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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


Validation

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.


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.


 
 

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


FDA Regulation on Validation


More About Food Safety Plans

More Posts


Verification

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.


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).


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)


 
 

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


Resources

Verification Log Template

Verification Log Template

FDA Regulation on Verification

FDA Regulation on Verification


More About Food Safety Plans

More Posts


Corrective Action

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)


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)


 
 

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

FDA Regulation on Corrective Actions

Corrective Action Template

Corrective Action Template


More About Food Safety Plans

More Posts


Monitoring

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.


Resources

FDA Regulation on Monitoring Preventive Controls

FDA Regulation on Monitoring Preventive Controls

 
Preventive Controls

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.


 
 

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)


Resources

Food Safety Plan Templates

Food Safety Plan Templates


More About Food Safety Plans

More Posts


References

Hazard Analysis

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

Hazard analysis Post Thumbnail.png

What you need to know:

  • A hazard analysis is the process of identifying all of the hazards present in your process that could potentially cause a customer injury.

  • Creating a Hazard Analysis is the first step in developing a food safety or HACCP plan.

  • You can read the requirements below or just use our self-guided hazard analysis template

Requirements for a Hazard Analysis:

  1. You must conduct a hazard analysis for each type of food manufactured, processed, packed, or held at your facility.

  2. Your hazard analysis must be written.

Steps in Creating a Hazard Analysis

1. Download our Hazard Analysis Template

It’s available for free here, and it will be much easier if you can follow along.

Example Process Flow - Each box corresponds to a process step.

Example Process Flow - Each box corresponds to a process step.

2. Identify the steps in your process from start to finish.

It’s important that you have every step in your process identified so that you don’t miss anything in your hazard analysis. Often, it’s easiest to conduct a process flow diagram to identify all of the steps in your process.

3. Conduct a Hazard Identification:

In this step, you review all of your process steps and identify if there are any hazards present at each step. For each step, you will consider 3 types of hazards:

  • Biological Hazards (bacteria, parasites, etc.)

  • Chemical hazards (i.e. toxins, pesticides, food allergens)

  • Physical hazards (i.e. stone, glass, metal fragments)

Your hazard identification should also include hazards that could be present in the food because:

  • The hazard occurs naturally (i.e. toxins in fish)

  • The hazard may be accidentally introduced (jewelry from employee falls into food)

  • The hazard may be introduced intentionally for economic gain (i.e. sabotage by a competitor)

4. Conduct Hazard Evaluation

The hazard evaluation is the last step in creating your Hazard Analysis. Here, you must evaluate each hazard that you identified to assess the probability that it would occur if left unaddressed.

If the probability is high that this hazard would cause an injury if unaddressed, then you must implement a “preventive control”.

You also must consider the effects of these things in your hazard evaluation.

  • Formulation of the food

  • Condition and design of the facility

  • Raw materials and other ingredients

  • Transportation practices

  • Processing procedures

  • Packaging and labeling activities

  • Storage and distribution

  • Intended use of the product

  • Sanitation, including employee hygiene

  • Any other relevant factors (i.e. weather, natural toxins)

  • Environmental pathogens whenever a ready-to-eat (RTE) food is exposed to the environment before packaging.


 
 

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


Resources

Hazard Analysis Template

Hazard Analysis Template


More About Food Safety Plans

More Posts


References

117 Subpart G: Supply Chain Program
Truck Supply Chain.png

What You Need To Know

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

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

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

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

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


Applicability & Exemptions

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

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

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

Exemptions:

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

  1. No hazards requiring a supply chain applied control exist

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

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

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

  5. The supplier is a "very small business"


What You Need to Do:

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

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

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

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

  5. Only use approved suppliers


What You Need to Have on File:

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

  • An explanation of how you approve suppliers

  • A list of approved suppliers

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

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

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

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

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

Summary of §117 Subpart G

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

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

117.405 Requirement to Establish and Implement a Supply-Chain Program

a. 

