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8/12/2019 Pre-Requisite Programs (PRP) & Critical Control Points (CCP)
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Pre-Requisite Programs(PRP)
andCritical Control Points (CCP)
STANDARD MALAYSIA CERTIFICATION BODY FORUM
19 June 2012
Zahara Merican
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Presentation GuideIntroduction
Pre-Requisite Program PRP
PRPs & oPRPs
Critical Control Point (CCP) & ItsDetermination
Summary
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Introduction
FOOD SAFETY
PLAN
PRP/support
programs
(GMP, SOP,SSOP, etc.)
+
HACCP
+Effective training
=
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HACCP= Hazard Analysis & Critical Control Point
A system that identifies, evaluates &
emphasize controls of hazards which aresignificant for food safety
Other hazards are controlled underGHP/GMP (PRP)
Identifies specific hazards & preventive
measures for their control
Consists of seven principles4
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FOOD SAFETY MANAGEMENT SYSTEM
PRP (GMP/GHP)
Design & facilities Control of operation
Maintenance & sanitation
Personal hygiene Transportation
Product information &consumer awareness
Training
HACCP PRINCIPLES
1.Conduct hazard analysis
2.Determine Critical Control Points
(CCP)
3.Establish critical limit(s)4.Establish monitoring system
5.Establish corrective actions
6.Establish verification procedures
7.Establish documentation &records
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Malaysian standards
MS 1480:2007 Food safety according to HACCP
MS 1514: 2009 Good Manufacturing Practices (GMP)
Equivalent: Codex Food Hygiene Basic Text, Rev. 2003
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References:
Others:o ISO 22000: 2005 Food Safety Mgt Systems
Requirements for any organization in the food chain
o USFDA cGMP Regulations & specific HACCP regulations
o EU legislations on Hygiene of Foodstuff, and specificsfor different food products
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PRE-REQUISITE PROGRAMS(PRP)
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PRE-REQUISITES TO HACCP
Establishment is legal - food premises mustbe registered
Operate according to relevant by-lawsProducts comply with appropriate regulatory
requirements such as:
Food Act 1983: Food Regulations 1985;Food Hygiene 2009; etc.
mandatory codes of hygienic practice
Products comply with:
customer/importer requirements
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Prerequisites to HACCP (PRP)
Practices and conditions needed
prior to and during
the implementation of HACCP
and which are essential for food safetyas described in the Codex
General Principles of Food Hygiene
and other Codes of Practice
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Required conditions can be achieved through:
Good Manufacturing Practices (GMP) / GoodHygienic Practices (GHP)
Sanitation Standard Operating Procedures
(SSOP)
PRP
Coverage depends on : regulatory requirement
size of business types of product
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PRP and operational PRPs PRPBasic food safety
conditions and activitiesthat are necessary tomaintain a hygienicenvironment throughout
the food chain suitable forthe production, handlingand provision of safe endproducts and safe food for
human consumption
Operational PRPMeasures identified by the
hazard analysis asessential in order tocontrol the likelihood ofintroducing food safety
hazards and/orcontamination orproliferation of food safetyhazards in the product(s)
or in the processingenvironment
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Ref: ISO 22000: 2005
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SSOP USFDA REGULATIONS Safety of water
contact with food, food contact surfaces, or used as ice
Condition & cleanliness of food contact surfaces
including utensils, gloves, and outer garments
Prevention of cross contamination
from insanitary objects to food / food contact surfaces
from raw product to cooked product
Maintenance of sanitary facilities hand washing, handsanitizing, and toilet
Protection of food from adulteration
Proper labeling, storage and use of toxic compound
Control of employee health condition
Exclusion of pests from the food plant
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CLEANING AND SANITATION
An effective cleaning and sanitation program isimportant to minimize food contamination
Need to consider (SSOP): what to clean
how to clean
when to clean, and who will clean
Need to have appropriate equipment cleaning
and sanitizing facilities
Cleaning of cleaning facilities/implements shall bedocumented & implemented
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PERSONNEL HYGIENE what active records are needed which needs to be filled in every
shift, every day, etc.
