Qual Manual

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Quality ManualUC Davis Analytical Laboratory

Effective Date:

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Rev.:

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CopyrightTheRegentsoftheUniversityofCalifornia

UC Davis Analytical LaboratoryQuality Manual

Director:

Dirk

Holstege

LaboratorySupervisor:TraciFrancis

ManagementServicesOfficer:NikkiSchwab

QualityAssuranceOfficer:KellyGardner

DateofIssue: October7,2010

UCDavisAnalyticalLaboratory

224HoaglandHall

OneShieldsAvenue

Davis,CA

95616

5270

Phone:5307520147

Email:[email protected]

WebSite:http://anlab.ucdavis.edu

See Document History File for approval signatures.


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TableofContents

Introductionand

Laboratory

Overview

1. Scope

2. References3. TermsandDefinitions4. ManagementProceduresandPolicies

4.1 Organization

4.2

QualityManagement

System

4.3 DocumentControl

4.4 ReviewofRequests

4.5 SubcontractingofTests

4.6 PurchasingServicesandSupplies

4.7 ServicetotheClient

4.8 Complaints

4.9 ControlofNonconformingTestResults4.10 CorrectiveAction4.11 PreventiveAction

4.12 ControlofRecords

4.13 InternalAudits

4.14 ManagementReviews

4.15 Improvements

5. TechnicalProceduresandPolicies5.1 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


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Introductionand

Overview

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

investigationsby

CE

Advisors.

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.


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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,orsystemsuitability

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


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PerkinElmerAAnalyst800flame/graphitefurnaceatomicabsorptionspectrometer

PerkinElmerAAnayst300flameatomicabsorptionspectrometer(AA) CEMmicrowavesampledigestionsystem LachatFlowInjectionAnalyzers(FIA) TimberlineFlowInjectionAmmoniumAnalyzer LECOFP528NitrogenAnalyzer LECOTruSpeccarbon/nitrogenanalyzer ThermoFinneganSeries1112carbon/nitrogenanalyzer DionexICS2000IonChromatograph Varian3800GasChromatographwithSaturn2000GC/MS SkalarFormacsHTTOC/TNAnalyzer

TestingServices

information

details

available

on

the

laboratory

website

Soilstestingservicesincludesalinity,alkalinityandtoxicitytests,soilfertilitytests,soilcharacteristicsandphysicalproperties,andmineralanalysis.

Plantandfeedtestingincludescarbonandnitrogentesting,nutrientandmineralanalysis,fibertestingandcarbohydratetesting.

Waterandwastewatertestingincludestestsforwaterquality,includingsediment,nutrients,salinity,alkalinityandtoxicity,andsolubleandacid

digestibleelements.

QualityControlandQualityAssurance

QualityControl(QC)referstostepstakentoensureandmonitorprecisionandaccuracy

oftestresults. QualityControlpracticesincludetheanalysisofqualitycontrolsamples

witheachsetofsamples.Theseincludecalibrationstandards,certifiedreference

materials,spikedsamples,duplicatesampleanalysis,andblanks. AdditionalQC

measuresincludetheanalysisofblindduplicatesamplesandparticipationinvarious

proficiencytestingprograms.

QualityAssurance(QA)referstoacompletelyseparateandindependentmonitoringof

laboratorystudies

and

Quality

Control

activities.

Quality

Assurance

activities

include

the

internalauditprogram,reviewofdatapackages,evaluationofnonconformances,and

anannualManagementReviewofqualitydata. ThelaboratoryfollowsISO17025and

ISO9001internationalstandardsastheyareapplicableandsignificantforthetesting

requestedbyclient.


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Section1. ScopeoftheQualityManual

TheQuality

Manual

contains

the

policies

and

procedures

used

for

the

quality

managementsystemoftheUCDavisAnalyticalLaboratory:

togeneratetestresultsthataretechnicallysoundandhavetherequiredaccuracyandprecision

tomeetclientrequirements tomeetregulatoryrequirements tomaintainclientsatisfaction

ThepoliciesandproceduresoftheQualityManualareapplicabletoalltesting

performedinthelaboratory,unlesssupersededbyaprojectorclientspecificquality

plan.

TheQualityManualisdividedintofivesections:

Section1,ScopeoftheQualityManual,describesthescopeoftheQualityManual.

