Subscribe to Email Updates

Quality Creates...Perspective

And So It Begins: New Rules from the FDA on Food Safety Management

Tim Lozier
by Tim Lozier on Fri, Jan 11, 2013

FSMAIt's a new year, and with it comes new and exciting challenges.  Have you ever got that feeling when you come back from vacation and you missed something, then you scour the Internet and speak to colleagues about what you missed, and desperately try to wrap your head around what's going on?  I got that feeling when I jumped into my inbox and saw this:  "FDA Offers Broad New Rules to Fight Food Contamination".  Well, I put my Food Safety Management hat on and started reading - here's what I think:

We've spoken at length on the Food Safety Modernization Act, and often.  While we've seen the makings of something great, it had seemed that things would be held up in bureaucracy and election wrangling, until we knew who was going to be our next President.  With Mr. Obama firmly ensconced in his second term (soon), we are now seeing action on new rules for this FSMA initiative.  Promising news, but what does it all mean?

Rule 1:  Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

Essentially, farmers who are growing produce destined for human consumption will be held to a scientific based standard on various elements on how the food is grown.  This would cover Agricultural Water, Biological Soil Amendments, Health and Hygiene (to prevent contamination), Domesticated Animals, and Equipment and tools.  The idea is that using a risk based analysis coupled with scientific measurements and metrics, growers are required to document and perform analysis on these factors and prove they are maintaining a safe and hazard-free environment.

Technology Options to Support the Rule:  While the details are still proposed (and 547 pages long), the idea is to identify and mitigate any hazards associated with the areas covered above.  Having a well-defined and automated process like HACCP or Risk Assessment can help to ensure these areas are being assessed and mitigated, while providing the documentation required to prove you are being compliant.  Linking these hazards to controls and procedures within a Document Control system will also provide a centralized repository for storing this critical data.  Finally, it is important to implement an Auditing system to regularly audit these processes, and ensure that any hazards and their related controls are still relevant and maintaining the needed compliance.

Rule 2: Preventive Controls for Human Food: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food

This rule is more broad-reaching to all food manufacturers to prevent any food borne illness by implementing preventive controls within their food safety systems.  The primary goal of the rule is to put the HACCP plan in the forefront of the process for food manufacturers.  Organizations are required to document and maintain a written food safety plan that identifies hazards within their process, conduct a risk analysis on those hazards, and implement controls to mitigate the risk of those hazards.  It also calls for a Corrective Action system to be implemented to take action on any adverse events resulting from missed compliance.  This rule is core to the FSMA, and many organizations can benefit from utilizing technology to support this initiative.

Technology Options to Support the Rule:  Food Safety Management Solutions provide a centralized framework for not only organizing and tracking food safety compliance, but also provide a method for impacting the continuous improvement efforts for organizations.  Let's break it down and look at the components of Rule 2, and how technology can help:

  • Hazard Analysis:  By implementing an automated HACCP plan, you can identify and document hazards and automatically link controls and procedures that can be continually reviewed and revised each year.  HACCP is an often overlooked opportunity for automation, but many are moving towards this trend, in order to maintain the hundreds of processes they use in their product portfolio.
  • Preventive Controls and Monitoring:  Not only does this include the processes and controls to prevent hazards, it also requires a recall plan for each product.  Automating the recall process can be a huge benefit to organizations, and an Enterprise Food Safety System is a great way to centralize this effort.
  • Corrective Action:  Any time a control is missed, or there is an adverse event, a corrective action must be issued.  Having an automated, workflow-based system for managing the Corrective Action process enables organizations to launch Corrective Actions directly from the event record, with full traceability from event detection to event correction.
  • Verification:  In order for a Corrective Action to be truly effective, it must reduce the risk of recurrence to acceptable levels.  Within an automated Corrective Action system, the ability to conduct residual Risk Assessments helps to ensure that these hazards are mitigated to acceptable levels.
  • Recordkeeping:  Visibility and transparency is what the FDA is striving for.  Having a system in place for tracking all steps within the Food Safety Management System provides organizations with not only the automation to move through the process more efficiently, but also provides a level of traceability that is easily accessed.  Auditors and Inspectors can come in and see the entire history of an event, with the click of a button.

These rules are the first step in a long process to getting tighter control on food safety within our nation.  What we hope to see in the coming year is a shift towards more standardization of the food safety program, and reforms that put compliance pressure on organizations to protect the consumer.  As we've said before, many organizations are already doing this with the GFSI schemes, and there isn't a gigantic gap between these new rules and what GFSI is already doing.  But this is a statement from the government that there is action being taken, and it sends a message that the consumer is protected when it comes to the overall safety of the food they consume. 

As the FSMA continues to evolve, so too will the need to implement tools and systems that support the various rules within.  Food Safety Management Solutions are there to help streamline these processes, mitigate risks, and improve the overall compliance footprint of the organization.

2013(Ok, now I'm all caught up.)

Free White Paper
Food Safety, From Farm to Fork:
A Best-Practice Approach to Implementing a Food Safety Management SystemFood Safety, From Farm to Fork: A Best-Practice Approach to Implementing a Food Safety Management System

You will learn:
• Best practices needed to successfully implement and automate the FSMS
• How an FSMS can help automate each process in the HACCP plan
• How an automated FSMS can help stakeholders comply with the various food quality and food safety initiatives

Download the Food Safety White Paper Now

Leave a comment

Tim Lozier
Written by Tim Lozier
Tim is the Manager for Marketing and Strategy at EtQ, Inc.
Written by Author

Related posts

6 Powerful Stats About the Growth of Quality Management Investments

What do Quality Pros and C-Levels Think About Quality Management Investments in 2020 and Beyond?

The goal of our survey of  300...

Chris Nahil
By Chris Nahil - August 5, 2020
The Importance of Quality Management in the Medical Device Industry

Quality and Compliance Standards for Med Device Manufacturers are Constantly Evolving - It's Critical to Keep Pace with Quality

Chris Nahil
By Chris Nahil - July 29, 2020
Medical Device Security: Ongoing Threats And New FDA Guidance


Connected medical devices are raising the cybersecurity stakes ... 

On October 1, 2019, the U.S. Food and Drug...

Rachel Beavins Tracy
By Rachel Beavins Tracy - October 18, 2019