CENTER FOR NUCLEAR WASTE REGULATORY ANALYSES CORRECTIVE ACTION REQUEST 'R No. 90-06 Associated AR,SR,NCR NO. N/A PART 1: DE TION OF CONDITION ADVERSE TO QUALITY lOCFR Part 50, Appendix B, Criterion 5, requires that activities affecting quality be accomplished as prescribed by documented instructions or procedures. TOP-001-02 was released as "Draft Rv. 1" ai9/13/89, however it has never been released as an effective document. In addition, significant changes to the methods of performing quality affecting SRA activities have been made without formal approval and controls that would assure proper communication of the changes to affected personnel. Initiated by: R. D. Brient 4 Date: 11/2/90 PART 2: PROPOSED ACTION Responsible Element Manager: A. Whiting/T. Romine a) Root Cause: c 'i/@ ,6 (See Attached Sheet) b) Corrective Action to Preclude Recurrence: In between procedure revisionstimely change notices will go forward to all users of the procedure;reflecting modifications and how they are to be implemented. Procedure will be re-issued as a Rev. 2 end of January 1991 incorporating all included changes. Target Date for Completion: 1/31/91 Response provided by: ok. Date: // PART 3: APPROVAL • Comments/lnstructions: g Director of k Date:z PART 4: VERIFICATION OF CORRECTIVE ACTION IMPLEMENTATION Verified by: Date: CNWRA FORM QAP 14-0
Transcript
CENTER FOR NUCLEAR WASTE REGULATORY ANALYSES
CORRECTIVE ACTION REQUEST
'R No. 90-06 Associated AR,SR,NCR NO. N/A
PART 1: DE TION OF CONDITION ADVERSE TO QUALITYlOCFR Part 50, Appendix B, Criterion 5, requires that activities affecting quality
be accomplished as prescribed by documented instructions or procedures. TOP-001-02
was released as "Draft Rv. 1" ai9/13/89, however it has never been released as an
effective document. In addition, significant changes to the methods of performing
quality affecting SRA activities have been made without formal approval and controls
that would assure proper communication of the changes to affected personnel.
Initiated by: R. D. Brient 4 Date: 11/2/90
PART 2: PROPOSED ACTION Responsible Element Manager: A. Whiting/T. Romine
a) Root Cause: c 'i/@ ,6(See Attached Sheet)
b) Corrective Action to Preclude Recurrence:In between procedure revisionstimely change notices will go forward to all users
of the procedure;reflecting modifications and how they are to be implemented.
Procedure will be re-issued as a Rev. 2 end of January 1991 incorporating all
included changes.
Target Date for Completion: 1/31/91
Response provided by: ok. Date: //PART 3: APPROVAL •Comments/lnstructions: g
Director of k Date:zPART 4: VERIFICATION OF CORRECTIVE ACTION IMPLEMENTATION
Verified by: Date:
CNWRA FORM QAP 14-0
CORRECTIVE ACTION REQUEST
CAR No. 90-06
PART 2: PROPOSED ACTION
a) Root Cause:
The above referenced "Draft Rev.l" of TOP-001-02 was released as an effectivedocument on September 11, 1989 as indicated by the attached Effectivity andApproval Sheet. At the client's specific request the TOP-001-02 Rev.l was issuedas a "Draft" Controlled Document on September 11, 1989 for the purpose of beingused as a "proof-of-system" test as so indicated by the incorporated "note" onthe attached effectivity and approval sheet for said procedure. Consistent withthe "note" caption, and subsequent to the delivery of several items and manyensuing discussions with the client, we received the two attached letters datedJanuary 31, 1990 and February 15, 1990 indicating conditional "acceptance" of theprocedure. Prior to and subsequent to the receipt of the above letters,insignificant changes were made to the "draft" procedure by red-line insertionto the controlled copy of the Manager of WSE&I with subsequent transfer ofinformation made to appropriate users. This transfer of information was providedin various forms of communication with the appropriate users of the procedure.Implementing guidance was provided by the Manager of WSE&I in verbal, written andtraining modes. Currently a change form notification is being prepared to besent to each "holder" of the "controlled document" procedure TOP-001-02 Rev. 1Draft, that will indicate that the "master copy" containing all the red-linedinserts made since September 11, 1989 will be maintained in the Manager ofWSE&I's office as the official copy of the procedure to be referenced and useduntil a Revision 2 is officially issued (currently scheduled for end of January1991).
