ML20206Q829
| ML20206Q829 | |
| Person / Time | |
|---|---|
| Issue date: | 06/30/1986 |
| From: | NRC |
| To: | |
| Shared Package | |
| ML20206Q818 | List: |
| References | |
| REF-WM-1 NUDOCS 8607030384 | |
| Download: ML20206Q829 (6) | |
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DRAFT -
GENERIC TECHNICAL POSITION ,
5 ON 1 PEER REVIEW
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, FOR HIGH-LEVEL NUCLEAR WASTE REPOSITORIES P
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- U.S. Nuclear Regulatory Commission i
i Washington, D.C. 20555
! June 1986 i .
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GENERIC TECHNICAL POSITION ON PEER REVIEW FOR HIGH-LEVEL NUCLEAR WASTE REPOSITORIES I. INTRODUCTION To obtain a license to operate a high-level waste repository,, the Department of Energy (DOE) must be able to demonstrate in a license application that the applicable health, safety, and environmental regulations in 10-CFR 60 have been fulfilled. Confidence in the adequacy of the data, data analyses, construction activities, and other items and activities associate'd with the license application is obtained through a quality assurance program. A quality assurance (QA) program meeting Subpart G of 10 CFR 60 mus,t be implemented by DOE to ensure that disciplined and documented plans and actions are utilized. Peer reviews may be employed as a part of the planned and systematic actions necessary to provide adequate confidence in the work under review where the work may be a design, a plan, a test procedure, a research report, a materials choice, or a site exploration. Because of the inherent uncertainty of geotechnical data and their analysis, the need to make projections over thousands of years, the lack of, unanimity among experts, and the first-of-a-kind nature of geologic repository technical issues, expert judgment will need to be utilized in assessing the adequacy of work. Peer reviews are the mechanism by which these judgments are made.
This GTP provides implementing guidance on the definition of peer reviews, the l areas where a peer review is appropriate, the qualifications of peers, and the I conduct and documentation of a peer review. Other methods may be proposed or I used and will be reviewed for acceptability by the NRC on a case-by-case basis. I 1
II. REGULATORY FRAMEWORK l The regulatory basis for peer reviews as a quality assurance measure is pro-vided by 10 CFR 60, Subpart G, which states that the repository QA program is to be based on the criteria of ' Appendix B of 10 CFR Part 50 "as applicable, and appropriately supplemented by additional criteria as required."
The NRC QA Review Plan for permanent geologic repositories (June 1984) provi, des ,
for the use of peer reviews to meet quality assurance requirements (Section 4
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3.8): "For. . . activities which involve use of untried or' state-of-the-art 4
i testing and analysis procedures and methods, or where detailed. technical criteria and requirements do not exist or are being developed, a peer review should be conducted. .The procedures defining the selection process for a peer group, and the process by which the peer group conducts its review should be described."
l III. DEFINITIONS Peer A peer-is a person knowledgeable in the subject matter to be reviewed (or a
- critical subset of the subject matter to be reviewed) to a degree at least
{ equivalent to that needed for the original work.
Peer Review Group A peer review group is an assembly of peers representing an appropriate spectrum of knowledge and experience in the subject matter to,be reviewed,'and will vary in size according to the subject matter and importance of the subject
! matter to safety or waste isolation. An odd number of peers, with three as a j minimum, is desirable. , ,
l Peer Review. .
A peer review is a documented, critical review performed by perso"nnel who are
. independent of the work being reviewed but have technical expertise at least 4
equivalent to that required for the original work. The peer's independence of the work being reviewed refers to independence of funding, supervision, and accountability for the original work under review. -
- A peer review is an indepth critique of assumptions, extrapolations, j methodology, and acceptance criteria employed, and of conclusions drawn in the original work. Peer reviews confirm the adequacy of work. In contrast to peer
! review, the term " technical review", as used in this GTP, refers to a review to '
verify conformance to predetermined requirements.
i Peer Review Report A documented in-depth report of the proceedings and findings of a peer review.
- Validation j The documented confirmation of the adequacy (suitabi.lity for its intended purpose) of the work under review.
Verification ,
i The documented determination.that work under review conforms to specified requirements. '
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3 IV. STAFF POSITIONS
- 1. Applicability of Peer Reviews
- a. A peer review should be used when the adequacy of information (e.g., data, interpretations, test results, design assumptions, etc.) or the suitabi-lity of procedures and methods essential to showing that the repository system meets or exceeds its performance requirements with respect to safety and waste isolation cannot otherwise be established through testing, alternate calculations or reference to previously established standards and practices.
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- b. In general, the following conditions are indicative of situations in which a peer review is appropriate or necessary:
Critical interpretations or decisions in the face of unceTtainty Decisions or interpretations having significant impact on performance assessment conclusions Novel or state-of-the-art testing, plans and procedures, or analyses i Detailed technical criteria or standard industry pr'ocedur'es do not
. exist.or are being deve' loped Results of tests are not reproducible or repeatable Data or interpretations are ambiguous Data adequacy is questionable--such data may not have been collected in conformance with an established QA program
- c. A peer review is recommended when the adequacy of a critical body of information can be established by alternate means, but there is disagreement within the cognizant technical community regarding,the applicability or appropriateness of the alternate means.
