haccp training guideline

8/22/2019 HACCP Training Guideline

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APPENDIX 5

HAZARD ANALYSIS AND

CRITICAL CONTROL POINT (HACCP) SYSTEM


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HAZARD ANALYSIS AND

CRITICAL CONTROL POINT (HACCP) SYSTEM

by Dr Nagah M. Hafiz

1. Introduction to the Hazard Analysis and Critical Control Point (HACCP) System.

1.1 What is HACCP ?

v HACCP is an abbreviation for Hazard Analysis and Critical Control Point.v HACCP system, which is science based and systematic, identifies specific hazards and

measures for their control to ensure food safety.v The Hazard Analysis and Critical Control Point (HACCP) System is a management tool for

food safety assurance focus on prevention rather than relying mainly on end product testing.v It can be applied at any stage in food chain, from the point where food is produced to the

point of consumption.v HACCP is derived from Failure Mode and Effect Analysis FMEA which looks at what

could potentially go wrong at each stage in an operation and along with possible causes andthe likely effect, before deploying effective control mechanisms.

HACCP steps

Look at your process / product from start to finish;

Identify potential hazards and decide where they could occur; Put in controls and monitor them;

Write them all down and keep records ;

Ensure that it continues to work effectively.

1.2 History of HACCP

During the airspace program in the 1960's, NASA was looking for a way to guarantee thatthe food for astronauts on space flights should totally safe.

The task was producing Zero Defect Food .

The Pillsbury Corporation developed the HACCP system and presented it in 1971 at the firstAmerican National Conference for Food Protection.

Then the concept has been evolving in the food industry.

Why use HACCP

v Management of product safety Top priority should be given to food safety.

HACCP is a system of food control based on prevention. In identifying where the hazards arelikely to occur in the process, we have the opportunity to put in place the measures needed toprevent occurrence of those hazards.

This will facilitate the move to preventive approach within the food business, reducing thetraditional reliance on end product inspection and testing.

v Limitation of inspection and testing


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v External pressures:Governments / Health Regulation / International standardization (GATT) / Customers / Media.

1.3 Benefits of HACCP

HACCP System

1.3.1 is the most effective method ofmaximizing product safety. 1.3.2 is a cost-effective control which target resources to critical areas of processing, so reduces

risk of manufacturing and selling unsafe products.1.3.3 facilitates international trade.1.3.4 can be easily integrated into quality management systems , e.g. ISO 9000 series.1.3.5 complies with legal requirements.1.3.6 helps to demonstrate effective food safety management through documented evidence

which can be used in the event of litigation.

1.4 Scope

HACCP is an applicable powerful system and can be used for both simple and complexoperations, new or existing products.

It may also be used to ensure the effectiveness of production supporting operations e.g.cleaning system.

As HACCP is a universal system, it can be passed to the suppliers to ensure raw materialsafety.

1.5 HACCP and Quality

HACCP system was developed initially for food safety but during recent years, there hasbeen increasing interest in the application of the HACCP technique to product quality.

There is a significant body of opinion that believes that HACCP should be restricted toproduct safety issues.

On the other hand, some believes that the flexibility of the HACCP techniques makes itapplicable to other areas such as product quality.

It is recommended that HACCP is targeted at product safety issues, but where quality issuesare included a clear distinction between safety and quality must be shown.

1.6 Principles of HACCP

HACCP is a system which identifies specific hazard(s) (i.e. any biological, chemical or physicalproperty that cause an adverse health effect) and specifies measures for their control. This systemconsists of seven principles (Codex Alimentarius Commission, Alinorm M 97/13 A) :

PRINCIPLE 1 Conduct a hazard analysis. Prepare a flow diagram of the steps inthe process. Identify and list the hazards and specify the controlmeasures.

PRINCIPLE 2 Determine the critical control point.

PRINCIPLE 3 Establish critical limit(s) which must be met to ensure that eachCCP is under control.


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PRINCIPLE 4 Establish a system to monitor control of the CCP by scheduledtesting or observations.

PRINCIPLE 5 Establish the corrective action to be taken when monitoringindicates that a particular CCP is not under control.

PRINCIPLE 6 Establish procedures for verification to confirm that HACCP isworking effectively.

PRINCIPLE 7 Establish documentation concerning all procedures and recordsappropriate to these principles and their application.

2. How to set up and conduct a HACCP Study

2.1 Prerequisite Programmes

The production of safe food products requires that the HACCP system be built upon a solidfoundation of prerequisite Programmes.

Prerequisite programmes provide the basic environmental and operating conditions that arenecessary for the production of safe and wholesome food.

Many conditions and practices are specified in federal, state and local regulations (e.g.,GMPs and food code).

In addition, industry often adopts policies and procedures that are specific to their operation. The Codex Alimentarius General Principles of food Hygiene describe the basic conditions

and practices expected for foods intended for international trade. The existence and effictiveness of prerequisite programmes should be assessed during the

design and implemention of each HACCP plan.

All prerequisite programmes should be documented and regularly audited.

Prerequisite programmes are established and managed separately from the HACCP plan.

Certain aspects, however, of a prerequisite program may be incorporated into a HACCP plan.

2.2 Education and Training

is the most important element in setting up the HACCP system.

Provides the technical skills required in implementing HACCP.

Helps in changing attitudes of people.

There are a number of key attributes and skills which are required to the HACCP team

1- HACCP team training

Team needs to be provided with technical expertise (hazard,risk assessment, drawing process flowdiagrams and collating data onto control charts, etc.) beside their knoweledge and additionalsupport skills e.g. GMPs, auditing, problem solving techniques.


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2- CCP monitor training

The training will be in two ways

Awareness of what HACCP is , why it is being used and how crucial their role as monitors ofCCP.

Specific training in Job requirements.

3- Company awareness training

2.3 Developing a HACCP plan

What is the HACCP Plan?

HACCP Plan is a formal document which pulls together the key information from theHACCP study and holds details of all that are critical to food safety management.

The HACCP Plan is drawn up by the HACCP Team and consists of two essentialcomponents the Process Flow Diagram and the HACCP Control Chart along with any

other necessary support documentation.

a). The Process Flow Diagram:

The Process Flow Diagram is a stepwise sequence of events through the whole process,giving a clear and simple description of the end product is made.

It is an essential part of the HACCP Plan which enables the HACCP Team to understand theproduction process, and is the basis for the hazard analysis.

It includes details of all ingredients, handling procedures and follows the process through tothe consumer.

Consumer action may also be included.

At the end of the HACCP study all CCPs identified are highlighted on the Process Flow

Diagram.

b). The HACCP Control Chart:

The HACCP control chart contains details of all steps or stages in the process where there areCCPs.

It is normally documented as a matrix or table of control parameters, and contains details ofthe hazard and preventive measures associated with each CCP, along with the control criteriaand responsibilities.

In order to put together a HACCP plan we use the HACCP principles and follow anumber of steps.


