Calibration With Some Importance

8/13/2019 Calibration With Some Importance

1/41


2/41

Calibration And Its Application

Group Members Kashif Bashir Qasim Nazeer Muhammad Shoaib Ali Waqas Ahmed Khawaja


3/41

Whycalibrate?


4/41

Whycalibrate?1. Whatiscalibration2. Calibrationinindustrialapplications3. Whatarethecostsandrisksofnotcalibrating4. Whyiscalibrationimportant5. Whentocalibrate6. Whycalibrate?Cusexplaintomers.


5/41

Whatiscalibration


6/41

Definition

Matching or reconciliation of ameasuring device of unverified accuracy withanother device that is known (verified) to be

of standard or superior accuracy. Any differencefound between their accuracies is used to adjustthe first (unverified) device.

OR

Calibration: The operations which assure that aninstrument readings are accurate referenced toknown standards.


7/41

Whattimeisit?Whattimeisitexactlyandhowdoyouknowit?

Calibrationcanbebrieflydescribedasanactivitywheretheinstrumentbeingtestediscomparedtoaknownreferencevalue.

Thekeywordshereareknownreference,whichmeansthattheknownreferenceusedinthecomparisonshouldbetraceabletorecognized

standards.

Inthiscase,calibrationwouldbecomparingthetimeanalarmclockshowstoawristwatch,whichhasbeensynchronizedwithaknowntimesignal(e.g.withtheradiotimesignal).

Whatiscalibration


8/41

Calibrationinindustrialapplications Whenprocessmeasuringinstrumentsageand

experiencephysicalstressortemperaturevariations,criticalperformancegraduallydeclines.Thisiscalleddrift.

Asaresultofthis,themeasurementresultsbecomeunreliableandultimatelytheproductionqualitycansuffer.

Driftcannotbeeliminated,butitcanbediscoveredthroughcalibration.Calibrationisthecomparisonofinstrumentperformancetoastandardofknownaccuracy.

Calibrationassuresthatthemeasurementsareaccurateandwithintherequiredspecificationlimitsoftheprocessinstrument.


9/41

Thecostsandrisksofnotcalibrating


10/41

Thecostsandrisksofnotcalibrating1. Neglectingcalibrationcanleadto

unscheduledproductiondowntime,qualityproblemsandproductrecalls.

2. Riskingemployeesafety.3. Riskingcustomer/consumersafety.4. Loosinglicencetooperateduetonot

meetingregulatory

requirements.

5. Directeconomicallossesinbusinesseswhereinvoicingisbasedonprocessmeasurements(e.g.energyindustry).


11/41

EXAMPLES OF CALIBRATION

Temperature Pressure Weight/mass pH

RPM Electrical Aseptic Fluid flow

Humidity Optical Time Volume


12/41

CALIBRATION OF SOME INSTRUMENTS

How to calibrate pH meter

How to calibrate Weighing Balance

How to calibrate Thermometer


13/41

Whyiscalibrationimportant


14/41

WhyiscalibrationimportantSpecificreasonsforcalibration

InstrumentsdriftduringtimeTo

keep

high

and

consistent

product

quality

Complywithregulations/qualitysystemsOptimiseprocessandincreasecapacitySafetyreasonsCheckqualityofmeasurementsDirecteconomicbenefits(e.g.fromproperbilling)Controllingemissions


15/41

Instrumentsdrift Oneofthemainreasonsforcalibrationisthat

even the best instruments driftandloosetheirabilitytogiveaccuratemeasurements.Thisdriftmakescalibrationnecessary.

Environmentconditions,elapsedtimeandtypeofapplicationcanallaffectthestabilityofaninstrument.Eveninstrumentsofthesamemanufacturer,typeandrangecanshowvaryingperformance.Oneunitcanbefoundtohavegoodstability,whileanotherperformsdifferently.


16/41

Compliance with regulations/quality systems

ISO9001,9002standardsISO14001standards

Qualitysystems(e.g.ISO9001,ISO9002,ISO14001)requiresystematicandwell-documentedcalibrations,withregardtoaccuracy,repeatability,uncertainty,confidencelevels,etc.

