It’s More Than Winning Over the Buyers

What is Quality Assurance?

At a food retailer, the QA team is responsible for maintaining the quality and safety of products sold by that retailer. In the case of a supermarket, this would include products sourced from suppliers, products made through contracted manufacturers, and even ready-to-eat food prepared at the onsite deli. The QA Team conducts quality inspections, handles food recalls, and conducts supplier verification.

The Quality Assurance team may be the reason your food product doesn't make it into major retailers and distribution chains. This would happen if you are unable to prove that you are following industry-standard practices. For this reason, it's important to understand what your purchaser's QA Team is looking for and how to work with them so that you can get your product onto retailer shelves and grow your sales.

Even after a major buyer has pledged to place an order, there’s another hurdle before you can start selling your products to a new retailer: The Quality Assurance (QA) Team.

The QA team’s job is to uphold quality standards and protect the company’s reputation. They evaluate hundreds of prospective (and current) suppliers to determine whether their products meet the company’s quality and safety standards.

They are the gatekeeper for all new products and if the product doesn’t pass quality assurance, then the retailer won’t risk carrying that product.

Don’t let this frighten you. The QA team has no incentive to arbitrarily reject new suppliers and they are often willing to work with new suppliers to help them pass QA and get their products onboard.

Before we go into strategies for working with QA teams, let’s review how the process typically works.

How QA Teams Approve Suppliers

After the buying team expresses interest carrying a new product, the QA team steps in to conduct some due diligence about the supplier.

The QA team will typically email the prospective supplier requesting information, such as a third party audit result or records showing your company’s food safety practices.

After, there may be some back-and-forth with your contact on the QA team. This depends on your company’s ability to provide the requested documents and demonstrate the safety and quality of your product.

Finally, the QA team will either give your products a “pass” or they will delay the company’s purchase of your products until you can achieve specific requirements.

With this in mind, having a positive relationship with your a prospective buyer’s QA team can mean the difference between winning a huge account or not. To stay in their good graces, consider the following tips:

1. Before asking a question or requesting a piece of material from the QA team, check and see if it’s available on the company’s supplier facing website.
   

2. Avoid asking them to explain food safety concepts or regulation to you. Instead, look it up on FDAreader.com or, if we’ve failed you, then google it.
   

3. Fill out all forms and documents as completely as possible and provide all requested documents.
   

4. Collate your submissions a minimum number of attachments and present it in the most straightforward possible manner. Your QA contact reviews thousands of these documents per month and will appreciate your efforts towards clarity.
   

5. Be honest. The QA team doesn’t demand perfect manufacturing programs as a prerequisite for approval and they appreciate when suppliers are honest about their process.

What the Quality Assurance Team is Looking For

QA teams want a supplier who presents them with a straightforward case about “why our product’s safety and quality is not worth worrying about.”

The most compelling evidence is a third party audit result— which reads like a physical exam for your company’s food safety practices. In the absence of that, a thoughtfully compiled and organized set of food safety policies and records can signal that your business is serious about food safety. Ultimately, the QA team will describe their needs — and it’s important to listen. Dozens of times, I’ve been able to get my clients’ products into new retailers despite their inability to meet the “official” supplier qualifications. All I did was follow the instructions we were given, provide the documents that we were able to come up with, and present it in an easy-to-read format.

Honesty is the Answer (Even When the Truth is Imperfect)

When confronted with a shortcoming in my clients’ food safety practices I have found that honesty is the answer. Specifically, I candidly explain the current state of that food safety issue and how the supplier is working to fix it. The following anecdote from my consulting career illustrates how this has worked in my favor:

One time, a distributor hired me to fix some trouble they were having with a nationwide supermarket chain. The supermarket had already been selling the distributor’s product for almost a year but the distributor was ignoring all of QA team’s emails. Eventually, the supermarket’s buying team threatened to halt all business with the distributor unless they responded to the QA team’s requests, and so the distributor hired me as a consultant to sort it all out. I quickly put together a basic food safety plan— a set documents showing how the distributor managed food safety across their operation— and sent it off to the supermarket’s QA team.  

The QA manager who was reviewing the documents noticed a problem and called me. He explained that, while the warehouse operation looked safe enough, the distributor didn’t have any evidence that the actual foods they were buying were safely manufactured. In other words, he pointed out that the distributor hadn’t done any supplier verification. He was 100% right and this could have been a deal breaker for working with the distributor.

I took a deep breath and told him the truth— that the distributor hadn’t verified the safety of any of the foods in their catalog prior to hiring me that week. I had just begun sending out requests to the distributor’s suppliers a few days before. So far only one supplier of ninety had responded. I sent the QA manager an overview of how I was beginning to implement a supplier verification program on behalf of the distributor. I also shared the records showing we had collected information from and approved one supplier. Then I waited.

To my surprise, the QA manager was grateful for the honesty and he approved the distributor to continue supplying the supermarket. We were able to organize a timeline by which the distributor would verify all of their suppliers over the course of several months and communicate this to the supermarket.

In my experience, displaying honesty— even about imperfections in my client’s food safety program— actually instilled a greater confidence in the program overall. QA teams are constantly being lied to (I’m sure they don’t like it) and they are quick to acknowledge that even the best suppliers have imperfect programs.

So how should you approach working with a new purchaser and their QA team?

• Figure out exactly what they want and don’t waste their time

• Be honest about where you can and and can’t meet their expectations

• Present your documents in an organized fashion.

Keep Reading

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What You Need to Know:

There are reduced requirements for small food importers. Here’s how to answer critical questions and determine the requirements for your business:

Step 1: Determine the Foreign Supplier Verification Requirements for Your Business

All food import businesses are required to confirm that their foreign supplier is handling food in a way that does not pose a risk to the consumer in the US. This burden falls on the importer and is called Foreign Supplier Verification (you can check out our guide, here)

However, certain business types, including very small importers are exempt from the bulk of foreign supplier verification program (FSVP). requirements.

To qualify as a Very Small Importer, you must import <$1mm in food product value (or $2.5mm for animal feed).

