Introduction to Shared Kitchen Storage

Your customers will probably want multiple options based on their business size

Storage can be a thorny area for shared kitchen operators. Food producers are typically interested in storing some combination of equipment, ingredients, and finished product onsite. Often, designated storage spaces are shared among multiple businesses. This requires the shared kitchen user to store their product in a set of containers.

This section is devoted to helping you find the best storage containers for use in a shared kitchen. It is informed by the FDA regulations, collaboration with health agencies nationwide, and the best practices I’ve observed in shared kitchens.

Or, you can skip to the FDA Reader List of Best Shared Kitchen Storage Containers.

Factors to Consider

Here are the major considerations:

• Material

• Size

• Airflow

• Secure

• Compatibility with other systems

Material

Food Safe: The material for your storage should be food safe — presumably there will be some contact between raw food (or packaging) and the container it will reside in. Ideally, the container is NSF approved, but if not, you should be able to discern whether it is made from food safe materials by reviewing the product spec.

Strong: You want a material that is going to be strong enough to endure the abuse of a kitchen. These containers will be full of heavy items, slammed down on tables, and dragged across wire shelves. It should be strong and also capable of enduring the temperatures of a refrigerator or freezer. While I recommend using metal bun-cabinets for easy storage, the cold can burn your hands when it has been sitting at -10ºF.

Color: Finally, it’s worth considering the color of the container. Since these containers might crack and they will be in close proximity to food, it’s best to get a color that will easily stand out (like blue). This is not necessary, but if color is a consideration, pick blue, the best color for minimizing foreign object contamination.

Water/Rust Proof: The storage container is going to get dirty and require washing. If it goes in the freezer, it will get covered in ice. Pick something that won’t rust and that can tolerate a lot of moisture. Wood and cardboard are no-no’s. Plastic and certain types of metal tend to work best.

Shape/Size

There are a few considerations when it comes to picking a storage solution. Ultimately, the most important considerations are what you are actually storing. You’ll want to make sure that your storage containers don’t affect the product stored inside them.

Weight An oversized plastic tote might fit all of your ingredients and equipment with ease… but it’s impossible to lift onto the shelf. If your container will live on a shelf, then pick a storage container that you can comfortably lift when it’s full.

Shape Avoid shapes that will minimize the amount of usable space, such as a box with walls that taper. Make sure the containers that you choose maximize the total space available on the shelf or in the space where they will live. Remember, finding the right storage container is being realistic about what is being stored.

Vented

If your storage container is going to live in a refrigerated or frozen environment, then it needs to be vented. Refrigeration works by blowing cold air across the surface of the food items in the space. If food is stored in a solid-walled container — e.g. a typical plastic storage box— the container will insulate the food and prevent it from cooling down.

This is a problem. Airflow is important for cooling purposes. This is why milk crates are crates not solid walled boxes.

The storage container should be vented to allow air to pass through it and across the surface of the food inside.

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This is for you if...

∆ You are considering or purchasing storage solutions for use in a shared kitchen.

Keep Reading

Shared Kitchen? Cloud Kitchen? Ghost Kitchen? Commissary Kitchen? Black Box Kitchen? Incubator Kitchen?

Unfortunately, these terms are often used interchangeably throughout the food industry. Not only in news articles but in government regulation, there are a litany of confusing and inconsistent definitions.

Fortunately, they have one commonality: They refer to a food production space which includes some shared infrastructure across multiple businesses.

Some of these terms have a more specific definition or were created to reflect a particular context. The sections below are an attempt to sort this out so we can find consistency in this sector:

Shared Kitchen:

At it's broadest, this entails multiple food businesses operating in a single location which makes use of some shared infrastructure. This term encompasses all of the other terms described in the article and I favor it as the overarching industry descriptor for these business models.

Other equivalent terms include: shared-use kitchen, licensed commercial kitchen (LCK) and commissary kitchen. However, the term commissary kitchen or simply commissary may also refer to a large food processing space operated by a single tenant. For this reason, I prefer not to use this term to describe shared processing spaces.

