Download - HACCP QPSP

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    HACCP

    Implementation inFood Industries

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    CONTENTS

    Part I HACCP Introduction, History

    HACCP Key Concepts

    Why HACCP

    Part II HACCP Pre-Requisites Program

    Part III How to HACCP

    Part IV

    HACCP & Quality System (ISO)Part V HACCP Practicing Bottlenecks

    Part VI

    HACCP Future

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    Part IModule 1Introduction to HACCP

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    H

    CP

    AC

    HAZARDS

    POINTSCONTROL

    CRITICALANALYSIS

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    HACCP

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    HACCP

    A preventive approach tofood safety management

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    The most

    effective tool to

    prevent occurrence

    of food bornediseases and avoid

    consumer illness

    and injuries linked

    to the

    consumption of

    our products

    H

    AC

    CP

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    H

    AC

    CP

    Systematicapproach to theidentification and

    assessment of thehazards and risksassociated with afood operation and

    the defining of themeans of theircontrol

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    Part IModule 2

    WHY HACCP

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    WHY HACCP ?

    To have safe, reliable

    and consistent qualityproduct

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    WHY HACCP ?

    Management of product safety

    Prevention of product safety incidents

    Limitations of traditional quality control External pressure

    Other benefits

    Foundation for the development of effectiveproduct management systems

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    WHY HACCP ?Successful implementation of HACCP bringsalong;

    Primary benefits Product Safety

    Secondary benefits: Quality improvement

    Cost effectiveness

    Loss and down time reduction

    Increase consumer confidence in product safety

    Design of line/product Hygiene, housekeeping & improve manufacturing

    conditions

    Reduce maintenance

    Reduce inspection time

    Competitive advantage

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    EXTERNAL PRESSURE FOR HACCP

    Government/Enforcementauthorities

    Customers Demand

    Media Pressure

    Customer Protection Societies

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    Part IModule 3W here it has com e from&W here does it work

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    WHERE DID HACCP COME FROM

    Concept Originated during

    NASA SPACE PROGRAMIn 1960

    Used Ist time in 1971 BY Pillsbury Company

    Basic Idea behind;To provide risk free safe food for astronauts.

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    HOW TO ASSURE FOOD SAFETY ?

    Traditional Quality Control- Inspection

    - Random sampling and testing Prevention base food safety

    assurance program

    - HACCP

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    HISTORY OF HACCP1960 - Concept originated - U.S space program (NASA)1971 - Used in by Pillsbury company in space program1971 - Concept took proper form in National Conference

    on Food Protection.1985 - Recommended by National Academy of Science

    (NAS) USA1989 - Final approval by National Advisory Committee on

    Microbiological Criteria for Foods (NACMCF)1991 - Accepted by Codex Committee.1995/6 - HACCP was first time used in US Regulations

    1997 - UN/Codex Alimentarious HACCP System wasdeveloped and adopted by US regulatoryauthorities.

    2000 - Embraced by USA, UK, European Union, Japan,Canada, Australia and New Zealand till now.

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    HACCP SCOPEHACCP is for every one !!

    From;

    Farm to Fork Stable to Table

    and Gate to Plate.

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    HACCP SCOPECommercially -This system is mainly applicable to;

    All food processing facilities/factories:

    Sea Food/Meat ConfectioneryJuice & Beverage CerealDairy Industries Rice IndustryCulinary/ Spices industry Food raw materialsHotels & Restaurants Hospitals

    Air line kitchens Pharmaceuticals

    &AllSpecialized areas/operations where

    effect of food may become critical.

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    Part IModule 3HACCP Key Concepts&Basic philosophy

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    HACCP KEY CONCEPTS

    FOOD QUALITY

    &FOOD SAFETY

    MODERN CONCEPT OF FOOD QUALITY

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    CLASSIFICATION OF FOOD

    HACCP KEY CONCEPTS -Food Spoilage

    According to Perisability;

    1.Non perishable e.g. Flour2.Semi Perisability e.g Apple

    3.Perishable e.g. Raw meat

    Key Perisability factors

    Water Activity (aw)storage

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    CLASSIFICATION OF FOOD

    HACCP KEY CONCEPTS-Food Spoilage

    According to Acidity;

    Low Acid Food Medium Acid Food

    Acid food High Acid food

    1. Acidity or pH plays important role inProduct shelf life..

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    Products with pH value of 4.6 or above thatthe sterilized in hermetically sealed containers,or sterilized and aseptically filled into sterilehermetically sealed containers for ambient

    distribution.

    Products containing fish, egg, vegetable, cerealand/dairy ingredients (any substitute of these)which need to be refrigerated. i.e. Raw meat,

    fish and dairy products.

    Infant Formula

    HACCP KEY CONCEPTS

    CATEGORY 1 - PRODUCTS (HIGH RISK)

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    Dried or frozen products containing fish, meat, egg,vegetable or cereal and/or dairy ingredients or anysubstitute for these or other products excluded inthe food hygiene regulations.

    Sandwiches and meat pies for fresh consumption.

    Fat-based products e.g. chocolate, margarine,spreads, mayonnaise and dressings.

    HACCP KEY CONCEPTS

    CATEGORY 2 PRODUCTS (MEDIUM RISK)

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    Acid product (pH value below 4.6) such aspickles, fruits, fruit concentrates, fruit juicesand acid beverages.

    Unprocessed and unpacked raw vegetables.

