ML21155A204
| ML21155A204 | |
| Person / Time | |
|---|---|
| Site: | 07000925 |
| Issue date: | 09/30/2013 |
| From: | Environmental Properties Management |
| To: | Document Control Desk, Office of Nuclear Material Safety and Safeguards |
| References | |
| QAPP-001, Rev 2 | |
| Download: ML21155A204 (35) | |
Text
Cimarron Environmental
Response
Trust f0 cimarronSite Quality Assurance Program Plan proper:Iesmanagemen:A Document No.QAPP-001 Rev.2 Effective date:
9/30/2013 Pagei Reviews andApprovals Reviewed byQuality Assurance Coordinator:
A.Joseph Nardi Signature:
Date:
Approved byRadiation Safety Officer:
JayMaisler, CHP Signature:
Date:
Approved byENERCON Project Manager:
Gerald
- Williams, PE Signature:
Date:
Approved byTrustee Project Manager:
Jeff Lux Signature:
Date:
Approved byAdministrator, Cimarron Environmental
Response
Trust:
Bill Halliburton Signature:
Date:
Thisdocument mustbeverified with aControlled Copyprior touse.
Cimarron Environmental
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Trust Vif0 Cimarron Site Quality Assurance Program Plan proper:Iesmanagemen:A Document No.QAPP-001 Rev.2 Effective date:
9/30/2013 Pageii Summary ofChanges Revisions tothis document will be identified, andrevisions oraddenda will beissued asneeded.
TheProject Manager maintains thesigned original ofthis document; nocontrolled copies are issued.
Theenduserisresponsible toverify withtheProject Manager that anyhardcopybeing referenced isthecurrent revision.
A summary description ofeachrevision oraddenda will be noted inthefollowing table.
Revision Number Date Comments Rev.0 April 11,2011 Original Rev.1 February 29, Changes Assigned Leader toActivity
- Leader, other 2012 editorial changes Rev.2 September 19, General review ofPlanincorporating editorial 2013
- changes, Revised Section 2.2 and addedSection 2.6.
Thisdocument mustbeverified with aControlled Copyprior touse.
Cimarron Environmental
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Trust f0E 8l cimarron Site Quality Assurance Program Plan propernesmanagemenne Document No.QAPP-001 Rev.2 Effective date:
9/30/2013 Pageiii TableofContents Section Title Page INTRODUCTION I-1 GLOSSARY G-1 1.0 ORGANIzATION 1-1 2.0 QUALITY ASSURANCE PROGRAM*
2-1 3.0 DESIGNCONTROL 3-1 4.0 PROCUREMENT 4-1 5.0 INSTRUCTIONS, PROCEDURES, ANDDRAWINGS 5-1 6.0 DOCUMENT CONTROL 6-1 7.0 CONTROL OFPURCHASED ITEMSANDSERVICES 7-1 8.0 IDENTIFICATION ANDCONTROL OFITEMS 8-1 9.0 CONTROL OFSPECIAL PROCESSES*
9-1 10.0 INSPECTION 10-1 11.0 TESTCONTROL 11-1 12.0 CONTROL OFMEASURING ANDTESTEQUIPMENT12-1 13.0 HANDLING,
- STORAGE, ANDSHIPPING 13-1 14.0 INSPECTION,
- TEST, ANDOPERATING STATUS 14-1 15.0 CONTROL OFNONCONFORMING ITEMS*
15-1 16.0 CORRECTIVE ACTION*
16-1 17.0 QUALITY ASSURANCE RECORDS*
17-1 18.0 AUDITS 18-1
- Animplementing procedure isassociated with this section.
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Trust bb bD0 Cimarron Site Quality Assurance Program Plan proper:Iesmanagemenz Document No.QAPP-001 Rev.2 Effective date:
9/30/2013 Pageiv Quality Assurance Program PlanImplementing Procedures QAPP Section Implementing Implementing Procedure Name Procedure No.
1.0Oranization 2.0ualit Assurance Proram 2.1QAPP Applicability 2.2Activity Specific Approach QAIP2.1 Activity Plan Development 2.3Personnel Trainin 2.4LeadAuditors andInsectors 2.5ualiAssurance ProramAssessment 2.6ProramChaneEvaluation Process AIP22 Pro ramChaneEvaluation Process 3.0DesinControl 4.0Procurement 5.0Instructions, Procedures, andDrawin s
6.0Document Control 7.0Control ofPurchased Items andServices 8.0Identification andControl ofItems 9.0Control ofS ecial Processes 9.1ualiAssurance Plan 9.2Activi Plan 9.3SamlinandAnalsisPlan AIP9.1 SamlinandAnalsis Plan 9.4Procurements forLaboratory Analytical Services 9.5DataManaementProcedure AIP17.1 DataManaementProcedure 10.0 Insection 11.0 TestControl 12.0 Control ofMeasurin andTestE uiment 13.0
- Handling, Storage and,Shipping 14.0Insection,
- Test, andO eratin Status 15.0Control ofNonconforming Items QAIP 15.1 Deficiency Reporting andCorrective Action 16.0Corrective Action QAIP 15.1 Deficiency Reporting andCorrective Action 17.0ualiAssurance Records 17.1DataRecords QAIP 17.1 DataManagement Procedure 18.0Audits Thisdocument mustbeverified with aControlled Copyprior touse.
Cimarron Environmental
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Trust 002l cimarron Site Quality Assurance Program Plan propernesmanagemenz Document No.QAPP-001 Rev.2 Effective date:
9/30/2013 INTRODUCTION PageI
- 1 Introduction TheCimarron facility operated asanuclear fuelproduction facility under License SNM-928 until thesite wasclosed in1975.
Facility decommissioning beganin1976.Thedecommissioning of equipment, structures, andsoil iscomplete.
Thecurrent mission attheCimarron Site istheremediation ofgroundwatercontaminants to release levels established bytheUSNuclear Regulatory Commission (NRC) andtheOklahoma Department ofEnvironmental Quality (ODEQ).
Asaresult ofanNRCorder dated February 16, 2011andeffective February 14,2011, thelicense hasbeen transferred totheCimarron Environmental
Response
Trust (CERT),
with Environmental Properties Management, LLC(EPM) namedasthetrustee.
Thegroundwater remediation activity requires
- planning, data collection andmanagement, and decision-making tasks thataresubject toNRCestablished quality requirements, aswell as remediation requirements established bytheState ofOklahoma andthe ODEQ. Theearlier version oftheCimarron Site Quality Assurance Manual contained implementing procedures bearing theKerr-McGee nameandhadnotbeenrecently revised.
EPMdetermined that thesite Quality Assurance Program (inclusive oftheQAPP,implementing procedures,and supporting documents) needed tobeupdated toreflect theorganizational structure setforth in the license andtransfer
- order, andalso toreflect thesite's current environmental remediationmission.
To thatend,EPMauthorized thedevelopment ofacompletely revised Quality AssuranceProgram Plan (QAPP),
issued asRev0.
Therevised QAPP isupdated andstreamlined tofocus ondatacollection andremediation activities that provide quality information tosupport site closure.