Incubator Kitchen

This refers to a shared kitchen specifically designed for early-stage food businesses where the site management takes an active role in growing the tenant businesses. Adopting the term incubator from the tech industry, the term Incubator Kitchen implies that the management supports the entrepreneurs to refine their idea and their business model. This may include taking an equity stake in the fledgling businesses but not necessarily.

Incubator Kitchen ≠ Shared Kitchen

Incubator Kitchen is often mistakenly used interchangeably with shared kitchen, especially when the majority of tenants in a shared kitchen are early-stage businesses. However, this does not alone make the business an “incubator kitchen” and the use of this term is misleading when the site management’s offering does not actually “incubate” these businesses in any meaningful way.

There’s a second reason for this term’s popularity: “incubator” is a buzzy term from the tech-sector that people associate with rocket ship growth trajectories, venture capital, and million dollar buyouts. In other words, it’s good marketing.

Here’s an easy way to differentiate the two: the goal of an incubator kitchen is to develop and grow the tenant businesses operating in the space, not maximize occupancy. If the operator is measuring success through occupancy, they probably aren’t an incubator.

Ghost Kitchens, Dark Kitchens, Black Box Kitchens & Cloud Kitchens

For simplicity, I’ll use the term ghost kitchen throughout this section.

These terms all refer to the same thing: a food processing facility which has no dine-in retail component. Typically, all of the food produced in a ghost kitchen is delivered to the customer, often via a food delivery service such as Seamless, Grub Hub, or Deliveroo.

A ghost kitchen is not necessarily a shared kitchen — a single delivery-only food production space would still be a ghost-kitchen but not a shared kitchen. However, these terms overwhelmingly imply a cluster of ghost kitchens in a single location. And when those tenants make use of common infrastructure (such as refrigeration, dishwashing, or cooking equipment), then they would fall into the category of “shared kitchen".

Regardless of whether they fall under the “shared kitchen” umbrella, multi-unit ghost kitchens tend to be focused on delivery food service with restaurants making up the bulk of their users. The equipment and layouts of these kitchens generally supports this type of user although a food business not requiring a walk-in retail component (such as a small-scale manufacturer) could also operate out of this space.

Finally, it’s worth noting that Cloud Kitchens is also the name a of a prominent ghost-kitchen provided started by uber founder Travis Kalanick.

The Bottom Line

The shared kitchen industry is still in its infancy and the terminology continues to formulate. If you subscribe to a different definition than the ones provided above, that’s fine. However, it’s important to acknowledge that there is currently a lack of consensus on naming conventions and that while terms may be tossed around interchangeably, they can have a specific connotation.

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Keep Reading

This article supports food producers answer the question, “What are GMPs?”

Introduction to GMPs

Good Manufacturing Practices (GMPs) are the set of production standards that have been embraced by regulators, retailers and consumers in the food and drug industries. 

GMPs provide a basic assurance that a product was produced under industry-standard conditions. Some of the areas addressed in GMPs include:

Contents

Introduction
Food vs. Drug GMPs
Understanding the GMP Certification Process GMP Requirements

• Building & facility conditions

• Equipment design and maintenance

• Employee practices

• Sanitation conditions

• Raw ingredient sourcing

• Maintaining strong production controls

• Records and reports

There are several sets of GMP standards which have been endorsed by different governments. Fortunately although they are nearly identical. Some versions of GMPs include:

• CGMP* (food) addresses the production of food for the US.

• CGMP* (drug) addresses the production of pharmaceutical drugs for the US

• EU-GMP addresses the production of pharmaceutical drugs for the European Union

• Guide 104 GMP addresses the production of pharmaceutical drugs for Canada
  

If you are considering aligning your business with GMPs, adopt the set of standards that reflects where your processing is located and where your product will be sold. If this includes more than one set of GMPs, you will want to make sure your operations are aligned with both. Again, they are nearly identical.

*CGMP stands for “Current Good Manufacturing Practices” and is regulated by the FDA.

