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Assessment Strategies

EIAO Training

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General Sanitation SPS/SSOP-Review:

• SSOP Regulations 9 CFR 416.11-416.17

• SPS Regulations 9 CFR 416.1-416.6

• Sanitation SOP must contain:

• Daily procedures conducted both before and during operations to

prevent direct contamination of product, or product contact surfaces.

• Establishment implementing and performing at the frequencies

stated in the plan. 

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General Sanitation SPS/SSOP-Review:

• The establishment shall routinely evaluate and revise the Sanitation

SOPs and procedures as necessary to keep them current.

• Corrective actions must be taken and documented when there is failure

to prevent direct contamination of product or product contact surfaces. 

Remember DRIP

• Disposition, Restore, Prevent

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General Sanitation SPS/SSOP-Review:

• Establishment must document the monitoring of the SSOP & any

corrective actions taken. 

• Records made available to FSIS personnel upon request.

• Use FSIS Directive 5000.1 as guidance

• Answer questions from the General Tool and any additional questions

contained in specific tools (i.e. Sanitary Dressing/RTE Sanitation).

• Review appropriate records

• Make direct observations

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Performing the Assessment

• The EIAO reviews and considers

• Sanitation NRs

• Salmonella Performance Standards results

• Impact of SPS findings on food safety

• Impact on the HACCP system

• View entire operation

• Determine if adequate level of sanitation is maintained to prevent

product adulteration

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Performing the Assessment

• The EIAO will

• Review SSOP design-assess the SSOP and its routine procedures are

designed and implemented to prevent direct product contamination.

• Analyze how the SSOP design and implementation impact the ability to

support decisions in the Hazard Analysis and HACCP plan.

• Observe SSOP implementation.

• Randomly review 13 days of SSOP records from the last 60 production

days.

• Answer questions from tools.

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Performing the Assessment

• The EIAO should analyze the information collected relating to sanitation

requirements and document a supportable agency position.

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General Tool – Dual Jurisdiction

• When establishments produce both FDA and FSIS regulated

products, gather info about how establishments address

production

• Directive 5730.1

• Assess how the food safety system prevents contamination of

FSIS products from insanitary conditions in FDA areas, especially

for RTE products

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Other Information - Recalls

• Recalls:

• 9 CFR 418.2-418.4

• Establishment must notify FSIS within 24 hours if reason to believe

adulterated product entered commerce

• Establishment must maintain written procedures

• Directive 5000.8 Verifying Compliance with Requirements for Written Recall

Procedures

• If EIAO determines noncompliance with 418-Work with Supervisor/FLS to

get NR issued.

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Methods Group Exercise I

• A cattle slaughter plant has had

multiple instances of rail dust

contamination on carcasses in the

cooler for the last 2 months.

• What would your regulatory & statutory

thought process be for taking a possible

enforcement action?

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