ML20138P885
| ML20138P885 | |
| Person / Time | |
|---|---|
| Issue date: | 10/11/1985 |
| From: | Miller H NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Purcell W ENERGY, DEPT. OF |
| References | |
| REF-WM-1 NUDOCS 8511140029 | |
| Download: ML20138P885 (7) | |
Text
'
l
, DISTRIBUTION g 3 - y , y ,W).Wy ngma g S p
=
RHohnson LPDRN REBrowning sFCameron Distribution: UIn a.ny , ,', ~~~
. . ace. MJ8 ell SBilhorn HJMiller- A tman MRKnapp 1 Return to WM,623 SS) (O JTGreeves JBunting a (in PDR William J. Purcell, Associate Director RRBoyle Office of Geologic Repositories SCoplan-Department of Energy.
JKennedy 1000 Independence Avenue, S.W. JLinehan Washington, DC 20585 DHedges & r/f RCook
Dear Mr. Purcell:
- TVerma ;
The purpose of this lettertis to provide the NRC staff's connents on the DOE Office of Geologic Repositories-(0GR) Quality Assurance Plan for Siting and Site Characterization of High Level Radioactive Waste Repositories dated September,'1984 The plan completed by OGR is the primary quality assurance planning document ,
for quality assurance activities conducted by OGR for siting and site characterization of high-level radioactive waste repositories. For each of the three sites selected for site characterization, the Field Project Office must also prepare planning documents that describe'the quality assurance ~ activities and assigned responsibil_ities for each respective site. The NRC staff will '
review and-comment on each of the Field l Project Office planning documents when
'0GR provides the NRC with copies approved by.0GR as. meeting the requirements.-
outlined in '10 CFR 60. In addition the NRC staff will review and coment on
~
i the quality assurance plans prepared by principal contractors after DOE .
approval of -the plans. ,
t Th'e NRC staff's review' of quality assurance ~ planning documents is only'a part-of the overall NRC review to assure that-DOE quality assurance programs in . ,
place at the start of any work which willipotentially support the construction authorization application meet the requirements'of 10'CFR 60. ' The NRC staff is .
also developing technical positions 'on specific issues, attending DOE auditstas 1 observers, and meeting with the DOE staff to discuss and resolve issues pertinent to the overall quality assurance program,- The NRC's objective is to have no unresolved comments concerning the QA programs when site characterization work begins.
General 1 Conclusions-The plan is written to be applicable to OGR only, not to OCRWM 'or to' the Field-
-Project Offices although it does contain-directives to the Field Project:
Offices.- The Field' Project. Offices lare to develop their own.QA plans which will be submitted to OGR for. approval.'
'~
-QA plans'for items and activities important to safety or waste isolation which are not the direct 1 responsibility of_OGR are not. addressed in the plan. For- .
i
^
8511140029 851011 PDR WASTE . -
WPt-1 PDR- _$
e _=_ .
E t
j . >
' 405/DH/85/09/03/1.
2 example, the waste form, which could impact ~the performance of the repository systems, can be prepared within the DOE defense program and the West Valley
- Demonstration Project, not OGR. . The-QA ~ plans for items and activities such as these-and the interfaces between these-various programs should either be described'or referenced in the OGR QA Plan.-
In Appendix A of the' quality assurance plan, 0GR' depicts in a table the '
^
applicability of each of the 18 criteria of 10 CFR 50, Appendix B~(referenced in 10 CFR 60, Subpart G): to OGR, and to the Field Project Offices. 0GR is shown as being responsible _for:
Criterion 'I. Organization II. Quality Assurance Program _
III. Design Control-(and Peer Review) i
-V._ Instructions, Procedures and Drawings VI. Document Control i XVI. Corrective Action XVII. Quality Assurance Records XVIII. Audits ;
The. remaining criteria:are shown' as not applicable to OGR activities. This may ,
be acceptable. If any activities related to the deleted criteria are to be performed by the OGR, however, the criteria should.be addressed in the plan. 1 For example, if OGR procures consulting or other services which are important to safety orm to design and characterization:of barriers important to waste isolation and to activities related ~thereto,.as defined in 10 CFR 60 Subpart.G, the OGR QA Plan must address Criterion IV " Procurement Document Control" and -
Criterion VII'" Control'of: Purchased ... Services."
