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MEASURING THE EFFECTIVENESS OF THE NATION’S FOODSERVICE AND RETAIL FOOD PROTECTION
SYSTEM
MEASURING THE EFFECTIVENESS OF THE NATION’S FOODSERVICE AND RETAIL FOOD PROTECTION
SYSTEM
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PRESENTATION OBJECTIVES
PRESENTATION OBJECTIVES
• Purpose of FDA’s Study
• Review What the Study IS and IS NOT
• Review the Design of the Study
• Preview of 2003 Results
• Present Recommendations
• Purpose of FDA’s Study
• Review What the Study IS and IS NOT
• Review the Design of the Study
• Preview of 2003 Results
• Present Recommendations
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BACKGROUNDBACKGROUND
• FDA National Retail Food Steering Committee
• Government Performance and Results Act (1993)“performance plans … measurable indicators”
• FDA National Retail Food Steering Committee
• Government Performance and Results Act (1993)“performance plans … measurable indicators”
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INTRODUCTION AND PURPOSE
INTRODUCTION AND PURPOSE
• Agency effort to change behaviors / practices related to foodborne illness
• Identify food safety practices and employee behavior most in need of attention
• Agency effort to change behaviors / practices related to foodborne illness
• Identify food safety practices and employee behavior most in need of attention
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INTRODUCTION AND PURPOSE
INTRODUCTION AND PURPOSE
• Establish a national baseline on the occurrence of foodborne illness risk factors
• Effort to collect sufficient data to measure patterns in the occurrence of foodborne illness risk factors over time
• Establish a national baseline on the occurrence of foodborne illness risk factors
• Effort to collect sufficient data to measure patterns in the occurrence of foodborne illness risk factors over time
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STUDY TIME LINESTUDY TIME LINE
• 1998 1ST Data CollectionReport of the FDA Retail Food Program Database of Foodborne Illness Risk Factors (2000)
• Established a Baseline for 9 different foodservice and retail food facility types
• 1998 1ST Data CollectionReport of the FDA Retail Food Program Database of Foodborne Illness Risk Factors (2000)
• Established a Baseline for 9 different foodservice and retail food facility types
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STUDY TIME LINESTUDY TIME LINE
• 2003 2nd Data CollectionFDA Report on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice, Restaurant and Retail Food Store Facility Types (2004)
• Begins the process for establishing multiple data collection periods
• 2003 2nd Data CollectionFDA Report on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice, Restaurant and Retail Food Store Facility Types (2004)
• Begins the process for establishing multiple data collection periods
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STUDY TIME LINESTUDY TIME LINE• 2008 3rd Data Collection will be
conducted
Report prepared for 2009 will begin the process of analyzing the three data sets (1998, 2003, and 2008) to assess improvement or regression changes from the 1998 Baseline
• 2008 3rd Data Collection will be conducted
Report prepared for 2009 will begin the process of analyzing the three data sets (1998, 2003, and 2008) to assess improvement or regression changes from the 1998 Baseline
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WHAT THE REPORT IS AND IS NOT
WHAT THE REPORT IS AND IS NOT
• IS – a national assessment of the relative strengths & weaknesses of food safety systems designed to control the occurrence of foodborne illness risk factors
• IS NOT – a correlation of the occurrence of foodborne illness risk factors with the actual incidence of human illness
• IS – a national assessment of the relative strengths & weaknesses of food safety systems designed to control the occurrence of foodborne illness risk factors
• IS NOT – a correlation of the occurrence of foodborne illness risk factors with the actual incidence of human illness
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WHAT THE REPORT IS AND IS NOT
WHAT THE REPORT IS AND IS NOT
• IS– an assessment that used the 1997 Food Code provisions as the standard upon which observations of food safety practices are based
• IS NOT– a determination of the industry’s OR a specific establishment’s regulatory compliance with prevailing laws & regulations
• IS– an assessment that used the 1997 Food Code provisions as the standard upon which observations of food safety practices are based
• IS NOT– a determination of the industry’s OR a specific establishment’s regulatory compliance with prevailing laws & regulations
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METHODOLOGYMETHODOLOGY
• Scope: 3 Industry segments / 9 facility types:
1.Institutions • Hospitals• Nursing Homes• Elementary Schools
• Scope: 3 Industry segments / 9 facility types:
1.Institutions • Hospitals• Nursing Homes• Elementary Schools
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METHODOLOGYMETHODOLOGY
• Scope: 3 Industry segments / 9 facility types:
2.Restaurants• Fast Food• Full-Service
• Scope: 3 Industry segments / 9 facility types:
2.Restaurants• Fast Food• Full-Service
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BACKGROUNDCONTRIBUTING FACTORS
BACKGROUNDCONTRIBUTING FACTORS
• Food from Unsafe Source
• Inadequate Cooking
• Improper Holding/Time-Temp.