Food vs. Drug GMPs

In the United States, the FDA defines two distinct sets of GMP standards — Food and Pharmaceutical (Drug).

Food CGMPs: These describe the “methods, equipment, facilities, and controls for producing processed food.” (FDA, 2004). These are meant to ensure that the food is safe to eat.

Drug CGMPs: These assure “the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations”. (FDA, 2018).

The sections below reflect the GMP requirements for food.

Understanding the GMP Certification Process

After a food manufacturer aligns their operations with GMPs, they may consider going through the certification process through a private auditing firm. This is how the certification process typically works:

1. A manufacturer adopts the GMP standards and makes the required adjustments to align with the standards. Depending on the preexisting practices and conditions, this could take 3-12 months.

2. The manufacturer chooses a private auditing firm (there are many) to conduct the GMP audit.

3. The auditing firm conducts the audit, which may include an inspection of the facility and a review of records. 

4. The manufacturer will correct any areas of non-compliance and, if they achieve a passing score, they will receive a certificate from the auditing firm.

5. The manufacturer can provide this certificate to prospective buyers as an indication of their alignment with industry standards.

Why You Should Align Your Operations with GMPs

Regardless of whether your business chooses to pursue certification, aligning your operations with GMPs will have the following benefits:

• Decrease in food safety risk to your customers

• Lower level of product defects

• When your buyers conduct supplier verification activities, they will want to want to know that your operations are GMP-aligned — even if you’re not certified

The Benefits of Achieving GMP Certification

• It will unlock access to the many buyers who require GMP certification from their suppliers.

• It will satisfy most supplier-verification requirements — meaning less back-and-forth between your team and the companies you sell to.

• You will have an advantage over competitors who haven’t been certified to this industry standard.

GMP Requirements

For a detailed set of FDA-aligned GMP requirements, see our comprehensive guide to GMPs

Or, you can learn about the individual good manufacturing practices by topic:

• Personnel

• Plants and Grounds

• Sanitary Operations

• Sanitary Facilities and Controls

• Equipment and Utensils

• Processes and Controls

• Warehousing and Distribution

• Holding and Distribution

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More About Food Safety Plans

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What You Need to Know:

Contents

Determining USDA Jurisdiction
Examples of Business Regulation
Examples of Food Product Regulation
Meat Products
Egg-Related Products
FAQ

• The USDA regulates the production of meat, poultry and egg products. USDA-regulated businesses are required to have a USDA inspector onsite at all times.

• The FDA regulates the production of everything else (non-meat foods, unusual meats, and fish products). No inspector is required onsite during production.

• A business that conducts activities falling under both umbrellas is regulated by both agencies.

• Food produced and sold in a retail environment (i.e. restaurant, deli) is not typically regulated by either the USDA or the FDA.

“How to determine food business jurisdiction: Start with USDA. If you can’t positively identify how it falls under USDA jurisdiction, then it’s regulated by the FDA.”

Determining USDA Jurisdiction

The USDA typically regulates the following business types:

• Slaughterhouses

• Meat Processors*

• Poultry Processors*

• Egg Processors

• Food processors whose products contain meat*

Food products with the following characteristics are regulated by the USDA.

• Contains >2% cooked meat

• Contains >3% raw meat

• Contains >2% cooked poultry meat

• Contains >10% cooked poultry skins

*For more detail, see the tables below

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Examples of Business Regulation

Business	Description of Operations	Federal Jurisdiction
Meat Product Processor	Producer of frozen meat pies, bone broth, steak delivered via mail	USDA
Poultry Product Processor	Poultry processor	USDA
"Egg Product" Processor	Producers dried, frozen, or liquid eggs	USDA
Egg processing plant	Egg washing, sorting, packing	FDA
Slaughterhouse	Slaughter and processing of carcasses for sale. *Slaughter for personal consumption is not regulated by the USDA	USDA
Commissary for retail outlets	A commissary produces deli meats to sell at multiple delis, all owned by the same company. Products are shipped ready-to-eat.	FDA
Restaurants and retail establishments	Retail establishment that sells meat to typical consumers in retail quantities.	Not typically regulated by the federal government