In this case, you are subject to modified requirements as it relates to verifying your suppliers. You can see those modified requirements in our guide to FSVP or in the federal regulation in 21 CFR §1.512

If not, then another exemption might apply, or else you will be required to conduct a more robust Foreign Supplier Verification Program (FSVP). If are looking to implement this type of program, we have a step-by-step guide

Step 2: Determine the FDA Requirements for the Other Activities you Conduct

If your business warehouses, re-packs, processes, distributes or arranges transport for the food that you import, then those activities are likely subject to additional FDA regulation. See below to learn how specific activities are regulated.

Transportation

If you transport or arrange for someone else to transport your product, then you are subject to the Sanitary Transport Rule. The requirements are contingent upon your role in the process:

• If you ship a product for someone else to transport then you are accountable for specifying the conditions (e.g. frozen, refrigerated) under which your product is shipped. This can be as simple as a written agreement with the company transporting your business (i.e. the carrier), This is not required when using postal services as your carrier.

• If you load a product (e.g. you put product onto your own or someone else’s trucks) then you must ensure that the truck is suitable for transporting products.

• If you receive product, then you’re required to make sure it arrives in safe condition (e.g. temperature and quality)

• If you are the carrier for a food product (i.e. you operate the trucks which transport the product), then you must ensure the product is kept safe (e.g. temperature, quality) throughout the transportation process.

Warehousing

Warehousing refers to the storage of fully packaged foods. If you store your product in the US, then you’ll need to align your space with the FDA standards. This typically entails keeping your facility reasonably clean and keeping refrigerated product sufficiently refrigerated.

Check out our FSMA for Food Distributors guide for more details.

Re-Packing or Processing

If you modify the food after it has been imported — even repacking the product into new containers— then you will be required to meet the requirements for a normal food processor.

The basic operational requirements for a food operation are known as Current Good Manufacturing Practices (cGMPs), and they are summarized in our guides below:

• Facility Requirements

• Process & Controls Requirements

• Personnel Requirements

• Cleaning Requirements

• Equipment & Utensils

You can also see our Guide to 117 Subpart B for a more comprehensive guide to cGMPs,

Next, there are requirements related to maintaining a safe supply chain and managing risks in your production process. Businesses which conduct under $1mm sales per year (they are called Very Small Businesses) typically qualify for the Qualified Facility Exemption. If you apply for the exemption and notify the FDA, then you don’t need to worry about the sections below. If you are not a qualified facility, then you’ll need to consider these sections:

1. Hazard Analysis and Risk Based Preventive Controls If your imported product is refrigerated, frozen, or requires any sort of control (e.g. cooking, sanitizing) before consumption, then you are likely required to implement a food safety plan. Writing and implementing a food safety plan is a comprehensive process that requires an employee who has been certified to author this plan.

If you’re looking to move quickly, a 3rd party consultant (like us) can be the best choice.

Learn more in our Guide to Subpart C Hazard Analysis and Risk Based Preventive Controls

2. Supply-Chain Program: If your process involves non-foreign suppliers, then you may have to conduct the same types of supplier verification activities described above for your domestic suppliers.

Learn more in our Guide to Subpart G

Step 3: Register Your Food Facility

If you have a site where you are holding, packaging, or processing food (including the food that you import), then you must register it with the FDA. Don’t worry, this won’t trigger an inspection, it just let’s the FDA know where you are operating from, what you’re doing, and that someday they’ll want to stop by and make sure you’re following the rules.

Check out our guide to learn more about facility registration

This applies to you if…

∆ You import food for consumption in the uS

∆ The value of products you import/process is <$1mm

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FDA Reader

FDA Reader: Simplifying Food Regulation

To learn more about Foreign Supplier Verification Programs overall, see our introduction article

How Do I Develop a Foreign Supplier Verification Program?

Contents

How Do I Develop a FSVP?

1. Determine Your Qualified Individual
2. Decide How Your Program Works
3. Conduct Your Verification Activities
4. Approve Your Suppliers and Maintain Your Program

Keeping Records of Your FSVP
Taking Corrective Actions
Re-evaluating Suppliers

If you import products for consumption into the US, you likely are required to develop a foreign supplier verification program (FSVP).

Below is a step by step guide to developing and implementing an FSVP.

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1. Determine your Qualified Individual

First, The FSVP must be prepared by a "qualified individual" who has the education, training or experience necessary to perform the activity. If this person is a 3rd party or consultant, that's fine. However, note that supplier verification is an ongoing process and it must always be completed by a qualified individual. For most companies, the easiest solution is to have someone on staff undergo a 2 day training course on developing a Foreign Supplier Verification Program.

Source 21 CFR 1.503

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2. Decide How Your Program Works

Before you begin approving suppliers, you must establish the procedures you will use to approve suppliers. The goal is to provide assurance that hazards in the food you import are being prevented.

You can rely on a 3rd party to conduct your supplier verification if you review and assess the documentation yourself and document your review and assessment of the materials.

Examples of appropriate verification activities:

• Onsite audit by a qualified individual

• Sampling & testing

• Review of foreign suppliers food safety records

• Other appropriate supplier verification activities

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3. Conduct Your Verification Activities

This step is the bulk of the process: collecting information from your suppliers, reviewing it, and documenting your review process.

You may rely on a 3rd party to conduct supplier verification activities (i.e. a 3rd party audit) if you assess their documentation with appropriate frequency. You must document your review and assessment of the activities and document that the activities were performed by a qualified individual.

The following are common verification methods for approving suppliers:

Hazard Analysis

You are required to review a hazard analysis for each type of food you import. Hopefully, each of your foreign suppliers has completed one and can provide this to you. If not, then you must conduct a hazard analysis to determine whether there are any hazards requiring a control. This hazard analysis must be written and contain an evaluation of environmental hazards.

Some key points about the hazard analysis:

• You must either conduct a hazard analysis for each type of food you import OR use a supplier hazard analysis.

• If you are importing Raw Agricultural Commodities (RACs) then no biological hazards need be considered in the Hazard analysis.

• If you are reviewing a hazard analysis supplied by the supplier or a 3rd party, then you must document your review of the hazard analysis and confirm that it was conducted by a qualified individual.

