You are on page 1of 18

Quality Manual

UC Davis Analytical Laboratory



Effective Date:
10/7/10
Rev.:
0004.02
Page:
1 of 18

CopyrightTheRegentsoftheUniversityofCalifornia


















UC Davis Analytical Laboratory
Quality Manual

Director:DirkHolstege
LaboratorySupervisor:TraciFrancis
ManagementServicesOfficer:NikkiSchwab
QualityAssuranceOfficer:KellyGardner

DateofIssue:October7,2010



UCDavisAnalyticalLaboratory
224HoaglandHall
OneShieldsAvenue
Davis,CA956165270
Phone:5307520147
Email:anlab@ucdavis.edu
WebSite:http://anlab.ucdavis.edu


See Document History File for approval signatures.

Quality Manual
UC Davis Analytical Laboratory

Effective Date:
10/7/10
Rev.:
0004.02
Page:
2 of 18

CopyrightTheRegentsoftheUniversityofCalifornia
TableofContents

IntroductionandLaboratoryOverview

1. Scope

2. References

3. TermsandDefinitions

4. ManagementProceduresandPolicies
4.1 Organization
4.2 QualityManagementSystem
4.3 DocumentControl
4.4 ReviewofRequests
4.5 SubcontractingofTests
4.6 PurchasingServicesandSupplies
4.7 ServicetotheClient
4.8 Complaints
4.9 ControlofNonconformingTestResults
4.10 CorrectiveAction
4.11 PreventiveAction
4.12 ControlofRecords
4.13 InternalAudits
4.14 ManagementReviews
4.15 Improvements

5. TechnicalProceduresandPolicies
5.1 General
5.2 Personnel
5.3 AccommodationandEnvironmentalConditions
5.4 TestMethodsandMethodValidation
5.5 Equipment
5.6 MeasurementTraceability
5.7 Sampling
5.8 SampleHandling
5.9 AssuringtheQualityofTestResults
5.10 ReportingTestResults


Quality Manual
UC Davis Analytical Laboratory

Effective Date:
10/7/10
Rev.:
0004.02
Page:
3 of 18

CopyrightTheRegentsoftheUniversityofCalifornia

IntroductionandOverview

Introduction

Overview
TheUCDavisAnalyticalLaboratorywasestablishedin1950atUCBerkeleyasan
Extensionsoilstestinglaboratory.TheLabwasrelocatedtoHoaglandHallatUCDavisin
1959.TheAnalyticalLaboratoryhassinceevolvedintoastateoftheartagricultural
andenvironmentalanalyticallaboratory,testingsoil,plantmaterial,water,wastewater,
andanimalfeed.TheAnalyticalLaboratoryisakeypartnerinthesuccessofUniversity
ofCaliforniaresearch.

LaboratoryPurpose
ThepurposeoftheAnalyticalLaboratoryistoprovideUCresearcherswithinexpensive,
highqualitytestingserviceinsupportofagriculturalandenvironmentalresearch
activities.Researchqualitytestingallowsresearcherstoobtaindependableresults
throughoutthelifetimeoftheirresearchprojects,whichareoftenmultiyearin
duration.Lowcostenablesresearcherstomeettheexpenseofthelargenumberof
testsnecessaryinagriculturalandenvironmentalresearch,andtocompetesuccessfully
forprojectfunding.Thelaboratoryprovidestestingsupportfordiagnosticfield
investigationsbyCEAdvisors.

LaboratoryOrganization
ThelaboratoryisaselffundedunitwithintheUCDavisCollegeofAgriculturaland
EnvironmentalSciences.ThelaboratoryisheadedbyaDirector,andstaffedwitha
ManagementServicesOfficer,aProgrammer,aQualityAssuranceOfficer,aLaboratory
Supervisor,oneofficeassistant,oneReceivingAreamanager,sixstaffchemistsand
severalparttimestudentassistants.Theuseofstateoftheartanalyticalequipment,
methodsandfacilitiesiscriticaltothesuccessofthelaboratory.Thelaboratoryoccupies
over5000squarefeetinHoaglandHallandtheHoaglandAnnex.

MissionQualityPolicyStatement

Toprovidehighqualityandtimelyanalysesofsoil,plant,water,feed,and
othersamplesandtocontinuouslymeettherequirementsand
expectationsofourclients.


Quality Manual
UC Davis Analytical Laboratory

Effective Date:
10/7/10
Rev.:
0004.02
Page:
4 of 18

CopyrightTheRegentsoftheUniversityofCalifornia
CoreValues
AttheUCDavisAnalyticalLaboratoryweholdthefollowingprinciplesandvaluestobe
themostimportant,andweconsiderthesevaluesinmakingdecisions:
honesty
safetyofouremployeesandcommunity
goodscience
fairness
quality

EthicsPolicy
Ethicsisasetofmoralprinciples,acodeforrightandwrong,orbehaviorwhich
conformstoacceptedprofessionalpractices.

