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8/3/2019 Haccp 1 Approach
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PEOPLE
SYSTEMHARDWARE PRODUCT
Four Legs Of the Sound QUALITY SYSTEM
Delighted
CUSTOMER
&
Empowered
EMPLOYEE
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Physical Hazards
The agent causes
physical damage to the
consumer. (broken
teeth, cuts, internal
injury)
Can occur during manufacture due to physical hazards such asglass, metal, packaging residues, etc. Unstructured or lumpy product can constitute a foreign matter
hazard
Promotional items can become serious foreign matter hazards
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Biological Hazards The action of a biological
agent harms the consumer Infection or Intoxication
Mostly bacteria
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Microbes are very small
World population is
5.5 BILLION
i.e. 5 500 000 000
1 cup
of yoghurt contains
22 X this number!
i.e. 120 000 000 000
separate living
organisms.
Go Home
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Bacteria Replicate
Division times are typically ~20 min in the
lab
So, bacteria can go from 1 cell108 cells in
18 hr!
This way:
1 -> 2 -> 4 -> ->-> -> ->8 16 32 64 128 ->-> 256 512
Go Home
Play Movie
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Chemical Hazards
Chemical agents which may
have a toxic effect in
consumers.
These are not normally
expected to be found in the
product. (contaminants)
Can occur from ingredients that are out ofspecifications
Excess addition of minor ingredients
Contamination from cleaning/disinfection
chemical residues
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Allergens
Food allergy is an immunological reaction to a food
protein which is a normal constituent of a particular food.
Fatalities due to allergens are rare and consumers who are
aware they suffer from food allergy are careful when
purchasing foods.
The vast majority of incidents with regard to death fromanaphylaxis are due to food service and
catering/restaurants, and not from industrially produced
consumer goods.
The WHO has produced a general list and companies havedeveloped their Allergen policies.
Some ingredients may potentially cause serious allergicreactions in sensitive consumers eg eggs, some fishes,peanut, milk( protein) and so on....Sensitivities may varydepending on target population
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What is it ?
Tool for management of consumer safety in
the food industry
Based on an engineering tool FMEA
Focuses most attention on critical areas
HACCP =
Risk-based
QualityAssuranceApproach
+
Validated bySelective
Application ofQuality ControlTechniques
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Identifying potential food safetyproblems
Determining how and where thesecan be controlled or prevented
Describing what to do and trainingthe personnel
Implementation and recording
he HACCP ConceptMove from QC
to QA through
HACCP
STEP-6
60 units/lot
25g/unit of 250g
10 tons
Homogeneous
distribution ofSalmonella
Lots with 800 unitscontaining Salmonellaare accepted with 30 %probability
End-product testing...
Sampling scheme:
Examined:
Lot size:
Assumption:
Confidence:
Traditional endproduct testing can
never guarantee
products free from
contamination
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Codex- 7 Principles
Conduct a hazard analysis
Determine CCPs
Establish critical limits
Establish CCP monitoring
Establish corrective action plan
Verification Plan Documentation
These principles do not themselves contain enough detail or
structure to enable the production of a useful HACCP plan...
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Codex- Tasks
0. Define terms of reference
1. Assemble team
2. Describe product
3. Describe intended use
4. Construct flow diagram5. Verify flow-diagram
6. Identify hazards and preventive measures
7. Identify CCPs
8. Set critical limits and target values9. Assign monitoring of CCPs
10. Define corrective actions
11. Validation and Verification
12. Documentation
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Definitions
HazardAn agent*, or condition, with the potential to
cause an adverse health effect * Allergen, Biological,Chemical, Physical
RiskThe likelihood that a hazardous situation will
occur
Critical Control PointA step at which control can be applied (and is
essential), to prevent or eliminate a consumer
safety hazard or reduce it to an acceptable
level.
