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  • Published on: 14th September 2019
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Challenge Definition

Identifying the Challenge

Our team has identified a lack of quality control in regards to temperature in the food and medical industries as a source of concern for suppliers and consumers. From our research, we have determined that the current product offerings are insufficient for suppliers and consumers, and only distributors in the cold chain use such temperature controlling measures to ensure food consumption safety. We have set out to create a product that competes with these existing products in the food industry and to create an indicator that both consumers and suppliers can identify, use, and rely on.  

From our research and customer discovery, we have found that food manufacturers, specifically the Tyson Food Corporation, who currently has a 21% share of the U.S. chicken market1, are interested in an item that can help them communicate to their consumers that their product is safe for consumption. Due to Tyson's interest, we have decided to focus on balancing our design requirements with their needs to secure them as a first consumer. After a prototype is created, the main challenge will be helping Tyson and other FreezeSure consumers market their product to their consumers so that the product lifespan expands past the end distributor of grocery stores.  

The main goal is to offer an easy and efficient way to determine whether frozen chicken can be consumed or not, mainly regarding if the product has been exposed to temperature outside of the required range for that specific food for an extended period of time. This challenge involves understanding how frozen chicken is processed, packaged and distributed, how the designed solution can be implemented in the supply chain, and how the device can be integrated into existing products. A number of companies are involved in this process and it is very important to comprehend the relationships and dynamics between the producers, suppliers and retailers in order to be able to provide a comprehensive product covering the most important aspects of the cold chain.

Root Causes of the Challenge

Imagine enjoying a nice dinner and evening with loved ones only to awaken in bed hours later with inexplicable throbbing leg pain accompanied by extreme nausea.  According to the New Yorker's “A bug in the system”, this nightmare was reality for Rick Schiller, a man from California that had become infected with salmonella, which is the most common food borne pathogen in poultry products (Hylton, 2015).  Schiller's case is just one of several that occur every year in the United States.

According to the Centers for Disease Control and Prevention (CDC) (2017), “Americans eat more chicken than any other meat,” and unfortunately, an estimated one million people annually are the victims of food poisoning from consuming contaminated poultry products.  The causes of poultry contamination cases are wide-ranging including the exposure to excessive temperatures as warmth creates an environment for bacteria to proliferate. As reported by the Food and Drug Administration (FDA) (2016), food poisoning cases result in “128,000 hospitalizations and 3,000 deaths” annually; with these incidence rates, it is evident that developing an affordable way for both suppliers and consumers to ensure greater health safety and avoid these scenarios is critical.

Credible Sources Proving Challenge Space

The Food Safety and Inspection Service (FSIS) in the United States Department of Agriculture has determined several bacterial sources of contamination that can be found in improperly processed poultry.  These include Salmonella enteritidis, Staphylococcus aureus, Campylobacter jejuni, Listeria monocytogenes, Clostridium botulinum, and Escherichia coli (FDA, 2011).  Some of these bacteria, such as S. enteritidis and E. coli, are present in poultry primarily as a result of the slaughter process.  Others, such as S. aureus and L. monocytogenes, contaminate poultry from external sources like humans or unclean machinery touching the product ("Chicken from farm to table," 2014). While these bacterial levels are stringently monitored in the slaughterhouse and processing factories, the FSIS does not have a zero-tolerance policy for any of these bacteria in frozen poultry.  This means that if at any point the bacterium is exposed to a temperature at which it can proliferate, it can quickly reach pathogenic levels before it reaches the consumer (Eglezos, 2008).   

A study of outbreaks that occurred between 1998 to 2012 in which the contamination could be pinpointed to one food category showed that 25% of outbreaks were from poultry.  The same study, which analyzed 1114 outbreaks, showed that 64% of the poultry-caused outbreaks were from food handling errors (Chai, 2016).   

