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Diff Sim HA RA 1
Differences and similaritiesDifferences and similaritiesbetween HACCP and Risk Analysisbetween HACCP and Risk Analysis
Differences and similaritiesDifferences and similaritiesbetween HACCP and Risk Analysisbetween HACCP and Risk Analysis
Mike van Schothorst
Diff Sim HA RA 2
TerminologyTerminology
Diff Sim HA RA 3
CommunicationCommunicationCommunicationCommunication
HazardHazardRiskRisk
SafetySafety
HACCPHACCP
Hazard Analysis / Risk AnalysisHazard Analysis / Risk Analysis
ALOPALOP FSOFSO
MRAMRA
MRMMRM
Diff Sim HA RA 4
HazardHazardHazardHazard
A biological, chemical or physical
agent in, or condition of, food
with the potential
to cause an adverse health effect
Codex Alimentarius, 1997
Diff Sim HA RA 5
RiskRiskRiskRisk
A function of the probability
of an adverse health effect
and the severity of that effect
consequential to a hazard in food
Diff Sim HA RA 6
Risk AnalysisRisk AnalysisRisk AnalysisRisk Analysis
A regulatory tool to maintain
or enhance the supply of safe food,
both locally produced and imported,
in a certain country
It is not only an analysis, it includes also risk management
Diff Sim HA RA 7
Risk AnalysisRisk AnalysisRisk AnalysisRisk Analysis
Risk Communication
MicrobiologicalRisk Assessment
MicrobiologicalRisk Management
Policy Policy basedbased
Science Science basedbased
Interactive exchange of information and opinions
concerning risks and control measures
MRAMRA MRMMRM
Diff Sim HA RA 8
Risk Analysis and HACCPRisk Analysis and HACCPRisk Analysis and HACCPRisk Analysis and HACCP
identification
quantification
decision
control
review
Government
Industry
HACCP
Assessment
Management
RISK
FFaaccttoorryy
Market
Diff Sim HA RA 9
HACCPHACCPHACCPHACCP
An operational system to select and implement
effective control measures
to ensure the safety of a food product
Microbiological Risk Assessment ( MRA )Microbiological Risk Assessment ( MRA )Microbiological Risk Assessment ( MRA )Microbiological Risk Assessment ( MRA )
A procedure to provide data
that are used in the selection of
appropriate risk reduction measures
Diff Sim HA RA 10
The HACCP systemThe HACCP system
Risk AnalysisRisk Analysis
compared with
Diff Sim HA RA 11
Codex HACCP GuidelinesCodex HACCP GuidelinesCodex HACCP GuidelinesCodex HACCP Guidelines
1. Assemble HACCP team
2. Describe product
3. Identify intended use
4. Construct flow diagram
5. Confirm on-site flow diagram
6. List all potential hazards, conduct a hazard analysis and consider control measure
7 - 12. Apply principles 2 - 7
Diff Sim HA RA 12
1. Conduct a hazard analysis
2. Determine the CCPs
3. Establish critical limit(s)
4. Establish a monitoring system
5. Establish corrective actions
6. Establish verification procedures
7. Establish documentation
HACCP PrinciplesHACCP PrinciplesHACCP PrinciplesHACCP Principles
Diff Sim HA RA 13
(1) Assemble HACCP team(1) Assemble HACCP team(1) Assemble HACCP team(1) Assemble HACCP team
Obtain top management commitment
Appoint a leader and a secretary
Assure participation of experts in QA, microbiology, chemistry, food technology
Assure co-operation of other experts
Define scope of the study
Set priorities
Diff Sim HA RA 14
Assemble Risk Assessment teamAssemble Risk Assessment teamAssemble Risk Assessment teamAssemble Risk Assessment team
Same general principles apply,but Risk managers are mainly governmental
regulators and scientists, while a HACCPteam consists mainly of production people.
