polyethylene (HDPE) is a plastic that can be used in the form, fill, and seal packaging
line as the primary packaging and provides a wide range of temperature stability, medium oxygen
permeability, and is a good barrier to water vapor (George 2000). The secondary packaging will
be paperboard, with an increased thickness as compared to the paper cone, to provide mechanical
strength to the box for protection during storage. This box will also use varnished paper for
moisture resistance. Tertiary packaging for distribution will be a single-wall corrugated box to
provide strength and rigidity during palletization and transport. A sample of product packaging is
shown in Figure 6.
Figure 6. Product Primary and Secondary packaging
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Product Evaluation: Quality and Safety
Shelf-Life
The shelf-life of a food is defined as the period in which it is both safe to consume and has
acceptable quality (Zaritzky and others 2000). The crepe product is intended to be immediately
frozen after processing and remain at frozen temperatures during distribution to the consumer.
Freezing is regarded as an effective method of food preservation that inhibits both the enzymatic
and microbiological activity that leads to food deterioration (Zaritzky and others 2000). Freezing
allows for an extension in shelf-life and delivers a high-quality product to the consumer.
Microorganisms are of limited concern in frozen foods, as they cannot grow at frozen temperatures.
During freezing, heat is removed from the product and water activity is reduced due to an
increased concentration of dissolved substances, however, while this significantly slows down
food deterioration, the physico-chemical reactions do not stop during frozen storage (Kennedy
2000). Quality deterioration is a concern for determining shelf-life of frozen foods and is directly
related to raw material quality, processing parameters, and storage conditions (Zaritzky and others
2000). Thus, adequate thermal processing and quick-freezing to promote the growth of small ice
crystals is critical to preserving the quality characteristics of any food product. For the frozen
crepe, this prevents destruction of cells of the egg and vegetable mixture which would result in
loss of texture and drip loss (Zaritzky and others 2000). Other quality concerns include loss of
pigments and enzymatic browning of the vegetable components of the crepe (Zaritzky and others
2000). These changes in color relate to a physical change in appearance and thus decreased quality.
Chlorophyll and carotenes are relatively stable to degradation under frozen conditions (Zaritzky
and others 2000). However, it is known that the chlorophyll in the kale ingredient of the crepe may
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degrade over time, resulting in an olive-brown colored crepe of inferior quality, leading to
consumer rejection of the product (Zaritzky and others 2000).
The mode of failure for this product is chemical deterioration via Vitamin C autoxidation.
Although nutrition degradation is considered minimal in frozen food products, water-soluble
vitamins, including B-Vitamins and ascorbic acid found in the vegetable component and scrambled
egg, are of concern during prolonged periods of frozen storage (Zaritzky and others 2000).
Degradation may occur prior to any negative sensory characteristics. All nutrients must meet the
label declaration, or the product is subject to recall.
Static shelf-life tests will be conducted over a one-year period to understand the
deterioration over time, while accelerated shelf-life tests will be performed prior to launch of the
product. Tests will include vitamin assays, as well as consumer testing of sensory characteristics,
specifically color, appearance, and taste. Based on the practical storage life of frozen peppers at -
18C (0F), the product shelf life is estimated to be 6 months (Man and Jones 1994).
Sensory Evaluation
In order to obtain feedback on the product in development and improve its potential
success, a consumer focus group was conducted. The focus group consisted of a general discussion
on breakfast foods, a more detailed discussion on ideal choices and opinions on frozen breakfast
foods, and a taste panel.
The overwhelming results of the focus group showed that participants considered
convenience and quick preparation to be a key factor when choosing what to eat in the morning.
The majority of participants ate breakfast on-the-go, either while driving in the car or while eating
at their desk at work. Some participants also ate a quick breakfast before leaving home in the
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morning. Next to convenience, health benefits ranked very highly in importance. Specific
characteristics consumers were looking for included protein, antioxidants, low calorie, low
sodium, and calcium. Finally, flavor was another key factor in choosing breakfast products. Bacon,
egg, sausage, cheese, and pancakes were popular choices for ideal flavors. However, protein bars,
oatmeal, cereal, and breakfast sandwiches made up the majority of products actually consumed on
busy mornings. Despite ranking health benefits as highly desirable, all participants stated they
would not continue to purchase a product with bad taste, even if it was very healthy.
Flavors from new cultures were discussed to get feedback on what consumers are familiar
seeing in the marketplace and may be interested in trying. Mexican flavors, especially for
breakfast, have been widely accepted in the United States and consumers are comfortable
purchasing these items at retail. Most other ethnicities are not well represented in the marketplace.
Panelists expressed interest in trying foods from new cultures but would find comfort in sampling
the products in a restaurant setting first. As restaurants become more creative and introduce new
offerings, the retail sector may also begin offering convenient at-home options. The Mediterranean
diet was familiar to participants for its health benefits, and they were interested in fitting these
choices in their daily diet.
Participants sampled Shakshouka-inspired filled crepe products of two variations. Each
crepe contained the same tomato, bell pepper, and onion vegetable and egg filling, but one crepe
had an addition of liquefied kale to add consumer appeal. Overall, the crepe was rated highly on
flavor, texture, perceived health benefits, and appearance. However, there were some notes
regarding texture of the crepe containing kale, leading to product reformulation to improve
acceptance. Figure 7 shows results of the panel.
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Figure 7. Results of focus group consumer preference panel. Sample 852 is the original whole
wheat crepe, Sample 518 contains the additional kale ingredient
These findings indicate there is an opportunity in the marketplace to combine convenience,
taste, health, and new culinary creations from different cultures across the globe. The next steps
for product testing would include producing product for a small test market and conducting
consumer testing to determine any final changes before scale-up. Surveys regarding product
acceptability and intent to purchase will be distributed to those purchasing a product.
