Quality Control Package Quality Control Net Content Control Billions of packages of all kinds are filled around the world every day. “Package” can mean bottle, jar, tube, box or can – any container filled with product. All prepackaged goods by law display net weight or volume and number of pieces. Today, the value of a product includes more than its function. Saleable elements include safety and image as well. Even simple products include these elements and can influence their perceived compliance with regulatory requirements and enhance consumer acceptance. Thorough product inspection checks – including ensur- ing packages contain what they state in legal amounts – are required for a successful product. Statistical Qual- ity Control (SQC) can help. A quality assurance system based on SQC provides (among other attributes) the following core quality data: • Production (period) mean value • Number of violations of the legally defined tolerance limits T1- and T2- • Mean standard deviation of the production (period) • Other quality or safety relevant attributes (CCPs)* Based on the legal requirements and test plans, this information allows real time assessment and control of production quality and safety parameters. A suitable control system must be fast, simple to oper- ate, reliable and objective and requires an up-front investment. However, the right system can provide ROI within 12 months or less through: • Minimized product giveaway caused by excessive overfilling • Prevention of government obstacles to product distri- bution • Better end-user product acceptance • Optimized production and packaging • Streamlined QA procedures/personnel • Prevent legal conflicts • Minimize customer complaints • Predictable quality This paper addresses the aspects and benefits of imple- menting robust quality data management solutions and systems, such as METTLER TOLEDO’s FreeWeigh.Net ® , to ensure overall product quality and safety improvement. Contents 1 Cost control through minimized overfill 2 Available methods 3 System considerations 4 Summary 5 Additional resources
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Qua
lity
Cont
rol
Package Quality Control Net Content Control
Billions of packages of all kinds are filled around the world every day. “Package” can mean bottle, jar, tube, box or can – any container filled with product. All prepackaged goods by law display net weight or volume and number of pieces. Today, the value of a product includes more than its function. Saleable elements include safety and image as well. Even simple products include these elements and can influence their perceived compliance with regulatory requirements and enhance consumer acceptance.
Thorough product inspection checks – including ensur-ing packages contain what they state in legal amounts – are required for a successful product. Statistical Qual-ity Control (SQC) can help. A quality assurance system based on SQC provides (among other attributes) the following core quality data:•Production(period)meanvalue•Numberofviolationsofthelegallydefinedtolerance
limits T1- and T2-•Meanstandarddeviationoftheproduction(period)•Otherqualityorsafetyrelevantattributes(CCPs)*
Based on the legal requirements and test plans, this information allows real time assessment and control of production quality and safety parameters.
A suitable control system must be fast, simple to oper-ate, reliable and objective and requires an up-front investment.However,therightsystemcanprovideROIwithin 12 months or less through:•Minimizedproductgiveawaycausedbyexcessive
This paper addresses the aspects and benefits of imple-menting robust quality data management solutions and systems,suchasMETTLERTOLEDO’sFreeWeigh.Net®, to ensure overall product quality and safety improvement.
Fillingissubjecttoalargenumberofinfluencesthatcan cause fluctuations in packaged goods weight. However, weight fluctuations must not cause the net weight of even a single package to fall appreciably belowstatednetweight.Governmentregulationsgen-erally specify permissible underfill amounts.
Some manufacturers systematically overfill to elimi-nate risk of consumer and legal complaints. But such
general overfills can be costly and lower the revenue considerably.Evenwiththemodestoutputrateofsmaller companies, corresponding product give-away costs are striking.
Accurate monitoring and quality data management providesbetterresults.Givingtheprocesscloselycontrolledlimitscanhelpreduceexpensiveproductgiveaway.
1 Cost control through minimized overfill
Inmanycountriesstaticscalesmustbeusedtoverifycompliance with net content legislation and produce packagetareweightverificationreports.Productspe-cific parameters and processes, in combination with financial and economic factors, usually dictate which method is beneficial on a production line.
In-depthunderstandingoffillingmachinescatterandpackage parameters are essential to select the right sampling method, random sampling on static scales or 100 % checks of all packages using dynamic Checkweighers.
2 Available methods – Random Sampling and 100% Inspection
Random sampling control with static scales
100% inspection control with dynamic checkweighers
To truly quantify and control product fill, an under-standing of Statistical Quality Control (SQC) is re-quired. SQC takes random sample data and creates comprehensive quality control information. This information helps ensuring that a batch meets legal requirements.