    Jams, marmalades and conserves.

    Sugar-based confectionery products.

    Edible oils and fats

    HACCP KEY CONCEPTS

    CATEGORY 3 PRODUCTS (LOW RISK)

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    HACCP KEY CONCEPTS

    A subject dealing with the study ofmicrobial life

    Microbial Growth Factors

    NutrientsTemperatureMoisture

    OxygenpHPresence of inhibitory substances

    FOOD MICROBIOLOGY

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    HACCP KEY CONCEPTS

    Presence of any any objectionablething in food

    Nature of contaminants could be;

    PhysicalChemical

    Microbiological

    FOOD CONTAMINATION

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    FOOD SPOILAGE

    HACCP KEY CONCEPTS

    Any change in food which makes itunacceptable for human consumption.

    It may be caused by variety of reasons;

    1. Insect damage2. Physical Injury3. Enzyme activity4. Chemical change

    5. Micro-organismsProduct shelf depends upon rate of spoilage1. Food preservation is done to stop spoilage

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    HACCP KEY CONCEPTS

    Wide variety of illness or clinicalcondition affecting the gastro-intestinaltract.

    CausesBacteriaVirusFungi

    PlantsChemical

    In the form of food allergins and toxicants

    FOOD POISONING

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    HACCP KEY CONCEPTS

    Diseases caused by food productscarrying pathogens

    1. Bacteria

    2. Viruses3. Parasites4. Chemical/toxins5. Enzymatic changes

    FOOD BORNE ILLNESS

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    HACCP KEY CONCEPTS

    Two TypesInfectious;Caused by ingestion of number of micro-organism

    of public health significance to cause illness e.g.Salmonellosis & Listeriosis

    Intoxication;Caused by ingestion of a performed bacterial toxin

    e.g.Staphylococcus aureus and botulism.

    FOOD BORNE ILLNESS

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    HACCP KEY CONCEPTS

    Having contact with food, it plays vitalrole in product safety

    Type of packaging Resistance to damage Labelling

    FOOD PACKAGING & CONSUMER SAFETY

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    Food Type

    Contaminants

    Cause

    Effect

    Cost

    IMPLICATION OF MAJOR FOOD INGREDIENTS

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    Worldwide occurrence

    Involve physical. Chemical or microbiologicalhazards

    Wide range of causes Raw materials

    Mishandling

    Change of process or formulations

    Cross contamination

    Inadequate maintenance

    Wrong addition Malicious contamination

    Direct & indirect costs

    SUMMARY OF FOOD INCIDENTS

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    HACCP KEY CONCEPTS

    Pre harvesting Post harvesting Transportation During Processing

    Post processing care Storage/Ware Housing By distributors By consumer

    SAFE FOOD HANDLING

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    Part IIModule 4HACCP Pre -Requisites

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    38The HACCP Basic Support Network

    HACCP IncidentManagement

    Plant design& Lay out

    StatisticalProcessControl

    SupplierQuality

    Assurance

    GoodLaboratoryPractices

    GoodManufacturing

    Practices

    QualityManagement

    System

    Environmentmonitoring

    Preventivemaintenance

    System

    Managementcommitment

    Training &education

    Recourses(finance &

    manpower)

    HACCP PRE-REQUISITES

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    BASIC REQUIREMENTS

    Management commitment

    A trained multidisciplinary team

    Product Knowledge Time

    Resource

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    GOOD PRACTICES SYSTEMS

    Manufacturing - GMP

    Distribution GDP

    Laboratory - GLP

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    HEALTH & SAFETY SYSTEMS

    Hazardous Chemical Control

    Occupational Health

    Procedures

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    ISO 14001

    Recycling and product safety

    ENVIRONMENT MANAGEMENT SYSTEMS

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    Reliability of Key processequipment

    Breakdown maintenance not

    enough

    Poor maintenance may lead tomore hazards

    PLANNED PREVENTIVE MAINTENANCE

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    Specifications Audit program

    Auditors training

    Approval of supplier

    Approved supplier list

    Code of practice Third party audit and accreditation

    SUPPLIER QUALITY ASSURANCE

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    Assure capability of meeting the

    process requirements

    Use in CCP monitoring provides

    trend information

    STATISTICAL PROCESS CONTROL

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    Monitoring critical limits

    Trained panelists

    Application of HACCP techniques

    SENSORY EVALUATIONS PRACTICES

    INCIDENT MANAGEMENT & RECALL

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    Must effectively manage potentially unsafeproduct incident

    Must be able to recall potentially unsafeproduct from the market place

    INCIDENT MANAGEMENT & RECALL

    PROCEDURES

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    Part IIIHow to HACCP

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    HOW TO HACCP ?

    Planningand

    preparation

    Studiesand

    the plandevelopment

    Implementation

    of theHACCP

    Plan

    Maintenance

    of theHACCPSystem

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    In 4 - STAGES

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    Part IIIModule 1Planning & Preparation

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    HACCP ConceptAwareness for

    Top Management

    External

    Expert

    HACCP Team Training

    Plan the Project

    Team formation

    STAGE - 1

    Gap Analysis to

    Assess Current Status

    Planning & Preparation

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    HACCP TEAM

    Team Leader (HACCP Expert)A MicrobiologistAn Engineer

    A Production representativeA Quality. Assurance representativeAny other person having crucial concern

    with the project.