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The HACCP Control Chart

---------------------------------------------------------------------------------------------------------

EXAMPLE OF A HACCP WORKSHEET

Describe Product

Process Flow Diagram

List

Step Hazard(s) Control

Measure(s)

CCPs Critical

Limits

Monitoring

Procedures

Corrective

Actions

Records

Verification


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2.4 Conducting the HACCP study

When conducting a HACCP study, the seven principles may be applied as twelve stages as

follows:

The HACCP Plan

Stage 1 Define terms of referenceStage 2 Select the HACCP teamStage 3 Describe the product and its intended useStage 4 Construct a flow diagramStage 5 On-site confirmation of flow diagramStage 6 List all potential hazards associated with each process step, conduct a hazard

analysis and consider any measures to control identifiedhazardsStage 7 Determine CCPsStage 8 Establish critical limits for each CCPStage 9 Establish a monitoring system for each CCPStage 10 Establish a corrective action planStage 11 Establish Verification Procedures.Stage 12 Establish documentation and record keeping

Preliminary steps

An introduction to the preliminary steps

The development of a HACCP plan is a logical step by step process.

Each step builds on the information gathered from the previous step.

The process works better if some preliminary steps are taken first.

They are five steps as follows:

Stage 1 : Define terms of reference

The HACCP study should be carried out on a specific product/ process line or a specific

range of activities. For the initial study, the product safety should given the priority and theterms of reference should be simple.

Case study : Raw Ground Meat Product(Beef Burger)

Terms of reference:

This HACCP study considers biological, chemical and physical hazard through out the wholeprocess. For this example, the HACCP plan covers one product, but additional products,undergoing similar processes may be added to the plan at later stage if the company expands itsproduct range.

As this product is to be sold as frozen raw in retail or wholesale, the holding and preparationinstructions should be on the packaging material.


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Stage 2 : Select the HACCP team

Selection of the people with correct skills is essential for success of the HACCP study and itis best carried out by a multi - disciplinary team from 4-6 persons according to the size of thecompany.

Core of HACCP team consists of experts from the following:q A quality assurance / quality control specialist

q A production specialistq An engineerq Others e.g. pakaging and distribution experts

q In addition, a technical secretary.

* The HACCP team needs to be aware of the following:

q The product / processq Food safety hazards of concern

q The seven principles of HACCPq

How to apprach the analysis logically.

* The HACCP team isnt limited to the internal resources. If needed, outside expertise may beasked.

It is important to list all team member and state clearly what their role is.


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HACCP Team Form

Team Members Role

------------------ General Manager ------------------ Quality control

------------------ Production supervisor ------------------ Packing supervisor

------------------- Local microbiologist

Approved by: . Date: .


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Stage 3 : Descri be the product and i ts intended use:

means complete description of the ingredients , the processing method and distribution of theproduct.

or

general overview of the product/ process ( big picture).

How/ by whom it will be used.

General description of the product includes: composition, structure, processing, packaging,storage and distribution, shelf life and instructions for use.

The intended use of the product by the consumer and the consumer target group should bedefined.

Product / process category

Product Description

Working with the Product/Process Description Form

Describe your product as completely as you can by answering the questions on the form. Add anyother important information. The Example Plant kept their descriptions brief, but specific.

Common name?(A common name for the product) For example, a cooked sausage could be calledfranks, hot dogs or wieners.

How will this product be used? (How is the product prepared and eaten?) Categories include:Ready-to-eat, heated prior to consumption, or sent out for further processing.

The type of package?(What is it mode of, what is special about it?) Categories might include: bulkpackaged (e.g. plastic bag, vacuum packaged), layer or stack packed, or patty packed.

Length of shelf life? At what temperature?(What is the sell by date? Does temperature affectshelf life?) Does it need to be refrigerated?

Where will it be sold? (Who is the intended consumer?) Will it be sold wholesale or retail? If yourproduct is purchased for use in hospitals, schools or institutions, you may need stricter distributioncontrols.

Labeling instructions?(What does the consumer need to know about the product?) Instructionscan include; keep refrigerated or keep frozen and cook thoroughly.

Is special distribution control needed?(Does the product need specific care?) Will the product

become unsafe if not taken care of properly in transit? Raw product being shipped to the grocerneeds to be kept refrigerated or frozen.

Sign and date the form.


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Raw Ground Meat Product Description

Common nameBeef Burger

Preparation instructionsCook and consume

Type of packageBurger layer stacked and wrapped with poly-lined paper.

Shelf life and storage temperature3-6 Months at -18

oC or below.

Sales locationRetail or wholesale.

Labeling instructionsKeep frozen.

Special distribution controlKeep frozen; Lot code based on production date.

Approved by .. Date: ..


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Stage 4: Construct a flow diagram

The purpose of a flow diagram is to provide a clear, simple outline of the steps involved inthe process.

Looking at your plants floor plan can help you visualize the process from receiving toshipping.

To construct the flow diagram, the HACCP team needs sufficient technical data about allingredients, raw materials, packaging, process activities, temperature and time profile,equipment and lay out, product reworking, floor plan, storage condition and distribution /customer issues (if included in terms of reference)

Working with the Flow Diagram.


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Flow Diagram Development &Verification Form

..

Product Process Name: Beef Burger

Flow Diagram:

Meat Other Ingredients Packaging

Receiving Receiving Receiving

Refrigerated

Storage

Storage Dry Storage

Assemble/ Pre-

weigh

Assemble/ Pre-

weigh

Grinding

Mix/ Regrind

Forming

Packaging/

Labeling

Freezing

Storage

Sales/Shipping

Developed by.

Approved by ..


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Stage 5 : On Site confi rmation of fl ow diagram

After the HACCP team has completed the flow diagram, it needs to be checked for accuracy. To dothis, walk-through the plant to make sure that the steps listed on the diagram realistically describewhat occurs during the production process. If possible, have someone who didnt make the flow

The example plant has successfully completed the fact-finding part of the HACCP developmentprocess. Your work through the preliminary steps should have produced two tangible pieces ofinformation.

1. A comprehensive list of ingredients and raw materials. and2. A step-by-step production process breakdown, laid out simply in a flow diagram

With these information you are now ready to proceed to the next stage: Utilizing the 7 Principlesof HACCP.

HACCP is a series of steps that help us maintain safe food. The steps include :

Hazard Analysis deciding what can cause unsafe food

Critical Control Points identifying steps that you must control

Critical Limits setting measurements for each critical control point

Monitoring watching critical points daily

Taking Corrective Action making immediate corrections if needed

Verification making sure what is being done is correct and still working

Record keeping recording what you do in monitoring and corrective action

Stage 6: L ist all potential hazards associated with each process step, conduct hazard analysis andconsider any measures to control identi fi ed hazards (pri nciple 1)

Before starting with the first principle, we need to quickly review two important things: Foodsafety hazards and control measures. There are three types of hazards: biological, chemical andphysical. The most common food safety hazards are biological. More than 95 percent of all human

food borne illnesses from meat or poultry are caused by bacteria.


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Table 1: Characteristics of Growth for Nine Pathogens Associated with Meat and PoultryProducts

Pathogens Temperature for Growth pH Minimum AW

Bacil lus cereus 5 48oC 4.9 9.3 0.912

Campylobacter jejuni 30 47oC 4.9 7.5 ----

Clostridium botulinum

(Types A,B,E)

3.3 46oC >4.6 0.94

Clostridium perf ri ngens 15 50oC 5.0-8.3 0.95

Escherichia coliO157:H7 10 44.5oC 4.5 9.0 -----

L isteria monocytogenes 1.0 - 45oC 4.4 9.6 0.90

Salmonella spp. 5 - 46oC 4 -9 0.94

Staphylococcus aureus 6.5 - 46oC 4.5 9.3 0.83

Yersin ia enterocoli tica 0 - 45oC 4.2 9.6 0.94

Table 2: Types of Chemical Hazards

Location Hazard

Raw Materials Pesticides, antibiotics, hormones, toxins, fertilizers, fungicides, heavy metal,PCBs...Color additives, inks, indirect additives, packaging materials

Processing Direct food additives preservatives (high levels of nitrites),flavorenhancers, color additives...