Thegoalistoestablish a
quality planthatiscompliant with therequirements ofLicense SNM-928, andwhich fully implements theguidelines established byNRCRegulatory Guide 4.15, Quality Assurance for Radiological Monitoring Programs (Inception through Normal Operations toLicense Termination)
- Effluent Streams andtheEnvironment.
Acrosswalk ofNRCRegulatory Guide 4.15program elements tothestructure ofthis QAPP isattached tothis section.
Thequality requirements arebased innuclear standards, butarealso fully supportive oftheremediation of chemical contamination.
TheCERTandits Trustee EPMarededicated topromoting quality ateverylevel ofCimarron Site
- work, andtofostering anenvironment that encourages continual quality improvement.
A keycharacteristic ofthis environment ismaintenance ofa"no-fault" climate andreinforcement oftheneedtoidentify andcorrect nonconforming
- items, processes, andactivities.
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Cimarron Environmental
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Trust f 0 l
cimarron site Quality Assurance Program Plan propernesmanagemenz Document No.QAPP-001 Rev.2 Effective date:
9/30/2013 INTRODUCTION PageI
- 2 TheTrust Administrator andthe Trustee's Project Manager arealso ultimately responsible for theapplication, deployment, periodic evaluation, anddocumentation oftheQuality Assurance Program
- Plan, andfor implementing and assessing appropriate actions necessary toensure:
a Products andservices (including sample collectionandanalysis services) are compliant withlicense andregulatory requirements.
a Quality management systems andprocedures areinplace andoperating effectively.
a Opportunities forimproving the organization, quality,compliance andcost performance areimplemented.
Timely evaluation ofpersonnel resources,needs, skillsandperformance tostress the importance of,andidentify opportunities for,continual quality improvement.
a Datausedfordecision making areofthequality needed fordecisionstosupport Cimarron Site goals andassure compliance with nuclear andenvironmental compliance requirements.
AllCimarron Site Personnel, contractors, andsubcontractors are responsible for:
a Maintaining familiarity withtherequirements oftheQAPP,andmaintaining a
personal commitment toimplementing theQAPP requirements intheir everyday work a
Identifying opportunities forquality improvement a
Responsible useofstopworkauthority whennecessary tomitigate risks
- tosafety, security, orquality Thisdocument mustbeverified withaControlled Copyprior touse.
Cimarron Environmental
Response
Trust f0 cimarronSite Quality Assurance Program Plan propernesmanagemenz Document No.QAPP-001 Rev.2 Effective date:
9/30/2013 INTRODUCTION PageI
- 3 Crosswalk ofNRC Regulatory Guide4.15Elements tothisQAPP NRCRegulatory Guide 4.15 Element QAPP Section orImplementing Procedure 1.0Organizational Structure and QAPP 1.0(description, chart)
Resonsibilities 2.0Specification ofQualifications of QAPP 2.3 (general),
QAPP 2.4(auditors/
Personnel inspectors),
QAPP7.0(contractors and consultants APP17.0(records ofqualification) 3.0Operating Procedures andInstructions QAPP 2.1 and QAIP 2.1(activity plans)
QAPP 5.0 (general),
QAPP Section 9.2(activity plans),
QAPP 9.3andQAIP 9.1 (sampling andanalysis plans andprocedures),
QAPP 9.4(laboratory ualicontrol 4.0Records QAPP 6.0(document control),
QAPP 9.4 (laboratory quality control),QAPP 17.0(quality assurance records),
QAPP 17.1 and QAIP 17.1 DataManaementProcedure 5.0Quality Control inEnvironmental QAPP 8.0(identification andcontrolof items),
Sampling QAPP 9.3andQAIP 9.1(sampling andanalysis plans andprocedures),
QAPP 12.0 (control of measuring andtest equipment),
QAPP 14.0 (inspection testandoperatin status 6.0Quality Control intheRadioanalytical QAPP 7.0(control ofpurchased services),
QAPP Laboratory 9.4(laboratory quality control),
QAPP 18.0 (audits),
QAPP 12.0(control ofmeasuring and testequipment),
QAPP 14.0(inspection test and operating status),
Radiation Protection Plan onsite radiation surveinstrument calibration Thisdocument mustbeverified withaControlled Copyprior touse.
Cimarron Environmental
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Trust Vif0 Cimarron Site Quality Assurance Program Plan propernesmanagemenz Document No.QAPP-001 Rev.2 Effective date:
9/30/2013 INTRODUCTION PageI
- 4 Crosswalk ofNRCRegulatory Guide4.15Elements tothisNQA-1 BasedQAPP (continued)
NRCRegGuide 4.15Element QAPP Section orImplementing Procedure 7.0Quality Control forRadioactive Effluent QAPP 8.0(identificationandcontrol ofitems),
Monitoring Systems QAPP 9.3andQAIP 9.1(sampling andanalysis plans andprocedures),
QAPP 12.0(control of measurin andteste uiment 8.0Verification andValidation QAPP3.0 (design
- control, general),
QAPP 9.4 (laboratory quality control) 9.0Assessments andAudits QAPP 2.5(QAPP assessment),
QAPP 2.6 (program change evaluations) QAPP 7.0 (control ofpurchased items andservices),
APP10.0ins ection APP18.0audits 10.0Preventative andCorrective Actions QAPP 15.0andQAIP15.1 (deficiency reporting andcorrectiveaction Thisdocument mustbeverified withaControlled Copyprior touse.
Cimarron Environmental
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Trust 002l cimarron Site Quality Assurance Program Plan propernesmanagemenz Document No.QAPP-001 Rev.2 Effective date:
9/30/2013 GLOSSARY PageG-1 Glossary Activity Plan:Aworking level document establishing theelements ofaworkactivity important toquality, andalso establishing thesequence ofworknecessary tosuccessfully complete theworkactivity.
Activity Leader:
Theindividual assigned by the Trustee Project Manager with overall responsibility tocomplete theworkdescribed inan Activity Plan.
Cimarron Environmental ResponseTrust (CERT):
The Trustestablishedashaving overall responsibility forenvironmental liabilities attheCimarron Site inaccordance withtheJanuary 26,2011Settlement Agreement with theDepartment ofJustice (DOJ), theNuclear Regulatory Commission (NRC) andtheState ofOklahoma.
TheCERTisrepresented bytheCERT Administrator.
Cimarron Site:Refers totheeffort toremediate thelocation oftheformer Kerr-McGee facility inCrescent, Oklahoma(near
- Cimarron, Oklahoma),
including characterization and remediation ofradioactive andchemical contamination, tofulfill requirements forthe Cimarron Site established bytheNRCandtheState ofOklahoma.
Cimarron SitePersonnel:
Anyperson performing remediation workorwork directly supporting remediation oftheCimarron Site inCrescent, Oklahoma.
Contractor:
Anyorganization orindividual contracted directly totheTrustee.
Controlled Document:Anydocument theTrustee Project Manager orQuality Assurance Coordinator determines should becontrolled toensure that thattheuserpossesses themost current revision ofthedocument.
Thisincludes theQAPP andallimplementing procedures.
Decisions Affecting License Termination orSiteClosure:
Decisions that support the Cimarron Site's characterization andremediation goals.
Thisincludes goals established in accordance withestablished requirements oftheNRCandtheState ofOklahoma.