:

Examples of Food Product Regulation

Misc Products	Regulator
Spaghetti Sauce (2% meat)	FDA
Sliced Egg sandwich (closed face)	FDA
Shrimp flavored instant noodles	FDA
Venison Jerky	FDA
Closed Face Sandwiches	FDA
Open face sandwiches	USDA
Pork Sandwich (open faced)	USDA
Corndogs	USDA
Frozen Beef pot pie	USDA

:

Meat Products	Regulator
Cow	USDA
Sheep	USDA
Pig	USDA
Horse	USDA
Mules	USDA
Goat	USDA
Domesticated Birds (chicken, turkey, ducks, geese, guineas, geese)	USDA
Wild Birds	FDA
Rabbit	FDA
Bison	FDA
Game animals	FDA
Deer, Elk, Moose	FDA
Zoo animals	FDA

:

Egg Related Products	Regulator
Dried Eggs	USDA
Frozen Eggs	USDA
Liquid Eggs	USDA
Egg Substitutes	FDA
Dried Custard Mixes	FDA
Egg Nog Recipes	FDA
Egg Noodles	FDA
Milk and Egg Dip	FDA
Cake Mixes	FDA
French toast Sandwiches Containing Egg	FDA
Products containing egg	FDA

:

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FAQ

What does the USDA inspector do?

The USDA inspector inspects:

• Slaughtered animals to confirm they were healthy

• Sanitation conditions of a plant

• Operations to confirm that they align with the firm’s HACCP plan

• Product is correctly labeled and packaged to be transported

What it FSIS?

The Food Safety and Inspection Service (FSIS) is the inspection arm of the USDA. So if you see the term FSIS, think USDA.

This article applies to you if…

∆ You are unsure whether your product is regulated by the FDA or the USDA.

References

USDA Inspection Requirements Overview

FDA vs. USDA Jurisdiction Guide

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What You Need to Know

Correction

A correction means taking action in a timely manner to identify and correct a minor and isolated problem that does not directly impact product safety.

Examples of corrections include:

• Re-cleaning the production line if it appears dirty after the first clean.

• An employee is asked to leave the production area and put on the proper attire before re-entering the production area.

• The temperature of a walk-in refrigerator is adjusted because it is a time of high traffic and the temperature is approaching the critical limit.

Corrections occur in the moment and don't require any documentation

Corrective Action

A corrective action is a procedure that must be taken if a corrective action is not properly implemented. This must be documented and the record should describe:

• What occurred

• How the problem was corrected

• How it will be avoided in the future

• What was done with the product in question

Examples where corrective action is required include:

• A sample of canned salsa is tested and the pH exceeds the requirement of <4.3.

• A refrigerator is found to have exceeded the temperature requirement of ≤41ºF for several hours.

• The producer of bottled juice realizes that during the last production run, numerous bottles were not properly sealed by the capping machine, possibly due to defective packaging.

For more about corrective actions, see our full guide

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Correction or Corrective Action?

The following examples illustrate how an operator may choose between a correction and a corrective action

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Scenario	Type of Action Required	Why	Recommended Action
Cookies on a conveyer oven are finished in 8 minutes instead of the required 10 minute cook time	Corrective Action	The cook step is (presumably) a preventive control used to kill bacteria present in raw cookie dough. Because the product failed to achieve the 10 minute cook time, then the preventive control has failed and a corrective action is required.	1. Adjust the belt temperature to reseet to 10 minute cook time. 2. Test to confirm the belt speed has increased the cook time to 10 minutes. 3. Re-cook the cookies for an additional 2 minutes (or discard) 4. Record this on a corrective action form.
Cookies on a conveyer oven are completed in 12 minutes instead of the required 10 minute cook time	Correction	Since the product was overcooked, it still achieved the preventive control that requires a >10 minute cook time.	Adjust the belt speed to reduce the cook time to 10 minutes. Consider testing the overcooked product for quality
Sheet pans are observed to be unclean immediately after being run through the dishwasher	Correction	This is a minor problem that poses no risk to the safety of the food if it is corrected.	Re-run the dishes through the dishwasher and confirm they are clean.
The dispenser for dishwasher sanitizer chemical is discovered to be empty after a day of production	Corrective Action	It is possible that many utensils and dishes were used in production without having been sanitized. This directly impacts food safety of product that was produced and so corrective action should be taken.	1. Refill the sanitizer chemical in the dish machine and confirm it is being applied during the cycle. 2. Assess why the sanitizer ran out and whether chemical levels should be checked more frequently to avoid this problem recurring. 3. Evaluate the food that contacted the un-sanitized utensils/dishes and determine whether it should be discarded, re-worked or served. If the food cannot be proven to be safe then it should be discarded.