Allemployeesatalltimesshallconductthemselvesinanhonestandethicalmanner.

Examplesofunethicalbehaviorinclude,butarenotlimitedtothefollowing:
Impropermanipulationofdataorsoftware
Improperhandlingofdataerrors,noncompliantdata,orQCoutliers
Lackofreportingunethicalbehaviorbyothers
Artificiallyfabricatingresults
Misrepresentingdatasuchaspeakintegration,calibration,tuning,orsystem
suitability
Improperclocksettingtomeetholdingtimes
Intentionaldeletionofnoncompliantdata

Anemployeemustreportanysuspectedunethicalbehaviororfraudulentactivitiestoa
supervisor.Anemployeehastherighttoremainanonymous.

Confidentiality
Clientinformationisconfidentialandwillnotbediscussedwithanyone,eventhose
affiliatedwiththeclientnotdesignatedasacontact,withoutpermissionfromtheclient.
Confidentialinformationincludestestresults,originofsamples,businessrelationship
withtheclient,anyproceduresandtestingthattheyconductorinvestigate,and
informationabouttheirresearch.

InstrumentServices
Thelaboratorymaintainsstateoftheartanalyticalequipment.Majorpiecesof
equipmentinclude:
ThermoIrisinductivelycoupledplasmaemissionspectrometer(ICPAES)
ThermoiCAP6500inductivelycoupledplasmaemissionspectrometers(ICPAES)
PerkinElmer/SciexAPI2000HPLC/MS/MS

Quality Manual
UC Davis Analytical Laboratory

Effective Date:
10/7/10
Rev.:
0004.02
Page:
5 of 18

CopyrightTheRegentsoftheUniversityofCalifornia
PerkinElmerAAnalyst800flame/graphitefurnaceatomicabsorption
spectrometer
PerkinElmerAAnayst300flameatomicabsorptionspectrometer(AA)
CEMmicrowavesampledigestionsystem
LachatFlowInjectionAnalyzers(FIA)
TimberlineFlowInjectionAmmoniumAnalyzer
LECOFP528NitrogenAnalyzer
LECOTruSpeccarbon/nitrogenanalyzer
ThermoFinneganSeries1112carbon/nitrogenanalyzer
DionexICS2000IonChromatograph
Varian3800GasChromatographwithSaturn2000GC/MS
SkalarFormacs
HT
TOC/TNAnalyzer

TestingServicesinformationdetailsavailableonthelaboratorywebsite
Soilstestingservicesincludesalinity,alkalinityandtoxicitytests,soilfertility
tests,soilcharacteristicsandphysicalproperties,andmineralanalysis.

Plantandfeedtestingincludescarbonandnitrogentesting,nutrientandmineral
analysis,fibertestingandcarbohydratetesting.

Waterandwastewatertestingincludestestsforwaterquality,including
sediment,nutrients,salinity,alkalinityandtoxicity,andsolubleandacid
digestibleelements.

QualityControlandQualityAssurance
QualityControl(QC)referstostepstakentoensureandmonitorprecisionandaccuracy
oftestresults.QualityControlpracticesincludetheanalysisofqualitycontrolsamples
witheachsetofsamples.Theseincludecalibrationstandards,certifiedreference
materials,spikedsamples,duplicatesampleanalysis,andblanks.AdditionalQC
measuresincludetheanalysisofblindduplicatesamplesandparticipationinvarious
proficiencytestingprograms.

QualityAssurance(QA)referstoacompletelyseparateandindependentmonitoringof
laboratorystudiesandQualityControlactivities.QualityAssuranceactivitiesincludethe
internalauditprogram,reviewofdatapackages,evaluationofnonconformances,and
anannualManagementReviewofqualitydata.ThelaboratoryfollowsISO17025and
ISO9001internationalstandardsastheyareapplicableandsignificantforthetesting
requestedbyclient.


Quality Manual
UC Davis Analytical Laboratory

Effective Date:
10/7/10
Rev.:
0004.02
Page:
6 of 18

CopyrightTheRegentsoftheUniversityofCalifornia
Section1.ScopeoftheQualityManual

TheQualityManualcontainsthepoliciesandproceduresusedforthequality
managementsystemoftheUCDavisAnalyticalLaboratory:
togeneratetestresultsthataretechnicallysoundandhavetherequired
accuracyandprecision
tomeetclientrequirements
tomeetregulatoryrequirements
tomaintainclientsatisfaction

ThepoliciesandproceduresoftheQualityManualareapplicabletoalltesting
performedinthelaboratory,unlesssupersededbyaprojectorclientspecificquality
plan.

