QUALITYASSURANCEPROJECTPLAN(QAPP)TEMPLATE

U.S.EnvironmentalProtectionAgencyGreatLakesNationalProgramOffice77W.JacksonBoulevard

Chicago,Illinois60604‐3511

Instructions:

ThisQAPPtemplatewaspreparedbasedonEPARequirementsforQualityAssuranceProjectPlans (EPAQA/R‐5),EPA/240/B‐01/003,March2001( ItcontainsanoutlineoftheQAPPelementsbasedontheEPAQA/R‐5,withanabridgeddescription ofthediscussionthatshouldbeincludedwithineachsection(includedinredlinetext).This templatewascreatedasatooltoassistindevelopmentofQAPPs.UsersofthisQAPPtemplatemustconsulttheEPAQA/R‐5orthemoregeneralGuidanceforQualityAssuranceProjectPlans (EPAQA/G‐5),EPA/240/R‐02/009,December2002( final.pdf)asappropriatetoobtainadditionaldetailsandguidancefordevelopmentofaQAPP.

Acknowledgements:

ThisQAPPtemplatewaspreparedbyCSC,underEPAcontractnumberEP‐W‐06‐046,withthedirectionofLouisBlume,QualityManagerofEPAGreatLakesNationalProgramOfficeand WorkAssignmentManager.

DRAFT

QUALITYASSURANCEPROJECTPLAN

TitleofProject(orportionofprojectaddressedbythisQAPP)

Preparedfor:

<Enterthecontactinformationincludingaffiliationandphysicaladdress>

Contract/WA/GrantNo./ProjectIdentifier<Enterspecificidentifier

Preparedby:

<Enterthecontactinformationincludingaffiliationandphysicaladdress>

<Enterdate>

SECTIONA–PROJECTMANAGEMENT

A.1TitleofPlanandApprovalQualityAssuranceProjectPlan

<EnterTitleofProject>

Preparedby:

<EnterAffiliation>

Date:

<Entername,Organization,ProjectManager/PrincipalInvestigator

Date:

<Entername,Organization,QualityAssuranceManager(orequivalent)

Date:

<Enteradditionalcontacts,asneeded>

Date:

<Enteradditionalcontacts,asneeded>

A.2TableofContents

<TOCmustberegenerateduponcompletionofQAPPcontent>

SECTIONA – PROJECT MANAGEMENT...... 2

A.1TitleofPlanand Approval...... 2

A.2Tableof Contents...... 3

A.3DistributionList...... 5

A.4Project/TaskOrganization...... 5

A.5Problem Definition/Background...... 6

A.6Project/TaskDescription...... 6

A.7Quality Objectives &Criteria...... 6

A.8SpecialTraining/Certification...... 7

A.9Documentsand Records...... 7

SECTIONB–DATAGENERATION &AQCUISITION...... 8

B.1Sampling Process Design(ExperimentalDesign)...... 8

B.2Sampling Methods...... 8

B.3Sampling Handling &Custody...... 9

B.4Analytical Methods...... 9

B.5QualityControl...... 9

B.6Instrument/EquipmentTesting,Inspection,andMaintenance...... 10

B.7Instrument/EquipmentCalibrationandFrequency...... 10

B.8Inspection/AcceptanceofSuppliesConsumables...... 11

B.9DataAcquisitionRequirementsforNon‐DirectMeasurements...... 11

B.10DataManagement...... 11

SECTIONC– ASSESSMENT AND OVERSIGHT...... 12

C.1AssessmentsandResponseActions...... 12

C.2ReportstoManagement...... 12

SECTIOND–DATAVALIDATIONANDUSABILITY...... 13

D.1DataReview,Verification,andValidation...... 13

D.2VerificationandValidationMethods...... 13

D.3ReconciliationwithUserRequirements...... 13

ListofTables

<insertlist oftables>

ListofFigures

<insertlist offigures>

A.3DistributionList

Listtheindividualsandtheirorganizations who need copies ofthe approved QA Project Plan and any subsequent revisions, including all persons responsible for implementation (e.g., project managers), the QA managers, and representatives of all groups involved.

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Name,Agency/Company,Title,othercontactinformationasneeded

A.4Project/TaskOrganization

Identifytheindividualsororganizationsparticipatingintheprojectanddiscusstheirspecific rolesandresponsibilities.Includetheprincipaldatausers,thedecisionmakers,theprojectQA manager,andallpersonsresponsibleforimplementation.Project QA manager position must indicateindependencefromunitcolleting/usingdata.