Section2,References,listsnormativedocumentsreferencedbythismanual. Section3,TermsandDefinitions,definestermsusedinthismanual. Section4,ManagementPoliciesandProcedures, specifieshowsoundmanagementisdemonstratedandclientsatisfactionismaintained.

Section5TechnicalProceduresandPoliciesspecifieshowtechnicalcompetence

in

the

laboratory

is

demonstrated.


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Section2. References

Thelaboratory

complies

with

the

requirements

of

this

Quality

Manual.

Totheextentthatisreasonableandfeasible,ISO17025requirementsareaddressedin

laboratorysystemsandprocedures. TheUCDavisAnalyticalLaboratoryisnotfully

compliantwithISO17025requirementsorISO17025certified. TheQualityManualis

intentionallynumericallyalignedwithISO17025requirementstoprovideastandard

format.

Thefollowingnormativedocumentscontainprovisionswhich,throughreferenceinthis

text,constituteprovisionsofthisQualityManual.

CertificationofEnvironmentalLaboratories.CaliforniaCodeofRegulations,Title22,Division4,Chapter19.

ISO17025:2005,GeneralRequirementsfortheCompetenceofTestingandCalibrationLaboratories.

ISO9001:2000,QualityManagementSystemsFundamentalsandVocabulary. ISO/IEC17000,ConformityAssessmentVocabularyandGeneralPrinciples. NationalInstituteofStandardsandTechnology(NIST),StandardReferenceMaterialsProgram,Gaithersburg,MD20899.


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Section3. TermsandDefinitionsAccreditationformalrecognitionofalaboratorybyanindependentsciencebased

organizationthat

the

laboratory

is

competent

to

perform

specific

tests

(CASCO).

Document ahardcopyorelectronicfilecontaininginformation,data,orprocedures

thataregenerallyinuse. AcurrentSOPisanexampleofadocument. Anobsolete

versionofaSOPthathasbeenarchivedisanexampleofarecord.

Frozen temperatureof0

Cto5

C(perEPAManualfortheCertificationof

LaboratoriesAnalyzingDrinkingWater)

Nonstandardtesting alaboratorytermthatdescribesanyanalysisthatisnotlistedon

theAnalyticalLaboratorywebsiteasastandardanalysisthatisofferedbythe

laboratory.

Record ahardcopyorelectronicfilecontainingdata,results,observations,orother

informationrelevanttolaboratorytestingandoperations. Ingeneral,arecordhasbeen

completedandstored,andisnolongerindailyuse.Examplesincluderesultsreports,

datapackages,obsoleteversionsofSOPs,andnonconformancereports.

Refrigerated temperaturerangeof6

C+/ 2

C(perEPAManualfortheCertification

ofLaboratoriesAnalyzingDrinkingWater)

RoomTemperature

ambient

temperature

20

30

C(per

EPA

Manual

for

the

CertificationofLaboratoriesAnalyzingDrinkingWater)

StandardMethod alaboratorytermthatdescribesanylaboratorymethodforwhich

aStandardOperatingProcedurehasbeenestablished.

StandardTesting AlaboratorytermthatdescribesanyanalysisthatislistedontheUC

DavisAnalyticalLaboratorywebsiteasastandardanalysisofferedbythelaboratory.

WorkRequestaformthatiscompletedbytheclientwithsampleinformationandthe

analysis

requested.

A

completed

Work

Request

Form

must

be

submitted

with

the

samples.

WorkRequestnumberauniqueidentificationnumberassignedtoasetofsamples.

TheformatfortheWorkRequestnumberisthelasttwodigitsofthefiscalyearcode

letterforthesampletype athreedigitsequentialnumber. Forexample10F012would

bethetwelfthsetoffeedsamplessubmittedinfiscalyear1011.


