7 Procedures You Are Required to Have in Your FSMA-Compliant Food Safety Plan

Now that the Food Safety Modernization Act (FSMA) is fully embedded in the food processing and manufacturing industry, every food brand is called to elevate its approach to food safety and transform reactive efforts into proactive plans. But if FSMA compliance has you struggling to understand and implement the proper regulations within your operation, you probably have some important questions about what’s required of you.

FSMA’s rule on Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food establishes that every facility must have its own written Food Safety Plan (FSP). So what does this mean? What actually goes into an FSMA-compliant Food Safety Plan?

compliant FSP encompasses all the primary documents in a preventive controls food safety system. This translates to any written documentation detailing your systematic approach to identifying food safety hazards, including activities that ensure the safety of food during manufacturing, processing, packing, and holding.

Boiled down to the essentials, your Food Safety Plan must include:

  1. The written hazard analysis as required by 117.130(a)(2)
  2. The written preventive controls as required by 117.135(b)
  3. The written supply-chain program as required by subpart G of this part
  4. The written recall plan as required by 117.139(a)
  5. The written procedures for monitoring the implementation of the preventive controls as required by 117.145(a)(1)
  6. The written corrective action procedures as required by 117.150(a)(1)
  7. The written verification procedures as required by 117.165(b)

Still, these plan necessities and code numbers can be confusing to digest and put into practice, so you may need some expert guidance on building or revising your Food Safety Plan in accordance with FSMA requirements. Here’s what you need to know about each of the seven mandatory elements.  

1. Hazard Analysis

A thorough hazard analysis outlines the food safety hazards at all stages of food production, assessing their likelihood of occurrence and identifying preventive measures for their control. A hazard is defined as any biological, chemical (including radiological) or physical agent that has the potential to cause illness or injury. It refers to conditions or contaminants in food that occur naturally, are added unintentionally or are added intentionally for purposes of economic gain.

To effectively identify these hazards, assemble a food safety team responsible for rigorously and thoroughly collecting the following elements:

  • Information about the product description, intended use and distribution
  • In-plant experience related to the likelihood of hazards, such as information from product testing results, consumer complaints or knowledge of facility personnel
  • Raw materials and ingredients used in the product
  • Activities conducted at each step in the manufacturing process
  • Equipment used to make the product
  • Types of packaging and packaging materials
  • Sanitary practices, including facility conditions and employee hygiene
  • External information like scientific papers, epidemiological studies, applicable government or industry food safety guidance documents and historical data for similar products

Based on this information, perform a complete evaluation to pinpoint any potential hazards requiring a preventive control.

2. Preventive Controls

Once your team renders a comprehensive list of hazards requiring preventive controls, the next step is to identify and implement the most effective controls to ensure that each hazard is significantly minimized or prevented. There is more than one control approach to apply, depending on the potential hazard and its place in the workflow (i.e., supply chain, food allergens, sanitation, process).

Use your written hazard analysis to design the approaches your organization will employ to control its hazards. The more thorough the hazard analysis, the more targeted your controls will be – and the more risk you’re poised to mitigate in terms of FSMA compliance, consumer health, and brand preservation.

3. Supply-Chain Program

You’re also responsible for ensuring that your suppliers are operating in accordance with applicable FSMA statutes, so your Food Safety Plan must detail your company’s efforts to confirm that suppliers have proper hazard analysis and risk-based preventive controls in place. Integrating a valid supply-chain program into your FSP reduces your risk of facing government penalties, potential recall repercussions, and reputational damage.

Think about how you can assimilate the following supply chain precautions:

  • Identification and evaluation of all suppliers, compiled in an organized list, including the sites at which the ingredients are sourced/produced
  • Investigation of evidence proving each supplier’s compliance with FSMA mandates and strict process for fulfilling their regulatory obligations
  • Maintenance of accurate, updated records of all certifications and food safety documentation from the suppliers on your list
  • Familiarization of FSMA’s Sanitary Transport laws, as well as confirmation of each supplier’s compliance with these laws in the transport and delivery of your facility’s supplies
  • Assessment of items that fall under the categories identified in FSMA’s rules for a Foreign Supplier Verification Program
  • Implementation of a fully compliant plan for ensuring that applicable foreign suppliers are following the necessary safety protocol
  • Scheduling of ongoing risk assessments for your suppliers, including audits
  • Documentation of all audit events, results and necessary corrective actions
  • Regular communication with suppliers and follow-up on any directives set forth to address problems detected in their processes