HoldPoint:
Astopping point inaprocedure orworkplanrequiring asignature orinitials to verify that datahasbeenrecorded orthat required actions areverified ascomplete before proceeding.
HoldPoints areusedasaquality assurance measure inActivity Plans.
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Cimarron Environmental
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Trust 002l cimarron Site Quality Assurance Program Plan propernesmanagemenz Document No.QAPP-001 Rev.2 Effective date:
9/30/2013 GLOSSARY PageG-2 Quality Activity:
Anyactivity that impacts thecharacterization orremediation ofthesite in order toachieve license termination orsite
- closure, orthatisotherwise required bytheTrustee Project Manager orQuality Assurance Coordinator tobesubject tothequality assurance program.
Quality Data:Datathat directly orindirectly support decisionsaffecting license termination or site closure.
Quality datacollection andmanagement, aresubject totherequirements ofthe QAPP.
Quality Assurance ProgramPlan(QAPP):
This document fortheCimarron Site.
TheQAPP establishes thestructure oftheQuality Assurance
- Program, including implementing procedures, referenced procedures
- andplans, andquality requirements directly established intheQAPP's 18 basic criteria descriptions.
Quality Assurance Program(QAP):
TheCimarron Site's overall program forquality assurance, asdescribed intheQuality Assurance Program Plan (QAPP).
Quality Assurance Records:
Records ofsite activities ordataasprescribed inSection 17.0 ofthisQAPP.
Subcontractor:
Anyorganization orindividual retained byacontractor.
Subject MatterExpert:
Anindividual whoisknowledgeable andexperienced inaspecialized discipline.
Trustee:
Environmental Properties Management (EPM),
theTrustee identified intheJanuary 26,2011Settlement Agreement withtheDepartment ofJustice (DOJ),
theNuclear Regulatory Commission (NRC) andtheState ofOklahoma.
Trustee Project Manager:Theemployee oftheTrustee assigned overall responsibility for theplanning, scheduling, andperformance ofworkattheCimarron Site.
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Cimarron Environmental
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Trust 00 l
cimarron site Quality Assurance Program Plan propernesmanagemenz Document No.RP-001 Rev.2 Effective date:
9/30/2013 Section 1
ORGANIzATION Page1
- 0 1.0 Organization TheCimarron Site's organizationalstructure asitaffects quality issummarized inthefollowing role-specific responsibility descriptions:
Cimarron Environmental
Response
Trust (CERT) Administrator:
TheCERTAdministrator hasoverall responsibility for Cimarron Site
- policies, quality assurance, andcompliance attheCimarron Site.
CERTTrustee, Environmental Properties Management, LLC(EPM) Project Manager TheTrustee Project Manager(PM) isresponsible for physical and financial management ofremediation andcompliance activities attheCimarron Site.This includes direct responsibility fortheimplementation andmaintenance ofthe Quality Assurance Program Plan requirements.
TheTrustee PMisresponsible tocommunicateto all sitepersonnel andcontractors therequirements oftheQAPP.
TheTrustee PMisresponsible toinclude Cimarron Site quality performance requirements incontract andpurchaseorder terms andconditions.
Quality Assurance Coordinator (QAC):
TheQuality Assurance Coordinator (QAC) isresponsible forthereview, revision and maintenance ofthequality assurance program.
TheQACcoordinates day-to-day activities withtheTrustee PM,butreports directly totheCERTAdministrator as necessary toassure implementation oftheQAPP andresolve quality matters.
Inaddition theQAC hasthefollowing responsibilities:
a TheQAC reports directly totheCERTAdministrator toresolve quality related problems andconflicts.
Maintains theQuality Assurance Program
- Plan, develops implementing procedures andinstructions, andmonitors their implementation.
=
Schedules andperforms QAaudits andsurveillances onaperiodic basis to assess theQAProgram effectiveness, andtoensure that workisperformed Thisdocument mustbeverified withaControlled Copyprior touse.
Cimarron Environmental
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Trust 002 cimarron site Quality Assurance Program Plan propernesmanagemenz Document No.RP-001 Rev.2 Effective date:
9/30/2013 Section 1
ORGANIzATION Page1
- 1 inaccordance with qualityprogram requirements.
TheQAC also makes updates andimprovements totheplanandprocedures asneeded.
Issues deficiency reports, identifiesnon-conformancesandapproves corrective actionsrequired toensure quality ofactivities/items.
a Verifies andapprovescorrective actions asaresult ofdeficiencies ornon-conformances.
Reviews andaccepts QAprograms andproceduresofcontractors and/or subcontractors supplying quality related services.
Provides QAtraining toCimarron Site Personnel (including contractor and subcontractor personnel) whomanage orperform activities affecting quality.
Subject MatterExpert(SME)
Asubject matter expert(SME) isaknowledgeable andexperienced individual whouseshisor herknowledge ofaspecific discipline tojudgewhatisimportant and useful.
TheSMEenriches information bysummarizing, combining, contrasting, andintegratingit into theexisting knowledge base.TheSMEassists inidentifying andmapping critical knowledge applicable to theproject, helps establish theproject organizing structure, works toensure that project knowledge objects arerelevant
- andvalid, works torefresh andexpand the knowledge
- base, andsuggests potential topics forproject meetings.
TheSMEparticipates inmeetings, reviews project membercontributions toensure quality andrelevancy ofmaterial, providesprocess analysis expertise, andparticipates intheproject asamemberofthedecommissioning team.
AllCimarron Site Personnel:
AllCimarron Site Personnel areencouraged tobediligent intheperformance oftheir ownwork tomaintain thelevel ofquality required
- byplans, procedures, andinstructions.
Inaddition, personnel areencouraged tobediligent andattentive toanyquality issues that mayexist inthe workoftheir
- peers, suppliers, contractors, andsubcontractors; because aconsistent and exemplary level ofquality canonlybeobtained through vigilant attention tothewholeofthe Cimarron Site's workproduct; notjustthepieces forwhich anindividual isimmediately responsible.
Reiterating therequirements discussed intheintroduction
- section, all Cimarron Site Personnel areresponsible for:
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Cimarron Environmental
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Trust Vif0 Cimarron Site Quality Assurance Program Plan proper:Iesmanagemen:A Document No.RP-001 Rev.2 Effective date:
9/30/2013 Section 1
ORGANIzATION Page1
- 2 Maintaining familiarity with the requirements oftheQAProgram, andmaintaining a
personal commitment to implementing theQAProgram requirements intheir everyday work Identifying opportunities for quality improvement a
Responsible useofstop work authority whennecessary tomitigate risks
- tosafety, security, orquality ACERTorganization chart isprovided below.
TheCimarron Environmental
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Trust Organization r
Administrator m
I I
I I
I I
I Project I
I Manager I
I I
I I
v f
g Radiation Safety Quality Assurance g
j officer 7
AdiviW Leader g
Coordinator J,x p
a I-
- I I
/
Health Physics Technician LineofAccountability LineofCommunication Thisdocument mustbeverified withaControlled Copyprior touse.
