Professional Documents
Culture Documents
1.1. Background
East Africa Bottling Share Company (EABSC) is one of the beverage companies
in Ethiopia which produces the coca-cola company products: coca-cola, coca-
cola light (sugar free), fanta orange, fanta pinaple, sprite, shweeps tonic, crystal
(carbonated water)
The first Coca-Cola bottler in Ethiopia was created in 1959 as the Ethiopian
Bottling Share Company. As the business expanded a branch was established in
Dire Dawa in 1965.
Coca-Cola SABCO and Ethiopian Bottling Share Company signed a joint venture
agreement on 19th May 1999. The name of the company is changed to East
Africa Bottling Share Company (EABSC) .This ‘marriage’ has proven to be a
perfect match which has brought about many positive changes, such as people
development, which is mandatory to grow the business. In line with this, a fully
equipped training centre was established as soon as the joint venture was
signed.
In June 6, 2003 after a major upgrade of the Addis Ababa plant it was officially
inaugurated by the Ethiopian President. In September 2007, a third production
line was installed in the Addis Plant, increasing the installed capacity by 75%.
1.2. Introduction
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• Level 1: Identification of processes
Plant’s system procedures have clearly identified processes and their interaction.
High level process map;
Master Control Document list
• Level 2: Process monitoring
By knowing processes as identified at level 1, plant’s TCCMS management
system has established procedures to manage them i.e. ensure that expected
outputs are met for each process.
ISO 22000 (HACCP) is fully implemented to ensure food safety available as
tangible evidence.
List of documented procedures is available in Master Control Document list
• Level 3: Maintenance
Documented procedures have been established to ensure that infrastructure and
work environment is properly maintained:
• EOSH performance are monitored and measured by EOSH coordinator
Training
The Plant is fully aware that training is one of the keys for maintaining a
successful Organization .Plant’s SHEQ management system includes key
activities like:
• Identifying skills and competencies required for each function and job;
• Evaluating the gaps between current and required skills and competencies;
• Eliminating the gaps by providing appropriate training;
• Evaluating the effectiveness of training conducted.
Audit
As auditing is an important activity that helps prevent problems and drives
continual improvement, EABSC management system has addressed this activity
and defined all the details of the process in the internal audit procedure
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Chapter Two
2.1. The production process
2.1.1. Cleaning & Sanitation
The program covers the cleaning & sanitation of all processing equipments and
processing rooms .It covers the steps from preparation of cleaning and sanitizing
material up to performing the cleaning and sanitation and measuring
effectiveness of cleaning and sanitation program. To prevent contamination of
ingredients or final products that comes in contact with processing equipments.
2.1.2. Cleaning
Is the washing of equipment and pipelines, or other surfaces to remove residual
product and unwanted material.
2.1.3. Sanitation
Is the treatment of clean surfaces and equipment by a process that destroys all
pathogenic bacteria and substantially reduces the population of all other
microorganisms.
2.1.4. Pungent Products
Are those flavored products that cannot easily be rinsed from processing
equipment and therefore require a detergent cleaning to remove traces of the
flavor components from the equipment
2.1.5. Scheduling
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to prevent contamination of product. A full 5-step cleaning & sanitation is
performed every 48 hours on processing machineries
The cleaning and sanitizing agents used in the plant are hot water, sodium
hypochlorite and caustic soda or tri-sodium phosphate (TSP). The suppliers
submit the certificate of analysis and letter of conformance to the Coca-Cola
requirement.
Cleaning & sanitation activities to all processing equipment are performed as per
the schedule i.e. for syrup room, bottling hall, and container washer. The
cleaning & sanitation performed could be rinsing, three steps or five steps
depending on the frequency or flavour type for product change over. Refer to
three steps & five steps procedure for detail. The cleaning & sanitation is also
done during product change over as per the change over matrix .On a day-to-day
basis, any type of sanitation on processing machinery are recorded on the daily
quality control report sheet.