Quality Controls
Quality control tests are critical to producing a consistent product over time and
maintaining customer loyalty. This includes all steps, from receiving of ingredients, to processing,
to the final product. Table 2 summarizes tests conducted for the Shakshouka inspired frozen filled
crepe. Quality controls at receiving are important for incoming fresh vegetables and fruit.
Technicians will monitor the visual appearance, color, and weight of samples from each product
lot and verify the COA matches internal specifications. During production, product monitoring is
implemented at each component line. The crepe will be monitored for batter viscosity, cooked
product diameter, and color after cooking. The Shakshouka mixture will be monitored for pH,
0
2
4
6
8
10Appearance
Crepe
Filling
FlavorTexture
Easyconsumption
Overallacceptability
Sample 852
Sample 518
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Brix, and deposit weight to ensure each crepe receives ½ cup of vegetables. The scrambled egg
will also be inspected for deposit weight to ensure each crepe receives one egg. Finally, the fully
assembled crepe will be weighed prior to freezing. After freezing, the product internal temperature
will be measured to ensure complete freezing. Finished product testing will include product net
weight with packaging and internal sensory tests for color, texture, flavor, and acceptability.
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Table 2. Quality controls tests during production and on finished product
Stage Test Method Initial Specifications
(to be validated)
Receiving
Raw Ingredient Quality: Fresh
Bell Peppers
Visual inspection of ½ pound of
each container from each
product lot; COA inspection and
verification
Defects < 1%
Raw Ingredient Quality: Onions Visual inspection of ½ pound of
each container from each
product lot; COA inspection and
verification
Defects < 1%
Raw Ingredient Quality: Parsley Visual inspection of ½ pound of
each container from each
product lot; COA inspection and
verification
Defects < 1%
Raw Ingredient Quality: Kale Visual inspection of ½ pound of
each container from each
product lot; COA inspection and
verification
Defects < 1%
Production
Crepe batter viscosity Bostwick 10 cm ± 2 cm
Crepe diameter Caliper/ruler 8 in ± 0.5 in
Crepe color after cooking Visual comparison to gold
standard photos
Light green with darker green specs
throughout
pH Shakshouka mixture Calibrated pH meter 4.5 ± 0.5
Soluble solids Shakshouka
mixture
Calibrated refractometer 10.0 Brix ± 2.0 Brix
Weight of Shakshouka mixture
deposited
Measure deposit from each filler
head using a scale 100 g ± 1 g
Weight of Scrambled egg
deposited
Measure deposited egg product
using scale 55 g ± 1 g
Filled product weight Scale 250 g ±2.5 g
Frozen product temperature Calibrated Thermometer -10C ±5C
Finished
Product
Product Net Weight Scale 500 g
Product Flavor Internal sensory comparison to
gold standard
Toasted wheat crepe with sweet and
tangy vegetable mixture and savory egg
and cheese flavor
Crepe texture Internal sensory comparison to
gold standard
Firm but light; not soggy
Cheese distribution and melt
test
Internal sensory comparison to
gold standard
Even distribution of cheese across
crepe; even and complete melt after
reheating
Color of crepe Internal sensory comparison to
gold standard
Light green with darker green specs
throughout; minimal brown/dark spots
Color of vegetable mixture Internal sensory comparison to
gold standard
Red with orange peppers
Color and visual appearance of
scrambled egg
Internal sensory comparison to
gold standard
Yellow-gold and fluffy
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Regulatory
Regulation of this product at the plant level will primarily be governed by the Food and
Drug Administration (FDA), but will also share oversight with the United States Department of
Agriculture Food Safety and Inspection Service (USDA FSIS) due to the inclusion of an egg
product as an ingredient (Aramouni and Deschenes 2018). The product does not fall under the
requirement of mandatory HACCP, however, with the recent Food Safety Modernization Act
(FSMA), FDA now requires a Food Safety Plan with preventive controls for all other food
processing operations. Because the product carries a content claim regarding protein, the Federal
Trade Commission (FTC) will work alongside the FDA and USDA to regulate this claim
(Aramouni and Deschenes 2018). The crepe product includes wheat, milk, and egg allergens which
will be controlled as described in the Food Safety Plan.
Prior to entering the plant as ingredients for further processing, several other organizations
are involved in the regulatory aspects of the product. The Environmental Protection Agency (EPA)
is involved in pesticides used for plant products. Animal and Plant Health Inspection Service
(APHIS) of the USDA will be involved in regulation and agricultural health of all vegetable, grain,
dairy, and egg ingredients in the product. The USDA Agricultural Marketing Service (AMS) will
be involved in any grading of the vegetable products, egg, and dairy ingredients (Aramouni and
Deschenes 2018). The Federal Grain Inspection Service (FGIS) will conduct mandatory grading
of the wheat grain (Aramouni and Deschenes 2018). Finally, after processing, state and local
agencies may be involved at the retail level where the product is sold regarding food hygiene and
sanitation.
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Labeling
Nutrition Label
INGREDIENTS: Egg, Tomato, Whole Milk, Bell Pepper, Wheat Flour, Onion, Mozarrella cheese (milk,
salt, enzymes), butter, kale, water, olive oil, garlic, sugar, sriracha (water, red jalepeno peppers (peppers,
salt, acetic acid, calcium chloride sodium benzoate), sugar, distilled vinegar, red anaheim chilies (chilies,
salt, citric acid, sodium benzoate, garlic, xanthan gum, spices, modified corn starch, potassium sorbate, and
sodium bisulfite (preservatives)), salt, pepper, parsley
Allergen Info - Contains: Wheat, egg, milk
Figure 8. Product nutrition label and ingredient declaration
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Figure 9. Product principal display panel
Figure 10. Information panel
Safety
A Food Safety Preventive Controls plan was developed to assess all hazards involved
during receiving, processing, storage, and distribution. Allergen, supply chain, process, and
sanitation preventive controls were identified through the hazard analysis for the product process.