Under .the QA ' Plan's Section.V " Quality. Assurance Program Requirements," program requirements are_ presented in two parts.. Part'A describes the OGR internal i activities and Part B describes the OGR overview of Field Project Office QA>
activities. The staff was unable to evaluate the adequacy of the OGR internal activities from the information presented in the plan. The plan states:-
" Activities affecting quality will be performed by th~e responsible OGR
. personnelinaccordancewithwrittenQuality~ImplementingProcedures'(QIPs),"
which have not been provided to the staff.
~
. The OGR-QA plan must describe the . internal' activities:in sufficient detail,that the staff can" determine how the applicable requirements of:10 CFR 60 are satisfied. ' Internal activities related to Criteria II, Quality-Assurance- ,
Program;'III. Design Control (&' Peer Review);' V, Instructions, Procedures - Drawings; VI,- Document Control;' XVI,LCorrective Action; XVII,1 Quality ~ Assurance
' Records; and -XVIII, Audits-must be described.- '
0FC.:WRPikb ::WMRP' ':WMRP .:IE- ::IE. " :DWM :DWM NAME-:DHedges* :JKennedy* :HJMiller* ::WA1tman*: :TAnkrum*^ :MJBell.* : :REBrowning*
DATE;:08[13/85; :08/13/853 1:08/15/85 :08/21/85 ::08/21/85 ::09/17/85 : 10/09/85:
_..m_.s
405/DH/85/09/03/1 The plan states that the Director, Office of Civilian Radioactive Waste Management (OCRWM), has ultimate responsibility for establishing and
. maintaining an effective OCRWM program-wide quality assurance program. The Associate Director. 0GR, has been delegated "... ultimate responsibility for establishing and implementing an effective Quality Assurance Program for the OGR subprogram at its four Headquarters Divisions, for providing QA policy guidance and direction to the field project offices, and for verification that field project offices have established and are implementing effective Quality Assurance Programs." The Associate Director, OGR delegated the quality ;
assurance responsibilities to the Director, Engineering and Licensing Division.
The Director further assigned the quality assurance responsibilities to the Licensing and QA team Leader who has on his staff a full-time dedicated position to assist in discharging the QA responsibilities. The staff believes that the DOE has relegated the quality assurance organization to a position too far down in the organization and the result will not be a strong management-oriented quality assurance program which is paramount for-the success of this project. It is for that. reason that the NRC staff included in l its QA Review Plan the following criterion for acceptability of the organization elements responsible for QA program:
DOE and its prime contractor [should] identify a management position within each respective organization that retains overall authority and responsibility for the QA program. This position, occupied by an i individual with appropriate management and QA knowledge and experience has the following characteristics:
- a. Is at the same or higher organization level as the highest line manager directly responsible for performing activities affecting quality (such as design, engineering, site investigations, procurement, manufacturing, etc.) and is sufficiently independent :
from cost and schedule,
- b. Has effective communication channels with other senior management positions.
- c. Has responsibility for approval of QA Manual (s),' changes thereto, and interpretations thereof.
- d. -Has no other duties or responsibilities unrelated to QA that would prevent full attention to QA matters.
Enclosure 1 lists additional information needed by the staff to evaluate the OGR quality assurance program. The staff may have additional coments on the revised ,nlan and new material submitted for review. I am certain you will l
)
0FC :WMRP:kb :WMRP :WMRP :IE :IE :DWM :DWM
.__._g____.....___:.__________.:............:..__........: ....__...._:........____:__.....____
NAME':DHedges* :JKennedy* :HJMiller* :WAltman* ' :TAnkrum* :MJBell* :REBrowning* ,
DATE :08/13/85 _08/13/85
- '08/15/85
- :08/21/85 :08/21/85 :09/17/85 :10/09/85 )
l
_ - - . - =
? .
405/DH/85/09/03/1 4-agree that it is important for the success of the site characterization program that a well-planned QA program be in place before work starts; therefore completion of this plan and resolution of the identified issues must be expedited. The NRC staff is available to meet with and assist you in meeting this objective. If you have questions or desire to arrange a meeting, please call me on 427-4177 or Dale Hedges of my staff on 427-4491.