Cimarron Environmental
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Trust bb bD0 Cimarron Site Quality Assurance Program Plan propernesmanagemenz Document No.QAPP-001 Rev.2 Effective date:9/30/2013 QUALITYASSURANCE Section 2.0 PROGRAM Page2
- 1 2.0 QUALITY ASSURANCE PROGRAM TheEPMCimarron Site QAPP isdesigned tocreateaquality assurance program meeting the applicable requirements ofthefollowing:
NRCRegulatory Guide 4.15, Quality Assurance for Radiological Monitoring Programs (Inception Through Normal Operations to License Termination)
- Effluent Streams andtheEnvironment NRCLicense SNM-928 TheEPMprocedures usedtoimplement this program are listed inAppendix A,Quality Assurance Program Plan Implementing Procedures.
EPMactsastheTrustee forCERTtodirectly manage activities atthe Cimarron site.
EPMhasa limited
- staff, andrelies uponcontractors forsignificant portions ofthesite work.
TheCimarron SiteQAPP isdesigned toensure EPMefforts areofsufficient quality tocomply withapplicable requirements.
Anequally important goaloftheQAPP istoensure that EPM establishes the qualifications ofits contractors, effectively communicates theCimarron Site'squality requirements tocontractors, andcontinually monitors contractor andsubcontractor performance andproduct quality.
Theemphasis ofthis quality program istoprovide quality management systems that ensure:
Anactivity-specific planisdeveloped foreachproject orcontracted scope ofwork that addresses quality assurance provisions.
Vendors performing quality critical activities orgenerating quality critical dataare qualified toprovide thequality ofdataneeded.
EPMownedandleased equipment issuitably designed andmaintained forits intended use.
a Theeffectiveness oftheEPMQuality Assurance Program isperiodically assessed.
2.1 Quality Assurance ProgramPlanApplicability TheQuality Assurance Program Plan requirements apply toall activities attheCimarron Site that areperformed tosatisfy regulatory and/or license requirements, including:
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Cimarron Environmental
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Trust bb bD0 Cimarron Site Quality Assurance Program Plan propernesmanagemenz Document No.QAPP-001 Rev.2 Effective date:9/30/2013 Section 2.0 @Am AEMG Page2
- 2 PROGRAM Groundwatermonitoring well
- drilling, installation, anddevelopment Sampling andanalysis ofenvironmental media a
Design andevaluation ofgroundwater characterization andremediation plans Groundwater remediation activities Other activities directlyaffecting licensetermination andsite closure decision
- making, asdetermined bythe Trustee PMorQAC Quality Assurance Program Plan requirements donot apply toactivitiessuchasmowing, fence
- repair, building maintenance, andother activities which are notrelated toregulatory requirements.
2.2 Activity Specific Approach TheCimarron Site QAPP isdesigned toassure thequality ofwork performed bothbythelimited EPMstaff anditscontractors.
Therequirements ofdifferent scopes ofwork vary, asdoesthe level ofsophistication ofdifferent contractor's in-house quality programs.The Cimarron Site QAPP ensures requirements aremetbyreviewing eachplanned
- activity, andresponding tothe unique quality requirements ofeachactivity withanactivity-specific plan.
Onceasite activity isidentified, theTrustee PMdetermines iftheactivity isaqualityactivity affecting decisions related tolicense termination andsite closure.
Activities affecting quality are required tobecontrolled using adocumented Activity Plan.
TheActivity Plan isdeveloped bytheTrustee PMordesignee, andprovides aconcise description oftheworktobecompleted.
EachActivity Plan mustbereviewed byaqualified person other thantheauthor.
Reference documents (e.g.
detailed sampling procedures) may beattached.
Separate documents (e.g.
sample inventories orshipping papers) todocument thecompletion ofanactivity mayalso beadded astheactivity iscompleted.
Thepurpose of theActivity Planistoensure that procedural stepsimportant toquality areclearly expressed.
TheActivity Plan also provides documentation that theactivity wasproperly completed, and mustprovide forverification signatures orinitials byeachperson performing steps intheplan deemedimportant toquality.
Thequality requirements andobjectives ofeachactivity mustbe clearly expressed ineachActivity Plan.
TheTrustee PM(or designee) hasoverall responsibility forthecontent ofeachActivity Plan.
TheActivity Leader hasresponsibility forimplementation ofeachActivity Plan.
When Thisdocument mustbeverified withaControlled Copyprior touse.
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Trust 002l cimarron Site Quality Assurance Program Plan propernesmanagemenz Document No.QAPP-001 Rev.2 Effective date:9/30/2013 Section 2.0 @Am AEMG Page2
- 3 PROGRAM appropriate, Subject Matter Experts (SME) maybedesignated specific responsibilities for decision making matters inthefield.
Periodic monitoringofworkperformance inaccordance with Activity Plans isperformed bythe Quality Assurance Coordinator (or designee).
Instructions forthedevelopment ofanActivity Plan arecontained inQAIP 2.1 2.3 Personnel Training EPMpersonnel andanypersonnel designated bytheTrustee PMwill receive detailed training in theCimarron SiteQAPP administered bytheQuality Assurance Coordinator (QAC).
All contractor organizations performing activities affecting quality shall begiven acopyofthe Cimarron Site QAPP whenworkisawarded.
Inaddition, all personnel performing onsite activities affecting quality shall bebriefed ontheCimarron SiteQAPP andthespecific quality requirements oftheir workassetforth intheActivity Plan.
This training maybeadministered bytheQAC,theTrustee PMordesignee, ormaybefulfilled bysignedacknowledgment ofan Activity Plan.
Anyother training theTrustee PMdeemsnecessary toperform activities onoroff site will be identified anddocumented intheactivity plan.
TheTrustee PMordesignee isresponsible to determine that personnel assigned totasks affecting
- quality, particularly related todecisions affecting license termination orsite
- closure, arequalified toperform their assigned work.
2.4 LeadAuditors andInspectors QALeadAuditors arecertified inaccordance withNQA-1 criteria.
NQA-1 LeadAuditors are preferred forinternal audits andassessments oftheEPMQAPP,andforexternal audits of laboratories andother service providers whoseworkiscritical toquality.
- However, theTrustee PMmaydesignate other personnel forthese functions with awritten justification oftheir qualifications foraparticular audit orassessment task.
Personnel performing inspections andsurveillances neednotbeLeadAuditors, andmaybe qualified based ontheir
- skills, experience, ortask specific
- training, andapproved
- bytheQAC, andtheTrustee PM.WhentheActivity Planrequires verification ofpersonnel
- training, the evidence oftraining should beattached totheActivity Plan.
Alternatively, theActivity Plan may reference thelocation oftraining files inwhich suchrecords arelocated (e.g.
EPMpersonnel
- file, project
- file, orvendor qualification file).
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Cimarron Environmental
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Trust Vif0l Cimarron Site Quality Assurance Program Plan proper:Iesmanagemen:A Document No.QAPP-001 Rev.2 Effective date:9/30/2013 Section 2.0 @Am AEMG Page2-4 PROGRAM 2.5 Quality Assurance Program Assessment TheTrustee PMortheQAC will require a management assessment oftheQAP atleast once every three years.
Theassessment may be aself-assessment performed jointly bytheQAC and EPMpersonnel, maybeperformed byanindependent contractorhired fortheassessment, or,a third partyaudit oftheCimarron SiteQAP may be usedtosatisfy this requirement.