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

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

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

i. May not be sold or given to the public

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

iii. Is supplied in small quantity and disposed of.

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

b. The supply-chain program must be written.

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

  1. verify the control themselves

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

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

a. The supply-chain program must include:

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

  2. The determination of appropriate supplier verification activities

  3. Conducting supplier verification activities

  4. Documenting supplier verification activities

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

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

  1. Onsite audits

  2. Product sampling

  3. Review of suppliers food safety records

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

d. 

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

i. The nature of the hazard

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

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

iv. Storage and transportation practices

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

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

117.415 Responsibilities of the Receiving Facility

a. 

1. the receiving facility must approve suppliers

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

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

i. establish procedures for receiving raw ingredients

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

iii. Determine and conduct supplier verification activities

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

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

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

  2. An audit conducted by the supplier

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

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

§117.420 Using Approved Suppliers

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

b. Written procedures for receiving raw materials and other ingredients 

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

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

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

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

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

b.

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

i. the appropriate supplier verification activity is an onsite audit

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

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

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

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

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

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

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

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

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

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

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

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

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

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

§117.435 Onsite Audit

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

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

c.

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

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

ii. Inspection results from an overseas FDA equivalent.

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

§117.475 Records Documenting the Supply Chain Program

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

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

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

  1. Written supply chain program

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

  3. Documentation of the approval of that supplier

  4. Written procedures for receiving raw materials and ingredients.

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

  6. Documentation of the approval of the supplier

  7. Documentation of an onsite audit, including:

i. the name of the supplier being audited

ii. documentation of audit procedures

iii. dates of the audit

iv. conclusion of the audit

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

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

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

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

ii. Identification of test conducted including the analytical methods.

iii. Dates of the tests

iv. Test results

v. Corrective actions taken in response to the testing

vi. Information identifying the lab conducting testing

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

i. The name of the supplier

ii. Dates of the record review

iii. General nature of the records review

iv. Conclusions of the review

v. Corrective actions taken in response to deficiencies found.

10. Documentation of other supplier verification activities conducted.

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

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

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

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

15. The written results of an inspection of the supplier

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

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

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

 
117 Subpart F: Record Keeping

What You Need to Know

Record Keeping Blog Image.png
  • Records can be electronic or paper.

  • They must have:

    • Plant name / address

    • The date/time

    • Product name

    • Signature/initials

    • Actual information/observations not summaries

  • You must store records onsite for at least 2 years

  • You must be able to retrieve records within 24 hours.

  • All records must be made available upon request

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

Summary of Subpart F: Record Keeping

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

This text is aligned with the coding used in the FDA Regulations so that you can hunt down the corresponding section with ease. For example,  you have a question about my wording in §117.305 (f) (2) then just look up this same code in the CFR.

§117.301 Records Subject to the Requirements of this Subpart

This section quickly states two points, neither of which are terribly important:

  1. Only the food safety plan must be dated and signed when created and updated.

  2. If a business is applying for a small business exemption (aka "Qualified Facility exemption") the standards for those records is less than what is described in this section.

§117.305 General Requirements Applying to Record

Records must:

a. Be kept as originals, true copies (i.e. scans, photocopies) or electronic records.

b. Contain the actual values and observations, not summaries.

c. Be accurate, unchangeable and legible

d. be created in real-time with the activity being documented.

e. Be as detailed as necessary

f. Include:

  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

g. Electronic records required by other regulations may be subject to the requirements in Part 11 (This is the FDA section about electronic records, it unlikely applies to your business if you are following this statute)

§117.310 Additional Requirements Applying to the Food Safety Plan

The owner or operator of the plant must sign and date the food safety plan when it is first authored and whenever it is modified.

§117.315 Requirements for Record Retention:

a.

