ML20058M188
| ML20058M188 | |
| Person / Time | |
|---|---|
| Issue date: | 10/12/1993 |
| From: | Rathbun D NRC OFFICE OF CONGRESSIONAL AFFAIRS (OCA) |
| To: | Lehman R, Lieberman J, Sharp P HOUSE OF REP., HOUSE OF REP., ENERGY & COMMERCE, SENATE, ENVIRONMENT & PUBLIC WORKS |
| References | |
| RULE-PRM-21-2 CCS, NUDOCS 9312200190 | |
| Download: ML20058M188 (3) | |
Text
_ - _ _. - - - - _ _
p Ka g I
/
o UNITED STATES
~
[7.,,
g NUCLEAR REGULATORY COMMISSION g
WASHINGTON D. C. 20555
%.....d October 12, 1993 1
The Honorable Joseph Lieberman, Chairman Subcommittee on Clean Air and Nuclear Regulation Committee on Environment and Public Works United States Senate Washington, DC 20510
Dear Mr. Chairman:
Enclosed for your information is a copy of a petition for l
rulemaking (PRM-21-2) requesting that the Nuclear Regulatory-Commission (NRC) amend 10 CFR Par'. 21.
The petition was filed with the NRC by the Nuclear Management and Resources Council.
i 1
l The petition requests that the NRC amend its regulations (1) to i
i revise the definition of the term ' commercial grade item"; (2) to l
include a flexible generic process for dedication of commercial l
grade items-for safety-related use; and (3)Eto_ clarify that the entity performing the dedication of a commercial grade item is responsible for discovering, evaluating, and reporting deficiencies as required by NRC's regulations.
AlsoenclosedisacopyoftheFedAral'Registernotice'that
~
contains additional information concerning the petition.- The i
notice will be published requesting public comment for a 75-day l
l period.
Sincerely,
%f4 l
Dennis K. Rathbun, Director l
Office of' Congressional Affairs
Enclosures:
1.
PRM-21-2 2.
Federal Register notice cc:
Senator Alan K. Simpson I
1 i
l !
I a
h' i 9312200190 931012 h
( '4 i
- j
t
[anc o
'o UNITED STATES
~,^
NUCLEAR REGULATORY COMMISSION l
{
WASHINGTON, D. C. 20555
%,,,,, 4 October 12, 1993 i
The Honorable Richard H. Lehman, Chairman Subcommittee on Energy and Mineral Resources Committee on Natural Resources United States House of Representatives Washington, DC 20515
Dear Mr. Chairman:
Enclosed for your information is a copy of a petition for-rulemaking (PRM-21-2) requesting that the Nuclear Regulatory Commission (NRC) amend 10 CFR Part 21.
The petition was filed with the NRC by the Nuclear Management and Resources: Council.
The petition requests that the NRC amend its regulations (1) to revise the definition of the term " commercial: grade item"; (2) to include a flexible generic process for dedication of commercial grade items for safety-related use; and (3) to clarify that'the entity performing the dedication of a commercial grade item is responsible for discovering, evaluating, and reporting deficiencies as required by NRC's regulations.
Also enclosed is a copy of the Federal Register-notice that contains additional information concerning.the petition.
The j
notice will be published requesting public comment for a 75-day 1
period.
Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosures:
1.
PRM-?l-2 2.
Federal Register notice ec:
Representative Barbara Vucanovich i
l I
i 1
--.I
October 12, 1993 The Honorable Philip Sharp, Chairman Subcommittee on Energy and Power Committee on Energy and Commerce United States House of Representatives Washington, DC 20515
Dear Mr. Chairman:
Enclosed for your information is a copy of a petition for rulemaking (PRM-21-2) requesting that the Nuclear Regulatory Commission (NRC) amend 10 CFR Part 21.
The petition was filed with the NRC by the Nuclear Management and Resources Council.
The petition requests that the NRC amend its regulations (1) to revise the definition of the term " commercial grade item"; (2) to include a flexible generic process for dedication of commercial grade items for safety-related use; and (3) to clarify that the entity performing the dedication of a commercial grade item is I
responsible for discovering, evaluating, and reporting deficiencies as required by NRC's regulations.