2.6 ProgramChangeEvaluation Process NRCLicense SNM-928(Condition 27(e))
provides flexibility for thelicenseetomakechanges to theNRC-approved Decommissioning Plan(DP) andthe Radiation Protection Plan(RPP) provided certain constraints aremet.QAIP-2.2, "Program Change Evaluation Process",
provides theprocess forthereview andimplementation ofsuch changesto ensure that thelicense condition requirements havebeenmet.
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Trust Vif0 Cimarron Site Quality Assurance Program Plan proper:Iesmanagemenz Document No.QAPP-001 Rev.2 Effective date:9/30/2013 Section 2.0 @Am A%MG Page2
- 1 PROGRAM Thisdocument mustbeverified withaControlled Copyprior touse.
Cimarron Environmental
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Trust 00 l
cimarron site Quality Assurance Program Plan propernesmanagemenne Document No.QAPP-001 Rev.2 Effective date:
9/30/2013 Section 3.0DESIGNCONTROL Page3
- 1 3.0 DESIGNCONTROL TheCERTanditsTrustee, EPM,do not design systems important tonuclear safety astypically contemplated byNQA-1Inthe License Transfer
- Order, dated February 16,2011,page3,the NRCnotes ithasdetermined that the Cimarron facilityposes noimmediate threat topublic safety.
Nonetheless, EPMiscommitted todesign control for those processesthat affect license termination andsite
- closure, e.g.
thesite Groundwater Decommissioning Plan(GDP).
Thefirst stepinassuring thequality oftheGDPiscontrolling the quality ofdesign inputs;
- namely, the groundwater sampling andanalysis methods andresults.
This QAPPandsupporting plans (such astheSampling andAnalysis Plan) havebeen developed toassure quality inputs.
AstheGDP(or other remediation designs developed bythe Cimarron Site)isdeveloped,the Trustee PMwill continuously review development toassure theGDP will meet therequirements ofSNM-928, commitments totheNRCandODEQ,andother applicable requirements and regulations.
Inaddition, theTrustee PMisresponsible toensure that theGDPandanyother document establishing adesign affecting license termination orsite closure issubject toadocumented independent review.
InthecaseofEPM-developed
- designs, review will beperformed by contractors, orbyEPMpersonnel sufficiently independent oftheoriginal design that they are notverifying their ownwork.Inthecaseofcontractor prepared
- designs, theTrustee PM or qualified designee will perform theindependent review.
Thereview mustdetermine that any calculations affecting license termination orsite closure havereceived anappropriate level of documented independent verification.
Inaddition totheTrustee PM,theCERTAdministrator mustapprove all quality related design products.
Contractors usedfordesign ordesign review mustbeevaluated andapproved vendors in accordance withSection 7.0ofthisQAPP.
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Trust 002 cimarron site Quality Assurance Program Plan propernesmanagemenz Document No.QAPP-001 Rev.2 Effective date:
9/30/2013 Section 4.0 PROCUREMENT Page4
- 1 4.0 PROCUREMENT Thetechnical,
- quality, regulatory,and administrative requirements applicable toprocurement of materials orservices fortheCimarron Site areestablished bytherequisitioner andspecified in procurement documents.
Ifthe procurement isrelatedtoanactivity towhich theQAPP
- applies, theprocurement mustalso reflectthe quality requirements established bytheActivity Plan.
Items andservices potentially affecting decisions for license termination orsite closure mustnot beprocured until itisdetermined that thesupplier iscapable ofensuringanappropriate level of quality fortheitemsorservices being provided.
Depending onthenature oftheproduct or service being
- obtained, procurement process mayincluderequiring evidence ofthesupplier's quality assurance
- program, third party
- audits, assessments, or certifications ofthesupplier's capabilities.
Whenthis evidence isrequired, itwill bereviewedby the QAC,theTrustee PM,or designee.
Satisfactory review ofthesupplier's documentation (anda physical audit ofthe supplier's facilities, ifappropriate) will bedocumented andrecords will be maintained inthe Cimarron Site's approved supplier's files (reference Section 7.0ofthis QAPP).
Ifaprocured itemisan"off theshelf" itemofcommercial
- grade, buthasperformance characteristics deemedimportant toquality, those characteristics mustbespecifically listed on therequisition.
Therequisitioner orTrustee PMwill also noteontherequisition whether receipt inspection ortesting isrequired prior toacceptance oftheitem(inspection should berequired ataminimumtoverify thatQArequirements established bytheprocurement documenthave beenmet).
Anycutsheets orspecifications usedtoselect
- theitem, andanyspecificationsor instructions delivered withtheequipment should becomepartoftheprocurement file and distributed totheenduserasnecessary.
Alternatively, these documents maybemaintained in asite equipment file.
Thisdocument mustbeverified withaControlled Copyprior touse.
Cimarron Environmental
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Trust 0
cimarronSite Quality Assurance Program Plan propernesmanagemenz Document No.QAPP-001 Rev.2 Effective date:
9/30/2013 INSTRUCTIONS, Section 5.0 PROCEDURES, AND Page5
- 1 DRAWINGS 5.0 INSTRUCTIONS, PROCEDURES, ANDDRAWINGS Theintent ofthis QAPP,its implementing procedures, andrelated plans andprocedures (e.g.
Sampling andAnalysis
- Plan, Data Management Procedure) istoprovide acomplete setof instructions andprocedures needed tocomplete license termination andsite closure.
Activity Plans provide detailed workinstructions for specific scopes ofwork.
AsworkattheCimarron Site progresses, itmaybedetermined that anewtypeofworkactivity isrequired.
Asconditions
- change, anexisting work activity may requireadditional control to ensure thatquality,
- safety, orperformance goals aremet.In these cases,theTrustee PMhas primary responsibility fordetermining whenactivities affecting quality requirespecific procedures orother documentation tocontrol theactivity andensure thequalitylevel is maintained.
Whenprocedural controls areimplemented, the Trustee PM (or designee) is responsible forassuring that activities areperformed inaccordance with the requirements of these documents.
Thesedocuments mayinclude quantitative andqualitative criteria toverify that theactivity hasbeensatisfactorily accomplished.
Monitoring for compliance withthese guidance documents maybeperformed atanytimebytheQAC.
Allinstructions, procedures, anddrawings mustshowevidence ofindependent review and approval.
Thesedocuments mustalsobearaunique identifying
- number, date, andrevision number Thisdocument mustbeverified withaControlled Copyprior touse.
Cimarron Environmental
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cimarronSite Quality Assurance Program Plan propernesmanagemenz Document No.QAPP-001 Rev.2 Effective date:
9/30/2013 CONTROL OFPURCHASED Section 7.0 ITEMSANDSERVICES Page7
- 1 6.0 DOCUMENT CONTROL Cimarron Site procedural documentssuch asthis QAProgram Plan andassociated implementing procedures andsupporting plans aremaintainedascontrolled documents.
Controlled documents areavailable tointernal users byelectronicmedia.Themaster document electronic file ismaintained inacentral location andformatted asa.pdf file sothat thedocument file cannot beinadvertently changed byanenduser.
Editable versions of electronic documents will beelectronically stored with limited access asdetermined bythe Trustee PMandtheQAC.