  1. All records must be retained onsite for 2 years

  2. A qualified facility must retain records attesting to their exempt status.

a. Small businesses operating under a Qualified Facility exemption must retain records to support that they apply for the exemption (typically 3 years of records)

b. Records that relate to equipment or processes that are no longer used must be retained for 2 years after their discontinuation.

c. You may store records offsite (not food safety plan) if you can retrieve them within 24 hours.

d. You can store a food safety plan offsite if the plant is closed

§117.320 Requirements for Official Review

All records must be made available upon request

§117.325 Public Disclosure

Your records may be disclosed by the FDA in accordance with Chapter 20 of the CFR

§117.330 Use of Existing Records

a. Existing records used for other purposes don't have to be duplicated to satisfy these requirements.

b. The records don't have to be kept in one set.

§117.335 Special Requirements Applicable to a Written Assurance

Any written assurance (which is required by other parts of the code) must contain the date and the names/signatures of the officials making the attestation.

Part 117 -- Subpart F: Requirements Applying to Records That Must Be Established and Maintained

 
117 Subpart C: Hazard Analysis and Risk-Based Preventive Controls

This is a regulation summary For a more general guide to Food Safety Plans, start here

What You Need to Know:

This section outlines the pre-requisite for a food safety plan and associated operational and documentation requirements.

binding-books-bound-272980.jpg

Summary of Subpart C: Hazard Analysis and Risk-Based Preventive Controls

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

This text is aligned with the coding used in the FDA Regulations so that you can hunt down the corresponding section with ease. For example,  you have a question about my wording in §117.126 (a) (2) then just look up this same code in the CFR.


§117.126 Food Safety Plan

a. Requirement for a food safety plan:

  1. You must have a written and implemented food safety plan

  2. It must be prepared or overseen by a Preventive Controls Qualified Individual

b. Contents of a food safety plan

It must include the following, in writing:

  1. A hazard analysis

  2. Preventive controls (if you identified a hazard in your hazard analysis that you deem requires a preventive control)

  3. Supply chain program

  4. Recall plan

  5. Procedures for monitoring your preventive controls

  6. Corrective Action Procedures

  7. Verification procedures

c. Records: The records generated are subject to regulations under Subpart F. (i.e. you must store them either in print or electronically)

§117.130 Hazard Analysis

a. Requirement for a hazard analysis:

1. You must conduct a hazard analysis for each type of food manufactured, processed, packed, or held at your facility.

2. The hazard analysis must be written.

b. Hazard Identification: This must consider

1. known or reasonable hazards, including:

i. Biological Hazards (bacteria, parasites, etc.)

ii. Chemical hazards (i.e. toxins, pesticides, food allergens)

iii. Physical hazards (i.e. stone, glass, metal fragments)

2. Hazards that could be present in the food because:

i. the hazard occurs naturally (i.e. toxins in fish)

ii. The hazard may be accidentally introduced (jewelry from employee falls into food)

iii. The hazard may be introduced intentionally for economic gain (i.e. sabotage by a competitor)

c. Hazard Evaluation: 

i. the hazard analysis must evaluate the hazards identified to assess the severity of illness or injury that would occur and the probability that it would occur if left unaddressed.

ii. The hazard evaluation must consider environmental pathogens whenever a ready-to-eat (RTE) food is exposed to the environment before packaging.

2. The hazard analysis must consider these effects on the food:

i. formulation of the food

ii. condition and design of the facility

iii. Raw materials and other ingredients

iv. Transportation practices

v. Processing procedures

vi. Packaging and labeling activities

vii. Storage and distribution

viii. intended use of the product

ix. Sanitation, including employee hygiene

x. any other relevant factors (i.e. weather, natural toxins)

§117.135 Preventive Controls

a.

  1. You must identify and implement preventive controls when required by your hazard analysis.

  2. Preventive controls include: Critical Control Points and other controls.

b. Preventive controls must be written

c. Preventive controls include:

  1. 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:

i. 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)

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

2. Food Allergen Controls include processes to control food allergens. These are implemented to:

i. Protect food from allergen cross contact

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

3. Sanitation Controls: Practices to ensure the facility is kept clean and to minimize biological hazards. These relate to:

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

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

4. Supply Chain Controls: This is described fully in Part G

5. Recall Plan: You are required to have a recall plan (see below)

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


§117.136 Circumstances in which preventive controls are not required

a. Circumstances 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)

  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.

b. Records: You must document any circumstance (related to a., above) that applies to you, including written assurances from customers.