CENTER FOR NUCLEAR WASTE Proc TOP-00 1 -02
REGULATORY ANALYSES Revision 1
TECHNICAL OPERATING PROCEDURE Page I of 12&Atchmen tTitle IPRWGRA ARCHITECTURE RELATIONAL DATABASE CONTENT D
DEVELOPHENT INSTRUCTIVE DRAFT REV. 1
EFFECTIVITY AND APPROVALDRAFT
Revision 1 of this procedure became effective on Se~t- 11- 1989 . This procedureconsists of the pages and changes listed below.
Page No. Change Date Effective
ALL 9/11/89
NOTE: This draft document is being used au a "proof-of-system"test. The NRC has been notified that work in process will beaccomplished to this procedure to determine its effectiveness.If this test proves the procedure provides the requiredinformation to the NRC and the Center, it will be publishedin Rev. 1 status. It may be changed to met NRC comentsand published/controlled as Rev. 1 to TOP-001-02 at a later date.
CNWRACONTROLLEDCOPY -/1.
Supersedes Procedure No.TOP-001-02 Revision 0
Approvals
n. S i
M. iKia
CNWRA Form TOP-1
&IAA ~~~~~~~ UNITED STATESNUCLEAR REGULATORY COMMISSION / F /'sr
As a test of the revised Technical Operating Procedure (TOP) 001-02 fordevelopment and preparation of information for the Program Architecture SupportSystem, the CNWRA provided completed input forms and Synopsis of informationfor two whrked Regulatory Requirement Topic examples - Erosion and SubstantiallyComplete Containment (Allen Whiting letter to Phil Altomre of November 2. 1989).This was considered a "baselining' of the Program Architecture and a number ofdiscussions and meetings on the subJect matter have been hold since the receiptof these example cases. The basic Process and modifications for databasecontent, as presented In the TOP-001-02 and Attachment A. are acceptable withlncorporation of the changes noted in the attachment and should now be forral1zed
______:33- 1n - controlled oroceaure. Not!n, nawever, tnat It nag been the conclusion ofboth the NRC and the CNWRA, that furmther amparitnCe should be gained with theIntent to streamline the process and the rocedures and to establish resourcea ftcTenT operals and maintainability the Progr Architecture Support1System.
Philip AltomareWSEVI Program Elements Manager
EnclosureAs stated
TOPLTR/1/31/9gENCLOSURE
NRC COMMENTS ON TECHNICAL OPERATING PROCEDURE (TOP) 001-02
GENERAL COMMENT
The Technical Operating Procedure (TOP) 001-02 and Attachment A ore ,erthorough and provide detailed explnation for th preparation of Inout for thcProgram Architecture 5upport SysteF (PASS). Unfortunately, in obtainingcompleteness, the resulting quant1ty of information has had a negative effect
on the reviewers in that it leaves a perception of com lexfitv and detail OMhndy be_ difficult to implemento Alithough this my De a false impresston,possible problems in fo o~-w agor lmplementing the TOP should be carefullyobserved In the coming months and smvDltfcation of the process and/orInstructions propoled. as appropriate. Also, the operability andmaintainability of the PASS Is very Important. particularly as regardsminimizing resources required tor intormation collection, input preparatLon,ant update, In general, Tnfomration collection should be part of the normalwork activities. Also, the P should stat that DOE, State and others programand technical InformatiOn Is only for reference Purposes. Instructions snouia
-F-gtee tDatxn ncia1 effort colliectina DOE pro ram or techntcalinformation for tte Program Archtecture, particu ar In view of the changingDOE program, but to concentrate uon prep ration of C technical and programinformation for irput to the Proram Architecture. The PASS should not beperceved means to record and track all ODE activities.
It is requested that the implementation of the TOP 001-02 procedures continueto be monitored with the intent of furthor stneamlinina the process andprocedures and developing resource ficient operability and maintainability.
SPECIFIC COMMENTS
Technical Ooeratlon Procedure
Page 2. first paragraph under 2.2 first sentence beginning with "The PASS __
change the sentence to read as follows, "The PASS is a management tool foruse in recording and monitoring the extensive information and activities thatcomprise the NRC HLY repository licensing program."