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Terms of Reference (1) Define what will be covered in this study
List the hazards that will be considered
Be realistic and reasonable
Cover all four hazard groups (allergens, biological, chemicaland physical) or explain why you dont
Make it specific (e.g. under chemical: lubricants, cleaning andsanitisation materials, cooling liquids, pesticides in rawmaterials, pesticides used on site, heavy metals in rawmaterials, etc)
Define the scope of the study (start & end)
Farm to fork List any related HACCP studies
Will you do a study for every product, or will you group?
List Pre-requisite Programmes / Systems
Training, pest control, personal hygiene, SEAC approval, plant
sanitation, .
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Select the Team
Chairman/Sourcing
Unit Head
Technical Secretary
Microbiologist**
Production
Engineer
Chemist
QA
** for HACCP studies
on Micro hazard
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Product Description and intended
use It is important that product and its use are clearly defined
Mention storage conditions and shelf-life
Repeat the information given to consumers on thepackaging- What do we tell people to do ?
Consider known or likely abuse- What do we know
people might realistically do ?
Mention target consumer group and any special needs
(e.g. Diabetic, High-cholesterol sufferers, Children,
Hospital patients)
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Flow Diagram
Provides the framework for hazard analysis Must be process based, and confined to
production processes within the scope given
in the Terms of Reference. Do not forget rework!
Keep it simple
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Flow Diagram Verification
Check that your work is accurate
Introduces non-local experts to your plant
Often overlooked
Eg water lines,
side processing,
mobile storage
tanks etc
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Identify Hazards and Controls
What can go wrong ? What can you DO to prevent it ?
This step applies both to HACCP anddHACCP
Dont forget:
Cleaning
Shift Changes
Breakdowns, Stoppages,
TPM
Training
Holiday periods
Rework
Why do we need to be clear about
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Why do we need to be clear about
the hazards
Hazards need to be defined very clearly as otherwise the
preventive measure may not be effective. For example, when the hazard only mentions contamination it will lead
to assumptions being made as it can mean
Contamination from dirty hands of workers
Contamination from the factory environment
Contamination from lubricants
Contamination with residues from cleaning liquids
Preventive measures for the different hazards can be as follows: Hand wash facilities & work instructions & training
Factory design & cleaning & training
SHE approval & preventive maintenance & training
Cleaning instructions & validation & SHE approval & training
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CCP vs DCP
Design Control Point:
A step where the study of a conceptual line design, process design
or plans and layouts identified a hazard and where there is a need
for the hazard to be prevented, eliminated or reduced. DCPs will be
identified prior to HACCP studies during development/clearance of
proposed product/process designs.
Critical Control Point:
A step at which control can be applied (and is essential), to prevent or
eliminate a food safety hazard or reduce it to an acceptable level.
Specific to a
factory or aprocess line
Generic for a
category
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Start:
Do control measures exist ?
Yes
NoIs control at this step necessary for
safety ?No
Yes
Not a CCP:
STOP
Modify step, process or
product
Could contamination with identified hazards occur in excess of
acceptable levels, or could these increase to unacceptable levels ?
Will a subsequent step eliminate identified hazards or
reduce likely occurrence to an acceptable level ?
Yes
No
Yes
No
Yes
No
Not a CCP:
STOP
CCP: STOP
CCP: STOP
Not a CCP:
STOP
Is the step specifically designed to eliminate or reduce the
likely occurrence of a hazard to an acceptable level ?
http://../DATA/powerpnt/QA%20South%20Africa/HACCP%20Course%20pt1.ppthttp://../DATA/powerpnt/QA%20South%20Africa/HACCP%20Course%20pt1.ppthttp://../DATA/powerpnt/QA%20South%20Africa/HACCP%20Course%20pt1.ppthttp://../DATA/powerpnt/QA%20South%20Africa/HACCP%20Course%20pt1.ppt8/3/2019 Haccp 1 Approach
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Reality Check !
Ensure that after determining each CCP that
there is consensus within the team.
Are your CCPs sensible ?
Have you determined CCP/QCP/DCP
correctly ?