Also enclosed is a copy of the Federal Register notice that contains additional information concerning the petition.
The notice will be published requesting public comment for a 75-day period.
Sincerely, Original signed by/
Dennis K.
Rathbun, Director Office of Congressional Affairs
Enclosures:
1.
PRM-21-2 2.
Federal Register notice cc:
Representative Michael Bilirakis IDENTICAL LETTER SENT TO:
The Honorable Joseph Lieberman, Chairman cc:
Senator Alan K. Simpson The Honorable Richard H. Lehman, Chairman cc:
Representative Barbara Vucanovich DISTRIBUTION:
RDG BGOLDEN DLMEYER OC SUBJ MLESAR PGNORRY RS:RRDB RS:RRD RRD RRDB:FIP FIPS:AD BGOLDENO} MLES BCALURE DLMEYER CHARRIS 10/G/93 10/j/93 10/f'/93 10/f/93 10($/93 FIPS.:A' M ADM:h OCA '
DGR[8SLEY PGNOjlRY DRA i
10/g'/93 10/ (/93 10/s /93
NUCLEAR MANAGEMENT AND RESOURCES COUNCIL 1776 Eye Street. N W = Suite 300. Wasnington. DC 20006 3706 (202)872-1280 Robot W. Nahop vce Rescent &
Genarof Counset June 21,1993 Mr. Samuel J. Chilk Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, D.C. 20555 i
NITENTION: Chief of Docketing
)
Dear Mr. Chilk:
The Nuclear Management and Resources Council, Inc. ("NUMARC"), on behalf of the nuclear industry, hereby submits a Petition for Rulemaking pursuant to 10 CFR
{ 2.800 et seg. NUMARC's Petition for Rulemaking requests that the U.S. Nuclear Regulatory Commission amend 10 CFR Part 21 in certain respects related to commercial grade items and their dedication for use in safety-related applications.
NUMARC would be pleased to discuss this petition and to respond to any questions NRC personnel may have regarding its content or application.
Sincerely,
\\
Robert W. Bishop RWB/ECG:bjb Enclosure d41 h
1 ruey
i (l
i-1 i
i l
i 1
i UNITED STATES OF AMERICA.
i NUCLEAR REGULATORY COMMISSION "
- i i
i In the Matter of
)
l Proposed Rulemaking
)
Docket No. [N' YY
[
Regarding Ama=Anents to
-)
{
-).
1 PETITION FOR RULEMAKING-l i
l INTRODUCTION j
1 s
l This petition for rela== king is submitted pursuant to 10 CFR f 2.802 by the j
Nuclear Management and Resources Council ("NUMARC") on behalf of the nuclear :
power industry. Petitioners request that the U.S. Nuclear Pag =1=*=y Commission -
l
("NRC"), following notice and opportunity for comment, amend certain portions of the l
regulations contained in 10 CFR f 21.3 to (a) replace the existing definition of :
j commercial grade item ("CGI") with a more practicable definition, (b) include a flexible -
i generic process for dedication of commercial grade items for safety-related use, and (c) -
clarify that the entity performing the dedicstion of a commercial grade item is responsible.
I for discovering, evaluating and reporting de6ciencies pursuant to Part 21 myord gl requirements.
l 1
l STATEMENT OF PETITIONER'S INTEREST NUMARC is the organintion of the nuclear power industry responsible for i
coordinating the combined efforts _of all utilities licensed by the NRC to construct or l
operate nuclear power plants, and of other nuclear industry organizations, in all matters i
f involving generic regulatory policy issues and regulatory aspects of generic operational -
and technical issues affecting the nuclear power industry. Every utility responsible for!
constructing or operating a commercial nuclear power plant in the United States is a-member of NUMARC. In addition, NUMARC's members include major.
3 architect / engineering firms and all of the major nuclear steam supply' system vendors.
[
Because NUMARC's members are subject to the requirements of 10 CFR Part 21, -
j NUMARC is an " interested person" within the meaning of 10 CFR f 2.802; q
i I
i 3
I-u.
... n.
.a,,___...