§117.139 Recall Plan

If your food has a hazard that requires a preventive control,

a. You  must establish a written recall plan.

b. The recall plan must include a procedure for a recall scenario and assign responsibility for taking those steps. It must address how to:

  1. Directly notify recipients of the product being recalled and how to dispose of/return the food.

  2. Notify the public about any hazard in the food, when this is required to protect public health.

  3. Conduct effectiveness checks to verify the recall is carried out.

  4. Dispose of recalled food.


§117.140 Preventive Control Management Components

a. You must conduct the following activities for each of your preventive controls:

  1. monitoring activities

  2. corrective actions

  3. verification activities

b. You must conduct the following activities for your supply-chain program:

  1. corrective actions, especially related to supplier non-conformance.

  2. Review of records

  3. Re-analysis of your supply chain program over time and as it changes.

c. You do not need to conduct the following activities for your recall plan: monitoring, corrective actions, verification activities.


§117.145 Monitoring

as appropriate to the nature of the preventive control, you must implement

a. Written Procedures: You must have written procedures for how and how often you will monitor preventive controls.

b. Monitoring: You must monitor preventive controls enough to ensure they are being peformed.

c. Records: 

  1. You must document your monitoring actions and verify this (see §117.165)

  2. Exception Records: You can use exception records (i.e. the record only shows when a deviation occured.) For example, a log monitoring refrigeration may only show records when the temperature is unacceptable


§117.159 Corrective Actions and Corrections

a. Corrective Action Procedures: 

  1. You must establish and implement written corrective action procedures. They must address:

i. the presence of a pathogen in a ready-to-eat product

ii. the presence of an environmental pathogen detected.

2. Corrective Action Procedures must describe the steps to be taken to ensure that:

i. appropriate action is taken to correct a problem associated with a preventive control.

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

iii. All affected food is evaluated for safety

iv. All affected food is prevented from entering commerce.

b. Corrective Action in the Event of an unanticipated food safety problem:

  1. You must follow the procedure in (b)(2) if

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

ii. a preventive control is found to be ineffective

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

2. If any of the circumstances above in (b) (1) apply, you must:

i. Take corrective action, Ensure it doesn't happen again, re-evaluate all food for safety.

ii. reanalyze your food safety plan to see if changes are required.

c. Corrections: You don't need to follow sections (a) and (b) above if

  1. You take action to correct a minor and isolated problem, insofar as these are not related to allergen controls or sanitation controls.

  2. You take action in a timely manner to correct a minor and isolated problem insofar as it doesn't directly impact product safety

d. Records: All corrective actions taken in this section must be documented. Corrective actions must also be verified according to §117.155


§117.155 Verification

Note: The Verification process is one that verifies various other parts of the plans have been undertaken as specified. This can take the form of a supervisor regularly reviewing records and verifying them with a signature.

a. Verification Activities: As it relates to a preventive control, you must verify

  1. That the preventive control is valid

  2. that monitoring is being conducted as required.

  3. that appropriate decisions are being made in relation to corrective action.

  4. that the preventive control is implemented and effective.

  5. the reanalysis of your preventive controls (as your process changes or at minimum every 3 years)

b. Documentation: All verification activities must be documented in records.

§117.160 Validation

a. You must validate that the preventive controls implemented actually work.

b. Your validation must:

1. Be performed by a Preventive Controls Qualified Individual (PCQI)

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

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

iii. Whenever the food safety plan is reanalyzed.

2. Must include scientific and technical evidence (or conducting your own studies) to determine whether preventive controls will control the hazards.

c. You do not need to validate:

  1. Food allergen controls

  2. Sanitation controls

  3. Recall plan

  4. Supply chain program

  5. 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.


