The US Department of Energy`s Yucca Mountain Project is implementing a quality assurance program that fulfills the requirements of the US Nuclear Regulatory Commission (NRC). Additional guidance for this program was provided in NUREG 1318, ``Technical Position on Items and Activities in the High-Level Waste Geologic Repository Program Subject to Quality Assurance Requirements`` for identification of items and activities important to public radiological safety and waste isolation. The process and organization for implementing this guidance is discussed. 3 refs., 2 figs

Hardin, E.L.

La Monica, L.B.

Waddell, J.D.

La Monica, L. B.

Waddell, J. D.

Hardin, E. L.

UNT Digital Library

IMPLEMENTATION OF NUREG 1318 GUIDANCEWITHIN THE YUCCA MOUNTAIN PROJECTCONF-900406—50DE90 008877L. B. la Monica, j. D. Waddell, E. L. HardinScience Applications International Corp.101 Convention Center Dr.las Vegas, NV 89109(702)794-7000ABSTRACTThe U. S. Department of Energy's Yucca MountainProject is implementing a quality assuranceprogram that fulfills the requirements of the U.S. Nuclear Regulatory Commission (NKC) as setforth in 10 CFR Part 60, Subpart G-QualityAssurance. Additional guidance for this programwas provided in NUREG 1318, "Technical Positionon items and Activities in the High-Level WasteGeologic Repository Program Subject to QualityAssurance Requirements" for identification ofitciss and activities important to public radio-logical safety and waste isolation for placementon a "Q-List" and "Quality Activities List" andalso for graded application of QA measures. Theprocess and organization for implementing thisguidance is discussed.INTRODUCTIONThe aims of the U. S. Department of Energy(DOE) and the Yucca Mountain Project are to (1)characterize the Yucca Mountain site in order todetermine its suitability for development of thenation's first high-level waste repository and(2) if the site is acceptable, obtain a licensefrom the U. S. Nuclear Regulatory Commission toconstruct and operate a repository at the site.The site characterization activities and relatedwaste package and repository design efforts en-cerpass a broad range of disciplines and workactivities, all of which must be controlled in aconsistent manner to achieve these aims.The principal regulation governing thelicensing of a repository is contained in 10 CFRPart 601. Subpart G specifies that the DOEshall implement a quality assurance (QA) programbased on the criteria of Appendix B of 10 CFRPart 50, as applicable, and supplemented byadditional criteria as necessary. The Subpart Grequirement applies to items on the "Q-List,"namely all systems, structures, and componentsimportant to public radiological safety("important to safety") and engineered barriers"important to waste isolation." The requirementapplies also to the "Quality Activities List,"which includes those activities that influencethe characterization of the site, may have anadverse impact on the site, or may impact itemson the Q-List. NUREG-1318, "Technical Positionon Items and Activities in the High-Level WasteGeologic Repository Program Subject to QualityAssurance Requirements2," provides guidance forthe identification of items and activitiessubject to QA and for the graded application ofQA measures.The Yucca Mountain Project has developedprocedures for a two step process (Figure 1) toimplement the guidance in NUREG 1318. The firststep involves the determination of importance ofitems and activities. The second step involvesthe application of graded QA. This grading stepnot only identifies controls for the "Q-List"and "Quality Activities List," but also allowsthe project to identify any necessary controlsrequired by DOE Order 5700.6B3 for those itemsand activities not appearing on these lists.Through this process important items andactivities and applicable QA controls are iden-tified early in the work planning and authori-zation process. In this way,appropriate re-sources and schedules may be developed to inte-grate applicable QA controls into the perfor-mance of work and ensure the quality of the workproduct. The procedures are general in scope toaccommodate the broad range of disciplines andwork activities in the project and yet allow de-tailed specification of controls.DETERMINATION OP IMPORTANCEA combination of methods have been employedby the Yucca Mountain Project Office (ProjectOffice) to determine the importance of items andactivities in a geologic repository. Thesemethods involve the conduct of probabilistic anddeterministic safety analyses, performance allo-cation, performance assessment, and