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OCT 2 7 199Z :. 890017 1

MEMORANDUM FOR: Division of High-Level Waste -!anagement Staff.. 1 . .

FROM: B. J. Youngblood, Director",Division of High-Level Waste ManagementOffice of Nuclear Material Safety:.

and Safeguards -

SUBJECT: IMPLEMENTATION OF DOCUMENT REVIEW AND APPROVAL PROCEDURE

This Policy Memorandum provides specific guidance to the Division of High-LevelWaste Management (HLWM) staff on the document review and approval process to beused within the Division.

The procedure is generic, and covers letters generatedCorrespondence Documents), reports and other documentsHLWM, and DOE/participant documents. The procedure isdocument reviews which do not warrant development of aprocedure.

by HLWM (HLWMgenerated by CNWRA andintended to be used forseparate, specific

Every staff member is responsible for the effective implementation of thisdocument review and approval procedure. Staff members should read theprocedure carefully'and follow the guidance contained within. Questionsregarding the implementation of this procedure should be raised with Ken Hooksor your Branch Chief.

l lB. J. Youngblood, DirectorDivision of High-Level Waste ManagementOffice of Nuclear Material Safetyand Safeguards

Enclosure: Document Review and Approval Procedure

cc: J. LinehanJ. ilulonichR. BallardM. Federline

DISTRIBUTIO1NMSS R/F LPDR ACNWHLPD R/F CNWRA BJYouRBallard, HILGE MFederline,HLHP JHoloKHooks, HLPD HLWM Staff PDR

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NAME:JBuc ley :KHooks :JHolonich :JL_--J 4-- OFFICIA ------- R -C-O------Y- ----

Date: 10/A /92 : lO/p|v02 : 1 0;gA/92 :10~

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ngblood, PLWMnich, HLPD

LSSJLinehan, HLWMOn-Site RepsCentral File

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MEMORANDUM FOR: Division of High-Level Waste Management Staff

FROM: B. J. Youngblood, DirectorDivision of High-Level Waste ManagementOffice of Nuclear Material Safety

and Safeguards

SUBJECT: IMPLEMENTATION OF DOCUMENT REVIEW AND APPROVAL PROCEDURE

Ihi% Policy Memorandum provides specific guidance to the Division of High-LevelWaste Management (HLWM) staff on the document review and approval process to beused within the Division.

the procedure is generic, and covers letters generated by HLWM (HLWMForresponidence Documents). reports and other documents generated by CNWRA andHLWM. and DOE/participant documents. The procedure is intended to be used foreoiument reviews which do not warrant development of a separate, specificprocedure.

Every staff member is responsible for the effective implementation of thisdocurment review and approval procedure. Staff members should read theprocedure carefully and follow the guidance contained within. Questionsr-ejardiriq the implementation of this procedure should be raised with Ken Hooksor Your Branch Chief

B. J. Y ngblood,/ i rectorDivisio of High-Level Waste ManagementOffice 'of Nuclear Material Safety

and Safeguards

Fnc:Ioture: Document Review and Approval Procedure

cc: J. LinehanJ. HolonichR. BallardM. Federline

Chapter 0430DOCUMENT REVIEW & APPROVAL

0430-01 PURPOSE

To provide Division of High-Level Waste Management (HLWM) staffguidance regarding the review and approval of correspondencegenerated within the Division, NRC/CNWRA technical documents, andDOE-generated High-Level Waste (HLW) documents. This procedureconforms to NUREG-1297, "Generic Technical Position On Peer ReviewFor High-Level Nuclear Waste Repositories".

0430-02 PROCEDURE

021 HLWM Correspondence Doctiments

Document review and approval is evidenced by the concurrenceinformation on the official record copy of a completed document.The concurrence procedure used within HLWM shall be consistent withthe procedure presented in Section S of NRC Appendix 0240. Theconcurrence process shall be as follows:

1. Coordinate correspondence with involved individuals.

2. The originating individual shall record the concurrence dataon the official record copy, and on other copies, ifdesirable.

3. Type the abbreviation of the originating office in the firstblock on the line titled "Office."

4. Complete the succeeding blocks by inserting the abbreviationsof the office through which the memorandum must be cleared;end with the office in which the memo will be signed. Whenused. place the "THRU" addressee's concurrence blockimmediately before the signer's block, except when the "THRU"office is the EDO. When the EDO is the "THRU" office, placethe addressee's concurrence block after the signer's block.When additional spaces are needed, the concurrence blocks maybe divided into halves by drawing a vertical line through themiddle of each block. Concurrence information may also beplaced immediately above the concurrence blocks whennecessary. If this is done, the originator's and signer'sblocks shall be the first and last on the printed grid.