• Contaminated Equipment/Protection
from Contamination
• Poor Personal Hygiene
• Other “Chemical Hazards”
• Food from Unsafe Source
• Inadequate Cooking
• Improper Holding/Time-Temp.
• Contaminated Equipment/Protection
from Contamination
• Poor Personal Hygiene
• Other “Chemical Hazards”
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METHODOLOGYMETHODOLOGY• Data Collection – Records status
for all individual data items
IN – In Compliance
OUT – Out of Compliance
N.O. – Not Observed
N.A. – Not Applicable
• Data Collection – Records status for all individual data items
IN – In Compliance
OUT – Out of Compliance
N.O. – Not Observed
N.A. – Not Applicable
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DATA ANALYSISDATA ANALYSIS• Three levels of data analysis are conducted
for each of the 9 facility types
A. Out of Compliance percentage for each individual data item
B. Out of Compliance percentage for each foodborne illness risk factor
C. Overall IN Compliance percentage for all 42 data items
• Three levels of data analysis are conducted for each of the 9 facility types
A. Out of Compliance percentage for each individual data item
B. Out of Compliance percentage for each foodborne illness risk factor
C. Overall IN Compliance percentage for all 42 data items
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Determining the Out of Compliance percentage for
each DATA ITEM
Determining the Out of Compliance percentage for
each DATA ITEM
Percent Out of Compliance =Percent Out of Compliance =Percent Out of Compliance =Percent Out of Compliance =
Total Out of ComplianceTotal Out of ComplianceObservations for a Data ItemObservations for a Data ItemTotal Out of ComplianceTotal Out of ComplianceObservations for a Data ItemObservations for a Data Item
Total number of Observations(IN and OUT) for the Data ItemTotal number of Observations(IN and OUT) for the Data Item
X 100%X 100%X 100%X 100%
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Determining Out of Compliance Percentages
FOODBORNE ILLNESS RISK FACTORS
Determining Out of Compliance Percentages
FOODBORNE ILLNESS RISK FACTORS
Observations of DATA ITEMS
FOODBORNE ILLNESS RISK FACTOR
Observations of DATA ITEMS
FOODBORNE ILLNESS RISK FACTOR
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RISK FACTOR
Number of Data Items
for each Risk Factor
Referenced Sections
From Data Collection
Form Food from Unsafe Sources
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Sections 1 – 3
Inadequate Cooking
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Sections 4 – 5
Improper Holding/Time Temperature
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Sections 6 – 9
Contaminated Equipment/Protection from Contamination
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Sections 10 – 11
Poor Personal Hygiene
5
Sections 12 – 15
Other (Chemical Contamination)
3
Section 16
TOTAL NUMBER OF DATA ITEMS 42
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Determining the Out of Compliance percentage
for each FOODBORNE ILLNESS RISK FACTOR
Determining the Out of Compliance percentage
for each FOODBORNE ILLNESS RISK FACTOR
Percent Out of Compliance =Percent Out of Compliance =Percent Out of Compliance =Percent Out of Compliance =
Total Out of ComplianceTotal Out of ComplianceObservations for a Risk FactorObservations for a Risk FactorTotal Out of ComplianceTotal Out of ComplianceObservations for a Risk FactorObservations for a Risk Factor
Total number of Observations(IN and OUT) for the Risk FactorTotal number of Observations(IN and OUT) for the Risk Factor
X 100%X 100%X 100%X 100%
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ExampleOut of Compliance Percentage
Poor Personal Hygiene - Risk Factor
ExampleOut of Compliance Percentage
Poor Personal Hygiene - Risk Factor
Poor Personal Hygiene
5 DATA ITEMS – Data collection Form
12A 13A 14A 15A 15B
Poor Personal Hygiene - RISK FACTOR
Poor Personal Hygiene
5 DATA ITEMS – Data collection Form
12A 13A 14A 15A 15B
Poor Personal Hygiene - RISK FACTOR
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Determining Overall IN Compliance Percentages
