This is an overview of record keeping requirements. For a more in-depth review, see our Guide to 117 Subpart F: Record Keeping

What You Need To Know

Part 117 Subpart F contains the requirements for record keeping

• Keep all of your records related to your food safety lan.

• Records can be electronic or paper.

• You must store records onsite for at least 2 years

• All records must be made available upon request

Record Keeping Requirements

How Records Must Be Kept

• Records must be kept as originals, true copies (i.e. scans, photocopies) or electronic records.

• They must contain the actual values and observations, not summaries.

• They must be accurate, unchangeable (i.e. pen) and legible

• They must have been created in real-time with the activity being documented.

Required Information on All Records

The following information is required on all records you keep:

1. information about the plant identity

2. The date (and time, if necessary)

3. Signature or initials of the observer

4. Product name and lot code, if applicable

How long do I need to keep them for?

All records must be retained onsite for 2 years. Additionally, you must be able to retrieve records within 24 hours if an authorized request is made.

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Looking for More?

Check out our comprehensive guide to Part 117 Subpart F, Record Keeping or the FDA Reader Complete Guide to FSMA

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This Article is For You if…

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

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

∆ You are any type of FDA regulated food business

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All of our food safety plan templates are aligned with this section.

Resources

FDA Regulation On Record Keeping

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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

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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

---

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:

• Monitoring means observing some activity in your production— such as checking the temperature of your walk-in refrigerator

• Monitoring is required for all preventive controls to ensure they are implemented properly.

• You must have written procedures for how and how often you will monitor preventive controls.

• You must monitor preventive controls enough to ensure they are being performed.

Record Keeping Requirements

1. You must document your monitoring actions, store them, and also verify them (see verification)

2. Exception records are acceptable type of monitoring record (this means records are only taken when a deviation occurs.) For example, a refrigeration log may shows records only when the temperature is outside the acceptable range.

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Resources

FDA Regulation on Monitoring Preventive Controls

This Article is For You if…

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

∆ You have implemented a preventive control

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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

These requirements are a part of the Current Good Manufacturing Practices that relates to Facility Requirements. You can see the full guide to cGMPs here

Plants & Grounds

Grounds must be kept in a condition that protects against contamination. Methods include:

1. Eliminate conditions for breeding/harboring pests
2. Maintain roads, yards, parking lots
3. Drain areas (i.e. puddles) that may breed pests or contribute to food contamination
4. Even if the grounds aren’t in your control, you must still mitigate contamination hazards.

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Plant Construction and Design

The space must be suitable in size, construction and design for food production.

1. Must have adequate space for equipment and storage.

2. Must allow you to take precautions which reduce allergen contamination and food contamination (for example -- by chemicals, filth, other materials). Ways to eliminate contamination include separating operations by: location, time, partition, air flow systems, dust control system, etc.

3. Protect food that is stored outside in bulk containers:

4. Floors, Walls, Ceilings must be constructed in a way that allows them to be cleaned. The construction of the space must allow employees to do their jobs and not contaminate food, packaging, and work areas.

5. There should be adequate lighting in all food and employee areas (including food storage areas and employee locker rooms). All bulbs and glass that is suspended over areas where food is exposed should be shatter resistant.

6. There should be adequate ventilation to minimize dust, steam, odors, and vapors.

7. Provide screens or other protection against pests (door sweeps, air curtains)

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Sanitary Facilities

Plumbing

Water Supply must be from an adequate source. Running water must be of a suitable temperature and pressure and be provided in all food processing/cleaning areas.

Plumbing must

1. Carry adequate amounts of water around the plant.
2. Remove sewage from the plant.
3. Avoid contaminating food, equipment, water supply, utensils, ec.
4. Provide floor drainage in spaces where floors get very wet
5. Avoid back flow between plumbing systems

Sewage Disposal: Sewage must be disposed of adequately

Toilet Facilities: Each plant must have clean toilet facilities.

Hand-washing facilities: Each plant must provide hand washing facilities.

Rubbish: store rubbish to minimize odor, pests, and contamination

ATP Testing

ATP testing is a popular method for determining the effectiveness of a sanitation program. Check out our article on ATP testing and Environmental Monitoring to learn more.

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Exemptions

This section applies to most traditional food processors that fall under FDA jurisdiction. However, there are some notable exceptions.

• Farms

• Fishing Vessels

• Establishments who solely hold and transport agricultural products

• Establishments who only raw process (i.e. shell or dry) nuts.