.,m
- ,.,..-.L.
i i
i l
This petition for rulemaking addresses procurement of parts described as j
commercial grade items. It is so focused because the circumstances of the procurement l
environment are different now than those extant in 1978 when 10 CFR Part 21 was
~
j initially promulgated. As nuclear power plants have been operating for several years, many pieces of equipment now require replacement or refurbishment of their i
components. That means that current nuclear utility procurement needs primarily involve i
replacement parts for existing equipment rather than the purchase of major new pieces of equipment. However, many of the original suppliers and manufacturers no longer maintain App *=dir B-qualified programs M-* of the diminichad market - no new plants are being ordered or are currently under construction - and the burdens of j
maintaining such a quality program. Thus, frequently replacement parts are not available j
from original or other Appendix B-q.ualified vendors. - Further, many parts currently j
available can be procured in a more cost-and time-effective manner from a commercial l
l source. In practice, the combined effect of the decreased availability of parts from i
Appendix B-qualified vendors and the greater expense is that licensees are increasingly forced to procure commercial grade replacement parts and dedicate them for use in j
safety-related applications. The proposed amendments to Part 21 would allow utilities to obtain the necessary parts from a commercial source (including from another utility),
j make more practicable the dedication of commercial grade items to ensure that they meet j
technical and quality requirements for their intended safety-related application, and j
specify that the entity performing the dedication is responsible for reporting safety-i significant de5ciencies.
4
)
In addition to setting forth the information required under 10 CFR { 2.802(c) for a j
petition for rulemaking, NUMARC has provided supplementary analysis to facilitate the NRC's consideration of the effect of the proposed action on the rvironment, small i
business entites and the paperwork required of those affected by me change. Further, i
l because the NRC must consider whether a regulatory analysis must be performed as well as whether the backfit rule applies to this rulemaking, NUMARC also has included its j
analysis of those issues. (See Appendix, Supplementary Analyses in Support of the Petition for Rulemaking).
1 i
B.
Argument Introduction
)
The current provisions of Part 21 related to commercial grade items, their dedication for use in safety-related applications, and the associated reporting requirements for manufacturers, suppliers, and sub-tier suppliers are unworkable, 3
4
.. _... ~, _ _,
..,r,
,..r,
i
's 1
I i
UNITED STATES OF AMERICA I
NUCLEAR REGULATORY COMMISSION i
j i
In the Matter of
)
j Proposed Rul== Mag
)
Docket No.. [M ' M 2---
j Regarding Amendments to
)
)
i i
PETITION FOR RULEMAKING
{
i i
l INTRODUCTION
-i i
This petition for rul== Mag is submitted pursuant to 10 CFR { 2.802 by the l
1 Nuclear Management and Resources Council ("NUMARC") on behalf of the nuclear.
power industry. Petitioners request that the U.S. Nuclear R=d=*ary Comminaion l
("NRC"), following notice and vyyudouity for comment, amend certain portions of the regulations contained in 10 CFR { 21.3 to (a) replace the existing definition of '
commercial grade item ("CGI") with a more practicable definition, (b) include a flexible -
generic process for dedication of commercial grade items for safety-related use, and (c) clarify that the entity performing the dedication of a commercial gmde item is responsible l
for discovering, evaluating and reporting de6ciencies pursuant to Part 21 reporting j
requirements.
1 0
STATEMENT OF PETITIONER'S INTEREST 1
NUMARC is the organintior, of the nuclear power industry responsible for j
coordinating the combined efforts of all utilities licensed by the NRC to ' construct or #
,l operate nuclear power plants, and of other nuclear industry organizations, in'all matters i
involving generic regulatory policy issues and regulatory aspects of generic operational j
and technical issues affecting the nuclear power industry. Every utility responsible for:
constructing or operating a commercial nuclear power plant in the United States is a -
member of NUMARC. In addition, NUMARC's members include major architect / engineering firms and all of the major nuclear steam supply system vendors.
Because NUMARC's members are subject to the requirements of 10 CFR Part 21, l
NUMARC is an " interested person" within the meaning of 10 CFR { 2.802, q
1 9
d 1
i l
l i
~.
u.