Is the process of rinsing the lines and machines with treated water to remove any
soil load. The lines and machines are rinsed until the appearance of the rinse
water becomes clear of any flavor taste or color.
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This step has found to be effective when there is no need to use a detergent for
cleaning and it is necessary to sanitize the equipment. The equipment is rinsed
with treated water to remove any remnant product from. Then it will be cleaned &
sanitized with hot water (75 OC), the hot water acts as cleaning agent and a
sanitizing agent to destroy microbial contamination. The water that circulate is
kept circulating for 15 minutes after the exit temperature of the water is above 75
O
C. If the exit temperature of the hot water can be maintained at or above 85 OC,
the re-circulation time can be reduced to 10mins. Then the equipment is rinsed
with treated water to cool the equipment.
2.1.9.3. Five Steps
This procedure is done to all equipments in syrup room & processing room (filler,
blender, piping systems) every 48 hours .First the equipment is rinsed with
treated water to minimize the soil load. This removes most of soluble material
and increases the effectiveness of the cleaning agent. Then flushed with hot
caustic solution (75oC) of 1.5 %( w/v) to loosen and remove any residual soil
particles from the surface of the equipments. Then rinsed with treated water. This
rinse prevents deposited of the soil up on the cleaning surface and removes any
residual detergent. All traces of detergent solution are removed by rinsing with
treated water .Lastly it is sanitized with hot treated water to destroy microbial
contamination using hot water.
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2.7.2. Equipment Exteriors
All equipment exteriors are thoroughly washed and rinsed with powder soap and
cold water to remove syrup, product, and any extraneous material
2.7.3. Conveyors
All conveyor systems are thoroughly rinsed with water including trays to remove
soap lubricant and mold, which has build up during the days of operation with
high-pressure spray is particularly used for this purpose.
2.7.4. Crowner
Crown dusts are removed from the crowner at least twice per shift. An increased
frequency may be needed, depending on the dusting tendency of the crowns in
use. Crown hopper and chutes are emptied at the end of the day’s production
and product changeover. Crown hoppers are cleaned using a clean, dry cloth
and a clean dry brush to get in to corners. Weekly crowner throats or closure
application heads are washed with water to remove any product and dust build
up. Water is not used to clean hoppers.
2.7.5. Drains
All drain of debris; broken bottles crowns and the like are cleaned by lifting the
drain covers
2.8.1.1. Pre Rinse, Warm Water, Cold Water & Fresh Water Compartments
The Pre rinse, cold water, warm water, fresh water compartments are inspected
at least once in a shift and flushed with soft water. The pre rinse, warm water,
cold water and fresh water compartments are always drained and flushed at the
end of production and leave dry until the next use.
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These compartments are cleaned at least weekly and if not in use they are
cleaned daily depending on the stoppage plan as per maintenance and sanitation
schedule.
2.8.1.2. Rinse Nozzles
All the nozzles are inspected for clogging and alignment twice per shift. The
sprays jets are brushed on line one at least once per Shift. Any materials causing
clogging or blocking are removed by brushing. The jets are disassembled at least
once in a week or as necessary and thoroughly clean.
The body of the washer is washed using powder soap daily and the stainless
steel parts are kept shiny at all times
Create washer is cleaned at least two times in a shift .The water in the tanks is
cleaned at all times and the filters are cleaned at least twice in a shift, the water
is changed once in a day
After the syrup is produced any syrup residual left is drained completely during
tank change over. The tanks and piping are cleaned as per cleaning and
sanitation matrix, to ensure that there is no color and odor of previous product in
rinse water.
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2.9.3. Concentrate & Beverage Base Handling Equipments
These equipments are rinsed with treated water to make sure all traces/
remnants/ are cleared.
All floors, walls, all drains of debris of the syrup room are cleaned with cleaning
detergent
Five steps Cleaning & Sanitation will be performed to all equipments in syrup
room as per procedure. The sanitation effectiveness is verified by doing
microbiological analysis on weekly basis and if the sanitation is not effective the
sanitation will be done again.
