3 Tips From the FDA on Preparing For An FDA Audit

November 20, 2019

Last month, food distributors, manufacturers, carriers, and other members of the food and beverage transportation and operations industry gathered in Orlando, Florida, for the annual International Foodservice Distributors Association (IFDA) conference.

One popular IFDA session, led by U.S. Food and Drug Administration officer Timothy M. Albright, focused on helping the food industry gain greater clarity around the Food Safety Modernization Act (FSMA) -- strategically ahead of a planned uptick in preventive control inspections of food facilities in the months to come.

FSMA is a set of seven foundational rules that aims to create a risk-based framework for food safety. During the session, Albright primarily offered advice about two FSMA rules—the Final Rule for Preventive Controls for Human Food and the Sanitary Transportation of Human and Animal Food

Read on to learn more about what the FDA considers the three most essential areas for food facilities to focus on when preparing for FDA inspections.

1. Create a food safety plan

The food safety plan is the keystone to FSMA compliance and helps food facilities establish processes to combat risks involved in the handling and selling of food. A robust food safety plan can help you identify potential hazards to public health, increase the success rate of your inspections, and decrease the risk of a recall.

The Final Rule for Preventive Controls for Human Food states that a food facility is required to create and implement a written food safety plan if:

  • You are required to register with FDA under section 415 of the Federal Food, Drug, and Cosmetic Act, and

  • You are involved in the manufacturing, processing, packing, or holding of human food for consumption in the United States

"If you do need a food safety plan, it's of the utmost importance that you actually have done a hazard analysis, and your food safety plan is going to address those hazards," said Albright. 

Your food safety plan must identify any potential hazards to public health that require preventive controls and must outline processes for implementing those preventive controls.

How to create a food safety plan:

  • Conduct a hazard analysis: Identify any known or potential hazards that might be present in the food supply chain and determine if they require a preventive control inspection. Examples of hazards include biological hazards like the presence of bacteria, chemical hazards like pesticide or drug residue, and physical hazards such as glass or metal fragments in the food.

  • Develop preventive controls: If you are able to identify hazards that require preventive controls, you must develop and implement a written plan that outlines processes to minimize or prevent these hazards. Types of preventive controls include: 

    • Process controls are procedures to control hazards during operations, like cooking or refrigeration.

    • Food allergen controls are procedures that help identify food allergens within your facility and prevent cross-contamination, such as correctly labeling any potential food allergens.

    • Sanitation controls are procedures to help ensure your facility is operating in a safe and sanitary manner. Examples of these include environmental monitoring and hygiene training, which will help control environmental pathogens.

  • Create a risk-based supply chain program: If you're a manufacturer, you are also required to identify potential hazards related to ingredients or materials you receive from your suppliers. If you do identify hazards, you will need to create and implement a supply chain program. It is also your responsibility to conduct a hazard analysis of the supplier’s food and processes before continuing to work with them.

  • Develop a recall plan: If you conduct your hazard analysis and find hazards that require preventive controls, you also need to have a written plan for recalling those food products. This written plan must account for all the steps required to perform the recall, including:

    • Notifying the direct consignees of the food being recalled

    • Instructing them on how to return or dispose of the food

    • Notifying the public about the recall

    • Creating processes for appropriately disposing of the recalled product

If you need to create a food safety plan but don’t know where to start, you can use the FDA's free Food Safety Plan Builder to develop a customized food safety plan for your facility.

2. Prioritize proper documentation of sanitary processes 

If you are involved in the transportation of human and animal food (i.e. you're a shipper, loader, receiver, or carrier) you must comply with the requirements outlined by the Sanitary Transportation of Human and Animal Food rule.

A crucial compliance focus for the FDA is ensuring that facilities are maintaining sanitary safety standards, according to Albright. Specifically, food facilities must ensure that food remains properly refrigerated and that they have processes in place to prevent food safety risks. Albright also emphasized the importance of thorough record-keeping, which helps facilities prove that their cold chain management processes are in place and effective.

"From the sanitary transportation inspections that we've done, almost everyone's controlling the hazard that's present," said Albright. "What they don't have is the procedures and paperwork in place to back it up."

Samsara’s FSMA-compliant environmental monitors (EMs) offer temperature and humidity tracking that can provide you with real-time insights into all your connected assets and eliminate the need for manual record-keeping.

For instance, Cowgirl Creamery, an artisanal cheesemaker based in California, has configured their Samsara dashboard to automatically email them historical temperature reports. They are then able to easily download or export the data from these reports in the case of any inspections.

Samsara EMs are also critical to Cowgirl Creamery’s cold chain management processes, helping them maintain precise environmental conditions. Operations Manager Maureen Cunnie, for example, uses Samsara to configure custom temperature alerts and receives instant mobile notifications when the temperature of a truck or room rises above her desired threshold.

3. Maintain records of driver training

Record-keeping is also a key focus of FDA inspections. Your FDA inspector might ask you to provide records proving that you've trained your drivers in sanitary transportation practices. According to the Sanitary Transportation rule, the written records must include:

  1. The training that's been provided

  2. The name of the driver that was trained

  3. The date that the driver was trained

Though drivers only need to be trained once, additional training can always be added on. For example, if a driver has already been trained in basic sanitary transportation practices, but will now be transporting eggs and dairy for the first time, the training for this specific task can be provided as an add-on component.

You can find the FDA's official online training course—the completion of which will satisfy the FSMA training requirement—and other resources here.

Interested in learning more about how Samsara can help you streamline FSMA compliance? Sign up for a free 30-day trial today.



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