J
l c
1 i
STATEMENT IN SUPPORT OF THE PETITION A.
Background
i Section 206 of the Energy Reorganization Act of 1974 (" ERA"), as --=d=1 requires that all licensees, as well as nonlicensees who construct facilities for licensees, supply basic c==aaa=*= to licensees and provide services associated with basic
.l components to licensees, report defects which could create a substantial safety hazard.
10 CFR Part 21 contains the regulations implementing Section 206..
Part 21 not only addresses the reporting r@ -
- - of Section 206, but also covers, in conjunction with 10 CFR Part 50, Appendix B, procurement of parts for nuclear power plants, including basic components and commercial grade items to be used in safety-related applications. Although Part 21 provided a reasonable foundation for regal =*ing procurement and imposing reporting requirements at the time it was prom =1g=**d, changes to Part 21 now are n~+<<='y. In fact, the current requirements of Part 21 often impede a utility's ability to obtain the highest quality part available for use in a safety-related application in a cost-and time-efficient manner. The inability to promptly procure appropriate parts could adversely affect plant safety.
l l
During the late 1980's, it became apparent to the commercial nuclear power
[
industry that changes in both utility pm e..rt needs and the nuclear c< --r-:= - :
j marketplace had significantly affected industry procurement practices and the impact of j
10 CFR Part 21 regulations on procurement. An in-depth evaluation was canied out by l
the industry in an effort to develop long-term solutions to industry and NRC concerns
~
about procurement activities and Part 21's regulatory requirements. In 1989, the nuclear l
power industry, through NUMARC, adopted an initiative that, inter alia, addressed procurement problems that had arisen because of the increasing need to procure more commercial grade replacement parts and dedicate them for use in safety-related applications. A dedication approach for commercial grade items was developed by the Electric Power Research Institute ("EPRI") and' documented in Guidelinefor Utilization ofCommercial Grade items in Nuclear Safety-Related Applicationr, EPRI NP-5652.
(Attachment 1) Implementation guidance was subsequently developed by the industry and issued in Nuclear Procurement Program improvement,- NUMARC 90-13.
(Attachment 2) The NRC conditionally endorsed EPRI's approach in Generic Letter 89-02 (Attachment 3) and, in Generic 1.etter 91-05 (Attachment 4), subsequently clarified its.
interpretation of Appendix B requirements for commercial grade item dedication. (See footnote 2 on page 6.)
2 j
..i
1 4
i i
2 l
I His petition for nda==Wg addresses procurement of parts described as commercial grade items. It is so focused because the circumstances of the procurement i
environment are different now than those extant in 1978 when 10 CFR Part 21 was l
initially promulgated. As nudear power plants have been operating for several years,
)
many pieces of equipment now require replacement or refurbishment of their j
components. That means that current nuclear utility procurement needs primarily involve replacement parts for existing equipment rather than the purchase of major new pieces of i
equipmeni. However, many of the original suppliers and manufacturers no longer i
maintain Appendix B-qualified programs ha===> of the diminished market - no new plants are being ordered or are currently under construction - and the burdens of 4
maintaining such a quality program. Hus, frequently replacement parts are not available from original or other Appendix B-qualified vendors. Further, many parts currently available can be procured in a more cost-and time-effective manner from a commercial l
source. In practice, the combined effect of the decreased availability of parts from j
Appendix B-qualified vendors and the greater expense is that licensees are increasingly forced to procure commercial grade replacement parts and dedicate them for use in safety-related applications. The proposed amendments to Part 21 would allow utilities to i
obtain the necessary parts from a commercial source (including from another utility),
j make more practicable the dedication of commercial grade items to ensure that they meet technical and quality requirements for their intended safety-related application, and j
specify that the entity performing the dedication is responsible for reporting sr.fety-j significant deficiencies.
l In addition to setting forth the information required under 10 CFR f 2.802(c) for a j
petition for rulemaking, NUMARC has provided supplementary analysis to facilitate the NRC's consideration of the effect of the proposed action on the environment, small business entites and the paperwork required of those affected by the change. Further, i
because the NRC must consider whether a regulatory analysis must be performed as well as whether the backfit rule applies to this rulemaking, NUMARC also has included its analysis of those issues. (See Appendix, Supplementary Analyses in Support of the j
Petition for Rulemaking).