comprehen-sive evaluations of site characterization, con-struction, performance confirmation, operation^*and decommissioning activities. *-*«*>UTiON OF THIS DOCUMENT IS UNLIMITEDDISCLAIMERThis report was prepared as an account of work sponsored by an agency of theUnited States Government Neither the United States Government nor any agencythereof, nor any of their employees, makes any warranty, express or implied, orassumes any leg&i liability or responsibility for the accuracy, completeness, or use-fulness of any information, apparatus, product, or process disclosed, or representsthat its use wouli not infringe privately owned rights. Reference herein to any spe-cific commercial product, process, or service by trade name, trademark, manufac-turer, or otherwise does not necessarily constitute or imply its endorsement, recom-mendation, or favoring by the United States Government or any agency thereof.The views and opinions of authors expressed herein do not necessarily state orreflect those of the United States Government or any agency thereof.Ihe overall process of determining impor-tance begins with the preparation and mainten-ance of a set of documents that form the basisfor the determination. This set of documents isknown as the "basis" (Figure 1). The "basis"includes those documents that describe Projectitems, the full scope of Project activities, andinformation or data that is useful for theiranalysis (meteorological, hydrological, etc.).Changes to the documents that form the basis areevaluated and their effects are factored intothe determination of the importance of items andactivities. This ensures that the results ofthe process of determining importance (Q-List,Quality Activities List) are a reflection of thecurrent version of the basis.The documents that form the basis are pro-vided to Assessment Teams (Figure 2) whoseresponsibility is to perform the technicalanalyses and evaluation required to determineimportance. Since there is a natural divisionof efforts involved in determining importance tosafety, a preclosure concern, and in determiningimportance to waste isolation, a postclosureconcern, there is a separate Assessment Team foreach effort. Following the guidance given inNUREG 1318, the Assessment Team responsible fordetermining the items important to safetyanalyzes the basis utilizing a combination ofdeterministic and probabilistic techniques todetermine those " engineered structures, sys-tems, and components essential to the preventionSTEP 1DETERMINATIONOF IMPORTANCEBASISDETERMINATiaN BYO ANALYSISO DIRECT INCLUSIONO EXEMPTIONITEHSIXPC5SANTTO SAFETYITEHSIMPORTANTTO WASTEISOLATIONQUALITYACTIVITIESLISTQ-LISTSTEP 2APPLICATIONOF GRADED QAGRADINGGRADING STATEMENTrTO WORK AUTHORIZATION PROCESSFIGURE 1. SIMPLIFIED LOGIC OF THE YUCCA MOUNTAIN PROJECT PROCESS FORIMPLEMENTATION OF NUREG 1318 GUIDANCE.YUCCA MOUNTAINPROJECT MANAGERI 51BP 1DtSUOMINft-| TION OFIMPORTANCEI STEP 2 - APPLICATION OFGRADED QAI__ — — 1 |PARTXCZPANT PARTICIPANTBASSESSMENTTERMMANAGERIASSESSMENTTEAMIMPORTANT TOSAFETYASSESSMENTTERMIMPORTANT TO WASTEISOLATION & QUALITYACTIVITIES LIST' - - IQUALITY REVIEWBOARDi rApproved Q-List,Quality ActivitiesList (to Step 2)ApprovedGradingStatementsFIGURE 2. YUCCA MOUNTAIN PROJECT ORGANIZATIONAL STRUCTURE FOR IMPLEMENTATIONOF NUREG 1318 GUIDANCE.or mitigation of an accident that could resultin a radiation dose...of 0.5 rem or greater ator beyond the nearest boundary of the unrestric-ted area..." (10 CFR 60.2). Other aspects ofsafety, such as worker radiological safety, arenot addressed in the analysis, but are addressedby the responsible Project participants duringthe grading step. The Assessment Team respon-sible for determining the items important towaste isolation utilize performance allocationand performance assessment techniques. ThisTeam also performs evaluations of activities toidentify those activities that are important tosite characterization or performance assessmentor that may adversely impact a natural barrierimportant to waste isolation.The Assessment Teams may also assign impor-tance through processes known as Direct Inclu-sion and Exemption. The Direct inclusion routinemay be used in those instances where either thebasis is not sufficiently mature to support ananalysis or where it is imperative that workproceed and the time involved in conducting ain-depth analysis would be counterproductive.In these instances, it is permissible by DirectInclusion to place an item on the Q-List or anactivity on the Quality Activities List and thenmove on to the assignment of controls in accor-dance with