Synthesize Knowledge Gained from Multiple Sources

According to Rebecca Chan, a TimeStrip representative, TimeStrip and other competitors have not entered the poultry industry, so it is evident that the market is currently untapped (Chan, 2017).  We also know that there is a valid safety concern with frozen chicken contamination.  The current Food and Drug Administration (FDA) standards are adequate but qualitative, and the current standard of regulation relies on spot checks.  As of April 2016, the Sanitary Transportation of Human and Animal Food Rule from the FDA has removed specific requirements for temperature monitoring and allows the shipper and carrier to agree on a mechanism together (U.S. Food and Drug Administration, 2016).  This ruling placed primary responsibility on the shipper, but leave it up to the receiver to determine how frequently they want to check and ensure proper temperature conditions.  This creates a great opportunity for a third party like ourselves to market an unbiased, easily verifiable system to reduce risk for both the shipper and receiver.  

Harms or Benefits Resulting from the Challenge

Possible harms in creating this product could mostly result from us using incorrect initial specifications. For example, if the device is too conservative, chicken could be wasted that is actually safe to eat. Another risk is people blindly relying on our product rather than using their senses to tell if something is obviously wrong with the chicken. The chemicals used could also pose a toxicological risk to people, the food, and the environment if not chosen properly. The extra plastic of the sticker could lead to additional pollution.  

 Stakeholders

Potential stakeholders and investors for FreezeSure include the US Food and Drug Administration, Tyson Food Corperation, Pilgrim's Corp, Purdue Inc., Koch Foods Inc., and Gebruder Stolle. Potential competitors and distributors include TimeStrip, DeltaTrak, ShockWatch, and SpotSee.

The Tyson Food Corporation has assisted FreezeSure in material development and selection by providing the group with necessary information regarding patents and FDA regulated materials. Tyson's point of contact, Stephanie Hull, has provided FreezeSure with a spreadsheet listing compounded materials and plastics used in their packaging facilities. These materials will assist the FreezeSure group in the material selection for the adhesive sticker when moving into the design phase. Since our product has not yet been patented we are limited to the amount of information we can provide to the Tyson's Food Corporation as well as the amount of information they can provide to us about their materials used for specific products due to a copyright policy in place.  

Areas in Which Multiple, Measurable Design Requirements can be Determined

We have a few key goals that need to be met to consider the product successful.  The device needs to irreversibly change color after being exposed to temperatures above 4oC for longer than 15 minutes (Commissioner, 2014). The product also needs to be FDA compliant, using materials either generally recognized as safe or ones that could pass the FDA's toxicology application process (Shanklin, 2005). More specifically, they need to be non-mutagenic, non-flammable, non-corrosive compounds. Ideally, they would also be non-toxic if accidentally ingested in small quantities.

It also needs to be a system that does not require a lot of additional time or labor for the manufacturer; our system should minimize extra training or safety classes for the workers interacting with the product.   

Price is another significant issue. Competitors in the market have indicators roughly costing two USD per indicator (Chan, 2017). These indicators are cheap at bulk level and when used for a single pallet of goods instead of per package, but they are infeasible for individual package use. For FreezeSure to be successful, we need indicators that are hopefully less than a dollar in cost, and that will hopefully be internalized by the supplier until consumers demonstrate interest in having them. If we are unable to reduce cost, it could marginalize lower income groups.  People below the poverty line in the United States already have difficulty affording fresh and healthy foods, and our product could make that problem worse if we're not careful.

We need to develop comprehensive toxicological, chemical, and environmental information about all products we use. This should not be an area of huge concern, however, because the risk assessment is for conditions of “intended use,” which means our product should have minimal to no interaction with the actual food, but rather existing external packaging. It would be better to use safe, non-corrosive materials approved by the FDA, though, to minimize hazards to workers and extent of contamination upon device failure. This would add value to the product for the manufacturer, who would have to absorb any costs of our equipment failure. It would also ease adoption due to FDA endorsement and help with the manufacturer's products achieving FDA approval as well.  

