Tag Archives: FSMA

FDA Inspections: Where are We Going?

Not only has COVID put a significant dent in our social lives, but it also has impacted many operations and practices throughout food processing facilities. Unfortunately, this includes one area that has consumers worried, inspections of food facilities. With all the new requirements and protocols that have come out of this pandemic, the industry has had to learn to alter their inspections. Some are even using video technology as a substitute. With COVID laying a foundation that will likely alter the way inspections are completed in the future, what should processing facilities across the country expect moving forward?

According to the FDA, inspectors are “required to inspect facilities that handle high-risk foods every three years. Facilities handling foods not deemed high-risk must be inspected every five years” (Fox, 2019, pp. 13). With being in the midst of a global pandemic, the FDA has halted these inspections, but is still conducting some necessary inspections for specific scenarios like outbreaks of foodborne illness and Class 1 recalls. 

To temporarily replace in-person inspections, many auditors are allowing for special accommodations to be made such as remote and hybrid audits (Black, 2021, pp. 5).

Aside from the FDA, other auditors such as BRCGS and SQFI are offering blended options. BRCGS is offering certificate extensions for up to 6 months with a risk assessment and review. Remote assessments are also available and require a video audit of the facilities storage and production spaces. SQFI is postponing certifications for extenuating circumstances and have implemented additional processes for risk assessment (Black, 2021, pp. 7). For more information on other auditors current COVID policies, click here.

Once in-person audits can resume in the future, the FDA plans to host pre-announced audits for FDA-regulated businesses. According to an interview with Frank Yiannas, it is predicted that health and safety are going to be important factors moving forward with inspections. It is also assumed that consumers are going to want to know not only how their food is produced, but also how it will be safe enough for them to eat. Fortunately, the FDA is in the works of implementing a Smarter Food safety initiative that will allow for a digital way to trace the food system (U.S. food & Drug Admin., 2020, pp. 31).

As for now it seems unknown when in-person audits will fully resume. The FDA stated in a press release that they will likely resume when there is a consistent downward trend in new COVID cases and hospitalizations in geographic areas they are working in (2020, pp. 6). Until then, they will continue to make significant strives with food safety, making it stronger than ever.

Sources:

Black, J. (2021, January 29). Food Safety Audits During a Pandemic: What You Should Know and How to Prepare. FoodSafetyTech. https://foodsafetytech.com/column/food-safety-audits-during-a-pandemic-what-you-should-know-and-how-to-prepare/.

FDA. (2020, April 16). Food Safety and Availability During and Beyond COVID-19. U.S. Food and Drug Administration. https://www.fda.gov/food/conversations-experts-food-topics/fdas-perspective-food-safety-and-availability-during-and-beyond-covid-19.

Fox, M. (2019, January 15). FDA to resume food safety inspections Tuesday. NBC News. https://www.nbcnews.com/health/health-news/fda-resume-food-safety-inspections-tuesday-n958631.

Hahn, S. M. (2020, July 10). Coronavirus (COVID-19) Update: FDA prepares for resumption of domestic inspections with new risk assessment system. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-prepares-resumption-domestic-inspections-new-risk-assessment-system.

 Sjerven, J. (2021, January 21). COVID-19 forces FDA to alter food safety inspection practices. Food Business News. https://www.foodbusinessnews.net/articles/15740-covid-19-forces-fda-to-alter-food-safety-inspection-practices.
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Taking the Initiative to Help Small Business Negotiate the Food Safety Modernization Act (FSMA)

In our efforts to help our customers produce the best safe, quality food that they can, we like to occasionally share resources that may be of use. Below, you will find a link discussing the Food Safety Modernization Act (FSMA) Training and Consultative Service program, (officially titled the Artisan Dairy Producer Foods Safety Initiative). In an effort to assist smaller businesses and producers, the Center for Dairy Research, Dairy Farmers of Wisconsin, and the Wisconsin Cheese Makers Association have come together to provide guidance for small businesses to meet the demands of FSMA compliance. John Lucey, from the Center for Dairy Research discusses the Initiative further here:

https://www.dairyfoods.com/articles/93071-a-collaborative-effort-to-help-small-dairy-manufacturers-meet-safety-guidelines

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FDA’s Food Safety Plan Builder Software

In the demanding everyday life of a food manufacturer it can be hard to slow down and think about the safety of the products being manufactured. Everything from the ingredients that come in the door to the way the product is shipped out to the customer, all have to be monitored for safety. That is what the Food Safety Modernization Act (FSMA) is all about, making sure the ingredients, the process, and how the end product is shipped out reduces the level of risk to the consumer. The manufacturing facility has to ask, what can be done to prevent the various risks in the plant from happening and causing a recall?