5. Type the writer's name and typist's Initials in the firstblock on the line titled "name." The writer's telephonenumber may be added in this block when it would be useful.such as on a communication requiring coordination ofsignature(s) outside the organizational unit.

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6. Include the date of preparation on the line titled "Date" inthe originator's block.

Concurrence on a document indicates approval with the document in theperson's area of expertise and responsibility. Concurrence does notnecessarily indicate agreement or approval with the contents of theentire document. However, the last individual on the concurrencechain is responsible for the contents of the entire document.

022 [IJRLCCNWRA Documents. ReDorts. Papers and Presentation Materials

I. Responsibilities

1.1 Program Element Managers are responsible forimplementation of this procedure.

1.2 Reviewers are responsible for performing theirassigned reviews in accordance with this procedure.

1.3 Document authors are responsible for preparingdocument packages for review and for resolvingreviewers' comments.

2. Definitions

2.1 Concurrence Reviews - Reviews which provide forgeneral concurrence with the author for the overallapproach and presentation of the work being reviewed,and provide a basis for consistency among likeproducts of the Center/NRC. Concurrence reviews areperformed by individuals cognizant of the applicabletechnical and procedural requirements, and of theobjectives of the warK being described or beingprescribed.

2.2 Peer - A peer is a person having technical expertisein the subject matter to be reviewed (or a criticalsubset of the subject matter to be reviewed) to adegree at least equivalent to that needed for theoriginal work.

2.3 Peer Review Group - A Peer Review Group is an assemblyof peers representing an appropriate spectrum ofknowledge and experience in the subject matter to bereviewed, and should vary in size based on the subjectmatter and the importance of the subject matter tolicensing.

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2.4 Peer Review - A Peer Review is a documented, criticalreview performed by peers who are independent of thework being reviewed.

The peer's independence from the work being reviewedmeans that the peer (a) was not involved as aparticipant, supervisor, technical reviewer or advisorfor the work being reviewed, and (b) to the extentpractical, has sufficient freedom from fundingconsiderations to assure the work is impartiallyreviewed.

A Peer Review is an in-depth critique of matters suchas assumptions, calculations, extrapolations,alternate interpretations, methodology, and acceptancecriteria employed, and of conclusions drawn in theoriginal work. Peer Reviews confirm the adequacy ofwork. In contrast to Peer Review, the term "TechnicalReview" refers to verification of compliance topredetermined requirements, industry standards, orcommon scientific, engineering, and industry practice.

2.5 Technical Review - A documented, traceable reviewperformed by qualified personnel who are independentof those who performed the work, but who havetechnical expertise at least equivalent to thatrequired to perform the original work. TechnicalReviews are in-depth, critical reviews, analyses andevaluations of documents, material or data thatrequire technical verification and/or validation forapplicability, correctness, adequacy and completeness.

3. Procedure

Center/NRC Technical Documents, Papers and PresentationMaterials, Guidance Documents, QA Program Documents, andAdministrative/Fiscal Documents shall receive, as applicable,Format, Technical/Peer, Concurrence, Programmatic, and QAReviews in accordance with this procedure. Draft documentsto be submitted, as well as revisions and changes topreviously submitted documents, shall likewise be reviewed inaccordance with this procedure.

3.1 Initiation of Reviews

(a) Authors/Analysts shall submit completed itemsrequiring review to the cognizant ProgramElement Manager, along with any supportingdocumentation needed to perform the review(scientific notebooks, calculationverifications, etc.)

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(b) The author shall also provide information forinitiating the Document Review to the ProgramElement Manager.

(c) Program Element Managers shall check the requiredreview types on the Document Review Request (DRR)form (see Attachment 1). For revisions andchanges to previously submitted documents, theDRR form shall specify reviews commensurate withthe extent of the revision/change, along with abrief justification for any reviews.