Did you include DCPs from dHACCP study
or GMP?
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Critical Limit
A value which separates the acceptable
condition, from the unacceptable.
Usually absolute or derived from science
Note
Critical limits are defined in dHACCP stage
already
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Target Value
The value which has been proven bypractical experience to deliver the desired
condition.
Accounts for offset and variation !
Note
Target values are defined in operational
HACCP! Not in dHACCP!!
M it i
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Monitoring
Must directly measure the CL/TV parameter
Must be able to detect loss of control
Should be able of detecting trends towards
loss of control
In dHACCP monitoring options for the
factory are only PROPOSED!
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Corrective Action
A clear statement to the responsible person about what must be done when
the CCP is out of control
It can make reference to other procedures if necessary- but these must be
well known and understood by all
Remember there are always two components
1. Protect consumer safety: what will be done with the products that are
potentially unsafe?
2. Process control: what should be done to bring the process back incontrol?
Preventive actions are not part of HACCP but are to be addressed in the
quality management system (non-conformance management)
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Validation
Obtaining evidence that the HACCP plan iseffective.
Are we doing the right things ?
Can we justify what we plan to do ?A critique of evidence supporting the study
Preventative measures, Critical Limits / Target
Values, Monitoring, Corrective actions
How were the Terms of Reference constructed?
Based on what?
Are acceptable (written) procedures in place.
Check references
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Verification Verification is the application of methods, procedures, tests
and other evaluations in addition to monitoring (and at alower frequency) to determine compliance with the
HACCP plan.
Trend analysis can be very powerful when applied to:
CCP monitoring data & corrective action data
Line test data
End-product testing (this is NOT monitoring)
Complaints (consumer and customer)
Hygiene test results
Increases in blocking, reworked or destroyed products
to spot deviation from our expectations
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Limitations
HACCP cannot patch gaps in basic systems e.g. GMP conformance, calibration, maintenance,
training, safe design of products
HACCP cannot prevent all possible causes
of consumer harm
Quality of the HACCP study depends of
quality of inputs and quality of
implementation
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HACCP Implementation issues
UKC Oct 11
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Good Manufacturing Practice - GMP
Design Control Points - DCPs
HACCP
Ensure GMP / GHP before embarking on HACCP
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Bridge gaps in Hardware / Infrastructure
and Implementation of GHP / GMP
Pest Proofing
Food Handling Area
Building / Roof / Wall / Floor
drain
Storage and handlingfacilities
Laboratory
Personnel Hygiene
Infrastructure
Hygiene Station at entrance
Change room
Toilet
PPE
Handling of lubricants /
cleaning aids / chemicals etc.
Process robustness
(pasteurisation, handling
of preservatives etc.)
Water management
Air
Valves
Pumps
Pipeline / fittings
Heat Exchangers/Vessels Generic CCPs
Cleaning & Disinfection
Rework Handling
Offline Processing
Plant & Building Infrastructure Manufacturing Hygiene & Design
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Food Handling
Area must be
Pest Proof
Hygienic Vessel Design
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Hygienic Vessel Design
Sloping Manifold
Angled Instrument
Ground Smooth
Short
Manway
Trap in Vent
Probe
Baffles
Welded
Single Outlet at lowest point
Shaft
Seal
Spray
Balls
Dished Ends