Specifically, the design requirements would be:

Product cost < $2

Readability and intuitiveness: bright color change

Product accuracy > ± 3 minutes

Production methods

Product toxicity < 1.5 µg/person/day of potential food contact

Distribution methods: store at room temperature

Product dimensions < 1x1x0.5 inches

Time recording: responds to multiple exposures

Easily implementable into supply chain: peel and stick. Storable for 2 years

Research Summary

Internal Research

Briere's Internal Research

Integrating the solution in already existing supply chains:

How is this going to affect companies and their operations

How expensive would the integration be

Type of design on ease of integration

Convincing companies to adopt our product

Marketing:

Higher safety for consumers

Better brand image

Financial return: reduce waste and costs / increase efficiency of operations

Target specific products

Competing products:

No well-known product

Why? Is it not working?

Not widespread enough?

Reluctance from companies to use such a product?

Low consumer awareness regarding problem and solution?

Stakeholders:

Government

Suppliers

Distributors and retailers

Companies providing the raw goods

Processing companies

Consumers

Production of solution

Make sure product does not “react” before being applied

How to store it?

Regulations

Regulations already existing

Possible to change it? How?

Why would the regulations change?

Gailey's Internal Research

Medical Application

   There are certain chemicals, like proteases for example, that have to remain frozen until ready to use.  Proteases are proteins that break down other proteins so if it is brought to room temperature for an extended period of time, the enzyme will begin to break itself down and inactivate.  Similar potential effects should be minimized because if someone is doing research and the chemicals are not working because they are already inactive, it could be costly.  Understandably, trained professionals or students would still handle the chemicals with caution, but accidents still occur.  If there is no way to monitor the handling process, the chemicals could have been exposed to warmer temperatures for an extended period of time before being re-frozen.

    Questions for Further Research

Is there a widespread technology for this purpose in the medical field?

How do large companies track the handling of chemicals through the shipping process?

Does this also apply to some vaccines and pharmaceuticals? If so, how do they track the process when there is more liability to make sure there has been no contamination or mishandling?  

Time Gradient

   There has to be a threshold for the amount of time any chemical can be exposed to a given temperature before exposure has adverse effects.  This is likely the same with food products.  To monitor this, the device would have to account for a range of temperatures over a specified range of time.  The product would have to indicate different levels based on time: “exposed but only limited exposure; safe to eat/use”, “exposure was too long for given product; do not eat/use", etc.

Questions for Further Research

What about using color-changing chemically–treated paper on the product?  

Would it provide a gradual indication or at-least step-wise?

Could this be less expensive and less dangerous?  

The chemically-treated papers that most people are familiar with only temporarily change due to heat sensitivity; are there any that permanently change?

What about time exposure? The reaction can't be all or nothing; it has to be gradual to allow for longer exposure times.

Nicholas's Internal Research

Plastic packaging

Safety to consumers is most important.

Contact a food plastics manufacturing company.

Inert to chemicals

Spill resistance to other materials/chemicals?

Will there be a clear film over the sticker?

Puncture Resistant

What is the amount of force the sticker can undergo before breaking?

Testing in the lab for corrosion and resistance?

Puncture of the product will remove its purpose.

Sticker adhesion

Is there a way to manipulate the temperature of the material causing a color change?

Various temperatures will affect the sticker adhesive surface.

Cost of the material ($400 budget)

Needs to be economical but still profitable.

How will this affect current companies and their existing products?

What is the delivery process for the sticker and how will that affect the delivery for the cold chain product?

Saxerud's Internal Research

Transportation Truck Technology

Cold-storage transport trucks have refrigeration units. They probably have gauges and everything to monitor the temperature, but how effective is it in keeping the whole truck at the same temperature? A small fridge has temperature variations that can cause food to spoil. If the truck's systems break down, then it needs some manual assurance of the temperature as well.

Questions for Further Research

What systems do refrigeration trucks use and who provides them?  