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Section4.ManagementPoliciesandProcedures

Thelaboratory

is

divided

into

five

groups

in

the

following

manner:

Group Components

Laboratory AnalyticalTesting

Administrative AdministrativeManagementandSupport

InformationTechnology ITSupport

LabSupport SampleReceivingandPreparation

QualityAssurance QualityAssurance

TheAnalyticalLaboratoryManagementSystemhasthefollowingcomponents:

4.1OrganizationalStructure. Thelaboratoryhasanorganizationalstructurethat:

givesmanagerialandtechnicalpersonneltheauthorityandresourcesneededtocarryouttheirduties,identifytheoccurrenceofdeparturesfromthequality

systemandtoinitiateactionstopreventsuchdepartures(nonconformances)

haspoliciesandprocedurestoensuretheprotectionofclients'confidentialinformationandproprietaryrights

haspoliciesandprocedurestoavoidinvolvementinanyactivitiesthatwoulddiminishconfidenceinthelaboratoryscompetence,impartiality,judgmentor

operationalintegrity

providesadequatesupervisionoftestingstaff,includingtrainees,bypersonsfamiliar

with

methods

and

procedures

hastechnicalmanagementwithoverallresponsibilityforthetechnicaloperationsandtheprovisionoftheresourcesneededtoensuretherequired

qualityoflaboratoryoperations

hasaqualityofficerwhohasdefinedresponsibilityandauthorityforensuringthatthequalitysystemisimplementedandfollowedatalltimes

4.2QualityManagementSystem.ThelaboratoryhasaQualityManagementSystem

thatsupportsthelaboratorymanagement'scommitmenttogoodprofessionalpractice

andtothequalityofitstesting.TheeffectivenessoftheQualityManagementSystemis

assessedin

several

ways:

byaprogramofplannedinternalaudits,coveringallaspectsoftheoperationofthequalitymanagementsystem

byregularmanagementreviewsofthesuitabilityandeffectivenessofthequalitymanagementsystem


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byanalysisofpotentialandactualproblemsasdocumentedinthenonconformancereportsystem,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

capableof

meeting

clients

requirements.

ThelaboratoryprovideseachclientwithapreprintedWorkRequestFormtocapturetheclientsrequestfortestingandassociatedrequirements. TheWork

RequestFormliststheanalysesavailableforeachsampletype.TheWork

RequestFormmustbecompleted,signedbytheclient,andsubmittedwiththe

samplestobetested.

Ifreviewoftheworkrequesthighlightsanyambiguitiesoruncertainties,theclientiscontactedandtheproblemresolved. Aconfirmationemailwithafee

estimateandthecompletedWorkRequestFormasascannedfileissenttothe

client.

Theclienthasanopportunitytonotifythelaboratoryifanychangesarerequiredorrequested. TestingiscommencedaccordingtothecompletedWorkRequest

Formunlessthelaboratoryisotherwisenotifiedbytheclient.

4.5SubcontractingofTests.Thelaboratoryhasaprocedureforsubcontractingtests

suchthatthisworkisplacedwithacompetentsubcontractor,thattheclientisnotified

ofthearrangement,andthatthelaboratorysresponsibilityforthetestingisdefinedto

theclient.

4.6PurchasingServicesandSupplies. Thelaboratoryhasproceduresfortheselection,

purchasing,receipt,andstorageofsuppliesthataffectthequalityofthetests,including

reagentsandlaboratoryconsumables.


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4.7Servicetotheclient.TheLaboratorycooperateswithclientstoclarifytheclient's

requestandtomonitorthelaboratory'sperformanceinrelationtotheworkperformed.

Servicetotheclientincludes:

affordingtheclientreasonableaccesstorelevantareasofthelaboratoryforthewitnessingofworkperformedfortheclient. Suchaccessmustnotconflictwith

rulesofconfidentialityofworkforotherclientsorwithsafety.

maintainingopencommunication.Contactwiththeclient,especiallyinlargeassignments,ismaintainedthroughoutthework.Thelaboratoryinformsthe

clientofanydelaysormajordeviationsintheperformanceofthetests.

preparing,packaging,anddispatchingofsamplesneededbytheclientforverificationpurposes.

thelaboratoryseeksfeedbackfromclients.4.8

Complaints.

The

Laboratory

has

apolicy

and

procedure

for

the

resolution

of

complaintsreceivedfromclients.Recordsofcomplaintsaredocumentedonthenon

conformancereportformandincludethefollowinginformation:

detailsofthecomplaint investigation correctiveandpreventiveactions followupverification

4.9ControlofNonConformingTesting. Thelaboratoryhasproceduresthatare

implementedwhenanyaspectofitstestingdoesnotconformtorelevantproceduresor

therequirements

agreed

upon

with

client.