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    HACCP TEAM RESPOSIBILITIES

    Plans the projectCompletes study and generates HACCPDocumentation

    Ensures verification of the PlanCommunicates and trainsReview deviation from CCPsReview HACCP activities in response to

    changeschedules and conducts internal audits

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    ROLE OF HACCP TEAM LEADER

    Keep management inform about theprogress of the projectEnsure that the right level of expertise isavailable

    Help the team to achieve its common taskMaintain the team unityEnsure that each team member contributeshis/her best

    Mange time effectively and help the team toappraise its progress

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    Basic awareness HACCP philosophy & scope Why HACCP Food Quality & Safety HACCP pre -requisites HACCP Plan development Role of Team members Gap Analysis HACCP documentation at planning

    stage

    HACCP TEAM TRAINING - STAGE I

    HACCP KEY CONCEPTS

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    HACCP KEY CONCEPTS

    (Pre-designing assessment)

    Objectives to achieve

    Current status

    GAP ANALYSIS

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    HACCP KEY CONCEPTS

    Considerable points Supplier QA GMP GLP

    QMS Preventive maintenance Recall & incident management SPC

    Calibration Personnel/Plant Hygiene & House keeping Sanitation

    GAP ANALYSIS

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    HACCP Milestone Plan

    PERFORMANCE CHALLENGE PROJECT PRIORITY : HIGH PROJECT TEAM LEADER : MABTo implement a system of Hazard Analysis ofCritical Control Points in the process to ensure

    production of safe and quality products.PROJECT TEAM : IDA, MA, QR, MNN, LIA, MDB

    January February March April May June July AugustID Tasks

    TargetDates

    W 02 04 06 08 10 12 14 16 18 20 22 24 26 28 30 32

    01 Start of project 01:01:00

    02 HACCP Steering groupawareness training

    01:01:00

    03 Team development and training 07:01:00

    04 Baseline audit and gap analysis 17:01:00

    05 Establish process capability 01:04:00

    06 Plan the HACCP study 10:01:00

    07 Determine method ofimplementation

    05:05:00

    08 Agree actions and time table 25:01:00

    09 Process flow diagram 01:02:00

    10 Hazard analysis 21:02:00

    11 Identify CCPs 15:03:00

    12 Complete control charts 30:03:00

    13 Validate the HACCP plan 03:04:00

    14 Conduct awareness training ofoperators

    10:04:00

    15 Set up monitoring system20:04:00

    16 Train monitoring personnel 30:04:00

    17 Set up facilities and equipment 10:05:00

    18 Implementations actioncompleted

    07:08:00

    19 Verify implementation actionthrough audit

    15:08:00

    20 HACCP plan re-validation 31:08:00

    Time of Completion

    Project Duration :

    32 weeksDate of initiation of project :

    01 : 01 : 00Issuance of status report :

    after every 15 daysDate of project completion :

    31:08:00

    PLAN THE PROJECT

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    Part IIIModule 2HACCP Studies

    &

    Plan Development

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    Define Termsof Reference

    Hazard Analysis

    Describe theProduct &

    Intended use

    ConstructFlow Diagram

    ValidateFlow Diagram

    CCP Identification

    Establish Critical Limits

    Identify Monitoring Sys

    Establish Corrective Action

    Validate HACCP Plan

    STAGE - 2

    HACCP Studies & Plan Development

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    Product & associated hazards Use of HACCP Principles Risk Assessment Usage of decision tree & CCP identification Establishing Critical limits Establishing monitoring system training

    monitoring people Corrective action HACCP documentation

    Establishing HACCP Validation system

    HACCP TEAM TRAINING - STAGE II

    HACCP KEY CONCEPTS

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    Type of hazard Physical Chemical Microbiological

    Scope Which Product Which Process Whole process or any module Start and end points

    DEFINE TERMS OF REFERENCE

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    Product Introduction Principle Raw materials used Recipe/Intrinsic control factors

    Process Parameter Packaging and finished product stage Storage Condition Shelf Life

    Consumer target group Usage Abuse potential

    PRODUCT DESCRIPTION & INTENDED USE

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    PRODUCT DESCRIPTION & INTENDED USE

    PRODUCT DESCRIPTIONSName: ShangoType: Standardized and pasteurized Juice drink available in four flavors (Mango, Apple,

    Mango Orange mix and Orange)

    PACKAGING / DISTRIBUTION / STORAGE / DESCRIPTIONPackaging: Filled in tetrapak and shrink wrapped in trays/packed in curuwall cartonsDistribution: Trucks and small vansStorage: Normal room temperature

    Shelf Life: 6 months

    INTENDED USE & SPECIAL CONSUMER CONSIDERATIONSProduct is taken as nutritious juice drink by all age groups.Keep in refrigerator after opening

    INGREDIENT

    1. Pulp/Concentrate2. Sugar 3. Stabilizer 4. Flavors 5. Colors 6. Citric Acid 7. Malic Acid 8. Sodium Benzoate9. Sodium Citrate

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    Raw materials Packaging Process activities

    Temperature & Time profile Equipment design Re-work Storage condition

    Distribution Waste handling

    CONSTRUCT FLOW DIAGRAM

    l i i i / i k

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    Process Flow Diagram - Fruit Juices/Drinks