Attachment A
1. Page AS: request that we do not introduce a new acronym, NWIM3.
2. Paco A4t Prmn +Oha *4+& kY-aPae49a+4Vm jclu9 a1 siteinvestigations prior to Construction Authorization (including surfaceexploration) rather than just those between Exploretory ShaftConstruction and Construction Authorization*
TOPLTR/1/31/90
3. Page 24, Related issues: 3) It should be clarified that DOE Issues areintended to be the DOE Issue Hierarchy; 2) oStatel issues should bechanged to "State and others" Issues and It should be clear these issuesare Kor informatitn purposes not NRC action. (If NRC adopts the issuesof others, they are included as open Items or uncertainties and thensubject to NRC action.)
4. Page A30, Section 5.6, second sentence: "methods and models" should notbe indicated to be included in the Format and Content Gulde.
5. Page A66 item 10.1: the General Guidelines and Criteria should be movedto the NAC Compliance Determination Methods.
6. Page At?, Compliance Determination Strategy: the Erosion and SCCRegulatory Requirement, ixamples each used different approaches todescribing the strategy. The record description should be modified tod*eeibm * *ene4s*;; eppreech thot case uatsi3L I *GaIj1hiliVty L1U VylVJof detail for the regulatory requirement and will be consistent with theNRC License Application Review Strategy.
7. Pg e A78, first paragraph: reconmendations should be submitted to theWSE&I Program Element Manager (PEH) and cognizant technical PEM for reviewand concurrence or redirection. The WSE&1 PEM has coordination responsi.bility and the cognizant technical PEN has responsibility for the specifictechnical area. The HLWM Technical Sponsor has overall responsibility forWLWI technical direction.
8. Page A99. second paragraph, item 2: delete this it.. An uncertainty on"how to reduce a previous uncertainty" is still the same uncertainty.
9. Page A119. Uncertainty Component: It is not clear that this set of recordscontinue to serve a useful purpose. I suggest that this be considered forrumoval from the database.
10. Page A129 Composite Uncertainty Reduction Methods Analysis and Pate A161,Composite Rank Orderings Consider treating attribute ranking as of-lineactivities (see Ted Ronine letter to Phil Altomere of 8/22/89).
11. Page A144, item 19f: 'Other' should be included under the uncertaintyreduction method types. It is not clear that a complete set Is given.
12. Page A173, second paragraph, second sentence: delete "for recomendationto the NRCO and replace with "in consultation with NRC."
TOPLTR//31/903
13. Pags A193, Recommended NRC Overall Research Program Plan, Section 24.1.4:the following should be incluced:
(a) A clear simple statement of the research need,(b) Technical reason the research is needed,k)j Regulatory reason the research is needed,(d Reference to NRC programs that will use the research results,(e) Associated NRC research and Technical Assistance, and(f) Associated DOE research or investigmtions
14. Page A201, Open Items, first paragraph: delete "DOE compliancedemonstration methods." NRC will not track uncertainties related to DOEcompliance demonstration methods in the PASS as open items. If It Is ofsufficient concern to NRC it would become an NRC uncertainty to be trackedas an open Item. Note. the open item described here is that related tothe Program Architecture. At some future time. the open Items as definedin the NRC Site Characterization Analysis are to be included. oraccessible. from the PASS.
Technical Content of Erosion and SCC Examole Regulatory Requirement Topics
The example Regulatory Requirement Topics served to demonstrate the ProgramArchitecture process and application of the PASS databas, content description,i.e., they served to "BaselineN the Program Architecture, There is still aneed to refine and update the technical content of the example cases. Also,
this exercise Indicated a need for a standardized hardcopy report forRegulatory Requirement Topics In addition to access to the computer database.Accordingly, consideration should be given to preparing a standard report forErosion and Substantially Complete Contalnment to be used as a guide for futurePASS data preparation.
The action taken by this Techrical Direction is considered to be within thescope of the current contra t NRC-Q2-88-005 , o0hanp s to cost or deliveryU' cUnraFCtet servVeit Ind N^uet£ are aut i212ed. aI eas notl+y meimmediately if you believe that this Direction would rosult in changes tocost or delivery of contracted services or products.