These

include

defining

the

responsibilities

for

themanagementofnonconformingwork,actionstakenwhennonconformingworkis

identified,anevaluationofthesignificanceofthenonconformingwork,remedial

actionstaken,andclientnotification.

Situationsthatrequireanonconformancereportinclude:

failureorsuspectedfailuretocomplywithtestmethod,orotherlaboratorySOPssuchthattheintegrityofthetestresultsmaybejeopardized

calibrationresultsormaintenanceactivitiesthatindicateanequipmentmalfunctionhasoccurredandmayhaveimpactedtestresults

testresultsdonotmeettheregulatoryorclientdefinedacceptancecriteria resultsofqualitycontrolsamples(duplicates,SRMs,blanks,spikes)thatareoutsideofestablishedranges

proficiencytestingprogramresultsthatareoutsideofexpectedranges clientcomplaints


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4.10CorrectiveAction.Thelaboratoryhasapolicyandprocedureforimplementing

correctiveactionwhennonconformingworkordeparturesfromthepoliciesand

proceduresinthequalitysystemortechnicaloperationshavebeenidentified.

4.11PreventiveAction.Neededimprovementsandpotentialsourcesofnon

conformancesareidentified.Ifpreventiveactionisrequired,actionplansare

developed,implementedandmonitoredtoreducethelikelihoodoftheoccurrenceof

suchnonconformancesandtotakeadvantageoftheopportunitiesforimprovement.

4.12ControlofRecords.Thelaboratoryhasproceduresforidentification,collection,

indexing,access,filing,storage,maintenanceanddisposalofqualityandtechnical

records.

Allrecordsarelegibleandareretainedinsuchawaythattheyarereadilyretrievable.

The

retention

time

for

hard

copy

records

is

one

year.

Electronic

recordsareretainedfiveyears.

Allrecords,includingtestreports,aresafelystoredinlockedareas. Proceduresareinplacefortheidentification,access,maintenance,andstorageofelectronicrecordstopreventunauthorizedaccessormodificationofthese

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.


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Section5. TechnicalProceduresandPolicies

5.1General

Information.

The

UC

Davis

Analytical

Laboratory

has

technical

procedures

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.Training

is

documented

to

ensure

all

procedures

are

performed

by

trained

personnel.Managementauthorizesspecificpersonneltooperateparticulartypesof

equipment,toperformparticulartypesoftesting,andtoissuetestreports.

5.3AccommodationandEnvironmentalConditions. Thelaboratoryisequippedto

provideasuitableenvironmentforcorrectperformanceofthetests.

Environmentalconditionsaremonitored,controlled,andrecordedasrequiredbythetestmethodsandproceduresorwheretheymayinfluencethequalityof

testresults. Testingisstoppedwhentheenvironmentalconditionsjeopardize

theresults

of

the

tests.

Effectiveseparationbetweenneighboringareasismadewhentheactivitiesareincompatible.Measuresaretakentopreventcrosscontamination.


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5.4TestMethodsandMethodValidation.

RoutinemethodsaredocumentedintheAnalyticalLaboratoryStandardOperating

Procedures(SOP)manual.SOPsarereviewedannuallyandrevisedasneeded;revision

datesand

summary

of

changes

are

documented

in

each

SOP.

The

references

used

for

eachmethodaredocumentedintheSOPs.

Thelaboratoryusesappropriatemethodsandproceduresforalltestswithinitsscope.Theseincludehandling,storageandpreparationofsamplestobetested.

Thelaboratoryhasinstructionsontheuseandoperationofallrelevantequipment,andonthehandlingandpreparationofsamples,wheretheabsence

ofsuchinstructionscouldjeopardizetheresultsoftests.

Thelaboratoryusestestmethodswhichmeettheneedsoftheclientandwhichareappropriateforthetestsitundertakes.

MethodsthataredevelopedormodifiedinhousearedetailedinmethodSOPsandarevalidatedtothedegreeappropriatefortheirintendeduse.

Calculationsanddatatransfersaresubjecttoappropriatechecksinasystematicmanner.Proceduresareestablishedandimplementedforprotectingthedata.