    Batch

    Preparation

    Tank

    Batchpreparation

    Raw Materials

    Weighing

    Standardization

    Stabilizer

    mixing

    Balance Tank of

    aseptic filler

    Stacking

    Final Analysis

    Pasteurization

    Temperature

    Product Pump

    Balance Tank

    Storage

    Pump

    Aseptic Storage

    Pasteurization

    Section

    - Regenerator-1

    - Homogenizer-1

    - Regenerator-2

    - Sterilizer

    - Holding Tube

    - Regenerator-2

    - Homogenizer-2

    - Regenerator-1- Cooler

    Aseptic

    Tetra Filling

    Tray Packing/ Shrink

    Filling Tube

    Forming

    Conveyer

    Sealing

    Warehousing

    - Hydrogen per oxide

    - Quality

    - Quantity

    T BA 19

    - M ain heater Temperature

    - Accurate & Careful

    weighing

    - Pulp/Concentrate

    - Sugar

    - Flavor

    - Vit - C

    - Color

    - Stabilizer

    - Sodium Benzoat e

    - Citric acid/M alice acid- Sodium Citrate

    - etc...

    - Proper storage

    of materials

    Sugar Syrup

    Preparation

    Filtration

    Pulp & Other

    Ingredients

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    ON SITE

    CONFIRMATION

    &VERIFICATION

    FLOW DIAGRAMS VERIFICATION

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    HACCP PRINCIPLES

    1. Conduct Analysis2. Identify Critical Control Points (CCPs)3. Establish target levels/critical limits4. Establish monitoring system

    5. Establish corrective action system6. Establish verification System7. Establish documentation system

    1

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    Hazard Analysis&Risk Assessment

    HACCP PRINCIPLES 1

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    1. A potential to cause harm to theconsumer Safety

    2. A property that may cause aproduct to be unsafe forconsumption

    HAZARDS

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    PHYSICAL

    CHEMICAL

    BIOLOGICAL

    HAZARDS TYPES

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    PHYSICAL HAZARDS

    Dirt Fruit pits Stones Wood

    Glass Metal Hairs Bones Insects broken parts

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    CHEMICAL HAZARDS

    1.Agricultural Chemicals

    Pesticide, Antibiotics, Growth stimulators,

    Growth hormones and Fertilizers etc..2. Industrial ChemicalsCleaners, Sanitisers, Oils, Lubricants & GreasesAmmonia and Polychlorinated biphenol etc...3. Naturally Occurring ChemicalsAflatoxins4. Environmental contaminants

    Lead, Arsenic, cadmium, mercury and PCVs5. Food ChemicalsSeasoning, Preservatives, acids, additives,sulfites and processing aids

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    MICROBIOLOGICAL HAZARDS

    Clostridium botulinum Clostridium perfringens

    Salmonella

    Listeria monocytogenes

    Staphylococcus aureus

    Shegella sp.

    Vibrio parahaemoliticus

    Bacillus cereus

    Vibrio cholera

    Comphaylobactor sp. Brucella sp.

    Streptococus sp.

    E. coli

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    The chance (probability) that a givenhazard will occur.

    HIGH RISK

    MEDIUM RISK

    LOW RISK

    RISK

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    HOW TO CARRY OUT HAZARD ANALYSISBy answering following questions for eachraw materials & process step;

    What can go wrong leading to unsafeproduct

    How can we prevent it going wrong What is the best control approach

    Is this currently in place

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    HAZARDS ANALYSIS

    Considerable points;Ingredients

    Intrinsic factorsProcedures used for processing

    Microbial contents of foodFacility designEquipment design and usePackaging

    SanitationEmployee health, health and educationStorage conditionIntended useIntended consumer

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    HAZARD ANALYSIS & RISK ASSESSMENTIdentify Hazards

    IdentifyContamination

    Point

    DetermineProbability

    DeterminePreventive Measures

    Assess riskseverity

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    HAZARD ANALYSIS TOOLS Fishbone diagram Brain Storming Documentation

    Hazard analysis chart HACCP Softwares Statistics

    Researching and evaluating the information

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    Physical, Chemical or other factorscan be used to prevent or eliminatean identified hazard or reduce it toacceptable level

    PREVENTIVE MEASURES

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    Factors capable of control Process steps

    Use of approved supplier

    Control storage

    Time management] Segregation

    Application of effective cleaning methods

    Application of effective training methods

    Effective pest control

    These are used to control not monitoring

    PREVENTIVE MEASURES EXAMPLES

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    HACCP ANALYSIS CHART

    Process Step Hazard and source Preventive Measures

    Raw MaterialsChicken portions

    Metal from de-boningknives

    1. Knife control procedures2. Effective metal detection of

    finish products

    Cooking Survival of Salmonella Correct lethal temperature andtime regime

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    HACCP ANALYSIS CHART

    Process Step Hazard and source Preventive Measure

    Raw materials:

    Sodium Benzoate

    Physical ,Chemical andBiological

    Sources: Raw materials itselfbefore reception or in storageif not stored properly

    Reception of risk free materials and

    store them properly

    Process:

    UHT

    Temperature

    Biological, Raw milk &Environment

    CIP

    Risk free milk, Perform (adulteranttests)

    Hygienic Environment.

    Temperature sensor calibration.