• If no hazards are identified which require a preventive control, then no verification is required for those products. Still you must have a hazard analysis on file to show that this has been determined. This provision does not apply to produce.

Subpart L  - FSVP for Food Importers

Onsite Audit

Certain importers may wish to independently conduct onsite audits of the foreign supplier. Or, they may simply review the audit results conducted by a reputable 3rd party auditor.

An audit is required as part of the supplier verification process when there is "reasonable probability that exposure to the hazard will result in serious adverse health consequences or death" you must conduct or obtain documentation of an onsite audit at least annually. (1.506 (d) (ii) (2)

In this case, an audit may be replaced by written inspection results by the FDA, USDA, or a food safety authority of a country whose food safety system is equivalent to that of the US.

Sampling & Testing of Food

If you choose to use product testing and sampling as part of your verification, you must retain documentation of the following:

• The number and type of samples tested

• identification of the food tested (lot numbers)

• tests conducted and the methods of the testing

• Any corrective action taken into detection of hazards

• Information identifying the lab

• Documentation that the tests were performed by a qualified individual.
  

Review of Foreign Supplier's Food Safety Records

The most common method of supplier verification is the review of a foreign supplier's food safety records.

If you choose to use your foreign supplier's food safety records as part of your verification, you must retain the following information:

• The records reviewed

• Dates of review

• General nature of the records reviewed

• Conclusions of review

• Any corrective actions taken in response to significant deficiencies identified.

• Documentation that the review was conducted by a qualified individual.

You may not allow on the foreign supplier to conduct supplier verification activities for their own business.

Final Considerations:

Hazards Not Controlled by the Foreign Supplier

Does a 3rd party control one of the hazards on behalf of your supplier (i.e. your overseas milk supplier has their pasteurization completed offsite by another company.) If so, you must collect this verification data from the 3rd party or have your supplier send it to you.

Supplier Performance & History

It is perfectly acceptable to take into consideration your supplier's history, procedures, practices, storage, transportation, etc as part of your verification activities.

Document Your Verification Activities

Remember, it's not enough to simply collect these documents from your foreign suppliers -- you have to assess them and document that assessment.

For example, let's say I'm an importer of Ned's Italian Tomato Sauce and they send me their most recent audit result. Beyond having that audit result on file, I need to record that I reviewed that audit, that it showed me they controlling the hazards in their process, and that my review occurred on such-and-such date.

The Whole Picture

For fear of stating the obvious, you must approve your foreign suppliers on the basis of your evaluation. In other words, you must consider all the information you gather in your approval process and cannot discount any piece of information simply because it is contrary to the result that you're looking for.

This doesn't mean that one failed audit in your supplier's history means you cannot approve them. However, you must acknowledge this information if it is revealed in your verification activities or outside of them.

Source 21 CFR -- 1.504

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4. Approve your Suppliers and Maintain the Program

Once you have completed your verification activities, you may add the relevant supplier's to your approved supplier list and begin sourcing product from them. At that point, the program should require only occasional ongoing maintenance

Keeping Records of Your Foreign Supplier Verification Program (FSVP)

Your records should comply with the following provisions:

• They must be originals, photocopies or digital records

• You must keep them for 2 years unless otherwise specified

• They must be available for review by the FDA

• You do not need to have a specific copy of each record for the FDA (e.g. you can have one copy of a record to satisfy both a state requirement and a federal requirement)

Source 21 CFR §1.510

There are several exemptions to Foreign Supplier Verification Requirements. This section applies to:

Taking Corrective Actions

You must take corrective actions if you determine that the food you are receiving is not meeting the requirements of the FDA regulations. Simply put, if the food you receive could cause harm to a consumer or is unsafe, then you must take some type of corrective action. This determination could be based on customer complaints or verification activities that you conduct (i.e. records review or viewing an inspection result.)

The appropriate corrective action to take could include discontinuing your use of that supplier until the hazards have been addressed.

If this determination occurs outside of the scope of your supplier verification activities, then it may reveal that your verification activities are not comprehensive. Simply put -- you didn't catch the mistake in your normal supplier verification practices therefore something is inherently wrong with your process. In this case you are obligated to update your plan so that you are able to adequately verify your suppliers.

Source 21 CFR §1.508

Re-evaluating Suppliers

You must re-evaluate your foreign suppliers (and document it),

• Every 3 years, at minimum

• When you learn anything new or when anything has changed that would warrant a re-evaluation.

You may use a 3rd party foreign supplier review as your re-evaluation, insofar as you document your assessment of that evaluation. The evaluation must be performed by a qualified individual.

Source 21 CFR -- 1.504

This article applies to you if…

∆ You are a food importer

∆ The products you import are regulated by the FDA

∆ You do not qualify for a small-food-importer exemption (<$10mm/yr imported)

∆ You need to build a foreign supplier verification plan

More About Supply Chain

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ConsultinG Services

For step-by-step instructions, see Guide to Developing an FSVP

What You Need to Know about FSVP

Contents

What You Need to Know
Applicability and Exemptions
Very Small Importer Exemption
Foreign Suppliers Requiring No Verification
Foods Subject To Special Foreign Supplier Verification Regulations
FAQ

• Nearly all food imported into the US must be produced in alignment FDA Regulations

• Foreign Supplier Verification Program (FSVP) is a major component of FSMA which requires US businesses to only import food products from suppliers they have vetted and approved.

• Most businesses which import food products for consumption inside the US must verify that the food is produced in alignment with FDA regulations. This is done through the implementation of a Foreign Supplier Verification Program (FSVP). When a certain type of food (i.e. seafood) is subject to specific regulation, a foreign supplier must also comply with those specific standards.

• The verification process may include, among other methods: an assessment of the supplier's food safety records, a review of an audit report, or a site visit.

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Applicability and Exemptions

Generally, foreign supplier verification is required for most importers, for most imported foods, and for most foreign suppliers. To better understand what types of businesses and products may not be regulated under Subpart L (Foreign Supplier Verification Program), see the exemptions below:

Very Small Importer Exemption

A "Very Small Importer" is a company that imports $<1mm year in product value for imported human food (or <$2.5mm year in value for imported animal food)

Modified requirements for "Very Small Importers"

• A very small importer must document that they meet the qualification for this exemption (i.e. be able to prove they are doing less than $1 million in imports)

• Receive a written assurance from each foreign suppliers, prior to importing any food. The written assurance must be obtained every 2 years and include the following

1. A brief description of the preventive controls being applied to control hazards in the food. This must be provided for each food that is imported.