Thelaboratoryestimatestheuncertaintyoftestmethodsbyidentifyingthesignificantcomponentsofmeasurementuncertainty,makingareasonable

estimation,andensuringthattheformatofreportingoftheresultsdoesnotgive

anexaggeratedimpressionoftheuncertainty.

5.5Equipment. Thelaboratoryisfurnishedwithallitemsoftestequipmentrequired

for

the

correct

performance

of

the

tests.

The

equipment

is

capable

of

achieving

the

accuracyrequired,andiscalibratedbeforeuse.

InstrumentCalibrationandStandardOperatingConditions.Specifications,settingsandinstructionsforcalibratingaredescribedinspecificmethodSOPs.

InstrumentMaintenanceLogs.Alogismaintainedforallmajorequipment.Operatorsincludeacontinuingrecordofproblems,repairs,andmaintenance

actionsineachinstrumentlog.

InstrumentPerformanceChecks.AdescriptionofhowtoevaluateinstrumentperformancebyperformancechecksiscontainedintheindividualAnalytical

MethodSOPs.Ifananalysisfailstomeetperformancecriteria,thecauseis

investigated.

CalibrationofSupportEquipment.BalancesarecalibratedagainstNISTtraceableweights.PipettesandPipettorsarecalibratedandcheckedbyweight.

Refrigeratorandfreezertemperaturesaremonitoredandrecordedonthelog

attachedtoeachunit.Allexhaustorfumehoodsarecheckedannuallyfor

averagefacevelocitywiththesashopentotheindicatedmark.


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5.6MeasurementTraceability.Thetraceabilityofmeasurementsisensuredthrough

equipmentcalibrationandmaintenance,andtheuseofanalyticalstandardswith

appropriatetraceability.

Theprogramforcalibrationofequipmentisdesignedandoperatedtoensure

measurementsaretraceabletotheInternationalSystemofUnits(SI)totheextent

necessaryandappropriaterelativetothestateduncertaintyofthetestormeasurement.

Thisistypicallyaccomplishedviatheuseofstandardsthatarecertifiedtobetraceableto

NISTorothernationalstandards.

WheretraceabilitytoSIunitsofmeasurementisnotpossibleand/ornotrelevant,other

meansforprovidingconfidenceintheresultsareappliedsuchas:

theuseofcertifiedreferencematerialsprovidedbyasuppliersuitabletogiveareliablephysical

or

chemical

characterization

of

the

material.

mutualconsentstandardsormethodswhichareclearlyspecifiedandagreeduponbyallpartiesconcerned.

participationinasuitableprogramofinterlaboratorycomparisonsorproficiencytesting.

inhousereferencematerialverifiedbyinterlaboratorycomparisonsorproficiencytesting.

5.7Sampling.TheUCDavisAnalyticalLaboratorydoesnotperformsamplecollection.

Samplingrecommendationsareprovidedonthelaboratorywebsite.

5.8SampleHandling. Proceduresareestablishedforthereceipt,handling,protection,

storage,retentionanddisposalofsamples,includingallprovisionsnecessarytoprotectthe

integrityofthesampleandtheinterestsofthelaboratoryandtheclient.

SampleSubmission.SamplesaresubmittedtothelaboratorywithaWorkRequestForm.TheWorkRequestFormdocumentsthesampling,holding,andshipmentof

samplesfromtheclienttothelaboratory.TheWorkRequestFormalsoservesasthe

client'srequest/ordertoperformspecifictests.

SampleLogIn.SamplesarereceivedintheSampleReceivingarea(110HoaglandAnnex)

where

the

Receiving

Manager

or

trained

personnel

are

responsible

for

logginginthesamplesinaccordancewiththeSampleReceivingSOP. Atlogin,each

clientusesacustomizedworkrequestformthathasthefollowinginformation:

o ClientID(assignedbytheLab)o ClientName/phonenumber/Email/AlternateContactinformationo Billinginformationo Numberofsamples


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o Sampleinformationanddescriptionso Desiredsampledispositiononcompletionofthetestingo Requiredsamplepreparationo Testsrequestedo SignatureoftheClientorresponsiblepartyo Deliverymethodornameofpersondeliveringsamples

AsequentialnumberisassignedtoeachWorkRequest.