• Mixed-Type farm facilities (defined in §1.227)

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This Article is For You if…

∆ You are seeking to understand facility requirements for your FDA-regulated food business.

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

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References

Guide to Current Good Manufacturing Practices (117 Subpart B)

These requirements are a part of the Current Good Manufacturing Practices that relates to Processes and Controls. You can see the full guide to cGMPs here

Requirements For Processes and Controls

Below are the processes and controls requirements for FDA regulated food businesses.

General Requirements

1. All operations involving food must align with sanitation principles.

2. Quality control must be used to ensure food and packaging is safe.

3. One or more competent individuals must be responsible for sanitation

4. You must protect your food from allergens and contamination.

5. Testing must be used to identify sanitation failures or possible product contamination.

6. Any contaminated food must be discarded or treated to eliminate the contamination.

Raw Materials & Ingredients

1. Ingredients must be inspected for cleanliness and stored safely. If necessary, raw materials should be washed using clean water.

2. Ingredients must be safe for consumption or treated to make them safe (i.e. washed or cooked).

3. Ingredients susceptible to toxins must comply with FDA regulations.

4. Ingredients that are contaminated must comply with FDA regulations if they are to be used.

5. Ingredients must be held in containers that prevent contamination and at an acceptable temperature and humidity level.

6. Frozen ingredients must be kept frozen.

7. Ingredients stored in bulk must be safe from contamination.

8. Ingredients that contain allergens must be identified and held in a way that prevents cross-contact.

Manufacturing Operations:

1. Equipment must be maintained in clean condition.

2. All operations should be controlled to minimize growth of bacteria, contamination and spoilage.

3. Food requiring refrigeration must be refrigerated throughout the operation.

4. Measures used to prevent bacteria growth (i.e. cooking, sterilizing, refrigerating) must be adequate.

5. Re-work must prevent contamination and bacteria growth.

6. When ingredients are unprotected they must not be handled in a way that could cause contamination. Food on conveyor belts must be protected.

7. Equipment, containers, and utensils must be constructed and used in a way that doesn’t contaminate food.

8. You must take measures to protect your product from metal or foreign objects.

9. Contaminated food must:

i. Be disposed of OR

ii. Re-worked and re-examined,

10. Food that is being processed must be protected from contamination.

11. Heat blanching --if used-- must be performed properly

12. Foods that are used repeatedly (i.e. dipping sauces, breading) must be protected from contamination and bacteria growth

13. Filling, assembling, and packaging processes must not contaminate food.

14. Dry foods that rely on low moisture for safety must be sufficiently dry.

15. Acidified foods that rely on acid for safety must be sufficiently acidic (pH≤4.6)

16. Ice that touches food must be food quality.

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Exemptions

This section applies to most traditional food processors that fall under FDA jurisdiction. However, there are some notable exceptions.

• Farms

• Fishing Vessels

• Establishments who solely hold and transport agricultural products

• Establishments who only raw process (i.e. shell or dry) nuts.

• Mixed-Type farm facilities (defined in §1.227)

This Article is For You if…

∆ Your business is regulated by the FDA

∆ Your business makes, packs, or holds food.

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References

Guide to Current Good Manufacturing Practices (117 Subpart B)

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These requirements are a part of the Current Good Manufacturing Practices. You can see the full guide to cGMPs here

Personnel Requirements

Employees working in food processing spaces are subject to basic requirements about disease control and cleanliness. The aim of these requirements is to make sure a food processor does contaminate their own food product which could cause a customer to become sick.

Disease Control:

Sick employees must be excluded from operations that could result in food contamination.

The typical way of doing this implementing an Employee Hygiene Policy that excuses sick employees from work. This may require food production employees who have been exposed to a serious contagious illness to refrain from working until they are no longer contagious.

Cleanliness:

This section states that employees must have clean practices

1. Clothing that protects against contamination
2. Adequate personal cleanliness
3. Hand washing
4. Removing unsecured jewelry
5. Wearing gloves in a safe manner
6. Wearing hair restraints
7. Storing other belongings in areas where food is exposed/equipment is washed.
8. Not eating food, chewing gum, drinking beverages, or using tobacco in food areas.
9. Taking other precautions

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Exemptions

This section applies to most traditional food processors that fall under FDA jurisdiction. However, there are some notable exceptions.

• Farms

• Fishing Vessels

• Establishments who solely hold and transport agricultural products

• Establishments who only raw process (i.e. shell or dry) nuts.