Asingle hardcopy ofcontrolled documents will bemaintained bytheTrusteePMordesignee, andwill beidentifiable bysignatures (original orelectronic).
Endusers areresponsible forverification that anyprinted copies ofcontrolled documents are thelatest revision bychecking their revision against therevision currently available electronically.
Printed copies notmarked "Original" mustbeassumed tobe uncontrolled copies ofthedocument.
Controlled copies arenotnormally distributed; aspecialprocedure for document control will berequired ifoutside distribution ofacontrolled document becomes necessary.
Since endusers will likely rely ontherevision numberonthecover pageofthe electronic controlled document toverify their printed
- version, revision ofindividual pageswithin a
document arenotpermitted.
Asagoodpractice, document revisions should beannounced tolikely endusers whenthey become available.
Documents specifically required tobecontrolled bythis QAPP include:
TheQuality Assurance Program Plan andImplementing Procedures Sampling andAnalysis Plan andProcedures DataManagement Procedure Other documents asdetermined bytheTrustee PMorQAC,ordocuments which must becontrolled inaccordance withother requirements (e.g.
theRadiation Protection Plan andProcedures)
Thisdocument mustbeverified withaControlled Copyprior touse.
Cimarron Environmental
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Trust 002l cimarron Site Quality Assurance Program Plan propernesmanagemenz Document No.QAPP-001 Rev.2 Effective date:
9/30/2013 CONTROL OFPURCHASED Section 7.0 ITEMSANDSERVICES Page7
- 2 7.0 CONTROLOFPURCHASED ITEMS ANDSERVICES TheCimarron Site qualifies supplierson an as-needed basis whentheir products orservices are required tocomplete quality work related to license termination orsite closure.
Initial qualifications maybebased onthe supplier's submitted statementofqualifications, third party
- audits, reference referrals, professional certifications orlicensure(particularly forconsultants),
orbythereview ofother information deemed relevant toestablishthevendor's qualifications to perform arequired scope ofwork.This mayinclude contract related requirements (e.g.
required minimum insurance orEMRrating).
Oncecompleted, arecord ofsupplier qualification ismaintained bytheTrustee PMordesignee, andthis record ofqualification ismadeavailable toCimarronSite personnel intheformofan approved supplier's list (ASL) maintained electronically inacentral location.
Supplier qualification isrequired forquality related procurements asdetermined bytheTrustee PM,
- designee, orQAC.
Adetermination that asupplier hasbeen approved is required aspartof eachActivity Plan.
TheTrustee reserves theright toaccess supplier facilities toperform assessments and inspections.
Thespecific procurement quality requirements established bythe requisitioner mayalso require thesupplier submit documentation andrecords that demonstratethe acceptability oftheservice orequipment provided.
Eachapproved supplier's performance isassessed periodically tomaintain supplier's acceptable status.
Assessments ofthesuppliers maybeaccomplished byreviewing assessment reports conducted byregulatory agencies orbyother customers.
Internally, theCimarron Site may basetheassessment onsupplier performance, ormayassess performance byphysical audit or receipt ofasupplier performance questionnaire.
Documented supplier reviews arevalid forup tothree years.
Approved suppliers ontheASLmayalso bere-evaluated when:
=
Asupplier's performance isdetermined tobeunacceptable bytheTrustee PM,orQAC.
a Atthediscretion oftheTrustee PMorQAC,based, forexample, ona trend ofnon-conformances, prolonged periods ofinactivity, orsignificant anddocumented problems withother clients orregulators.
Atthediscretion oftheTrustee PMorQAC,suppliers whoseperformance isconsidered tobeunacceptable mayberemoved fromtheASLormaintained onholdpending a
review andapproval ofthesupplier's corrective actions implemented tocorrect the performance issue.
Thisdocument mustbeverified withaControlled Copyprior touse.
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cimarronSite Quality Assurance Program Plan propernesmanagemenne Document No.QAPP-001 Rev.2 Effective date:
9/30/2013 IDENTIFICATION AND Section 8.0 CONTROL OFITEMS Page8
- 1 8.0 IDENTIFICATION AND CONTROL OFITEMS InNQA-1,theIdentification andControl ofItems requires that:
"Controls beestablished to assure that only correct andaccepted items areusedandinstalled."
Therequirement generally applies tohardware parts andcomponentsaffecting nuclearsafety; andrequires that theybe verified asacceptable, physically identifiable(e.g. byserialnumber),
andtraceable toapplicable specifications orprocurement documents.
AttheCimarron
- Site, thephysical hardware items towhich quality requirements apply is generally limited tomeasuring andtest equipment; controlled inaccordance withSection 12.0 ofthisQAPP.
Services arecontrolled through procurement documents, supplier qualification/approval, and site Activity Plans asrequired byvarious sections ofthis QAPP.
Data"items" (e.g.
environmental
- samples, andresulting analysis) are identified, tracked, and controlled through theActivity
- Plans, Sampling andAnalysis Plan procedures, Procurement of Laboratory Analytical
- Services, andDataManagement Procedures describedin Section 9.0of this QAPP.
Activity Plans which reference theuseofequipment relevant toquality mustidentify the equipment used(e.g.
bytypeofequipment andserial number) andalso verify current calibration orperformance checks asapplicable.
Thisrequirement applies regardless of whether theequipment isownedandcontrolled bytheTrustee orbyacontractor.
Whenequipment isfound tobeinneedofrepair/rework, orifitistaken outofservice, the equipment inventory isupdated toreflect thecurrent status andtomaintain control ofitsuse.
Outofservice equipment mustbevisibly marked andphysically separated frominservice equipment.
TheTrustee PMandQAC areresponsible toensure theIdentification andControl ofother items notcurrently contemplated bytheQAPP.
Thisdocument mustbeverified withaControlled Copyprior touse.
Cimarron Environmental
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Trust 002l cimarron Site Quality Assurance Program Plan propernesmanagemenne Document No.QAPP-001 Rev.2 Effective date:
9/30/2013 CONTROL OFSPECIAL Section 9.0 PROCESSES Page9
- 1 9.0 CONTROLOFSPECIAL PROCESSES NQA-1 defines special processes asthose that controlorverify quality.
Inmanufacturing operations, special processes include welding procedures andthenon-destructive testmethods usedtoensure weldquality.
Atthe Cimarron
- Site, conventional manufacturing special processes arenotbeing usedtoensure nuclear safety.
However,this QAPP defines special processes relevant toCimarron Site activities asthose thatgeneratedatainsupport oflicense termination andsite closure.
TheCimarron Site QAPP,implementing procedures, andrelated plansaredesigned tocontrol these special processes; theenvironmental andmonitoringprocesses inuseforsite characterization andremediation.
This section explains the function oftheQAPP andits implementing procedures tocontrol special processes aspart ofthe overall QAprogram inplace attheCimarron Site.
9.1 Quality Assurance ProgramPlan TheQAPP provides forCimarron Site management toconduct regular surveillance ofonsite sampling activities andadherence tospecial process procedure requirements.
The QAPP also provides foraudits ofoffsite laboratories toensure thelaboratories areemploying good analytical process control techniques.
- Finally, theQAPP provides anNQA-1 based structure that includes deficiency reporting; theability toidentify preventive andcorrective actions todata generation andreporting efforts; andtheability toidentify areas forimprovement where the potential fordeficiencies exist.