Table A.1 Roles & Responsibilities

Individual(s) Assigned / Responsible for: / Authorized to:
Name /
  • Responsibility
  • Responsibility
 /
  • Action
  • Action

Provideaconciseorganizationchartshowingtherelationshipsand the lines of communication amongallprojectparticipants.Theorganization chart must also identify any subcontractor relationshipsrelevanttoenvironmentaldata operations, including laboratories providing analytical services.

Figure A.1 Organization Chart

insertorgchart

A.5ProblemDefinition/Background

Statethespecificproblemto besolved,decisiontobemade, or outcome to be achieved. Includesufficientbackgroundinformationtoprovide a historical, scientific, and regulatory perspectiveforthisparticularproject.

  • Clearlystateproblemtoberesolved,decisiontobemade,orhypothesistobetested
  • Historicalbackgroundinformation
  • Cite applicable technical, regulatory,orprogram-specificquality standards, criteria, or objectives

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A.6Project/TaskDescription

Provideasummaryofallworktobeperformed,productstobeproduced,andtheschedulefor implementation. Provide maps or tables that showorstatethegeographiclocations of field tasks. This discussion need not be lengthyoroverlydetailed,butshouldgive an overall picture of how theprojectwillresolvetheproblemorquestiondescribedinA.5.

  • List measurements to be made/data to obtain
  • Note special personnel or equipment requirements
  • Provide work schedule

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A.7QualityObjectivesCriteria

Discussthequalityobjectivesfortheprojectand the performance criteria to achieve those objectives. EPA requires the use ofa systematicplanning process to define these quality objectives and performance criteria.

  • State project objectives and limits,both qualitatively & quantitatively
  • Statecharacterizemeasurementqualityobjectives as to applicable action levels or criteria

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A.8SpecialTraining/Certification

Identify and describe any specialized training or certificationsneededbypersonnelinorderto successfullycompletetheprojectortask.Discuss how such training will be provided and how thenecessaryskillswillbeassuredanddocumented.

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A.9DocumentsandRecords

Describetheprocessandresponsibilitiesforensuring the appropriate projectpersonnelhavethe most current approved version of the QA ProjectPlan,includingversioncontrol,updates, distribution,anddisposition.

Itemizetheinformationandrecordswhichmust beincludedinthedatareportpackageand specifythereportingformatforhardcopyandany electronic forms. Records can include raw data, data fromother sources suchas data bases or literature, field logs, sample preparation and analysis logs, instrument printouts,modelinputandoutputfiles,and results of calibration and QC checks.

Identify any other records and documents applicabletotheprojectthatwillbeproduced,suchas auditreports,interimprogressreports, and final reports. Specify the level ofdetail ofthe field sampling,laboratoryanalysis,literatureordatabase data collection, or modeling documents or records needed to provide a complete descriptionofanydifficulties encountered.

Specifyorreferenceallapplicablerequirementsforthefinaldispositionofrecordsand documents,includinglocationandlength of retention period.

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SECTIONB–DATAGENERATIONAQCUISITION

B.1SamplingProcessDesign(ExperimentalDesign)

Describetheexperimentaldatageneration or data collection design for the project, including as appropriate:

  • Types and number of samples required
  • Sampling network design & rationale for design
  • Sampling locations & frequency of sampling
  • Sample matrices
  • Classification of each measurement parameter aseither critical or neededfor information only
  • Validation study information, for non-standard situations

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B.2SamplingMethods

Describethesamplingprocedures:

  • Identify sample collection procedures.
  • Identify sampling methods and equipment
  • Samplingmethodsbynumber,date,and regulatory citation,where appropriate
  • Implementation requirements
  • Sample preservation requirements
  • Decontamination procedures
  • Any support facilities needed
  • Describe specific performance requirements for the method.
  • Addresswhattodowhenafailureinthe sampling or measurement system occurs
  • Who is responsible for correctiveaction
  • How the effectiveness ofthe correctiveaction will be determined and documented

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B.3SamplingHandlingCustody

Describetherequirementsforsamplehandlingand custodyinthefield,laboratory,andtransport. Examples of sample labels, custody forms, and sample custody logs should be included.

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B.4AnalyticalMethods

Identify analytical methods to be followed(withalloptions)& required equipment.

