ML20206Q185

Draft Generic Technical Position on Qualification of Existing Data for High Level Nuclear Waste Repositories

ML20206Q185
Person / Time
Issue date:	06/30/1986
From:	NRC
To:
Shared Package
ML20206Q171	List: ML20206Q165 ML20206Q178 ML20206Q185
References
REF-WM-1 NUDOCS 8607030051
Download: ML20206Q185 (4)

Text

_ ._ _. . . . . .. . .. _ _ _ _ _ . . _ . . _ _ _

.. r _ . .

\ ' -

4 .

i f

a i.

1 i

4 2 EiiAFT GEhERIC TECHNICAL POSIT 10te ON (UALIFICATION OF EXISTING DATA

- i FOR' P

EIGH-LEVEL NUCLEAR WASTE REPOSITORIES i

1 1

i I,

i i

i l

l1 L

U.S. Nuclear Regulatory Ccrmission 3 .

Washington, D.C. 205th

> .Jur,c 19F.6

) 8607030051 860626 PDR WASTE "

• ~ I PDR ' 3, ,

I f

T .

s GENERIC TECHNICAL POSITION ON (UALIFICATION OF EXISTING DATA FOR nIGH-LEVEL NUCLEAR WASTE P.EPOSITCPIES I. INTRODUCTION To obtain a license to crerate a high-level waste repositcry, the Department of Energy (DOE) must Le cble to demonstrate in a license application that the applicable health, safety, and environmental regulations in 10 CFR Part 60 have been fulfilled. Conticence in the adequacy of data and data ert. lyses asscciated with the license applicaticn is obtained through,a quality assurance i prcgrcm.10 CFR Part 60 Subpart G, specifies the requirements for this quality assurance progran. The stdif expects that some data which have r.ot been generated urder e quCity assurance program meetir.g the requirements of 10 CFR Part 60 Subpart C wiii neec tc be qualified in support of DOE's license application te cer.struct and operate a permanent gecicgic repository for high-level waste. The purpose of this Generic Techrical Pesition (GTP) is to provide guidance to DOE or tre ese and qualification of data that have not been initially collected in conferinance with 10 CFP Part 60, Subpart G.

II. REGULATORY FRAMEWORK l

NPC regulations (10 CFR 60, Subpart G) require that DOE implement a quality assurance program that applies to all systems, structures and components important to safety, to design and characterization of barriers important to ,

? waste isolation ard tc activities related thereto. Site characterization l activities will lead to the development of data v:hich will be used in support of a DOE licerse eff licatiun to' construct and operate a permanent geo-logic repositcry. Site characterization d te used in support of the license application must ultimately be qualified to ineet the quality assurance rec,uirements of 10 CFR 60, Subpart G. Data ray meet these requirements by l

Leir.g initially devc . ced under a Subptrt C quality assurance program or by satisfying alternati.e cor.c'i tie r s . This GTP provides guidance on a set of  !

alternative conditions wh.ich may be used to qualify data not initially collected,under an approvcd 10 CFR 60, Subpart G QA program. This GTP is intenced as guidance on certain methods which the NRC currently views as acceptable for qualificaticr of data. Other methods may be proposed or. used .

and will be revia.ee for.acceptabil'ity by the NPC on a case-by-case basis.

III. DEFlhlTI0hS 1 Qualification (ofdatal:

A fcmal precess intended to provide a desired level of confidence that data cre suitable for their intended ese.

~

\ .

.t Qualified Data:

Data meeting the requirements of a 10 CFR 60, Subpart G quality assurance program.

Existing Data Data developed prior to the implementation of a 10 CFR 60 Subpart G QA program by DOE and its contractors, er data developed outside the DCE repository pro-gram, such as by oil companies, commercial well drillers, and universities.

Confirmatory Testing (NQA-1, Supplement S-1, Definition of " Testing")

An element cf verification for the determination of the capability of an item tc meet specified requirements by subjecting the item to a set of physical, chcrical, environmental, or operating conditions.

IV. STAFF POSITION

1. Data related to systems, structures and components importa~nt to safety, to design and characterizaticn of barriers important to waste isolation and to activities related thereto which are used in support of a license application should be qualified to meet the quality assurance requirements of 10 CFR 60, Subpart G. .

2. Four methods er ccmbination of methods are acceptable to the staff for the qualification of non-qualified data: (A) peer review in accordance with the staff's draft Generic Technical Position on Peer Review for High-level Nuclear Waste Repos1 tories; (B) corroborating data; (C) confirmatory testing; and (D) an equivalent QA program. These methods are briefly described in Section V, Discussion.

3. Non-qualified data shculd be qualified in accordance with approved and

controlleo procedures. These procedures should prcvide for documentation of the decision prccess and provide an auditable trail of all factors used ,

in arriving at a . decision concerning the qualification process. The procedures may provide for a graded approach to qualification depending on the importa %e of the data to assuring safety or waste' isolation.

V. DISCUSS 10h. .

The process of qualification of non-qualified data should consist of any of the

' cur methods or combination of methcds described below. .

i A. Peer Review - -

Non-qualifieo cata may.be qualified through the use of peer reviews..The peer review should' establish that the level .of confidence in the data is comensurate wi,th its intended use by consideration of attributes .such as:

• qualifications of personnel or organizations generating the data compared ,

to the qualification requirements of personnel generating similar data

.under the approved 10 CFR 60, Subpart G program; the technical adequacy of equipment and procedures used to collect and analyze the data; the environmental conditions under which the data were obtained if germane to

, ,the quality of data, the quclity ard. reliability of the measurement i

(

• h

. control program under which the data were generated; the extent to which conditions under which the dcta were generated may partially meet Subpart G; prior uses of the data and associated verification processes; prior peer or other professional reviews of the data and their results; extent and reliability of the documentation associated with the data; extent and quality of corroborating data or confirmatory testing results; the degree to which indepencent audits of the process that generated the data were conducted; and irportance of the data to showing that the proposed DOE repository design meets the performance objectives of 10 CFR 60, Subpart E.

The attributes to be considered for qualification will depend on the importanceofthedatatosafetyorvasteigation. .

i B. Corroborating Data Non-qualified data nay bt: qualified through the use of corrobcrating data.

To establish that the level of confidence in the corroborating data is commensurate with its intended use, the corroborating data.should demon-strate the prcperties of interest (e.g., physical, chemical, geologic, mechanical). Inferences drawn to corroborate the ncn-dualified data shall be clearly identified u.d justified in the written justification of

. qualificeticn. The level of confidence associated with corroborating data is related to the strength cf tFC quality assurance program ander which'it wcs develcpeo and/ct the degree to which the cerroborating data support the ron-qualified data. The arcunt cf corroborating data needed should be dealt with on a case-by-case basis in the written procedure for qualification. j C. Confirmatory Testing Non-qualified data may be qualified through ccnfirmatory testing. Such I confirmatory testirs shall be conducted in accordance with a 10 CFR 60, Subpart G quality assurance program. The confirmatory testing should demonstrate the prcperties.of interest (e.g., physical, chemical, geologic, mechanical). The amount of confirmatory testing required should be dealt with on a case-by-case basis.

D. Ecuivelect 0A Program hon-qualified data may be qualified by showing that it was collected under a quality assurance program which is equivalent to a 10 CFR 60, Subpart G quality assurance program. This demonstration should include an assessment of, any differences between the two QA progtams and how these differences may bear on the intended use of the data.

9 *

• s e

I