new risk-based inspection[1]
DESCRIPTION
based inspectionTRANSCRIPT
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Risk-Based Inspection
Philip Derfler Assistant Administrator, Office of Policy, Program and
Employee Development
&
Don Anderson Office of Program Evaluation, Enforcement & Review
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Purpose of Inspection
Traditional Approach Designed to find
problems if they occur
Risk-Based Approach Designed to find
problems that occur Designed to anticipate
problems, thereby minimizing risk
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Deployment of Resources
Traditional Based on what needs
to be done Inspecting carcasses Making inspection
once per plant per shift
Risk-Based Align resources also
with level of risk: Hazards based on type
of species and process Likelihood hazard will
exist in plant Significance of effects Ongoing assessment
of food safety system
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Work to Be DoneTraditional Perform assigned
procedures Under HACCP, 70%
food safety and 30% other procedures.
Risk-Based Varies based on risk
Basic procedures Others based on
inspectional findings and decision criteria
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Activities of Inspection PersonnelTraditional Procedures designed
to find non-compliance
Risk-Based Focused on where loss
of control: Is more likely to occur Would have serious
public health consequences
Intensify inspection if plant is losing/has lost control
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Response to Inspection FindingsTraditional Evidence of compliance
or non-compliance has no effect on intensity of inspection.
Evidence of non-compliance could lead to enforcement action.
Risk-Based Evidence of non-
compliance could lead to enforcement action.
Intensity of inspection based on findings: Good control = less
intense inspection Losing control =
intensified inspection
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Response to Emerging ProblemTraditional Not designed to have
inspectors make a judgment about risk of non-compliance
Risk-Based Inspection personnel
would have flexibility, data, responsibility and training to be able to focus on emerging problems
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Factoring in Food DefenseTraditional Food defense
procedures performed with specified frequency
Risk-Based Food defense
procedures performed at frequency appropriate for national security situation and security situation in establishment
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Attention to Product in Commerce
Traditional Random visits to
facilities that handle meat and poultry products to ensure conditions are sanitary
Risk-Based Scheduled visits to
facilities based on findings and other information
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Risk Control Components
Important Components of Risk ControlFood Safety System ImplementationFood Safety System DesignPathogen ControlIn-Commerce FindingsEnforcement ActionsOther Components
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Food Safety System Implementation
System implementation consistencyFSIS documents all regulatory
noncompliances– and will continue to do so under RBI
However, not all NRs are equally indicative of risk control deficiencies
Our goal is to identify, enumerate, and properly weight public health-related NRs
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Food Safety System Design
Efficacy of the food safety systemFood Safety Assessment Findings
When was the last FSA?What was the outcome?
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Pathogen Control
Pathogen Control in Ready-to Eat Products, Ground Beef, and Other Raw Products
Lm, Salmonella, and E. coli O157:H7 RTE testing program results
E. coli O157:H7 (raw ground beef) testing program results
Salmonella verification testing program results
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In-Commerce Findings
Adverse Findings In-CommerceSignificant Consumer Complaints?Class I or II Recalls?Other Considerations?
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Enforcement Actions
Enforcement ActionsInvolving Food SafetyNot preceded by significant NRsNot initiated as a result of an FSA
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Other Considerations
Other Serious Public Health ConcernsE. coli O157:H7 Positives Suppliers?USDA/AMS school lunch testing results?Others?
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Questions for the Committee
Are these all appropriate objectives for measuring risk control? Should any objectives or corresponding features be deleted? Should any be added?
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Questions for the Committee
Are some components more important—i.e. better indicators of risk control—than others? If yes, should more important components have greater “weight” in our numerical control measure than less important components?
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Questions for the Committee
Should findings from Food Safety Assessments or other sources that indicate exceptionally effective risk controls be allowed to lower (improve) an establishment’s risk control measure?
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FSIS RBI Announcement February 22, 2007
The Following Slides Were Prepared by Dr. Joe Blair of the HACCP Consulting Group, L.L.C. based on a Memorandum of this date by:
Olsson, Frank and Weeda, P.C.
Attorneys at Law
Washington, DC
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FSIS RBI AnnouncementFebruary 22, 2007Begin “piloting” RBI in about 250
processing plants in 30 locationsPhase I
Selected ‘prototype’ locations in April 2007Phase II
Begin in January 2008
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Ranking Plants – Phase I
Inherent Product RiskPlant’s ControlsFinal RankingInspection Intensity
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Inherent Product Risk
Use Current Expert Elicitation for Phase I and New Elicitation for Subsequent Phases Each Product Assigned a Score of 1-20 Plants with Multiple Products – Use the Highest
Risk Product
Multiply Risk by Volume 5 Categories for Volume (highest volume = 5)
Plant Will Have a Product Score of Between 1 and 100
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Plant Controls
Algorithm Criteria Enforcement Actions
Notice of Intended Enforcement (NOIE) = 3 points Suspension = 6 points
Recalls Class I = 3 points (Reasonable Probability of
Adverse Health Risk) Class II = 2 points (Remote Probability of Adverse
Health Risk) Consumer Complaints (verified by FSIS as
accurate) = 1-3 points
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Plant Controls 2
Algorithm Criteria - Continued FSIS Microbiological Test Results
Positive E. coli O157:H7 = 3 points Positive Listeria monocytogenes = 3 points Maximum of 9 points for this category
RTE Regulatory Alternative (Listeria regulations) Alt. 1 (Post Lethality Treatment) = 0 points Alt. 2 (Post Lethality Suppression) = 2 points Alt. 3 (Sanitation Only) = 3 points
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Plant Controls 3
Algorithm Criteria - Continued
Salmonella Performance Standards Verification CategoriesCat. 1 -- < 50 % of Standard = 0 pointsCat. 2 -- 51-100% of Standard = 2 pointsCat. 3 -- Exceeds Standard = 3 points
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Plant Controls 4
Algorithm Criteria - Continued Non-Compliance Records (NRs)
Only Consider NRs having Public Health Significance
Rank Each NR on Severity (1-3) Compare Totals with Other Plants in Phase I Divide Plants into Quintiles (I/5th)
Top 20% = 5 points Bottom 20% = 1 point
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Plant Controls 5
Algorithm Criteria - Continued
Once a Score is Generated by AlgorithmDetermine % for Plant by Using the Actual
Score Divided by the Maximum Score for any Plant in Phase I that Conducts the Same Type of Operation
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Final Ranking
The Plant’s Final Score will be the Average of:
The Product Risk Divided by the Volumeand
Plant’s Control Score
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Phase I Specifics
Ranking -- FSIS will NOT use the Precise Calculated Number -- Rather the Plants will be Grouped into 3 Categories:
Highest Risk Plants - Receive More Inspection Intensity
Middle Risk Plants – Receive about the Current Level of Inspection Intensity
Lowest Risk Plant – Receive Less Inspection Intensity.
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Inspection Intensity
All Plants will Continue Receiving Daily Inspection Inspectors at Higher Risk Plants will have
Extra Scheduled Tasks to Perform (more time in the plant)
Inspectors Lower Risk Plants will have Fewer Scheduled Tasks to Perform (less time in the plant)
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Phase II – 2008 ?
The Results from Phase I will be Utilized to Refine and Improve the Program Before Moving to Phase II
Acceptance by Industry, Consumers and Inspection Personnel Unknown at this Point.
Such an Approach Offers Opportunity for More Effective Use of Resources
Time Will Tell!