What Happens During a USDA Food Safety Assessment?
When a Food Safety Assessment is scheduled, even an experienced USDA-inspected establishment can feel the pressure.
The Enforcement, Investigations, and Analysis Officer (EIAO) may request extensive records, examine scientific support, observe production, speak with establishment personnel, and compare the written food safety system with what is actually happening on the floor.
But an FSA is not simply a test of whether the establishment has all the right documents.
It examines whether the establishment’s food safety system is properly designed, scientifically supported, implemented as written, and working as an integrated system.
Understanding that distinction can help an establishment approach the assessment in an organized, informed manner.
What Is a Food Safety Assessment?
A Food Safety Assessment, commonly called an FSA, is an evaluation conducted by the USDA Food Safety and Inspection Service. It is generally conducted by an Enforcement, Investigations, and Analysis Officer, or EIAO. FSIS Directive 5100.1 also uses the term EIAO to include an EIAO-trained Public Health Veterinarian conducting EIAO activities.
According to FSIS Directive 5100.1, Revision 6, the FSA evaluates an establishment’s food safety system to determine whether meat, poultry, or egg products are safe, wholesome, and produced in accordance with applicable statutory and regulatory requirements.
An FSA is different from the routine verification activities performed by in-plant inspection personnel. It is a risk-based, targeted examination of the establishment’s HACCP system as a whole.
That system includes:
The hazard analysis
HACCP plans
Sanitation Standard Operating Procedures
Prerequisite and supporting programs
Scientific and technical support
Initial validation and ongoing verification
Establishment sampling programs
Monitoring and verification records
Corrective actions and reassessments
Actual production and sanitation practices
The EIAO is looking at the connections between these elements, not just whether each document exists independently.
Why Is an FSA Conducted?
Before an FSA is scheduled, the FSIS District Office evaluates establishment performance through a Public Health Risk Evaluation, or PHRE.
The PHRE considers both for-cause and routine risk-based criteria and helps FSIS determine whether an FSA is appropriate and what areas should receive focused review.
Information considered during a PHRE may include:
Patterns of noncompliance
FSIS and establishment sampling results
Recall or foodborne illness information
Repeated sanitation or HACCP concerns
Questions about the adequacy of the hazard analysis
Evidence that a food safety control may not be operating effectively
Establishment compliance and enforcement history
An FSA does not automatically mean FSIS has concluded that the establishment is out of compliance. It does mean the District Office has determined that a closer evaluation of the food safety system is appropriate.
The establishment should take the assessment seriously without assuming that enforcement action is inevitable.
What Happens at the Beginning of an FSA?
The EIAO may provide the establishment with up to two weeks’ advance notice and identify the types of documents that should be available when the assessment begins.
Under the current FSIS methodology, the in-plant portion of an FSA is generally completed within seven production days. Limited extensions may occur when additional tools are required, sampling results are delayed, or more time is needed to develop an enforcement recommendation.
The assessment begins with an entrance meeting involving establishment management and, when possible, in-plant inspection personnel and the Frontline Supervisor.
The EIAO will generally explain:
Why the FSA is being conducted
How the scope was developed through the PHRE
Which products and processes will be evaluated
What records and documents will be requested
The anticipated work and production schedule
How findings will be communicated
The possible FSA outcomes
The EIAO may also tour the establishment during the first or second day to understand product flow, review processing activities, and identify operations that need to be observed.
This is where preparation and communication matter.
Establishment personnel should answer questions accurately and avoid guessing. If a record, scientific support document, or explanation is not immediately available, it is generally better to locate and review the correct information than to offer an incomplete or inaccurate response.
What Is the EIAO Really Evaluating?
Although every FSA is different, the assessment generally centers on four questions.
1. Is the Food Safety System Properly Designed?
The EIAO will evaluate whether the establishment has identified the biological, chemical, and physical hazards associated with its products and processes, as required under 9 CFR Part 417.
This review may consider:
Raw materials and incoming ingredients
Product formulations
Processing steps
Intended use and intended consumers
Pathogens and other biological hazards
Allergens and other chemical hazards
Physical hazards
Storage and distribution
Relevant scientific and historical information
The EIAO may examine both hazards that the establishment determined are reasonably likely to occur and hazards determined not reasonably likely to occur.
A statement in the hazard analysis is not enough by itself. The establishment must have support for its decisions.
If a hazard is reasonably likely to occur, the HACCP plan must include one or more critical control points designed to control it. If a hazard is controlled through a prerequisite program, that program must support the corresponding decision in the hazard analysis.
2. Are the Establishment’s Decisions Scientifically Supported?
Scientific support and validation remain challenging areas for many establishments.
A published study, regulatory guideline, challenge study, process authority letter, or other technical document does not automatically support every product or process.
The EIAO may evaluate whether the support applies to the establishment’s actual:
Product
Formulation
Process
Equipment
Time and temperature parameters
Critical operating factors
Target organisms or hazards
Consider a cooking process supported by documentation that depends on specific relative humidity parameters. If the establishment cannot demonstrate that those parameters are met during production, the support may not apply to the actual process.
The same issue can occur when a study addresses a different product thickness, formulation, casing diameter, drying process, cooling method, or equipment configuration.
