FDA Reader
A Food Industry Guide to the FDA

Blog

A Food Producer's Guide to FSMA and FDA Regulation
Posts tagged food safety and modernization act
Record Keeping

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

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


Resources

FDA Regulation On Record Keeping

FDA Regulation On Record Keeping


More About Food Safety Plans

More Posts


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.