Resources

Corrective Action Template

More About Food Safety Plans

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What You Need To Know:

• Validation answers the question “How do you know it works?”

• You must validate that the preventive controls that you implement actually work.

• Validation activities includes using scientific and technical evidence (or conducting your own studies)

Example of Validation: Collecting scientific research, and conducting tests to prove that the cooking temperature in your recipe is effective in killing the harmful bacteria in the product.

Hint: you can find information to validate many food processing practices on the FDA website.

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What is Validation?

Validation means obtaining and evaluating scientific and technical evidence that a control measure, combination of control measures, or the food safety plan as a whole, when properly implemented, is capable of effectively controlling the identified hazards.

21 CFR 117(c)(1)(i)

When is Validation Required?

You are required to validate every preventive control you are implementing. This means that if you use cooking as a means to kill bacteria, then you need to show that the time and temperature are a valid method for killing that bacteria type. This can often be achieved by referencing FDA guidance materials.

You are not required to validate the following types of preventive controls:

• Sanitation Preventive Controls

• Food Allergen Controls

• Recall Plan

Who Conducts Validation?

All validation activities must be performed by a preventive controls qualified individual.

When do I need to validate my preventive controls?

You must validate your preventive controls:

• Within 90 days of beginning production or there must be written justification for why if  >90 days after production begins.

• Whenever a change is made that could impact how a hazard is controlled.

• Whenever the food safety plan is reanalyzed.

What Part of My Food Safety Plan Require Validation?

Some parts of your food safety plan do not need to be validated. Sanitation activities, for example, do not need to be validated because most people use a small set of scientifically proven processes (i.e. soap and water, common chemical sanitizers). As a result, there is no need to require each business to prove their sanitation practices actually work.

The following activities do not require validation

• Food allergen controls

• Sanitation controls

• Recall plan

• Supply chain program

• Other preventive controls if the PCQI prepares the written justification that a validation is not applicable based the nature of the hazard and the preventive control.

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This Article is For You if…

∆ You are developing a food safety plan or HACCP plan.

∆ You have implemented a preventive control or identified a hazard that requires a preventive control

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Resources

Verification vs. Validation

View fullsize

FDA Regulation on Validation

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If you are unsure whether corrective action is required, see Verification vs. Validation

What You Need To Know

• Verification means confirming that other parts of the food safety plan have been undertaken as specified.

• Verification can take the form of a supervisor regularly reviewing records and verifying them with a signature.

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What is Verification?

Verification means the application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whether a control measure or combination of control measures is or has been operating as intended and to establish the validity of the food safety plan.

21 CFR 117(c)(1)(i)

Examples of Verification

Common examples of verification include:

• Reviewing cooking records to confirm the required temperature and cook time was reached

• Reviewing refrigeration records to confirm food was held sufficiently cold

• Observation that employees are following good food-handling practices

• Calibrating thermometers – this verifies that they are reading properly

• Sampling your own product for pathogens to verify that your process was faithfully performed

• Environmental monitoring – testing your production space for pathogens living on surfaces, in drains, etc.

• Supplier Verification – reviewing a supplier’s records to confirm they are faithful to their food safety practices and claims.

When is Verification Required?