    (Monthly)

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    Team members Scientific literature

    Technical consultants &

    research organizations Company specialists

    Supplier/ Customers

    Trade associations

    Experimental data

    Mathematical models

    INFORMATION SOURCES

    HACCP PRINCIPLES 2

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    Identification

    ofCritical Control

    Points (CCPs)

    HACCP PRINCIPLES 2

    CCP IDENTIFICATION

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    What is a Critical ControlPoint (CCP)

    How do we find them

    CCP IDENTIFICATION

    CRITICAL CONTROL POINTS (CCP)

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    A point, step or procedure atwhich control can be appliedand a food safety hazard can beprevented, eliminated orreduced to an acceptablelevel.

    CRITICAL CONTROL POINTS (CCP)

    RAW MATERIAL DECISION TREE

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    RAW MATERIAL DECISION TREE

    Q1.Is there hazard associatedwith raw materials?

    Yes

    Q2. Are you or the consumer going to

    process this hazard out of this product?

    Yes

    Q3. Is there a cross contamination risk to the

    facility or to other products which will not

    be controlled?

    YesSensitive raw materials

    High level of control required .. CCP

    No

    Process to next raw

    materials

    No

    No

    Sensitive raw materials

    High level of control required .. CCP

    Process to next raw

    materials

    RAM MATERIAL DECISION TREE MATRIX

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    RAM MATERIAL DECISION TREE MATRIX

    Raw Materials Q1 Q2 Q3 CCP HACCP TeamComments

    PROCESS DECISION TREE

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    PROCESS DECISION TREE

    Q1.Is there a hazard at this process step?What is that ?

    Yes

    Q2. Do preventive measure(s) exist for

    the identified hazard?

    YesQ3. Is the step specifically designed to

    eliminate or reduce the likely occurrence

    of the hazard to an acceptable level?

    NoQ4. Could contamination occur at or

    increase to an unacceptable level?Yes

    Q5. Will a subsequent step or action eliminate

    or reduce the hazard to an accpteptible level?

    Yes

    No

    Not aCCP Stop*No

    Yes

    No Is control necessary atthis step for safety

    YES

    Modify step, process or

    product

    Not aCCP Stop *

    CCP

    No Not aCCP Stop *

    Not aCCP Stop *No

    * Proceed to next step or process step

    PROCESS DECISION TREE MATRIX

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    PROCESS DECISION TREE MATRIX

    Process Stepand Hazard

    Q1 Q2 Q3 Q4 Q5 CCP HACCP TeamComments

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    Controllingthe Critical Control Points

    (CCPs)

    CONTROLLING THE CCP S

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    BY: Critical Limits & Target levels

    Monitoring

    Corrective Actions Responsibility

    Validation

    Principles 3, 4, & 5

    CONTROLLING THE CCP S

    HACCP CONTROL CHART

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    HACCP CONTROL CHARTFruit Juice/Drinks

    Monitoring Corrective ActionCCPNo.

    Process steps Hazard

    Types

    Preventive

    Action

    Critical limits

    Procedure Frequency Responsibility Procedure Responsibility

    HACCP CONTROL CHART

    IDENTIFIED CCPS

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    HACCP CONTROL CHARTFruit Juice/DrinksMonitoring Corrective ActionCCP

    No.

    Process steps Hazard

    Types

    Preventive

    Action

    Critical limits

    Procedure Frequency Responsibility Procedure Responsibility

    Blending Section/Batch Preparation01 Sodium Benzoate

    UHT Section/Pasteurizationst.incharge/ Instrumentation incharge02 Balance tank

    strainer

    03 UHTTemperature

    Aseptic Tetra Filling04 Hydrogne per-

    oxide

    Quality/dosagequantity

    05 Main heaterTemperature

    IDENTIFIED CCPS

    CCPS WITH HAZARDS TYPES & PREVENTIVEMEASURES

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    HACCP CONTROL CHART

    Fruit Juice/DrinksMonitoring Corrective ActionCCP

    No.Process steps Hazard

    TypesPreventive

    ActionCritical limits

    Procedure Frequency Responsibility Procedure Responsibility

    Blending Section/Batch Preparation01 Sodium Benzoate C Proper weighing

    UHT Section/Pasteurizationst.incharge/ Instrumentation incharge02 Balance tank

    strainer

    P, B Weekly Cleaning

    03 UHTTemperature

    B Temperaturesensor calib.(Monthly)

    Aseptic Tetra Filling04 Hydrogne per-

    oxide

    Quality/dosage

    quantity

    C Qualityevaluation forbeing food grade

    Measure and addexact dosage/badge

    05 Main heaterTemperature

    B Temperaturesensor calib.

    Annually

    MEASURES

    HACCP PRINCIPLES 3

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    Establishingtarget levels/critical limits

    HACCP PRINCIPLES 3

    WHAT ARE CRITICAL LIMITS

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    The value of a preventive measure,determined during monitoring, thatdistinguishes acceptable and

    unacceptable.

    WHAT ARE CRITICAL LIMITS

    CRTICAL LIMITS

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    CRTICAL LIMITS

    Considerable points;

    Chemical LimitsPhysical limits

    Procedural limitsMicrobiological limits

    Must be measurable by test or observation

    Criteria which must be met for eachpreventive measures at CCP

    Not necessary the same as the existingprocessing parameters

    TARGET LEVEL/CRTICAL LIMITS

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    TARGET LEVEL/CRTICAL LIMITS

    82

    75

    Temp OC

    Critical Limit

    Target Level

    Safety Buffer Zone

    ESTABLISHING CRITICAL LIMITS

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    HACCP CONTROL CHARTFruit Juice/Drinks

    Monitoring Corrective ActionCCPNo.

