FSMA Compliance Checklist

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

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

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

4. Determined which FSMA requirements are applicable to the facility

1. Are hazards evaluated based on the significance they pose?

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

3. Do identified hazards pose severe threat to consumers? 

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

1. Are raw ingredients containing allergens properly labeled? 

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

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

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

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

2. Are staging areas designed for thorough cleaning between production runs?

1. Are separate utensils used for preparing allergen-free foods?

2. Are utensils for preparing allergen-free foods clearly marked?

3. Do utensils share storage or cleaning areas?

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

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

1. Are suppliers of potentially-hazardous ingredients routinely audited?

2. Have the preventive controls of suppliers been documented and reviewed?

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

1. Could a malicious employee or intruder intentionally contaminate products?

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

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

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

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

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

1. Do verification processes follow a regular schedule?

2. Is verification performed by a designated Qualified Individual?

3. Are implementation records regularly audited for compliance?

4. Is testing equipment routinely calibrated to ensure accuracy corrections?

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

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

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

3. Does the plan reflect the latest food safety research?

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

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

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

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

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

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

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

1. Additional comments and recommendations

2. Name & Signature of Assigned Auditor