• Mixed-Type farm facilities (defined in §1.227)

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This Article is For You if…

∆ Your business is regulated by the FDA

∆ You have employees who work in a space where food is handled, packed, or produced.

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References

Guide to Current Good Manufacturing Practices (117 Subpart B)

These requirements are a part of the Current Good Manufacturing Practices that relates to Sanitary Operations. You can see the full guide to cGMPs here

Requirements For Sanitary Operations

Inadequate storage of chemicals and poor sanitation indicate a breakdown in food safe systems

General Maintenance:

Your space and everything in it must be in good repair to prevent food from being contaminated (i.e. no leaky ceilings, which could drip in food). Your cleaning processes should protect your food, packaging, and workspace from contamination.

Cleaning Chemicals:

1. You must only use safe cleaning chemicals. Toxic chemicals may only be allowed in food areas if they are:

• Required for cleaning

• Used in lab testing

• Necessary for equipment maintenance

• Absolutely necessary

2. You must store toxic chemicals in a way that protects food from contamination (Label it with the everyday name and keep it away from food and packaging)

Pest Control

Pests aren’t allowed in any area of the plant. You must exclude pests in the space and only use pesticides when it won’t result in contamination of food, packaging or work spaces.

Sanitation

You must clean food contact surfaces, including utensils, tables, equipment, to protect against contamination.

1. If you process low moisture (dry) food, your food contact areas must be clean and dry before use.

2. In “wet processing” food processing areas must be cleaned before use and after any contamination occurs.

3. Paper towels, paper cups and other single-use items must be protected from contamination.

ATP Testing

ATP testing is a popular method for determining the effectiveness of a sanitation program. Check out our article on ATP testing and Environmental Monitoring to learn more.

Non-food-contact-surfaces

These surfaces (i.e. walls, ceilings or anything that doesn’t touch food) must be cleaned as much as necessary to prevent contamination of food, packaging, or work areas.

Portable equipment and utensils must be stored in a way that doesn’t contaminate work areas.

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Exemptions

This section applies to most traditional food processors that fall under FDA jurisdiction. However, there are some notable exceptions.

• Farms

• Fishing Vessels

• Establishments who solely hold and transport agricultural products

• Establishments who only raw process (i.e. shell or dry) nuts.

• Mixed-Type farm facilities (defined in §1.227)

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This Article is For You if…

∆ Your business is regulated by the FDA

∆ You operate a space where food is handled, packed, or produced.

∆ You want to understand cleanliness standards for your space.

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References

Guide to Current Good Manufacturing Practices (117 Subpart B)

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ATP Testers

3M Clean-Trace Luminometer

Hygiena SystemSure Luminometer ATP Test Meter

What You Need to Know

Part 117 Subpart B is called Current Good Manufacturing Practices (CGMPs). 

These CGMPs outline the major requirements that a food processor must adhere to, including:

• Facility requirements

• Employee requirements

• Equipment requirements

• Cleaning requirements

• Warehousing & Distribution requirements

Summary of Current Good Manufacturing Practices

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 §117.110 (b) (2) then just look up this same code in the CFR.

117.10 Personnel:

For a reduced summary of this section, see Personnel

a. Disease Control: Sick employees must be excluded from operations that could result in food contamination

b. Cleanliness: Employees must have clean practices:

1. Clothing that protects against contamination

2. Adequate personal cleanliness

3. Hand washing

4. Removing unsecured jewelry

5. Wearing gloves in a safe manner

6. Wearing hair restraints

7. Storing other belongings in areas where food is exposed/equipment is washed.

8. Not eating food, chewing gum, drinking beverages, or using tobacco in food areas.

9. Taking other precautions

§117.20 Plants & Grounds

For a reduced summary of this section, see Facility Requirements

a. Grounds: They must be kept in a condition that protects against contamination. Methods include:

1. Eliminate conditions for breeding/harboring pests

2. Maintain roads, yards, parking lots

3. Drain areas (i.e. puddles) that may breed pests or contribute to food contamination

4. Even if the grounds aren’t in your control, you must still mitigate contamination hazards.

b. Plant Construction & Design: The space must be suitable in size, construction and design for food production.

1. Must have adequate space for equipment and storage.

2. Must allow you to take precautions which reduce allergen contamination and food contamination (for example -- by chemicals, filth, other materials). Ways to eliminate contamination include separating operations by: location, time, partition, air flow systems, dust control system, etc.