Indirect food additives boiler water additives, peeling aids, defoamingagents.

Building andEquipment

Maintenance

Lubricants, paints, coatings

Sanitation Pesticides, cleaners, sanitizers

Storage and

shipping

All types of chemicals


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Table 3: Examples of Physical Hazards

Cause Source

Glass Bottles, jars, light fixtures, utensils, gauge covers,

thermometersMetal Nuts, bolts, screws, steel wool, wire, meat hooks

Stones Raw materials

Plastics Packaging materials, raw materials

Bone Raw materials, improper plant processing

Bullet/BB Shot/Needles Animals shot in field, hypodermic needles used for injections

Jewelry Pens/pencils, buttons

Table 4: Examples of Preventive Measures for Chemical Hazards

Hazard Preventive Measure

Naturally Occurring

Substances

Supplier warranty or guarantee; verification programme totest each suppliers compliance with the warranty orguarantee.

Added HazardousChemicals

Detailed specifications for each raw material and ingredient;warranty or letter of guarantee from the supplier; vesitingsuppliers; requirement that supplier operates with a HACCPplan; testing programme to verify that carcasses do not have

residues.In Process Chemicals Identify and list all direct and indirect food additives and

color additives; check that each chemical is approved; checkthat each chemical is properly used; record the use of anyrestricted ingredients.

Table 5: Examples of Preventive Measures for Physical Hazards

Hazard Preventive Measure

Foreign objects in rawmaterials

Suppliers HACCP plan; use of specifications, letters ofguarantee; vendor inspections and certification; in-linemagnets; screens, traps, and filters; in-house inspections ofraw materials.

Foreign objects in

packaging materials,cleaning compounds,

etc.

Suppliers HACCP plan; use of specifications, letters ofguarantee; vendor inspections and certification; in-houseinspections of materials.

Foreign objectsintroduced by

processing operationsor employee practices

In-line metal detectors; visual product examinations; propermaintenance of equipment; frequent equipment inspections.


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Table 6: Examples of Control Measures for Biological Hazards

Pathogen Control measures

Bacil lus cereus Proper holding and cooling temperatures of foods; thermal

processing of shelf-stable canned food.

Campylobacter jejuni Proper pasteurization or cooking; avoiding cross-contamination of utensils, equipment; freezing; atmosphericpackaging.

Clostri dium botulinum Thermal processing of shelf-stable canned food; addition ofnitrate and salt to cured processed meats; refrigeration ofperishable vacuum packaged meats; acidification below pH4.6; reduction of moisture below water activity of 0.93.

Clostridium perf ri ngens Proper holding and cooling temperatures of foods; proper

cooking times and temperatures; adequate cooking andavoidance of cross-contamination by unsanitary equipment.

Listeria monocytogenes Proper heat treatments; rigid environmental sanitationprogramme; separation of raw and ready to- eat productionareas and product.

Salmonella spp. Proper heat treatments; separation of raw and cooked product;proper employee hygiene; fermentation controls; decreasedwater activity; withdrawing feed from animals beforeslaughter; avoiding exterior of hide from contacting carcassduring skinning; antimicrobial rinses; scalding procedures;

disinfecting knives.

Staphylococcus aureus Employee hygiene; proper fermentation and pH control;proper heat treatment and post-process product handlingpractices; reduced water activity.

Yersini a enterocoliti ca Proper refrigeration; heat treatments; control of salt andacidity; prevention of cross-contamination.

Hazard identification

The HACCP team should list all potential hazards as defined in the scope of the studythat may be expected to occur at each step from primary production until the point ofconsumption.

The consideration should include:1)- hazards which may be present in the raw materials,2)- hazards that may be introduced during the process (e.g. contamination from the

equipment, environment or personnel) and


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3)- hazards that survive the process step. The team should also consider the way in which theprocess is managed and what could realistically occur that may not be covered by the flowdiagram (e.g. process delays, temporary storage).4)- The condition of the food (i.e. intrinsic factors including pH, aw, temperature) must also beconsidered because it might have an effect on the ability of biological, chemical and orphysical agents to cause an adverse effect on health.

Hazard identification can be regarded as a brain storming session.

Hazard Analysis

To determine which hazards are of such a nature that their elimination or reduction toacceptable levels is essential to the production of a safe food.

The significance of any hazard to final food safety will need to be assessed, particularly whendeciding on the control measures to be implemented. This process is known as risk

assessment.

Risk: The likelihood the hazard will happen.

Control measures

The HACCP team must then consider what control measures. Control measures are thosefactors or activities which required to eliminate or reduce the occurrence of hazard, to anacceptable level.

It is necessary to consider what control measures you have in place and what new measures

may need to be put in place.

Working with the Hazard Analysis Form:

The form is structured so that the three food safety hazard categories (biological,physical and chemical) are addressed in each of the three questions.

The top of the form should be filled out with appropriate information.

Sign and date the form.


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The first production step to look at is receiving meat.

Hazard Analysis Form.

Product/Process Name : Beef Burger

Process step from Flow Diagram : Receiving Meat

Food Safety Hazard Analysis:

B: Biological P: Physical C:Chemical

List the hazards:

Pathogens Plastic PesticidesBone Fragments Hormones

Antibiotics

Is the hazard reasonably likely to occur? Yes/NoYes No No

What is the basis for your decision?

Loss of control in No historically plants justificationtemperature may lead occurrence at is these sourcesto bacterial growth this plant are within defined

Limits

What control measures can be applied at this step to prevent, eliminate, orreduce the hazard to an acceptable level?

Temperature controlof the truck and meat.

Approved by .. Date: ..


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The fourth production step to look at is Grinding.

Hazard Analysis Form..

Product/Process Name : Beef Burger

Process step from Flow Diagram : Grinding

Food Safety Hazard Analysis:

B: Biological P: Physical C:Chemical

List the Hazards:

Introduction of Pathogens Presence or introductionResidues ofof foreign materials sanitizer/or

Cleaners

Is the hazard reasonably likely to occur? Yes/NoYes No No

What is the basis for your decision?Loss of temp.control Visual inspection Correct clean up

Unclean processing in place and sanitizingEnvironment/incorrectcleaning of equipment/unhygienic practices

What control measures can be applied at this step to prevent, eliminate, orreduce the hazard to an acceptable level?

Temperature control/Maintain aClean processing enviromentProper cleaning equipment/utensils

Correct employee hygiene

..

Approved by ..


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Stage 7: Determine CCPs (principle2)

A critical control point is a point, step or procedure at which control can be applied andis essential to prevent or eliminate a food safety hazard or reduce it to an acceptablelevel.

One strategy to facilitate the identification of each CCP is the use of decision tree.

Decision tree is a logical series of questions which are asked for each identified hazardat each process step.

Examples of CCPs may include: thermal processing, chilling, testing ingredients forchemical residues, product formulation control, and testing product for metalcontaminants.