- FACILITY TYPES -
Determining Overall IN Compliance Percentages
- FACILITY TYPES -
6 RISK FACTOR CATEGORIES
Overall In Compliance %
Facility Types
6 RISK FACTOR CATEGORIES
Overall In Compliance %
Facility Types
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Overall PERCENTAGE (%) of OBSERVABLE and APPLICABLE
data items found IN Compliance
Industry Segment
Facility Type
1998 Baseline*
% IN Compliance Observable Items
(rounded to nearest %)
2010 FDA
Improvement
Goal** (rounded to nearest
(%) Institutions Hospital 80% 85%
Nursing Home 82% 87% Elementary
School
80%
85%
Restaurants Fast Food 74% 81% Full Service 60% 70%
Retail Food Deli 73% 80% Meat & Poultry 81% 86% Produce 76% 82% Seafood 83% 87%
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Foodborne Illness Risk Factorin Need of Priority Attention
(2000 Report)
Foodborne Illness Risk Factorin Need of Priority Attention
(2000 Report)
• Improper Holding/Time and Temperature
• Poor Personal Hygiene
• Contaminated Equipment / Protection from Contamination
• Improper Holding/Time and Temperature
• Poor Personal Hygiene
• Contaminated Equipment / Protection from Contamination
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2004 ReportData Results and Discussion
2004 ReportData Results and Discussion
• For each of the 9 facility types the Data Results will present:
A. Overall Out of Compliance percentage for each of the foodborne illness risk factors
B. Individual data Items that comprise each of the risk factors that are in need of priority attention
• For each of the 9 facility types the Data Results will present:
A. Overall Out of Compliance percentage for each of the foodborne illness risk factors
B. Individual data Items that comprise each of the risk factors that are in need of priority attention
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2004 ReportData Results and Discussion
2004 ReportData Results and Discussion
• For each of the 9 facility types the Data Results will present:
C. A national strengths/weaknesses assessment of management systems
for controlling the occurrence of foodborne illness risk factors
• For each of the 9 facility types the Data Results will present:
C. A national strengths/weaknesses assessment of management systems
for controlling the occurrence of foodborne illness risk factors
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SUMMARY – DELI DEPARTMENTS
FOODBORNE ILLNESS
RISK FACTOR in need of priority attention
INDIVIDUAL DATA ITEMS
In need of priority attention
Commercially-processed RTE, PHF Date Marked
PHF Held Cold at 41º F or Below RTE, PHF Date Marked After 24 Hours PHF Held Hot at 140º F or Above PHF Cooled to 70º F in 2 Hours/41º F in Total of 6 Hours
Improper Holding/ Time & Temperature
RTE, PHF Discarded After 4 Days/45º F or 7 Days/41º F
Proper, Adequate Handwashing
Handwashing Facility, Convenient/Accessible
Poor Personal Hygiene
Handwashing Facility, Cleanser/Dry Device
Surfaces/Utensils Cleaned/Sanitized
Contaminated Equipment/ Protection from Contamination Raw/RTE Foods, Separated
Other/Chemical
Poisons/Toxic ID Store/Use Properly
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Hot Holding at 140 oF (Data Item 8A) vs.
Hot Holding at 135 oF (Data Item 18A)
Facility Type Total
IN 140 oF
Total Out
140 oF
% IN 140 oF
Total IN
135 oF
Total Out 135 oF
% IN 135 oF
Difference (%IN)
Hospitals 59 36 62.1% 65 30 68.4% 6.3% Nursing Homes 53 17 75.7% 54 16 77.1% 1.4% Elementary Schools 61 21 74.4% 62 20 75.6% 1.2% Fast Food Rest. 66 28 70.2% 71 23 75.5% 5.3% Full Service Rest. 45 42 51.7% 48 39 55.2% 3.5% Delis 38 59 39.2% 41 56 42.3% 3.1% Meat & Poultry* 0 2 0%* 1 1 50.0%* 50.0%* Seafood* 3 3 50.0%* 3 3 50.0%* 0%*
Produce* 6 0 100%* 6 0 100%* 0%* * The number of observations for these 3 facility types is too low to make comparisons
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Risk Factors with Statistically Significant Differences Between Establishments
WITH and WITHOUT a Certified Food Protection Manager
Facility Type
Foodborne Illness Risk Factors
Fast Food
Restaurants