What laws are the refrigeration trucks adhering to?

What backup systems are in place?

FDA Meat Laws

Since the horrible meat packing facilities of the 1930's, the US FDA has been regulating production, packaging, and shipping of meat. The meat market sprawls across many different sectors and types of products, and they probably have different regulations for each type. The FDA probably has data to base their laws upon.  

Questions for Further Research

Have the regulations stalled? Are there any new ones being added with frequency?

What requirements are already in place? What is their rigor and what are they based upon?

How does food regulation differ from medical?

Consumer Palatability

Are there any indicators based on the same premise that normal consumers interact with frequently? What are their views and how do they interact with the indicator? Sell-by date? Consumers would never really agree to pay a premium for the indicator, but would they notice a small increase in the price? Price fluctuations of meat and other products: do they cause any swings in demand, or are they relatively demand-inelastic? Have any similar ideas been marketed, or just placed in the market without any push? Is this the kind of "product" you can inspire jealousy and desire with?  

Questions for Further Research

Are there existing products in the market?

Where in the supply chain are those products and who interacts with them?

Zecchini's Internal Research

How do we make sure cold/frozen goods stay cold from manufacturer to consumer?

How long will the chemicals be exposed if ever? Contamination?

What melting point temperatures should we be targeting?

How long do we need these to last?

Do the compounds break down?

Are the chemicals safe for normal trash?

If they break during shipment is that safe?

Can't react with casing

Will the chemicals react when frozen or just when they melt?

Does just one need to melt?  Or both?

Could one melt at a “too high” temp and one at a “too low” temp?

Could I talk to my inorganic professor, Machan, about this?

What we have so far, chemically

2 chemicals react at a certain temp

I do know lots of chemicals and how to read SDS sheets

Will the people at the third-party companies ever have to interact with the chemicals directly?  Will that require more training?

Read the SDS- flammable? corrosive? Packaging cannot be compromised

Cost range of chemicals/how much extra are people willing to pay for this?

Internal (Collective)

Sticker Structure

Two halves shipped separately where the employees at the plant are exposed to the chemicals and require training, or pre-assembled and mandated to be held “upside-down” until frozen.  

Questions for Further Research

Is plastic recyclable or breaks down easily in landfills and doesn't contribute to long-term waste?

Frozen Truck Regulations

A lot of rules for temperature, but no real way to check it. Grocery stores pay the distributors/supplier after they sell the product, so they might want the indicator as a guarantee that they have good products for the grocery store and won't lose money. Grocery store also wants the guarantee for their brand and publicity.  

Questions for Further Research

Is it honor based? Or checking their gauges?

Biomedical Challenges

Proteases and some immunizations are to remain frozen until ready to use because proteases, especially, will break down and inactivate if thawed for an extended period of time or continuously thawed/re-frozen.   

Questions for Further Research

Is there a specific amount of time for exposure before these begin breaking down?  

How do chemical and medical companies measure temperature exposure with time gradients and how could this be applied to the frozen food industry?

External Research

ShapeSupply Chain  

Food is mainly divided in three kinds: fresh, refrigerated and frozen. We will be mainly focusing on frozen goods.

Frozen goods are usually processed, stored, transported and distributed through different phases. This process is usually iterated more than once. Different layers of the supply chain are usually operated by different companies, specialized in their respective area; sometimes the same company control one or more layers of the supply chain. This usually depends on the type of good, size and type of company and the leverage and influence of the company has on the supply chain. The different companies need to appropriately design their operations the make the supply chain run as smoothly and efficiently as possible.  

Distributors and retailers often have more than one supplier, depending on the size of the operations, and suppliers also have numerous clients to which they supply the requested goods. Suppliers might specialize in one specific type product.

In the case of frozen goods, the supply chain is often referred to as the cold chain. One of the most important characteristics is to ensure that the products are kept within the right temperature range and they are therefore safe for consumption.