TheQAPP isNQA-1 based toaddress activities that could be performed within thescopeofNRCLicense SNM-928, butfocuses onaddressing theQA elements forenvironmental monitoring expressed inNRCRegulatory Guide 4.15.
9.2 Activity Plan AnActivity Plan(as implemented byQAIP 2.1) isrequired forthose activities which mayaffect decisions forlicense termination orsite closure.
TheActivity Plan provides ataskdescription andworkplan toidentify task-specific quality requirements, andalso actstoensure those requirements aremetandappropriately documented.
Activity Plans identify locations and requirements forindividual sampling campaigns (or other activities),
andmayusestandardized sampling procedures fromtheSampling andAnalysis Plan toprovide detailed well drilling or sampling workinstructions.
Thisdocument mustbeverified withaControlled Copyprior touse.
Cimarron Environmental
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cimarronSite Quality Assurance Program Plan propernesmanagemenz Document No.QAPP-001 Rev.2 Effective date:
9/30/2013 CONTROL OFSPECIAL Section 9.0 PROCESSES Page9
- 2 9.3 Sampling andAnalysisPlan TheSampling andAnalysis Plan andProcedures addresssampling procedures attheCimarron
- Site, including:
Welldrilling anddevelopment Sample Collection Sample Identification,
- Tracking, andManagement Chain ofCustody Decontamination ofSampling Equipment TheCimarron Site Sampling andAnalysis Plan ismaintained asQAIP 9.1 9.4 Procurements forLaboratory Analytical Services Procurements forlaboratory analytical services establish thelaboratory's contractual obligations totheCimarron
- Site, including laboratory procedure dataquality requirements and referenced analytical procedure standards.
Theprocurement constitutes theauditable standard of performance forthelaboratory foranalyses theCimarron Site requests.
Procurements for laboratory services mustclearly identify theCimarron Site quality requirements (e.g.
standard methods
- tobeused, minimumdetectable concentrations).
Therequisitioner mustverifythe requirements intheprocurement forlaboratory services areconsistent withestablished Cimarron Site data quality objectives iftheyexist, oractivity-specific quality objectives established bytheActivity Plan.
9.5 DataManagementProcedure TheDataManagement Procedure addresses standards forelectronic datadeliverable (EDD) formats fromthelaboratory, quality review oflaboratory analytical
- data, anddataarchiving.
Refer toSection 17.1ofthis QAPP andtotheDataManagement Procedure Procedure QAIP 17.1 Thisdocument mustbeverified withaControlled Copyprior touse.
Cimarron Environmental
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Trust 00 l
cimarron site Quality Assurance Program Plan propernesmanagemenne Document No.QAPP-001 Rev.2 Effective date:
9/30/2013 Section 10.0 INSPECTION Page10
- 1 10.0INSPECTION Thelevel ofinspection foranitemor service isspecified inprocurement documents orthe Activity Plan.
TheQAPP doesnot establish specific inspection orsurveillance requirements or frequencies foritems orservices; butall equipment items andactivities attheCimarron Site are subject toinspection orsurveillance bytheTrustee PMorQAC(or their designees).
Contractors providing
- services, either onoroff site, arerequiredtoallow EPMaccess tosupplier facilities toperform assessments andinspections.
Theacceptance requirements forinspection, orfor test records that verify theitemorservice is acceptable, mustbeclearly stated inprocurement documents.
Thesupplier mayprovide the required documentation, orCimarron Site personnel mayperform independent inspection activities toverify conformance withtheprocurement requirements.
WhenCimarron Site personnel inspection isappropriate toverify conformance ofanitem oractivity tospecified requirements, theinspection mustbedocumented.
Inspection records contain ataminimum, theiteminspected, dateofinspection, inspector, typeofobservation,results, andacceptability orreference tononconformance ifnotacceptable.
Laboratory services arerecognized ascritical toquality andhaving adirect effect on decision making related tolicense termination andsite closure.
Therequirements expressed ineach procurement establish thelaboratory's contractual obligations totheCimarron Site,including dataquality requirements andreferenced analytical procedure standards.
Theprocurement documents provide theauditable standard ofperformance forthecontract laboratory.
Thisdocument mustbeverified withaControlled Copyprior touse.
Cimarron Environmental
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Trust Vif0 Cimarron Site Quality Assurance Program Plan propernesmanagemenne Document No.QAPP-001 Rev.2 Effective date:
9/30/2013 Section 11.0 TESTCONTROL Page11
- 1 11.0TESTCONTROL TheTrustee fortheCimarron Sitedoes notroutinely perform independent testing.
Inthecase ofprocured items orservices, the Cimarron Site delegatestheresponsibility forcompliance with applicable regulations andindustry standards for testingtoapproved suppliers.
TheCimarron Site wili designate themethod ofverifyingcompliance intheprocurement documents orActivity Plan asappropriate.
Verification mayconsistof obtaining test certification fromthesupplier, reviewing thesupplier's quality
- program, orwitnessing supplier testing.
Performance requirements forlaboratory testing arespecificallyestablished ineachprocurement for laboratory analytical services.
IntheeventtheCimarron Site undertakes anindependent testing
- task, thetask will be controlled using anActivity Planestablishing thequalifications of thetestingpersonnel, detailed testing procedures, equipment andcalibration requirements, data quality objectives, andother information asneeded toassure theconsistency andquality ofresults.
Thisdocument mustbeverified withaControlled Copyprior touse.
Cimarron Environmental
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Trust Vif0 Cimarron Site Quality Assurance Program Plan propernesmanagemenz Document No.QAPP-001 Rev.2 Effective date:
9/30/2013 CONTROL OFMEASURING Section 12.0 ANDTESTEQUIPMENT Page12
- 1 12.0CONTROLOFMEASURING ANDTESTEQUIPMENT (M&TE)
Equipment requiring calibration mustnot be used unless thecalibration iscurrent.
When contractor-supplied M&TEequipment
- isused, Activity plans should require verification and documentation ofevidence ofcalibration (current dated calibrationstickers, orcalibration reports asappropriate).
Theadequacy ofsupplier controls onmeasuring andtest equipment is subject toaudit bytheTrustee PM,QAC,ordesignee.
TheTrustee normally delegates theresponsibility for implementing calibrationcontrol of Trustee ownedorcontrolled M&TEtotheapproved equipment orcalibration supplier.
Any equipment which could affect activities ordataimportant toquality (e.g.calibratedinstruments) will bemarked with aunique identifier.
Aninventory ofequipment owned orcontrolledbythe Trustee mustbemaintained
- onsite, along withrecords ofcalibration.
Whenequipment isfound tobeinneedofcalibration
- orrepair, itmustbe taken outofservice.
Outofservice equipment mustbevisibly marked andphysically separatedfrom inservice equipment.
Iftheequipment isownedorcontrolled bytheTrustee, theequipment inventory mustbeupdated toreflect thecurrent status oftheequipment andtomaintaincontrol ofits use.
Thisdocument mustbeverified withaControlled Copyprior touse.