Risks involved with receiving ingredients are related to chemical hazards such as pesticides and
drug residues. These risks will be mitigated via a supply chain control through a Letter of
Guarantee and third-party audit from the supplier. Allergen risks are controlled via package
labeling. All products produced in the facility contain the wheat, egg, and milk allergens, so there
is no risk of cross contamination. Packaging will be verified for the correct information at receipt
and during final product packaging.
Risks during processing include thermal destruction of vegetative pathogens such as E. coli
and Salmonella spp. Temperature requirements have been established for each crepe component
to mitigate the risk of pathogen survival and growth. The FDA Food Code 2017 was used to
establish safe cooking temperatures. The product could be considered a ready-to-eat product, even
though it is frozen and contains safe handling instructions; there is always the potential for
consumer mishandling and processors must consider these risks. Although the risk is low for a
frozen product, the plant will take extra precautions for environmental monitoring due to the
hands-on assembly of the product. This includes established hygienic zoning and sanitation
procedures. The full summary of risks and controls can be found in the Food Safety Preventive
Controls Summary plan below.
Allergen Preventive Controls Summary Form: PC for Human Foods
Product Name: Shakshouka Inspired Filled, Frozen Crepe
Allergen
Control
Hazard(s) Criterion or
Parameter
Monitoring Procedures Corrective Action Verification Records Record Responsibility
C1 –
Receiving
Packaging:
Pre-labeled
paperboard
box
Undeclared
Allergens
Labeled box
must declare
wheat, egg, and
milk allergens
What is going to be
measured?
Label on packaging will
be confirmed against
current approved label on
file. Must include allergen
information: Wheat, Milk,
Eggs.
How will it be
measured?
Prior to receiving, label
coordinator or trained
designee will verify
correct label and allergen
information for all lots on
truckload.
Who will be responsible
for monitoring?
Label coordinator or
trained designee
How frequently will it be
measured?
Each lot of each delivery
How will the product be
evaluated for safety?
If packaging does not
contain correct info, reject
load and do not receive into
facility.
How will affected food be
prevented from entering
commerce if it cannot be
ensured that the product is
not adulterated?
Packaging is not received
into facility if allergen
information is incorrect. Any
incorrect packaging is
rejected/destroyed.
What measures will be
implemented to reduce the
likelihood of occurrence?
If product is received with
wrong label, reject load.
Supplier will be required to
destroy all product with
incorrect information.
What equipment needs to be
calibrated (or checked for
accuracy) for monitoring and
verification, what is
frequency of calibration and
who is responsible?
Operators verify correct label is
present at receiving station at
the beginning of each day.
If appropriate, what product
testing for an allergen hazard
is being conducted, including
frequency and who is
responsible?
None. All products produced at
the facility contain wheat, milk,
and egg allergens.
How often are records
reviewed by a PCQI for
monitoring and CA?
All receiving records for PC C1
are reviewed within 7 working
days of product receipt.
How often are records
reviewed by a PCQI for
calibration and verification
testing?
All records are reviewed within
7 working days of product
receipt.
Label
Receiving
for
Allergens
Training
Form
Incoming
Packaging
Material/
Allergen
Labels
Log
PC C1
Corrective
Action
Form
Label Receiving for Allergens
Training Form:
PCQI or QA Manager completes
for each new labeling
coordinator or receiving
personnel prior to solo work and
after each corrective action
incident
Incoming Packaging Material/
Allergen Labels Log:
- Label coordinator or trained
designee will verify correct
information and complete log for
each lot of incoming labels.
- QA Manager or trained
designee verifies PC through
operator observation twice per
production shift
- PCQI reviews within 7
working days of production
PC C1 Corrective Action Form
- QA Manager or trained
designee provides product
disposition for non-conforming
product and will complete
documentation for each
corrective action incident.
- PCQI verifies each corrective
action incident through
observation
- PCQI reviews record within 7
days of production date
- 25 -
C2-
Packaging
into pre-
labeled
paperboard
box
Undeclared
Allergens
Labeled box
must declare
wheat, egg, and
milk allergens
What is going to be
measured?
Label on packaging will
be confirmed against
current approved label on
file. Must include allergen
information: Wheat, Milk,
Eggs.
How will it be
measured?
Label coordinator or
trained designee will
verify correct label once
per production shift
Who will be responsible
for monitoring?
Label coordinator or
trained designee
How frequently will it be
measured?
Once per production shift
How will the product be
evaluated for safety?
If packaging does not
contain correct info, stop the
line and place all product on
hold back to the last
acceptable check.
How will affected food be
prevented from entering
commerce if it cannot be
ensured that the product is
not adulterated?
All product between
acceptable checks will be
placed on hold and evaluated
for accuracy by QA
Manager. Any non-
conforming product will be
reworked into the correct
packaging. Incorrect
packaging will be destroyed.
What measures will be
implemented to reduce the
likelihood of occurrence?
Determine the root cause and
provide retraining to
operators or implement
corrections as appropriate.
What equipment needs to be
calibrated (or checked for
accuracy) for monitoring and
verification, what is
frequency of calibration and
who is responsible?
Operators verify correct label is
present at receiving station at
the beginning of each day.
If appropriate, what product
testing for an allergen hazard
is being conducted, including
frequency and who is
responsible?
None. All products produced at
the facility contain wheat, milk,
and egg allergens.
How often are records
reviewed by a PCQI for
monitoring and CA?
All receiving records for PC C1
are reviewed within 7 working
days of product receipt.
How often are records
reviewed by a PCQI for
calibration and verification
testing?
All records are reviewed within
7 working days of product
receipt.
Finished
Product
Label
Check for
Allergens
Training
Form
Finished
Product
Label
Check
Labels
Log
PC C2
Corrective
Action
Form
Finished Product Label Check
for Allergens Training Form:
-PCQI or QA Manager
completes for each new labeling
coordinator or receiving
personnel prior to solo work and
after each corrective action
incident
Finished Product Label Check
Labels Log
- Label coordinator or trained
designee will record label
verification
- QA Manager or trained
designee verifies PC through
operator observation twice per
production shift
- PCQI reviews within 7
working days of production
PC C2 Corrective Action Form
- QA Manager or trained
designee provides product
disposition for non-conforming
product and will complete
documentation for each
corrective action incident.