§117.165 Verification of Implementation and Effectiveness

a. Verification Activities: You must verify that preventive controls are consistently implemented and effective. This includes doing the following:

  1. Calibrating instruments for accuracy

  2. Product testing

  3. Environmental monitoring

  4. Review of records to ensure they are complete and activities were performed according to the plan

i. Records of monitoring and corrective action must occur within 7 days (or provide a written justification for why not)

ii. Other records (calibration, supplier, product testing) must occur in a reasonable amount of time.

b. Written Procedures: The following activities must be written:

  1. The method and frequency of calibrating tools

  2. Product testing. These procedures must be scientifically valid, they must identify the tests conducted, the methods used, the pathogens, the laboratory conducting the testing, and the corrective action procedures.

  3. Environmental monitoring must be: scientifically valid, identify the locations and sites to be tested, the timing and frequency of these samplings, the tests conducted and methods used, the laboratory, and the corrective action procedures.


§117.170 Reanalysis

a. You must reanalyze your food safety plan every 3 years.

b. You must reanalyze your plan whenever:

  1. A change creates a new hazard or increases an existing hazard

  2. Whenever you become aware of a new hazard

  3. Whenever appropriate after an unanticipated food safety problem.

  4. When you find a part of your plan or a preventive control is ineffective

c. You must complete the reanalysis

  1. before any changes in activities OR

  2. Within 90 days of the beginning of production for a new product (or >90 days if written justification is provided)

d.  You must also document the basis for the conclusion that no revisions are required.

e. A preventive controls qualified individual must oversee this reanalysis.

f. You must conduct a reanalysis when the FDA determines necessary and when there are new developments in scientific understandings.


§117.180 Requirements Applicable to a Preventive Control Qualified Individual and a Qualified Auditor

a. One or more PQCI must do or oversee the following:

  1. preparation of the food safety plan

  2. validation of the preventive controls

  3. written justification for >90 day time frame for validation

  4. Determination that validation is not necessary.

  5. Review of records

  6. Written justification for exceeding 7 day time frame for reviewing records.

  7. reanalysis of food safety plan

  8. determination that reanalysis can be completed in a time frame that >90 days of the production of the new food being produced.

b. A qualified auditor must consult an onsite audit:

c. 

  1. To be a PCQI, one must have completed training equivalent to that developed by the FDA or be qualified through job experience. This individual may or may not be an employee of the facility.

  2. To be a qualified auditor requires technical expertise achieved through training, education, or experience.

d. All training in the development and applications of preventive controls must be documented in records.


§117.190 Implementation Records Required for this Subpart

a. You must establish records regarding the implementation of a food safety plan, including:

  1. Documentation for not establishing a preventive control (you can do this in the hazard analysis using our template)

  2. Records documenting the monitoring of preventive controls

  3. Records documenting corrective actions

  4. Records that document verification, as related to

i. Validation

ii. Verification of monitoring

iii. Verification of corrective actions

iv. Calibration of process monitoring and verification instruments

v. Product testing

vi. Environmental monitoring

vii. Records review

5. Records documenting the supply chain program

6. Records documenting training for the Preventive Conrols Qualified Individual and qualified auditor.

b. These records are subject to requirements in subpart F.


 
 

This Article Is For You If…

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

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

More About Food Safety Plans

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Resources

FDA Regulation Title 21 — Part 117 — Subpart C Hazard Analysis and Risk-Based Preventive Controls

FDA Regulation Title 21 — Part 117 — Subpart C Hazard Analysis and Risk-Based Preventive Controls

Food Defense and Intentional Adulteration

What You Need to Know:

  • "Intentional Adulteration" refers to the risk of someone deliberately contaminating a food product with aim of causing harm.

  • The Intentional Adulteration Rule was implemented to address bio-terrorism threats committed against food companies to contaminate the US food supply.

  • It applies to some, but not all food businesses (see "Applicability" below)

  • You can fulfill the requirements for a Food Defense Plan using our template

Applicability:

Does the  Final Rule on Intentional Adulteration  Apply to you?