Application of a decision tree should be flexible and requires common sense. Training in the application of a decision tree is recommended.


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HACCP Plan: Beef Burger

Hazard Analysis and Critical Control Point

Process Step Potential Hazard Control measures Is the potentialhazard reasonablylikely to occur?

CCP

Receiving Meat B Growth ofPathogens

P Presence ofForeign Material

C Presence ofChemical

Contamination

Proper temperature ofmeat & truck

Visual inspection ofcontainer

Product inspection

Yes

No

No

CCP-1(B)

Refrigeratedstorage

B Growth ofPathogen

P None

C None

Temperature control Yes

No

No

CCP-2(B)

Assemble/pre-

weigh

B Introduction of

Pathogens

P Introduction ofForeign Material

C None

Temperature control-

Maintain cleanenvironment propercleaning of equipment correct employeehygiene.

Visual inspection

Yes

Yes

No

CCP-3

(B)

CCP4-(P)

Approved by: .. Date : .


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Hazard Analysis and Critical Control Point

Process Step Potential Hazard Control measures Is the potentialhazard reasonablylikely to occur?

CCP

Grinding B Introduction of Pathogens

P Introduction of

Foreign Material

C Residues ofSanitizers

and/or Cleaners

Temperature controlMaintain cleanprocessing environmentproper cleaning ofequipment correctemployee hygiene.

Visual inspection

Correct clean up andsanitizing

Yes

No

No

CCP-5(B)

Mix/ Regrind B Introduction ofPathogen

P Introduction of

Foreign Material

C Residues ofSanitizers and/ or

Cleaners

As previous

Visual inspection

Correct clean up andsanitizing

No

Yes

No

CCP-6(P)

Forming B Introduction andGrowth of Pathogens

P None

C None

As previous No

None

None

Approved by: ------------- Date:--------------------------


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Stage 8: Establish cri tical l imi ts for each CCP (pr inciple 3)

Critical limit is the criterion which separates acceptable from unacceptable product (i.e.the division between safe and unsafe).

The HACCP team must have detailed knowledge of the potential hazards, along with afull understanding of the factors which are involved in their control.

For many practical purposes a target level may be specified as an additional measure toindicate drift in the process, so the process can be adjusted to maintain control beforethe CCP actually deviates from its critical limits.

The specific target level and critical limits set for each CCP/control measure mustrepresent some measurable parameter related to the CCP

Types of Cri tical limit

Each critical limit will be related to the type of hazard that the CCP is designed tocontrol.

q Chemical limits

Examples: maximum acceptable levels of mycotoxins, pH, salt, a w or the presence or absenceof allergens.

q Physical limits

Examples: absence of metal, intact sieve and temperature and time.

q Microbiological limits

Should be avoided as a part of the HACCP system, this is because time consuming.

Microbiological factors are best for verification.

Stage 9: Establish a moni toring system for each CCP (principle 4)

Monitoring is one of the most important aspects of any HACCP system and it is aplanned sequence of observations or measurements of CCP control measures.

The monitoring system describes methods by which, it is able to confirm that all CCPsare operating within specifications and it produces a record of performance forverification

Monitoring procedures must be able to detect loss of control at the CCP. Ideallymonitoring should provide this information in time for corrective action to be taken toregain control of the process before there is a need to segregate or reject product.

There are two basic types of monitoring procedures:

1- On Line systems , where the critical factors are measured during the process. Thesemay be continuous systems where critical data are continuously recorded.

2- Off line systems

where samples are taken for measurement of the critical factors else where e.g. saltconcentration, pH, aw, total solids.


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In an ideal situation, a monitoring system should be chosen that gives an on-line continuousmonitor of performance and responds dynamically to correct changes exceeding the specifiedtolerance.

Five main types of monitori ng are employed:

Visual observation.

Sensory evaluation.

Physical.

Chemical.

Microbiological testing.

Microbiological monitoring systems is of limited value for monitoring CCPs.

The person who will carry out the monitoring must have the knowledge and authority totake corrective action if the critical limit is not achieved. All records and documentsassociated with monitoring CCPs should be signed by the person involved inmonitoring procedures.

The frequency of monitoring will depend on the nature of CCP and the type of

monitoring procedures. The designated operators must be trained to understand their monitoring functions and

how to carry them out correctly.

Stage 10: Establi sh a corrective action plan (pr inciple 5)

* HACCP Principle 5 requires that corrective action be taken when the monitoring resultsshow a deviation from the critical limit(s) at a CCP.

* Or preferably, what action should be taken when monitoring resultsindicate a trend towards loss of control.

There are two main types of corrective action:

1- Actions which adjust the process to maintain control and prevent a deviation atthe CCP

This first type of corrective action normally involves the use of target levels within thecritical limits.

When the process drifts towards or exceeds the target levels, it is adjusted, bringing itback within the normal operating bands.

This is typified by on line continuous monitoring systems which automatically adjustthe process, e.g. automatic diversion valves in pasteurization process of milk.

The factors which are often adjusted to maintain control include temperature and / ortime, pH/acidity, ingredient concentrations, flow rates and sanitizer concentrations.

2- Actions to be taken following a deviation at a CCP

Following a deviation, there are two types of action

q The process must be adjusted to bring it back under control.q Disposition action need to be taken with the food that has been produced during the

time period that the CCP was out of control.

Both corrective action and deposition action should be documented.


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Critical Limit,Monitoring & Corrective Action

Process StepCCP

Critical Limit Monitoring Procedures Corrective Action

Receiving MeatCCP-1(B)

Temperature< 45oF What will be measured?

Temperature andappearance

Were will the CL bemeasured?In receiving area

How will the CL bemeasured?Thermometer

Who will monitor theCL?Receiving personnel

Frequency?Each shipment

How will the process becorrected ?Identify and controlaffected product

Product dispositionReject chill.If the product is over45

oF move to blast cooler

Who is responsible for

implementing the CAdesignee

Measures to prevent

recurrenceNotify supplier

Refrigerated

storage CCP-2(B)

Temperature 45oF What will be measured?

Temperature

Were will the CL bemeasured?In storage refrigerator

How will the CL be

measured?Refrigerator thermometer

Who will monitor the

CL?Person in charge

Frequency?Towice daily

How will the process be

corrected ?Identify and correctaffected product

Product dispositionReject chill.

Who is responsible for

implementing the CAperson in charge

Measures to prevent

recurrenceAdjust refrigerator

Approved by: .. Date :


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Critical Limit,Monitoring & Corrective Action

Process StepCCP

Critical Limit Monitoring Procedures Corrective Action

Assemble/Pre-weigh CCP4-P

Grinding CCP-5(B)

No Visible foreignmaterial

Temperature aftercourse grind for freshproduct


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Stage 11.Establi sh Veri f ication Procedures

The study team should put into place procedures that can be used to demonstratecompliance with the HACCP plan.

Verification should examine the entire HACCP system and its records.

The study team should specify the methods and frequency of verification procedures.

Verification activities may include: internal/ external auditing systems.

microbiological examination of intermediate and final product samples, moresearching/vigorous tests at selected CCPs.

surveys of the market place for unexpected health/spoilage problems associated withthe product.

updated data on consumer use of the product.

The findings of customer visits and analysis of customer complaints can also form partof verification procedures.