3. Protect food that is stored outside in bulk containers:

4. Floors, Walls, Ceilings must be constructed in a way that allows them to be cleaned. The construction of the space must allow employees to do their jobs and not contaminate food, packaging, and work areas.

5. There should be adequate lighting in all food and employee areas (including food storage areas and employee locker rooms). All bulbs and glass that is suspended over areas where food is exposed should be shatter resistant.

6. There should be adequate ventilation to minimize dust, steam, odors, and vapors.

7. Provide screens or other protection against pests (door sweeps, air curtains)

§117.35 Sanitary Operations

For a reduced summary of this section see Sanitary Operations in Food Processing Facilities

a. General Maintenance: Your space and everything in it must be in good repair to prevent food from being contaminated (i.e. no leaky ceilings, which could drip in food). Your cleaning processes should protect your food, packaging, and workspace from contamination.

b. Cleaning chemicals:

1. You must only use safe cleaning chemicals. Toxic chemicals may only be allowed in food areas if they are:

i. Required for cleaning

ii. Used in lab testing

iii. Necessary for equipment maintenance

iv.  Absolutely necessary

2. You must store toxic chemicals in a way that protects food from contamination (Label it with the everyday name and keep it away from food and packaging)

c. Pest Control - Pests aren’t allowed in any area of the plant. You must exclude pests in the space and only use pesticides when it won’t result in contamination of food, packaging or work spaces.

d. Sanitation - You must clean food contact surfaces, including utensils, tables, equipment, to protect against contamination.

1. If you process low moisture (dry) food, your food contact areas must be clean and dry before use.

2. In “wet processing” food processing areas must be cleaned before use and after any contamination occurs.

3. Paper towels, paper cups and other single-use items must be protected from contamination.

e. Non-food-contact-surfaces (i.e. walls, ceilings or anything that doesn’t touch food) must be cleaned as much as necessary to prevent contamination of food, packaging, or work areas.

f. Portable equipment and utensils must be stored in a way that doesn’t contaminate work areas.

§117.37 Sanitary Facilities and Controls

For a reduced summary of this section see Facility Requirements

a. Water Supply must be from an adequate source. Running water must be of a suitable temperature and pressure and be provided in all food processing/cleaning areas.

b. Plumbing: Must

1. Carry adequate amounts of water around the plant.

2. Remove sewage from the plant.

3. Avoid contaminating food, equipment, water supply, utensils, ec.

4. Provide floor drainage in spaces where floors get very wet

5. Avoid back flow between plumbing systems

c. Sewage Disposal: Sewage must be disposed of adequately

d. Toilet Facilities: Each plant must have clean toilet facilities.

e. Hand-washing facilities: Each plant must provide hand washing facilities.

f. Rubbish: store rubbish to minimize odor, pests, and contamination

§117.40 Equipment and Utensils

For a reduced summary of this section see Equipment and Utensils

a. Equipment and Utensils

1. Equipment and utensils must be designed to be cleanable and maintained to avoid contamination.

2. Equipment and utensils must not contaminate food with lubricants, metal fragments, water, etc.

3. Equipment must be installed in a way that they can be cleaned and maintained.

4. Food-contact surfaces must be corrosion-resistant.

5. Food-contact surfaces must be non-toxic

6. Food-contact surfaces must be maintained to protect food from allergen cross-contact

b. Seams on food-contact surfaces must be seamless to minimize accumulation of particles.

c. Equipment kept in food areas must be constructed so it can be kept clean -- even if it doesn’t contact food.

d. Machinery must be designed in a way that can be kept clean

e. Each freezer and refrigerator must have a thermometer in it.

f. pH meters, thermometers, and other measuring devices must be accurate.

g. Compressed air must be treated in a way that it does not contaminate food.

§117.80 Processes and Controls

For a reduced summary of this section see Processes and Controls

a. General:

1. All operations involving food must align with sanitation principles.

2. Quality control must be used to ensure food and packaging is safe.

3. One or more competent individuals must be responsible for sanitation

4. You must protect your food from allergens and contamination.

5. Testing must be used to identify sanitation failures or possible product contamination.

6. Any contaminated food must be discarded or treated to eliminate the contamination.

b. Raw Materials & Ingredients

1. Ingredients must be inspected for cleanliness and stored safely. If necessary, raw materials should be washed using clean water.

