Free FSMA Compliance Checklist Template | Free Download

FSMA compliance checklist

About the FSMA compliance checklist

The Food Safety Modernization Act (FSMA) is a comprehensive set of regulations aimed at strengthening the food safety system. Designed for food industry professionals, this FSMA compliance checklist helps you and your team assess risks, manage hazards, and maintain compliance with ease. With this template, you can standardize inspections, assign responsibilities, and track and verify every detail of your food safety plan.

A step-by-step guide to using the FSMA compliance checklist

You can address every aspect of your compliance strategy with this template:

Customize your template: Begin by editing the checklist in the Lumiform app. Add, remove, or adjust sections to match your facility’s specific needs and regulatory requirements. Highlight high-risk areas for extra scrutiny.
Conduct inspections systematically: Use the checklist during audits to evaluate each compliance area, from hazard analysis to recall readiness. Walk through each point carefully, documenting your findings directly within the app for a complete and accurate record.
Assign roles and track progress: Delegate tasks based on findings. If an issue arises, create action tasks directly from the checklist and assign them to team members. This feature makes follow-ups seamless and prevents gaps in accountability.
Generate a professional report: Once you’ve completed the checklist, compile your findings into a detailed report directly through the app. This can include photos, signatures, and notes for a comprehensive document that’s ready for internal reviews or external audits.
Maintain an audit-ready state: Regularly revisit and update the checklist to ensure it aligns with the latest FSMA guidelines. Staying proactive reduces the risk of compliance gaps and helps you prepare for external audits with confidence.

Why you should use the FSMA compliance checklist

An FSMA compliance checklist is a powerful tool for simplifying your compliance process and protecting your business. By using this checklist, you can standardize inspections and audits so you don’t overlook any critical aspect of food safety.

This customizable template aids you in staying organized, whether you’re conducting hazard analysis, verifying supplier practices, or managing sanitation protocols. It’s designed to save you time by streamlining repetitive tasks and improving team coordination. Additionally, it provides a clear framework for documenting compliance, which can be invaluable during regulatory audits.

By adopting this checklist, you not only improve efficiency but also reduce the risk of errors that could lead to non-compliance or food safety incidents. It’s an essential resource for maintaining high standards while staying audit-ready.

Download Lumiform’s FSMA compliance checklist today

Streamline your audits and compliance efforts with a tool designed for efficiency. This checklist empowers you to tackle key areas of food safety, from hazard analysis to recall readiness. Its structured format allows you to stay organized and focused so you can strengthen your workflows, delegate responsibilities with confidence, and document results with ease.

Related categories

Preview of the template

Inspection

Scope and Personnel

Designated an FSMA Qualified Individual, competent FSMA Auditor and competent Sanitation Manager

Established roles for qualified individuals and delegated responsibility for every step of safety plan's implementation, verification, validation, and correction

Qualified individuals have been trained in the application of risk-based preventive controls

Determined which FSMA requirements are applicable to the facility

Hazard Analysis

Are hazards evaluated based on the significance they pose?

Are identified hazards likely to occur even with preventive measures taken?

Do identified hazards pose severe threat to consumers?

Are allergens evaluated on points which cross-contamination hazards could emerge?

Labeling

Are raw ingredients containing allergens properly labeled?

Storage

Are storage areas organized to minimize the chances of allergen contamination from a spill?

Can storage areas be effectively cleaned in the event of an allergen spill?

Are bulk storage containers and silos designated as allergen-free?

Staging

Do ingredients containing allergens share staging areas with allergen-free areas?

Are staging areas designed for thorough cleaning between production runs?

Utensils

Are separate utensils used for preparing allergen-free foods?

Are utensils for preparing allergen-free foods clearly marked?

Do utensils share storage or cleaning areas?

Personnel

Are workers able to move between areas preparing allergen and allergen-free products?

Do personnel use PPE and sanitation procedures to prevent cross-contamination?

Please specify what these are

Biological

Equipment

Is processing equipment designed for sanitation?

Are processing surfaces free of cracks that could harbor bacteria?

