On November 21, 2022, the United States Food and Drug Administration (FDA) published a Final Rule titled Requirements for Additional Traceability Records for Certain Foods which implements Section 204(d) of the FDA Food Safety Modernization Act (FSMA). This rule is commonly referred to as the “Final Rule”. The Final Rule requires companies to keep additional records for designated foods to protect public health. The additional recordkeeping requirements that the FDA has established are outlined in the Federal Register Notice.

What is the traceability plan?

The plan itself doesn’t have a specific format, but it needs to cover certain elements outlined by the FDA . These elements include: Recordkeeping Procedures : How you’ll document the traceability information. Point of Contact : Someone designated to answer questions about the plan. Traceability Lot Code Assignment : A system for assigning unique identifiers to track food throughout the supply chain. Farm Map (For Farms on the FTL) : A visual representation of your growing areas with details for identification. Examples (by FDA) : Farms: https://www.fda.gov/media/174057/download?attachment Restaurants: https://www.fda.gov/media/174058/download?attachment

Does TRAKKEY help me comply with FSMA 204?

Yes, TRAKKEY is designed to help food businesses comply with FSMA 204 by: · Capturing and storing key data: Track origin, processing, transportation, and other relevant information for designated foods. · Facilitating record keeping: Maintain detailed records electronically, simplifying compliance and audit readiness. · Enhancing traceability: Gain real-time visibility into your supply chain, allowing for quicker identification and isolation of potential issues.

Who is required to comply with FSMA 204?

The FSMA 204 applies to persons who manufacture, process, pack, or hold foods that appear on the Food Traceability List (FTL). The FTL includes, but is not limited to, soft cheeses, eggs, nut butters, finfish, crustaceans, bivalve mollusks, ready-to-eat deli salads, or fresh fruit or vegetables. You can find a full list of designated foods on the FDA website: https://www.fda.gov/ .

When does FSMA 204 come into effect?

The compliance date for FSMA 204 is January 20, 2026 . However, it's crucial to start planning and implementation well in advance to ensure smooth compliance by the deadline.

Does FSMA 204 apply to imported foods?

Yes, FSMA 204 applies to both domestic and imported foods . Importers have specific responsibilities under the rule, including obtaining certain records from their foreign suppliers.

What are the “designated foods” subject to FSMA 204 requirements?

The FDA maintains a list of designated foods subject to FSMA 204, which is constantly being updated. You can find the current list on the FDA website: https://www.fda.gov/ .

Do the rules apply to companies outside of the U.S.?

The requirements of the Final Rule apply to all persons or companies who manufacture, process, pack, or hold foods on the FTL (unless an exemption applies), regardless of whether the person/company is in the United States or a foreign country.

What is the Food Traceability List?

The Food Traceability List (FTL) is a list of foods that are subject to additional recordkeeping requirements under FSMA Rule 204. https://www.fda.gov/food/food-safety-modernization-act-fsma/food-traceability-list

Is the Food Traceability List final?

The final rule sets forth a process for the FDA to update the FTL if the agency concludes that updates are appropriate. When FDA tentatively concludes that an update is necessary, the FDA will publish a notice in the Federal Register stating the proposed changes to the list and the reasons for the changes and will solicit feedback and information on the proposal. After considering any feedback or information submitted, the FDA will publish a second notice in the Federal Register, stating whether any changes are being made, and the reason for the decision. Any additions to the list would become effective two years after the date of the second Federal Register notice, unless otherwise stated. Any deletions from the FTL would become effective immediately.

What is the dashboard used for?

The dashboard is used for creating new events, printing labels, checking inventory, and recent activity among other features. You can easily check outgoing and incoming shipments, create new shipping events, and generate all the necessary documentation. It’s a hub of all features.

Can I do all tasks from the dashboard?

Events and everything related to them can be done from the dashboard . Master data, such as locations and other advanced features can be found in the vertical menu on the left side of your screen.

Can I select a specific product from the inventory and ship it?

Of course! This speeds up the process and allows you to see inventory live. It’s as easy as clicking the "Ship this lot" button.

What does the recent activity window show?

It shows all recent activity processed by TRAKKEY. Date and time, which product on what LOT/ID, what event was done, and a small icon that will guide you to the next recommended step for this product.

How to generate an invoice or shipping slip?

On the dashboard, click on the Ship button, and a new window will open. In this window, select which product you want to ship, from where and to whom, how many pieces, and what the price per piece is. In the summary section, this product will appear, and under status, you will see “waiting to submit”. If you’re entering multiple products, they will all be processed independently. After processing, a smaller window will appear where you can create the shipping slip, generate invoices, and perform other features.