All records which monitor a preventive control must be verified within 7 days of their creation.

All corrective action records must be reviewed within 7 days of their creation.

Other verification records, such as instrument calibration, product testing, and environmental monitoring, must be verified “within a reasonable amount of time” as determined by the producer.

Who Conducts Verification?

All verification activities must be performed by a preventive controls qualified individual (PCQI).

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What You Need to Do:

• Verify that your preventive controls are being implemented and monitored. You can do this by checking that monitoring records were completed.

• Verify that corrective actions are taken when necessary and that the right decisions are being made in relation to any process deviations.

• You must keep your verification records on file (digital is fine)

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This Article is For You if…

∆ You are developing a food safety plan or HACCP plan.

∆ You have implemented a preventive control or have identified a hazard that requires a preventive control

∆ You take any records as part of your food safety plan

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Resources

Verification Log Template

FDA Regulation on Verification

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If you are unsure whether corrective action is required, see Corrective Action vs. Correction

What You Need To Know:

• Corrective Action is a response that must be taken if a preventive control is not properly implemented.

• Corrective Actions must be written and are often completed using a standard form (see our free Corrective Action template)

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What You Need to Do:

1. Write Corrective Actions Procedures

You must establish and implement written corrective action procedures. These procedures must describe the steps to be taken to ensure that:

• Appropriate action is taken to correct a problem associated with a preventive control.

• Appropriate action is taken to reduce the likelihood that the problem will recur.

• All affected food is evaluated for safety

• All affected food is prevented from entering commerce.

2. Take Corrective Action When it is Required

When to Take Corrective Action:

You must take a corrective action if

• A preventive control fails and a corrective action hasn't been established.

• A preventive control is found to be ineffective

• Verification records are found to be incomplete or improper decisions were made about corrective action

3. Keep Records of Your Corrective Actions

All corrective actions taken in this section must be documented. We recommend using a pre-written form so that it’s easy to complete and no details are missing. Check out our corrective action template here

Corrective actions must also be verified (See Verification or §117.155)

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This Article is For You if…

∆ You are developing a food safety plan or HACCP plan.

∆ You have implemented a preventive control or identified a hazard that requires a preventive control

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Resources

FDA Regulation on Corrective Actions

Corrective Action Template

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These requirements are a part of our comprehensive Food Safety Plan Guide

What You Need To Know:

• A preventive control is a strategy implemented to eliminate a hazard in a food manufacturing environment

• You must identify and implement preventive controls when you identify a hazard that is reasonably likely to cause injury to a customer if left unaddressed.

• Preventive controls include Critical Control Points and other types of controls.

• Preventive controls must be written

Types of Preventive Controls

Process Controls:

These are procedures and processes that are used to control parameters of processing (i.e. acidifying, refrigerating, cooking.) They must be written in a way that is specific to your process and they must include:

• parameters associated with controlling the hazard (i.e. if you are using cooking as a process control, then you must include the required cook temperature and cook time)

• The maximum or minimum values required to control the hazard.

Food Allergen Controls

These include processes to control food allergens. These are implemented to:

• Protect food from allergen cross contact

• Label food properly with allergens to ensure it isn't misbranded

Sanitation Controls:

These are practices to ensure the facility is kept clean and to minimize biological hazards. They relate to:

• Cleanliness of food-contact surfaces (equipment, utensils, tables)

• Prevention of contamination of food from dirty sources (i.e. dirty people, dirty food, dirty packaging, dirty raw ingredients)

Supply Chain Controls:

Supply Chain Controls are described fully in Part G

Other Controls

You may have other types of controls (i.e. hygiene training and current good manufacturing practices)

What To Do If You Implement a Preventive Control

If you implement one or more preventive controls then you must conduct the following activities for each one:

1. Monitoring activities

2. Corrective actions

3. Verification activities

Circumstances Where Preventive Controls Are Not Required

You aren't required to implement preventive controls if any of the following apply:

1. The food cannot be consumed without application of an appropriate control (i.e. coffee beans cannot be consumed without pouring boiling water on them, which would kill any bacteria on the bean. By preparing coffee the consumer is inherently applying the necessary control)

2. You rely on your customer, who is subject to this subpart, to ensure that the hazard is mitigated. You must:

i. Disclose in writing that the food is "not processed to control [identify hazard]" and

ii. Annually obtain written assurance that the customer is following the procedures you have provided, which will eliminate the hazard.