- PCQI completes observation
verification each time deviation
occurs/corrective action is
required
- PCQI reviews record within 7
days of production date
- 26 -
Process Preventive Controls Summary Form: PC for Human Foods
Process
Control
Step
Hazard(s) Parameters,
Values or
Critical
Limits
Monitoring
Procedures
Corrective Action Verification Records Record Responsibility
B1a –
Cooking
crepe at
contact
cooker
(milk,
liquid egg,
wheat
flour, salt,
kale
flakes)
Pathogenic E.
coli, Bacillus
cereus,
Salmonella
spp., Listeria
monocytogenes
growth in
milled wheat
flour
Crepe ≥158°F
(70C)
instantaneous
after exiting
contact cooker,
prior to transfer
to assembly
station
Section 3-
401.11 Raw
Animal Foods
(A)(2)
FDA Food
Code 2017
What is going to be
measured?
Crepe internal
temperature will be
monitored after product
exits contact cooker.
Crepe operator will
measure internal
temperature of 3 crepes,
1 from each position
across the belt to ensure
even cooking across the
contact cooker and
record temperatures.
How will it be
measured?
Crepe operator will
measure internal
temperature using a
calibrated thermometer.
Who will be
responsible for
monitoring?
Crepe operator or
trained designee
How frequently will it
be measured?
Crepe operator or
trained designee will
measure product
temperature every 30
minutes +/- 5 minutes
How will the product be
evaluated for safety?
If product does not reach
158°F, stop the line and hold
product back to the last good
check.
How will affected food be
prevented from entering
commerce if it cannot be
ensured that the product is
not adulterated?
All product between
acceptable checks will be
placed on hold and inspected
by QA Manager. Product
will be destroyed if deemed
unsafe.
What measures will be
implemented to reduce the
likelihood of occurrence?
Determine the root cause and
provide retraining to
operators or implement
corrections as appropriate.
What equipment needs to be
calibrated (or checked for
accuracy) for monitoring and
verification, what is
frequency of calibration and
who is responsible?
Hand-held thermometers used
by operators must be calibrated
annually. Contact cooker
operator or trained designee
will check for accuracy daily
during production against a
calibrated NIST standard.
If appropriate, what product
testing for a pathogen or
indicator organism or other
hazard is being conducted,
including frequency and who
is responsible?
Pathogen testing for E. Coli
0157:H7, L. monocytogenes,
and Salmonella spp. is
performed quarterly by the
microbiologist or trained
designee.
How often are records
reviewed by a PCQI for
monitoring and CA?
All production records are
reviewed within 7 working
days of production.
How often are records
reviewed by a PCQI for
Contact
Cooker
Operator
Training
Record
Crepe Cooked
Temperature
Record
Thermometer
Check Record
PCB1a
Corrective
Action
Record
Quarterly
Pathogen
Testing
Report
Contact Cooker Operator
Training Record
- QA Manager completes for
each new hire prior to the
first operation and after each
related corrective action
incident.
- Trainee signs record of
completion
Crepe Cooked Temperature
Record
- Contact cooker operator or
trained designee records
temperatures as required
- QA Manager verifies PC
through operator observation
twice per production shift.
- PCQI reviews within 7
working days of production
Thermometer Check Record
- Lab technician verifies
thermometer against
calibrated NIST standard at
the start of each production
day.
- PCCI reviews within 7
working days of production
PCB1a Corrective Action
Record
- QA Manager or trained QA
designee provides
disposition for non-
conforming product and
- 27 -
calibration and verification
testing?
All production records are
reviewed within 7 working
days of production.
completes form after each
incident
- PCQI completes
observation verification each
time deviation
occurs/corrective action is
required
- PCQI reviews record
within 7 days of production
date
Quarterly Pathogen Testing
Report
- Microbiologist or trained
QA designee records/tracks
results of quarterly tests
- PCQI reviews within 7
working days of production
- 28 -
B1b –
Cooking
of
scrambled
egg on
electric
griddle
(pasteuriz
ed liquid
egg,
pasteurize
d whole
milk, salt)
Survival of
vegetative
pathogens from
inadequate
pasteurization
of liquid egg
product by
supplier –
Salmonella
spp. and
Campylobacter
spp.
Scrambled
eggs ≥158°F
(70C)
instantaneous
prior to transfer
to assembly
station
Section 3-
401.11 Raw
Animal Foods
(A)(2)
FDA Food
Code 2017
What is going to be
measured?
Scrambled egg surface
temperature measured
at 4 pre-determined
locations across electric
griddle to ensure
adequate cook
temperatures have been
reached
How will it be
measured?
Griddle operator or
trained designee will
record product surface
temperature from each
location using a
calibrated infrared
surface thermometer.
Who will be
responsible for
monitoring?
Griddle operator or
trained designee
How frequently will it
be measured?
4 temperatures will be
measured and recorded
for each batch of eggs
produced; daily during
all production shifts
How will the product be
evaluated for safety?
If product does not reach
158°F, do not transfer
product to assembly.
Continuously monitor
product temperature until it
reaches critical limit.
How will affected food be
prevented from entering
commerce if it cannot be
ensured that the product is
not adulterated?
All product between
acceptable checks will be
placed on hold and inspected
by QA Manager. Product
will be reworked or
destroyed if deemed unsafe.
What measures will be
implemented to reduce the
likelihood of occurrence?
Determine the root cause and
provide retraining to
operators or implement
corrections as appropriate.
What equipment needs to be
calibrated (or checked for
accuracy) for monitoring and
verification, what is
frequency of calibration and
who is responsible?
Hand-held thermometers used
by operators must be calibrated
annually. Contact cooker
operator or trained designee
will check for accuracy daily
during production against a
calibrated NIST standard.