Industries:

Allprocessindustries


17/41


ISO9001:2000(7.6ControlofMonitoring&MeasuringDevices):Theorganizationshalldeterminethemonitoringandmeasurementtobeundertakenandthemonitoringandmeasuringdevicesneededtoprovideevidenceofconformityofproducttodeterminedrequirements.Theorganizationshallestablishprocessestoensurethatmonitoringandmeasurementcanbecarriedoutandarecarriedoutinamannerthatisconsistentwiththemonitoringandmeasurementrequirements.Wherenecessarytoensurevalidresults,measuringequipmentshall

a)becalibratedorverifiedatspecifiedintervals,orpriortouse,againstmeasurementstandardstraceabletointernationalornationalmeasurementstandards;wherenosuchstandardsexist,thebasisusedforcalibrationorverificationshallberecorded;b)beadjustedorre-adjustedasnecessary;c)beidentifiedtoenablethecalibrationstatustobedetermined;d)besafeguardedfromadjustmentsthatwouldinvalidatethemeasurementresult;e)beprotectedfromdamageanddeteriorationduringhandling,maintenanceandstorage.

Inaddition,theorganizationshallassessandrecordthevalidityofthepreviousmeasuringresultswhentheequipmentisfoundnottoconformtorequirements.Theorganizationshalltakeappropriateactionontheequipmentandanyproductaffected.

Records of the resultsofcalibrationandverificationshallbemaintained(see4.2.4).Whenusedinthemonitoringandmeasurementofspecifiedrequirements,theabilityofcomputersoftwaretosatisfytheintendedapplicationshallbeconfirmed.Thisshallbeundertakenpriortoinitialuseandreconfirmedasnecessary.


18/41


FDAregulations(pharmaceuticalcompanies): Calibrationrecordsmustbemaintainedandcalibrations

mustbedoneaccordingtowritten,approvedprocedures. Eachinstrumentshouldhaveamasterhistoryrecord. AllinstrumentationshouldhaveauniqueID;allproduct,

processandsafetyinstrumentsshouldbephysicallytagged.

Acalibrationperiodanderrorlimitsshouldbedefinedforeachinstrument.

Standardsshouldbetraceabletonationalandinternationalstandards.

Standardsmustbemoreaccuratethantherequiredaccuracyoftheequipmentbeingcalibrated.


19/41


FDAregulations(pharmaceuticalcompanies): Theremustbedocumentedevidencethatpersonnel

involvedinthecalibrationprocesshavebeentrainedandarecompetent.

Documentedchangemanagementsystemmustbeinplace.

AllelectronicsystemsmustcomplywithFDAsregulation21CFRPart11.

Alloftheaboveshouldbeimplementedinconjunctionwithfollowingregulations:

21CFRPart211:CurrentGoodManufacturingPracticeforFinishedPharmaceuticals

21CFRPart11:ElectronicRecords;ElectronicSignatures


20/41

Optimizeprocess&increasecapacity Enhancedcalibrationequipmentperformance

resultsinbetteruncertaintylevels,withwhichitispossibletoimproveannualproductionlevels.

Forinstance,byimprovingthemeasurementoftheparametersfrom2%to0.4%(parametersassociatedwiththedeterminationofreactorpower),enabledthepowerineachunittobeincreasedby1.6%atNuclearPowerPlantAlmaraz(Spain).Thishasasignificanteffectontheannualproduction.

Industries:

Power&Energy


21/41

Safetyreasons Employeesafety:productionenvironmentscan

involvehighpressuresandtemperaturesfalsemeasurementscouldhaveseriousconsequencesinthistypeofenvironment,especiallyinOil&Gas,Petrochemical&Chemicalindustry.

Customersafety:especiallyinpharmaceutical,foodandbeverageindustry,productswithbadqualitycanhavefatalconsequences.

Industries:

Oil&Gas Petrochemical&Chemical Power&Energy Pharmaceutical,Food&Beverage


22/41

Economicconsequences Ifinvoicingisbasedonaccurateprocess

measurements(e.g.custodytransfer,weighingscales,gasconversiondevices),calibrationcanhaveadirectimpactonfinancialprofits.Ontheotherhand,neglectingcalibrationcanhaveadirectimpactingeneratingfinanciallosses.