Cimarron Environmental
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Trust O
cimarron Site Quality Assurance Program Plan propernesmanagemenne Document No.QAPP-001 Rev.2 Effective date:
9/30/2013 HANDLING, STORAGE, AND Section 13.0 SHIPPING Page13
- 1 13.0HANDLING,STORAGE, AND SHIPPING Theprinciple
- handling, storage, andshipping activity critical toquality incurrent Cimarron Site operations relates totheproper containerization, preservation, andshipping ofenvironmental samples foranalysis.
Thequality ofthese efforts are controlled through thedetailed work instructions insampling Activity
- Plans, andinthe Sampling andAnalysis Planprocedures specific toeachtypeofanalysis.
Intheeventtheshipment ofother materials (e.g.
legacy wastes, remediated soils) is necessary, theCimarron Site will contract with suppliers toprovide handling, storage and shipping services.
Thesuppliers will either bequalified bythe Cimarron Site inaccordance with Activity Plan requirements (appropriate toaone-time shipping event), orarequalified asa general resource andincluded ontheapproved supplier list (appropriate for multipleshipments orextended shipping campaigns).
Suppliers areperiodically assessedto assure these services meetapplicable requirements andstandards.
Thisdocument mustbeverified withaControlled Copyprior touse.
Cimarron Environmental
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Trust Vif0 Cimarron Site Quality Assurance Program Plan proper:Iesmanagemenz Document No.QAPP-001 Rev.2 Effective date:
9/30/2013 Section 14.0 INSPECTION,
- TEST, AND Page14-1 OPERATING STATUS 14.0INSPECTION,
- TEST, AND OPERATING STATUS Thecontrol oftesting andmonitoring equipment relevant tothis requirement isdescribed in Sections 8.0and12.0ofthis QAPP.
Thisdocument mustbeverified withaControlled Copyprior touse.
Cimarron Environmental
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Trust Vif0 Cimarron Site Quality Assurance Program Plan propernesmanagemenne Document No.QAPP-001 Rev.2 Effective date:
9/30/2013 CONTROL OF Section 15.0 NONCONFORMING ITEMS PageM
- 1 15.0CONTROLOFNONCONFORMING ITEMS AttheCimarron
- Site, nonconforming items arecontrolled toprevent inadvertent installation or use.Anonconformance isdefined asadeficiency incharacteristic, documentation, or procedure that renders thequality ofanitem or activity unacceptable orindeterminate.
This includes anydatamadedeficient orsuspect through failure ofsampling,
- analysis, ordata processing procedures.
Aprocedure hasbeenestablished forreporting, identifying, documenting, evaluating, and disposition ofnonconforming items fortheCimarron Site (reference QAIP 15.1, Deficiency Reporting andCorrective Action).
Thedeficiency report isusedtoreport conditions adverse
- tosafety, and toreport accidents that occur.
Thedeficiency report isalso usedtodocument stopwork actions initiated bysite staff or management, aswell asanydeficiency inprocured
- items, services, documents, procedure
- content, orprocedure adherence.
Theadoption ofthis single reportingmechanism isdesigned tosimplify deficiency reporting, andintegrates thedocumentation ofresolution ofthemyriad of factors thatcanaffect quality atthesite.
Thisdocument mustbeverified withaControlled Copyprior touse.
Cimarron Environmental
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Trust Vif0 Cimarron Site Quality Assurance Program Plan proper:Iesmanagemen:A Document No.QAPP-001 Rev.2 Effective date:
9/30/2013 Section 16.0 CORRECTIVE ACTION Page16
- 1 16.0CORRECTIVE ACTION TheCimarron Site implements corrective action for non-conformances andincidents through theuseofadeficiency reporting process.This process provides forthepromptidentification of conditions adverse toquality, determinationof their cause,andresolution ofthespecific conditions adverse toquality.
Alogofdeficiencies and corrective actions ismaintained to permit trending analysis ifappropriate.
Thetrendanalysis canbeusedtoidentify timely corrective actions toprevent recurring problems andimprove performance.
Deficiency reporting andthecorrective action process arecontrolled by asingleprocedure(reference QAIP 15.1, Deficiency Reporting andCorrective Action).
Thisdocument mustbeverified withaControlled Copyprior touse.
Cimarron Environmental
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cimarronSite Quality Assurance Program Plan propernesmanagemenne Document No.QAPP-001 Rev.2 Effective date:
9/30/2013 QULAITYASSURANCE Section 17.0 RECORDS Page17
- 1 17.0QUALITY ASSURANCE RECORDS TheTrustee PMisresponsible toassure thatquality records relevant tolicense termination and site closure aremaintained.
Ingeneral, quality recordsinclude anydocumentation ofactivity that produce dataorotherwise supportdecisions relatedtolicense termination andsite closure.
Quality records also include personnel records ofqualification,
- training, andexposure.
Records fitting this description areclassed asLifetimeRecords, andmustbemaintained foruntil license termination, except that theretention for exposure records isindefinite.
Quality records specifically required bythis QAPP include:
=
Deficiency Reports andCorrective Actions a QAInspections, Surveillances, andAudits
=
Activity Plans
=
Procurement documents containing quality requirements and specifications, including laboratory analytical services
=
Dataresulting fromlaboratory analytical services a
Regulatory Communications, Submittals,
- Permits, License documents Equipment Inventory andCalibration Records (3yearretention)
=
Previous revisions ofcontrolled documents Other documents asdetermined bytheTrustee PMorQAC Redundant storage ofrecords isrequired.
Thiscantaketheformofremote electronic storage combined withonsite hardcopy storage.
Records thatdonotneedtobeimmediately accessible maybearchived forstorage ataremote location asdetermined bytheTrustee PMorQAC.
Theadequacy ofCimarron Site records issubject tointernal audit bytheQAC.
17.1 DataRecords Thedataobtained fromsampling campaigns andlaboratory analysis ofcollected samples affects decisions related tolicense termination andsite closure.
Thecontrol andarchiving of this dataisimplemented through theCimarron Site DataManagement Procedure.
The procedure establishes standards forelectronic datadeliverable (EDD) formats fromthe laboratory, andfordataarchiving.
Reference theCimarron Site DataManagement Procedure, QAIP 17.1 Thisdocument mustbeverified withaControlled Copyprior touse.
Cimarron Environmental
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Trust 0E 8 l cimarron site Quality Assurance Program Plan proper:Iesmanagemen:A Document No.QAPP-001 Rev.2 Effective date:
9/30/2013 Section 18.0 AUDITS Page18
- 1 18.0AUDITS TheQuality Assurance Coordinator (QAC) isresponsible fortheplanning andexecution of internal andexternal audits andsurveillances fortheCERTTrustee.
TheQAC will identify internal andexternal candidates for
- audits, andwill planandschedule audits andsurveillances onanannual basis.
Audits areperformed in accordance withNQA-1, andanaudit report is issued totheTrustee PM(for internal audits) or tothesupplierquality representative.
The report will betransmitted witharequest toidentify corrective actions forreported findings.
TheQAC will schedule areturn visit orreview documentation toverify corrective actions are
- complete, after which theaudit isclosed out.Desktop audits maybesubstituted foron-site audits depending onthecomplexity oftheproducts and services being supplied.
Third party audits orindependent certifications mayalso bereviewed in lieu ofdirect auditing.
Thisdocument mustbeverified withaControlled Copyprior touse.