If appropriate, what product
testing for a pathogen or
indicator organism or other
hazard is being conducted,
including frequency and who
is responsible?
Pathogen testing for E. Coli
0157:H7, L. monocytogenes,
and Salmonella spp. is
performed quarterly by the
microbiologist or trained
designee.
How often are records
reviewed by a PCQI for
monitoring and CA?
All production records are
reviewed within 7 working
days of production.
How often are records
reviewed by a PCQI for
calibration and verification
testing?
All production records are
reviewed within 7 working
days of production.
Griddle
Operator
Training
Record
Scrambled
Egg
Temperature
PC B1b
Record
Thermometer
Check Record
Quarterly
Pathogen
Testing
Report
Griddle Operator Training
Record
- QA Manager completes for
each new hire prior to the
first operation and after each
related corrective action
incident.
- Trainee signs record of
completion
Scrambled Egg Temperature
PC B1b Record
- Griddle operator or trained
designee records
temperatures as required
- QA Manager verifies PC
through operator observation
twice per production shift.
- PCQI reviews within 7
working days of production
Thermometer Check Record
- Lab technician verifies
thermometer against
calibrated NIST standard at
the start of each production
day.
- PCCI reviews within 7
working days of production
PCB1b Corrective Action
Record
- QA Manager or trained QA
designee provides
disposition for non-
conforming product and
completes form after each
incident
- PCQI completes
observation verification each
time deviation
occurs/corrective action is
required
- 29 -
- PCQI reviews record
within 7 days of production
date
Quarterly Pathogen Testing
Report
- Microbiologist or trained
QA designee records/tracks
results of quarterly tests
- PCQI reviews within 7
working days of production
- 30 -
B1c –
Cooking
of
vegetables
in Bratt
pan
(diced
canned
tomatoes,
bell
pepper,
onion,
garlic,
olive oil,
sugar salt,
sriracha)
Survival of
vegetative
pathogens from
product
contamination:
Pathogenic E.
Coli,
Salmonella
spp, Listeria
monocytogenes
, Shigella spp.,
S. aures,
Giardia
lambila
Vegetable
mixture
internal
temperature
≥135°F (74C)
prior to transfer
Section 3-
401.13 Plant
Food Cooking
for Hot
Holding
FDA Food
Code 2017
What is going to be
measured?
Vegetable mixture
internal temperature
measured at 4 pre-
determined locations
across pan to ensure
adequate cook
temperatures have been
reached
How will it be
measured?
Bratt pan operator or
trained designee will
record product
temperature from each
location using a
calibrated thermometer.
Who will be
responsible for
monitoring?
Bratt pan operator or
trained designee
How frequently will it
be measured?
4 temperatures will be
measured and recorded
for each batch of
vegetable mixture
produced; daily during
all production shifts
How will the product be
evaluated for safety?
If product does not reach
135°F, do not transfer
product to assembly.
Continuously monitor
product temperature until it
reaches critical limit.
How will affected food be
prevented from entering
commerce if it cannot be
ensured that the product is
not adulterated?
All product between
acceptable checks will be
placed on hold and inspected
by QA Manager. Product
will be reworked or
destroyed if deemed unsafe.
What measures will be
implemented to reduce the
likelihood of occurrence?
Determine the root cause and
provide retraining to
operators or implement
corrections as appropriate.
What equipment needs to be
calibrated (or checked for
accuracy) for monitoring and
verification, what is
frequency of calibration and
who is responsible?
Hand-held thermometers used
by operators must be calibrated
annually. Contact cooker
operator or trained designee
will check for accuracy daily
during production against a
calibrated NIST standard.
If appropriate, what product
testing for a pathogen or
indicator organism or other
hazard is being conducted,
including frequency and who
is responsible?
Pathogen testing for E. Coli
0157:H7, L. monocytogenes,
and Salmonella spp. is
performed quarterly by the
microbiologist or trained
designee.
How often are records
reviewed by a PCQI for
monitoring and CA?
All production records are
reviewed within 7 working
days of production.
How often are records
reviewed by a PCQI for
calibration and verification
testing?
All production records are
reviewed within 7 working
days of production.
Bratt Pan
Operator
Training
Record
Vegetable
Temperature
PC B1b
Record
Thermometer
Check Record
Quarterly
Pathogen
Testing
Report
Bratt Pan Operator Training
Record
- QA Manager completes for
each new hire prior to the
first operation and after each
related corrective action
incident.
- Trainee signs record of
completion
Vegetable Temperature PC
B1b Record
- Bratt pan operator or
trained designee records
temperatures as required
- QA Manager verifies PC
through operator observation
twice per production shift.
- PCQI reviews within 7
working days of production
Thermometer Check Record
- Lab technician verifies
thermometer against
calibrated NIST standard at
the start of each production
day.
- PCQI reviews within 7
working days of production
PCB1c Corrective Action
Record
- QA Manager or trained QA
designee provides
disposition for non-
conforming product and
completes form after each
incident
- PCQI completes
observation verification each
time deviation
occurs/corrective action is
required
- 31 -
- PCQI reviews record
within 7 days of production
date
Quarterly Pathogen Testing
Report
- Microbiologist or trained
QA designee records/tracks
results of quarterly tests
- PCCI reviews within 7
working days of production
- 32 -
P1 –
Metal
detection
Metal
fragments
may be
introduced at
any point in
the process
due to
broken
equipment
or breach in
employee
SOPs
No metal
fragments in
finished
product
≥7 mm or ≤25
mm
Metal detector
detects:
≥2 mm ferrous,
≥2 mm
nonferrous, ≥2
mm stainless
steel
FDA
Compliance
Policy Guide
555.425 Foods
- Adulteration
Involving
Foreign
Objects
What is going to be
measured?
The ability of metal
detector to reject the 2
mm ferrous, 2 mm
nonferrous, and 2 mm
stainless steel standards.
How will it be
measured?