Does the Final Rule on Intentional Adulteration Apply to you?

If you are a business under FDA regulation with >$10m/year in sales, then you most likely are required to comply with the Intentional Adulteration Rule.

Check the exemptions below and, if they do not apply to your businesses, see "What You Need to Do?"

Exemptions from the Intentional Adulteration Rule:

See if one of the following exemptions applies to your business or check out the applicability flowchart below


Does the Intentional Adulteration Rule Apply to My Business?

  • Food businesses that are not regulated by the FDA and aren't required to register as a food facility.

  • Small food businesses that produce, distribute, or hold less than $10 million dollars in product retail value per year, averaged over the last 3 years.

  • Food businesses that exclusively produce one of the following:

    • Licensed alcoholic beverage producers

    • Animal-food producers

    • Food which is packed, re-packed, or re-labeled food in a way that the container around the food remains intact.

    • Food businesses that only hold food, such as a distributor (unless the food is held in large liquid storage tanks).

    • Certain foods packaged on farms (See 21 CFR 121.5)

The FDA offers a flow chart to determine if the Rule on Intentional Adulteration applies to your food business.

Compliance Timeline:

Large Businesses (>500 Employees): July 26th, 2019

Small Businesses (< 500 employees): July 27th, 2020


What You Need To Do:

Access our Free Food Defense Plan Template

If you are required to follow the Intentional Adulteration Rule, then you must develop a Food Defense Plan. This plan documents that you have developed and implemented the following activities:

  1. Conduct a "vulnerability assessment" to identify where your business is vulnerable

  2. Develop "mitigation strategies" for addressing food defense threats.

  3. Monitor your mitigation activities to make sure they're working

  4. Develop corrective actions for when things go wrong

  5. Conduct verification checks

  6. Maintain records

  7. Re-analyze your food defense as necessary

1. Conduct A Vulnerability Assessment

This is a written assessment of what areas your facility and product might be at risk to a threat of intentional adulteration. You should evaluate the following:

  • The potential impact if your product was contaminated

  • The degree of access available to your product

  • The ability of an attacker to contaminate your product

  • The possibility of an inside attacker.

The easiest way to conduct a vulnerability assessment, is to use our Food Defense Plan Template and modify it to suit your business' needs.

Source 21 CFR 121.130

2. Develop Mitigation Strategies

If you identify a vulnerability in your business, then you must address it. Your mitigation strategies could include:

  • Upgrading security around your facility (i.e. adding fencing, upgrading locks, reducing access)

  • Developing a way to record and manage visitors in your facility.

  • Minimizing access to sensitive areas to only the people who require that access.

  • Changing how you store in-process product

  • Upgrading your packaging to minimize opportunity for contamination.

This section must include a written explanation of how your strategy specifically minimizes the risk(s) that you identified in your vulnerability assessment.

3. Monitor Your Mitigation Strategies

You must monitor your food defense efforts to verify that they're effective.

Some of your mitigation strategies may be a simple structural fix (i.e. fencing the facility grounds) while others may require ongoing management (implementing a visitor-access policy).

The strategies that require ongoing maintenance should be monitored to ensure that they are effective. For example, if you implement a visitor-access policy for your facility, then a supervisor should occasionally monitor that guests are wearing the required badge and that the sign-in document that you developed is actually being used.

How often must I monitor my mitigation strategies?

This is your choice. You should monitor your practices which support food defense enough to ensure that they're being performed effectively.

Do I need to keep records of my monitoring?

Yes. All of your monitoring efforts should be recorded. You can do this by keeping "exception records" where the only records kept are to document when the strategy is not working.

4. Develop Corrective Actions For When Things Go Wrong

You must have written corrective action procedures that will guide you in what to do if one of your mitigation strategies fails.

