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Food Safety Assessment-FSA

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The FSA: Purpose

• Focus on certain processes based on the PHRE

• Assess and analyze a plant’s food safety system as a

whole

• Prepare a written report with a supportable

recommendation focusing on documenting

vulnerabilities and noncompliance.

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The FSA: Purpose

• FSA Methodology

• Focus based approach.

• Allows for EIAOs to focus time and resources on vulnerable portions

of the Establishment’s Food Safety System.

• Allows for EIAO’s to focus their observations, review and analysis to

focus on public health risk.

• Increases consistency of FSA in time, analysis and documentation.

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Process from PHRE to Finalizing FSA

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Enforcement

Preparing for the FSA

• Define the scope and the tools to be completed.

• Develop a plan for conducting the FSA.

• Complete the General tool for every FSA.

• Any additional tools to complete will depend on the specific

scenario.

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Preparing for the FSA

• Situations when >2 tools are completed:

• New establishments coming under inspection

• All applicable tools

• Criteria in Directive 5100.4 spans multiple HACCP categories

• STEC positive in raw non-intact

• Lm positive in RTE

• Any issues identified during the FSA or PHRE

• Add tool associated with the issue identified

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Tools

Product Types HACCP Category Tool to Use

Raw Poultry Slaughter; Raw Intact; Poultry Tool

Raw Non-Intact

Raw Meat Slaughter; Raw Intact; Meat Tool

Raw Non-Intact

NRTE Meat or Poultry HT SS; NHT SS; HT NFC NSS; RTE/NRTE Products Tool

Secondary Inhibitors NSS

RTE Meat or Poultry HT SS; NHT SS; FC NSS; RTE/NRTE Products Tool

Secondary Inhibitors NSS

Thermally Processed Thermally Processed Thermally Processed

Meat or Poultry Commercially Sterile Commercially Sterile Tool

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Scope of the FSA

• Determine if pathogen sampling is to be performed.

• RLm- sample during the week prior to the FSA and consider the results

in the FSA outcome.

• IVT- Intensified Verification Testing will be discussed later in this course

• IIT- If an Incident Investigation Team is formed, it will include subject

matter experts who will focus on the unique issue of concern.

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RLM, IVT, or IIT

• Sampling is completed prior to an FSA.

• Not a part of the 5-7 day window.

• Provide the establishment with at least 1-week

notice that RLm sampling will occur,

• Delay in results or sampling may extend FSA

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Notifying Establishment of FSA

• Give the establishment 1-2 weeks advance notice of

the visit; and

• Give the FLS and IPP 1-2 weeks advance notice of the

establishment visit.

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Notifying Establishment of FSA

• Exception to 1-2 week advance notice

• “For Cause” FSA prompted by

• Positive sample results

• Shipment of adulterated product

• Other high priority food safety incidents

• See FSIS Directive 5100.4

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Notifying Establishment of FSA

• During the Discussion with Est./ FLS/ IPP

• Communicate documents needed

• SSOPs, HACCP Plan, HA, PRP, Supporting Documents, Testing Records, 

etc.

• At least the last 60 days of records

• At least 13 productions days for very small plants.

• Must express the need for these documents to be available to

accomplish 5-7 day time frame.

• May follow up discussions with a MOI to assure clear

communication.

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Objective Check-Up

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• What is the overall purpose of an FSA?

Pre-FSA Correlation

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• Prior to Visiting the Establishment

Prior to Visiting the Plant

• Review PHRE that contains

• All relevant data available regarding the establishment including any previous

FSAs

• Review relevant agency issuances that pertain to plant processes,

compliance guidelines, training and AskFSIS questions

• Correlate with the Case Specialist about issues and discuss strategy

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Prior to Visiting the Plant

• EIAO should also review relevant

• Policy issuances

• Guidance materials

• Training materials

Professionalism reminder:

• Being prepared improves your credibility

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Pre-Entrance Meeting

• EIAO should meet with FSIS personnel first to discuss the process and

any issues

• Advise that EIAO role is not to resolve disputes

• EIAO assesses food safety systems and formulates an agency

supportable recommendation based on findings

Professionalism reminder:

 contact IIC and reach out

as a team member

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Entrance Meeting

• Conduct entrance meeting with management, inplant inspection team, FLS and discuss:

• Reason for and scope of the FSA

• Discuss Public Health Regulations

• How an FSA differs from day-to-day inspection

verification

• Typical work schedule

• Accessing production areas and special rules

• Where EIAO will work

• Where records are stored and access to them

• Photographs as an extension of inspection authority

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Entrance Meeting

• Explain

• EIAO role is not to resolve disputes

• Communication with in-plant inspection team and establishment management

about findings

• Possible outcomes

• Exit conference held upon completion of FSA

• Draft copy of FSA report will be provided at exit conference. 

• Final copy provided by the EIAO or DO. 

• EIAO ContactInformation

• Document entrance meeting in the General Tool

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Performing the Assessment

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On-going Communication

Ongoing Communication

• FSIS expects the EIAO to communicate with

establishment management throughout the FSA

process.

• Remain fair and objective.

• Bring attention to and discuss non-compliances and

vulnerabilities as they are identified.

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IMPORTANT 

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Ongoing Communication

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• Do not predict the FSA outcome!