    Process steps HazardTypes

    PreventiveAction

    Critical limits

    Procedure Frequency Responsibility Procedure Responsibility

    Blending Section/Batch Preparation01 Sodium Benzoate C Proper weighing Permissible limits

    UHT Section/Pasteurizationst.incharge/ Instrumentation incharge02 Balance tank

    strainerP, B Weekly Cleaning No choking or

    leakage/damage

    03 UHTTemperature

    B Temperaturesensor calib.(Monthly)

    Set point140oC

    Aseptic Tetra Filling04 Hydrogne per-

    oxide

    Quality/dosagequantity

    C Qualityevaluation forbeing food grade

    Measure and add

    exact dosage/badge

    Food gradeNo heavy metalsNo arsenic or lead

    Exact quantity as

    per standard

    05 Main heaterTemperature

    B Temperaturesensor calib.

    Annually

    Set pointTemperature360 0oCPressure 0.5 bar

    ESTABLISHING CRITICAL LIMITS

    HACCP PRINCIPLES 4

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    Establishing

    MonitoringSystems

    HACCP PRINCIPLES 4

    MONITORING

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    Observations or measurements to assesswhether preventive measures at criticalpoints are being implemented

    effectively.

    Observation at CCPs that the process isoperating within critical limits

    MONITORING

    CCP MONITORING

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    CCP MONITORING

    Considerable points;1. Continuous2. Non Continuous

    Monitoring On line Off Line Observational procedures

    FrequencyResponsibility

    CCP MONITORING

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    HACCP CONTROL CHART

    Fruit Juice/DrinksMonitoring Corrective ActionCCP

    No.Process steps Hazard

    TypesPreventive

    ActionCritical limits

    Procedure Frequency Responsibility Procedure Responsibility

    Blending Section/Batch Preparation01 Sodium Benzoate C Proper weighing Permissible limits Careful

    weighingPer batch Pasteurization

    operator

    UHT Section/Pasteurizationst.incharge/ Instrumentation incharge02 Balance tankstrainer P, B Weekly Cleaning No choking orleakage/damage Physicalinspection for

    choking andleakage

    Hourly UHT operator

    03 UHTTemperature

    B Temperaturesensor calib.(Monthly)

    Set point140oC

    Temperaturemonitoringfrom panel &graph

    Hourly UHT operator

    Aseptic Tetra Filling04 Hydrogne per-

    oxide

    Quality/dosagequantity

    C Qualityevaluation for

    being food grade

    Measure and addexact dosage

    /badge

    Food gradeNo heavy metals

    No arsenic or lead

    Exact quantity asper standard

    Check labrelease for

    quality

    Recorddosage/ checkend usage

    Per can/Every can

    Tetraoperator/Foreman

    05 Main heaterTemperature

    B Temperaturesensor calib.

    Annually

    Set pointTemperature360 0oCPressure 0.5 bar

    Temperaturemonitoringfrom regulatorPressure formgauge

    Hourly Tetra operator

    CCP MONITORING

    CCPS LOG SHEET

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    CCPS LOG SHEET

    Time Results Deviation? Action taken Signature

    Reviewed by : Date:

    Line/product:

    Monitoring Procedures:.

    Monitoring frequency:

    Target levels:

    CCP Ref. No.

    Date:Shift:

    Corrective action ..

    HACCP PRINCIPLES 5

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    Establishing

    CorrectiveActions

    HACCP PRINCIPLES 5

    ESTABLISHING CORRECTIVE ACTIONS

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    ESTABLISHING CORRECTIVE ACTIONS

    Prevent deviation- Only possible if target levels in place

    Correction following deviations;- Adjust the process to bring it back to control

    - Deal with the materials produced during the deviationperiod

    Destroy non complying products Re-work

    Direct into less sampling products Release following sampling and testing Release?

    CORRECTIVE ACTIONS

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    HACCP CONTROL CHART

    Fruit Juice/Drinks Monitoring Corrective ActionCCPNo.

    Process steps Hazard

    Types

    Preventive

    Action

    Critical limits

    Procedure Frequency Responsibility Procedure Responsibility

    Blending Section/Batch Preparation01 Sodium Benzoate C Proper weighing Permissible limits Careful

    weighingPer batch Pasteurization

    operatorDont use the

    productShift Inchargeerator

    UHT Section/Pasteurizationst.incharge/ Instrumentation incharge02 Balance tank

    strainerP, B Weekly Cleaning No choking or

    leakage/damagePhysicalinspection forchoking andleakage

    Hourly UHT operator Urgentlyreplace onchoking ordamage

    UHT operator

    03 UHTTemperature

    B Temperaturesensor calib.(Monthly)

    Set point140oC

    Temperaturemonitoringfrom panel &graph

    Hourly UHT operator Immediatecalibration

    UHT incharge/Instrumentationincharge

    Aseptic Tetra Filling04 Hydrogne per-

    oxide

    Quality/dosagequantity

    C Qualityevaluation forbeing food grade

    Measure and addexact dosage

    /badge

    Food gradeNo heavy metalsNo arsenic or lead

    Exact quantity asper standard

    Check labrelease forquality

    Recorddosage/ checkend usage

    Per can/Every can

    Tetraoperator/Foreman

    Ask lab forproductresults/Safe productshould bereleased

    Tetraoperator/Foreman

    05 Main heaterTemperature

    B Temperaturesensor calib.