2. A statement that the foreign supplier is compliant with FDA regulations or (when equivalent) the relevant laws of their own country

• You must take corrective action (such as suspending your import of this food) if you determine that the supplier is not producing food consistent with their assurance.

• You must keep signed and dated records of these activities for > 2 years.

Foreign Suppliers Requiring No Verification

An importer is not required to conduct verification activities for certain foreign suppliers, including

• Qualified Facilities, or

• farms that grow produce and are not covered under part 112, or

• A shell egg producer that has fewer than 3,000 laying hens.

• Suppliers operating in countries with an officially recognized or equivalent food safety system

If you are importing products from a foreign supplier that is exempt, the modified requirements are as follows:

• You must obtain a written assurance of their exemption type (i.e. farm or qualified facility or small shell egg producer)

• You must initially evaluate your foreign supplier's performance history as it relates to compliance with FDA regulations. You must re-evaluate this if you become aware of any relevant changes or information or ever 3 years at minimum.

• You must take corrective action (such as suspending your import of this food) if you determine that the supplier is not producing food consistent with their assurance.

• You must keep signed and dated records of all verification activities for > 2 years.

• You must approve your foreign suppliers based on the activities described above.

• You must establish written procedures to ensure that you are using only approved foreign suppliers. You may import from unapproved suppliers on a temporary basis, if you have other, adequate verification prior to import.

Source 21 CFR §1.512

Countries with Officially Recognized or Equivalent Food Safety Systems

If you are importing from a country with a recognized equivalent food system, you may be free from the following the majority of FSVP requirements (§1.504-§1.508). As of 2018, the only countries who have achieved this are: Australia, Canada, and New Zealand.

However, your program still must be developed by a qualified individual, your company must be identified upon food import, and you must maintain your FSVP records in compliance with §1.510.

Source 21 CFR §1.513   

Foods Subject to Special Foreign Supplier Verification Regulations:

Certain foods are exempt from Subpart L (the requirements for Foreign Supplier Verification Programs outlined in this article) and are subject to different requirements.

Imported Seafood Products (aka Fish / Fishery Products)

Since seafood products are subject to specific FDA regulations found in Part 123, importers of seafood products are required to verify that the overseas manufacturer is aligned with Part 123. You can read about the specific requirements for verifying a foreign seafood supplier here

Imported Juice Products

Juice products are subject to specific FDA regulations found in Part 120, importers of seafood products are required to verify that the overseas manufacturer is aligned with Part 120 (specifically, that they have and follow a HACCP plan).

Meat Products

The Foreign Supplier Verification Program does not apply to meat products that, at the time of import, are under USDA jurisdiction.

Food that cannot be consumed without the hazards being controlled

You aren’t required to conduct an evaluation or foreign supplier verification when:

• The food can’t be consumed without controlling for the hazard

• You rely on the customer (who must be subject to 117C) to control the hazards. In this case you must disclose this to the customer and obtain annual assurance that they are controlling for the hazard

• You rely on a subsequent entity in the supply chain (further downstream from you and the customer) to control for the hazard.

Source 21 CFR §1.507

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FSVP FAQ

How must the importer be identified at entry?

You must identify your firm as the importer and include your FDA identification (DUNS) number and email address when filing for entry. The foreign owner or consignee of the food oversees must designate a US representative as the importer as the food.

Source 21 CFR §1.509

What are some consequences of failing to comply with the requirements of this subpart?

• The food may be inadmissible for import.

• The importer may be found in violation of federal law.

Source 21 CFR §1.514

What FSVP must I have if I am importing a food subject to certain requirements in the dietary supplement current good manufacturing practice regulation?

Source 21 CFR Section 1.511

More About Supply Chain

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Consulting Services

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To learn more about foreign supplier verification and imported foods, see our guide

Importers of seafood products must verify that the foreign supplier is compliant with FDA regulations -- even though the food is processed outside the US.

There are two ways to verify a supplier of imported fish / fishery (a.k.a. seafood) products from another country:

1. The importer obtains the product from a country that has an active memorandum of understanding (MOU) with the FDA that documents the equivalency of their food safety systems, or

2. The importer implements verification procedures for ensuring the fishery products being importer were processed in accordance with FDA seafood requirements.

Memorandum of Understanding:

An importer can check if there is a MOU with the exporting country looking it up on the FDA website, here. Note that MOUs are not particularly common.

Verification Requirements for Importing Fish / Fishery Products

If you are unable to obtain the fish / fishery products from a country that has an active MOU, then you must conduct your own verification to confirm that the product was produced in compliance with FDA regulations. This verification may be completed by a competent 3rd party.

The importer's verification process must be written and must include the following, at minimum:

• Product specs for each imported product that ensure that product is not adulterated.

• One or more of the following:

  • HACCP and sanitation monitoring records that relate to the specific lot of fish being imported.

  • A lot-by-lot or continuing certificate from a government authority or 3rd party certifying that the food was processed in accordance with FDA regulation on fish / fishery products (21 CFR §123)

  • Regularly inspecting the foreign processor's facilities to ensure that the imported product is being processed according to FDA regulation.

  • Maintaining on file a copy of the foreign processors HACCP plan and a written guarantee (English) that the imported product is being processed according to FDA regulation.

  • Periodically testing the imported products and maintaining on file a written guarantee (English) that the imported product is being processed according to FDA regulation.

  • Another equivalent method of verification.

All verification records must be kept on file by the importer.

What’s next:

Guide to Developing a Foreign Supplier Verification Program (FSVP)

More About Supply Chain

Businesses involved in the transportation of food in the US must follow 'Sanitary Transport' rules to ensure the food does not become unsafe during travel.