Ongoing Communication

• Noncompliances will be documented in the FSA even

if the establishment comes into compliance after

notification

• NRs by IPP

• NOIE or suspension letter

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Ongoing Communication

• EIAO communicates with in-plant team and FLS throughout the FSA

• Describe noncompliances and vulnerabilities

• Discuss establishment production practices

• Document in the FSA report any information provided by FLS or inplant team that may affect outcome if not already captured in NR or

MOIs

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Teamwork! 

Teamwork! 

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Ongoing Communication

• The EIAO, in-plant inspection team, and FLS work

collaboratively to ensure all noncompliances are

communicated to plant management and documented for

issuance at the exit meeting.

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Ongoing Communication

• Example

• EIAO recommends in-plant team issue NRs

• Contacts DDM and SEIAO to discuss prior to sending draft FSA for

review.

• After concurrence EIAO contacts FLS and works with IIC and in-plant

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team to ensure NRs are issued

Ongoing Communication

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• FSIS must provide due process to the plant through ongoing

communication with plant officials throughout the course of the

FSA.

Due Process

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Ongoing Communication

• EIAO provides frequent updates to SEIAO, DDM, or DM on FSA

progress and strategy

• Frequent updates to IIC and FLS on findings and any

recommendations

• DDM may request additional info or provide resources

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Ongoing Communication

• Request, don’t demand!

• Be able to explain statutory authority to examine facilities and

copy records

• If EIAO encounters resistance

• Contact SEIAO or DO to develop strategy

• DO may contact EARO who may then contact OIEA to get administrative

subpoena to obtain records

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Objective Check-Up

• What are the reasons an FSA is scheduled at an establishment?

• What are the timeframes involved in preparing for, notifying

other parties, conducting, and concluding an FSA.

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FSA Methodology Overview

• Complete FSA in 5-7 days

• If additional time needed explain to DO

• If a delay is necessary, discuss reasons with establishment and

when it will resume

• Possible reasons for an extension:

• Enforcement

• 3 or more tools

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FSA Methodology

• Evaluate the HACCP System as a whole.

• Use system-based approach to determine adequacy

• Focus on:

• Vulnerabilities and noncompliances - their effect on the food safety

system

• The establishment’s ability to produce a safe and wholesome product

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FSA Methodology Overview

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• FSA is conducted by:

• Records review

• Direct observation of establishment operations

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The FSA Tools

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• Every FSA must have:

• PHRE & General Tool

• At least one of the processing category tools

The FSA Tools

• Function of FSA tools questions

• Provide a structured format

• Aid in gathering all necessary info

• Aid in determining risk relative to other establishments

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The FSA Tools

• Each tool is only completed once 

• For example, if an establishment produces

products under multiple HACCP processing

categories that fall under the same tool such as

raw intact and raw non-intact the tool should be

completed once with an assessment of both

HACCP categories included throughout.

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The FSA Tools

• Be familiar with the tool questions. 

• Enhances your ability to complete FSA in 5-7 days

• Limits redundancy.

• Document all noncompliance and vulnerability findings.

• Vulnerability- a less than perfect finding that may lead to noncompliance if it is not

addressed

• Several questions could have similar responses

• Do not “copy and paste” 

• Instead, reference the original response

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The FSA Tools

• Limit responses in the tools to information related to the HACCP

categories being evaluated

• Do not to include information from other categories unless the

information has a bearing on the category being evaluated as part of the

focused FSA.

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The FSA Tools - Overview

• General Tool:

• The General Tool contains the following sections: 

• FSA Recommendation

• General Sanitation

• Other General Questions

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The FSA Tools - Overview

• Meat Tool & Poultry Tool contains:

• Hazard Analysis and HACCP System

• Slaughter and Sanitary Dressing

• Outside Source Materials for Further Processing

• Antimicrobial Treatment for Slaughter and Further Processing

• Sampling and Testing for Slaughter and Further Processing

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The FSA Tools - Overview

• Ready-to Eat (RTE) Processed Products FSA Tool:

• Hazard Analysis and HACCP System

• Lethality and Stabilization: Fully Cooked, Not Shelf Stable

• Lethality and Stabilization for Fermentation, Drying, and Salt-curing

• Non-meat Ingredients for RTE Products

• Listeria Rule (9 CFR 430) for RTE Products

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The FSA Tools- Overview

• Not Ready-To-Eat (NRTE) Processed Products:

• Hazard Analysis and HACCP System

• Design of the Heat Treatment, Fermentation, or Other

Processes for NRTE Processed Products

• NRTE Processed Products: Appearance

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FSA TOOLS 

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The FSA Tools - Overview

• Thermally Processed: 

• Hazard Analysis and HACCP System

• Following Canning Regulations as Pre-Requisite Program to

Prevent Biological Hazards

• Chemical and Physical Hazards

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The FSA Tools

• Use tools to document all findings

• Do not keep outside notes

• If an enforcement is recommended, any notes outside FSA Report must

be forwarded to DCS

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The FSA Tools – Analysis Sections

• EIAO analyzes findings to reach an agency supportable

recommendation

• Summary documented as part of each tool

• Analysis is summarized in the Decision- Making Analysis 

Question in the General Tool 

• The Executive Summary is documented in the General Tool 

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FSA Methodology Overview

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• Use AskFSIS to obtain expert advice on scientific and technical

issues.

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