Hygiene and health requirements
Communicable diseases & Injuries
Attire and conduct of workers
Policy on visitors
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CHEMICAL CONTROL
Documented procedures in place to ensure segregation,storage and proper use and control of non-food chemicalsin the plant. Includes cleaning chemicals, fumigants, baits,etc. Chemical safety data sheets available
Chemicals should be:
correctly labeled including containers for mixing stored in designated and well ventilated area, hazardouschemicals under lock
protected from cross-contamination with food or food
contact surfaces or packaging material dispensed and handled by trained and authorized staff with
procedures for receiving & issuing in place > records
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PEST CONTROL
PRP
Pests include birds,
rodents, cockroaches,flies and other insects
Effective and continuouspest control program in
place prevent entry of pests
elimination of breedinggrounds of pests
if using chemicals, getexpert advice
oPRP
In-house monitoring
activities What
How
Who
Frequency
CA
External service provider
monitoring activities
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WASTE MANAGEMENT Solid and liquid waste disposal
SSOP Schedule of waste disposal from processing
area and from plant Drains to have proper flow & traps for solids
Proper covering of waste disposal containers,
including those in the processing area Cleaning of waste containers &
Central waste collection bins away from
processing area Discharge must comply with DOE requirements
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SPECIFICATIONS
Written specifications for raw (including origin) andpackaging materials and finished products
Based on regulations, standards, scientific references or
own experiments
Ensure raw materials meet companys requirements
Prevent / reduce hazards in raw materials
Prevent unsuitable raw materials being used in production
Ensure uniform products
Contribute to HACCP implementation, e.g. reduce cost of
analysis, etc.
Meet regulatory requirements
Meet customers requirements
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RECALL AND TRACEABILITY
Documentation of recall procedure andtraceability system in place to ensure completeand rapid recall of affected lot
Do a mock recall to evaluate effectiveness Able to trace up & down
XCUSTOMER COMPLAINTS
Documented procedure for customer complaints(including auditing)
Records of complaints and actions taken. Use as
feed back Returned products isolated & appropriate action
taken (destroyed, reworked or reprocessed)
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Maintenance of PRP
Maintenance is essential to ensure continuous
control of favourable operational conditions The premises & equipment should be kept in
good state of repair
Sanitation control should be monitored for theirsuitability & verified for effectiveness
Good record keeping to provide evidence oncontinuous adherence to sanitation control
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GENERAL REQUIREMENTS
All PRPs should be:
- Documented (including plant lay-out for materials,equipment, workers amenities, footbaths, bait stations)
- Monitored and records/checklists kept
- Corrective actions taken and documented
- Records and CA verified- PRPs maintained & verified where applicable, e.g. hygiene
& sanitation, raw materials, clean rooms
- Use results to update and improve PRPs if necessary- Reviewed before implementing HACCP Plan, to verify if all
requirements have been met, and if all the necessarycontrols and documentation are in place
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CRITICAL CONTROL POINT&
ITS DETERMINATION
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Critical Control Point
A step in the food chain where activities are
carried out, or conditions prevail which can
have an influence on the safety of the
product, and where control can beexercised overone or more factors to
prevent or eliminate a food safety hazardor reduce it to an acceptable level
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Critical Control Point (CCP)
HACCP Principle 2
CCPs are points, procedures or operational
steps in the process that can be controlled toprevent or eliminate the hazard, or minimize thelikelihood of its occurrence
CCPs are determined through thoroughknowledge & expert judgment of team
members (& specialist advisor) in Principle 1