TheQualityManualisdividedintofivesections:
Section1,ScopeoftheQualityManual,describesthescopeoftheQuality
Manual.
Section2,References,listsnormativedocumentsreferencedbythismanual.
Section3,TermsandDefinitions,definestermsusedinthismanual.
Section4,ManagementPoliciesandProcedures,specifieshowsound
managementisdemonstratedandclientsatisfactionismaintained.
Section5TechnicalProceduresandPoliciesspecifieshowtechnical
competenceinthelaboratoryisdemonstrated.

Quality Manual
UC Davis Analytical Laboratory

Effective Date:
10/7/10
Rev.:
0004.02
Page:
7 of 18

CopyrightTheRegentsoftheUniversityofCalifornia
Section2.References

ThelaboratorycomplieswiththerequirementsofthisQualityManual.

Totheextentthatisreasonableandfeasible,ISO17025requirementsareaddressedin
laboratorysystemsandprocedures.TheUCDavisAnalyticalLaboratoryisnotfully
compliantwithISO17025requirementsorISO17025certified.TheQualityManualis
intentionallynumericallyalignedwithISO17025requirementstoprovideastandard
format.

Thefollowingnormativedocumentscontainprovisionswhich,throughreferenceinthis
text,constituteprovisionsofthisQualityManual.

CertificationofEnvironmentalLaboratories.CaliforniaCodeofRegulations,Title
22,Division4,Chapter19.

ISO17025:2005,GeneralRequirementsfortheCompetenceofTestingand
CalibrationLaboratories.

ISO9001:2000,QualityManagementSystemsFundamentalsandVocabulary.

ISO/IEC17000,ConformityAssessmentVocabularyandGeneralPrinciples.

NationalInstituteofStandardsandTechnology(NIST),StandardReference
MaterialsProgram,Gaithersburg,MD20899.


Quality Manual
UC Davis Analytical Laboratory

Effective Date:
10/7/10
Rev.:
0004.02
Page:
8 of 18

CopyrightTheRegentsoftheUniversityofCalifornia
Section3.TermsandDefinitions
Accreditationformalrecognitionofalaboratorybyanindependentsciencebased
organizationthatthelaboratoryiscompetenttoperformspecifictests(CASCO).

Documentahardcopyorelectronicfilecontaininginformation,data,orprocedures
thataregenerallyinuse.AcurrentSOPisanexampleofadocument.Anobsolete
versionofaSOPthathasbeenarchivedisanexampleofarecord.

Frozentemperatureof0

Cto5

C(perEPAManualfortheCertificationof
LaboratoriesAnalyzingDrinkingWater)

Nonstandardtestingalaboratorytermthatdescribesanyanalysisthatisnotlistedon
theAnalyticalLaboratorywebsiteasastandardanalysisthatisofferedbythe
laboratory.

Recordahardcopyorelectronicfilecontainingdata,results,observations,orother
informationrelevanttolaboratorytestingandoperations.Ingeneral,arecordhasbeen
completedandstored,andisnolongerindailyuse.Examplesincluderesultsreports,
datapackages,obsoleteversionsofSOPs,andnonconformancereports.

Refrigeratedtemperaturerangeof6

C+/2

C(perEPAManualfortheCertification
ofLaboratoriesAnalyzingDrinkingWater)

RoomTemperatureambienttemperature2030

C(perEPAManualforthe
CertificationofLaboratoriesAnalyzingDrinkingWater)

StandardMethodalaboratorytermthatdescribesanylaboratorymethodforwhich
aStandardOperatingProcedurehasbeenestablished.

StandardTestingAlaboratorytermthatdescribesanyanalysisthatislistedontheUC
DavisAnalyticalLaboratorywebsiteasastandardanalysisofferedbythelaboratory.

WorkRequestaformthatiscompletedbytheclientwithsampleinformationandthe
analysisrequested.AcompletedWorkRequestFormmustbesubmittedwiththe
samples.

WorkRequestnumberauniqueidentificationnumberassignedtoasetofsamples.
TheformatfortheWorkRequestnumberisthelasttwodigitsofthefiscalyearcode
letterforthesampletypeathreedigitsequentialnumber.Forexample10F012would
bethetwelfthsetoffeedsamplessubmittedinfiscalyear1011.

