FDA Reader
Simplifying Food Regulation

Blog

FDA Reader: Simplifying Food Regulation

Posts tagged corrective action
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


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