(d) A Peer Review shall be used when the adequacy ofinformation (e.g., data, interpretations, testresults, design assumptions, etc.) or thesuitability of procedures and methods importantto licensing cannot otherwise be establishedthrough testing, alternate calculations,or reference to previously established standardsand practices. In general, the followingconditions are indicative of situations in whicha Peer Review is required:

* Critical interpretations or decisionswill be made in the face of significantuncertainty or subjective judgement,including the planning for datacollection, research, or testing;

* Interpretations having significantimpact on licensing decisions will bemade;

* tNovel or beyond state-of-the-arttesting, plans, and procedures oranalyses are or will be utilized;

* Detailed technical criteria orstandard industry procedures do notexist or are being developed;

* Results of tests are not reproducibleor repeatable;

* Data or interpretations are ambiguous;

* Data adequacy is questionable--such as,data may not have been collected inconformance with an established QAprogram.

S

(e) A Peer Review shall also be used when theadequacy of a critical body of information canbe established by alternate means, but there isdisagreement within the cognizant technicalcommunity regarding the applicability orappropriateness of the alternate means.

(f) If Technical, Peer, or Concurrence reviews arerequired, the Program Element Manager shallselect reviewers based on the criteria describedin paragraphs 3.3 and 3.4, and identify themon the DRR form.

(g) If Technical or Peer Reviews are required,instructions to reviewers shall be prepared asspecified in paragraphs 3.3(c) and 3.4(c).Separate review instructions shall be preparedfor different reviewers, as necessary, when thereview assignments are to different criteria.

(h) Review items, the DRR form, and supportingdocumentation shall be routed for reviews in theorder of listing on the DRR form, however,Technical, Concurrence, and Programmatic reviewsmay be conducted simultaneously. Instructions toreviewers shall also be provided to Technical andPeer Reviewers, as applicable. Any commentsshall be resolved as specified below, and theDRR form shall be initialled and dated by thereviewer before proceeding for the next specifiedreview.

3.2 Format Reviews

(a) Format Reviews shall be performed by personnelcognizant of correspondence, report and otherdocument requirements.

(b) Format Reviews shall verify the following:

* Spelling, grammar, and general clarity andreadability;

* Conformance to applicable document formatrequirements;

* Internal and Center document distributionrequirements, as applicable, are met.

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3.3 Technical Reviews

(a) Formally planned and fully documented TechnicalReviews shall be performed to verify thetechnical correctness of the work againstestablished practices.

(b) Individuals performing Technical Reviews shallhave technical qualifications at leastequivalent to those required to perform theoriginal work under review. Reviewers shall beindependent of the work being reviewed.

(c) The Program Element Manager shall identify thoseTechnical Review items applicable to the workbeing reviewed. Instructions to TechnicalReviewers shall be approved by the cognizantDirector. The basis for verification shall bepredetermined requirements, industry standards,or common scientific, engineering, and industrypractice.

(d) Technical Review comments requiring resolutionand the status of each of the review Itemsidentified in the Instructions to TechnicalReviewers shall be identified. Editorialcomments of a minor nature (not requiringresolution) may be made as marginalia on thereviewer's copy of the document.

(e) When checks of calculations are specified in theInstructions to Technical Reviewers, theverifications shall be performed and documented.

(f) The author shall respond to the reviewer'scomments, and the reviewer shall indicateconcurrence with the responses by signature inthe appropriate block in the lower left handportion of the form. If resolution between theauthor and reviewer cannot be reached, theDivision Director shall serve as final arbiter.

3.4 Peer Reviews

(a) Peer Reviews shall be conducted by individualstechnically capable of performing the originalwork. Peer Reviews shall be planned and fullydocumented, evaluating the technical adequacy ofwork based on expert Judgement when significantuncertainties in methods or data exist, or whenno accepted practices have been established.

(b) In addition to having qualifications equivalentto Technical Reviewers (paragraph 3.3.2), PeerReviewers cannot have been involved asparticipants, supervisors, technical reviewers,or advisors in the work being reviewed. PeerReviews shall be conducted by an individual or bya Peer Review Group of sufficient size andcomposition to span the technical issues andareas Involved in the work to be reviewed,including differing bodies of scientific thought,as appropriate. Technical areas more central tothe work to be reviewed should receiveproportionally more representation on the PeerReview group.

(c) The Program Element Manager shall identify thosePeer Review issues applicable to the work beingr-eviewed. Instructions to Peer Reviewers shallbe approved by the Division Director. The basisof the evaluation shall be the reviewer's expertjudgement.

(d) Individual reviewer's comments, minutes of PeerReview Group meetings and telephone conferencerecords, as applicable, shall be compiled into aPeer Review Report and presented to the author ofthe work being reviewed. The report shallinclude a clear description of the work or issuethat uniderwent the peer review process for eachof the issues identified in the Instructions toPeer Reviewers, and individual statements by PeerReview Group members reflecting dissenting viewsor additional comments, as appropriate.