Industries:

Power&Energy Pipelines Gas Steel Consumergoods(e.g.food&beverage)

Beamex 2009


23/41

Beamex2009

EconomicconsequencesTheconsequenceofpoorcalibrationhasseverefinancialimpacts*:

Theaveragecostofpoorqualitycalibrationcostsmanufacturers$1,734,000eachyear.

Whenconsideringsolelylargecompanieswithrevenuesofmorethan$1billion,thecostballoonstoanaverageof$4,000,000annually.

*NielsenResearch/ATSStudies,2006&2008


24/41

exampleinstrumentsrelatedtoCO2andNOx

Controllingemissions Fortheefficientcombustioninfurnacesand

theassociatedemissions,thecalibrationofinstrumentsiscrucial.

Governmentregulationscanrequirethatspecificinstrumentsmustbecalibrated,foremissions.

Emission-relatedinstrumentsareusuallyconsideredtobecritical,astheyareassociatedwiththelicensetooperate.

Industries:

Allprocessindustries


25/41

Commonmisbelieves1.

2.

3.

Wedontneedtocalibrate.WedontneedtocalibrateFieldbusinstruments,becausetheyaredigital.Andadigitaloutputisalwaysaccurateandcorrect.Newinstrumentsdonotrequirecalibration.

1.

2.

3.

Ifaccuracyofmeasurementsisimportantforyourplantsprocesses,thenhowdoyouknowyourinstrumentsdisplaycorrectmeasurements?Doesyourplantoperateaccordingtoregulatoryrequirements(e.g.ISO,FDA)?Ifyouarefollowingregulatoryrequirements,calibrationisanecessity .Themaindifferencebetweenfieldbusandconventionaltransmittersisthattheoutputsignalisafullydigitalfieldbussignal.Changingtheoutputsignaldoesnotchangetheneedforperiodiccalibration!Althoughmodernfieldbustransmittershavebeenimprovedcomparedtooldertransmittermodels,

itdoes not

eliminate

the

need

forcalibration.

Firstofall,thefactthataninstrumentisnewdoesnotguaranteeautomaticallythatitiswithinrequiredspecifications.Inaddition,bycalibratinganinstrumentbeforeinstallationyouareabletoenterallthenecessaryinstrumentdatatocalibrationdatabase(e.g.calibrationmanagementsoftware)aswellasstartfollowingtheinstrumentsstability.


26/41

Whentocalibrate


27/41

Whentocalibrate

Afteraperiodoftime,instrumentsdriftandcannolongergiveaccuratemeasurementresults.Toresolvethisissue,instrumentsmustbecalibratedatregularintervals.Buthowoften?Calibrationintervalcanbedeterminedby:1.

2.

3.

4.

FollowingmanufacturersrecommendationAccordingtocriticalityoftheinstrumentQualitystandardguidelines(e.g.ISO)Based

on

history

trend

analysis

Themostoptimalcalibrationintervalfordifferentinstrumentscanonlybedeterminedwithsoftware-basedhistorytrendanalysisasaresult,highlystablesensorsarenotcalibratedasoften

as

sensors

that

tend

to

drift.


28/41

Whycalibrate?Customersexplain.

Sh ll N th l d


29/41

ShellNetherlandsEddeJong,InstrumentMaintenaceEngineer:Untilrecentlycalibrationwasmainlydrivenbyeconomicmotives:eventhesmallestoferrorsindeliveryquantitiesareunacceptableinShellsoperationduetothevastsumsofmoneyinvolvedforbothcustomersandgovernments(fiscalmetering).Nowadayscalibrationhasanimportantroleespeciallyforthelicensetooperate.Governmentregulationsdemandthatspecificinstrumentsmustbecalibrated,forexampleinstrumentsrelatedtoCO2andNOxemissions.

H i k E


30/41

HeinekenEspaaArmandoRiveroRubalcaba,HeadofInstrumentation:ForHeineken,thequalityofthebeerisanumberonepriority.AlltheplantsinSpainhavereceivedISO9001andISO14001certifications,inadditiontotheBRCcertificateoffoodsafety.Theymustthereforeensurethatallprocessescorrespondtotheplannedcharac-teristics,andtheroleofcalibrationisveryimportanttoensurethequalityandsafetyoftheprocesses.