I j
B.
Argument Introduction The current provisions of Part 21 related to commercial grade items, their i
j dedication for use in safety-related applications, and the associated reporting requirements for manufacturers, suppliers, and sub-tier suppliers are unworkable, 3
4 5
- =
l i
ineffective and could be counter-productive. That is, safety may actually be adversely affected due to delay caused by inability to obtain replacement parts needed for use as basic components. It is the objective of the proposed rule to alleviate the current regulatory problems associated with procurement and dedication of commercial grade items without decreasing responsibility for discovering, evaluating and reporting defects and noncompliances. The proposed changes to Part 21 are intended to facilitate the use of more feasible procurement and dedication practices, and clarify the responsibility for reporting any defects, in order to ensure that high quality components for nuclear power plant use can be procured and placed into service on a timely and cost-effective basis.
These changes will have positive operational and, thus, safety benefits.
Part 21. as it relates to commercial arade items and their dedication. is not effectively accomolishina its intended obiectives.
The legislative intent behind Section 206 of the ERA was to assure that the NRC "has prompt information conceming defects in major components of facilities subject to licensing which could create a substantial safety hazard." Conf. Rep. No. 1445,93rd Cong.,2nd Sess.(1974), reprinted in 1974 U.S. Code Cong. & Ad. News 5550. Further, the application of section 206 was "to benefit electric utilities in particular, which usually have no way of knowing that a sealed, prefabricated part is defective until it triggers a shutdown costing tens of thousands of dollars a day in lost generating capacity." S. Rep.
No. 980,93rd Cong.,2nd Sess.(1974), reprinted in 1974 U.S. Code Cong. & Ad. News
$527. While these are reasonable objectives, the current Part 21 regulations involving posting, document retention and deficiency evaluation and reporting, make their implementation unnecessarily burdensome, and, more crucial, create very substantial liability for those subject to Part 21. The effect has been to discourage vendors from maintaining Appendix B quality programs.
j Not only have some of the original manufacturers and suppliers abandoned J
Appendix B programs, but some have also refused to provide parts to nuclear utilities because of the reporting responsibility and potential liability that attaches through Part
- 21. In addition to the vendors' concems about liability for unknown defects in their products, there is concern that sub-tier vendors may be aware of defects but not identify them, creating the fear that the vendor could nonetheless be held accountable for the defect.
While there are several options available to nuclear utilities to procure replacement parts, most have serious drawbacks direedy or indirectly related to the current regulatory approach set out under Part 21. For examp'c, one option is to procure items from a 4
. ~
i 1
i i
1
)
supplier who maintains an Appendix B-quali6ed program, but the cost of procuring an j
item from that source uniformly is much higher than if comparable items are procured.
j through commercial channels. In comparison, the cost is often exorbitant and the
]
delivery time often does not meet utility needs, potentially adversely affecting plant i
operations and/or safety. A member of the industry has estimated that 6e cost for a safety-related parts (Appendix-B qualified) may be three to seven times greater for large/ expensive parts (over $1 million) and up to 100 times greater for a lower cost item.I j
A second option involves procuring replacement parts that are slightly different than the original parts. However, even if such parts are obtained from an Appaadir B-qualified
]
supplier, a design change is likely to be required tojustify the use of the proposed replacement parts. Dapanding upon their volume and complexity, these design changes j
can signi6cantly add to operations and maintenance costs without a commensurate 1
improvement in plant safety. A third option is to obtain the item from the surplus market j
or another utility, but this may be impossible if the product does not fit into the basic component or commercial grade definitions. Fourth, the item may be procured as j
commercial grade (ifit satis 6es all three of the regulatory requirements contained in the j
current Part 21 definition) and the utility or a third party must verify its suitability for use i
as a basic component under provisions of an Appendix B-qualified program. However, l
difficulty often arises in meeting all of the definitional requirements. Finally, under 10 q
CFR 21.7 an application may be filed for an exemption, but this process is impractical because of the time it generally takes to obtain a decision.