the procedure for the grading step.The use of Direct Inclusion will in some caseslead to the conservative assignment of QArequirements. Once an item or activity isplaced on either list by Direct Inclusion, itmay be removed only by completing the requiredanalysis and proving that the item or activitydoes not have a relationship with safety orwaste isolation.The Exemption routine is provided for usein those instances where the basis indicates aitem or activity whose function and purpose areobviously unrelated to safety or waste isola-tion. Items and activities receiving exemptionwill be placed in the Non-Selection Record alongwith those items and activities found notimportant through analysis. Although an item oractivity may be exempt from in-depth analysis,it is not exempt from the secondary screeningfor importance described by the procedure forthe grading step.After completion of their analyses andprocessing of requests for Direct Inclusionsand/or Exemptions, the Assessment Teams compilethe "Items Important To Safety" and "ItemsImportant To Waste Isolation" portions of theQ-List, the Quality Activities List and theNon-Selection Record, These three documentsidentify all items and activities described bythe basis and indicate their importance. TheQ-List contains all items that are important topublic radiological safety and all engineeredbarriers important to waste isolation. TheQ-List also includes an appendix that identifiesall natural barriers important to waste isola-tion. The Quality Activities List contains allsite characterization activities, performanceassessment activities, and activities that mayhave an adverse impact on a natural barrierfound to be important to waste isolation. TheNon-Selection Record contains all items andactivities that have been evaluated and do notqualify for entry on the Q-List or QualityActivities List.The Q-List, Quality Activities List,Non-Selection Record and their supporting docu-mentation are submitted to the Project OfficeQuality Review Board (QRB) (Figure 2) for tech-nical and policy reviews. The function of theQRB is three fold: (1) to perform or direct atechnical review of the lists and supportingdocuments, (2) to identify those areas where theQ-List, Quality Activities List, orNon-Selection Record differ from existing DOEpositions, such that adjustments in other areascan be initiated, and (3) to assure that thedocumentation meets the standards for complete-ness specified by procedure. The approvedQ-List, Quality Activities List, andNon-Selection Record are maintained and distri-buted as controlled documents in accordance withproject records management procedures.APPLICATION OF GRADED QAThe second step in the implementation ofthe guidance in NUREG 1318 is the determinationand assignment of appropriate QA controls, aprocess called "grading." This step is carriedout by the Project participants as part of thework planning exercise. The procedure definingthis grading step not only idsntifies the con-trols required by 10 CFR Part 60 Subpart G forthe "Q-List" and "Quality Activities List," butalso allows the Project Participants to identifyany necessary controls required by DOE Order5700.6B for those items and activities appearingon the Non-Selection Record. The procedureinvolves the following sequence of actions:identify item or activity, determine importance,rate characteristics, identify applicable QAcriteria, approve grading statement, anddistribute statement.initially, the participant identifies anddescribes the item or activity to be graded.The Participant next reviews the current versionof the Q-List or Quality Activities List andNon-Selection Record to determine its impor-tance. If the participant's item is an item orcomponent of an item on the Q-List (important tosafety), the Participant's item is thereforeimportant to safety. Likewise, an activity isimportant if it is part or all of an activity onthe Quality Activities List. By this means theparticipant may label the item or activity asimportant to safety, important to waste isola-tion, quality activity, or as non-selected.This tag is used later in the grading process.The lumping of lower level items or activi-ties under a higher level Q-List item or qualityactivity will sometimes result in conservativeassignment of QA controls. The procedure foridentification of importance (Step 1 in Figure1) provides for participant requests to re-evaluate and revise the Q-List and Quality Acti-vities List to properly allocate importance insuch cases.Each item or activity not selected asimportant under the NUREG 1318 guidance is sub-jected