  • Specify any specific method performance criteria
  • Staterequestedlabturnaroundtime
  • Providevalidationinformationfornon-standardmethods
  • Identifyprocedurestofollowwhenfailuresoccur
  • Identifyindividualsresponsibleforcorrectiveactionandappropriatedocumentation

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B.5QualityControl

Identify QC activities neededforeachsampling,analysis,ormeasurementtechnique.Foreach requiredQCactivity,listtheassociatedmethodorprocedure,acceptancecriteria,andcorrective action. State or reference the required controllimits for each QC activity and corrective action required when control limits are exceeded andhow the effectiveness of the corrective action shall be determined and documented.

Describeorreferencetheprocedures to be used to calculate applicablestatistics(e.g.,precision, bias, accuracy).

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B.6Instrument/EquipmentTesting,Inspection,andMaintenance

Describe how inspections and acceptance testingofinstruments,equipment,andtheir componentsaffectingqualitywillbe performedand documented to assure their intended use as specified.

Describehowdeficienciesaretoberesolved,whenre-inspectionwillbeperformed,andhowthe effectiveness of the corrective actionshall be determined and documented.

Identifytheequipmentand/orsystemsrequiring periodic maintenance and/or calibration. Describe how periodic preventative maintenance will be performed, including frequency, to ensure availability and satisfactory performance ofthe systems. Note availability & location of spare parts.

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B.7Instrument/EquipmentCalibrationandFrequency

Identify all tools, gauges, instruments, and othersampling,measuring,andtestequipmentused for data generation or collection activities affecting quality that must be controlled and calibrated.

Describeor referencehowcalibrationwillbeconducted using certified equipment and/or standards with known valid relationships to nationallyrecognized performance standards. If no such nationally recognized standards exist, documentthebasisforthecalibration.

Indicate how records ofcalibration will be maintained and be traceable to the equipment.

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B.8Inspection/AcceptanceofSuppliesConsumables

State acceptance criteria for suppliesand consumablesanddescribehowtheywillbeinspected for use in the project. Note responsible individuals.

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B.9DataAcquisitionRequirementsforNon‐DirectMeasurements

Identify type of data needed fromnon-measurement sources (e.g., computer data bases and literature files), along with acceptance criteria for theiruse.Defineintendeduseanddescribe any limitations of such data.

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B.10DataManagement

Describe data management process fromgenerationto final use or storage. Describe standard recordkeepingdatastorage andretrievalrequirements.Provide examples of any forms or checkliststobeused.

Describedatahandlingequipmentproceduresusedtoprocess,compileandanalyzedata(e.g., required computer hardware & software). Describetheprocessforassuringthatapplicable information resource management requirements, including EPA specific requirements, are satisfied.

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SECTIONC–ASSESSMENTANDOVERSIGHT

C.1AssessmentsandResponseActions

Describeeachassessmenttobeusedintheprojectincludingthefrequency and type (e.g., surveillance,management systems reviews, readiness reviews, technical systems audits, performance evaluations,data quality).

  • Whatisexpectedinformationfromassessment?
  • What is assessment success criteria?
  • What is assessment schedule?

Describeresponseactionstoeachassessment.

  • Howwillcorrectiveactionsbeaddressed?
  • Who is responsible forcorrectiveactions?
  • Howwillcorrectiveactionsbeverifiedanddocumented?

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C.2ReportstoManagement

Identify frequency and distribution ofreports toinformmanagementofprojectstatus:

  • Results of performanceevaluationsaudits
  • Resultsofperiodicdataqualityassessments
  • Any significant QA problems

Identifythepreparerandrecipients of reports, and describe anyactions the recipient should take as a result ofthe report.

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SECTIOND–DATAVALIDATIONANDUSABILITY

D.1DataReview,Verification,andValidation

State criteria for accepting, rejecting,orqualifyingdata;includeproject-specific calculations or algorithms.

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D.2VerificationandValidationMethods

Describetheprocessfordatavalidationandverification.Identifyissueresolutionprocedureand responsible individuals.Identifythemethodforconveyingresultsto data users.Provide examples of any forms or checklists to be used.

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D.3ReconciliationwithUserRequirements

Describe how the project results will be reconciledwiththerequirements defined by the data userordecisionmaker.Outlinetheproposedmethodstoanalyzethedataanddetermine departures fromassumptions established in the planning phase of data collection. Describe how reconciliationwithuser requirementswillbedocumented, issues will be resolved, andhow limitations on the use of the data willbereportedtodecisionmakers.

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