Contents

Applicability
Exemptions
General Requirements
Specific Requirements
Requirements for Shippers
  Requirements for Loaders
  Requirements for Receivers
  Requirements for Carriers

Applicability

The "Sanitary Transport Rule" applies to nearly every businesses involved the transportation cycle.

To understand the requirements for your business, assess what role(s) your business plays in the transportation process and review the requirements below.

You can click  to see the requirements for that specific role

Carrier: A person who physically moves food by rail or motor vehicle in commerce within the US (excluding parcel delivery services).

Shipper: A person who arranges for the transportation of the food by carriers.

Loader: A person who loads food onto a motor or rail vehicle as part of the transportation operation.

Receiver: a person who receives food in the US, regardless of whether it is the final destination of that food.

Source

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Exemptions:

The following is a list of exemptions to the Sanitary Transport of Human Food regulations:

Non-Covered Businesses:

Certain small businesses are exempt from this rule. There are two ways to achieve the "non-covered business" exemption:

1. A business that is not a motor vehicle carrier (i.e. doesn't physically transport food themselves) and employs fewer than 500 full time employees.

2. A motor vehicle carrier that is not a shipper (i.e. doesn't arrange for shipping of food by other carriers) and has <$27.5 million in annual receipts.

Other Exemptions

The following operations are exempt from this rule:

• Transportation activities performed by a farm.

• Food that is merely passing through the US on its way to another country.

• The transportation of food that is regulated entirely by the USDA.

• Transportation of the following products:

  • Food gases

  • Food contact substances.

  • Food that is completely enclosed by a container and does not require a temperature control for safety (i.e. a refrigerated food).

  • Live animals, excluding shellfish (they are not exempt)

  • food byproducts that will be used for animal food without further processing.

Waivers

A company may apply for a waiver to waive a specific requirement in this subpart. You can learn more about waivers in 21 CFR §1.914

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What are the Requirements for Sanitary Transport?

The goal of this regulation is to ensure that food does not become unsafe during transportation. In order to protect food, all parties involved in transportation must adhere to the following general rules. Additionally, there are rules specific to shippers, carriers, loaders and receives, listed below.

General Requirements:

Protect food from contamination from other items in the same load. It's important that food doesn't get contaminated from other food (i.e. raw fish in the same truckload) or non-food (chemicals that are being shipped in the same truckload). Some ways to do this include:

• Segregation - physically separate items that could contaminate one another

• Use of packaging - Use packaging to protect food from contamination

Protect food that is transported in bulk-vehicles or not completely enclosed by a container. For example, if you are shipping a tanker full of milk (bulk-vehicle) or an open truck bed full of corn (no enclosed container) then it must be protected from contamination.

Control the temperature of food that requires it. If a food requires refrigeration or freezing, then this must be maintained during transportation.

If the food is exposed to temperatures that render the food unsafe (i.e. the refrigerator in a truck fails during transport), then the food may not be sold or distributed. However, If a qualified individual (someone with adequate training) determines that the food was not rendered unsafe by this deviation, then the food may be sold and distributed.

Consider the type of food and the stage of production. It's important to understand whether the nature of the food (human food or pet food) when determining how you will keep it safe. Additionally, you should understand the production stage: is the food going to be further processed or is it on it's way to a supermarket?

Food that is going to undergo additional inspections and processing may not need to be transported under as strict conditions than if it is being transported directly to the consumer. For example, The carrier may assess that a truck full of corn can be exposed to a certain amount of dirt during transportation because it is being shipped to a cannery that has agreed to wash it prior to further processing.

Source: CFR §1.908

Specific Requirements:

There are specific requirements for the actors involved in transportation. Note that an entity subject to these requirements may re-assign them in writing to another party.

For example, let's say the shipper is a meal-kit service that delivers meals in individual refrigerated coolers loaded with dry ice. In turn, the shipper doesn't have to pay the expensive cost of refrigerated transportation, since each package is itself refrigerated. Instead, they can ship via a carrier who operates un-refrigerated trucks. Whereas the requirement in this section states that the carrier is responsible for maintaining the proper temperature of the food, they may assign this responsibility to the shipper, who is clearly responsible for making sure each product is packaged with enough ice and in the right container to arrive sufficiently cold.

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Requirements for Shippers:

A shipper is the person who arranges for the transportation of food by a carrier (who physically transports the food on trucks/rail). The shipper must do the following:

• Inform the carrier of all necessary sanitary specifications required to keep the food safe during transportation. This may be a specific design requirement for a carrier's vehicle or a cleaning procedure required to keep the food safe.

• Inform the carrier of the temperature requirement for the food during transportation. This must be written.

• Implement written procedures that prevent the food from becoming unsafe during transportation. Although the shipper must develop these procedures, they may be enacted by another party during the transportation process (i.e. the carrier), and this must be agreed upon in writing. For example, if the shipper requires the temperature of their product to be taken and recorded every 24 hours throughout transportation, then the carrier and the receiver may complete this task.

• If food is being shipped in bulk (i.e. a tanker full of milk), then the shipper must develop written procedures to make sure the previous cargo doesn't make the food unsafe.

• If the food requires temperature control (i.e. refrigeration) then the shipper must have written procedures to ensure the food is transported under adequate temperature.

Source 21 CFR -- 1.908(b) Requirements applicable to shippers

Record keeping Requirements for Shippers:

Shippers must maintain the following records and provide them to officials upon request. These records (digital or paper) should be kept for at least 12 months beyond their applicability (i.e. 12 months the end of the contract or the discontinuation of a particular activity).

• Records that the shipper provides specifications and operating temps to carriers

• All written procedures and policies

• The assignment of any responsibility to another party

Source 21 CFR -- 1.912

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Requirements for Loaders:

• Before loading food that isn't enclosed in a container, the loader must determine that the vehicle is appropriate to transport the food safely. This could be a visual inspection to ensure the truck doesn't have pest infestation or filth that would make the food unsafe.

• Before loading the food that requires temperature control, the loader must confirm that the refrigerated area is properly cooled and sufficiently clean to transport the food safely.