    Annually

    Set pointTemperature360 0oCPressure 0.5 bar

    Temperaturemonitoringfrom regulatorPressure formgauge

    Hourly Tetra operator ImmediatecalibrationProcess getsstop in caseof deviationinbuilt securitysystem

    Tetra incharge/Instrumentationincharge

    CORRECTIVE ACTIONS

    HACCP PRINCIPLES 6

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    EstablishingHACCPValidation

    HACCP PRINCIPLES 6

    VALIDATION OF HACCP PLAN

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    VALIDATION OF HACCP PLAN

    1. What is validation2. How it can be done

    WHAT ?

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    WHAT ?

    The assessment of the HACCP plan beforeimplementation to provide confirmationthat it is accurate and complete

    HOW TO VALIDATE ?

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    HOW TO VALIDATE ?

    Use personnel with audit skillsAssess all elements of the HACCP plan

    - Process flow diagram- HACCP Control chart

    Assess the process area- Preventive measures

    - Process capability

    HACCP PRINCIPLES 7

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    Establishing

    HACCPDocumentation

    HACCP PRINCIPLES 7

    HACCP DOCUMENTATION

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    HACCP DOCUMENTATION

    Main Records A summary of Hazards analysis, with rationale of

    determining hazards and control measures. The HACCP Plan

    Support documentation such as validationrecords

    Records that are generated during the operationof the plan.

    RECORDS OF POSSIBLE RETENTION

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    RECORDS OF POSSIBLE RETENTION

    Hazard analysis chart

    HACCP Control Chart CCP log sheet Hold/ Trace/ Recall records Training records

    Audit records HACCP Team meeting records Calibration records HACCP Plan

    History of amendments

    Records are essential to provide evidenceof safe production

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    Part IIIModule 3

    Implementation ofHACCP Plan

    STAGE - 3

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    Determine TheMethod of

    Implementation

    Awareness

    TrainingSet UpImplementation

    Team

    Agree actions & Time table

    Take Necessary Corrective Actions

    Confirm Implementation Actions Completed

    Set upMonitoring

    Sys

    EstablishProcess

    Capability

    Set up

    Facilities

    TrainMonitoringPersonnel

    EstablishRecord Keep

    Requirements

    VerifyImplementation

    Through Audit

    STAGE 3

    Implementation Of HACCP Plan

    HACCP PLAN IMPLEMENTATION

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    HACCP PLAN IMPLEMENTATION

    Determine Method ofImplementation

    HACCP IMPLEMENTATION

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    HACCP IMPLEMENTATION

    Method Big BangMethod Advantages Disadvantages

    All at

    once

    1. Rapid

    implementationpotential2. Works well in

    companies with wellestablished QualitySystems

    3. Whole work forceinvolved

    4. Ease of work forcebriefing

    1. May take longer period overall than

    anticipated- All HACCP monitoring andcontrol procedure will have to bedeveloped before implementationstarts

    2. No trial of individual system elements3. Loss of credibility If employ see that it is poorly managed If CCP fails through poor support

    network Large immediate training requirement Resource thinly spread e.g. HACCP

    Team

    HACCP IMPLEMENTATION

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    HACCP IMPLEMENTATION

    Method - PhasedMethod Advantages Disadvantages

    Phased 1. Quality managementsystem support can be

    developed as requiredand alongside

    2. Staged training allowsmore individualattention

    3. System can be trailedand refined asimplementation

    progress4. More manageable

    approach5. HACCP Resource can

    be focused on eachstage

    1. Longer over all implementation timetable

    2. Working of small group in isolationdifficult to change culture

    3. Implementation may loose momentum

    HACCP IMPLEMENTATION TEAM

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    HACCP IMPLEMENTATION TEAM

    Team Leader (HACCP Expert)An Maintenance Engineer (Optional)A Production representativeA Q. Assurance representatives

    Any other person who has the main concern

    PERSONNEL CONSIDERATIONS

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    PERSONNEL CONSIDERATIONS

    Fundamentals to HACCP effectiveness

    Key Questions

    - Enough people- Ability- Time- Supervisor- Training

    TRAINING PERSONNEL

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    TRAINING PERSONNEL

    All personnel- An understanding of HACCP- How HACCP applies to process- Why monitoring is vital

    CCP monitors and their Supervisors- How to monitor- Monitoring frequency required- Record keeping /Deviation reporting

    - Use of critical limits/Target levels- Adjusting the process to maintain control- Corrective action

    ESTABLISHING PROCESS CAPABILITY

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    ESTABLISHING PROCESS CAPABILITY

    Equipments Considerations;

    - Availability

    - Capability- Reliability- Ease of use

    - Special facilities- Other implications

    Facility Considerations;

    - Production

    - Additional space requirements

    - Extra facilities- Training and briefing staff

    - Space- Environment- Equipment

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    Part IIIModule 4

    Maintaining the

    HACCP System

    STAGE- 4

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    Define standardsand regular audits

    Data

    analysis

    Corrective &

    PreventiveAction

    HACCP Plan

    Validation

    Documentationcontrol Update

    Ongoing Maintenance

    ProblemSolving

    Maintaining the HACCP System

    HACCP AUDITING

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    Types of audits

    The system Audit- Where ISO is used

    The compliance audit Against- HACCP Plan

    The investigative audit- To solve any problem)