Syrup tank
Filling line
Syrup tank
Filling line
Syrup tank
Filling line
Syrup tank
Filling line
Syrup tank
Filling line
Filling line
Syrup tank
Syrup tank
From
FAOR 3ST 3ST NA RW RW 3ST RW 3ST RW 3ST 3ST 3ST 5ST 5ST
SPRITE 3ST 3ST RW 3ST NA RW RW 3ST RW 3ST 3ST 3ST 5ST 5ST
F.ANANAS 5ST 5ST 5ST 5ST 5ST 5ST NA RW 5ST 5ST 5ST 5ST 5ST 5ST
TONIC 3ST 3ST RW 3ST RW 3ST RW 3ST NA RW 3ST 3ST 5ST 5ST
COKE 3ST 3ST 3ST 3ST 3ST 5ST RW RW 5ST 5ST 5ST 5ST NA RW
LIGHT
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Definitions
N.A – Not Necessary
R.W - Rinse with Treated Water
3 ST – 3 Steps with Hot Water
5 ST – 5 Steps with hot Caustic and water
Is a bottle or crate washing machine, which has different compartments for step-
by-step cleaning of the company bottles and crates?
The Bottle washer operation is prepared in order to remove all dirt from inside
and out side of bottles and to kill moulds, yeasts, and any pathogenic bacteria
from the bottles. Before bottle washing operation is began the washer itself is
cleaned thoroughly.
Then all water compartments will be filled with water and caustic compartments
will be filled with pre heated caustic. The temperature & concentration of caustic
in all caustic tanks will be checked for minimum requirements before starting to
feed the washer with bottles. The temperature and concentration in the main
caustic tank should be > 62 OC, and >2.0% respectively.
If these conditions are met then starting up of the washer can be done. If the
temperature is below 60 oC the washer will be warmed-up. the machine will be
run for 10 min before feeding bottles in order to stabilize the temperature
through out the machine. If the conditions stated in step one are met, then feed
the bottles to the washer and run the machine
2.1.2.2. Monitoring the Bottle Washer Operation Condition
Bottles to be filled with product should be sterile and free from residual detergent.
The minimum allowable condition of the bottle washer operation is as follows:
1• Temperature: Minimum 60 °C
2• Caustic concentration: (2.0-3.0)% caustic (as NaOH)
3• Min. soak contact time: >= 5 min. (in at least 1 comp.)
4• Rinsing with potable or treated water; chlorine residual 1–3 mg/l.
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5• Local laws and regulations are followed.
6• Pre-Final Rinse pH 7.5± 0.5
All pressure gauges, conductivity meter, & thermometers fitted on both line
washers are calibrated regularly as per the procedure detailed in Calibration
Program of the plant to ensure that they are working properly.
Any changes to the above container washing condition must be tested and
verified through Division Quality Assurance to provide the same microbiological
level and degree of cleanness.
The following parameters are checked while the machine is running to ensure the
above conditions are met or not.
if the nozzles are properly spraying or not (Once in a shift).
Rinse pressure and jets alignment (Once in a shift). Final rinse pressure
must be within the range of 2.8gm/cm 2 to 4.2gm/cm2
the strainers in pre-rinse, warm water & cold-water tanks. (Once in a shift)
the final rinse chlorine residual. (Every Four Hours)
Microbiology for final rinse water as per microbiological monitoring
program (Weekly).
The caustic solutions level in the tanks.
Concentration of caustic in all the caustic compartments, appearance,
odour & temperature of the caustic solution as per prior to start up and
every four hours interval.
the thermal difference between tanks not to exceed 25 0C to prevent
bottles from thermal shock
In addition to the above, quality control checks are performed on the bottle
washer
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2.1.2.3. Bottle Discharge
The bottles discharged from washer are checked for proper cleaning and rinsing.
This include
Caustic carry over
Mould carry over test for the first set of washer discharge and every four
hours.
Visual inspection for cleanness and any foreign matter as per container
program.