Continuous monitoring
using functional metal
detector able to detect 2
mm ferrous, 2 mm
nonferrous, and 2 mm
stainless steel standards.
Operators will verify
the metal detector is
functional using
standard seeded wands
through the detectors
with positive rejection.
Each metal test standard
must be passed through
the metal detectors with
positive rejection twice.
Who will be
responsible for
monitoring?
Packing line operator or
trained designee
How frequently will it
be measured?
Packing line operator or
trained designee will
verify the equipment is
functioning properly at
start-up of production,
hourly during
production, and at the
end of production.
How will the product be
evaluated for safety?
The packing operator will place
all product on hold until the last
acceptable hourly production
check. PCQI or QA Manager
will reanalyze product through a
functioning metal detector
How will affected food be
prevented from entering
commerce if it cannot be
ensured that the product is not
adulterated?
All product between acceptable
checks will be placed on hold
and reevaluated using a
functional metal detector as
described above. If product does
not pass check, the product will
be destroyed
What measures will be
implemented to reduce the
likelihood of occurrence? The
packing operator shall
immediately stop the line and
place all product on hold until
the last acceptable check.
Maintenance will perform any
adjustments needed and the
equipment will be verified to
perform properly before use.
Frequency of checks will be
increased to every 30 minutes
during production shifts by
packing operator or trained
designee until an official
calibration is performed.
Calibration by the equipment
manufacturer will be required
after a corrective action incident.
What equipment needs to be
calibrated (or checked for
accuracy) for monitoring
and verification, what is
frequency of calibration and
who is responsible?
Metal detector is calibrated
annually by equipment
manufacturer. Operator or
trained designee will perform
accuracy checks of the
machine at the start of
production, hourly during
production, and at the end of
production each day
If appropriate, what
product testing for a
pathogen or indicator
organism or other hazard is
being conducted, including
frequency and who is
responsible?
None
How often are records
reviewed by a PCQI for
monitoring and CA?
All production records for PC
P1 are reviewed within 7
working days of production
How often are records
reviewed by a PCQI for
calibration and verification
testing?
All production records for PC
P1 are reviewed within 7
working days of production
In-Line Metal
Detector
Operator
Training
Record
Metal
Detection PC
P1 Record
PC P1
Corrective
Action
Record
In-Line Metal Detector
Operator Training Record:
- PCQI or QA Manager
completes for each new
operator prior to first
equipment operation and after
each corrective action incident
related to operator error
Metal Detection PC P1
Record:
- Packing line operator or
trained designee is responsible
for verifying equipment is
properly functioning at start-
up of production, hourly
during production, and at the
end of production
- QA Manager or trained
designee is responsible for
verification of PC through
operator observation twice per
production shift
- Daily production record is
reviewed by PCQI within 7
days of production date
PC P1 Corrective Action
Record
- QA Manager or trained QA
designee will provide
disposition for product that
did not meet critical limits and
will complete record at each
corrective action incident
- PCQI completes observation
verification each time
deviation occurs/corrective
action is required
- PCQI reviews record within
7 days of production date
- 33 -
Supply Chain Preventive Controls Form: PC for Human Foods
Ingredient
(Requiring supply
chain applied
control)
Approved
Supplier
Hazard(s) requiring
supply chain applied
control
Preventive Controls
applied by the
Supplier
Date of
Approval
Receiving Procedure
Refrigerated peppers
and onions
Bell
Peppers: The
Horton Fruit
Company
Onions:
Taylor
Farms
Pesticide residues GAPs 5/2/2108 Who will be responsible for receiving procedures?
Receiving personnel or trained operator
How frequently will receiving procedures be performed?
Each delivery
What are the receiving procedures?
Personnel shall inspect trailer for appropriate temperature
requirements and dirt/debris/etc.; reject trailer if criteria not
met. A LOG is required for each lot to be accepted prior to
receiving into plant. Supplier most recent third-party audit must
be current and on file.
Whole Wheat Flour ADM
Milling
Pesticide residues
Mycotoxins
GAPs 5/2/2018 Who will be responsible for receiving procedures?
Receiving personnel or trained operator
How frequently will receiving procedures be performed?
Each delivery
What are the receiving procedures?
A LOG is required for each lot to be accepted prior to receiving
and unloading. Supplier most recent third-party audit must be
current and on file.
Milk, butter Milk:
Berkeley
Farms
Butter: Land
O Lakes
Drug residues
Heavy metals
Cleaning/sanitizing
Chemicals
GAPs
GMPs
SSOPs
5/2/2018 Who will be responsible for receiving procedures?
Receiving personnel or trained operator
How frequently will receiving procedures be performed?
Each delivery
What are the receiving procedures?
A LOG is required for each lot to be accepted prior to receiving
and unloading. Supplier most recent third party audit must be
current and on file.
- 34 -
Sanitation Preventive Controls Form Summary: PC for Human Foods
Location
Purpose Frequency Sanitation
Procedures Corrective
Action
Verification Procedures Records Record Responsibility
B2 –
Crepe
rolling
Cleaning and
sanitizing of the
rolling station is
critical to prevent
recontamination
of L.
monocytogenes
and S. aureus in a
frozen RTE
product
Cleaning:
Daily, at the
end of
production and
after any shift
change.
Sanitizing:
Daily, before
production
begins, at shift
change, and at
the end of
production.
Who will be
responsible?
Sanitation team
member or trained
designee
What is the
Procedure?
Clean:
Remove any debris
and loose soil with
a sponge. Clean the
surface with a clean
cloth and cleaning
solution. Rinse
table with clean
water.
Sanitize:
Apply sanitizing
solution to entire
surface. Allow
station to dry.
How will it be
monitored?
Sanitation team
member or trained
designee will
inspect table for
cleanliness after
each
cleaning/sanitizing
session.
If area is not
properly
cleaned,
reclean and
resanitize.
If product is RTE and there
is an environmental pathogen
hazard requiring a PC, what
environmental monitoring is
conducted, including
frequency and who is
responsible?
