Food Safety
search
Ask Food Safety AI
cart
facebook twitter linkedin instagram youtube
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Food Safety
  • NEWS
    • Latest News
    • White Papers
  • PRODUCTS
  • TOPICS
    • Contamination Control
    • Food Types
    • Management
    • Process Control
    • Regulatory
    • Sanitation
    • Supply Chain
    • Testing and Analysis
  • PODCAST
  • EXCLUSIVES
    • Food Safety Five Newsreel
    • eBooks
    • FSM Distinguished Service Award
    • Interactive Product Spotlights
    • Videos
  • BUYER'S GUIDE
  • MORE
    • NEWSLETTERS >
      • Archive Issues
      • Subscribe to eNews
    • Store
    • Sponsor Insights
    • ASK FSM AI
  • WEBINARS
  • FOOD SAFETY SUMMIT
  • EMAG
    • eMagazine
    • Archive Issues
    • Editorial Advisory Board
    • Contact
    • Advertise
  • SIGN UP!

FSMA

Why Documentation is Vital to FSMA Compliance

With FDA inspections underway, you’ll want to be sure your plant is following rules and regulations.

By Dr. Elis Owens
Birko
If an FDA inspector shows up at your plant, they will ask for documentation and, if it wasn’t documented, it’s as if it never happened. Plus, if you fail to produce the right records, the FDA could shut down production. Source: Birko
May 31, 2018

The Food Safety Modernization Act (FSMA) has many fresh-cut and produce processors examining the ways they’re handling food safety. With FDA inspections underway, you’ll want to be sure your plant is following rules and regulations.

Nearly as important as doing the right things is documenting the who, what, when and where of your food safety processes. If an FDA inspector shows up at your plant, they will ask for documentation and, if it wasn’t documented, it’s as if it never happened. Plus, if you fail to produce the right records, the FDA could shut down production.

Where to Start

The first step is to identify which of the five FSMA rules you are expected to follow:

  1. The Produce Rule: Applies mainly to farms handling raw agricultural commodities.
  2. Preventive Controls Rule for Human Food: For food production taking place outside of a farm.
  3. Preventive Controls Rule for Animal Food: Analogous to the human rule.
  4. Foreign Supplier Verification Program: For vendors of imported food products.
  5. Sanitary Transportation Rule: Applies to producers that ship food products.

FSMA also requires that each facility designate a Preventive Controls Qualified Individual (PCQI) who has gone through proper training to develop and oversee their food safety programs. The person in this role is ultimately responsible for outlining, managing and documenting a facility’s all-encompassing food safety plan. Smaller facilities may use an external consultant

Developing and Documenting Your Food Safety Plan

When developing a food safety plan, it is essential to examine both your products and processes. What are the food safety risks at each stage? What preventive controls are required? How will you validate and document the efficacy of those controls?

While FSMA rules do not tell you specifically what to do, or how to do it, they do spell out compliance standards. Your plant must determine the best ways to get in compliance.

There are many things to consider as you develop a food safety plan. You’ll need to include the details of your Sanitation Standard Operation Procedures (SSOP) as well as how specific preventive controls are carried out in your plant.

The various processes to outline in your plan include but are not limited to:

  • Details of environmental monitoring and microbiological testing
  • Standardized recall plans
  • Sanitation schedules
  • Detailed cleaning instructions
  • Pest control management
  • Control of employee traffic
  • Hand sanitation protocols
  • Temperature controls

The food safety plan could be in a large binder full of hard copies, or it could be an electronic file, but you must be able to produce a consolidated plan when the FDA asks for it.

Looking for quick answers on food safety topics?
Try Ask FSM, our new smart AI search tool.
Ask FSM →

After documenting the details, you must also be able to produce records proving these standards are being followed. For example, if your environmental monitoring plan calls for 15 samples a day, you should have the ability to show that 15 tests are actually being taken daily, along with your justification that shows why that is an adequate number of samples.

Working towards FSMA compliance can seem overwhelming, but the stakes for failing an inspection are high. To help make documentation easier, fresh-cut and produce processors should consider sanitation automation solutions that provide reporting. Reaching out to food safety experts for consultation and guidance can also help you develop an effective plan.

For more information, visit BirkoCorp.com. Dr. Elis Owens is Birko’s director of technical services and can be reached at eowens@birkocorp.com or 303-289-1090.

 

KEYWORDS: produce

Share This Story

Elis owens 200x200
Dr. Elis Owens is the director of technical services at Birko Corp., Henderson, Colo.

Recommended Content

JOIN TODAY
to unlock your recommendations.