4. Recall Plan

A pre-planned strategy for addressing food safety issues that can spur a recall is essential to a compliant Food Safety Plan. Your written recall plan must include procedures that describe the steps to be taken, as well as assign responsibility for taking those steps, including:

  • Directly notifying the direct consignees of the food being recalled and how to return or dispose of the affected food
  • Notifying the public about any hazard presented by the food, when appropriate, to protect public health
  • Conducting effectiveness checks to verify that the recall is carried out
  • Appropriately disposing of the recalled food through means such as reprocessing, reworking, diverting to a use that does not present a safety concern or destroying it entirely
  • Accurately recording all recall actions and updating government agencies
  • Updating your food safety plan to prevent a recurrence

5. Procedures for Monitoring the Implementation of Preventive Controls

You must establish and implement written procedures for monitoring preventive controls. To fully describe your monitoring program, the procedures should detail exactly what will be monitored, how it will be done, how often it will take place and who will be responsible for doing it.

A proactive and compliant Food Safety Plan relies on having a strong monitoring program in place, one that facilitates a high level of data tracking, visibility, and communication. For any multi-department, multi-system operation to successfully detect and resolve non-conformances, automated data tracking is crucial. Make sure that your FSP leverages a smart solution for:

  • Visualizing your preventive control points
  • Quickly identifying locations and patterns that require attention
  • Keeping the team apprised of important alerts and information regarding non-conformances
  • Responding efficiently to food safety hazards
  • Supplying the necessary documentation in the event of an audit

6. Corrective Action Procedures

If your monitoring program detects that any preventive control has not been properly implemented, corrective actions are needed. Therefore, your FSMA-compliant Food Safety Plan must describe predetermined corrective action procedures with detailed instructions for an employee to follow in the event of a deviation.

The FDA stipulates that an appropriate corrective action procedure ensures the following:

  • The appropriate action is taken to identify and correct the problem that has occurred with the implementation of a preventive control
  • The appropriate action is taken when necessary to reduce the likelihood that the problem will recur
  • All affected food is evaluated for safety
  • All affected food is prevented from entering into commerce unless an evaluation has determined that the product is not adulterated or misbranded

7. Verification Procedures

For your Food Safety Plan to be fully compliant with FSMA regulations, there must be a verification process that ensures the methods in place are protecting food quality at every juncture. Verification activities should include procedures that confirm:

  • Validation of the adequacy of each control measure
  • Evidence that monitoring is being conducted as required
  • Evidence that appropriate decisions about corrective actions are being made as required
  • Evidence of verification of the implementation and effectiveness of controls (such as product testing or environmental monitoring)
  • Calibration of instruments, when appropriate
  • Review of records

Depending on the food, the facility and the nature of the preventive control, you must verify monitoring and corrective actions, calibrate monitoring and verification instruments, and test products and the environment.

The Compliance Catalyst for Your Food Safety Plan

There are some common themes that bind an FSMA-compliant Food Safety Plan together, including: data tracking, visibility, proactivity, communication, and efficiency. The truth is any failure to maintain these pillars in your FSP is going to negatively impact the safety of your product, the success rate of your audits, the risk of experiencing a recall and the overall stability of your operations. Unfortunately, many manufacturers in the food and beverage industry are relying on manual systems like email and spreadsheets to pull their Food Safety Plans together.

By adopting an automated software solution to govern your food safety efforts, you’re empowered to support a robust and compliant plan built on:

  • Powerful scheduling
  • Visual monitoring of your entire plant
  • More accurate analysis
  • Automated reporting
  • Document security
  • Dynamic communication
  • Visibility for cross-functional transparency
  • Efficiency and organization

For more information about how a smart software solution supports an FSMA-compliant Food Safety Plan – minimizing your risk of recall repercussions and brand damage – access your free Food Recall Prevention Kit.

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