Quality Manual
UC Davis Analytical Laboratory

Effective Date:
10/7/10
Rev.:
0004.02
Page:
9 of 18

CopyrightTheRegentsoftheUniversityofCalifornia
Section4.ManagementPoliciesandProcedures

Thelaboratoryisdividedintofivegroupsinthefollowingmanner:

Group Components
Laboratory AnalyticalTesting
Administrative AdministrativeManagementandSupport
InformationTechnology ITSupport
LabSupport SampleReceivingandPreparation
QualityAssurance QualityAssurance

TheAnalyticalLaboratoryManagementSystemhasthefollowingcomponents:

4.1OrganizationalStructure.Thelaboratoryhasanorganizationalstructurethat:
givesmanagerialandtechnicalpersonneltheauthorityandresourcesneededto
carryouttheirduties,identifytheoccurrenceofdeparturesfromthequality
systemandtoinitiateactionstopreventsuchdepartures(nonconformances)
haspoliciesandprocedurestoensuretheprotectionofclients'confidential
informationandproprietaryrights
haspoliciesandprocedurestoavoidinvolvementinanyactivitiesthatwould
diminishconfidenceinthelaboratoryscompetence,impartiality,judgmentor
operationalintegrity
providesadequatesupervisionoftestingstaff,includingtrainees,bypersons
familiarwithmethodsandprocedures
hastechnicalmanagementwithoverallresponsibilityforthetechnical
operationsandtheprovisionoftheresourcesneededtoensuretherequired
qualityoflaboratoryoperations
hasaqualityofficerwhohasdefinedresponsibilityandauthorityforensuring
thatthequalitysystemisimplementedandfollowedatalltimes

4.2QualityManagementSystem.ThelaboratoryhasaQualityManagementSystem
thatsupportsthelaboratorymanagement'scommitmenttogoodprofessionalpractice
andtothequalityofitstesting.TheeffectivenessoftheQualityManagementSystemis
assessedinseveralways:

byaprogramofplannedinternalaudits,coveringallaspectsoftheoperationof
thequalitymanagementsystem
byregularmanagementreviewsofthesuitabilityandeffectivenessofthequality
managementsystem

Quality Manual
UC Davis Analytical Laboratory

Effective Date:
10/7/10
Rev.:
0004.02
Page:
10 of 18

CopyrightTheRegentsoftheUniversityofCalifornia
byanalysisofpotentialandactualproblemsasdocumentedinthenon
conformancereportsystem,byclientcomplaints,andotherrelevant
assessments

4.3DocumentControl.TheLaboratorycontrolsalldocumentsthatformpartofits
qualitysystem,suchastheQualityManual,testmethods(methodSOPs),other
laboratoryprocedures(SOPs),andinstrumentmanuals.Regulations,standards,and
publishedtestmethodsarereferenced,whenused.

4.4ReviewofTestRequestsandContracts.Thelaboratoryhasproceduresforthe
reviewofrequestsforworktoensurethattherequirements,includingthemethodsto
beused,areadequatelydefined,thatthelaboratoryhasthecapabilityandresourcesto
meetclientrequirements,andthattheappropriatetestmethodisselectedandis
capableofmeetingclientsrequirements.

ThelaboratoryprovideseachclientwithapreprintedWorkRequestFormto
capturetheclientsrequestfortestingandassociatedrequirements.TheWork
RequestFormliststheanalysesavailableforeachsampletype.TheWork
RequestFormmustbecompleted,signedbytheclient,andsubmittedwiththe
samplestobetested.

Ifreviewoftheworkrequesthighlightsanyambiguitiesoruncertainties,the
clientiscontactedandtheproblemresolved.Aconfirmationemailwithafee
estimateandthecompletedWorkRequestFormasascannedfileissenttothe
client.

Theclienthasanopportunitytonotifythelaboratoryifanychangesarerequired
orrequested.TestingiscommencedaccordingtothecompletedWorkRequest
Formunlessthelaboratoryisotherwisenotifiedbytheclient.

4.5SubcontractingofTests.Thelaboratoryhasaprocedureforsubcontractingtests
suchthatthisworkisplacedwithacompetentsubcontractor,thattheclientisnotified
ofthearrangement,andthatthelaboratorysresponsibilityforthetestingisdefinedto
theclient.

4.6PurchasingServicesandSupplies.Thelaboratoryhasproceduresfortheselection,
purchasing,receipt,andstorageofsuppliesthataffectthequalityofthetests,including
reagentsandlaboratoryconsumables.


Quality Manual
UC Davis Analytical Laboratory

Effective Date:
10/7/10
Rev.:
0004.02
Page:
11 of 18

CopyrightTheRegentsoftheUniversityofCalifornia
4.7Servicetotheclient.TheLaboratorycooperateswithclientstoclarifytheclient's
requestandtomonitorthelaboratory'sperformanceinrelationtotheworkperformed.
Servicetotheclientincludes:
affordingtheclientreasonableaccesstorelevantareasofthelaboratoryforthe
witnessingofworkperformedfortheclient.Suchaccessmustnotconflictwith
rulesofconfidentialityofworkforotherclientsorwithsafety.
maintainingopencommunication.Contactwiththeclient,especiallyinlarge
assignments,ismaintainedthroughoutthework.Thelaboratoryinformsthe
clientofanydelaysormajordeviationsintheperformanceofthetests.
preparing,packaging,anddispatchingofsamplesneededbytheclientfor
verificationpurposes.
thelaboratoryseeksfeedbackfromclients.