(e) The author shall respond in writing to eachcomment requiring resolution. The Peer ReviewGroup shall document concurrence with theresolutions by written memoranda, letters, orteleconference records. If concurrence betweenthe Peer Review Group and author cannot bereached, the Division Director shall serve asfinal arbiter.

(f) The Peer Review Group Chairman shall verify thatresolved comments have been incorporated into thefinalized document.

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3.5 Concurrence Reviews

(a) Concurrence reviews shall be performed byindividuals cognizant of the applicabletechnical and procedural requirements, and ofthe objectives of the work being described orbeing prescribed. These reviews provide generalconcurrence with the author for the overallapproach and presentation of the work beingreviewed, and provide a basis for consistencyamong like products of the NRC.

(b) Concurrence reviews shall verify the following,as appropriate for the type of document beingreviewed:

* The document satisfies the technicalrequirements of the work: methodsconform to established practices andthe application of the method isappropriate:

* The document reads clearly and thepresentation is appropriate for theintended audience;

* The overall objectives of the workbeing planned or described are met bythe document being reviewed.

(c) Concurrence Review comments requiring resolutionshall be identified. Editorial comments of aminor nature may be marginalia on the reviewer'scopy of the report.

(d) The author shall respond to the reviewer'scomments, and the reviewer shall indicateconcurrence with the responses by signature inthe appropriate block in the lower left handportion of the form. If resolution between theauthor and reviewer cannot be reached. theDirector, Division of High-Level Waste Management(HLWM) shall serve as final arbiter.

3.6 QA Programmatic Reviews

(a) Performed by the HLWM QA staff, QA reviews verifythat the requirements of this procedure, andother applicable procedures are met.

(b) QA reviews shall be conducted by HLWM QA staffcognizant of the applicable QA program andprocedural requirements.

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(c) QA reviews shall verify the following:

* Required reviews are conducted inaccordance with applicable QAPrequirements;

* The review item and supportingdocumentation provide objectiveevidence that the work was performed inaccordance with applicable OperationsPlan, Project Plan, and QAPrequirements;

* The review item satisfies applicablecontent and format requirements.

(d) QA review comments requiring resolution shall bedocumented and forwarded to the author. Theauthor shall provide responses to the comments,and the reviewer shall indicate concurrence withthe responses by signature. The reviewer shallverify revision of the review item based onresolution of his comments, if necessary. Incases when satisfactory resolution is notobtained, the Director, (HLWM) shall be finalarbiter.

023 DOE-Generated High Level Waste Documents

I. Definitions

1.1 Detailed Technical Review - An in-depth documentreview which focuses onidentifying technicalconcerns with thecontent of the report.

1.2 Scoping Review - Brief review to identifywhether the documentcontains data, ordiscussions of technicalissues affecting thedirection of the currentDOE program. Suchcontents signify that adetailed technicalreview is required.

2. General Approach to Reviews

Each document is to receive a very brief scoping review todetermine what level of review is needed. In many instances(e.g., compilations of three-year-old previously reviewed datapublished for the record; position papers out of date relativeto current DOE positions) this screening may be all that Isneeded; on the other hand, in cases where the documentcontains data and discussions of technical issues affecting

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the direction of the current DOE program, a detailed technicalreview (DTR) will be necessary. Such a review should focus ontechnical or programmatic concerns that the NRC staff has withthe content of, or activities proposed in, the report.Extensive uncritical summary of the text is not useful.

In those cases where it is concluded that a DTR of aparticular document is not needed, the reasons for thatconclusion should be documented on the Document Scoping Sheet(Attachment 2). Where a DTR is deemed necessary, the formatfor such a review should ordinarily follow that shown inAttachment 3 (WM Document Review Sheet). Key sections includeBrief Summary of Document; Significance to Waste ManagementProgram; Problems, Limitations, or Deficiencies of Report;Action Taken; Action Recommended. This format is adaptable toreviews of any length. The length and detail of discussionunder each heading may vary from a paragraph to several pages,depending on what the technical reviewer believes to beappropriate and warranted. Exceptions to the standard formatfor DTRs are justifiable in reviews of DOE documents where theNRC staff will clearly be expected to transmit comments to theVO[. In buch cases the format will be determined during theoverall planning for the review, but generally will be thesamne as that used for objections, comments and questions inthe NRC staff's Site Characterization Analysis.