Sincerely,
'TT,!T!. f**3 ET' Hubert J. Miller, Chief I Repository Projects Branch Division of Waste Management Office of Nuclear Material Safety l and Safeguards
Enclosure:
! Request for Additional Information cc: M. Langston, DOE C. Head, DOE C. Newton, DOE R. Stein, DOE Record Note:
The primary basis for this letter was a memorandum from B. Grimes of IE to R. Browning dated August 28, 1985. Two points raised by IE have not been included in the letter: DOE's use of a matrix organization with project offices reporting both the field offices and OCRWM, and. DOE's use of the term
" siting" in the title of the plan, as opposed to " site characterization." For the first point, DWM staff will request additional information from IE on the applicability of reactor matrix organizations and their attendant problems to the repository program before formally presenting this comment to DOE. For the second point, the Commission is now involved in determining the NRC's role in " siting" decisions in connection with the interpretation of when a
" preliminary determination" should be made. This comment is therefore being withheld until the Commission has given the staff additional guidance.
Theis letter was coordinated with Chip Cameron of ELD.
- See previous concurrence page.
OFC :WMRP:kb :WMRP :WMRP :IE :IE :DWM :DWM e................:............:............:............:............:............:...........
NAME :DHedges* :JKennedy* :HJMiller* :WAltman* :TAnkrum* :MJBell* :REBrowning*
e....:............:............:............:............:............:............:...........
DATE :08/13/85 :08/13/85 :08/15/85 :08/21/85 :08/21/85 309/17/85 :10/09/85
! - { ., Encicsure L.
1 .
4 4
Request for Additional Infonnation OGR QA Plan dated September 1984 i
! 1. Part IV.83 of the plan (page 10, last ball) states that the Licensing QA
! Team Leader (L&QATL) is responsible for auditing HQ-0GR and field project offices. Specify the frequency of these audits. (1.4)*
, 2. Describe the management, QA, and technical experience'and knowledge ;
requirements for the person (s) assigned to the quality assurance function.
(1.10).
- 3. Describe the scope of the OGR QA program. If items and activities i important to safety or waste isolation as defined in 10 CFR 60.2 will be j identified in the field project offices QA plans, so state. (2.1) l
- 4. Clarify that OGR will not develop, control, or use computer programs that are important to safety or waste isolation as defined in 10 CFR 60.2 or :
i provide a commitment that such activities will be conducted in accordance-
! with NUREG-0856 and the QA program. (2.2) l S. Part IV.83 of the plan (page 10, first. ball) indicates the L&QATL i coordinates the development of OGR procedures which implement the plan.
! Clarify that the L&QATL reviews and documents concurrence with these
! procedures relative to QA requirements.- (2.4, 5.1, 6.2, and .16.1) '
- 6. Describe how management (above or outside the L&QAT) regularly assesses the scope, status, adequacy,.and compliance of the OGR QA program to i subpart G of 10 CFR 60. (2.7).
?
- 7. It appears that design control has been delegated to the field project '
i offices. However, part V.B.6d of the plan (pages 14-15) calls for HQ technical reviews of design. Appendix A of the plan (pages 19 and 20) l commits OGR to design control per the basic and supplemental requirements of NQA-1, and Appendix B of the plan (page 21) indicates OGR has three j Quality Implementing Procedures in the area of design control. Clarify
- OGR responsibilities for design control and descrii:e how OGR will meet E
these responsibilities. ' Address each of the applicable design control criteria in Appendix A of the NRC's QA Review Plan. (3) I l l 3
i
. "The numbers in parentheses after each RAI refer to the criterion 'in the QA '
~
l
! Review Plan. l s
i I i
i 5
---. y . . , - , , , , . _,v ...,y,3 y ,.m. ,_._,,...,,_%,, ..,...,._..,_,.,4..,, , , . - . . ..,.,,,,_.,-_-.,,.m,.,,,o-,,. . , . , , . . . , , -ww,.,
I I s-..