Already have an account? Sign In

  • people holding baby chicks

    Serovar Differences Matter: Utility of Deep Serotyping in Broiler Production and Processing

    This article discusses the significance of Salmonella in...
    Methods
    By: Nikki Shariat Ph.D.
  • woman washing hands

    Building a Culture of Hygiene in the Food Processing Plant

    Everyone entering a food processing facility needs to...
    Management
    By: Richard F. Stier, M.S.
  • graphical representation of earth over dirt

    Climate Change and Emerging Risks to Food Safety: Building Climate Resilience

    This article examines the multifaceted threats to food...
    Risk Assessment
    By: Maria Cristina Tirado Ph.D., D.V.M. and Shamini Albert Raj M.A.
Manage My Account
  • eMagazine Subscription
  • Subscribe to Newsletters
  • Manage My Preferences
  • Website Registration
  • Subscription Customer Service

More Videos

Sponsored Content

Sponsored Content is a special paid section where industry companies provide high quality, objective, non-commercial content around topics of interest to the Food Safety Magazine audience. All Sponsored Content is supplied by the advertising company and any opinions expressed in this article are those of the author and not necessarily reflect the views of Food Safety Magazine or its parent company, BNP Media. Interested in participating in our Sponsored Content section? Contact your local rep!

close
  • This image displays a multi-stage water filtration system designed to remove contaminants from drinking water.
    Sponsored byWaterdrop Filter

    The 4.0 ppt Era: Future-Proofing Your Food Supply Chain Against "Forever Chemicals"

  • The image displays a bottling plant production line, commonly used in the beverage industry for filling and packaging soft drinks.
    Sponsored byBIOIONIX

    Sustainability with ROI: A Beverage Producer Case Study in Water Savings

  • factory
    Sponsored byIFC

    A Clean Break to Reset the Environment with Chlorine Dioxide

Popular Stories

workers and inspector in processing facility

Gearing Up for an FDA Inspection

woman looking at box of packaged food in grocery store seeming pensive

RFK Jr. Says Federal Ultra-Processed Foods Definition is Coming in April

magnifying glass hovering over question mark on yellow background

FDA Redacts All Key Details in Summary of Fatal Listeriosis Outbreak Linked to Produce

Events

March 26, 2026

Continuous Pathogen Control: Enhancing Sanitation and Environmental Monitoring in Food Processing

Live: March 26, 2026, at 2:00 pm EST: This session explores the role of continuous airborne pathogen control technology in supporting sanitation and environmental monitoring programs within food processing environments.

March 31, 2026

Regulatory Risk, Ingredient Safety, and GRAS: What Companies Need to Act on Now

Live: March 31, 2026, at 11:00 am EDT: From this webinar, attendees will recognize patterns in food policy affecting dietary guidelines, UPFs, state legislative actions, and expected GRAS reform.

April 8, 2026

Foreign Material Contamination: Why In-Line Reinspection Isn't Enough

Live: April 8, 2026, at 11:00 am EDT: From this webinar, attendees will learn why re-inspecting with in-line equipment is not sufficient when it comes to potential foreign material contamination.

View All

Products

Global Food Safety Microbial Interventions and Molecular Advancements

Global Food Safety Microbial Interventions and Molecular Advancements

See More Products

Related Articles

  • Birko Elis Owens

    FSMA compliance and the cold food industry: Risks, challenges, solutions

    See More
  • warehouse worker checking pallets of onions

    Why Staying the Course on FSMA Rule 204 is a Strategic Advantage for Forward-Looking Food Companies

    See More
  • TOMRA Sorting Bjorn Thumas

    Why sorting technology is crucial to enhanced sustainability

    See More

Related Products

See More Products
  • 9781138198463.jpg

    Food Safety Management Programs: Applications, Best Practices, and Compliance

  • 1119258073.jpg

    FSMA and Food Safety Systems: Understanding and Implementing the Rules

  • 0813808774.jpg

    Improving Import Food Safety

See More Products

Related Directories

  • ComplianceMate

    A patented combination of wireless temperature sensors and automated checklists that track and improve operational efficiencies and food safety compliance. Provides total control over workflows and data in all types of foodservice establishments. See rapid ROI from significant labor and food waste savings, as well as improved audit scores.
  • ETQ, part of Hexagon

    ETQ Reliance is the world’s most flexible, powerful & easy-to-use advanced Quality Management System. Automate & standardize all aspects of quality, from document control, training, CAPA, audits, supply chain & more. Benefit from improved compliance, enhanced reputation, reduced costs, speed to market & visibility into your supply chain.
×

Never miss the latest news and trends driving the food safety industry

Newsletters | Website | eMagazine

JOIN TODAY!
  • RESOURCES
    • Advertise
    • Contact Us
    • Directories
    • Store
    • Want More
  • SIGN UP TODAY
    • Create Account
    • eMagazine
    • Newsletters
    • Customer Service
    • Manage Preferences
  • SERVICES
    • Marketing Services
    • Reprints
    • Market Research
    • List Rental
    • Survey/Respondent Access
  • STAY CONNECTED
    • LinkedIn
    • Facebook
    • Instagram
    • X (Twitter)
  • PRIVACY
    • PRIVACY POLICY
    • TERMS & CONDITIONS
    • DO NOT SELL MY PERSONAL INFORMATION
    • PRIVACY REQUEST
    • ACCESSIBILITY

Copyright ©2026. All Rights Reserved BNP Media.

Design, CMS, Hosting & Web Development :: ePublishing