ShapePractical Storage Life (PSL)  

Practical storage life refers to “how long certain categories of products can be effectively stored without creating undue quality damage to the products. This storage period is commonly called the Practical Storage Life (PSL), or shelf life which is about equivalent to the duration of consumer acceptability” (WFLO, 2008).

From figure 1, we can see that the shelf life mainly depends on two factors:  

Temperature: the lower the temperature of the product the longer it will be preserved without losing quality. For example, meat can be preserved from 2 to 12 months at 23°F, but can be consumable for more than 70 months with a temperature of -22°F.  

Type of food: different types of food have an acceptable quality for different amounts of time, furthermore, they also react differently to changes in temperatures. For example, fish has a lower PSL compared to meat.

Main Issues for Frozen Goods Within the Supply Chain

Three main issues specifically related to this challenge space can be identified in the supply chain, as suggested by Dr. Tim Kraft, Operations Professor at Darden School UVA

Frozen products are most vulnerable to an increase in temperature when they are waiting to be transported from one location to the next one, such as when they are placed on a dock and subsequently loaded into their vehicle of transportation, for example, a refrigerated truck. This is also referred as ‘broken cold-chain'. The actual transportation of the goods is normally not the biggest challenge regarding keeping the products at the right temperature.  

Goods need to be kept within the appropriate temperature at all time, even though the air temperature can be slightly higher for a small amount of time without having a significant effect on the actual temperature of product2. The goods might be frozen and thawed, intentionally or not, throughout the different stages of the supply chain, especially if there are bad operating practices within a company and poor coordination between different companies handling the lots. Companies handling this type of goods have the proper equipment and processes to ensure that this does not happen, however failures and/or mismanagement of the stock can occur. The stock is most vulnerable when handled by different companies, as the procedures might differ and the risk of mismanagement increases.

Furthermore, it is very hard for the company next receiving the stock to verify whether the lot has previously been exposed to temperatures outside of the required range when it arrives at its destination, as sometimes the quality loss becomes apparent only after further storage.  

In a supply chain of perishable and temperature sensitive products, the number of stages the goods go through should be as low as possible to reduce the risks of contamination, decrease in quality and mismanagement. As the number of links of supply chain increase, the chances of the product being non-consumable grow.

Transportation  

On a national level, in the United States in this case, frozen goods are mostly transported by refrigerated trucks form one place to the other, unless they are originating from foreign countries, in which case maritime transportation is most often used to initially import the goods in the country, they might then need to be further transported from that initial location if required. Mainly products originating within country where they are processed and then sold will be covered. The trucks are refrigerated, through a refrigerating unit, and well insulated, making it difficult to have major temperature changes when the refrigeration is on and the backdoors are closed. A data logger is installed on the truck, monitoring the air temperature, of insulated container, but not the actual temperature of the cargo.

Transportation vehicles should be precooled to an air temperature of -7°C or lower before loading the merchandise. The doors must then be closed and truck must be able to maintain -18°C for the duration of the transportation. The doors should be kept closed and the refrigerating unit turned on during any period of time between loading and unloading. Goods should be securely loaded in the truck to provide free circulation of air in every direction, to ensure a good circulation of cold air, fundamental to keep the all the products refrigerated in the same way. When the truck arrives at destination, it is unloaded, minimizing amount of time frozen goods are exposed to undesired temperature.

Moreover, the vehicles used to transport frozen merchandise must be clean and free of odors before loading operations, in order to respect sanitary rules.

Food Handling and Reception

At the arrival of the refrigerated vehicles, the temperature of the products is taken, to ensure that the actual temperature of the frozen goods is under -18°C. This might not always be the case and companies need to have well defined policies and procedures regarding how to handle goods having a temperature slightly higher than the one desired3. Taking the temperature of the goods is useful for a few reasons. One of them is to prioritize which products need to be moved into the right storage facility faster than others, according to the measured temperature; some freezers are especially designed for products slightly above the desired temperature to freeze them down fast. Another reason is to gather evidence in case there is some damage for later claims, this is crucial as some products might not deteriorate immediately, but it may take a few days to see damages.