4.8Complaints.TheLaboratoryhasapolicyandprocedurefortheresolutionof
complaintsreceivedfromclients.Recordsofcomplaintsaredocumentedonthenon
conformancereportformandincludethefollowinginformation:
detailsofthecomplaint
investigation
correctiveandpreventiveactions
followupverification

4.9ControlofNonConformingTesting.Thelaboratoryhasproceduresthatare
implementedwhenanyaspectofitstestingdoesnotconformtorelevantproceduresor
therequirementsagreeduponwithclient.Theseincludedefiningtheresponsibilitiesfor
themanagementofnonconformingwork,actionstakenwhennonconformingworkis
identified,anevaluationofthesignificanceofthenonconformingwork,remedial
actionstaken,andclientnotification.

Situationsthatrequireanonconformancereportinclude:
failureorsuspectedfailuretocomplywithtestmethod,orotherlaboratorySOPs
suchthattheintegrityofthetestresultsmaybejeopardized
calibrationresultsormaintenanceactivitiesthatindicateanequipment
malfunctionhasoccurredandmayhaveimpactedtestresults
testresultsdonotmeettheregulatoryorclientdefinedacceptancecriteria
resultsofqualitycontrolsamples(duplicates,SRMs,blanks,spikes)thatare
outsideofestablishedranges
proficiencytestingprogramresultsthatareoutsideofexpectedranges
clientcomplaints


Quality Manual
UC Davis Analytical Laboratory

Effective Date:
10/7/10
Rev.:
0004.02
Page:
12 of 18

CopyrightTheRegentsoftheUniversityofCalifornia
4.10CorrectiveAction.Thelaboratoryhasapolicyandprocedureforimplementing
correctiveactionwhennonconformingworkordeparturesfromthepoliciesand
proceduresinthequalitysystemortechnicaloperationshavebeenidentified.

4.11PreventiveAction.Neededimprovementsandpotentialsourcesofnon
conformancesareidentified.Ifpreventiveactionisrequired,actionplansare
developed,implementedandmonitoredtoreducethelikelihoodoftheoccurrenceof
suchnonconformancesandtotakeadvantageoftheopportunitiesforimprovement.

4.12ControlofRecords.Thelaboratoryhasproceduresforidentification,collection,
indexing,access,filing,storage,maintenanceanddisposalofqualityandtechnical
records.
Allrecordsarelegibleandareretainedinsuchawaythattheyarereadily
retrievable.Theretentiontimeforhardcopyrecordsisoneyear.Electronic
recordsareretainedfiveyears.
Allrecords,includingtestreports,aresafelystoredinlockedareas.
Proceduresareinplacefortheidentification,access,maintenance,andstorage
ofelectronicrecordstopreventunauthorizedaccessormodificationofthese
records.

4.13InternalAudits.Thelaboratoryconductsinternalauditsofitsactivitiestomonitor
compliancewiththerequirementsofthequalitysystem.Theinternalauditprogram
involvesperiodicauditsofallelementsoftheQualityManual.Theseauditsinclude
systemaudits,suchasTraining,andtheNonConformanceSystem,andalsodata
packageaudits.

4.14Managementreviews.Thelaboratory'smanagementteamperiodicallyconductsa
reviewofthelaboratory'squalitysystemandtestingactivitiesforcontinuingsuitability
andeffectiveness,andtointroducenecessarychangesorimprovements.

4.15Improvements.Thelaboratorycontinuallyimprovestheeffectivenessofits
managementsystemthroughtheuseofthequalitypolicy,qualityobjectives,audit
results,analysisofdata,correctiveactions,preventiveactions,andmanagementreview.


Quality Manual
UC Davis Analytical Laboratory

Effective Date:
10/7/10
Rev.:
0004.02
Page:
13 of 18

CopyrightTheRegentsoftheUniversityofCalifornia
Section5.TechnicalProceduresandPolicies

5.1GeneralInformation.TheUCDavisAnalyticalLaboratoryhastechnicalprocedures
andpoliciesinplacetodeterminethecorrectnessandreliabilityoftestresults.The
correctnessandreliabilityoftestresultsareimpactedbymanyfactors:

analysttechnique/staffperformance
facilityandenvironmentalconditions
testmethodsandmethodvalidation
equipment
measurementtraceability(referencematerialsandcalibration)
sampling
samplehandling

ThesefactorsareaddressedbythetechnicalproceduresandpoliciesoftheAnalytical
Laboratory.Theextenttowhichthesefactorscontributetototalmeasurement
uncertaintydiffersbetweentypesoftests.Thesefactorsaretakenintoconsideration
andevaluatedduringtesting,thetrainingandqualificationofpersonnel,the
developmentandvalidationoftestmethodsandprocedures,andintheselectionand
calibrationofequipment.

