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Compliance   19 min read

FSMA Compliance Checklist & Final Rule Update

December 28, 2022

1 in 10 people fall sick or perish annually from contaminated food, and 40% of those affected are children - World Health Organization 

Another report shows that more than 5 million cases of diarrhea, 60 thousand cases of acute respiratory infections, and 85 thousand malaria cases are due to the same source.  

These stats give us a glimpse into the enormous economic and health toll created by foodborne illnesses.  

While keeping these figures in view, the Food and Drug Administration (FDA) presented food safety rules in the form of FSMA Compliance to ensure healthy food intake for Americans. 

What is FSMA Compliance? 

The FDA designed the Food Safety Modernization Act (FSMA) to prevent foodborne illnesses. By replacing old standards focused on response with new methods to enforce prevention, FDSMA compliance reduces foodborne illness's economic and public health impact. The Act aims to educate food processing facilities – improving the inspection, compliance, and safety of imported foods.   

The FDA enforces all the major rules through accredited third-party certification. It is an FDA-sponsored voluntary program. As part of this program, international establishments are subjected to food safety audits by accrediting bodies that have received FDA approval.  

This voluntary certificate enables facilities to participate in the voluntary qualified importer program. In some situations, the FDA requires certification of an imported item to prevent the entrance of dangerous substances into the United States.  

A compliance date has yet to be set for the decision on third-party certification bodies' accreditation.

Food & Beverage Manufacturing Software 

Update: Food Traceability List & Additional Traceability Requirements 

A recent update includes requirements for additional traceability for certain foods. This new FSMA rule affects persons working with foods on the Food Traceability List (FTL), including: 

  • Manufacturing 
  • Processing
  • Packing
  • Holding 

The rule establishes traceability recordkeeping requirements. Any person involved in the listed roles with items on the Food Traceability List must keep records that include KDEs (Key Data Elements) and CTEs (Critical Tracking Events). Records must be provided to the FDA within 24 hours – or an agreed-upon reasonable timeframe.  

This FSMA compliance update will improve traceability and faster identification of potentially contaminated products. As a result, more foodborne illnesses and deaths can be prevented. The Food Traceability Final Rule compliance date is January 20, 2026. The FDA is currently assessing methods of sharing electronic sheets and digital records with the agency, such as online reporting through a web-based portal. Quickly generating digital reports will be important for FSMA compliance under this update.  

A complete Food Traceability List is available from the FDA. 

6 Step FSMA Compliance Checklist 

The FSMA Compliance Checklist explores the base steps in creating a food safety plan. The aim is to ensure a high-quality food supply to Americans by tracking contaminated food products and hazard analysis to prevent serious health problems. 

Food safety and quality are a must for any producer in the food industry. It has been streamlined for years by the FDA. Food manufacturers that knowingly break these regulations may be subject to legal penalties or have their licenses revoked. 

This checklist provides an overview of the key steps that you need to take to ensure FSMA compliance in your facility. This list is not meant as legal advice or to replace the need for your legal team to ensure compliance. For more information on the Act and legal documents, visit the FDA online. 

  1. Risk-Based Preventive Controls

In the food industry, risk-based preventive controls ensure the safety of food and ingredients. These controls should be based on an analysis of the potential hazards in your facility.  

Reducing the risk of hazards during pre-production requires a safety setup based on FSMA guidelines. These can involve monitoring fresh products' growth, harvesting, packaging, and holding.  

Harmful compounds contained in sprays, which can lead to significant changes at the genetic level, are the primary cause of stomach and intestine cancer. Therefore, fruits and vegetables must be thoroughly cleaned to avoid such risks and hazards. 

  1. Establish a Plan Follow Food Safety Regulations

Organizations need a plan with proper guidelines to ensure compliance with all food safety laws and regulations. Some examples of ways facilities plan for adherence include: 

  • Protecting sensitive buildings with a reliable sign-in system to restrict access and create a digital record of entrants.  
  • Dedicated food storage sites: ex., dry storage, cold storage, and separate cold storage for fresh fish and meat. 
  • Using insecticides for pest management. 
  1. Analysis of Risk and Potential Hazards in Your Building

Evaluate any chemical or physical hazard in your building to reduce the danger of environmental contamination. These hazards could be in the form of physical (fragments, dirt, stones), chemical (sprays), or biological (insects) substances from your surroundings.  

Evaluate the severity of each risk. First, assess the intensity of the risk factors. Then identify actions to prevent these dangers or control the risk if you cannot remove the hazard. 

Food Safety Reporting

  1. Monitoring and Food Safety Audits 

You must regularly monitor your food safety compliance and carry out food safety audits. This involves performing audits, documenting all findings, and identifying aspects that cause damage. 

This empowers organizations to spot any issues and determine whether the food defense plan is being implemented properly. If any non-compliance is discovered during an audit, be prepared to take corrective action. 

  1. Accurate Record Keeping and Documentation

Accurate recordkeeping or documentation is a necessary step for FSMA compliance. This data gives you directions for the next steps.  

Make sure to follow the proper procedure to avoid double-data entry mistakes. Digital recordkeeping solutions ease sharing with the FDA and allow for automated, organized, efficient record keeping. 

An optimized workplace visitor policy can support FSMA compliance to prevent data loss due to visitor incidents. 

FSMA Warehouse Management

  1. Preventive Process Controls Analysis

Proper monitoring of control measures is necessary to confirm efficacy. Reviewing and verifying records and auditing food safety records gives you an idea of where you need to improve. Moreover, it is necessary to assess food vulnerabilities and identify mitigation strategies to monitor food safety plans properly. 

The Role of Visitor Management Software in FSMA Compliance 

Changing FSMA compliance standards are increasing the reliance on digital tracking and records for the food and beverage industry. A powerful visitor management system (VMS) can add valuable support to ease compliance with industry regulations. 

iLobby is an industry-leading facility management platform providing cloud-based visitor control software to track visits, securely gather data, and generate reports. Smart automation solutions like digital watchlists and access control integrations are just some of the tools that your VMS can leverage to ease compliance to industry standards. 

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