Bottles with moisture
Chip neck or cracked bottles
None flavour bottles
Upon inspection, if the bottles meet the requirement, they are released to the
filler or if still dirty they will be sent back to the washer in feed for rewash. If the
condition of the bottles is unusable (need for manual washing), then they will be
taken out from the line through the return conveyor and putted. The bottle
inspectors give feedback for washer operators and QATs in the case of too much
rejects at the sighting station.
Filling and crowning is the process of mixing the product in the blender as per the
procedure in carbonating & blending, and filling in to washed bottles, which are
verified to be clean by inspection.
Preparing the filler includes adjusting the stem of vent tubes, cleaning the valves,
and the entire system, counter pressuring etc .Clean and sanitize the filler as per
the procedure in cleaning and sanitation program .Rinse the filler with beverage
blended that has a lower brix used for adjusting on the blender to remove any
extraneous water left in the filling valves. Then transfer the properly blended
beverage to the filler, fill few bottles and crown for laboratory test on
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Carbonation
Brix
Net content
Odor
Taste
Color
Appearance
Date code
Crown crimp
If it is with in specification then release the product If not reject the product and
rinse the filler with the product in the filler bowl. Then adjust the setting of the
blending machine and pump in another batch from the blender and repeat the
test.
The filling and crowning process is monitored throughout the production shift
every 30 minutes. This includes checking the following parameters,
The net content and the crown crimp of the bottled product at least once
per shift (at start up) and during changeover.
Brix and gas content of the product.
The number of bottle bursts that happen on the filler as this can help in
identifying areas where problems are being seen (like high washer water
temperature, excessive scuffed bottles and the like)
The full bottle inspectors also control the filling process. They inform to the
filler operators if contaminated, under fill and overfill bottles are too much
on the line.
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Syrup manufacture involves preparation of simple syrup in one tank, its filtration
into a second tank, and thereafter conversion to final syrup (also called flavored
or finished syrup) through addition of concentrate or beverage base.
All equipment coming into contact with ingredients, syrup, or finished product in
the course of preparation, handling, and storage are of sanitary design and free
draining.
There is sufficient clearance between the top of tanks and overhead structures,
including the ceiling, to permit access of personnel and equipment for operation,
maintenance, and cleaning and sanitation. All equipment coming into contact
with ingredients, syrup, or finished product are made from approved materials
and are capable of being properly sanitized. Stainless steel (types 304 or 316)
satisfies all requirements used for construction of syrup handling equipment. It
has a bright appearance, it is impervious to syrup, it may be fabricated without
too much difficulty, and it is capable of taking a high polish.
All stainless steel product contact surfaces have a polished finish. Syrup is
viscous and thus adheres to a rough surface. Better drainage is accomplished
through the use of a highly polished inside surface. Every contract or purchase
order for stainless steel processing equipment must specify that “all stainless
steel parts in contact with the product shall be of AISI Type 304 or 316. Any parts
that are found to be not of these two types shall be replaced by the manufacturer
free of charge to the purchaser or at the manufacturer’s expense.”
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2.1.4.5. Simple syrup
Is filtered solution of nutritive sweeteners before the addition of Concentrate or
Beverage Base?
2.1.4.6. Brix
Percentage by weight of sucrose in the solution
Firstly the simple syrup tank is filled with 5627 liter of treated water and then
heated to 800 c.10129 Kg of sugar is added while it is agitated slowly.
Once the dumping of the required amount of sugar is finished, heat up the simple
syrup to a temperature of 80 0c.Effective agitation is needed to formulate uniform
solution. Otherwise, sugar will be settled at the bottom of the tank. Continue
agitation until all the sugar is dissolved. If the sugar is completely dissolved, then
the next step which is filtration.
The pre-coating tank is filled with water and an appropriate quantity of filter aid is
added while the agitator is running. Then gradually the outlet valve of the pre
coat tank is opened and the solution is allowed to flow in to the filter press. Then
the mixture is circulated through the filter press and back to the pre-coat tank to
form “Cake” with in each frame of the filter press. Circulations of the solution of
filter aid continue through the filter press until it is completely clear. This indicates
that the filter aid has been properly deposited. After the pre coating is clear,
slowly open the simple syrup outlet valve while closing the pre coating valve at
the same time and start circulating the sugar solution to the filter press.
