Powered by
Build a proactive approach to food safety and gain confidence in complying with FSMA standards
Why Mitti digital checklists?
Free to use for up to 10 users
Eliminate paperwork with digital checklists
Generate reports from completed checklists
FSMA (Food Safety Monitoring Act) is a U.S food safety law signed in 2011 that focuses on preventing serious adverse health consequences by establishing a proactive and risk-based approach in food safety. FSMA is mandated by the FDA, which has also provided 7 major rules for food companies to follow in compliance with FSMA.
An FSMA compliance checklist is a monitoring tool primarily used in the agricultural industry to comply with the U.S. Food Safety Monitoring Act of 2011, especially for Rule 1 or developing and implementing preventive controls. FSMA compliance checklists usually specify the scope and personnel (e.g., designating a competent auditor and sanitation manager) and include food hazard analysis (biological, at the facility, or in the supply chain), validation and verification of the preventive controls, and re-analysis of the established comprehensive food safety program.
It is vital for all food companies involved in the U.S. food supply to implement a food safety program that complies with FSMA regulations. Failure to comply with FSMA regulations can result in repercussions such as fines, product recalls, lawsuits, or worse, plant shutdown. Below is a breakdown of the 7 major rules essential for compliance:
This rule establishes a mandatory federal standard for growing, harvesting, packing, and holding of fresh produce. The produce safety makes it the farm’s responsibility to protect their crops from contamination by creating requirements for water quality testing, raw manure application, examining grazing areas, employee health and hygiene training, and more.
This rule requires food facilities to implement a food safety plan that includes hazard analysis and risk-based preventive controls to minimize hazards.
Similar to preventive controls for human food, this rule requires food facilities to establish CGMP, hazard analysis, and risk-based preventive controls for the production of animal food.
The FSVP requires importers to perform certain risk-based activities to verify that food imported into the U.S. are produced in compliance with FDA regulatory requirements. Under this rule, importers should perform evaluations in approving suppliers, which entails evaluating suppliers’ performance and determining risks and potential hazards associated with food supplies.
This rule establishes a voluntary program for the accreditation of third-party certification bodies that will conduct food safety audits and issue certifications for foreign facilities and the food they produce. Accredited third-party certification bodies perform two types of audits: consultative and regulatory.
This rule requires shippers, receivers, loaders, and carriers that transport food in the U.S. to take appropriate measures in ensuring food safety. It makes an effort to protect food from farm to table by maintaining proper temperature controls and preventing contamination during transportation.
This aims to prevent intentional adulteration from acts that can potentially cause harm to public health. The rule requires all food facilities to develop and implement a food defense plan that covers the assessment of food vulnerabilities, identification of mitigation strategies for vulnerabilities, and determination of monitoring procedures to ensure the effectiveness of mitigation strategies.
Preparing for FSMA Compliance starts with learning these FSMA rules. Determine which applies to your organization and identify any exemptions from set rules.
Ensuring FSMA compliance in your organization can be quite overwhelming at first, but proper training and preparation can mean the difference between a failed and successful FSMA program. Below are 5 helpful tips that can help you prepare your organization and achieve FSMA compliance.
This requires primary documents that describe activities to ensure the safety of food during manufacturing, processing, packing, and holding. Documents that make up the food safety plan include:
Hazard analysis
Preventive controls (in the event of identifying a hazard that requires preventive controls)
Monitoring procedures
Corrective action procedures
Verification procedures
Have trained and skilled individuals responsible for developing your facility’s food safety plan. Establish roles and delegate responsibility for every step of the safety plan’s implementation, verification, validation, and correction.
Identify and assess potential hazards that may arise from the food facility or food itself, including:
Biological hazards
Chemical hazards
Physical hazards
Radiological hazards
Natural toxins
Pesticides
Drug residues
Decomposition
Parasites
Allergens
Unapproved food and color additives
Hazards that occur naturally or may be unintentionally introduced
Hazards that may be intentionally introduced, including acts of terrorism
Set preventive controls to ensure the mitigation or elimination of identified hazards. Doing so ensures that food manufactured, produced, packed, or held by the food company is not altered, misbranded, or contaminated.
The effectiveness of the preventive controls you set up heavily depends on diligence. Frequent monitoring ensures consistency in procedures and allows traceability in the event of any safety issues.
Search, filter, and customize 60,000+ templates across industries and use cases.
Powered by
This Product Traceability form was developed by a Mitti (by SafetyCulture) Industry Expert Partner to ensure traceability of materials and components throughout the production process, supporting compliance with ISO 9001:2015 Clause 8.5.2 (Identification and Traceability). Use this for food traceability procedures to ensure food safety across all stages of food production and distribution.
