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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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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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- 22 -

Figure 9. Product principal display panel

Figure 10. Information panel

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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.

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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

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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

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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

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- 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

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- 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

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- 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

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- 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

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- 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

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- 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

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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.

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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.

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- 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.

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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

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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

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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.

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39

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