Beamex2009


31/41

NokianTyresHeikki

Karhe,

Measurement

Technician:

Calibrationisofgreatimportance,especiallyfromtheviewpointofproductionsafetyandqualityofthefinalproduct.Preparationoftherightrubbermixtureisprecisionworkandasampleistakenfromeachrubbermixturetoensurequality.Measuringinstrumentswhichyieldwrongvaluescouldeasilyruinthefinalproduct.Thefactoryisalsofullofpressureinstrumentsanditisalsoimportantforthesafetyoftheworkersthatthoseinstrumentsshowtherightvalues.

Eli Lilly and Company Limited Speke Operations


32/41

EliLillyandCompanyLimited,SpekeOperationsDerekCross,ReliabilityEngineer:Apartfrombeingaheavilyregulatedindustry,manufacturingmedicinesisaseriousbusiness

that

affects

everyones

lives

directly

or

indirectly,

including

our

own

employeesandtheirfamilieswhoarealsocustomers.Theimportanceofqualitycalibrationof

instrumentation,andhowitrelatestothemanufactureofourproducts,cannotbeoverstated.Weinvestheavilyinthefinestinstrumentation,controlsystems,andsecondarystandardtestequipmentavailabletoensureweachievethehighstandardsofcompliancewedemand.

Mazovian Gas Company


33/41

MazovianGasCompanyJacekMidera,MeasurementSpecialist:Mostimportantly,accuratemeasurementsensureproperbilling.Theimpactofevenasmall

measurement

error

can

be

tremendous

in

terms

of

lost

revenue.

Customers

want

topayfortheexactamountofgastheyvereceived.Therefore,gasconversiondevicesmust

beextremelyaccurateinmeasuringdeliveredgas.Thismeansthatrequirementsforthecalibratorsareespeciallyhigh.


34/41

IMPORTANCE IN PHARMACEUTICAL

INDUSTRY

The pharmaceutical industry produces productsthat directly affect the life of the majority of thebillions of people that inhabit the Earth.

As such, a seemingly small mistake or failure

could adversely affect the health of thousands ofpeople. Regulators in the pharmaceutical industryrecognize these stakes and have implementedvarious regulations to ensure the integrity of

pharmaceutical processes and, hence, the safetyand efficacy of the pharmaceutical products onwhich billions of people rely.


35/41

Continued

Today, calibration is basically used for the processof manufacturing so less and less possiblemistakes and errors can be made. This process ormeasuring apparatus is also used to lower the

cost of manufacture or possible production bydetermining or ensuring the quality.

.


36/41

Continued

Calibration is also ideal in minimizing possible

errors because it uses scientific method to

determine impending miscalculations while

doing something to correct the errors if therewere any. Calibration becomes more and more

popular to companies because the method

aims to economize time, labor, and otherresources in any production by means of

accurate verification.


37/41

Continued

If there were one industry that benefits a lot

in the discovery and utilization of calibration,

that would be the numerous laboratories all

over the world that conduct seeminglyendless and continuous research. The

researcher or the tasked observer usually uses

this measuring apparatus to refine his or herwork.


38/41

Continued

Calibration is also greatly beneficial to a

researcher is he or she doesn't the time to

develop his/her own apparatus due to lack of

time and he/she needs a set of methods foraccurate testing.


39/41

Continued

Aside from the field of research

laboratories, calibration is also extremely

beneficial because it makes the construction

of instruments that are capable of measuringwith sufficient precision and lesser probability

to ensure correction.


40/41

Continued

Considered as the actual accuracy of a scale orbalance, calibration is widely used in testing theproducts to get their accurate weight. In theUnited States alone, an agency called NationalInstitute of Standards and Technology that istasked to maintain standards for values of SI unitsand industrial standards, calibration has become

a helpful tool in providing the traceability of theirsubjects of study by adhering to the basicstandards of calibration


41/41

Calibration With Some Importance

Documents

Transcript of Calibration With Some Importance