to a secondary screening for its impor-tance relative to factors such as worker radio-logical safety, operational reliability, andother categories of importance to be determinedby the Project Office. This evaluation isnecessary to ensure that QA controls are appliedas required by DOE Order 5700.6B.After determining the importance of theitem or activity being graded, the participantnext evaluates the characteristics of the item,or activity to identify where and to what extentQA controls are necessary. The specific cri-teria for this evaluation are derived from theguidance in NUREG 1318 Section 5.5:UniquenessReproducibility or ReplacementComplexityQuality HistoryDegree of StandardizationAvailable Codes or StandardsNeed for Process ControlSpecial Shipping, Handling, and StorageThe participant rates the characteristics of theitem or activity against these criteria to iden-tify areas where control is critical. Alterna-tive methods of control such as codes and stan-dards may also be identified. The results ofthe characteristics rating process are enteredon the grading statement.The identification of applicable QArequirements is the final action in the prepar-ation of the grading statement. The processinitially assumes that all the requirements ofthe Yucca Mountain Project Quality AssurancePlan apply to the subject item or activity. Theparticipant then reviews each of the 18 QAcriteria versus the work scope for the item oractivity in order to identify those requirementsthat are not pertinent. For example, require-ments governing procurement are irrelevant foractivities where no procurement is made.Next, the participant considers the impor-tance of the item or activity and the character-istics ratings to determine the applicabilityand extent of applicability of the remaining QAcriteria. For Q-List items and quality activi-ties and non-selected items and activitiesdeemed important through the secondary screeningprocess, the QA criteria shall apply, but theextent of applicability may be modified inresponse to the characteristics ratings toallow, for example, the use of final inspectionand testing in place of in process controls toensure quality. For non-selected items andactivities not deemed important the QA criteriamay not apply; however, applicable codes andstandards may still be identified.Once the participant completes a gradingstatement, the statement is submitted to theQuality Review Board, lite review board's re-sponsibility in this area is three fold: (1) toensure the grading statement accounts for allaspects of an item or activity; (2) to ensurethat the logic given for not selecting certainQA requirements is sound and consistent withthat specified for other items or activities ofa similar nature; and (3) to assure that thegrading statement meets the standards set by theprocedure. The grading statement is thenreleased through the participant responsible forthe item or activity and is the basis for imple-mentation of QA controls during the course ofthe work.CONCLUSIONThe preparation and maintenance of theQ-List, Quality Activities List, theNon-Selection Record and the associated gradingstatements is a necessary part of the planningand implementation of technical activities onthe Yucca Mountain Project. The process de-veloped by the Yucca Mountain Project for thedetermination of importance and application ofgraded QA implements the guidance in NUREG 1318and will result in the application of QA controlwhich reflects the importance of the item oractivity. The process determines importance ina manner that allows conservative assessment ofQA requirements early on but provides for order-ly and consistent re-evaluations as sitecharacterization proceeds and designs mature.The grading statements establish criteria fromwhich implementation of the QA program can bemeasured.ACKNOWLEDGEMENTThis paper is sponsored by and describes workperformed for the U. S. Department of EnergyYucsa Mountain Project.REFERENCES1. U. S. Nuclear Regulatory Commission,"Disposal of High-Level Wastes in GeologicRepositories," 10 CFR Part 60, February 29,1988.2. A. B. Duncan, S. G. Bilhorn, and J. E.Kennedy, "Technical Position on items andActivities in the High-Level Waste GeologicRepository Program Subject to QualityAssurance Requirements," NUREG-1318, U. S.Nuclear Regulatory Commission, Washington,D. C , April, 1988.3. U. S. Department of Energy, DOE Order5700.6B, "Quality Assurance," Washington,DC, September 23, 1986.

Implementation of NUREG-1318 guidance within the Yucca Mountain Project

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