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FSMA Rule 1: Double-Check Your Plan

 

By: Bill Bremer

Principal, Food Safety Compliance, Kestrel Management

Posted: 10/15/16

 
 
 
FSMA Rule 1: Double-Check Your Plan

The food processing industry is still collectively scrambling to get food safety programs in place so their plants fully comply with the first new rule of the Food Safety and Modernization Act, or FSMA. And while the deadline for that first rule, titled Preventive Controls for Human Food and Animal Food passed in mid-September, many plant managers are still left wondering if they’ve covered all their bases. Below are a few fundamental questions to help guide you on the path to full compliance.

Have You Named Your Preventive Controls Champion?

The goal of FSMA is to change the focus of food safety programs under HAACP from reactive to actively preventing foodborne illness outbreaks. Compliance with the new law requires hazards leading to re-evaluating your existing food safety plans, and updating your preventive controls to include not only your plant but also your supply chain. Before you start, the new law requires that you identify one Qualified Individual who is fully trained on preventive controls as outlined in the new Section 117 of FSMA. Your food safety champion in this role has to assess possible food safety hazards, analyze the potential risks, and estimate the likelihood of any incident caused by those hazards. Most importantly, your champion must document the controls they will institute to prevent any potential hazards, so let’s cover that next.

Know the Numbers: Section 110 Has a New Number: 117.

Good Manufacturing Practices (GMPs) outlined in Section 110 of FSMA, are still valid, but the updates or what is now known as Current Good Manufacturing Processes (CGMPs) are now found in Section 117 of FSMA. The updated section will in time replace Section 110, but for now, keep an eye on both, as 117 outlines the updates according to the new legislation.

Have You Started Documenting
Your Preventive Controls?

Review your food processes for preventive hazards and set aside some time to do the research on published reports about food safety violations and outbreaks in your industry. FoodSafety.gov is a good place to check for recent recalls and violations. Another site, foodsafetynews.com stays current with recent food recalls and foodborne illness outbreaks. Also check the Centers for Disease Control (CDC) and The Food and Drug Administration (FDA) websites, and any food processing associations specific to your industry. This provides you with additional information for determining your hazards and determining preventive controls.

When you find a report about an incident you think could happen in your facility or supply chain, look closely at why it happened, and see if any of those hazards exist. If they do, this is an opportunity to create a new preventive control. Look for as many examples as possible, and start to develop your own library of source materials. Documentation for why you developed your preventive controls is an important part of your new food safety plan. Having this documentation ready when the inspector shows up demonstrates your commitment to FSMA, and it’s a big part of compliance.

Continue to assess your possible preventive controls and build on your library and develop a food safety reading list. This could be as simple as a list of links to articles that outline issues that have happened in your industry. Make a commitment to checking this regularly. Make sure everyone in charge of food safety at your plant has easy access to the library, and encourage them all to contribute to the library and help keep the library current. You must document the final determination of your preventive controls in your food safety plan.

Are Employees Trained and Is the Training Documented?

Once you establish new preventive controls, everyone has to be trained and on board. This is part of the job. A documented plan with training materials and communication processes showing times, dates, and frequency goes a long way toward showing your commitment.

Here’s a real simplified example of how this could play out. Let’s say that while creating your new food safety plan, you notice employees all over the plant are walking from lower-risk contamination areas to higher-risk contamination areas without washing or sanitizing their hands. You decide an obvious preventive control would be to install hand sanitizers or hand-washing stations between all risk areas. In order for this new preventive control to comply with FSMA, you would also need to do the following:

  1. Get the word out to employees that they have to wash their hands when moving from one area to another.
  2. Document that you communicated the new rule to your employees.
  3. Verify that employees are following the rules and washing their hands by observing them actually washing their hands.
  4. Documenting that you have actually seen your employees using the new hand washing stations.

Are You Building on Your Program?

Initially taking these important steps toward updating your food safety plan is a great place to start compliance with FSMA for Preventive Controls. But unfortunately, hazards like bacteria never sleep, and the work of your food safety program is never done. Be sure to set up frequent and routine self-inspections as well as stay up to date on the latest violations and reports. In the early months of enforcing the new rules, food inspectors will stop in and ask to see the progress you’ve made toward improved food safety handling and prevention of foodborne illnesses—and your business has to be prepared.

Bill Bremer is a Principal with Kestrel Management’s Chicago area practice and heads Kestrel’s food safety consulting group. In his food compliance roles, he has led compliance and assurance activities to help many food industry companies meet FDA/FSMA, GFSI (i.e., BRC, IFS, FSSC22000, SQF), HACCP, EHS, and overall operations management requirements.

 

 

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