The lots of frozen goods also need to be labelled, for stock management purposes.

Data is when the food was received and the conditions of the reception, such as the recorded temperature. This allows companies to have records of their stock and better identify where a fault occurred, in this case if the product was exposed to a temperature outside the required range.

The stacking of the products inside the freezer affects the freezing and quality of the goods. It is important to allow for a cold air flow to pass between the stocks, especially in freezers used to quickly decrease the temperature after the goods are received. The following graph shows the difference between tightly stacked cases and cases stacked allowing for an air flow:

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Material Selection  

Adhesive Surface Materials  

Cold temperature adhesives work at low temperatures that range from 10°C to -30°C. When temperatures decrease material structure and strength stiffen and are decreased. Specifically, with the cold chain industry when moving frozen meats from one refrigerated location to another the temperature fluctuates. These temperature changes often times cause condensation, therefore increasing the chances of labels falling off or lifting up on the label's edge. Various tests for material surface conditions and how they can affect the adhesive performance include:

The initial track is used to define the amount of time it takes for the bond to form between the surface and the adhesive. When the initial track is high then the surface adhesion will be high.

The peel strength determines the force necessary to break the bond. It requires the angle or direction, the amount of time and the application pressure.

The shear resistivity is depicted by the durability of the bond adhesion. The higher the shear adhesion the less likely the bond will split if stressed.  

Other Features of Supply Chain

Effective Changes  

It is very hard to drive changes in a supply chain and the cold chain management is no different. Some of the main reasons include:

One company rarely has control over the whole supply chain, as multiple companies interact with the products.

Very often at one given stage, the company has no visibility past the previous layer, meaning that it might not exactly know, nor care, about what happened to the goods before it received them. For example, a local grocery store may not know the logistics past its supplier.  

Companies usually have a direct contact/relationship only with the company supplying the product, not with all the companies in the supply chain, making it hard to effectively communicate and drive change throughout the supply chain.  

Supply chains operate on high volume, usually with highly automated operations. This makes it significantly harder and costly to introduce changes into an already functioning supply chain.

Companies need incentives to change their operations, otherwise the chances of things changing are very low. Two main incentives can be identified. The first one is direct financial return, this could be an increase in quality, a higher profit margin, waste reduction or higher efficiency. The second can be from brand perspective, especially if a company is threatened by public opinion concerning a food-security related incident, where a way to show that their products are more secure would benefit them.

Not enough pressure from either government and consumers to drive changes. The government, at the moment, feels that there are enough regulations in place and the frozen goods are safe enough and that more regulations would hurt the development and prosperity of companies operating in the sector. The consumers are not pressuring enough either the government to introduce new legislation or companies to take action into making sure their products are safe.

Often supply chains are highly automated, making it very hard and expensive to change. A human element might need to be introduced and trained to handle the new procedures. This is expensive, and companies are rarely willing, to change operations, which are usually well studied before being developed.

Food vs Medical  

Two main market with similar applications can be identified: frozen food and temperature sensitive medical goods. Both of them have similar features and supply chains.

Medical  

Quality is one of the most important concerns for medical products. Some of them depend of the temperature, for example, often biotech products require deep frozen storage (down to -80°C) to be appropriately conserved and some chemical reactions stability depends on temperature. Regulations are given by CGMP4, enforcing the “compliance with strict temperature control along the process/distribution chain” (Abbott Laboratories), these include: complete tracking of temperature storage conditions, validated storage areas, qualified shipping, documentation and procedures to handle excursions. Drugs, and medical applications more generally, are more regulated than food. Temperature, equipment and storage are also tightly regulated, to ensure safer products. FDA has strict regulations concerning facilities, equipment and manufacturing of drugs that need to be met by companies in order to successfully manufacture and sell their drugs.