How to see all outgoing shipments?

Click on the dashboard on the left vertical menu, scroll down, and a window labeled “Outgoing shipments” will appear.

I have an incoming shipment, what’s next?

Click on the dashboard on the left vertical menu, scroll down, and a window labeled “Incoming shipments” will appear. Hover your mouse over a shipment you’d like to receive, and you will see two choices: “Mark as received” and “Receive this lot”.

Click on the dashboard on the left vertical menu, and at the top, there will be a button labeled “Print labels”. Click on the button, select which product, location, and other necessary information, and state how many labels you need in the “Number of labels” line. Your printer will automatically print them out . Please make sure that you have all necessary printer drivers and support for web based printing installed.

My printer isn’t working, what should I do?

Please check all necessary connections, drivers, and set up the printer according to the instructions. If the problems persist, contact your company's IT department or our support team at support@enseso.com, and one of our technicians will assist you.

My labels are in a different format, what should I do?

Please contact us at fsma@enseso.com , and one of our technicians will assist you.

My product isn’t showing up.

On the left vertical menu, click on “Products”, and a new window will open. In this window, you'll see “FTL food” and “Non-FTL food”. If a product isn’t showing up and isn’t listed on the “Products” page, you can easily create it by clicking the + icon in the top right corner of the window (not the orange button, but the smaller one below it).

Location isn’t correct or showing up.

On the left vertical menu, click on “Locations” and check existing information or create a new location.

Can the harvesting date be in the future?

The harvesting date can’t be in the future, but can be in the past.

What is the unit of measure used?

Unit of measure is defined for every product on Product screen. Definition from the Product screen is then used everywhere.

How do I see all my products?

On the left vertical menu, click on “Products”, and a new window will open. In this window, you can see all your products.

How do I edit product properties?

On the left vertical menu, click on “Products”, and a new window will open. Select a specific product you want to edit and click on the “Edit product” icon

How do I see all my locations?

On the left vertical menu, click on “Locations”, and a new window will open. In this window, you can see all your locations, location type, address, and contact information.

How do I edit a specific location?

On the left vertical menu, click on “Locations”, and a new window will open. Click on a specific location you want to edit, and a new window will open where you can see all information about this location

Is it possible to add a specific field?

Yes, it is possible to add a specific field. Field is a location like any other location (farm, factory, store).

What are TRAKKEY partners?

TRAKKEY partners are companies you work with that also use TRAKKEY. It makes sharing information much easier, such as shipping, receiving, and transformation events. More permissions can be configured using the Advanced button.

Can I invite an outside firm to be my partner?

Please contact us at fsma@enseso.com , and one of our administrators will take care of adding your partners who are still not registered with TRAKKEY.

Events are specific processes your product goes through.

How does track and trace work?

Track and trace can be accessed on the left vertical menu by clicking on Advanced and selecting track and trace in the submenu. Select which product, enter batch or serial, and an interactive map of the selected product will appear, making it much easier to see all the events it went through, at which location, date and time, and other information . Please note that relevant track and trace information about the specific product will be listed only for those points in supply chain where events have been tracked through TRAKKEY.

IoT integration is not mandatory by FSMA 204 regulative but provides an extra layer of security and insurance of quality for the products that are equipped with ENIOT sensors which are fully integrated into TRAKKEY Mobile app for ease of use.

What is the plant menu used for?

The plant menu is used for entering products that have just been planted and the expected yield. This information can be used to determine the status of this product in the future, expected stock, and other important information.

How do I determine expected yield?

Expected yield is a quantity with a margin of error. Check your seed manufacturer's information on what yield is expected on what area in your specific region or contact them directly to make a more accurate calculation.

How do I start a harvest event?

On the left vertical menu, click on “Dashboard”, and a new window will open. Click on the “Harvest” button and enter all necessary information. After entering all data, click on save in the bottom right corner of your screen.

What is the reference record type and number?

Reference record types and numbers are information about records connected to specific event – record(document) type and number. Example: For harvesting we will have Reference record type Harvesting order (HO) and number of Harvesting order as Reference record number. For shipping we will have Reference record type Shipping order (SO) and number of Shipping order as Reference record number.

How do I choose the correct reference record number?

Because Cooling event is event after Harvesting, for specific product you need to choose Reference record type and number of Harvesting event from which you are taking product to be cooled.

Why is the harvesting location filled out automatically?

Because Cooling event is using data from Harvesting event where Harvesting location is defined.

What does immediate subsequent recipient mean?

Immediate subsequent recipient is location where product will be after specific event.

What does source product mean?