Continuous flow during circulation is essential. Sugar is circulated until the
appearance of the sugar meets specification
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Once the solution is clear the flow should be directed to the final syrup tank,
again being careful not to interrupt the flow through the filter. To avoid air in the
simple syrup, the simple syrup tank agitator is put off before the level of the liquid
in the tank reaches the blades. The entire simple syrup gets in to the final syrup
tank by pushing the ruminant of simple syrup out of the filter press. This is done
by adding the volume of water equal to the capacity of the filter press and feed
lines in to the simple syrup tank to push the simple syrup completely. As soon as
the water leaves the tank, stop the pump and close the valves. The filtration
process is completed. After simple syrup filtration is completed check Brix,
appearance (turbidity & colour) taste, and odour as per the procedures in
standard method manual
The liquid parts containing the flavoring components, coloring, and acids
manufactured by company concentrate plants. They are used in the preparation
of Coca-Cola syrup.
2.1.6.4. Adding Concentrate or Beverage Base and Mixing
After filtration is completed, the simple syrup is verified for the standards of
colour
Turbidity
Brix
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Appearance
Taste and
Odor
microbiology
Then it is checked
the Concentrate container is in a good condition,
Count carefully the containers and the parts to make sure they align with
the number of units to be prepared.
dry parts must be pre- dissolved in treated water set aside for that
purpose.
each part must be mixed thoroughly in to the bulk of the syrup before the
next part is added, otherwise syrup can result in adverse reaction between
the parts
add the concentrate or beverage base in accordance with the mixing
instruction
rinse the Concentrate or Beverage Base containers thoroughly with
treated water which is held from simple syrup manufacture, and add the
rinse to the final syrup tank.
Note: When adding Concentrate, any crystal remaining on the screen after
rinsing is dissolved in warm treated water and added to the batch.
Then it is agitated thoroughly for at least one hour after adding all concentrate
and beverage base
2.1.6.5. Sampling & Testing
The agitator is stopped and allowed the syrup to stand for 5 minutes to allow any
bubbles to escape. Take sample and test the final syrup for brix and measure its
volume. If the syrup Brix is above the standard the brix is adjusted by adding the
required amount of water. The results are recorded on syrup manufacturing
report form.
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2.1.6.6. Release the syrup to Production
If the brix is ok the final volume of the syrup will be recorded and the syrup is de-
aerated for one hour before realizing to production. All final syrup are used on the
day of manufacturing date. But when this is impractical, the following guidelines
apply to their storage.
o
These storage periods apply only if the syrup temperature remains below 25
C/77 o F
2.1.6.7. Records
Syrup Manufacturing records include the following information and kept for two
years in QAM office.
The date code is used to promote proper stock rotation, removal of over aged
product from the market, and effective product traceability.
2.1.7.1. Production date code
A code used for traceability which includes plant, time and date of production.
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2.1.7.2. Open style date code
a style of coding which can be easily understood by consumers without training
or decoding aids, for example, 01/04/2005.
2.1.7.4. Requirements
Enforce a no code/no run policy. If the line is not capable of applying legible date
codes (open date style code and product date code) to packages, filling on the
line does not occur.
• Each package must have both:
− a production date code that identifies the production plant and
date; and
− an open style date code or a durability label.
2.1.7.5. Monitor the print Quality
All bottles are removed from the line whenever illegible or un-date coded product
is identified. At all condition the policy of “NO CODE NO RUN” is applied by all
personnel’s at all time. The filler operator makes sure that the date coding comes
back to its original condition.
The Date code print is checked on the line according the specific checklists
provided. Date Code checklist is filled to monitor the effectiveness of the date
code.