The microbiologist is
responsible for conducting
environmental monitoring for
pathogens such as L.
monocytogenes from pre-
determined sample sites of
each production plant zone. A
rotating sampling plan is
repeated on a monthly basis.
Other environmental
monitoring procedures,
including frequency and who
is responsible?
None
How often are records
reviewed by a PCQI for
monitoring and CA?
-PCQI reviews all records
within 7 working days
following production.
How often are records
reviewed by a PCQI for
calibration and verification
testing?
-PCQI reviews all records
within 7 working days
following production.
Assembly
Station Daily
Sanitation
Record
Assembly
Station Daily
Sanitation
Record
Corrective
Action Form
Environmental
Monitoring
Sampling
Record and
Lab Results
Assembly Station Daily
Sanitation Record
- Sanitation Team member
records results at frequency
specified.
- Sanitation supervisor is
responsible for verification of
cleaning/sanitizing after each
shift.
- PCQI reviews all records
within 7 working days
following production.
Assembly Station Daily
Sanitation Record Corrective
Action Form
- Sanitation supervisor or
trained QA designee will
complete record at each
corrective action incident
- PCQI completes observation
verification each time
deviation occurs/corrective
action is required
- PCQI reviews all records
within 7 working days
following production.
Environmental Monitoring
Sampling Record and Lab
Results
- Microbiologist completes
sampling/records results
- PCQI reviews all records
within 7 working days
following production.
- 35 -
B2 –
Crepe
rolling
Hygienic Zoning
and adherence to
GMPs and good
employee hygiene
is critical to
prevent
recontamination
of L.
monocytogenes
and S. aureus in a
frozen RTE
product
Daily, during
production
Who will be
responsible?
Crepe assembly
team member or
trained designee;
others entering area
What is the
Procedure?
Before entering the
assembly area, put
on a clean smock,
boots, and hair net.
Wash hands
thoroughly and take
a pair of new
gloves. Wash each
boot in the boot
wash.
How will it be
monitored?
QA Manager will
monitor employees
at start-up and shift
change to ensure
proper GMPs are
followed, and twice
per hour. Record on
the GMP Record.
Employees
may not
begin
production
shift if GMPs
not properly
followed
If product is RTE and there
is an environmental pathogen
hazard requiring a PC, what
environmental monitoring is
conducted, including
frequency and who is
responsible?
The microbiologist is
responsible for conducting
environmental monitoring for
pathogens such as L.
monocytogenes from pre-
determined sample sites of
each production plant zone. A
rotating sampling plan is
repeated on a monthly basis.
Other environmental
monitoring procedures,
including frequency and who
is responsible?
None
How often are records
reviewed by a PCQI for
monitoring and CA?
-PCQI reviews all records
within 7 working days
following production.
How often are records
reviewed by a PCQI for
calibration and verification
testing?
-PCQI reviews all records
within 7 working days
following production.
Assembly
Station GMP
Record
Assembly
Station Daily
GMP Record
Corrective
Action Form
Environmental
Monitoring
Sampling
Record and
Lab Results
Assembly Station Daily GMP
Record
- Sanitation Team member
records results at frequency
specified.
- Sanitation supervisor is
responsible for verification of
cleaning/sanitizing after each
shift.
- PCQI reviews all records
within 7 working days
following production.
Assembly Station Daily GMP
Record Corrective Action
Form
- Sanitation supervisor or
trained QA designee will
complete record at each
corrective action incident
- PCQI completes observation
verification each time
deviation occurs/corrective
action is required
- PCQI reviews all records
within 7 working days
following production.
Environmental Monitoring
Sampling Record and Lab
Results
- Microbiologist completes
sampling/records results
- PCQI reviews all records
within 7 working days
following production.
36
Financial Considerations
To analyze the potential success of the new product, costs and sale prices must be considered to
determine if the investment is worth moving forward. The fixed costs estimated for the building, equipment,
vehicles, and manager salary equate to $100,575 annually. Table 3 outlines anticipated annual fixed costs.
Variable costs including ingredients, labor, benefits, utilities, packaging materials, and cleaning supplies
equate to $834,600 annually. Table 4 summarizes theses costs. Total costs equal roughly $935,175. Product
ingredient costs equal $1.67 per unit and packaging costs are equal to $1.45, for a total cost of $3.12 per
unit. Prices were estimated using ingredient and packaging costs from Kroger and Amazon, actual prices
may vary greatly due to supply contracts and volume purchased. Tables 5 and 6 outline details of raw
material cost. Considering an estimate of 200,000 units sold per year at a mark-up price of $6.07 per unit,
an estimated profit margin of 23.0% and return on investment of 62.7% can be realized. Calculations are
summarized in the tables below.
Based on the profit margin potential and return on investment, the product has potential for success.
Projected product price is competitive with other similar products on the market, however, with only 2
servings per package some consumers may opt for choices with more servings. It should also be noted that
findings from the Consumer Focus group showed participants were willing to pay a maximum of $3 per
serving, when they considered the product to be of high quality and with multiple health benefits.