j The substitution of a more oracticable definition of commercial arade item and the i
addition of a flexible neneric orocess for dedication would assist in resolvina n_any of the difficulties cited above.
l The proposed rule would broaden the restrictive definition of commercial grade j
item under 10 CFR f 21.3(a)(4Xa-1). Part 21 does not allow an item to qualify as j
commercial grade unless the item meets all three of the requirements defined in 10 CFR f 21.3(a)(4)(a-1): (1) the item may not be subject to design or specification reqmrements i
J I
!{
The New York Power Authority recently compiled data on comparative costs for yism. e ; of safety-related parts (Appendix-B qualified) versus commercially available (non-safety-related) items. See Letter to Chairman l
Selin from Mr. John Brons, dated September 18, 1992, Attachment 5.
The data, excerpted in Table 1, demonstrates that there is a very large difference in cost between the two types of parts, i
l' 1
1 j
5 i
l i
m i
d 1
f unique to nuclear facilities, (2) the item is used in applications other than nuclear facilities, and (3) the item is ordered from the manufacturer's published product l
description (e.g. a catalogue). Unless an item is manufactured under Appendix B l
standards or meets the three pronged de6nition of a commercial grade item and is then appropriately dedicated, it may not be used in a safety-related application. As noted, because many of the replacement parts needed are no longer available from the original manufacturers or suppliers who have maintained Appendix B-quali6ed programs, the 4
three-pronged definition presents a significant obstacle for licensees in procuring j
appropriate parts in the most cost-and time efficient manner. The proposed changes would expand the commercial grade item de6nition to include any item obtained on the 1
open market. It would then be incumbent upon the dedication process to provide j
reasonable assurance that the item will perform its intended function in the safety-related j
application and upon the dedicating party to report any deficiencies covered under Part l
21.
i j
Allowing commercially available items to qualify as commercial grade items will
]
provide significant benefits without any impact on safe plant operation. Not only does it 1
allow procurement from the original manufacturer or supplier even if that entity no longer maintains an Appendix B-qualified program, as well as other commercial sources, but it also reduces the potential need for design changes and makes much more likely a
{
reasonable price and delivery time.
4 j
Although d>.dication is currently defined in 10 CFR { 21.3(a)(4)(c-1) as the point in time where a commercial grade item becomes a basic component for the purpose of l
Part 21 responsibility, dedication also has come to represent the process for determining j
that a commercial grade item is appropriately used in a safety related application. By j
codifying a flexible but acceptable approach to dedication - in principle, one that the 2
i NRC has already conditionally endorsed - the proposed regulation will serve the needs I
1 The NRC's endorsement of the EPRI Gua,eline for the Utilization of Commercial-Grade hems in Nuclear Safety-Related Applications was contained in NRC Generic Letter 8942, dated March 21,1989. (Attachment 3)
Therein the NRC indicated its concern for detection of counterfeit and fraudulently marketed products as well as for the overall quality of products procured for nuclear plants. The NRC endorsed the EPRI guidelines, j
j conditioned upon implementation by licensees with relatively minor modifications in :->--f=-=
methods l
invohing the supplier survey and supplier / item performance history. Later, in Generic letter 91-05 (Attachment 4), the NRC " clarified" its concerns about licensee implementation of procurement and dedication programs in the opinion of the industry, in doing so, the NRC went beyond the previous position, stated in Generic Letter 89-02, to one which significantly exrwded prmiding reasonable assurance that commercial grade items which are dedicated will be suitable to perform their intended safety-related functions.
i 1
6 i
i 4
g j,
i
)
j of the industry and allow the NRC to fulfill its charter to adequately protect public health and safety.
j l
As has been explained herein, utilities have found it increasingly necessary to j
dedicate commercial grade items to ensure that the items are suitable for the intended j
i safety-related application. In the past, this process largely has been a =m of i
establishing or following a paper trail for the item, i.e., dedication based solely on a..