The question of the optimum or lowest, possible fill quantity can be answered irrespective of the control system used. The goal of the filling process is to attain optimum mean filling quantity while fulfilling net con-tent legislation requirements.
3 System considerations
SQC spot-checks determine batch acceptability
Ideally,asolutionshouldaddressanyneedsforqual-ity data acquisition points throughout the factory and testlabs.Itshouldbehighlyconfigurableandexpand-able to ensure an enhanced degree of control with no need for software engineering during implementation or daily routine. System design considerations include:
System usability
Intuitiveuserinterfacesallowincreasedsetupflexibility,ease of operation and more precise control during fill-ing and packaging.
Dataconnectivity
IndustrystandarddatacommunicationinterfacessuchasEthernetwithTCP/IPprotocol,helpkeepinginfrastructure costs low when adding and networking instrumentation such as balances and scales, check-weighers, metal detectors, terminals and sensors to a comprehensive quality control system.
Easydataaccess
Easyaccesstoproductionparametersiscrucial.Akeyparameter in most cases is fill quantity. However, in-creasingly other parameters such as foreign body de-tection, ingredient analysis data (e.g. pH, moisture...), results from visual inspection or any results from other critical control points.
Step 4: Sampling / data acquisitionSamples are taken, guided by the system according to test plan
Step 5: Monitoring and reportingResultsareautomaticallyanalyzedbythesystemandprocessdeviationsleadtoimmediate,alarmmessagestooperators and supervisors.Printedreportsinadditiontoelectronicrecordscanbeproducedbasedondocumentationrequirements
EnhancedCompliance
Iftheprocessbeginsdeviatingfromthetarget,thechosen solution should ensure that appropriate correc-tive measures can be taken for enhanced compliance aswellasoptimizedproduction.Forcompliancetrack-ing, traceability of all quality and safety relevant data is critical over the entire life of ingredients as well as final products.
Increasingregulatoryrequirementsrequirefoodindus-tries such as infant formula or nutraceuticals to adapt thelongerthemoretoPharmalikepracticessuchas‘audittrail’orelectronicrecordkeeping.
TheUSFDAhasimplemented21CFRPart11insucha way that electronic audit documents become the original, while paper printouts are non-binding copies. Companieswishingtocomplywith21CFRPart11must therefore implement systems that support it.
Overall,awell-implementedqualitydatamanagementsolution or system reduces user error and subsequent loss of product information. The resulting improved product quality helps a manufacturer reach important operating targets.
Overfillcostisdirectlyrelatedtorawmaterialcosts.But safe-margin overfills are an effective way to en-sure compliance with net content legislation. Overfillsarecostly,evenwiththemodestoutputrateofsmallcompanies.Calculated,minimizedoverfillingcan be very effective at controlling giveaway and its resultingexpensewithoutincreasingpersonnelcosts.
Various solutions are available such as static scales with built in SQC intelligence for random sampling of netcontentdataorinlineCheckWeighersfor100%data checks.
A state of the art quality data management system, suchasMETTLERTOLEDO’sFreeWeigh.Net® offers multiplebenefitstofoodmanufacturers.Itallowsdatacollection for important quality attributes from static scales,in-lineCheckweighers,ForeignBodyDetectors,pHmeters,sensorytestpanels.Italertsoperatorstorequired adjustments almost immediately, thus helps preventingfailedproductionbatches.Further,central-izedtestplanninganddecentralizeddataacquisitionat individual workstations can account for unique companystructureandexpansion.ItalsointegrateseasilywithMESorERPsystems.
An integrated quality data management system is an excellentwaytoachievebetterqualitycontrolandrealcost-savings.METTLERTOLEDOofferssolutionsandsystemsthatpayforthemselvesandprovideafullROIwithin 12 months or less.
Package quality parameters
Product quality parameters
Sealing ok?
Labelok?
Undamaged?
Net content ok?
Expirydateok?
Batch/lotIDok?
Sensory test
Visual appearance (colour...)
Single piece weight
Viscosity
Texturei.e.particlessize
Moisture
pH-value
Metalfree?
TypicalFreeWeigh.Net® screens
Mettler-Toledo AG CH-8606GreifenseeSwitzerlandPhone +41449442211Fax +41449443060