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- 2. Structure of Peer Review Group The number of peers comprising a peer group will vary with the complexity of the work to be reviewed, its importance to establishing that safety or waste isolation perfo.rmance goals are met, the number of technical disci-plines involved, the degree to which uncertainties in the data or technical approach exist, and the extent to which differing viewpoints are strongly held within the applicable technical and scientific community concerning the issues unde'r. review. The collective technical expertise and qualifications of peer group members should span the technical issues and areas involved in the work to be reviewed, including any differing bodies of. scientific thought. Technical areas.more central.to the work to i be reviewed should receive proportionally more representation on the peer l rev'iew group.
As a general rule, the size of the peer review group is less important than the professional stature of the peer reviewers, their ability to span the technical issues involved and represent major schools of scientific views, and independence. l l
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- 3. Qualifications of Peers
- a. Each peer reviewer should have recognized technical credentials in the technical area he or she has been selected to cover. The technical quali-fications of the peer reviewers in their review areas should be at least equal to the technical qualifications needed for the work or analysis
- ' under review. The prestige of each peer, and hence of the peer review group as a whole, relates to the importance of the subject matter to be reviewed. Peers should have recognized technical / scientific credentials !
that can be verified,
- b. Members of the peer review group should be independent of the original work to be reviewed. Independence in this case means that the peer (a) was not involved as a participant or technical advisor in the work being reviewed, and (b) has no past, existing, or anticipated financial stake in the work being reviewed. Because of the pervasive nature of* DOE's effort in the waste management area, it is acceptable that both the. work under review as well as the peer review of this work are funded by DOE.
The independence criterion is not meant to exclude eminent scientists or engineers, upon whose earlier work certain of the work under review is based, so long as a general scientific consensus has been re, ached regard-ing the validity of their earlier work. Nothing in this section is intended to impede full and frank discussions between the peer reviewers and the performers of the original work during the review. ,
- 4. Peer Review Process
! The peer review process may vary from case to case, and should be determined by the chairperson of the peer review group, consistent with the guidance provided in this GTP. In meetings and/or correspondence, the peer review group should evaluate and report on: (a) validity of assumptions; (b) alternate interpretations; (c) uncertainty of results and consequences if wrong; (d) appropriateness and limitations of methodology and procedures; (e) adequacy of application; (f) accuracy of calculations; (g) validity of conclusions.
Procedures should be developed for the peer review process to implement the guidance and staff positions in this GTP. Written minutes should be prepared of meetings, deliberations, and activities of the peer review process.
- 5. Peer Review R+~ et A. written report ddcumenting the results of the peer review should be issued. It is usually prepared u.nder the direction.of the chairperson of the peer review group, and is signed .by each member individually., It should clearly. state the work or issue that.was peer reviewed and the conclusions reached by the peer review process (item 4 above), including minority positions. A listing of the reviewers and their qualifications should also be a part of the peer review report. The report should contain qualification information for each member of the peer group. Included in ,
the qualification information should be identification of to whom the peer 1 member reports, where funding comes from for his/her salary, and who l
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. g determines the adequacy of the peer member's performance for salary increases.
The report may also include individual statements by peer review group members reflecting dissenting views or additional comments, as appropriate.
V. DISCUSSION Due to the first-of-a-kind nature of a repository, state-of-the-art testing, and inherent uncertainty in geotechnical and scientific work, peer reviews should be used as a management tool to achieve confidence in the validity of certain technical and programmatic judgments. The intent of a peer review is to pass judgment on the technical adequacy of the work or data submitted for review, to identify aspects of the work on which technical consensus exists, to identify aspects on which technical consensus does not exist, andito identify aspects of the reviewed work which the reviewers believe to be incorrect or which need need amplification. A peer review provides assurance in cases where scientific uncertainties and ambiguities exist but in which t chnical e and programmatic judgments and decisions still must be made.
In general, peer reviews will be used in a confirmatory-sen,se. Peer reviews should not be used to establish information that is not available' by other deans. Arbitrary conclusions based on inadequate or limited data cannot be
- improved by subjecting those conclusions to the peer review process. Peer'
- reviews should not be confused with technical reviews. Technicaf reviews are performed to verify conformance to predetermined requirements such as requirements listed in a technical specification or on a design drawing.
It is anticipated that the quality assurance organization will participate in the peer review process as an observer, to ensure that the procedures conform to the guidance of tnis GTP and that they are followed by the peer review group.
The NRC staff will use this GTP as guidance in its evaluation of DOE's peer review reports and to determine acceptability of peer review reports for licensing, i
i REFERENCES
- 1. U.S. Nuclear Regulatory Commission, NRC Review Plan: Quality Assurance Programs for Site Characterization of High-Level Nuclear Waste' Repositories, June 1984.
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