    AUDIT CHECK LIST

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    Process step Considerations Auditors findings

    Raw materials(List of raw materials)

    Process(List of process steps)

    Packaging anddispatch(List of packaging here)

    DATA CHECKING BY AUDITORS

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    CCP log sheet Process control charts

    Audit reports

    Customers complaints data

    Pest control records

    Minutes of meeting

    - HACCP

    - Hygiene

    - Quality

    HACCP NON COMPLIANCE NOTE

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    HACCP Audit Non Compliance Note NO:

    Location: Date:

    Area under review:

    Non Compliance:

    Action required by (date):

    Auditors:

    Accepted by Audi tee:Corrective Action:

    Verified (Auditor): Date:

    ON GOING TRAINING REQUIREMENT

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    Refresher Training New Personnel

    - HACCP- CCP monitors- Others

    Updating training- New emerging hazards

    - Developments in HACCP Awareness training

    HACCP MAINTENANCE PLAN

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    HACCP System Approved By:

    Maintenance Requirements

    Date:

    Quarterly audit of HACCP plan

    annual plan revalidation HACCP plan to be revised for all process ingredients changes

    Quarterly CCP log sheet review for deviation trend analysis

    Monthly review of consumer complaints data for trends

    6 monthly simulation of trace/recall procedures

    Ongoing technical update through symposia and technical journals

    Quarterly analysis of training needs

    HACCP Team Leader

    HACCP PLAN REVIEW/AMENDMENTS

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    Amendments Protocol

    Product safety assessments Maintain a history sheet

    Incorporate changes Frequency of review

    AMENDING THE HACCP PLAN

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    New raw materials suppliers Changes in the process Factory enviroionment alterations New packaging

    HACCP audit changes after improvements HACCP review

    Changes need to be documented

    FOOD FOR AMENDMENTS

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    New technologies New natural foods New combinations of foods Changing legislations

    New information on existing issues New ways of packaging foods Changing eating habits

    HISTORY OF AMENDMENTS

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    HACCP Plan Ref.Page:

    Date Amendment Reason ApprovalSignature

    HACCP VERIFICATION

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    1. Initial validation of plan2. Subsequent validation of plan3. Verification of CCP monitoring as per plan4. Review of monitoring, corrective action records

    to show compliance with plan5. Comprehensive HACCP system verification.

    HACCP VERIFICATION

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    1. Establish procedures

    2. Responsibility

    3. Frequency of Verification

    ROLE OF REGULATORY AGENCIES

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    Review theHACCP plan Review the CCP record Review the corrective action records on deviation Review of the critical limits

    Review of all the records pertaining to theHACCP plan Direct measurement or observation at CCP Sample collection & analysis product safety On-site observation and record review

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    Part IVModule 1FOOD SAFETY &

    Quality System

    FOOD SAFETY INTEGRATED QUALITY SYSTEM

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    HACCP&

    Quality ManagementSystem e.g ISO

    QUALITY MANAGEMENT & FOOD SAFETY

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    ISO 9000 ensures the products meetsspecification 100% of the time.

    HACCP specifies and ensures a safe product.

    Managing HACCP using ISO 9000 ensuresthat the specific safe product is made everytime

    Documented procedures & records provideessential evidence of safe productmanufacture

    ISO/QS WITHOUT FOOD SAFETY

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    The Danger

    If unsafe product is specified ..

    ..then it will always be produced

    LINKING HACCP TO Q. MGT. TECHNIQUES

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    Quality Management system : 1SO 9000

    Good Practice System : Manufacturing

    : Distribution

    : Laboratory

    Health & Safety System : Chemical control

    : Occupational health

    procedures Environment Management system : ISO 14001

    Supplier Quality Assurance : Specification

    : Audit

    Statistical Process Control

    Sensory Evaluation

    Incident Management and

    recall procedures

    QUALITY PLANS ( 4.2.3 Quality Planning)

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    HACCP & Quality Control Chart

    DATE : Supersedes

    Approved By: Ref No:

    Process

    stepsControl Points Preventive

    measuresCritical

    limitsMonitoring Corrective

    actionResponsibility

    CCP QCP LQP Procedure Frequency

    CCP = Critical Control Points = Food Safety

    QCP = Quality Control Points = Quality other than food safety

    LCP = Legal Control Points = Legal Compliance

    QUALITY PLANS - KEY POINTS

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    Keep CCPs separate from QCPs/LCPs Enable same degree of control product

    spoilage, sensory attributes, legalcompliance etc..

    Assists with ensuring clear understandingand separation of food safety control versusnon food safety control.

    More meaningful within processenvironment.

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    Part VModule 1System Bottlenecks

    BOTTLENECKS IN HACCP PROJECTTENANCE)

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    Managements diluted vision/Lack of interest

    Wrong selection of team Clarityof concept of food safety and quality

    Weak Supplier QA/supplier support Too many CCPs Take too long to put modifications

    in place

    Resources to implement modifications

    BOTTLENECKS IN HACCP PROJECTTENANCE)

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    Coordination of HACCP Team andavailability to attend the

    HACCP maintenance meetings People reluctance for change/

    Conservation of ideas Unavailability of like GMP, GLP,

    preventive maintenance, sanitation and lack of personnel health Unavailability of experts Poor Traceability & Improper recall system

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    Part VIModule 1HACCP FUTURE

    HACCP FUTURE

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    Outside Pakistan

    In Pakistan