The international aspect is more present in medical supply chains, as chemicals might be sourced in one country, the product may be processed in another country and then distributed in another nation. This is not always the case, but it is a common practice for drug substances.

It can also be noted that there are large monopolies, especially in the pharmaceutical industry, which could make changes into supply chain more difficult to implement.

Food

The food industry initially appears to be more attractive compared to medical. Some of the reasons include:  

Higher transparency between companies and a lower domination of companies in the industry. This also means that individual companies have less leverage throughout the supply chain, which offers both advantages and disadvantages.

Companies have more freedom regarding their operations, especially as regulations are looser.

Very high volume, making economies of scale easier to achieve

Companies operate on low margin per product, making the possibility of reducing waste and costs or increasing their efficiency a very attractive proposal.

The operations of frozen goods are less developed and advanced compared to the medical industry

Approach to Introducing the Solution into the Supply Chain  

Stakeholder's Leverage in Supply Chain  

It is crucial to understand the dynamics present in the supply chain and the relationships between the companies operating in different layers, having exposure to different aspects of the market. This allows the identification of which company has the most leverage over the other companies; it is usually the company controlling and having a direct contact with the final consumer, usually grocery stores and retail centers. The size of the company also matters, as the bigger and more important a company is in its respective market, the more leverage it will have in the supply chain.  

Company Approaches  

Depending on the dynamics of the supply chain, two different strategy could be adopted to introduce the solution in the supply chain.  

The first one is an “upstream” approach, where companies in the early stages of the supply chain introduce our solution and it would force other companies to act on it.  

The second one is a “downstream” approach, where companies at the latest layers of the supply chain, for example a grocery store, decide to adopt the designed solution and force their retailers to adjust their operations to suit the needs of their clients.  

Stage of Introduction

Supply chains operate through different stages, complexly linked to one another. The stage in which the designed solution is first introduced will greatly affect the effectiveness of the product. If the solution is introduced in one the early stages, it will check the quality of the product throughout more layers of the supply chain and a longer time span. However, if it first applied in a later stage of the supply chain, it will not be able to determine the quality of the frozen good and whether was maintained at the required temperature in the preceding layers of the supply chain, making it less useful in determining the quality of the final product.  

Applications of the Solution

The designed solution could be used in two slightly different ways.

External use  

The designed solution is targeted towards the final consumer (external application), where the individual consumer can check whether the frozen good is still consumable or not through the designed solution. A business to consumer strategy.  

This would imply that the solution would need to be applied to every single packed good to be effective and useful to the consumer.

Internal use

The designed solution is aimed towards an internal use, meaning that companies throughout the supply chain, and not the final consumer, use the designed solution to determine the quality of the goods at any given time, whether they are received or stored. This would a business to business strategy.

This means that the solution might not need the applied to the single product, but could be applied to an entire lot to determine the quality of the whole lot.

Product identification

It is best to initially focus on and target one specific product, such as meat, poultry, fish or fruits and vegetables. This simplifies the designing process and marketing, while making it easier to ensure the solution has desired effect.

Remains the question of which product and company to target. Companies currently experiencing bad public opinion, through their products safety scandals and bad press, are more susceptible to make changes in their operations to ensure better products, while ensuring a higher and more positive brand awareness. On the other hand, companies affected by financial and/or operations struggles might be more receptive to the opportunity of increasing their efficiency and/or decrease their costs.

Furthermore, initially focusing on products at a national level would greatly simplify the design of the solution, as it would need to take into consideration less requirements and international aspects usually increases the complexity of the operations and supply chain management.  

Finally, frozen poultry appears to be a good initial product, as it is fairly easy to conserve as it is not as sensitive to temperature changes as other products, such as beef, and its quality is easier maintained.

Poultry Data:

Figure 3 shows the amount of frozen poultry in United States warehouses in 2016. Figure 4 shows the amount of frozen chickens, turkeys and ducks in United States warehouses in 2016. There is a clear seasonality in the turkey data, as it builds up until August and then the stock decreases, with the lowest point in November; this is most probably due to Holiday Season.