The CO2 gas is produced from the complete combustion of a liquid or gaseous
fuel.
a) Fuel is fed to the combustor under carefully controlled conditions to obtain
maximum CO2 in the flue gas without trace of smoke. A CO2 analyzer
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and smoke test gun are provided to assist regulation of fuel to obtain
complete combustion.
b) Air is introduced to the combustor through a positive displacement type
blower. From the Brower the air is divided into two streams, primary air
and secondary air. The primary air atomizes the fuel oil at the combustor
head. The secondary air completes combustion of fuel within the
combustor and firebox. Both streams of air are thoroughly mixed together
within a stainless steel cone incorporated in the combustor.
c) Flue gas passes through the re-activator firebox and tubes, transferring
heat to the absorption solution. The flue gas then passes through the
scrubber tower where it is water washed and cooled before entering
Absorber tower.
Chemical Reaction
2.1.8.2. Absorption
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2.1.8.3. Monitoring Operation
Fuel is t regulated to avoid smoke or low CO 2 Content in the flue gas . MEA is
charged when the strength is below 7.5% (Add 2 liters of MEA per 1000 kg of
CO2 produced to keep the solution at operating strength) .The PH dosing tank
must be filled regularly with 25kg of caustic soda in 125lt of water. The
permanganate solution (which is used to avoid impurity gases) is changed after
100hrs of operation or if the purple color of the permanganate solution is
changed
The CO2 produced is checked for quality conformance before it used in the
production of beverage. CO2 produced is checked for its quality for
odor,
purity ≥99.9%,
Appearance
taste
Other un wanted gases
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well water is relatively free from most of turbidity ,colour organic matter and
bacteria. However in passing down through the earth it has been in extensive
contact with minerals and has too much soluble minerals content. If the mineral
content of water is too high it will cause the water to have a salty taste and
therefore make it unusable for the production. This alkaline mineral content has a
property of neutralizing one of the basic acidulent flavours of the coca cola and
for this reason the alkalinity of any water always be reduced to a very low level.
The water treatment system includes enhanced filtration, alkalinity reduction,
disinfections, carbon purification & polishing filtration processes.
Water may be of good flavor in it self and perfectly safe to drink, yet it can be
responsible for many defects in “coca cola”. Harmless substance dissolved or
suspended in un treated water may react with the ingredients of “coca cola
“syrup to produce one or more defects .The most prevalent of these to occur in
the bottled beverage are:
Poor flavor
Stringy and flaky sediments
Unsightly rings at the neck of the bottle
Turbid beverage
Poor carbonation and foaming at the filling machine
There fore practically every water requires treatment which will remove from it
the reacting substances responsible for an inferior beverage .only then can it
be used safely in preparing “coca cola”
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2.1.9.3. Sand Filtration
Sand filter is used as a strainer to catch any suspended matter that may have
been carried along with the water.
After the water has been passed through the sand filter it then passes through a
bed of activated carbon which is specially treated charcoal of very high degree of
activity .The primary function of carbon bed is to remove chlorine from the water.
It is necessary to remove this chlorine before the water is used in preparing
products because any chlorine carried into the drink will have a bad effect on
flavor. Carbon will also absorb organic impurities responsible for off taste and
odors
2.1.9.5. Disinfection
The water is finally exposed to UV light to kill any microbiological organisms that
would be found in the water.
2.1.9.6. Monitoring & Record
IF the following parameters are met then continue running of the plant and
monitor the parameters regularly but if they not met appropriate corrective action
should be taken. The corrective action may require stopping the specific part of
the plant for maintenance while running the others.
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Chapter three
3.1. Quality control and testing (Quality Assurance Laboratory)
Total count & coli form for washed bottles, final rinse water, process water
& raw water.
Yeast & mold count for simple syrup, final syrup & final beverage.