Record Keeping and Verification Procedures

Process StepCCP

Records Responsibility CCP-Verification

Receiving MeatCCP-1 (B)

Grinding CCP-

5(B)

HACCP Receivinglog

Grinding log

Receiving personnelMonitoring

..Production personnel

Monitoring

Daily check of receivinglog-receiving personnelretrained

Accuracy of thethermometer will bechecked each dayrecalibrated or replacedas necessary..Daily check of grinding

log

Production personnelretrained

Approved by: .. Date :


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Stage 12: Establish documentation and record keeping (pri nciple 7)

Record Keepingq HACCP principle 7 requires that effective record keeping procedures are established to

document HACCP system.q Records need to be kept of all areas which are critical to product safety, as written

evidence that the HACCP plan is in compliance i.e verification that the system has beenworking correctly.

Records

q Will support a defense under litigation proceedings.q Will be useful in providing a basis for analysis of trends (towards improvements in the

system). As well as for internal investigation of any food safety incident.q The records do not all have to be in typed format e.g. Hazard analysis charts and CCP

monitoring log sheets.

The type of HACCP records which might be retained

HACCP plan,

History of amendments to the HACCP plan,

Critical Control point (CCP) monitoring records,

Hold/Trace/Recall record,

Training records,

Audit records,

Meeting records,

Calibration records,

The HACCP system procedures, It may consist of a HACCP manual which containsfirstly companys policy on food safety management.

Review the HACCP plan

* A periodic review should be carried out, the frequency of which should be establishedbased on the risk of the product and its intended use. In addition, it is necessary tohave a system in place that will automatically trigger a review of a HACCP plan priorto any changes which affect overall product safety.

* Data arising from HACCP reviews must be documented and form a part of the HACCPrecord keeping system. Any changes arising from a HACCP review must be fullyincorporated into the HACCP plan.


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HACCP Form No : Receiving Log

Use for CCP-1(B)

CCP-1(B)

Date Inspectedby

Company Meattemp.(

oF)

Correctiveaction

Verification

DateVerif. by

PreshipmentreviewDate TimeReviewSignature

Critical limit : CCP1-B temp. < 45oFVerification to be done each shipment

corrective action must ensure:1)- The cause of the deviation is identified and eliminated

2)- The CCP is under control after the corrective action is taken

3)- Measures to prevent recurrence are established4)- No product that is injurious to health or otherwise adultered

as a result of the deviation enters commerce

Approved by : Date:.


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HACCP Form No : Grinding Log

Use for CCP-4(B)

CCP-4(B)

Date Inspectedby

Company Meattemp.(

oF)

Correctiveaction

Verification

DateVerified by

PreshipmentreviewDate TimeReviewSignature.

Critical limit : CCP4-B temp. < 40oF

Verification to be done each time the process takes placePre shipment review to be done daily

And for all CCPs before product can be shipped

corrective action must ensure:1)- The cause of the deviation is identified and eliminated

2)- The CCP is under control after the corrective action is taken

3)- Measures to prevent recurrence are established

4)- No product that is injurious to health or otherwise adultered

as a result of the deviation enters commerce

Approved by : Date:.


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Product / Process Description Form

Common name

How will this product be used?

The type of package

Length of shelf life

Where will it be sold?

Labeling instructions

Is special distribution control needed?

Approved by:-------------------- Date: -----------------


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Ingredients & Raw Materials Form

Product / Process Category :

Product Name :

Meat/Poultry and By-products Nonmeat Food Ingredients Binders/Extenders

Spices/Flavorings Restricted Ingredients Preservatives Acidifiers

Liquid Packaging Materials Others

Approved by: ----------------- Date: ------------------------


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Flow Diagram Development & Verification Form

-----------------------------------------------------------------------------------------

Product Process Name:

Flow Diagram:

Developed by: --------------------- Date: -----------------------

Approved by: --------------------- Date: ------------------------


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Hazard Analysis and Critical Control Point:

Process Step Potential Hazard Control MeasuresIs the potential hazardreasonably likely tooccur?

CCP

Approved by: --------------------- Date: ------------------------


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Critical Limit, Monitoring & Corrective Action

Process Step

CCP

Critical limit Monitoring Procedures Corrective action

What will be measured? How will the processcorrected?

Where will the CL bemeasured?

Product disposition

How will the CL bemeasured?

Who is responsible forimplementing the CA?

Who will monitor the CL?

Measures to preventrecurrence

Frequency?

What will be measured? How will the process

corrected?

Where will the CL be

measured?

Product disposition

How will the CL bemeasured?

Who is responsible forimplementing the CA?

Who will monitor the CL? Measures to prevent

recurrence

Frequency? Adjust refrigerator

Approved by: --------------------- Date: ------------------------


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Record Keeping and Verification Procedures

Process Step CCP Records Responsibility CCP-Verification

Approved by: --------------------- Date: ------------------------


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References

Bryan, F.L. (1992): Hazard Analysis Critical Point Evaluation. A guide to identifying hazards andassessing risks associated with food preparation and storage WHO, Geneva.

Codex Alimentarius commission (1997): Hazard Analysis and Critical Control Point (HACCP)

System and guidelines for is Application. Codex Alimentarius commission AlinormM97/13A.

Pearson, A.M. and Dutson, T.R. (1995): HACCP in meat, poultry and fish processing. BlackieAcademic & professional, Chapman & Hall, Wester Cleddens Road, Bishopbriggs, GlasgowG 64 2 N Z.

Sara Mortimore and Carol Wallace (1994): HACCP: A practical Approach Chapman and Hall,London.

USDA-FSIS, National Advisory Committee on Microbiology Criteria for foods(1990) HACCPPrinciples for food production. USDA FSIS Information Office, Washington, D.C.

World Health Organization (1995): Hazard Analysis Critical Control Point System. Concept andApplication, Report of a WHO Consultation With the participation of FAO 29 31 May1995. WHO/FUN/FOS, 95.7.


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Case Studies


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Product Description: Poultry Slaughter

Common name: Ready to cook whole chicken

How will this product be used?Cooked by consumers

The type of packageFoam trays wrapped with poly film.

Length of shelf life?Fresh 5 days at


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Product Process Name: Poultry Slaughter

Flow Diagram: Ready to cook whole chicken

Developed by. Date: ..

Approved by .. Date:

Chickenreceiving Evisceration

Holding Trim/Final wash

Shackling

Slaughtering

Scalding

Plucking

Head/feet

removal

Venting/

opening

Final inspection

Chilling

Package

Freeze orrefrigerate

DistributionWashing


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Case StudyPasteurized Milk

----------------------------------------------------------------------------------------------------

Product description

Common name : Pasteurized milk.

Preparation instructions: Direct consume.

Type of package: Glass or plastic bottles or bags

Shelf life and storage temp. 2 - 3 days 6C

Sales location: Retail.