Improper Holding/Time and Temperature Contaminated Equipment/Protection from
Contamination
Full Service Restaurants
Poor Personal Hygiene Contaminated Equipment/Protection from
Contamination
Meat and Poultry Departments
Poor Personal Hygiene
Produce Departments
Poor Personal Hygiene
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Average Inspection Time per Establishment for each of the 9 Facility Types (Total MINUTES per Establishment)
Facility Type Average Inspection Time
(In Minutes)
HOSPITALS 155 ELEMENTARY SCHOOLS 99 NURSING HOMES 129 FAST FOOD RESTAURANTS 87 FULL SERVICE RESTAURANTS 133 DELI 94 MEAT & POULTRY 48 SEAFOOD 56
PRODUCE 41
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Pathways to Reach the Goals Pathways to Reach the Goals
Risk Factors +
InterventionStrategies
+ Performance
Measures
FDA Foodborne Illness Risk Factor Study
Standardization &Certification
Program
Standards
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RECOMMENDATIONS FOR INDUSTRY
RECOMMENDATIONS FOR INDUSTRY
ACTIVE MANAGERIAL
CONTROL OF FOODBORNE
ILLNESS RISK FACTORS
ACTIVE MANAGERIAL
CONTROL OF FOODBORNE
ILLNESS RISK FACTORS
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ACTIVE MANAGERIAL CONTROL
ACTIVE MANAGERIAL CONTROL
Purposeful incorporation of
specific actions or procedures
by industry management
to attain control of
foodborne illness risk factors
Purposeful incorporation of
specific actions or procedures
by industry management
to attain control of
foodborne illness risk factors
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RECOMMENDATIONS FOR INDUSTRY
RECOMMENDATIONS FOR INDUSTRY
• Develop and implement Standard Operating Procedures (SOPs) to address FBI risk factors
• Develop and implement Standard Operating Procedures (SOPs) to address FBI risk factors
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RECOMMENDATIONS FOR INDUSTRY
RECOMMENDATIONS FOR INDUSTRY
• Provide employees with specific training and equipment to implement the SOPs
• Provide employees with specific training and equipment to implement the SOPs
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RECOMMENDATIONS FOR INDUSTRY
RECOMMENDATIONS FOR INDUSTRY
• Incorporate critical limits and measurable standards for control of FBI risk factors in SOPs
• Incorporate critical limits and measurable standards for control of FBI risk factors in SOPs
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RECOMMENDATIONS FOR INDUSTRY
RECOMMENDATIONS FOR INDUSTRY
• Establish monitoring procedures that focus on critical processes and practices
• Establish monitoring procedures that focus on critical processes and practices
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RECOMMENDATIONS FOR INDUSTRY
RECOMMENDATIONS FOR INDUSTRY
• Identify methods to routinely assess the effectiveness of the SOPs
• Identify methods to routinely assess the effectiveness of the SOPs
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RECOMMENDATIONS FOR INDUSTRY
RECOMMENDATIONS FOR INDUSTRY
• FDA guidance document for industry
Managing Food Safety: A Guide for Voluntary Use of HACCP Principles for Operators of Foodservice and Retail Establishments
www.cfsan.fda.gov/~dms/hret-toc.html
• FDA guidance document for industry
Managing Food Safety: A Guide for Voluntary Use of HACCP Principles for Operators of Foodservice and Retail Establishments
www.cfsan.fda.gov/~dms/hret-toc.html
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RECOMMENDATIONS FOR REGULATORY
RECOMMENDATIONS FOR REGULATORY
• Use risk-based inspection methodology
- risk factors should be the primary focus of every inspection
• Provide flexible work schedules
• Use risk-based inspection methodology
- risk factors should be the primary focus of every inspection
• Provide flexible work schedules
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RECOMMENDATIONS FOR REGULATORY
RECOMMENDATIONS FOR REGULATORY
• Properly train and equip field personnel
• Document compliance determination (IN; OUT; N.O.; N.A.)
• Properly train and equip field personnel
• Document compliance determination (IN; OUT; N.O.; N.A.)