5.2Personnel.Managementensuresthecompetencyofallpersonnel,includingthose
performingtestsandsupportfunctions,thoseevaluatingresults,andthosesigningtest
reports.Trainingisdocumentedtoensureallproceduresareperformedbytrained
personnel.Managementauthorizesspecificpersonneltooperateparticulartypesof
equipment,toperformparticulartypesoftesting,andtoissuetestreports.

5.3AccommodationandEnvironmentalConditions.Thelaboratoryisequippedto
provideasuitableenvironmentforcorrectperformanceofthetests.

Environmentalconditionsaremonitored,controlled,andrecordedasrequired
bythetestmethodsandproceduresorwheretheymayinfluencethequalityof
testresults.Testingisstoppedwhentheenvironmentalconditionsjeopardize
theresultsofthetests.

Effectiveseparationbetweenneighboringareasismadewhentheactivitiesare
incompatible.Measuresaretakentopreventcrosscontamination.


Quality Manual
UC Davis Analytical Laboratory

Effective Date:
10/7/10
Rev.:
0004.02
Page:
14 of 18

CopyrightTheRegentsoftheUniversityofCalifornia
5.4TestMethodsandMethodValidation.
RoutinemethodsaredocumentedintheAnalyticalLaboratoryStandardOperating
Procedures(SOP)manual.SOPsarereviewedannuallyandrevisedasneeded;revision
datesandsummaryofchangesaredocumentedineachSOP.Thereferencesusedfor
eachmethodaredocumentedintheSOPs.

Thelaboratoryusesappropriatemethodsandproceduresforalltestswithinits
scope.Theseincludehandling,storageandpreparationofsamplestobetested.
Thelaboratoryhasinstructionsontheuseandoperationofallrelevant
equipment,andonthehandlingandpreparationofsamples,wheretheabsence
ofsuchinstructionscouldjeopardizetheresultsoftests.
Thelaboratoryusestestmethodswhichmeettheneedsoftheclientandwhich
areappropriateforthetestsitundertakes.
MethodsthataredevelopedormodifiedinhousearedetailedinmethodSOPs
andarevalidatedtothedegreeappropriatefortheirintendeduse.
Calculationsanddatatransfersaresubjecttoappropriatechecksinasystematic
manner.Proceduresareestablishedandimplementedforprotectingthedata.
Thelaboratoryestimatestheuncertaintyoftestmethodsbyidentifyingthe
significantcomponentsofmeasurementuncertainty,makingareasonable
estimation,andensuringthattheformatofreportingoftheresultsdoesnotgive
anexaggeratedimpressionoftheuncertainty.

5.5Equipment.Thelaboratoryisfurnishedwithallitemsoftestequipmentrequired
forthecorrectperformanceofthetests.Theequipmentiscapableofachievingthe
accuracyrequired,andiscalibratedbeforeuse.

InstrumentCalibrationandStandardOperatingConditions.Specifications,
settingsandinstructionsforcalibratingaredescribedinspecificmethodSOPs.
InstrumentMaintenanceLogs.Alogismaintainedforallmajorequipment.
Operatorsincludeacontinuingrecordofproblems,repairs,andmaintenance
actionsineachinstrumentlog.
InstrumentPerformanceChecks.Adescriptionofhowtoevaluateinstrument
performancebyperformancechecksiscontainedintheindividualAnalytical
MethodSOPs.Ifananalysisfailstomeetperformancecriteria,thecauseis
investigated.
CalibrationofSupportEquipment.BalancesarecalibratedagainstNISTtraceable
weights.PipettesandPipettorsarecalibratedandcheckedbyweight.
Refrigeratorandfreezertemperaturesaremonitoredandrecordedonthelog
attachedtoeachunit.Allexhaustorfumehoodsarecheckedannuallyfor
averagefacevelocitywiththesashopentotheindicatedmark.


Quality Manual
UC Davis Analytical Laboratory

Effective Date:
10/7/10
Rev.:
0004.02
Page:
15 of 18

CopyrightTheRegentsoftheUniversityofCalifornia
5.6MeasurementTraceability.Thetraceabilityofmeasurementsisensuredthrough
equipmentcalibrationandmaintenance,andtheuseofanalyticalstandardswith
appropriatetraceability.

Theprogramforcalibrationofequipmentisdesignedandoperatedtoensure
measurementsaretraceabletotheInternationalSystemofUnits(SI)totheextent
necessaryandappropriaterelativetothestateduncertaintyofthetestormeasurement.
Thisistypicallyaccomplishedviatheuseofstandardsthatarecertifiedtobetraceableto
NISTorothernationalstandards.