Labeling instructions: Keep cool, lot code based on production date

Approved by: --------------- Date: -------------------------


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Process Flow Diagram

----------------------------------------------------------------------------------------------

Product name : Pasteurized milk

Raw Milk Packaging Materials

Receiving Receiving

Refrigerated storage Dry storage

Clarification

Standardization

Homogenization

Heating

Cooling

Intermediate storage

Filling / packing / labeling

Storage & distribution

Developed by ------------------- Date: --------------------

Approved by -------------------- Date: --------------------


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APPENDIX 6

MICROBIOLOGICAL RISK ASSESSMENT


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MICROBIOLOGICAL RISK ASSESSMENT

by Dr Juliane Brunig, BgVV

Statutes of the Codex Alimentarius Commision

FAO/WHO publications regarding Risk Analysis

Principle and guidelines for the conduct of microbiological risk assessment

Microbiological risk assessment in foods

Microbiological risk assessment in foods takingListeria monocytogenes as an example

Recommendations for the detection and evaluation ofListeria monocytogenes foods

Quantitative microbiological risk assessment regardingListeria monocytogenes A German example

Listeria monocytogenes - criteria for foods

WHO expert consultation on hazard identification and hazard characterization of non typhoid andnon paratyphoid Salmonella in broilers and eggs


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STATUS OF THE CODEX ALIMENTARIUS COMMISSION


Slide 1

Codex

- Statutes of the Codex

Al imentar ius Comm iss ion -

An introduction in the Codex Alimentarius Procedure

/bru/2002

Slide 2

Rules of Procedure

Elaboration Procedures for Codex Standards

General Principles and Acceptance of Codex Standards

The Statutes and Rules of Procedure of the Codex Alimentarius

Commission were first established by FAO Conference and theWorld Health Assembly in 1961/1962 when the Commission itself

was established. The Statutes were revised in 1966. The Rules of

Procedure form the legal basis of the Commissions work and

provide its mandate of terms of reference. The Rules of Procedure

describe the formal working procedures appropriate to an

intergovermental body.

/bru/2002

Codex

- Statutes of the Codex A l imentarius Comm ission -

Codex

- Statutes of t he Codex Al imentar ius Comm ission -


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Slide 3

Article 1:

The Codex Alimentarius Commission shall be responsible for making

proposals to, and shall be consulted by, the Directors General of the Food

and Agriculture Organization (FAO) and the World Health Organization

(WHO) on all matters pertaining to the implementation of the Joint

FAO/WHO Food Standards Programme, the purpose of which is:

(a) protecting the health of the consumers and ensuring fair practices in

the food trade;

(b) promoting co-ordination of all food standards work undertaken by

international governmental and non governmental organizations;

(c) determining priorities and initiating and guiding the preparation of

appropriate organizations;

/bru/2002

Codex- Statutes of the Cod ex Al imentar ius Commission -

Codex

- Statutes of the Co dex Al imentar ius Comm ission -

Slide 4

(d) finalizing standards elaborated under (c) above and, after

acceptance by governments, publishing them in a Codex

Alimentarius either as regional or world wide standards,

together with international standards already finalized by other

bodies under (b) above, wherever this is practicable;

(e) amending published standards, after appropriate survey in the

light of development.

/bru/2002

Codex

- Statutes of the Codex Al imentar ius Comm ission (2) -

Codex

- Statutes of th e Codex Al imentar ius Comm ission (2) -


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Slide 5

Article 2:

Membership of the Commission is open to all Member Nations and

Associate Members of FAO and WHO which are interested in

international food standards. Membership shall comprise such of

these nations as have notified the Director General of FAO or of

WHO of their desire to be considered as Members.

/bru/2002

Codex

- Statutes of the Codex A l imentarius Comm ission -

Codex

- Statutes of t he Codex Al imentar ius Comm ission -

Slide 6

Codex-Conf i rmat ion of Chai rmanship o f Codex Comm it tees (1)-

Codex-Conf i rmat ion of Chai rmanship of Codex Commit tees (1)-

/bru/2002

Committee Chairmanship

Codex Committee on General Principles France

Codex Committee on Food Additives and

Contaminants The Netherlands

Codex Committee on Food Hygiene USA

Codex Committee on Food Labelling Canada

Codex Committee on Methods of Analysis and

Sampling Hungary

Codex Committee on Pesticides Residues The Netherlands

Codex Committee on Residues of Veterinary

Drugs in Food USA

Codex Committee on Food Import andExport Inspection and Certification Systems Australia

Codex Committee on Nutrition and Food

for Special Dietary Uses Germany

Codex Committee on Cocoa Products

and Chocolate Switzerland


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190

FAO/WHO PUBLICATIONS REGARDING RISK ANALYSIS


Report of the Joint FAO/WHO Consultation on Application of Risk Analysis to Food StandardsIssues, Geneva, March 1995. (WHO/FNU/FOS/95.1)

Report of the Joint FAO/WHO Consultation on Risk Management and Food Safety, Rome, January1997. (FAO Food and Nutrition Paper No. 65)

Report of the Joint FAO/WHO Consultation on the Application of Risk Communication to FoodStandards and Safety Matters, Rome, 1998. (FAO Food and Nutrition Paper No. 70)

Report of a First Joint FAO/WHO Consultation on Microbiological Risk Assessment, Geneva,

March 1999. (WHO/SDE/PHE/FOS/99.5)

The interaction between Assessors and Managers of Microbiological Hazards in Food. Report of aWHO Expert Consultation, Kiel, Germany, 21-23 March 2000. (WHO/SDE/PHE/FOS/007)

Report of the Joint FAO/WHO Consultation on Risk Assessment of Microbiological Hazards inFood. Hazard characterization and exposure assessment ofSalmonella spp. in broilers and eggs andListeria monocytogenes in ready-to-eat foods, Rome 17-21 July 2000. (FAO Food and Nutritionpaper No. 71)

Report of the Joint FAO/WHO Consultation on Risk Assessment of Microbiological Hazards inFood. Hazard Identification, hazard characterization and exposure assessment of Campylobacter

spp. in broiler chickens and Vibrio spp. in seafood, Geneva, 23-27 July 2001.

Report of the Joint FAO/WHO Consultation on Risk Assessment of Microbiological Hazards inFood. Risk characterization of Salmonella in eggs and broiler chickens and Listeria monocytogenesin ready-to-eat foods, Rome 30 April-4 May 2001. (FAO Food and Nutrition paper No. 72)

Technical documents also available in the internet:

http:/www.fao.org/WAICENT/FAOINFO/ECONOMIC/ESN/pagerisk/riskpage.htm

http://www.fao.org/es/ESN/pagerisk/riskpage.htm

http://www.who.int/fsf/mbriskassess/index.htm


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PRINCIPLES AND GUIDELINES FOR THE CONDUCT OFMICROBIOLOGICAL RISK ASSESSMENT CAC/GL-30 (1999)

INTRODUCTION

Risks from microbiological hazards are of immediate and serious concern to human health.Microbiological Risk Analysis is a process consisting of three components: Risk Assessment, RiskManagement, and Risk Communication, which has the overall objective to ensure public healthprotection. This document deals with Risk Assessment which is a key element in assuring thatsound science is used to establish standards, guidelines and other recommendations for food safetyto enhance consumer protection and facilitate international trade. The Microbiological RiskAssessment process should include quantitative information to the greatest extent possible in theestimation of risk. A Microbiological Risk Assessment should be conducted using a structuredapproach such as that described in this document. This document will be of primary interest togovernments although other organizations, companies, and other interested parties who need toprepare a Microbiological Risk Assessment will find it valuable. Since Microbiological Risk

Assessment is a developing science, implementation of these guidelines may require a period oftime and may also require specialized training in the countries that consider it necessary. This maybe particularly the case for developing countries. Although Microbiological Risk Assessment is theprimary focus of this document, the method can also be applied to certain other classes ofbiological hazards.