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RECOMMENDATIONS FOR REGULATORY
RECOMMENDATIONS FOR REGULATORY
• Establish a dialog with industry foodservice and retail food store operators
• Recognize existing industry Quality Assurance Systems and Training Programs
• Establish a dialog with industry foodservice and retail food store operators
• Recognize existing industry Quality Assurance Systems and Training Programs
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RECOMMENDATIONS FOR REGULATORY
RECOMMENDATIONS FOR REGULATORY
• Take appropriate corrective action
– Obtain immediate corrective action at the time of inspection for risk factors found out of compliance
• Take appropriate corrective action
– Obtain immediate corrective action at the time of inspection for risk factors found out of compliance
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RECOMMENDATIONS FOR REGULATORY
RECOMMENDATIONS FOR REGULATORY
• Take appropriate corrective action
– Assist in developing Standard Operating Procedure and Risk Control Plans designed to attain long-term managerial control of risk factors
• Take appropriate corrective action
– Assist in developing Standard Operating Procedure and Risk Control Plans designed to attain long-term managerial control of risk factors
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IMPLEMENT A CONSISTENT AND EFFECTIVE
ENFORCEMENT PROTOCOL
IMPLEMENT A CONSISTENT AND EFFECTIVE
ENFORCEMENT PROTOCOL
• Develop enforcement procedures
• Ensure credibility
• Develop enforcement procedures
• Ensure credibility
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VOLUNTARY NATIONAL RETAIL FOOD REGULATORY
PROGRAM STANDARDS
VOLUNTARY NATIONAL RETAIL FOOD REGULATORY
PROGRAM STANDARDS
Standards of Excellence for
Continuous Improvement
Standards of Excellence for
Continuous Improvement
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Voluntary National Retail Food Voluntary National Retail Food Regulatory Program StandardsRegulatory Program StandardsVoluntary National Retail Food Voluntary National Retail Food Regulatory Program StandardsRegulatory Program Standards1. Regulatory FoundationRegulatory Foundation
2. Staff Training2. Staff Training
3. HACCP Principles-based Inspection 3. HACCP Principles-based Inspection Program Program
4. Inspection Uniformity4. Inspection Uniformity
5. Foodborne Illness and Food Security5. Foodborne Illness and Food Security
Preparedness and ResponsePreparedness and Response
1. Regulatory FoundationRegulatory Foundation
2. Staff Training2. Staff Training
3. HACCP Principles-based Inspection 3. HACCP Principles-based Inspection Program Program
4. Inspection Uniformity4. Inspection Uniformity
5. Foodborne Illness and Food Security5. Foodborne Illness and Food Security
Preparedness and ResponsePreparedness and Response
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Voluntary National Retail Food Voluntary National Retail Food Regulatory Program StandardsRegulatory Program StandardsVoluntary National Retail Food Voluntary National Retail Food Regulatory Program StandardsRegulatory Program Standards
6. Compliance and Enforcement6. Compliance and Enforcement
7. Industry and Community Relations7. Industry and Community Relations
8. Program Support and Resources8. Program Support and Resources
9. Self Assessment9. Self Assessment
6. Compliance and Enforcement6. Compliance and Enforcement
7. Industry and Community Relations7. Industry and Community Relations
8. Program Support and Resources8. Program Support and Resources
9. Self Assessment9. Self Assessment
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Voluntary National Retail Food Voluntary National Retail Food Regulatory Program StandardsRegulatory Program StandardsVoluntary National Retail Food Voluntary National Retail Food Regulatory Program StandardsRegulatory Program Standards
• Identify program areas where an agency can have the greatest impact on retail food safety.
• Promote wider application of effective FBI risk factor intervention strategies
• Identify program areas where an agency can have the greatest impact on retail food safety.
• Promote wider application of effective FBI risk factor intervention strategies
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Voluntary National Retail Food Voluntary National Retail Food Regulatory Program StandardsRegulatory Program StandardsVoluntary National Retail Food Voluntary National Retail Food Regulatory Program StandardsRegulatory Program Standards
• Assist in identifying program areas most in need of additional resources
• Assist in identifying program areas most in need of additional resources
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Standards as a Tool for Continuous ImprovementStandards as a Tool for
Continuous Improvement
*Self Assess Improve *Self Assess Improve
PlanPlan
MeasureMeasure
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FDA Retail Food Program Resource Disk
FDA Retail Food Program Resource Disk
Contains all FDA’s technical guidance for retail food protection programs:– National Retail Food Program
Standards
– FDA’s 2000 Baseline Report
– Software Program & Guidance documents for jurisdictions to use to conduct their own foodborne illness risk factor studies
Contains all FDA’s technical guidance for retail food protection programs:– National Retail Food Program
Standards
– FDA’s 2000 Baseline Report
– Software Program & Guidance documents for jurisdictions to use to conduct their own foodborne illness risk factor studies
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FDA Retail Food Program Resource Disk
FDA Retail Food Program Resource Disk
– 2001 Food Code (AND 2003 Food Code Supplement)
– FDA Standardization Procedures
– HACCP @ Retail Guides
– Plan Review Guide
– Temporary Events Guides
– 2001 Food Code (AND 2003 Food Code Supplement)
– FDA Standardization Procedures
– HACCP @ Retail Guides
– Plan Review Guide
– Temporary Events Guides
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PROGRAM GOALPROGRAM GOAL
ACTIVE MANAGERIAL CONTROL
OF
FOODBORNE ILLNESS RISK FACTORS
ACTIVE MANAGERIAL CONTROL
OF
FOODBORNE ILLNESS RISK FACTORS