The pack event can also be used for transformation events, such as a change in packaging. Source product refers to the product as it was received from the harvester, while the packaged product can be different from the source product. Source product is input to Initial packaging event and Transformation (Produce) event.

How to edit harvesting locations?

On the left vertical menu, click on “Locations”, and a new window will open. Click on a specific location you want to edit, and a new window will open where you can see all information about this location.

Why are some fields filled out automatically?

It’s due to already entered locations, harvesters, fields, products, etc. TRAKKEY has advanced algorithms integrated that aim to speed up the process. Sometimes data is taken from default values (defined on Products), sometime from previous event in workflow.

What does produce mean?

Produce is a transformation event that converts one or multiple products into one or multiple different products. For example, a mixed salad: inputs are tomatoes, peppers, broccoli, and the output is a Mixed salad as a new product.

How to enter multiple inputs?

It’s as easy as entering a single input and clicking on the + icon to add a new row.

How to enter multiple outputs?

It’s as easy as entering a single input and clicking on the + icon to add a new row.

How to enter multiple products?

First, fill out the information for the first lot and click on “Add LOT”. In the summary below, you will see the product just entered. Then go back to the same window you entered the first product in, and you will see that it is now empty again. Fill out the information for the second lot and click on “Add LOT” again. Repeat this process until you’re done entering all lots. Afterwards, click on save and TRAKKEY will start processing this information.

What does waiting to submit mean?

TRAKKEY is waiting for you to finish entering data. When you’re done, click on Save in the bottom right corner, and TRAKKEY will start processing all your entered lots.

Can the generated invoice be used as a legal document?

Yes, it can also be customized to your liking. Please contact us at fsma@enseso.com .

How to print multiple labels?

To print multiple SSCC labels, just enter the necessary number of labels in the Print menu.

TRAKKEY Wiki

Learning tool for TRAKKEY Traceability Solution

Please login or register before viewing the wiki content.

FSMA 204 Frequently Asked Questions

FSMA 204

What is FSMA 204?

On November 21, 2022, the United States Food and Drug Administration (FDA) published a Final Rule titled Requirements for Additional Traceability Records for Certain Foods which implements Section 204(d) of the FDA Food Safety Modernization Act (FSMA). This rule is commonly referred to as the “Final Rule”. The Final Rule requires companies to keep additional records for designated foods to protect public health. The additional recordkeeping requirements that the FDA has established are outlined in the Federal Register Notice.
What is the traceability plan?
The plan itself doesn’t have a specific format, but it needs to cover certain elements outlined by the FDA.

These elements include:
- Recordkeeping Procedures: How you’ll document the traceability information.
- Point of Contact: Someone designated to answer questions about the plan.
- Traceability Lot Code Assignment: A system for assigning unique identifiers to track food throughout the supply chain.
- Farm Map (For Farms on the FTL): A visual representation of your growing areas with details for identification.
Examples (by FDA) :

Farms: https://www.fda.gov/media/174057/download?attachment

Restaurants: https://www.fda.gov/media/174058/download?attachment
Does TRAKKEY help me comply with FSMA 204?

Yes, TRAKKEY is designed to help food businesses comply with FSMA 204 by:

· Capturing and storing key data:

Track origin, processing, transportation, and other relevant information for
designated foods.

· Facilitating record keeping:

Maintain detailed records electronically, simplifying compliance and audit
readiness.

· Enhancing traceability:

Gain real-time visibility into your supply chain, allowing for quicker
identification and isolation of potential issues.
Who is required to comply with FSMA 204?

The FSMA 204 applies to persons who manufacture, process, pack, or hold foods that appear on the Food Traceability List (FTL). The FTL includes, but is not limited to, soft cheeses, eggs, nut butters, finfish, crustaceans, bivalve mollusks, ready-to-eat deli salads, or fresh fruit or vegetables.

You can find a full list of designated foods on the FDA website: https://www.fda.gov/ .
When does FSMA 204 come into effect?

The compliance date for FSMA 204 is January 20, 2026. However, it’s crucial to start planning and implementation well in advance to ensure smooth compliance by the deadline.
Does FSMA 204 apply to imported foods?

Yes, FSMA 204 applies to both domestic and imported foods. Importers have specific responsibilities under the rule, including obtaining certain records from their foreign suppliers.
What are the “designated foods” subject to FSMA 204 requirements?

The FDA maintains a list of designated foods subject to FSMA 204, which is constantly being updated.

You can find the current list on the FDA website: https://www.fda.gov/ .
Do the rules apply to companies outside of the U.S.?