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PRINCIPLE 1
Conduct a hazard analysis Prepare a list of steps of the plants
processes Identify where significant hazards could
occur
Also identifies all possible hazards
Describe the control/preventive measures
At all identified steps
Controlled under HACCP or PRP
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Hazard Analysis - definition
The process of collecting and evaluating
information on hazardsand conditions leading to their presence
to decide which are
significant for food safetyand should be addressed
in the HACCP plan
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hazard analysis involves two stages:
hazard identification & hazard evaluation
1. Hazard identification
Consider all potentially significant hazards
Assess likelihood of occurrence of the hazards
2. Hazard evaluation assess severity of thehazard
Use flow diagram that has been verified
identify preventive measures for theircontrol
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hazards that are reasonably likely tooccur
Decision is based on: Experience
Illness data
Scientific reports
Other information (e.g., Hazards and Control
Guide)
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Hazard-Analysis Worksheet
Set up the hazard-analysis worksheet
Identify the potential species-relatedhazards
Identify the potential process-relatedhazards
Complete the hazard-analysis
worksheet
Understand the potential hazard
Determine if the potential hazard is
significant
Identify the critical control points
(Identify the oPRPs)Zahara Merican 32
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HAZARD ANALYSIS WORKSHEET (MS 1480)
1 2 3 4 5 6
Process
Step
Potential
hazardState
whether
B, C or P
Rational for
inclusion or
exclusion as
a hazard
Is this a
significant
hazard?
(Yes / No)
Whatpreventivemeasureor controlcan beapplied topreventthissignificanthazard?
Is this
step a
criticalcontrol
point?
(Yes /
No)
CCP 1
B =
C =
P =
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Control Measures
Actions and activities that can be used to
prevent or eliminate a food safety hazardor reduce it to an acceptable level
Control measures must be validated foreffectiveness
Column 5 on Hazard-Analysis Worksheet
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Hazard Analysis Worksheet1 2 3 4 5 6
Process StepPotentialhazard1
State whetherB, C or P
Rational forinclusion or
exclusion as ahazard
Is this asignificant
hazard?(Yes / No)
What preventivemeasure or
control can beapplied to
prevent thissignificant
hazard?
Is thisstep aCCP?5
(Yes/No)
Biological In / Ex: justify
Chemical In / Ex: justify
Physical In / Ex: justify
Example
1. Receiving ofsemi-processraw soya sauce
2B: Pathogens:
S aureus
In: Likely to occur
based onhistorical data
Yes Control water
activity below (aw)0.75; salt contentabove 20%.
No
3C: 3 MCPD (3-chloro-1,2-propanediol)
Ex: Strictcontrol ofsuppliers underApprovedSupplierProgram
(LeaveBlank)
Testing every 6months to ensurecompliance. PRP #5Chemical Analysis
Records
4P: None (Leave Blank) (LeaveBlank)
(Leave Blank)
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PRP or CCP?
How to know if the hazardis to be controlled under
PRP or HACCP
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Hazard Analysis Worksheet - Explanation
1 2 3 4 5 6
ProcessStep
Potential
hazard1
State
whether
B, C or P
Rational forinclusion orexclusion as
a hazard
Is this asignifica
nthazard?(Yes /
No)
Whatpreventivemeasure or
control can beapplied to
prevent thissignificant
hazard?
Is this
step aCCP?5
(Yes/No)
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1 Identify potential food safety hazards introduced, controlled orenhanced at this step. Do not carry the hazard through subsequent
steps5Column 6 will be answered yes only if the step in column 1 is acritical control point. The control measure is applied at that step
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H d A l i W k h E l i
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Hazard Analysis Worksheet - Explanation1 2 3 4 5 6
ProcessStep
Potentialhazard1
State
whether
B, C or P
Rational forinclusion or
exclusion as ahazard
Is this asignificant
hazard?(Yes /
No)
What preventivemeasure or
control can beapplied to
prevent thissignificant
hazard?
Is thisstep aCCP?5
(Yes/No)
Example
1.Receivingof semi-
processraw soyasauce
2B:Pathogen:S aureus
In: Likely tooccur basedon historicaldata
YesControl wateractivitybelow (aw)0.75; salt
contentabove 20%.
