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Introduction to Record Keeping

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

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.



 
 

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


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

Resources

FDA Regulation On Record Keeping

FDA Regulation On Record Keeping


More About Food Safety Plans

More Posts


Facility Requirements

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.


Plant Construction and Design

20180711_115335.jpg

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)


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


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…

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

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


More About Operating Requirements

More Posts


References

Guide to Current Good Manufacturing Practices (117 Subpart B)

Guide to Current Good Manufacturing Practices (117 Subpart B)

Processes and Controls

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

Processes and controls.png

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.


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)

 
Personnel Requirements in Food Processing Spaces

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

Personnel Requirements

adult-business-container-1267312.jpg

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


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

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


More About Operating Requirements

More Posts


References

Guide to Current Good Manufacturing Practices (117 Subpart B)

Guide to Current Good Manufacturing Practices (117 Subpart B)

Requirements for FDA Food Producers
Requirements for FDA Food Producers.jpg

Introduction

Great! You have already confirmed that your business is regulated somehow by the FDA

The easiest way to understand what regulations apply to your business is to identify what kind of food you make.

Some foods are subject to special requirements. If your business produces one of the food types below, click the link to learn about their special requirements. Otherwise, keep reading

Do you make one of these specially regulated foods?

If you make one of these foods, check out our section on Specially Regulated Foods 
Otherwise, your product likely falls under Part 117 (See Below)


Part 117 Overview

If you are producing human food, then you are most likely governed under Title 21 -- Chapter 1 -- Subchapter B -- Part 117.  This section contains the majority of requirements for typical food producers.

What You Need To Know To Be FDA Compliant:

Everything a food producer needs to know is located in Subpart B. To find exactly what you're looking for, read the sections below:

Subpart B -- Current Good Manufacturing Practices: This contains Requirements for Facilities, Employees, and Sanitation.
     Guide to Subpart B

Subpart C -- Hazard Analysis and Risk Based Preventive Controls: This section outlines the requirements for a Food Safety Plan and other requirements related to the implementation of preventive controls.
    Guide to Subpart C

Subpart F -- Requirements Relating to Records that Must Be Established and Maintained: This section dictates the record keeping requirements for food businesses. 
     Guide to Subpart F

Subpart G -- Supply-Chain Program: This section outlines the requirement for verifying supplier partners and documenting this process.
Guide to Subpart G

Other Parts of 117:

These sections relate to a minority of food processors. In case you are interested, I have linked them below:

Subpart A -- General Provisions:This section contains definitions, exemptions, and the training requirements for employees working in a food production space.
Source Text: Title 21 -- Chapter 1 -- Subchapter B -- Part 117 -- Subpart A: General Provisions

Subpart D -- Modified Requirements: This section describes modified requirements that apply to Qualified Facilities and Storage Facilities.
Source Text: Title 21 -- Chapter 1 -- Subchapter B -- Part 117 -- Subpart D: Modified Requirements

 Subpart E -- Withdrawal of  a Qualified Facility Exemption: This section describes how a business would transition from being exempt to provisions of the code to non-exempt status. This only applies to businesses who previously but no-longer apply for the Very Small Business Exemption
Source Text: Title 21 -- Chapter 1 -- Subchapter B -- Part 117 -- Subpart E: Withdrawal of a Qualified Facility Exemption

 
Sanitary Operations in Food Processing Facilities

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

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.

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.


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

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

∆ You want to understand cleanliness standards for your space.


More About Operating Requirements

More Posts


References

Guide to Current Good Manufacturing Practices (117 Subpart B)

Guide to Current Good Manufacturing Practices (117 Subpart B)

Part 117 Subpart B: Current Good Manufacturing Practices

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)



 
Equipment and Utensils

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.


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.


References

Guide to Current Good Manufacturing Practices (117 Subpart B)

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


More About Operating Requirements

More Posts