FSMA Compliance Checklist

• Company Name

• Conducted on

  Date

• Audited by

• Location
  Address

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

• Please specify what these are

Biological

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

• Specify procedures

• 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

Facility

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

• 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)?

  Yes

  No

  N/A

• 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?

  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

  • Yes
  • No
  • N/A

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

  Yes

  No

  N/A

Completion

• Additional comments and recommendations

• Name & Signature of Assigned Auditor

  Sign