No
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2 If the group identifies a potential hazard in column 2, and is Inclusion,
justification is required in column 3. This justification normally includesthe scientific, regulatory, or historical reasons for the decision. A controlmeasure is required in column 5. The group then determines whetherthe hazard is significant using the hazard matrix (Y/N in column 4)
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H d A l i W k h t E l ti
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Hazard Analysis Worksheet - Explanation
1 2 3 4 5 6
Process StepPotentialhazard1
State whetherB, C or P
Rational forinclusion or
exclusion as ahazard
Is this asignificant
hazard?(Yes / No)
What preventivemeasure or
control can beapplied to
prevent thissignificant
hazard?
Is thisstep aCCP?5
(Yes/No)
Example
1.Receivingof semi-
processraw soyasauce
3C: 3MCPD (3-chloro-1,2-
propanediol)
Ex: Strictcontrol ofsuppliersunder
ApprovedSupplierProgram
(LeaveBlank)
Testing every6 months toensurecompliance.
PRP #5ChemicalAnalysisRecords
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3
If the group identifies a potential hazard in column 2, & is Exclusion,justification is required in column 3. This justification normally includesPRP or procedures that manage the hazard to ensure that this step isnot necessary to be controlled under HACCP. A control measure isrequired in column 5. Column 4 will be left blank
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More examples safety alone is not sufficient
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More examples safety alone is not sufficient
1 2 3 4 5 6
Process Step
Potentialhazard1
StatewhetherB, C or P
Rational forinclusion or
exclusion as ahazard
Is this asignificant
hazard?(Yes / No)
What preventivemeasure or controlcan be applied to
prevent thissignificant hazard?
Is this stepa CCP?5
(Yes/No)
1. Pasturi-zation (soysauce)
B: 1. Saureus
Inc. Known tooccur due to xcontn from fdhandler
No
- Testing of fdhandlers every 3months toensure not acarrier, oPRP #7.- Fd handlershygiene in place.
SOP 1
*No/Yes
2. A.oryzae
Exc. Qualityissue(Inc.)*
-(Yes)*
Ensure time-To
met
3. Filmyeast
Exc. Qualityissue
(Inc)*
-(Yes)*
Ensure time-To
met
C: Nil
P: Nil
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* No technically correct, but need Yes to control spoilage, so its CCP
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More examples
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More examples
1 2 3 4 5 6
Process StepPotentialhazard1
State whetherB, C or P
Rational forinclusion or
exclusion as ahazard
Is this asignificant
hazard?(Yes / No)
What preventivemeasure or controlcan be applied to
prevent thissignificant hazard?
Is this stepa CCP?5
(Yes/No)
2. Pasturi-zation(milk)
B:SalmonellaBrucella, S.aureus
Inc.Known tooccur inmilk
YesEnsure time-T
o
to destroypathogens met(>65oC,>15min)
Yes
C: Nil
P: Nil
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More examples
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More examples1 2 3 4 5 6
ProcessStep
Potentialhazard1
State
whether
B, C or P
Rational forinclusion or
exclusion as ahazard
Is this asignificant
hazard?(Yes / No)
What preventivemeasure or
control can beapplied to prevent
this significanthazard?
Is thisstep aCCP?5
(Yes/No)
3. Washingof hands
(bakery/catering/restaurant)
B: E coli, S.aureus,Salmonella
Inc:Happen -ned before.Likely tooccur from
fd handlershands
Yes
1. Ensure fdhandlers wash& sanitizehands every h2. Fd handlersundergo
medical checkevery 6 monthto isolatecarriers
Yes
C: freechlorine
Exc: Residuevalidated for
SOP
- Ensure correctamount used,
strict adheren-ce to SOP
P: Nil - - -
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HAZARD ANALYSIS WORKSHEET (US)
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1 2 3 4 5 6
INGREDIENT/PROCESSINGSTEP
IDENTIFYPOTENTIAL B,C & PHAZARDS
ASSOCIATEDWITH THISPRODUCT &PROCESS
ARE ANYPOTENTIALFOODSAFETYHAZARDS
SIGNIFICANTAT THISSTEP?(YES/NO)
JUSTIFYYOURDECISIONFORCOLUMN3
WHATPREVENTIVEMEASURE(S)CAN BEAPPLIED FOR
THESIGNIFICANTHAZARDS?