The pathogen and food of concern is often already decided upon
by the Risk Managers
MRA
Diff Sim HA RA 15
(2) Describe product(2) Describe product(2) Describe product(2) Describe product
Formulation and composition
Raw materials & ingredients
Parameters influencing safety Processing Packaging Distribution
Diff Sim HA RA 16
Products to analysedProducts to analysedProducts to analysedProducts to analysed
Same general principles apply,but the product is a commodity,
not a specific one.It is a product produced in different manners
by different manufacturers,including manufacturers in other countries
MRA
Diff Sim HA RA 17
(3) Identify intended use(3) Identify intended use(3) Identify intended use(3) Identify intended use
Food service establishments
Caterers
Hospitals
General population
Specific groups of the population
Preparation practices
Exportation
Diff Sim HA RA 18
Use of ProductsUse of ProductsUse of ProductsUse of Products
Same categories may apply,
however, products for export
may need to be treated separately
because of the differences
in use and users
MRA
Diff Sim HA RA 19
(4) Construct flow diagram(4) Construct flow diagram(4) Construct flow diagram(4) Construct flow diagram
Cover all steps which might have an influence on the safety of the product
Include important data such as time & temperature
Indicate hygiene level of areas and barriers
Indicate personnel movements etc.
Raw materials
Mixing
Heating
Filling
Diff Sim HA RA 20
Perform aPerform aProduct / Pathogen / PathwayProduct / Pathogen / Pathway
( PPP ) analysis( PPP ) analysis
Perform aPerform aProduct / Pathogen / PathwayProduct / Pathogen / Pathway
( PPP ) analysis( PPP ) analysis
The fate of the pathogen of concern
from “farm to fork”
will be described in detail,
data concerning conditions at the various steps
need to be collected and treated,
growth, survival etc. will be “modelled”
MRA
Diff Sim HA RA 21
(5) On - Site confirmation(5) On - Site confirmation of flow diagram of flow diagram
(5) On - Site confirmation(5) On - Site confirmation of flow diagram of flow diagram
Check correctness of information
Check whether important information was not overlooked
Check during all periods of operation and cleaning, but also during idle hours
Discuss practices with operators
Diff Sim HA RA 22
PPP confirmationPPP confirmationPPP confirmationPPP confirmation
The pathway and its conditions
need to be checked,
models need to be validated
and the outcomes verified as far as possible.
Uncertainties need to be identified.
the PPP in risk analysis is less specific as the one used in HACCP
MRA
Diff Sim HA RA 23
(6) List all hazards(6) List all hazardsassociated with each step,associated with each step,conduct a Hazard Analysis,conduct a Hazard Analysis,
consider any measuresconsider any measuresto control identified hazardsto control identified hazards
(6) List all hazards(6) List all hazardsassociated with each step,associated with each step,conduct a Hazard Analysis,conduct a Hazard Analysis,
consider any measuresconsider any measuresto control identified hazardsto control identified hazards
Determine which potential hazards
are significant and should be controled
Diff Sim HA RA 24
Hazard identificationHazard identificationHazard identificationHazard identification
The hazard of concern is identified by MRM.
Important aspects of the ecology and
behaviour of the pathogen are collected.
This is particularly difficult when the risk
of a “new” pathogen is assessed
in HACCP hazard identification meansdetermination which hazards are significant
MRA
Diff Sim HA RA 25
Perform a Hazard AnalysisPerform a Hazard AnalysisPerform a Hazard AnalysisPerform a Hazard Analysis
Collect and interpret information on hazards
and conditions leading to their presence
at unacceptable levels
and decide which need to be controlled
"the analysis of hazards
must be quantitative
if it is to be meaningful"
ICMSF 1988
HA is not RA
Diff Sim HA RA 26
Hazard DeterminationHazard DeterminationHazard DeterminationHazard Determination
Presence of agentin raw material probable ?
Presence of agent in lineor environment probable ?