3. You rely on the customer who is not subject to this subpart to eliminate the hazard. You must:

i. Disclose in writing that the food is "not processed to control [identify hazard]" and

ii. Annually obtain written assurance that the customer is following the procedures you have provided, which will eliminate the hazard.

4. You rely on the customer to provide assurance that the food will be processed to control the hazard by a subsequent entity in the supply chain

i. Disclose in writing that the food is "not processed to control [identify hazard]" and

ii. Annually obtain written assurance that your customer will:

A. Disclose in documents accompanying the food that it is "not processed to control [identify hazard]"

B. Will only sell to another entity that agrees in writing that it will mitigate the hazard and obtain similar written assurance from subsequent customers.

5. You have established and implemented a system that ensures control of the hazards in your product, at the distribution step.

Note: You must document any circumstance (related to the section above) that applies to you, including written assurances from customers.

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This Article is For You if…

∆ You manage a facility that makes, holds, or packs food.

∆ You are developing a food safety plan or HACCP plan.

∆ You have identified a hazard in your hazard analysis

∆ You are subject to Part 117 Subpart C (very small businesses are exempt from this requirement)

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Resources

Food Safety Plan Templates

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References

What You Need to Know:

Verification means conducting a review to confirm a process was performed correctly. Verification answers the question "How do you know it actually happened?"

Example: A manager in a cookie factory reviews production records to confirm that the cookies were baked to the temperature described in the recipe.

Validation refers to the requirement that a food processor use scientifically proven methods to control a hazard. Validation answers the question "How do you know it works?"

Example: A food safety manager collects scientific research to demonstrate that the cooking temperature used in the recipe is effective in eliminating harmful bacteria in the raw product.

Why Verification and Validation are Important:

Both verification and validation are required or else food-safe outcomes may not be achieved.

Validation Without Verification...

Hand washing with soap is a valid method for removing dirt/grime from hands. However, if verification does not occur and employees do not actually wash their hands, then it doesn't matter how scientifically-proven the strategy is.

Verification Without Validation...

Hand washing without soap is not a valid method for cleaning hands. Even if a manager verifies that hand washing is occurring as required, it doesn't matter because hand washing without soap is not a valid method for cleaning hands.

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Verification

Verification means the application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whether a control measure or combination of control measures is or has been operating as intended and to establish the validity of the food safety plan.

21 CFR 117(c)(1)(i)

Examples of Verification

• Reviewing cooking records to confirm the required temperature and cook time was reached

• Reviewing refrigeration records to confirm food was held sufficiently cold

• Observation that employees are following good food-handling practices

• Calibrating thermometers - this verifies that they are reading properly

• Sampling your own product for pathogens to verify that your process was faithfully performed

• Environmental monitoring - testing your production space for pathogens living on surfaces, in drains, etc.

• Supplier Verification - reviewing a supplier's records to confirm they are faithful to their food safety practices and claims.

When is Verification Required?

All records which monitor a preventive control must be verified within 7 days of their creation.

All corrective action records must be reviewed within 7 days of their creation.

Other verification records, such as instrument calibration, product testing, and environmental monitoring, must be verified "within a reasonable amount of time" as determined by the producer.

Who Conducts Verification?

All verification activities must be performed by a preventive controls qualified individual.