ShapeShape

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Competitors and Stakeholders

Competitors

ShockWatch

ShockWatch is a company involved in the indicator business for quality control and damage prevention. They manufacture WarmMark® and WarmMark2 which are time-temperature indicators operating similarly to FreezeSure and relying on a dye spreading at a fixed rate through blotter paper (Chan, 2017).  ShockWatch is uninvolved in the actual sale of their temperature indicators to their consumers, and instead rely on distributors such as DeltaTrak and SpotSee. ShockWatch is a competitor to FreezeSure because their product fulfils the exact same capabilities. We need to make sure that we have a competitive product to be successful and that requires being competitive on price, features, and marketability to a wider audience. WarmMark® seems to only have application in the cold chain, and has no presence for consumers and is not widely known to suppliers. They are not widely used in distribution either (Chan, 2017).  

TimeStrip  

TimeStrip is a UK company also specializing in cold chain quality control, and manufactures their own time-temperature safety strips for food, seafood, and medical supplies. TimeStrip primarily exists in the pharmaceutical and blood cold chains with one of their blood indicators for 10oC recently being approved by the US FDA (Chan, 2017). They expanded recently into the food industry on request by Amtrak when they contacted TimeStrip for a custom product for their food and beverage trucks. They also developed their seafood indicators specifically for the Ferme Marine de Mahebourg fish farm in Mauritius so they could more successfully sell their products throughout the world. TimeStrip does not have a large presence outside of these specific companies, and solely sells to suppliers for use in the cold chain. They do not sell to distributors nor consumers beyond the grocery store (Chan, 2017). TimeStrip is looking next to expand to livestock and specifically beef.  

Stakeholders

USFDA

The Food and Drug Administration is one of the biggest stakeholders in our endeavor. They control, through their regulations, what our product is made of, how we make it, and how we integrate it into the cold chain. The Food Safety and Modernization Act passed in 2011 covers foreign food imports, sanitation, and preventative controls of food distribution and sale in the United States (FDA, 2017). Due to these new regulations (most rules have taken affect within the last year), companies have to adapt to stricter verification procedures. If FreezeSure can be made to FDA specifications, then it can be used by food packagers and distributors to pass the strict regulations more easily, just as the Ferme Marine de Mahebourg does with TimeStrip Seafood indicators.  

FDA Fish and Fishery Products Hazards and Controls Guidance

The FDA requires processors of fish and fishery products to create Hazard Analysis Critical Control Point (HACCP) plans to ensure quality and reduce risk of illness and contamination. Time-Temperature Indicators (TTIs) are fully endorsed by the FDA for use in this market to ensure seafood is maintained at an adequate temperature to prevent the proliferation of C. Botulinum, which is a bacterium that causes the deadly disease botulism (FDA, 2011). For HACCP compliance, TTIs need to be used with full control strategies for monitoring, data logging, record keeping, and quality control.

OSHA  

The Occupational Safety and Health Administration (OSHA) is a stakeholder in FreezeSure due to the involvement of chemicals around employees. OSHA has strict requirements on how chemicals are used and how the information on them is disseminated when in contact with employees (OSHA, 2012). Due to the possible nature of FreezeSure, the manufacturing and assembly of the indicators need to adhere to OSHA guidelines. This requires extra attention if the assembly and activation of the indicator at the point of affixion to the product exposes those employees to the chemicals.  

Environmental Protection Agency

The Environmental Protection Agency has regulations on the import and export of chemicals (controlled by the Customs and Border Protection) that FreezeSure could be subject to depending on its composition (EPA, 2016). Compliance with the Toxic Substances Control Act (TSCA) is essential for expanding the market internationally or serving customers importing and exporting in the United States. WarmMark® is considered an article and is exempt from TSCA regulations (Chan, 2017).  

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