1
('
. 2 .
l
- 8. Describe the OGR program for controlling internal documents as well as documents being transmitted to and from field offices and other project l i
participants to' assure controlled transmittal, receipt, internal i distribution, filing, and recall. Address each of the applicable document !'
control criteria in Appendix A of the QA Review Plan. (6)
- 9. Part IV.B.3 (page 10, last ball) of the plan indicates that the L&QATL is responsible for performing QA audits of HQ-0GR, but Part VI.A (page 16) I does not show these audits as a source of identification of QA-related problems and issues. Clarify. . (18.6)
- 10. Part VI.B.4 of the plan (page 16) indicates that procedures provide for dispositioning quality and QA-related problems and issues. Describe measures which assure that procedures identify personnel (by position title) authorized to make such dispositions and that the dispositions include signature approval by these authorized personnel. Clarify that the L&QATL documents concurrence that QA requirements are satisfied.
(15.1, 15.3, and 16.2)
- 11. Describe the OGR records management system. Address each of the applicable QA records criteria in Appendix A of the QA Review Plan. (17) i 12. Part IV.B.3_of the plan (page 10, last ball) indicates that the L&QATL is
- responsible for performing QA audits of HQ-0GR and field project offices and for participating in field project _ offices QA audits of their contractors. In this regard, address audit criteria 18.2, 18.3, 18.4, 18.5, and 18.7 in Appendix A of the QA Review Plan. (noted) -
1
- 13. Clarify the meaning of GRD on page 8 of the plan, QACG on page 16, and i RD&D on page 6.
- 14. The ANSI /ASME NQA-la-1983 addenda to ANSI /ASME NQA-1-1983 edition were issued December 31, 1983. Provide the OGR position with respect to l
[ following the ANSI /ASME NQA-la-1983 addenda.
! 15. A number of the 18 QA criteria.of 10 CFR 50 Appendix B, are shown in j i Appendix A of the OGR QA plan as being not applicable because activities ;
i are not performed by OGR. This is acceptable. ~ However, if any such ' :
f activities are performed by OGR, the criteria should be addressed. For l 4
example, if OGR procures consulting or other services which are important I to safety or waste isolation as defined in 10 CFR 60.2, the OGR QA plan i should address both Criteria IV,." Procurement Document Control," and VII, t
" Control of Purchased... Services."
i
, _ , m-_, , ._,m.~ .
._-.__.~.,.m-- ,,,_,.r _. . . , _ _ . ~ . _ , . ~ . , .. .,_+.,#m,_ ,,,..~.=m. m,-,,, ,.
c i .; .
fy
. . 3 ,
" Inspection" and " Test Control" are two of the criteria shown as being not applicable to OGR. As noted above, this is acceptable. However, this leaves.0GR audits as the principal means for OGR to independently verify confonnance to established requirements. Since audits are "after the fact" checks, discuss the degree to which contemporaneous technical surveillance of activities selected on the basis of their importance to safety or waste isolation will be used to identify quality and QA-related problems on a timely basis. Also discuss the degree to which the QA audits will be based on technical evaluation of work products as opposed to progransnatic checks.
- 16. The plan makes no reference to the "NRC QA Review Plan: Quality Assurance Programs for Site Characterization of High-Level Nuclear Waste Repositories." Identify and justify differences between the guidance in the NRC QA Review Plan and the DOE positions in the revised Headquarters QA Plan. In cases where NQA-1 provides more detailed guidance than the QA Review Plan but does not contradict the Plan, no justification need be provided.
- 17. In the meeting minutes from the SRPO QA meeting in December, 1984, the NRC staff had the following comment:
! A geologic repository is a disposal system that consists of both engineered (i.e., waste form and packaging) and natural barriers. The DOE license application must ensure that data of adequate quality are obtained for the waste fonn and packages as well as for the site and underground facility. An issue for follow-up with DOE-HQ is how DOE plans to assure i
that an appropriate level of quality is applied to the total geologic repository system (i.e., inclusion of' West Valley and DWPF wastes, and 4 data from WIPP which may be utilized in licensing a consnercial repository).
{
- Discuss the relationship between OCRWM and these other programs which may support OCRWM/0GR in licensing. Where necessary, revise the OGR QA Plan j to incorporate these programs.
t
)
i f