The question is not simply, “Do you have scientific support?”
The question is, “Does the support match what you are actually doing?”
The establishment must also have in-plant validation data demonstrating that the HACCP system can be implemented as designed under actual operating conditions.
3. Is the System Implemented as Written?
A technically sound written program can still create regulatory problems when actual practices do not match it.
The EIAO will make direct observations within the facility. Depending on the assessment, this may include observing:
HACCP monitoring and verification
Sanitation SOP implementation
Pre-operational and operational sanitation
Slaughter and sanitary dressing practices
Antimicrobial applications
Cooking, cooling, drying, or fermentation processes
Employee handling practices
Establishment sampling
Raw and ready-to-eat separation
Product and personnel movement
For example, a prerequisite program may require a particular receiving temperature, supplier document, sanitation activity, or employee practice. If the program is used to support a decision in the hazard analysis, the establishment must follow, monitor, document, and maintain it as written.
The production floor, the records, and the written program should tell the same story.
4. Do the Records Show That the System Is Working?
An FSA is not limited to isolated records.
Under the current methodology, the EIAO generally selects a random sample of 13 production days from the preceding 60 days for review. The review may expand when the records point to a broader food safety concern.
The EIAO may examine:
HACCP records
Sanitation records
Prerequisite-program records
Sampling and testing results
Corrective actions
Reassessments
Noncompliance records
Complaints and recalls
FSIS inspection and sampling history
The EIAO is also looking for patterns.
One deviation may be an isolated event. Repeated deviations involving the same process, recurring sanitation findings, inconsistent monitoring entries, or multiple corrective actions addressing the same condition may reveal a larger system weakness.
Corrective action must do more than address the affected product. Where required, it must also identify and address the cause and include measures to prevent recurrence.
Where Do Establishments Commonly Encounter Problems?
Every establishment and assessment is different, but recurring problem areas include:
Hazards missing from the hazard analysis
Unsupported decisions that a hazard is not reasonably likely to occur
Scientific documentation that does not match the actual product or process
Incomplete initial validation
HACCP plans that no longer reflect current operations
Prerequisite programs that are written but not consistently implemented
Monitoring or verification conducted at the wrong frequency
Records that are incomplete, inconsistent, or created after the fact
Corrective actions that address product but not recurrence
Missed reassessments following material changes
Employee practices that differ from written procedures
Repeated findings that have not been evaluated as a broader trend
The underlying issue is often not one missing form or one incorrect entry. It is a disconnect between the written food safety system and the operating system.
What Happens After the Assessment?
At the conclusion of the FSA, the EIAO conducts an exit meeting with establishment management. In-plant inspection personnel and the Frontline Supervisor may also attend.
The EIAO will discuss the findings, explain the basis for any noncompliance or enforcement recommendation, answer questions, and provide either a draft or final copy of the FSA report.
The EIAO recommends one of three outcomes:
No further action
Issuance of noncompliance records
Enforcement action
When noncompliance records are warranted, the in-plant inspection team issues the NRs. When enforcement action is warranted, the District Office may issue a Notice of Intended Enforcement or a Notice of Suspension.
When the EIAO identifies systemic issues that are documented through NRs but do not rise to the level of enforcement action, the current methodology directs the Frontline Supervisor to conduct an in-person follow-up visit within 30 days of the exit meeting.
The EIAO may communicate findings and vulnerabilities throughout the assessment but will not predict the final FSA outcome while the assessment is still underway.
Preparation Is More Than Paperwork
The best time to evaluate FSA readiness is before an assessment is scheduled.
Preparation should examine whether the written system, scientific support, records, employee practices, and production conditions are aligned.
Pre-Assessment Readiness Checklist
As part of a pre-assessment readiness review, consider whether:
Current hazard analyses, HACCP plans, Sanitation SOPs, prerequisite programs, reassessments, and corrective actions are organized and readily available.
Scientific support and validation documents match the establishment’s actual products, formulations, equipment, processes, and operating parameters.
Recent HACCP, sanitation, prerequisite-program, sampling, verification, and corrective-action records are complete, accurate, and internally consistent.
Employees understand the procedures relevant to their duties and can explain or demonstrate how they monitor, verify, document, and respond to deviations.
A walk-through of the production floor confirms that product flow, sanitation, employee practices, monitoring activities, critical limits, and supporting programs match the written system.
Recurring deviations, findings, complaints, sampling results, and reassessments have been reviewed for trends and addressed where necessary.
The strongest establishments are not necessarily the ones with the largest binders.
They are the ones whose hazard analysis, scientific support, written programs, records, employee practices, and production conditions work together as one food safety system.
AgriForaging Compliance Services works with USDA-inspected slaughter and processing establishments to evaluate food safety systems, identify vulnerabilities, and address concerns involving hazard analyses, HACCP plans, prerequisite programs, scientific support, validation, corrective actions, and operational practices before or during a Food Safety Assessment.
Have a question about an upcoming FSA or a concern within your food safety system?
Contact AgriForaging or call the free, confidential AskHACCP Hotline, Monday through Friday from 10 a.m. to 4 p.m. Eastern Time.
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