1. SCOPE

The scope of this document applies to Risk Assessment of microbiological hazards in food.

2. DEFINITIONS

The definitions cited here are to facilitate the understanding of certain words or phrases used in thisdocument.

Where available the definitions are those adopted for microbiological, chemical, or physical agentsand Risk Management and Risk Communication on an interim basis at the 22nd Session of theCodex Alimentarius Commission. The CAC adopted these definitions on an interim basis becausethey are subject to modification in the light of developments in the science of risk analysis and as aresult of efforts to harmonize similar definitions across various disciplines.

Dose-Response Assessment - The determination of the relationship between the magnitude ofexposure (dose) to a chemical, biological or physical agent and the severity and/or frequency of

associated adverse health effects (response).Exposure Assessment - The qualitative and/or quantitative evaluation of the likely intake ofbiological, chemical, and physical agents via food as well as exposures from other sources ifrelevant.Hazard - A biological, chemical or physical agent in, or condition of, food with the potential tocause an adverse health effect.Hazard Characterization - The qualitative and/or quantitative evaluation of the nature of theadverse health effects associated with the hazard. For the purpose of Microbiological RiskAssessment the concerns relate to microorganisms and/or their toxins.Hazard Identification - The identification of biological, chemical, and physical agents capable ofcausing adverse health effects and which may be present in a particular food or group of foods.Quantitative Risk Assessment - A Risk Assessment that provides numerical expressions of risk

and indication of the attendant uncertainties (stated in the 1995 Expert Consultation definition onRisk Analysis).


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Qualitative Risk Assessment - A Risk Assessment based on data which, while forming aninadequate basis for numerical risk estimations, nonetheless, when conditioned by prior expertknowledge and identification of attendant uncertainties permits risk ranking or separation intodescriptive categories of risk.Risk - A function of the probability of an adverse health effect and the severity of that effect,consequential to a hazard(s) in food.

Risk Analysis - A process consisting of three components: risk assessment, risk management andrisk communication.Risk Assessment - A scientifically based process consisting of the following steps: (i) hazardidentification, (ii) hazard characterization, (iii) exposure assessment, and (iv) risk characterization.Risk Characterization - The process of determining the qualitative and/or quantitative estimation,includingattendant uncertainties, of the probability of occurrence and severity of known orpotential adverse healtheffects in a given population based on hazard identification, hazardcharacterization and exposureassessment.Risk Communication - The interactive exchange of information and opinions concerning risk andrisk management among risk assessors, risk managers, consumers and other interested parties.Risk Estimate - Output of Risk Characterization.Risk Management - The process of weighing policy alternatives in the light of the results of riskassessment and, if required, selecting and implementing appropriate control* (*control meansprevention, elimination, or reduction of hazards and/or minimization of risks.) options, includingregulatory measures.Sensitivity analysis - A method used to examine the behavior of a model by measuring thevariation in its outputs resulting from changes to its inputs.Transparent - Characteristics of a process where the rationale, the logic of development,constraints, assumptions, value judgements, decisions, limitations and uncertainties of theexpressed determination are fully and systematically stated, documented, and accessible for review.Uncertainty analysis - A method used to estimate the uncertainty associated with model inputs,assumptions and structure/form.

3. GENERAL PRINCIPLES OF MICROBIOLOGICAL RISK ASSESSMENT

1. Microbiological Risk Assessment should be soundly based upon science.2. There should be a functional separation between Risk Assessment and Risk Management.3. Microbiological Risk Assessment should be conducted according to a structured approach that

includes Hazard Identification, Hazard Characterization, Exposure Assessment, and RiskCharacterization.

4. A Microbiological Risk Assessment should clearly state the purpose of the exercise, includingthe form of Risk Estimate that will be the output.

5. The conduct of a Microbiological Risk Assessment should be transparent.6. Any constraints that impact on the Risk Assessment such as cost, resources or time, should be

identified and their possible consequences described.

7. The Risk Estimate should contain a description of uncertainty and where the uncertainty aroseduring the Risk Assessment process.

8. Data should be such that uncertainty in the Risk Estimate can be determined; data and datacollection systems should, as far as possible, be of sufficient quality and precision thatuncertainty in the Risk Estimate is minimized.

9. A Microbiological Risk Assessment should explicitly consider the dynamics of microbiologicalgrowth, survival, and death in foods and the complexity of the interaction (including sequelae)between human and agent following consumption as well as the potential for further spread.

10.Wherever possible, Risk Estimates should be reassessed over time by comparison withindependent human illness data.

11.A Microbiological Risk Assessment may need reevaluation, as new relevant informationbecomes available.


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4. GUIDELINES FOR APPLICATION

These Guidelines provide an outline of the elements of a Microbiological Risk Assessmentindicating thetypes of decisions that need to be considered at each step.

4.1GENERAL CONSIDERATIONS

The elements of Risk Analysis are: Risk Assessment, Risk Management, and Risk Communication.The functional separation of Risk Assessment from Risk Management helps assure that the RiskAssessment process is unbiased. However, certain interactions are needed for a comprehensive andsystematic Risk Assessment process. These may include ranking of hazards and risk assessmentpolicy decisions. Where Risk Management issues are taken into account in Risk Assessment, thedecision-making process should be transparent. It is the transparent unbiased nature of the processthat is important, not who is the assessor or who is the manager.

Whenever practical, efforts should be made to provide a Risk Assessment process that allowscontributions by interested parties. Contributions by interested parties in the Risk Assessmentprocess can improve the transparency of the Risk Assessment, increase the quality of RiskAssessments through additional expertise and information, and facilitate risk communication byincreasing the credibility and acceptance of the results of the Risk Assessment.Scientific evidence may be limited, incomplete or conflicting. In such cases, transparent informeddecisions will have to be made on how to complete the Risk Assessment process. The importanceof using high quality information when conducting a Risk Assessment is to reduce uncertainty andto increase the reliability of the Risk Estimate. The use of quantitative information is encouraged tothe extent possible, but the value and utility of qualitative information should not be discounted.

It should be recognized that sufficient resources will not always be available and constraints arelikely to be imposed on the Risk Assessment that will influence the quality of the Risk Estimate.Where such resource constraints apply, it is important for transparency purposes that these

constraints be described in the formal record. Where appropriate, the record should include anevaluation of the impact of the resource constraints on the Risk Assessment.

4.2STATEMENT OF PURPOSE OF RISK ASSESSMENT

At the beginning of the work the specific purpose of the particular Risk Assessment being carriedout should be clearly stated. The output form and possible output alternatives of the RiskAssessment should be defined. Output might, for example, take the form of an estimate of theprevalence of illness, or an estimate of annual rate (incidence of human illness per 100,000) or anestimate of the rate of human illness and severity per eating occurrence.

The microbiological risk assessment may require a preliminary investigation phase. In this phase,

evidence to support farm-to-table modeling of risk might be structured or mapped into theframework of risk assessment.