Transportation

Are transportation containers routinely sterilized?

Are ingredients transported at proper temperatures?

Are containers designed to effectively seal out environmental contaminants?

Sanitation

Are sanitation procedures in place to prevent cross-contamination from employees?

Specify procedures

Are processing areas designed for routine sanitation?

Raw Materials

Are raw ingredients checked for spoilage and contamination prior to processing?

Facility

Grounds

Are pests, dirt, and other potential contaminants present on the facility’s grounds?

Structure

Are roofs and walls effectively sealing out environmental contaminants?

Non-contact surfaces

Are the facility’s floors and fixtures free of cracks that could harbor bacteria or other contaminants?

Plumbing and HVAC

Are drains and vents able to be sanitized?

Non-food chemicals

Are potentially hazardous chemicals properly labeled and stored?

Do routine maintenance tasks require introducing non-food chemicals into the processing area?

Supply Chain

Are suppliers of potentially-hazardous ingredients routinely audited?

Have the preventive controls of suppliers been documented and reviewed?

Does your Food Safety Plan require taking action if a supplier fails to conform to your standards?

Intentional Adulteration

Could a malicious employee or intruder intentionally contaminate products?

What supervisory measures are in place to prevent and detect intentional contamination?

Preventive Controls

Monitoring

Does your food safety plan identify Critical Control Points where contamination can be stopped at its source (ie, handwashing stations, pasteurization baths)?

What oversight procedures are in place to ensure the Safety Plan is followed at these points?

Do your food safety plan specify critical limits (e.g., temperature, or cooking time) which must not be exceeded?

Is product testing to verify the effectiveness of controls routinely scheduled?

Is the processing environment (e.g., condensation from pipes, accumulation of waste materials) constantly monitored to ensure conditions don't promote contamination?

Validation

Do verification processes follow a regular schedule?

Is verification performed by a designated Qualified Individual?

Are implementation records regularly audited for compliance?

Is testing equipment routinely calibrated to ensure accuracy corrections?

If a critical limit is exceeded, what new testing protocols will be used to validate the effectiveness of new controls?

Re-anlaysis

Has your Food Safety Plan been reanalyzed in the past three years?

Is there a new process for revising the plan to mitigate new hazards?

Does the plan reflect the latest food safety research?

Recalls

Is there a documented plan in the event of a recall?

Has a recall team been designated? Are the team members’ roles clear?

Can at least 98% of the affected product be removed from the supply chain?

Can all affected products be identified and located within four hours?

Can the supply chain be traced to locate the source of contamination?

Are there notification procedures in place to alert distributors in the event of a recall?

Are disposal procedures followed to ensure the removal of contaminated products and ingredients?

Completion

Additional comments and recommendations

Name & Signature of Assigned Auditor

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Frequently asked questions

What are the most common challenges businesses face with FSMA compliance?

One major challenge is staying updated with changing regulations, which can vary based on the type of food product or operation. Smaller businesses often struggle with limited resources to conduct hazard analyses or maintain thorough documentation. Additionally, implementing effective preventive controls and managing supply chain transparency can be demanding.

What types of records are required to stay compliant with FSMA?

FSMA requires detailed records covering your food safety plan, hazard analyses, preventive controls, monitoring activities, and corrective actions. You must also document supply chain oversight and employee training. These records need to be kept for at least two years and be readily available during an audit.

Are there FSMA requirements for employee training?

Yes, FSMA mandates that employees be trained in the principles of food safety, preventive controls, and proper handling procedures. Training should be role-specific, focusing on tasks like monitoring critical control points or preventing cross-contamination. With regular refreshers, employees can stay updated on the latest standards and better identify potential risks.

This template, developed by Lumiform employees, serves as a starting point for businesses using the Lumiform platform and is intended as a hypothetical example only. It does not replace professional advice. Companies should consult qualified professionals to assess the suitability and legality of using this template in their specific workplace or jurisdiction. Lumiform is not liable for any errors or omissions in this template or for any actions taken based on its content.