FSMA Compliance Template
A FSMA compliance checklist is a tool used to help guide food companies develop an efficient food safety plan that meets FSMA standards. Use the questions in this checklist to evaluate current procedures and identify areas to improve on. Use and customize this checklist depending on FSMA requirements applicable to your facility.
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Cut inspection time by 50% Uncover more issues and solve them 4x faster Select from over 4000 expert-proofed templates FSMA Compliance Template (page name not set) Inspection Scope and Personnel Designated an FSMA Qualified Individual, competent FSMA Auditor and competent Sanitation Manager Yes No N/A Established roles for qualified individuals and delegated responsibility for every step of safety plan's implementation, verification, validation, and correction Yes No N/A Qualified individuals have been trained in the application of risk-based preventive controls Yes No N/A Determined which FSMA requirements are applicable to the facility Yes No N/A Hazard Analysis Are hazards evaluated based on the significance they pose? Yes No N/A Are identified hazards likely to occur even with preventive measures taken? Yes No N/A Do identified hazards pose severe threat to consumers? Yes No N/A Are allergens evaluated on points which cross-contamination hazards could emerge? Yes No N/A Labeling Are raw ingredients containing allergens properly labeled? Yes No N/A Storage Are storage areas organized to minimize the chances of allergen contamination from a spill? Yes No N/A Can storage areas be effectively cleaned in the event of an allergen spill? Yes No N/A Are bulk storage containers and silos designated as allergen-free? Yes No N/A Staging Do ingredients containing allergens share staging areas with allergen-free areas? Yes No N/A Are staging areas designed for thorough cleaning between production runs? Yes No N/A Utensils Are separate utensils used for preparing allergen-free foods? Yes No N/A Are utensils for preparing allergen-free foods clearly marked? Yes No N/A Do utensils share storage or cleaning areas? Yes No N/A Personnel Are workers able to move between areas preparing allergen and allergen-free products? Yes No N/A Do personnel use PPE and sanitation procedures to prevent cross-contamination? Yes No N/A Equipment Is processing equipment designed for sanitation? Yes No N/A Are processing surfaces free of cracks that could harbor bacteria? Yes No N/A Transportation Are transportation containers routinely sterilized? Yes No N/A Are ingredients transported at proper temperatures? Yes No N/A Are containers designed to effectively seal out environmental contaminants? Yes No N/A Sanitation Are sanitation procedures in place to prevent cross-contamination from employees? Yes No N/A Are processing areas designed for routine sanitation? Yes No N/A Raw Materials Are raw ingredients checked for spoilage and contamination prior to processing? Yes No N/A Grounds Are pests, dirt, and other potential contaminants present on the facility’s grounds? Yes No N/A Structure Are roofs and walls effectively sealing out environmental contaminants? Yes No N/A Non-contact surfaces Are the facility’s floors and fixtures free of cracks that could harbor bacteria or other contaminants? Yes No N/A Plumbing and HVAC Are drains and vents able to be sanitized? Yes No N/A Non-food chemicals Are potentially hazardous chemicals properly labeled and stored? Yes No N/A Do routine maintenance tasks require introducing non-food chemicals into the processing area? Yes No N/A Supply Chain Are suppliers of potentially-hazardous ingredients routinely audited? Yes No N/A Have the preventive controls of suppliers been documented and reviewed? Yes No N/A Does your Food Safety Plan require taking action if a supplier fails to conform to your standards? Yes No N/A Intentional Adulteration Could a malicious employee or intruder intentionally contaminate products? Yes No N/A Monitoring Does your food safety plan identify Critical Control Points where contamination can be stopped at its source (ie, handwashing stations, pasteurization baths)? Yes No N/A Do your food safety plan specify critical limits (e.g., temperature, or cooking time) which must not be exceeded? Yes No N/A Is product testing to verify the effectiveness of controls routinely scheduled? Yes No N/A Is the processing environment (e.g., condensation from pipes, accumulation of waste materials) constantly monitored to ensure conditions don't promote contamination? Yes No N/A Validation Do verification processes follow a regular schedule? Yes No N/A Is verification performed by a designated Qualified Individual? Yes No N/A Are implementation records regularly audited for compliance? Yes No N/A Is testing equipment routinely calibrated to ensure accuracy corrections? Yes No N/A If a critical limit is exceeded, what new testing protocols will be used to validate the effectiveness of new controls? Yes No N/A Re-anlaysis Has your Food Safety Plan been reanalyzed in the past three years? Yes No N/A Is there a new process for revising the plan to mitigate new hazards? Yes No N/A Does the plan reflect the latest food safety research? Yes No N/A Recalls Is there a documented plan in the event of a recall? Yes No N/A Has a recall team been designated? Are the team members’ roles clear? Yes No N/A Can at least 98% of the affected product be removed from the supply chain? Yes No N/A Can all affected products be identified and located within four hours? Yes No N/A Can the supply chain be traced to locate the source of contamination? Yes No N/A Are there notification procedures in place to alert distributors in the event of a recall? Select Yes No N/A Are disposal procedures followed to ensure the removal of contaminated products and ingredients? Yes No N/A Completion Name & Signature of Assigned Auditor
Please note that this checklist template is a hypothetical appuses-hero example and provides only standard information. The template does not aim to replace, among other things, workplace, health and safety advice, medical advice, diagnosis or treatment, or any other applicable law. You should seek your professional advice to determine whether the use of such a checklist is appropriate in your workplace or jurisdiction.