The requirements of the Final Rule apply to all persons or companies who manufacture, process, pack, or hold foods on the FTL (unless an exemption applies), regardless of whether the person/company is in the United States or a foreign country.
What is the Food Traceability List?

The Food Traceability List (FTL) is a list of foods that are subject to additional recordkeeping requirements under FSMA Rule 204.

https://www.fda.gov/food/food-safety-modernization-act-fsma/food-traceability-list
Is the Food Traceability List final?

The final rule sets forth a process for the FDA to update the FTL if the agency concludes that updates are appropriate. When FDA tentatively concludes that an update is necessary, the FDA will publish a notice in the Federal Register stating the proposed changes to the list and the reasons for the changes and will solicit feedback and information on the proposal. After considering any feedback or information submitted, the FDA will publish a second notice in the Federal Register, stating whether any changes are being made, and the reason for the decision. Any additions to the list would become effective two years after the date of the second Federal Register notice, unless otherwise stated. Any deletions from the FTL would become effective immediately.

TRAKKEY Frequently Asked Questions

Dashboard

What is the dashboard used for?

The dashboard is used for creating new events, printing labels, checking inventory, and recent activity among other features. You can easily check outgoing and incoming shipments, create new shipping events, and generate all the necessary documentation. It’s a hub of all features.
Can I do all tasks from the dashboard?

Events and everything related to them can be done from the dashboard . Master data, such as locations and other advanced features can be found in the vertical menu on the left side of your screen.
Can I select a specific product from the inventory and ship it?

Of course! This speeds up the process and allows you to see inventory live. It’s as easy as clicking the “Ship this lot” button.
What does the recent activity window show?

It shows all recent activity processed by TRAKKEY. Date and time, which product on what LOT/ID, what event was done, and a small icon that will guide you to the next recommended step for this product.
How to generate an invoice or shipping slip?

On the dashboard, click on the Ship button, and a new window will open. In this window, select which product you want to ship, from where and to whom, how many pieces, and what the price per piece is. In the summary section, this product will appear, and under status, you will see “waiting to submit”. If you’re entering multiple products, they will all be processed independently. After processing, a smaller window will appear where you can create the shipping slip, generate invoices, and perform other features.
How to see all outgoing shipments?

Click on the dashboard on the left vertical menu, scroll down, and a window labeled “Outgoing shipments” will appear.
I have an incoming shipment, what’s next?

Click on the dashboard on the left vertical menu, scroll down, and a window labeled “Incoming shipments” will appear. Hover your mouse over a shipment you’d like to receive, and you will see two choices: “Mark as received” and “Receive this lot”.

Printing labels

How to print labels?

Click on the dashboard on the left vertical menu, and at the top, there will be a button labeled “Print labels”. Click on the button, select which product, location, and other necessary information, and state how many labels you need in the “Number of labels” line. Your printer will automatically print them out . Please make sure that you have all necessary printer drivers and support for web based printing installed.
My printer isn’t working, what should I do?

Please check all necessary connections, drivers, and set up the printer according to the instructions. If the problems persist, contact your company’s IT department or our support team at support@enseso.com, and one of our technicians will assist you.
My labels are in a different format, what should I do?

Please contact us at fsma@enseso.com , and one of our technicians will assist you.
My product isn’t showing up.

On the left vertical menu, click on “Products”, and a new window will open. In this window, you’ll see “FTL food” and “Non-FTL food”. If a product isn’t showing up and isn’t listed on the “Products” page, you can easily create it by clicking the + icon in the top right corner of the window (not the orange button, but the smaller one below it).
Location isn’t correct or showing up.

On the left vertical menu, click on “Locations” and check existing information or create a new location.
Can the harvesting date be in the future?

The harvesting date can’t be in the future, but can be in the past.
What is the unit of measure used?

Unit of measure is defined for every product on Product screen. Definition from the Product screen is then used everywhere.

Products

How do I see all my products?

On the left vertical menu, click on “Products”, and a new window will open. In this window, you can see all your products.
How do I edit product properties?

On the left vertical menu, click on “Products”, and a new window will open. Select a specific product you want to edit and click on the “Edit product” icon

Locations

How do I see all my locations?

On the left vertical menu, click on “Locations”, and a new window will open. In this window, you can see all your locations, location type, address, and contact information.
How do I edit a specific location?

On the left vertical menu, click on “Locations”, and a new window will open. Click on a specific location you want to edit, and a new window will open where you can see all information about this location
Is it possible to add a specific field?

Yes, it is possible to add a specific field. Field is a location like any other location (farm, factory, store).

Partners

What are TRAKKEY partners?