3. Specific Approach

3.1 The PM will provide a copy of the document to theSection Leader (SL) in the appropriate discipline fora scoping review. In cases where more than onediscipline should review the document, the PM willprovide a copy of the document to all appropriateSL s. In all cases, the PM will provide the SL(s)with a TAC # assigned by PMDA. The PM also will placethe scoping request into the HLPD ProjectAdministrative Tracking System, which is to beroutinely distributed to the project team and to allHLGE. HLHP, and HLPD SL's and Branch Chiefs (BC's).

3.2 The SL will assign the review to an appropriate staffmember and that person will complete the scopingreview, routinely within two weeks. If it isconcluded that no DTR is needed at that time, theperson responsible for the review will transmit thatfinding and the reasons for it to the PM on theDocument Screening Sheet after it has been approved bythe St or SI designee. If a DTR is deemed necessary,the reviewer will transmit that conclusion to the PMverbally.

Materials received a month or more prior to atechnical exchange or meeting automatically requiredetailed review and hence the scoping steps I and 2

I1

will not be necessary. The DTR will be conductedaccording to steps 5 and 6. However, the reviewer isnot ordinarily expected to generate the final writtenreview prior to the meeting. Instead, the reviewerwill compile the input from all reviews into a set ofpreliminary comments for NRC use during the technicalexchange or meeting and for possible transmission tothe DOE prior to the technical exchange or meeting.After a meeting, the PM and reviewer may decideto transmit final written comments to the DOE. If so.the reviewer generates the final review as outlined insteps 5 and 6.

3.3 The PM and the SL decide, based on the documentscreening sheet, the review, recommendations and anyinput from other staff members, SLs, or BCs. whether aDTR of the document is warranted at that time.

3.4 If a DIR is deemed necessary, the PM and the SL planthe review. and the PM places a DIR agreement into theHLPD Administrative Tracking System. In the case ofmajor multidisciplinary DOE documents, it may benecessary to involve some or all disciplines in theplanning. Planning should incorporate: who is to beinvolved in the review, responsibilities of theindividual reviewers, time frame, scope, and level ofdetail of the review. In instances where there is noobvious lead reviewer due to the multidisciplinarynature of the document, the PM and the appropriate SLsdecide which discipline will be assignedresponsibility as lead reviewer. The PM will thenhave the responsibility for coordinating the reviewand ensuring that the lead reviewer gets all necessaryassistance and input from reviewers from otherdisciplines. The lead reviewer will have theresponsibility for writing the review.

3.5 The lead reviewer, in conjunction with other NRC staffand contractors as determined in the planning phase,critically examines the document at the level ofdetail agreed upon in planning the review. The leadreviewer prepares the review, incorporating staff andcontractor comments as appropriate, and keeps the PMapprised of progress and any problems encountered.The lead reviewer transmits the review to the ProjectDirector (IiLPD) from the appropriate BC.

3.6 Ihe PM sends copies of all DTRs to the project teammembers. If comments are to be sent to the DOE, theyare sent with a transmittal letter which, inconjunction with the staff's review, makes clear tothe DOE the NRC position concerning the contents ofthe document reviewed. Concurrence by the Deputy

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Director and Director will be required, asappropriate. Copies of the transmittal package arealso sent to the State of Nevada and affected units oflocal government and Indian tribes.

M

DOCUMENT REVIEW REQUEST FORMIS CURRENTLY BEING DEVELOPED

Attachment I

DOCUMENT SCOPING SHEET

ELQUUUMENR:

REVIEWER: DATE SCOPING COMPLETED:

LIArc APPROVLD:

F~ESOU(S)WHYA DAII. C.) ECH I ANOTIE NEEDIjIPALThUjLjIME:

Attachment 2

e

DOCUMENT REVIEW SHEEt*

FILE NUMBER:

DOCUMENI:

REV I EWER: DATE REVIEW COMPLETED:

DAlE APPROVED:

H._tUi4Lp iO lANAGEMLENT PROGRAM:

DIIE_ SUMMAtRYOF DO(MtN1:

Attachment 3

a

PROBLEMS. 2EFICIEIICIE5 OR LIMITATIONS OF REPORT:

ACII 10I TAKfIJ:

AC T LON REC4MiiPiV:

*If afi item is not applicable to a particular review, write N/A next to thei te"m.