NO NOYES
Unaccept. contaminationat this step probable ?
Unaccept. survival, persistence or increaseat this step probable ?
YES
YES
NO NOYES
Reduction, if any, at afurther step adequate ?
No hazard*
YES**
HAZARDHAZARDHAZARDHAZARD
No hazard*
NO
* Not a hazard to be controlled at this step ** Reduction step becomes thus a CCP
Questions to be answered for each potential hazard for each step
Diff Sim HA RA 27
Acceptable levels Acceptable levels ( 1 )( 1 )Acceptable levels Acceptable levels ( 1 )( 1 )
Not all levels (or sizes) of all agents
are harmful to all individuals under
all conditions
Agents (contaminants) are acceptable
as long as their levels remain
below a certain maximum
Diff Sim HA RA 28
Acceptable levels Acceptable levels ( 2 )( 2 )Acceptable levels Acceptable levels ( 2 )( 2 )
Products with a good record of safety
are used as a “benchmark”
New products, or changed products
should be as safe as the “benchmark”
Performance Objectives are “benchmarks”
set by authorities
Diff Sim HA RA 29
Hazard Analysis of aflatoxin in milkHazard Analysis of aflatoxin in milkHazard Analysis of aflatoxin in milkHazard Analysis of aflatoxin in milk
Maximum Level accepted 15 μg / kg
Q1: Presence of hazard at unacceptable levels in raw material
Q2: Persistent during processing
Q3: Recontamination
Q4: Increase during shelf-life
Q5: Reduction during preparation
Possible Probable Likely No
CCP
Diff Sim HA RA 30
HA of Listeria in hotdogs HA of Listeria in hotdogs HA of Listeria in hotdogs HA of Listeria in hotdogs
Maximum Level accepted <100 / g ?
Q1: Presence of hazard at unacceptable levels in raw meat
Q2: Survival during processing
Q3: Recontamination
Q4: Increase during shelf-life
Q5: Reduction during preparation
Possible Probable Likely No
or
CCP
Diff Sim HA RA 31
Assessment of probabilityAssessment of probabilityAssessment of probabilityAssessment of probability
Possible
Probable
Likely
Reasonably expected to occur
These are semi - quantitative expressions of probability ,based on analytical data or expert knowledge
Diff Sim HA RA 32
ProbabilitiesProbabilitiesProbabilitiesProbabilities
Risk assessors use “models”
to calculate probabilities of
survival, persistence, growth etc.
Models for recontamination
are being developed
the same models can be and are used in HACCP
MRA
Diff Sim HA RA 33
MRA componentsMRA componentsMRA componentsMRA components
Hazard identificationwhich pathogen will be assessed
Hazard characterizationwhat are the effects and what influences the effects
Exposure assessment how often and how many will be ingested
Risk characterizationwhat is the chance that the effects will happen
MRA
Diff Sim HA RA 34
HazardHazard characterization curve ofcharacterization curve ofListeria monocytogenesListeria monocytogenes
HazardHazard characterization curve ofcharacterization curve ofListeria monocytogenesListeria monocytogenes
0
1
2
3
4
5
6
2 3 4 5 6 7 8 9 10
L.m. dose-response
Log Noof casesper 100,000
Log No of ingested L.m., all servings contaminated
worst - casescenario
Buchanan e.a.1997
MRA
Diff Sim HA RA 35
Probabilistic calculation of exposureProbabilistic calculation of exposureProbabilistic calculation of exposureProbabilistic calculation of exposure
MRA
Diff Sim HA RA 36
the chance for a person of falling ill by consuming a food
the estimated number of illnesses (e.g. per year in a country) due to consumption of a specific food/pathogen combination
risk estimates for different processing, distribution and consumer use conditions and risk reduction scenarios
Outcomes of MRAsOutcomes of MRAs
HACCP in product development uses also different scenarios,but the outcome is a level of safety, not a level of risk
MRA
Diff Sim HA RA 37
7) Determine Control Measures 7) Determine Control Measures 7) Determine Control Measures 7) Determine Control Measures
Determine where measures must be taken (CCPs)
Determine how and to which extent they are to be controlled at these CCPs
Establish the critical limits and monitoring procedures
Diff Sim HA RA 38
MRM componentsMRM componentsMRM componentsMRM components
Preliminary MRM activitieswhich pathogen / food will be assessed and why
Evaluation of MRM optionsselection of control measures
Implementation of MRM decisions communicate with stakeholders and follow-up
Monitoring and Reviewcollect epidemiological and other data, revise decisions if appropriate
MRM
Diff Sim HA RA 39
Control measuresControl measuresControl measuresControl measures
Risk managers are responsible for
the evaluation and selection of
control measures.