Weld Seams
Hygienic CouplingsFor Agitator Blades
To Shaft
RIGHT HYGIRNIC DESIGN OF PLANT & EQIPTS
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Eliminate other
possibilities ofContamination
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HAZARD ANALYSIS CRITICAL CONTROL POINT ANALYSIS REPORT
D TreeProcess Step Hazards PreventativeMeasures Q1 Q2 Q3 Q4
CCP Critical TargetLimit Value
MonitoringProcedures
CorrectiveActions
Receipt ofRM/PM
Black specs,Foreignmatter
QC of materialbefore unloadingthe material
Y Y CCP-1
NoContamination
NoContamination
Checking ofevery lot ofRM/PM anduse only if itpasses
Rejection ofConsignment
Unloading ofLiquidRM/Blending& Storage
Foreignmattercontamination
Strainers providedin theunloading/transferpumps
Tanks are coveredErs
* SS Lining to DFAstorage tank fromtop side
* Magnetic strainersto transfer lines
Y Y CCP-2
No FM NO FM Checking ofblend beforetransfer to Panroom
Checkcondition ofseive
Hazard Analysis of Critical ControlPoint - Foreign Matter
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HAZARD ANALYSIS CRITICAL CONTROL POINT ANALYSIS REPORT
D TreeProcess Step Hazards PreventativeMeasures Q1 Q2 Q3 Q4
CCP CriticalTargetLimitValue
MonitoringProcedures
CorrectiveActions
BLS No hazardscontributing toblackspecs/Foreign
matterSoap transferto receivingPan
Open pans Soap from scrap
pan added toreceiving pan
Pan lining
Covering of all thesoap pans
Strainers providedin the soap lines
DCP
Scrap additionin scrap pan
Foreign mattercontaminationthrough scrapaddition
Sorting of scrapbefore adding toreceiving pan
Y Y CCP-3 NOFM
NO FM VisualInspection/sorting
Resorting/eject
T/S Crutching
Open manhole Contamination
while unloading ofcodex/EDTA inday tank
Contaminatedadditives added tocrutcher
Oil leakage fromgearbox
Manholes coveredStrainers providedto Codex/EDTATanks
Regular preventiveMaintenance ofCrutcher gear box.
N N GMP
Hazard Analysis of Critical ControlPoint - Foreign Matter (Cont.)
AFTER HACCP
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CCP CONDITION OF SIEVE MESHHAZARD TEARING OF SIEVE MESHWHO CHECKS MIXER TEAMWHAT TO CHECK CONDITION OF SIEVE MESHHOW TO CHECK VISUAL CHECKTARGET VALUE SIEVE MESH SHOULD BE INTACT
WITHOUT ANY DAMAGECRITICAL LIMITS SIEVE MESH SHOULD BE INTACT
WITHOUT ANY DAMAGEFREQUENCY OF CHECK ONCE A SHIFTWHERE TO RECORD MIXER LOG BOOKWHOM TO INFORM INCASE OF DEVIATION SHIFT OFFICERPREVENTIVE MEASURE TO CHANGE THE SIEVE MESH BY NEW ONE.
Modified Sieve t o prevent ing ress of
foreign m ateria l even when t he mesh
screen is torn
20# sreen
Anti bl ind rings
8# screen
Perforated sheet w ith
20 mm dia
perforations
Normal Sieve
20# screen
Anti blind rings
Perforated sheet with 20
mm dia perforations
Review&
further
Improvethe
Hardware
AFTER HACCP
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LEARNINGS : HACCP
Restore the basic condition of Plant & equipment - AM step 1 &2
Address the DCPs first
Make the shopfloor Pest Proof as part of GMP implementation
One day inhouse training capsule to everyone by QA
Active participation by QA as HACCP Team member
Designate QA manager / officer as Consumer Safety Manager
with responsibility of HACCP implementation
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LEARNINGS : HACCP
Any Change in Process / Product / Equipment should triggerHACCP Review
Visual Display Boards at Workplace means Thousand Words
Involve operators while designing CCP monitoring Sheets
Include QCCP & CCP Trend Monitoring in monthly
Factory Review
Above all Top mgt commitment & build in Key Tasks;
use OPLs for workers training/appreciation
Always focus on results after HACCP impl &
review effectiveness of implementation
REVIEW OF HACCP PLAN
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REVIEW OF HACCP PLAN
Review HACCP in case of any of thefollowing changes:
Change in RM or Product formulation
Change in Process
Change in packaging, storage and
Distribution system
Receipt of market feedback.
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T H A N K Y O U