Table 3. Annual Fixed Costs
Investment Total Purchase Price Life of Investment Annual Cost
Building $275,000 20 $13,750
Equipment $125,000 10 $12,500
Vehicles $45,000 8 $5,625
Manager’s Salary $42,000
Total Investment $445,000
Opportunity Cost 6% $26,700
Total Fixed Cost $100,575
AFC= TFC/Q
$100,575/200,000 = $0.50 / unit
37
Table 4. Variable Cost
Variable Costs Number of Units Cost/Unit Annual Cost
Ingredients/unit 200,000 $1.67 $334,000
Labor/Hour 10 $9.00 $180,000
Fringe benefits 15% $27,000
Electricity/month 12 $250 $3000
Packaging material/unit $1.45 $290,000
Cleaning
Supplies/month
12 $50.00 $600
Total Variable Costs $834,600
AVC = TVC/Q
$834,600/200,000 = $4.17/unit
Breakeven cost = $4.67
Table 5. Packaging Costs
Packaging Price/unit $ Units
Needed
Total Price/year Price per unit
Varnished paper cone 0.21 400,000 84,360 0.42
Varnished paperboard
box 0.93 200,000
186,533.333 0.93
HDPE Film 0.05/ft 250,000 12,500 0.10
TOTAL 283,393.33 1.45
Table 6. Ingredient Costs
Ingredient % of Product Price/pound Price per
crepe (250 g)
Price per unit
(2 crepes/box)
Egg 28.14 2.59 0.40 0.80
Tomato 20.19 0.49 0.05 0.11
milk 14.91 0.12 0.01 0.02
Bell Pepper 11.81 1.60 0.10 0.21
Wheat flour 7.09 0.56 0.02 0.04
Onion 6.04 0.66 0.02 0.04
Cheese 4.80 3.50 0.09 0.18
Butter 2.11 2.79 0.03 0.06
Kale 1.97 3.00 0.03 0.07
water 0.79 0.05 0.00 0.00
Olive oil 0.66 5.00 0.02 0.04
Garlic 0.56 3.25 0.01 0.02
Sugar 0.29 0.50 0.00 0.00
Sriracha 0.29 2.50 0.00 0.01
Salt 0.25 0.49 0.00 0.00
Pepper 0.05 17.36 0.00 0.01
Parsley 0.04 122.46 0.03 0.05
TOTAL 100.00 166.92 91.81 1.67
38
Total Price of Goods per unit: $3.12
Calculating Cost
Total costs = $935,175
Avg cost/unit (Pc = Tc/Q)
$935,175/200,000 units = $4.67
Total Revenue (Tr = Q*Pm) (30% markup))
200,000 units x $6.07 = $1,214,552.50
Profit (P = TR – TC)
$1,214,552.50- $935,175 = $279,377.50
Profit Margin (P/TR)
($279,377.50/ $1,214,552.50) *100 = 23.0%
Return on Investment (ROI = P/Investment)
$279,377.50/$445,000 = 62.7%
Average price received for products sold (Pm = TR/Q)
$1,214,552.50/200,000 units = $6.07
Conclusion
Crepes Around the World! Shakshouka Inspired Crepe has potential for success in the
marketplace for four key reasons: appeal to health-conscious consumers, niche-offering for
Mediterranean cuisine, portable eating on-the-go, and the possibility for line extension. Next steps
would be investigation of formula to provide decreases in cholesterol on nutrition label.
Consumers may be aware of changing nutrition guidelines for egg cholesterol, however the
product is very high in both cholesterol and saturated fat per serving. It can be difficult to break
into the market with a new product, but an option that features a crepe is unique compared to the
many breakfast sandwiches, burritos, waffles, and pancakes currently on the market.
39
References
Aramouni, F. and Deschenes K. 2018. Regulatory Considerations. Methods for Developing New
Food Products An Instructional Guide 2nd Edition. Lancaster, PA. DEStech Publications, Inc.
p177-201.
Atchley, C. 2015 Tracking breakfast ingredient trends. Food Business News.
www.foodbusinessnews.net/articles/5685-tracking-breakfast-ingredient-trends Accessed 12 April
2018
Doris, Carolyn. “Breakfast Wake-Up Call: Consumers Want It All.” Food Technology. February
2018, Volume 72, No.2
Fellows, PJ. 2016. Food Processing Technology Principles and Practice 4th Edition. Woodhead
Publishing.
Fellows, PJ. (2016) Bratt pan [Photograph] Retreived from Fellows, PJ. 2016. Food Processing
Technology Principles and Practice 4th Edition. Woodhead Publishing.
Food and Drug Administration. Hazard Analysis and Risk-Based Preventive Controls for Human
Food: Draft Guidance for Industry. 2016.
Food Safety Preventive Controls Alliance. 2016. FSPCA Preventive Controls for Human Food
Particpant Manual.
Garrison, R 2018. 2018 Meal Trends. Prepared Foods Retail State of the Industry.
https://www.preparedfoods.com/articles/121022-meal-trends-familiar-foreign-fast-fresh
Accessed 12 April 2018
George, M. 2000. 10-Selecting Packaging for Frozen Food Products. In: Kennedy, CJ. Managing
Frozen Foods 1st Edition. Woodhead Publishing.
Holmberg, M. 2012. Crepes: 50 Savory and Sweet Recipes. San Francisco California. Chronicle
Books LLC.
International Food Safety and Quality Network. “Metal Detection Discussion.” June 4, 2009.
Man and Jones. 1994. Shelf Life Evaluation of Foods. Springer Science + Business Media.
Moine, M.P. 2014. Mediterranean Cookbook: Fresh, fast, and easy recipes. New York, New York,
DK Publishing.
PM Industries (nd) Paddle blender. [Photograph] Retrieved from:
http://www.pmindustriesindia.com/mixers.html#paddle-mixers
Starfrost Freezing and Chilling Systems (2017) Spiral freezer and chiller [Photograph] Retrieved
from http://www.starfrost.com/our-systems/helix/
40
Univelever NV. Filled Crepe Products and Process for their Preparation. US Patent ES2263740T3.
Filed 22 January 2002. Granted 16 December 2006.
https://patents.google.com/patent/ES2263740T3/en
Uniworld Fooservice Equipment. (nd) Electric griddle [Photograph] Retrieved from
https://www.uniworldfoodequip.com/products/food-processing-
United States Food and Drug Administration. FDA Food Code 2017. Section 3-401.13 Plant
Food Cooking for Hot Holding
United States Food and Drug Administration. FDA Food Code 2017. Section 3-401.11 Raw
Animal Foods (A)(2) FDA Food Code 2017
Zaritzky, NE and others. 2000. 7-Factors Affecting the Stability of Frozen Foods. In: Kennedy,
CJ. Managing Frozen Foods 1st Edition. Woodhead Publishing.