IS THISSTEP A
CRITICAL
CONTROLPOINT?
(YES / NO)
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FIRM NAME: PRODUCT DESCRIPTION:FIRM ADDRESS: METHOD OF DISTRIBUTION AND STORAGE:
INTENDED USE AND CONSUMER:
HAZARD ANALYSIS WORKSHEET (US)
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DETERMINING CCP
CCP - step where control can be applied & isessential to prevent, eliminate or reduce afood safety hazard to acceptable levels
CCPs can be determined through the Use ofthe CCP Decision Tree
Caution - CCP must be correctly identified
too many CCPs will dilute effort
too few could result in unsafe food
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use of a CCP decision tree Application of the CCP decision tree
can be useful in determining if aparticular step is a CCP for a previouslyidentified hazard
It is merely a tool and not a mandatoryelement of HACCP
A CCP decision tree is not a substitutefor expert knowledge
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CCP Decision Tree (MS/Codex)
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CCP
Q1. Are there preventive measure(s)
for the identified hazard?
NOIs control at this step necessary
for product safety?
NO Not a CCP STOP
Modify process step, Process
or product?
YES
YES
Q2. Is step specifically designed to
eliminate or reduce likely occurrence
of a hazard to an acceptable level?
YESNO
Q3. Could contamination occur at unaccept.
levels or increase to unaccept. levels?
NO Not a CCP STOPYES
Q4. Will a subsequent step eliminate or
reduce hazard to an acceptable level?
NO
Questions to be answered for each potential hazard for each step
YES
CCP DECISION TREE (US)
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CCP DECISION TREE (US)
Q1. DOES THIS STEP INVOLVE A HAZARD OF SUFFICIENT RISK ANDSEVERITY TO WARRENT ITS CONTROL?
YES NO NOT A CCP
Q2. DOES CONTROL MEASURE FOR THE HAZARD EXIST AT THIS STEP?
YES NO
Q3 NO
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IS
CONTROL
AT THIS
STEP
NECESSARY
FOR
SAFETY?
MODIFY THISSTEP, PROCESS
OR PRODUCT
YES
NOT A CCP STOP*49
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CCP DECISION TREE
Q3. IS CONTROL AT THIS STEP NECESSARY TO PREVENT, ELIMINATE
OR REDUCE THE RISK OF THE HAZARD TO CONSUMERS?
YES
CCP
NO NOT A CCP
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STOP*
This decision tree is derived from one that was developed by the National
Advisory Committee on Microbiological Criteria for Foods, USA
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HAZARD
A biological, chemical orphysicalagent in, or condition of,
foodwith the potentialto cause an adverse health
effect
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SUMMARY
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HACCP is not a stand alone system
depends on management commitment
depends on a solid foundation of PRPs: GMP/GHP; SSOPs & relevant codes of practice
HACCP does not replace nor diminish PRP
attention must be focused on basic hygienicpractices before embarking on HACCP
The effectiveness of PRP has to be assessedduring the development & implementation of theHACCP Plan
SUMMARY
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CCP HACCP Principle 2 determined
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Principle 1 identifies hazards associated withfood production at all stages from raw materials
to point of consumption The first most important step, wrong hazard analysis
results in faulty HACCP plan
Identifies steps to be controlled as CCPs or oPRPs
Significant hazard = likelihood x severity
Identify control measures for hazard elimination/
reduction/ prevention in the HACCP Plan
CC CC c p e dete edfrom hazard analysis in Principle 1
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