  Source 21 CFR -- 1.908(c) Requirements applicable to loaders

Record Keeping Requirements for Loaders:

Loaders must maintain records of any written agreements that assigns tasks required by this regulation. These records (digital or paper) should be kept for at least 12 months beyond their applicability (i.e. 12 months the end of the contract or the discontinuation of a particular activity). These records must be provided to officials upon request.

Requirements for Receivers:

Upon receipt of food requiring temperature controls, the receiver must assess whether the food was subject to temperature abuse (i.e. a safe temperature was not maintained during transport.) This could be achieved by one of the following measures.

• Taking the temperature of the product upon arrival

• Taking the temperature of the vehicle's refrigerated space upon arrival.

• Visually inspecting the food - consider how easy it is to tell if ice cream has melted and been re-frozen.

• Smelling it - products subject to temperature abuse may produce foul odors.

Source 21 CFR -- 1.908(d) Requirements applicable to receivers

Record Keeping Requirements for Receivers:

Receivers must maintain records of any written agreements that assigns tasks required by this regulation. These records (digital or paper) should be kept for at least 12 months beyond their applicability (i.e. 12 months the end of the contract or the discontinuation of a particular activity). These records must be provided to officials upon request.

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Requirements for Carriers:

• The carrier's equipment/vehicles must meet the shippers specifications for keeping food safe.

• The carrier must demonstrate to the receiver that they maintained the agreed upon temperature conditions during transportation. This could be the product's temperature at loading, unloading and at various intervals during transportation.

• The carrier must pre-cool any refrigerated vehicle before transporting food.

Source 21 CFR -- 1.908(e) Requirements applicable to carriers

Requirements for Carriers who use bulk-vehicles

A bulk-vehicle means food is stored openly in a bulk container, such as a tanker full of milk or a truck bed full of loose ears of corn

• The carrier must be able to provide information to the shipper about the identity of the previous cargo.

• The carrier must be able to provide information to the shipper describing the most recent cleaning of the bulk-vehicle.

Training Records for Carriers

• When a carrier is responsible for sanitary conditions during transportation, they must train their staff to be aware of and address potential problems that may arise.

• Carriers must have records documenting the training that includes: the date of the training, type of training, the persons trained.

Source -- 21 CFR 1.910

Record Keeping Requirements for Carriers:

Carriers must maintain the following records and provide them to officials upon request. These records (digital or paper) should be kept for at least 12 months beyond their applicability (i.e. 12 months the end of the contract or the discontinuation of a particular activity).

• The written procedures for cleaning, sanitizing, and (if applicable) inspecting their equipment/vehicles

• The written procedures for maintaining temperature control.

• The written procedures for maintaining bulk-vehicles.

• Training Records

• Any other written agreements that assigns tasks required by this regulation.

Source -- 21 CFR 1.912

More About Distribution

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What You Need To Know

Contents

What You Need to Know
What You Need to Do
What You Need to Have on File
Summary of Subpart G

• Subpart G describes the requirements for a Supply Chain Program.

• A Supply Chain Program demonstrates that your suppliers are producing their products (typically ingredients and packaging) in a safe manner.

• You must have a Supply Chain Program if your hazard analysis revealed a hazard requiring a supply-chain control.

• You have considerable leeway in how you verify your suppliers but there are some specific requirements (see below).

• You are obligated to document and take prompt action if you learn a supplier is not controlling a hazard as required.

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Applicability & Exemptions

This section applies to any business whose hazard analysis reveals a hazard requiring a supply-chain-applied control. This means you can't complete your Supply Chain Program until you have completed your hazard analysis.

For Example - Let's say that Ned's Raw Cookies uses pasteurized eggs as an ingredient in their product. Since Ned's Raw Cookies are sold and consumed raw, the company is not controlling for the salmonella hazard that is present in eggs.

In this case, Ned's Raw Cookies would likely rely on a supply-chain-applied control to minimize the salmonella hazard in their product. Ned's Raw Cookies would request documentation from their egg supplier to prove that the supplier is controlling the risk of salmonella. This documentation may be an audit result, a copy of supplier's food safety plan, or sufficient food safety records to show that that hazard has been controlled.

Exemptions:

You are not required to apply a supply-chain-applied-control in the following scenarios:

1. No hazards requiring a supply chain applied control exist

2. Your business (the receiving facility) is able to use a process control to eliminate/minimize the hazard.

3. Your customer provides a written assurance that they must control the hazard.

4. The food produced is not consumed by the public (i.e. it's only for research purposes within the company)

5. The supplier is a "very small business"

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What You Need to Do:

1. Review your hazard analysis to determine whether there is a hazard which requires a supply-chain-applied control.

2. Determine how you will approve the suppliers of those ingredients/packaging.

3. Request documents from your suppliers (i.e. a recent inspection report or their food safety plan) to demonstrate that they are controlling for that hazard. You may also verify your supplier's product yourself by conducting tests.

4. Review your suppliers' documents and document that you have reviewed them.

5. Only use approved suppliers

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What You Need to Have on File:

Your supply chain program must be written and contain the following:

• An explanation of how you approve suppliers

• A list of approved suppliers

• A procedure for receiving products (i.e. a receiving SOP)

• Each of the following documents for each supplier (if their ingredient has a hazard which requires a supply-chain control)

  • Documentation of having reviewed the supplier's food safety records.

  • A written inspection report of the supplier by the state, FDA, city, or other agency

• Any records of supplier non-conformance and your response to that (could be a corrective action).

Summary of §117 Subpart G

Below is a summary of Subpart G so that you can get a quick sense of the requirements. If you want to read the original text, check out the source texts, linked below.

This text is aligned with the coding used in the FDA Regulations so that you can hunt down the corresponding section with ease. For example,  you have a question about my wording in §117.405 (a) (2) then just look up this same code in the CFR.

117.405 Requirement to Establish and Implement a Supply-Chain Program

a. 

1. A facility must establish a risk-based supply-chain program for the ingredients and raw materials that have a hazard requiring a supply-chain-applied control.

2. Importers who conduct foreign-supplier-verification programs don't need to conduct supply-chain-applied controls for those materials whose hazards have been mitigated.