4.3HAZARD IDENTIFICATION

For microbial agents, the purpose of hazard identification is to identify the microorganisms or themicrobial toxins of concern with food. Hazard identification will predominately be a qualitativeprocess. Hazards can be identified from relevant data sources. Information on hazards can beobtained from scientific literature, from databases such as those in the food industry, governmentagencies, and relevant international organizations and through solicitation of opinions of experts.Relevant information includes data in areas such as: clinical studies, epidemiological studies andsurveillance, laboratory animal studies, investigations of the characteristics of microorganisms, the

interaction between microorganisms and their environment through the food chain from primary


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production up to and including consumption, and studies on analogous microorganisms andsituations.

4.4EXPOSURE ASSESSMENT

Exposure Assessment includes an assessment of the extent of actual or anticipated human

exposure. For microbiological agents, Exposure Assessments might be based on the potentialextent of food contamination by a particular agent or its toxins, and on dietary information.Exposure assessment should specify the unit of food that is of interest, i.e., the portion size inmost/all cases of acute illness.

Factors that must be considered for Exposure Assessment include the frequency of contaminationof foods by the pathogenic agent and its level in those foods over time. For example, these factorsare influenced by the characteristics of the pathogenic agent, the microbiological ecology of thefood, the initial contamination of the raw material including considerations of regional differencesand seasonality of production, the level of sanitation and process controls, the methods ofprocessing, packaging, distribution and storage of the foods, as well as any preparation steps suchas cooking and holding. Another factor that must be considered in the assessment is patterns ofconsumption. This relates to socio-economic and cultural backgrounds, ethnicity, seasonality, agedifferences (population demographics), regional differences, and consumer preferences andbehavior. Other factors to be considered include: the role of the food handler as a source ofcontamination, the amount of hand contact with the product, and the potential impact of abusiveenvironmental time/temperature relationships.

Microbial pathogen levels can be dynamic and while they may be kept low, for example, by propertime/temperature controls during food processing, they can substantially increase with abuseconditions (for example, improper food storage temperatures or cross contamination from otherfoods). Therefore, the Exposure Assessment should describe the pathway from production toconsumption. Scenarios can be constructed to predict the range of possible exposures. The

scenarios might reflect effects of processing, such as hygienic design, cleaning and disinfection, aswell as the time/temperature and other conditions of the food history, food handling andconsumption patterns, regulatory controls, and surveillance systems.

Exposure Assessment estimates the level, within various levels of uncertainty, of microbiologicalpathogens or microbiological toxins, and the likelihood of their occurrence in foods at the time ofconsumption. qualitatively foods can be categorized according to the likelihood that the foodstuffwill or will not be contaminated at its source; whether or not the food can support the growth of thepathogen of concern; heather there is substantial potential for abusive handling of the food; orwhether the food will be subjected o a heat process. The presence, growth, survival, or death ofmicroorganisms, including pathogens in foods, re influenced by processing and packaging, thestorage environment, including the temperature of storage, he relative humidity of the environment,

and the gaseous composition of the atmosphere. Other relevant actors include pH, moisture contentor water activity (aw), nutrient content, the presence of antimicrobial `substances, and competingmicroflora. Predictive microbiology can be a useful tool in an Exposure Asessment.

4.5HAZARD CHARACTERIZATION

This step provides a qualitative or quantitative description of the severity and duration of adverseeffects that may result from the ingestion of a microorganism or its toxin in food. A dose-responseassessment should be performed if the data are obtainable.There are several important factors that need to be considered in Hazard Characterization. Theseare related to both the microorganism, and the human host. In relation to the microorganism thefollowing are important: microorganisms are capable of replicating; the virulence and infectivity of

microorganisms can change depending on their interaction with the host and the environment;genetic material can be transferred between microorganisms leading to the transfer of


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characteristics such as antibiotic resistance and virulencefactors; microorganisms can be spreadthrough secondary and tertiary transmission; the onset of clinical symptoms can be substantiallydelayed following exposure; microorganisms can persist in certain individuals leading to continuedexcretion of the microorganism and continued risk of spread of infection; low doses of somemicroorganisms can in some cases cause a severe effect; and the attributes of a food that may alterthe microbial pathogenicity, e.g., high fat content of a food vehicle.

In relation to the host the following may be important: genetic factors such as Human LeucocyteAntigen (HLA) type; increased susceptibility due to breakdowns of physiological barriers;individual host susceptibility characteristics such as age, pregnancy, nutrition, health andmedication status, concurrent infections, immune status and previous exposure history; populationcharacteristics such as population immunity, access to and use of medical care, and persistence ofthe organism in the population. A desirable feature of Hazard Characterization is ideallyestablishing a dose-response relationship. When establishing a dose-response relationship, thedifferent end points, such as infection or illness, should be taken into consideration. In the absenceof a known dose-response relationship, risk assessment tools such as expert elicitations could beused to consider various factors, such as infectivity, necessary to describe HazardCharacterizations. Additionally, experts may be able to devise ranking systems so that they can beused to characterize severity and/or duration of disease.

4.6RISK CHARACTERIZATION

Risk Characterization represents the integration of the Hazard Identification, HazardCharacterization, and Exposure Assessment determinations to obtain a Risk Estimate; providing aqualitative or quantitative estimate of the likelihood and severity of the adverse effects which couldoccur in a given population, including a description of the uncertainties associated with theseestimates. These estimates can be assessed by comparison with independent epidemiological datathat relate hazards to disease prevalence.

Risk Characterization brings together all of the qualitative or quantitative information of the

previous steps to provide a soundly based estimate of risk for a given population. RiskCharacterization depends on available data and expert judgements. The weight of evidenceintegrating quantitative and qualitative data may permit only a qualitative estimate of risk.

The degree of confidence in the final estimation of risk will depend on the variability, uncertainty,and assumptions identified in all previous steps. Differentiation of uncertainty and variability isimportant in subsequent selections of risk management options. Uncertainty is associated with thedata themselves, and with the choice of model. Data uncertainties include those that might arise inthe evaluation and extrapolation of information obtained from epidemiological, microbiological,and laboratory animal studies. Uncertainties arise whenever attempts are made to use dataconcerning the occurrence of certain phenomena obtained under one set of conditions to makeestimations or predictions about phenomena likely to occur under other sets of conditions for which

data are not available. Biological variation includes the differences in virulence that exist inmicrobiological populations and variability in susceptibility within the human population andparticular subpopulations.

It is important to demonstrate the influence of the estimates and assumptions used in RiskAssessment; for quantitative Risk Assessment this can be done using sensitivity and uncertaintyanalyses.

4.7DOCUMENTATION

The Risk Assessment should be fully and systematically documented and communicated to the riskmanager. Understanding any limitations that influenced a Risk Assessment is essential for

transparency of the process that is important in decision making. For example, expert judgementsshould be identified and their rationale explained. To ensure a transparent Risk Assessment a


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formal record, including a summary, should be prepared and made available to interestedindependent parties so that other risk assessors can repeat and critique the work. The formal recordand summary should indicate any constraints, uncertainties, and assumptions and their impact onthe Risk Assessment.

4.8REASSESSMENT

Surveillance programmes can provide an ongoing opportunity to reassess the public health risksassociated with pathogens in foods as new relevant information and data become available.Microbiological Risk Assessors may have the opportunity to compare the predicted Risk Estimatefrom Microbiological Risk Assessment models with reported human illness data for the purpose ofgauging the reliability of the predicted estimate. This comparison emphasizes the iterative nature ofmodeling. When new data become available, a Microbiological Risk Assessment may need to berevisited

haccp training guideline

Documents