Examples of Verification

Verification

Example of Preventive Control	Verification Required?	Why?	Verification Example
Cooking Chicken to a temp of 165ºF as a preventive control to reduce the hazard of Salmonella Bacteria	Yes	The cook step is a preventive control. Therefore, the production record containing the cook temp/time must be verified	A manager reads the cook log and confirms that all chicken cooked that day was cooked to 165º
Fermentation and low pH are used as a method to prevent bacterial growth in pickled cucumbers stored at room temperature	Yes	Low pH is a preventive control applied to stop bacteria growth. Therefore, the pH records must be verified.	A manager reviews the daily production records to confirm the pH was below the required threshold in all batches. If there is a deviation, the manger verifies that the appropriate corrective action was taken.
Preservatives are used to kill harmful bacteria in chicken meat so that it can be consumed raw	Yes	This is a preventive control and must be verified	A manager confirms that the appropriate level of preservative was used to render the product safe. Additionally, in such a high-risk scenario, it may be advisable to test the chicken for pathogens.
Chlorine sanitizer used to sanitize dishes	Possibly	Depending on the nature of the product, it may not be a requirement to verify that the appropriate concentration of sanitizer was used.	Manager verifies a record showing that the sanitizer was tested and the chemical concentration fell into the designated range.
Items containing peanuts are stored in different-colored containers from non-peanut products	No	There is no requirement to verify the implementation of storage practices to mitigate an allergen concern, although it may be a good idea.	A manager may inspect storage spaces occasionally to confirm that practices are being followed to avoid allergen contact.

SOURCE: Sources

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Validation:

Validation means obtaining and evaluating scientific and technical evidence that a control measure, combination of control measures, or the food safety plan as a whole, when properly implemented, is capable of effectively controlling the identified hazards.

21 CFR 117(c)(1)(i)

When is Validation Required?

You are required to validate every preventive control you are implementing. This means that if you use cooking as a means to kill bacteria, then you need to show that the time and temperature are a valid method for killing that bacteria type. This can often be achieved by referencing FDA guidance materials.

You are not required to validate the following types of preventive controls:

• Sanitation Preventive Controls

• Food Allergen Controls

• Recall Plan

Who Conducts Validation?

All validation activities must be performed by a preventive controls qualified individual.

Examples of Validation

Example of Preventive Control	Validation Required?	Why?	Validation Example
Cooking chicken to a temp of 165ºF as a preventive control to reduce the hazard of salmonella bacteria.	Yes	The cook step is a preventive control. While it's largely accepted that a 15 second exposure to 165ºF temps will kill salmonella, it's good to cite a source showing that this control is valid. You can simply link or reference any reputable text which states this fact.	5D reduction for Salmonella: 15 seconds at 165ºF Table A4.1, “Limiting Conditions for Pathogen Growth” FSPCA Preventive Controls for Human Food 1st Ediiton, 2016
Fermentation and low pH are used as a method to prevent bacterial growth in pickled cucumbers stored at room temperature	Yes	You'll need to describe exactly how you know that this combination of controls are effective in controlling specific bacterial pathogens. The validation must be specific to the hazards you are controlling. You can cite a study showing that a certain concentration of bacteria produced by the ferment is effective in limiting the growth of relevant, harmful pathogens. You might also link a source which describes the pH threshold for specific bacteria growth.	For example: pH is an effective limiter for pathogenic bacteria growth in lactic acid producing fermented products if a <4.6 pH is maintained. Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry, Chapter 4 “Preventive Controls” p.27
Preservatives are used to kill harmful bacteria in chicken meat so that it can be consumed raw	Yes	This is a less common type of control (using preservatives to make raw chicken edible) so you would need to make a compelling case that this preservative is effective in eliminating harmful bacteria. You can state the simple facts of the study in one of two sentences and then cite the source.	[cite your source]
Chlorine sanitizer used to sanitize dishes	No	Validation is not required for sanitation controls. In this case, it is widely accepted that chlorine is an effective sanitizer.	N/A
Items containing peanuts are stored in different-colored containers from non-peanut products	No	Validation is not required for allergen controls	N/A

SOURCE: Sources

This Article is For You if…

∆ You are developing a food safety plan or a HACCP plan.

∆ You are an FDA regulated food facility.

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Resources

Food Safety Plan Guide to Validation

Food Safety Plan Guide to Verification

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