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

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Resources

FDA Regulation on Corrective Actions

Corrective Action Template

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What You Need to Know

• 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

Resources

FDA Regulations: Part 117 -- Subpart F (Record Keeping)

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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.

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.

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§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)

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§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.

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§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.

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§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.

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§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

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§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

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§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.

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§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.

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§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.

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§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.

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§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.

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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)

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

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.

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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

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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.

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This Article is For You if…

∆ You purchase ingredients or packaging from another company

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