Food business operators are responsible for
their execution
in HACCP both activities are in the same hands
MRM
Diff Sim HA RA 40
Establish Critical Limits Establish Critical Limits Establish Critical Limits Establish Critical Limits
They must assure that the required level of safety is obtained
This level can be the “benchmark”
or the “Performance Objective (PO)”
The PO may be the outcome of MRM evaluation
Diff Sim HA RA 41
Performance Objective ( PO )Performance Objective ( PO )Performance Objective ( PO )Performance Objective ( PO )
The maximum frequency and / or concentration
of a microbial hazard in a food
at a specified step in the food chain
before time of consumption
that still provides or contributes to
the achievement of an Food Safety Objective
or Appropriate Level Of Protection, as applicable.
A PO is an acceptable level of a hazardin HACCP terminology
MRM
Diff Sim HA RA 42
9) Monitoring in HACCP9) Monitoring in HACCP9) Monitoring in HACCP9) Monitoring in HACCP
The act of conducting a planned sequence of
observations or measurement of control parameters
to assess whether a CCP is under control
Monitoring and Review in MRMMonitoring and Review in MRM
Assessment of effectiveness of measures taken
Review risk management and / or assessment as necessary (new option, new information)
Diff Sim HA RA 43
An example of differencesAn example of differencesand similarities and similarities
An example of differencesAn example of differencesand similarities and similarities
Product Pathogen Pathway of
Listeria monocytogenes
in a specific paté produced
according to GHP and HACCP
and a “generic” paté, as used
in Microbiological Risk Assessment
Diff Sim HA RA 44
PPP of L. monocytogenes PPP of L. monocytogenes (paté 1)(paté 1)PPP of L. monocytogenes PPP of L. monocytogenes (paté 1)(paté 1)
-3
-2
-1
0
1
Reception Heating Packaging Consumption.
Log.Lm./g
safe level
RecontaminationRecontamination GrowthGrowth
GHP and HACCP assure safety of specific product
HACCP
Diff Sim HA RA 45
PPP of L. monocytogenes PPP of L. monocytogenes (paté 2)(paté 2)PPP of L. monocytogenes PPP of L. monocytogenes (paté 2)(paté 2)
-4
-2
0
2
4
Reception Heating Packaging Consumption.
Log.Lm./g
InputforMRA
RecontaminationRecontamination GrowthGrowth Changeconditions ?
A “generic product” under general conditions in a country
MRA
Diff Sim HA RA 46
Risk estimates of listeriosisRisk estimates of listeriosisRisk estimates of listeriosisRisk estimates of listeriosis
0
1
2
3
4
5
6
7
8
1/g 10/g 100/g 1000/g
cases oflisteriosis
per 100 Mioinhabitantsof the USA
which levelacceptable ?
level of L. monocytogenes
Diff Sim HA RA 47
Risk Acceptability conceptRisk Acceptability conceptRisk Acceptability conceptRisk Acceptability concept
Intolerable
region
Acceptableregion
ALARAregion
As low asreasonablyachievable
Severity
At which levels are these lines set ?
Diff Sim HA RA 48