Sincerely,
Philip Altomare, WSE&IProgram Elmmnt Manager
Enclosure:As stated
cc: Mary Mace, ADM/CAB
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NUCLEAR RAGULATORY COMMIS3ONWASHINGTON, 0. aw31n
FEB 0 2 SO
Mr. Alan Whiting, DirectorSystems Engineering and IntegrationCenter for Nuclear Waste Regulatory AnalysisP. 0. Box 285106220 Culebra RoadSan Antonio, Taxes 78234
Dear Mr. Whiting!
SUBJECT: NRC Staff Comnts on Draft Report CNWRA 90-003
MRC staff have previously provided and discussed coaents on the CNWRA 90-003report (sea CNWRA Meeting Roports for J)nuwry 1., 1990, and January 18, 1990).Additional commlents are attached from the gwoscience, performance assessment,*ngineering and legal staff for your information (these were Informallyprovided at the January 29. 1990 meeting). Please note that the conentsor regulatory analysis provided do not represent an agency position but are theindividual views or analyss of the The Intent IS to provide theOWRX with the know experience gained bY a nuber taff byproviding input as if it wee*o cnr bt1nznn f kCUR t ChcalWvrking Ur u lbs The CNWRA still hs the responsib111ty for fine analysis andpreparation of the report. It tS expec~e that the CNWRA will consider the NRCinput In their analysis but It 1s not Mepted that a rspone will be requlredfor each NRC coment. Recoras of the disposition of each comnt should behandled the same manner as that presently usod for workling groups andmaintalned at the CNWRA. Where an important consideration is Identiffed. it isexpected that It would be Incorporated in the rationale statement. No furthercomments are to be expected from the NRC however, plase fel free to contactme or the specific staff person if clar1i1cation Is needed.
In our meeting of January 29 1990, you informed me that the CMNRA willdeliver the fint1 report CNiWA 90-003 on Februw 28 1,990. Accordingly, Iwill infoim our contracts offiem, by copy O this a t , proceed toestablish that date as the contract deliverable date (referene the Mary Macaletter to John Litz of January 10. 1990).
ora a T9 9oE-T g-Td- dO-D En * 7tV69 : 0 T a ISO 'Z O
PLEASE TYPE OR USE BOLD FELT TIP PIN. TELECOPS13 WILL NOT St RETURNED.
TO LOCATION
FAXf Z VERIFICATION 372-- -52 - -( -
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FAX f 72-0-2-J07 CRIFCAIO ? o-
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FAX I VERIFICATIM
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FAX # _ERIF!CATION
FAX __ VSI ICATION
S.z
FAX I VgRIFICATION
40_ AND COVER SHEETE of PASS
FRON PHONE EXT.-
t o CZ 9 C- s - 7TV6 a; 0 T ae *s9o Co
/ (1tcd4 @UNITED STATES
NUCLEAR REGULATORY COMMISSIONWASHINGTON, 0. C. 20555
r:r -D . -r- Mm 1 5 1990
John E. Latz, PresidentCenter for Nuclear WasteRegulatory Analyses
Post Office Box 285106220 Culebra RoadSan Antonio, Texas 78228-0510
/do &~-/7/z/ v?" X eS1 4, ,?,,0 G/7 17•9 r Vv
R 8WCs -z
Dear Mr. Latz:
Subject: Technical Operating Procedure (TOP) 001-02 Under the "WasteSystems Engineering and Integration" Program Element UnderContract No. NRC-02-88-005
Revised TOP-001-02 entitled "Program Architecture Relational DatabaseContent and Development Instructions", and synopses of information for twoworked regulatory requirement topic examples entitled "Extreme Erosion" and"Substantially Complete Containment" which are considered a "baselining" of
_rachitecture are acceptable with the incorporation of thef / enlosed comment
uld you estions, please contact me on area code 301-492-4291.
Sincerely,
Mary H/Mace, Contracting OfficerContract Administration BranchDivision of Contracts
and Property ManagementOffice of Administration
cc: J. Funches, NMSS
i' eCC 9ve/g/ ?t7*5-.
TUPLTFIi/3'1f1L ENCLOSURE
NRC CCHMtENTS ON TEZHNICAL OPERATING PROCEDURE (7OP) 001-02
GlIVEAL CW~MENT 'O)01rmn
The Technical Operating Procedure (T 0 ) 001-C2 and Attacr'reft A =rLX
tncrough And nrinvide detailed xlnto fo thi i I Iafo of- 1ot for-the-