For example, let's pretend your visitor-access policy requires all guests to be checked-in and wear a badge in the processing space. When you develop that food defense strategy, you should also create a corrective-action to answer the question "What do we do if there is an unauthorized person in the production space?". Your corrective action could be registering the visitor and reviewing security footage prior to releasing the product that was being processed.

If something goes wrong in your food defense procedures, you must document that a corrective action was taken and how the problem was solved. Store this in your records.

Additionally, if take a corrective action to address a failure then you must also take action to ensure that the same failure does not recur.

5. Conduct Verification Checks

You must conduct verification activities to confirm that your mitigation strategies are being carried out effectively. This is a "double check" to make sure everything is happening according to plan.

Specifically, you must verify that monitoring is effective and that your corrective actions were taken appropriately. This verification can take the form of a manager reviewing the records that were taken during a given time-period and signing off on them.

A manager may conduct verification on the facility's visitor-access policy by reviewing the visitor registration sheet each week to ensure that it is being used.

How often must I conduct verification checks?

This is up to you. Verification should occur often enough that you can make adjustments if something is found to be wrong. For example, records are typically verified before the relevant product leaves the facility. This way, the product can be inspected or reconsidered if the verification reveals something improper occurred.

Do verification activities need to be written?

Yes. However, it does not need to be a separate form. A manager can verify a document by signature and date showing that the document was reviewed and that verification occurred.

6. Keep Records

Your Food Defense Plan must be written and on file. Additionally, you should keep records of the following for at least 2 years:

  • Monitoring records

  • Corrective Action records

  • Verification Records

  • Any documents related to the food defense plan

  • When your food defense plan was changed or updated

Your records should meet the requirements outlined in Part 117 Subpart F: Record keeping

7. Reanalyze Your Food Defense As Necessary

You must reanalyze your food safety plan:

  • Every 3 years at minimum

  • Whenever a change is made that might expose a new vulnerability or increase your risk of intentional adulteration.

  • If the FDA identifies new vulnerabilities that they deem relevant to your business.

If your business makes a change that requires an adjustment to your food safety plan, you have 90 days to update your plan and implement the new strategies.


 
Digital vs. Paper Record keeping in a Food Processing Environment

I am often asked by food producers whether they should convert their record-keeping to a digital entry process. I always respond by asking them why do you want to do this?

It seems like a natural change, that adopting digital record keeping in food production is a natural transition as an operation matures.  Actually, digital logs aren’t always better than paper logs.

I implemented a fleet of iPads and digital logs in my own commissary, only to return to pen-and-paper record keeping when I struggled with accountability and completeness.

record keeping paper or digital Blog Post Thumbnail (1).png

Digital Logs:

Pros

  • Can be accessed via tablet in the production space.

  • Updates can be rolled out seamlessly (i.e. sent to the iPad remotely).

  • Past records are accessible anywhere: simply print out a copy.

Cons

  • Technology inevitably gets complicated. iPads must be charged, housed, sterilized, and updated.

  • Missing entries are more difficult to see when records are housed digitally

  • They are easy to fabricate

  • Requires a substantial setup and training to implement

  • Often requires proprietary or expensive software

  • Expensive hardware


Paper Logs:

Pros:

  • They’re stupid simple.

  • They are harder to fabricate and missing entries are easy to spot

  • Simple technology means zero training

  • They are cheap to implement (printer access + clipboards + pencils)

Cons:

  • Paper records can get lost and are lost forever.

  • They require manual updating: printing new sheets and setting them around the production facility.

  • Requires a paper filing system for storage.

So Where Should I start?

Here’s my advice: start with paper logs. They’re easy to implement and will get you into the habit of record keeping. You will probably change the format of your record keeping materials a lot in the beginning: paper will support this. Once you get comfortable with this and missing entries ease to become a problem, you may consider transferring to digital.

The real benefits of digital record keeping goes beyond eliminating paper copies: seamless integration of technology (bluetooth thermometers! WIFI enabled scales!) will bring an unprecedented level of professionalism and ease to your production process. But to start, I recommend keeping it as simple as possible: pencil and paper.