WheretraceabilitytoSIunitsofmeasurementisnotpossibleand/ornotrelevant,other
meansforprovidingconfidenceintheresultsareappliedsuchas:
theuseofcertifiedreferencematerialsprovidedbyasuppliersuitabletogiveareliable
physicalorchemicalcharacterizationofthematerial.
mutualconsentstandardsormethodswhichareclearlyspecifiedandagreeduponby
allpartiesconcerned.
participationinasuitableprogramofinterlaboratorycomparisonsorproficiency
testing.
inhousereferencematerialverifiedbyinterlaboratorycomparisonsorproficiency
testing.

5.7Sampling.TheUCDavisAnalyticalLaboratorydoesnotperformsamplecollection.
Samplingrecommendationsareprovidedonthelaboratorywebsite.

5.8SampleHandling.Proceduresareestablishedforthereceipt,handling,protection,
storage,retentionanddisposalofsamples,includingallprovisionsnecessarytoprotectthe
integrityofthesampleandtheinterestsofthelaboratoryandtheclient.

SampleSubmission.SamplesaresubmittedtothelaboratorywithaWorkRequest
Form.TheWorkRequestFormdocumentsthesampling,holding,andshipmentof
samplesfromtheclienttothelaboratory.TheWorkRequestFormalsoservesasthe
client'srequest/ordertoperformspecifictests.

SampleLogIn.SamplesarereceivedintheSampleReceivingarea(110Hoagland
Annex)wheretheReceivingManagerortrainedpersonnelareresponsiblefor
logginginthesamplesinaccordancewiththeSampleReceivingSOP.Atlogin,each
clientusesacustomizedworkrequestformthathasthefollowinginformation:
o ClientID(assignedbytheLab)
o ClientName/phonenumber/Email/AlternateContactinformation
o Billinginformation
o Numberofsamples

Quality Manual
UC Davis Analytical Laboratory

Effective Date:
10/7/10
Rev.:
0004.02
Page:
16 of 18

CopyrightTheRegentsoftheUniversityofCalifornia
o Sampleinformationanddescriptions
o Desiredsampledispositiononcompletionofthetesting
o Requiredsamplepreparation
o Testsrequested
o SignatureoftheClientorresponsibleparty
o Deliverymethodornameofpersondeliveringsamples
AsequentialnumberisassignedtoeachWorkRequest.

IdentificationofSamples.Samplesaresystematicallyidentifiedusinguniquetracking
numbers(consistingoftheWorkRequestnumberfollowedbyauniquesequential
number)aftertheyarriveatthelaboratory.Thisidentificationisretainedthroughout
thelifeoftheiteminthelaboratory.Thesystemisdesignedandoperatedsoasto
ensurethatitemscannotbeconfusedphysically,orwhenreferredtoinrecordsor
otherdocuments.

ChainofCustody.Thelocationofthesamplesaretrackedinternallyusingabar
codingsystem.Internaltrackingofsamplelocationisfollowedforallsamples.
ExternalChainofCustody(CoC)proceduresarefollowedforsamplesreceivedwith
CoCforms.TheCoCrecordisusedtodocumentthechangeinpossessionfrom
samplingtodeliverytoreceiptbythelaboratory.Eachsamplemustbeclearly
identifiable.Theconditionofthesampleisnoteduponreceipt.Signaturesofparties
relinquishingcustodyaswellasthedatearedocumentedontheWorkRequest
FormandanyexternalCoCform.

ClientNotificationofSampleReceipt.TheLaboratoryInformationManagement
System(LIMS)organizessampledatainsuchamannerthatloginentriescanbe
verified,sampleprogresscanbetracked,analyticaldatacanbeappendedtothe
record,andfinalreportscanbecreated.Whenloginhasbeenreviewed,asample
confirmationemailissenttotheclient.

SampleStoragePriortoAnalysis.Samplesareloggedinwithinoneworkingdayof
receipt.Samplesarestoredappropriatelyafterreceipt.Samplesrequiring
immediateprocessingsuchasdryingareprocessedimmediatelyfollowinglogin.
SamplesthathavebeenloggedinandprocessedarestoredbyWorkRequest
Number.Separatestorageismaintainedtosegregatesampletypeswherecross
contaminationisapossibility.

ShippingandReceiving.TheLabisopenforsamplereceiptfrom8:00a.m.to5:00
p.m.,MondaythroughFriday,excludingUniversityofCaliforniaholidays.Adropbox
isavailableforafterhourssampledropoff.Latenight,weekend,orholidaysample

Quality Manual
UC Davis Analytical Laboratory

Effective Date:
10/7/10
Rev.:
0004.02
Page:
17 of 18

CopyrightTheRegentsoftheUniversityofCalifornia
receiptcanbearranged.Foremployeesafety,anyknownsamplehazardsmustbe
explainedinthepaperworksentwithsamples.