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Treated Total count Total count < 25 Once in a week
Water After UV /ML
Final Rinse Yeast & Mold Filter Press < 10 /100ml Once in a week
Water from CIP Filler 6valves
Process Simple Syrup Once in a week
Total count Tank <25 /ml
Final Syrup
Tanks
Filler Valve /Snift Total Count Filler valve <10/valve Weekly
Yeast & Mold Filer valve <10/valve Weekly
At least weekly review microbiological data is done for trend and non-conforming
situations. When adverse situation occurs, initiate corrective action is taken. An
unsatisfactory microbiological test result indicates an effective cleaning and
sanitizing procedures and corrective action will be taken accordingly.
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The program covers the procedure to control all nonconforming incoming
materials, intermediate products, & final products. The program is followed to
prevent the use or distribution of nonconforming materials & products.
Materials & products that don’t meet the Coca-Cola Company specification are
segregated and stored in a separate area. And after different testing of the
quality of nonconforming materials or products it will be decided to reject the
nonconforming materials or products
Corrective action are taken to correct and eliminate the reoccurrence of non-
conformance, which are identified through different sources such as
internal/external audit, management review, and any employee request
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3.1.3.4. Process Capability
The measured, inherent reproducibility of process.
3.1.3.5. Process Capability study
A systematic investigation to determine the ability of a process to meet stated
accuracy and precision requirements.
Samples are taken from the filler for testing brix and carbonation of the product.
If the brix and carbonation test result show that it is with in the Coca-Cola
Company specification limit, then the result is recorded on the daily
quality control report form and production will start.
If specification limit don’t met, then the product is rejected from the
system and adjustment will be done on the machine. Then again sample
will be tasted after adjustment for brix & carbonation until the product
meets the company specification.
If the product meets the company specification production will continue and
samples will be analysed every thirty minutes to ensure the process is running
smoothly and to make sure that all products that do not meet company release
criteria does not released to the warehouse.
If there is any non-conformance in between the production run, then the line will
be stopped and non-conforming product will be isolate to investigate the problem
to remove reoccurrence. After analyzing the isolated product, necessary
measure will be taken.
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Sample Standard Deviation (s) = [n X i 2 - ( X i) 2 /n (n-1)] ½
Where s = Sample standard deviation
The potential capability index (Cp) and Actual Capability Index (Cpk) are
calculated using the following formula.
Use the lowest or smallest value of the two formulas to calculate the Cpk value.
Cpk = Lowest Value /3.
The result will be evaluated against the standard to ensure that the
sample satisfies the company specification.
Cp & Cpk should always be > 1.33 for the process capability to be
considered acceptable.
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When the process is properly targeted, Cpk = Cp.When the process is not
targeted properly Cpk < Cp.
If the company process performance specifications are met, then they are
recorded serve as objective evidence.
If not met, the problem will be investigated and an appropriate corrective action
will be taken.
For purchase of new equipment if they don’t meet company stated
accuracy and precision requirement the supplier will be contacted for
corrective action and redesign.
When the existing processing equipment does not meet the company
performance specification a corrective action plan will be initiated to
address this concern. Specifically, the corrective action plan will ensure
that all products manufactured or tested with the equipment conform to
company release requirement.
If the result of the Corrective action plan indicates that the only long-term solution
is to purchase new equipment, but funds are not available, a problem interim
solution would be to increase inspection effort until capital becomes available.
3.1.4.Calibration
Testing and measuring equipments reliability measures are applied for the
Quality monitoring activities in the plant. In order to have accurate and reliable
measures for the different tests and analysis performed, Plant’s system requires
a strong calibration program that covers the following activities:
• Identification of testing and measuring equipment to be verified and
Calibrated with frequencies and responsibilities;
• Verification/re-calibration and calibration working instructions applied for
concerned equipment;
• Qualified person assigned for conducting calibration
• Handling of celebrants and reference standards.
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3.1.4.1. Identify Equipment
The followings are the processing and measuring equipment, which are
calibrated. Pressure gauge, balances, thermometers, turbidity meters, tanks, and
all other new measuring equipment used in the laboratories, water treatment,
syrup room, bottling hall, CO2 plant, air compressor, & boiler.
equipments are used for measuring or processing, they are only use for
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