TRAKKEY partners are companies you work with that also use TRAKKEY. It makes sharing information much easier, such as shipping, receiving, and transformation events. More permissions can be configured using the Advanced button.
Can I invite an outside firm to be my partner?

Please contact us at fsma@enseso.com , and one of our administrators will take care of adding your partners who are still not registered with TRAKKEY.

Advanced

What are events?

Events are specific processes your product goes through.
How does track and trace work?

Track and trace can be accessed on the left vertical menu by clicking on Advanced and selecting track and trace in the submenu. Select which product, enter batch or serial, and an interactive map of the selected product will appear, making it much easier to see all the events it went through, at which location, date and time, and other information . Please note that relevant track and trace information about the specific product will be listed only for those points in supply chain where events have been tracked through TRAKKEY.
IoT integration?

IoT integration is not mandatory by FSMA 204 regulative but provides an extra layer of security and insurance of quality for the products that are equipped with ENIOT sensors which are fully integrated into TRAKKEY Mobile app for ease of use.

Plant

What is the plant menu used for?

The plant menu is used for entering products that have just been planted and the expected yield. This information can be used to determine the status of this product in the future, expected stock, and other important information.
How do I determine expected yield?

Expected yield is a quantity with a margin of error. Check your seed manufacturer’s information on what yield is expected on what area in your specific region or contact them directly to make a more accurate calculation.

Harvest

How do I start a harvest event?

On the left vertical menu, click on “Dashboard”, and a new window will open. Click on the “Harvest” button and enter all necessary information. After entering all data, click on save in the bottom right corner of your screen.
What is the reference record type and number?

Reference record types and numbers are information about records connected to specific event – record(document) type and number. Example: For harvesting we will have Reference record type Harvesting order (HO) and number of Harvesting order as Reference record number. For shipping we will have Reference record type Shipping order (SO) and number of Shipping order as Reference record number.

Cooling

How do I choose the correct reference record number?

Because Cooling event is event after Harvesting, for specific product you need to choose Reference record type and number of Harvesting event from which you are taking product to be cooled.
Why is the harvesting location filled out automatically?

Because Cooling event is using data from Harvesting event where Harvesting location is defined.
What does immediate subsequent recipient mean?

Immediate subsequent recipient is location where product will be after specific event.

Pack

What does source product mean?

The pack event can also be used for transformation events, such as a change in packaging. Source product refers to the product as it was received from the harvester, while the packaged product can be different from the source product. Source product is input to Initial packaging event and Transformation (Produce) event.
How to edit harvesting locations?

On the left vertical menu, click on “Locations”, and a new window will open. Click on a specific location you want to edit, and a new window will open where you can see all information about this location.
Why are some fields filled out automatically?

It’s due to already entered locations, harvesters, fields, products, etc. TRAKKEY has advanced algorithms integrated that aim to speed up the process. Sometimes data is taken from default values (defined on Products), sometime from previous event in workflow.

Produce

What does produce mean?

Produce is a transformation event that converts one or multiple products into one or multiple different products. For example, a mixed salad: inputs are tomatoes, peppers, broccoli, and the output is a Mixed salad as a new product.
How to enter multiple inputs?

It’s as easy as entering a single input and clicking on the + icon to add a new row.
How to enter multiple outputs?

It’s as easy as entering a single input and clicking on the + icon to add a new row.

Shipping

How to enter multiple products?

First, fill out the information for the first lot and click on “Add LOT”. In the summary below, you will see the product just entered. Then go back to the same window you entered the first product in, and you will see that it is now empty again. Fill out the information for the second lot and click on “Add LOT” again. Repeat this process until you’re done entering all lots. Afterwards, click on save and TRAKKEY will start processing this information.
What does waiting to submit mean?

TRAKKEY is waiting for you to finish entering data. When you’re done, click on Save in the bottom right corner, and TRAKKEY will start processing all your entered lots.
Can the generated invoice be used as a legal document?

Yes, it can also be customized to your liking. Please contact us at fsma@enseso.com .
How to print multiple labels?

To print multiple SSCC labels, just enter the necessary number of labels in the Print menu.

Combo

What is combo used for?

Combo is used for performing multiple events in one go with the help of TRAKKEY advanced algorithms. It’s aimed at speed and accuracy while ensuring everything goes smoothly, minimizing user input and making the experience more simple.
How to choose which event template is suitable for me?

Events are described with icons and names of each event. Analyse your process and compare it with some of the templates. If more help is needed, please contact us at fsma@enseso.com .
Why are some fields filled out automatically?

It’s due to already entered locations, harvesters, fields, products, etc. This all gets filled out automatically to speed up the process.