SampleDisposition.SampleDisposition:Clientscanselectsampledisposition
preferenceontheWorkRequestForm.Samplesarediscardedorreturnedtothe
client30daysafterthefinalreportisissued.

5.9QualityControl/QualityAssurance.Qualitycontrolproceduresareusedforalltest
methodsperformedinthelaboratorytomonitorthevalidityoftestresults.The
resultingdataareevaluatedbytheanalystandsupervisor.Resultsarealsotrackedand
trendedatleastannuallyorasneeded.Theseproceduresincludethefollowing:
regularuseofreferencestandards,whereavailable,forcalibration
analysisofatleastonereferencematerialsamplewitheachbatch
participationininterlaboratorycomparisonsandproficiencytestingprograms
analysisofblanksandspikedsamplesasappropriate
replicatetestsofthesamesampleduringanalysis(duplicates)
retestingofretainedsamples(blindduplicateprogram)
correlationofresultsfordifferentcharacteristics

Thequalitycontrolprogramconsistsofbothinternalandexternalchecksonprecision
andaccuracyofanalyticalresults.Theresponsibilityformaintainingtheprogramrests
withtheQualityAssuranceOfficer.Employeesaretrainedinqualitycontrolprocedures
andconcepts.

InternalQualityControl.
ThefollowingQCsamplesareanalyzedwithclientsamples:
Blank.Areagentblankisanalyzedwitheverysetofsamplesthatisextractedor
digested.Thisreagentblankincludesanyandallreagentsthatareusedinthe
analyticalprocessandiscarriedthroughtheentireprocess,includingextraction
andfilteringordigestion.
Duplicates.Atleasttenpercentofsamplesareanalyzedinduplicatetoyielddata
ontheprecisionoftheanalysis.Duplicateresultsareincludedinthereport.
ReferenceMaterials.Atleastonereferencematerialisanalyzedwitheachsetof
samples.Thevaluesforthereferencematerialsareincludedinthefinalreport.
Samplesrunwithareferencematerialthatfallsoutsidethecontrollimitare
reanalyzed,includingdigestionorextractionifnecessary.Theuseofdataoutside
ofwarninglimitsisatthediscretionoftheLabSupervisororreviewinganalyst.
SpikeSamples.Samplefortificationsorspikesareusedtoverifyaccuracyoftests
requiringextensivesamplemanipulation(suchasaciddigestion)orfornon
standardsampletypes.


Quality Manual
UC Davis Analytical Laboratory

Effective Date:
10/7/10
Rev.:
0004.02
Page:
18 of 18

CopyrightTheRegentsoftheUniversityofCalifornia
BlindDuplicates.Periodictestingisperformedonasubsetofsamplesthathavebeen
previouslyanalyzed.Thesesamplesarereloggedintothelaboratoryasnewsamples,
andtheresultscomparedtotheoriginalresults.

ExternalQualityControlPrograms
TheUCDavisAnalyticalLaboratoryparticipatesinanumberofsampleexchangeand
certificationprograms.
InternationalPlantAnalyticalExchange(IPE)planttissueanalyses
ManureAnalysisProgram(MAP)manureanalyses
NorthAmericanProficiencyTestingProgram(NAPT)planttissueanalyses
NorthAmericanProficiencyTestingProgram(NAPT)soilanalyses
NorthAmericanProficiencyTestingProgram(NAPT)wateranalyses
NationalForageTestingAssociation(NFTA)feedanalyses
AgriculturalLaboratoryProficiencyprogram(ALP)planttissueanalyses

5.10ReportingTestResults.Theresultsofeachtestarereportedaccurately,clearly,
unambiguouslyandobjectively,andinaccordancewithanyspecificinstructionsinthe
testmethods.

Testreportsincludethefollowinginformation,asappropriate:
clientprovidedinformation:commodity,sampletype,datesampled,grower/
location/project
methodSOPused
analysisdate
unitsofmeasurement
sampleidentificationnumber
sampledescription(ifsubmittedbyclient)
testresults
asummaryofqualitycontrolresults
o methoddetectionlimit(MDL)whichistypicallyaquantitationlimitfor
theanalysis
o referencematerialresultsandcriteria
o resultsofduplicateanalyses
notesandcommentsrelatedtotestresults
signatureandtitleofperson(s)reviewingandapprovingreport(maybe
electronic)

Datareportedtotheclientcontainstheappropriatesignificantdigitsforeachtest
method.TestresultsthatarebelowthelaboratoryMDLarenotedassuch.All
appropriatewarningsandnotesareincludedonthefinalreport.

You might also like