3. Requirements in this part don't apply to food whose use is research or testing. However this food,

i. May not be sold or given to the public

ii. Must be labeled "food for research or evaluation use"

iii. Is supplied in small quantity and disposed of.

iv. Is accompanied with documents stating the food is for research and not for public consumption.

b. The supply-chain program must be written.

c. If the supply-chain-applied control is applied by a 3rd party (i.e. not the receiving facility and not the produce supplier -- let's say it's a 3rd party that washes produce on behalf of a farm who sells it to a food processor), then the receiving facility must:

1. verify the control themselves

2. obtain documentation to verify that the control was applied.

§117.410 General Requirements Applicable to a Supply-Chain Program:

a. The supply-chain program must include:

1. Using approved suppliers (i.e. an approved supplier list)

2. The determination of appropriate supplier verification activities

3. Conducting supplier verification activities

4. Documenting supplier verification activities

5. When applicable, verifying that a supply-chain-applied control was applied by a 3rd party.

b. The following are appropriate supplier verification activities for raw materials and other ingredients:

1. Onsite audits

2. Product sampling

3. Review of suppliers food safety records

c. The supply chain program must provide assurance that a hazard requiring a supply-chain-applied control is minimized or prevented.

d. 

1. In approving suppliers and determining verification activities, you must consider:

i. The nature of the hazard

ii. Who will be applying the controls on behalf of your supplier

iii. Supplier performance, including their history, audit results, test results, etc.

iv. Storage and transportation practices

2. If you are considering the suppliers history, this may be limited if they are a small business, a farm, or a facility that is exempt from some FDA provisions.

e. If you learn that a supplier is not controlling a hazard that you identified must be controlled by the supplier, then you are obligated to document this and take prompt action.

117.415 Responsibilities of the Receiving Facility

a. 

1. the receiving facility must approve suppliers

2. The receiving facility must conduct all supplier verification activities.

3. A 3rd party may do the following on behalf of the receiving party:

i. establish procedures for receiving raw ingredients

ii. Document that written procedures for receiving raw materials are being followed

iii. Determine and conduct supplier verification activities

4. The supplier may conduct product testing themselves and provide this to the facility conducting the supplier verification.

b. A receiving facility may not accept any of the following as a supplier verification activity:

1. Determination by the supplier of appropriate supplier verification activities.

2. An audit conducted by the supplier

3. A review of records by the supplier of the supplier.

c. The receiving facility may accept a 3rd party audit result provided by the supplier.

§117.420 Using Approved Suppliers

a. Approval of Suppliers The receiving facility must approve suppliers and document it before receiving ingredients from them.

b. Written procedures for receiving raw materials and other ingredients 

1. You must write and implement procedures for receiving products (i.e. a receiving SOP)

2. Your written procedures must ensure that ingredients are only received from approved suppliers

3. The use of these written procedures must be documented (i.e. you must have a receiving log to show that you are following your written receiving procedure)

§117.430 Conducting Supplier Verification Activities for Raw Materials and Other Ingredients

a. You must conduct supplier verification activities before using the supplier.

b.

1. When a hazard in a raw material will be controlled by the supplier and the outcome of exposure to the hazard results in a serious injury or death, then:

i. the appropriate supplier verification activity is an onsite audit

ii. the audit must be conducted before that raw material is supplied and at least annually thereafter.

2. The requirements above (b) (1) don't apply if other verification activities can provide assurance that this hazard is controlled.

c. If the supplier is a qualified facility, the receiving facility doesn't need to comply with parts (a) and (b) of this section.

1. The receiving facility must get an annual written assurance of the quality facility exemption for their supplier.

2. The receiving facility must get written assurance every 2 years that the supplier is compliant with FDA regulations or the equivalent. This must include

i. description of the preventive controls in place used to control hazards.

ii. Statement that the facility is in compliance with all applicable laws.

d. If the supplier is a farm that grows produce not covered under 112 (FDA produce standards), the receiving facility doesn't need to comply with parts (a) and (b) of this section.

1. The receiving facility must get an annual written assurance of the supplier's exemption from part 112 for their supplier.

2. Obtains written assurance that acknowledges that the food is subject to FDA regulations

e. If the supplier is a shell egg producer not subject to requirements of part 118 (FDA Shell Egg Standards) because they have fewer than 3,000 laying hens, the receiving facility doesn't need to comply with parts (a) and (b) of this section.

1. The receiving facility must get an annual written assurance of the exemption from part 118 for their supplier, because the supplier has fewer than 3000 laying hens.

2. Obtains written assurance that acknowledges that the food is subject to FDA regulations

f. There must not be any financial conflicts of interests related to verification (i.e. payments to a company performing supplier verification cannot be related to the results of the activity).

§117.435 Onsite Audit

a. An onsite audit must be performed by a qualified auditor

b. The auditor must consider all regulations to which a supplier is subject. The audit must include a review of food safety plan/HACCP plan.

c.

1. The following may be substituted for an onsite audit:

i. Inspection results from the FDA, State, or local agency.

ii. Inspection results from an overseas FDA equivalent.

2. If the inspection is from a foreign authority recognized as equivalent to the FDA, then the food produced by the supplier must fall within the scope of that recognized authority.

§117.475 Records Documenting the Supply Chain Program

a. Records related to supply-chain program are subject to requirements of Subpart F

b. The receiving facility must review the supplier records below in part (c) in the same manner that they would complete their own record verification (as defined in §117.465)

c. The facility must document the following records in their supply-chain program

1. Written supply chain program

2. Documentation that an importer is in compliance with the supply chain verification program requirements.

3. Documentation of the approval of that supplier

4. Written procedures for receiving raw materials and ingredients.

5. Documentation demonstrating the use of written procedures for receiving raw ingredients (This could be a receiving log)

6. Documentation of the approval of the supplier

7. Documentation of an onsite audit, including:

i. the name of the supplier being audited

ii. documentation of audit procedures

iii. dates of the audit

iv. conclusion of the audit

v. corrective actions to be taken in response to deficiencies found in the audit.

vi. documentation that the audit was conductected by a qualified auditor

8. Documentation of sampling and testing (if conducted as part of supplier verification) 

i. Identification of ingredient tested, number of samples tested.

ii. Identification of test conducted including the analytical methods.

iii. Dates of the tests

iv. Test results

v. Corrective actions taken in response to the testing

vi. Information identifying the lab conducting testing

9. Documentation of the review of the supplier's relevant food safety records.

i. The name of the supplier

ii. Dates of the record review

iii. General nature of the records review

iv. Conclusions of the review

v. Corrective actions taken in response to deficiencies found.