IdentificationofSamples.Samplesaresystematicallyidentifiedusinguniquetrackingnumbers(consistingoftheWorkRequestnumberfollowedbyauniquesequential

number)aftertheyarriveatthelaboratory. Thisidentificationisretainedthroughout

thelifeoftheiteminthelaboratory.Thesystemisdesignedandoperatedsoasto

ensurethatitemscannotbeconfusedphysically,orwhenreferredtoinrecordsor

otherdocuments.

ChainofCustody.Thelocationofthesamplesaretrackedinternallyusingabarcodingsystem.Internaltrackingofsamplelocationisfollowedforallsamples.

ExternalChainofCustody(CoC)proceduresarefollowedforsamplesreceivedwith

CoCforms.TheCoCrecordisusedtodocumentthechangeinpossessionfrom

samplingtodeliverytoreceiptbythelaboratory.Eachsamplemustbeclearly

identifiable.Theconditionofthesampleisnoteduponreceipt.Signaturesofparties

relinquishingcustodyaswellasthedatearedocumentedontheWorkRequest

FormandanyexternalCoCform.

ClientNotificationofSampleReceipt.The LaboratoryInformationManagementSystem(LIMS)organizessampledatainsuchamannerthatloginentriescanbe

verified,sampleprogresscanbetracked,analyticaldatacanbeappendedtothe

record,andfinalreportscanbecreated.Whenloginhasbeenreviewed,asample

confirmationemailissenttotheclient.

SampleStoragePriortoAnalysis.Samplesareloggedinwithinoneworkingdayofreceipt.Samplesarestoredappropriatelyafterreceipt.Samplesrequiring

immediateprocessingsuchasdryingareprocessedimmediatelyfollowinglogin.

SamplesthathavebeenloggedinandprocessedarestoredbyWorkRequest

Number.Separate

storage

is

maintained

to

segregate

sample

types

where

cross

contaminationisapossibility.

ShippingandReceiving.TheLabisopenforsamplereceiptfrom8:00a.m.to5:00p.m.,MondaythroughFriday,excludingUniversityofCaliforniaholidays.Adropbox

isavailableforafterhourssampledropoff.Latenight,weekend,orholidaysample


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receiptcanbearranged.Foremployeesafety,anyknownsamplehazardsmustbe

explainedinthepaperworksentwithsamples.

SampleDisposition.SampleDisposition: ClientscanselectsampledispositionpreferenceontheWorkRequestForm.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.Areagentblankisanalyzedwitheverysetofsamplesthatisextractedordigested. Thisreagentblankincludesanyandallreagentsthatareusedinthe

analyticalprocessandiscarriedthroughtheentireprocess,includingextraction

andfilteringordigestion.

Duplicates.Atleasttenpercentofsamplesareanalyzedinduplicatetoyielddataontheprecisionoftheanalysis.Duplicateresultsareincludedinthereport.

ReferenceMaterials.Atleastonereferencematerialisanalyzedwitheachsetofsamples. Thevaluesforthereferencematerialsareincludedinthefinalreport.

Samplesrun

with

areference

material

that

falls

outside

the

control

limit

are

reanalyzed,includingdigestionorextractionifnecessary.Theuseofdataoutside

ofwarninglimitsisatthediscretionoftheLabSupervisororreviewinganalyst.

SpikeSamples.Samplefortificationsorspikesareusedtoverifyaccuracyoftestsrequiringextensivesamplemanipulation(suchasaciddigestion)orfornon

standardsampletypes.


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Copyright The Regents of the University of California

BlindDuplicates.Periodictestingisperformedonasubsetofsamplesthathavebeen

previouslyanalyzed.Thesesamplesarereloggedintothelaboratoryasnewsamples,

andtheresultscomparedtotheoriginalresults.

ExternalQualityControlProgramsTheUCDavisAnalyticalLaboratoryparticipatesinanumberofsampleexchangeand

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)whichistypicallyaquantitationlimitfortheanalysis

o referencematerialresultsandcriteriao resultsofduplicateanalyses

notes

and

comments

related

to

test

results

signatureandtitleofperson(s)reviewingandapprovingreport(maybeelectronic)

Datareportedtotheclientcontainstheappropriatesignificantdigitsforeachtest

method.TestresultsthatarebelowthelaboratoryMDLarenotedassuch. All

appropriatewarningsandnotesareincludedonthefinalreport.

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