2. Ingredients must be safe for consumption or treated to make them safe (i.e. washed or cooked).

3. Ingredients susceptible to toxins must comply with FDA regulations.

4. Ingredients that are contaminated must comply with FDA regulations if they are to be used.

5. Ingredients must be held in containers that prevent contamination and at an acceptable temperature and humidity level.

6. Frozen ingredients must be kept frozen.

7. Ingredients stored in bulk must be safe from contamination.

8. Ingredients that contain allergens must be identified and held in a way that prevents cross-contact.

c. Manufacturing Operations:

1. Equipment must be maintained in clean condition.

2. All operations should be controlled to minimize growth of bacteria, contamination and spoilage.

3. Food requiring refrigeration must be refrigerated throughout the operation.

4. Measures used to prevent bacteria growth (i.e. cooking, sterilizing, refrigerating) must be adequate.

5. Re-work must prevent contamination and bacteria growth.

6. When ingredients are unprotected they must not be handled in a way that could cause contamination. Food on conveyor belts must be protected.

7. Equipment, containers, and utensils must be constructed and used in a way that doesn’t contaminate food.

8. You must take measures to protect your product from metal or foreign objects.

9. Contaminated food must:

i. Be disposed of OR

ii. Re-worked and re-examined,

10. Food that is being processed must be protected from contamination.

11. Heat blanching --if used-- must be performed properly

12. Foods that are used repeatedly (i.e. dipping sauces, breading) must be protected from contamination and bacteria growth

13. Filling, assembling, and packaging processes must not contaminate food.

14. Dry foods that rely on low moisture for safety must be sufficiently dry.

15. Acidified foods that rely on acid for safety must be sufficiently acidic (pH≤4.6)

16. Ice that touches food must be food quality.

§117.93 Warehousing and Distribution

Storage and transportation of food must protect the food from contamination.

(That’s it!) See source code 21 CFR 117.93 to see for yourself

§117.95 Holding and distribution of Human food by-products for use as animal food

a. By-products held for use as animal food must be protected from contamination:

1. Containers must be safe

2. Food by-products must be protected from contamination

3. By-products used for animal food must be labeled

b. Labeling must use common name

c. Shipping containers must be inspected for contamination prior to use

§117.110 Defect Action Levels

a. Quality control must be used to minimize defects

b.Mixing contaminated food with uncontaminated food to dilute the contamination level is not permitted.

Exemptions

This section applies to most traditional food processors that fall under FDA jurisdiction. However, there are some notable exceptions.

• Farms

• Fishing Vessels

• Establishments who solely hold and transport agricultural products

• Establishments who only raw process (i.e. shell or dry) nuts.

• Mixed-Type farm facilities (defined in §1.227)

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This Article is For You If…

∆ You produce, pack or pack food that is consumed in the US.

∆ Your food product enters interstate commerce

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Table of Contents

§117.10 Personnel
§117.20 Plants and Grounds
§117.35 Sanitary Operations
§117.37 Sanitary Facilities and Controls
§117.40 Equipment and Utensils
§117.80 Processes and Controls
§117.93 Warehousing and Distribution
§117.95 Holding and Distribution of Human Food Byproducts for Use as Animal Food
§117.110 Defect Action Levels
Exemptions

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References

FDA Regulations on cGMPS

These requirements are a part of the Current Good Manufacturing Practices that relates to Equipment and Utensils You can see the full guide to cGMPs here

Equipment Requirements

• Equipment and utensils must be designed to be cleanable and maintained to avoid contamination.

• Equipment and utensils must not contaminate food with lubricants, metal fragments, water, etc.

• Equipment must be installed in a way that they can be cleaned and maintained.

• Equipment kept in food areas must be constructed so it can be kept clean -- even if it doesn’t contact food.

• Machinery must be designed in a way that can be kept clean

• Each freezer and refrigerator must have a thermometer in it.

• pH meters, thermometers, and other measuring devices must be accurate.

• Compressed air must be treated in a way that it does not contaminate food.
  

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Food Contact Surface Requirements

• Food-contact surfaces must be corrosion-resistant.

• Food-contact surfaces must be non-toxic

• Food-contact surfaces must be maintained to protect food from allergen cross-contact

• Seams on food-contact surfaces must be seamless to minimize accumulation of particles.

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References

Guide to Current Good Manufacturing Practices (117 Subpart B)

This Article is For You if…

∆ Your business is regulated by the FDA

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

∆ You use equipment and utensils in your operation

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