A Food Safety Plan is a robust, detailed plan that is meant to anticipate and meet these challenges. A cohesive plan is based on food safety principles which include: hazard analysis, preventative controls, supply-chain programs, and a recall plan. For smaller businesses, putting a Food Safety Plan in place and maintaining that Plan can be daunting. Where do you start? Making sense of the regulatory language can be difficult, making it hard to determine what the FDA is going to be looking for if you were to receive an audit.

After some feedback from the food industry, the FDA created a free software tool, called the Food Safety Plan Builder. It is a tool designed to assist owners/operators of food facilities with the development of food safety plans that are specific to their facilities, and to assist them in meeting the requirements of the current regulations. Using this software is not required by the FDA, but facilities may find it of use as they continue to critically engage their Food Safety Plans.

Filling out all the information that the software requests can be labor intensive but with some effort and investment though, the Builder can act as a great framework to build upon.  According to Eric Edmunds, food safety director with The Acheson Group, “as with any other electronic tool, the product that you get out of it is as good as the information you put into it!”

If you are interested in using this tool here is the website:
https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm539791.htm

The bottom line is that there are no shortcuts in creating a culture of food safety. Tools like the Builder are excellent resources to engage and assist in implementing comprehensive programs, but don’t make a complete toolbox in themselves. While food law and requirements can be laborious to understand and read they are important to get right. FSMA was created so that food facilities are held responsible for every bit of food safety including the supply chain from one facility to another. The FDA wants food facilities to know that when guidelines are followed and a good a Food Safety Plan is in place they are setting themselves up for success.

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Become a “Preventive Controls Qualified Individual” Today!

In Nelson-Jameson’s continued commitment to provide industry professionals with the latest in food science and food safety education, we’ve partnered with Cherney Microbiological Services to offer a brand new course offering!  The upcoming “FSPCA Preventive Controls for Human Food” is a class that will be of special interest to those in plant operations, and will focus on Food Safety Modernization Act (FSMA) compliance.  As an added bonus, Nelson-Jameson customers will receive a 5% discount, simply by mentioning “Nelson Jameson” when registering!

Image courtesy Cherney Microbiological Services.

Continuing Food Safety Education through FSPCA Preventive Controls for Human Food course

The Food Safety Modernization Act is the most extensive change to food safety laws in 70 years, shifting the industry perspective from a reactive to a proactive approach when addressing and preventing food contamination. The new regulations require specified activities to be completed by a “Preventive Controls Qualified Individual” who has “successfully completed training in the development and application of risk-based preventive controls.” The FSPCA Preventive Controls for Human Food course helps support both compliance with FSMA and provides FDA-recognized training for your designated Preventive Controls Qualified Individual. This standardized course was developed by the Food Safety Preventive Controls Alliance (FSPCA) in partnership with the FDA, and the lead instructors and course content and materials are FSPCA-approved.

The FSPCA Preventive Controls for Human Food course is a great fit for quality directors, managers, supervisors and practitioners who will be responsible for managing his or her company’s Food Safety Plan under FSMA.  This course will be held March 29th-31st, 2016, at Cherney Microbiological Services in Green Bay, Wisconsin. The cost is $800, but be sure to mention “Nelson Jameson” while registering to receive a 5% discount!  To register, please click HERE.

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The Food Safety Modernization Act: In Small Bites

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If you have been following the development of the Food Safety Modernization Act (FSMA), from its inception, to its passage, to its implementation, it has been quite a long ride! Signed into law in 2011, there has been no shortage of discussion as to what the effects of the law will be on the food industry. What was somewhat abstract became much more immediate when two of the seven key rules were recently released. These first two, respectively pertaining to Human Food Risk Analysis and Animal Food Risk Analysis, came out in late August.

By the time this blog appears on our site, three additional rules will be set for publication. Produce Safety, Foreign Supplier Verification, and Accreditation of Third Party Auditors rules are all set for late October.

As we have highlighted in past blogs concerning FSMA, Nelson-Jameson aims to bring together as many quality resources as possible to help our customers navigate this sweeping change in food safety law in the United States. Recently, 3M, one of our suppliers here at NJ, teamed up with The Acheson Group to provide a 15-part webinar series on the Food Safety Modernization Act.

The series is free of charge and is geared toward food industry interests looking to better understand FSMA and its related standards. The monthly series will run throughout 2016. The impressive first installment, “FSMA: How Do I Comply? How To Determine Which FSMA Rules Apply To You” is available on 3M’s Healthcare Academy site. To sign up for access to the episode, or to sign up for upcoming installments of the series click here.

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