10. Documentation of other supplier verification activities conducted.

11. Documentation of the determination that verification activities conducted in lieu of an onsite audit are sufficient in the case that the hazard controlled by the supplier is one that could cause serious health consequences or death. You must provide adequate assurance that the supplier is controlling those hazards.

12. Documentation of an alternative verification activity if the supplier is a qualified facility.

13. Documentation of an alternative verification activity if the supplier is a farm.

14. Documentation of an alternative verification activity if the supplier is a shell egg producer.

15. The written results of an inspection of the supplier

16. Documentation of actions taken with respect to non conformance.

17. Documentation of mitigation of a hazard, if that control is applied by a 3rd party.

18. When applicable, documentation about the 3rd party and their verification activities.

This article is for you if…

∆ You are an FDA-regulated food business

∆ You purchase packaging/ingredients from one or more suppliers

∆ You are not defined as a very small business

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Resources

FDA Regulation: Part 117 Subpart G - Supply Chain

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Supplier visits are a wonderful thing to procrastinate on if you’re a food manufacturer or restaurant owner. There’s barely enough time to get through your own production, so why lose a day to go visit one of your suppliers? Here are 3 reasons your business will benefit from a field trip upstream:

1. Your customers care about product quality

2. You are legally compelled to conduct supplier visits

3. You will learn how to improve your business

1.  Your Customers Care About Product Quality

Your customers demand the highest quality products from you. This means consistency of product, zero risk of food borne illness, and a product that tastes perfect every time. As a food producer, your sole focus is to get an "A+" on this every single day in your own facility. But can you guarantee the same of each of your suppliers?

Here is a simple and yet difficult truth to swallow: when you take custody of purchased ingredients/packaging/goods, you are responsible for them. For example, if you produce chocolate bars and your customers gets sick because of salmonella-infected sugar that was mishandled by your supplier (not you!) then your product will be recalled. Perhaps theirs will too, but that hardly matters when your production is halted and your brand reputation is at stake.

Here is a less extreme example: a supplier visit might show you that one of your suppliers is taking risks that you don't feel comfortable with. Whether it's a less-than-clean facility or lax attitudes about food safety basics, this may open a conversation with them about raising their food safety standards or losing your business.

2.  You Are Legally Compelled to Conduct Supplier Visits

Ahh, the Food Safety and Modernization Act (FSMA). All food manufacturers except exempt facilities (i.e. small timers and very low risk operations) must have a Supplier Verification Plan. In short, you have to prove that you are doing your due diligence when it comes to vetting your suppliers, beyond picking the vendor with the lowest prices.

Fortunately, the standard for "Supplier Verification" plans is fairly low from a regulatory standpoint because FSMA is new and everyone is still catching up. It doesn't necessarily require supplier visits, but this is actually one of the easiest ways to comply with FSMA without having to write out long, complicated food safety documents. Just visit the supplier and record that you conducted a visit, who you visited, and when.

3.  You Will Learn How to Improve Your Business

Supplier visits are a great way to learn about how to improve your operations. Chances are that your supplier is a more advanced operation than yours and that they've solved a lot of the problems that you haven't solved yet.

When I was managing a commissary, I visited one of our suppliers with the expectation of learning very little. I was completely wrong. Even though their product was completely different from ours: (them: raw chopped vegetables, us: gourmet hot meals) I saw what my facility was going to look like when we scaled 10x.

The quality assurance manager toured me around the facility and answered every question I had. It was an hour of free consulting that my company would have paid thousands of dollars for. He also sent me home with a flash-drive of  documentation and their recent audit results that I used to cut costs in my own operation and prepare for our next inspection.

Every business wants to increase their output by 10x but very few of us truly understand what that looks like. How many hires does that require? How will the layout of your facility change? Visiting your suppliers will show you what's happening in the big leagues and illuminate the path to getting there.

How to Conduct a Supplier Visit

1. Get in touch with your contact and ask if there's a time that works for you to come by and visit. Your suppliers will be very familiar with this request and probably have a process in place.
   

2. Show up on time and be respectful of their time. Remember, someone is taking time from their production role to tour you around, so be considerate and thankful.
   

3. Be a sponge
   

   • Ask if you can take photos. If so, photograph anything and everything. You may not think much of their eyewash stations now, but you'll be happy to revisit photos of theirs when it comes time to install your own.

   • Take notes. First, confirm it's OK to bring your note-taking apparatus into the facility. If so, scribble like your memory is fading. Otherwise, you'll forget all of it.

   • Ask questions. The goal here is twofold: First, it's a great way to learn about how to improve your own operations. Second, it's a great insight into their food safety awareness and culture.

   • Ask for documents. Request their food safety plan, audit results, log entries, everything. This isn't an unreasonable request: it's part of your due diligence. They'll probably only give you some of it, but this is priceless. Wouldn't it be helpful to have the scoresheet used by the auditor that's going to decide whether your product should be allowed on Whole Foods shelves? Bring a flash drive so you can accept digital copies.
     

4. Act on your findings. If you are aware that your supplier is creating a food safety hazard and you pass that risk along to your customer without doing anything about it (i.e. changing suppliers) you could go to jail. Yeah.
   

5. Send a thank you note. Anyone in the business long enough knows that supplier relationships are critical. A simple 3 sentence email will suffice and you'll be happy to have the contact.
   

As busy as you undoubtedly are with your own business, supplier visits are a critical part of your commitment to food safety. If nothing else, the field trip will show you how to host visitors in your own facility because it's only a matter of time before someone wants to walk through your space and see your records. Are you ready?

Have you conducted a supplier visit? Whats' the most surprising thing you saw? Let us know in the comments section below.

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This Article is For You if…

∆ You purchase ingredients or packaging from another company

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More about Supplier Verification

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