comparison of the speci6 cations with the commercial grade item part number or with the l
l catalog information. Although extensive utility reviews ofindustry p
; practices i
have not ievealed issues significant to safety, the industry believes that the documentation i
approach involving part number verification is not the most effective means of meeting l
the objective of dedication. That is, the third prong of the commercial grade item definition essentially restricts the information on the commercial grade item. If, for j
j example, a survey is used to verify the design or manufacturing control process, or to '.
establish the basis for certification of traceability, certainly the potential user's knowledge -
l and understanding of that commercial grade item will be well_beyond ordinarily.
published information.
j l
The industry proposes that the regulation define the dedication process as one that.
l
{
will provide reasonable assurance that the item will perform its intended function. There -
l
[
are a number of ways to provide reasonabic assurance, including (1) testing and/or l
inspection; (2) surveying the commercial grade supplier to determine that the appropriate l
quality control in place; (3) observing the manufacturing process; and (4) analyzing the 4
j historical record of the item for acceptable performance. In addition, there may be other
]
l methods of verification for dedication acceptable to the NRC which should be considered l
in evaluating whether the reasonable assurance' standard is met in this context. Further,-
l l
the industry proposes that documentation of the dedication process be maintained by the i
i dedicating entity for the purpose of an audit or inspection.
1 j
The primary benefit of establishing the proposed dedication process is that the user j
f or other party performing the dedication, who understands the safety significance of the proposed component and thus is best able to identify the characteristics necessary for it to 1
F perform its intended function, rather than the manufacturer, is responsible for the quality j
of the item. This requires the utility, as will most frequently be the case, to evalu ste the l
]
suitability of the component through the development of an in-depth understanding of the-i j
impacts of the item's function on its performance in a safety-related application.
j l
r y
i t
i
)
i 3
7 i
l i
.j i
i
,,-.m-
, _.. ~. _ _
It is.oereeriate to olace responsibility for isoci*.o deficiencies in cows icial-nrade items with the entity nerformine the. dedication process.
This clari6 cation is appropriate for a number of reasons, including that suppliers and sub-tier suppliers do not necessarily know whether a c+=- ?cial grade item is destined for a safety-related application, and that there is no time limitation upon Part 21 seperdog responsibility for suppliers. The petitioner recommends that br-iper.6c be added to Section 21.21(b) to make clear that the entity performing the dedication of a commercial-grade item is responsible for discovering, evaluating and reporting de6ciencies.
I l
CONCLUSION j
t For the reasons stated herein, Part 21 should be modified to acco.uoedste the '
I current procurement needs of the nuclear power industry. Petitioners recommend =
changes to 10 CFR f 21.(3) to broaden the definition of a commercial grade item and to define and set out a standard for the dedication process. Additionally, all parties would bene 6t from the inclusion oflanguage in 10 CFR { 21.21(b) clanfying the responsibility associated with dedication. The recommended changes will not have any adverse impact on safety as the use of properly dedicated commercially available parts neither decreases equipment performance nor affects safe plant operation.
1 l
i l
I i
1 8
l l
i i
i i
i l
l PROPOSED CHANGES TO 10 CFR PART 21 l-l
[ Proposed additional language is shown in bold; proposed language to be i
deleted is indicated by brackets and double undeiining.]
j i 21.3(a) i (4)
A commercial grade item is not a part of a basic component until after dedication (see i 21.3(c-1)).
)
(a-1) Commercialgrade item means any item that has not been dedicated for use as a basic component. Ian item that is (1) not subiect to desian or specification reauirements that are umane to facilities or activities lic=W --
i to Parts 30. 40. 50. 60. 61.
- 70. or 72 of this chapter and (2) used m anohcstions other than i
facilities or activities lic-M oursuant to Parts 30. 40. 50. 60. 61.
- 70. or 72 of this chapter and (3) to be ordered from the -
manufacturer /supoher on the basis of specifications set forth in the i
manufacture 1's published oroduct derpotion (for example a E518!2111)
]
i (b)
Commission means the Nuclear Regulatory Commission or its duly authorized representatives.
i (c)
Constructing or construction means the analysis, design, manufacture, fabrication, placement, erection, installation,-
l modification, inspection, or testing of a facility or activity which is subject to the regulations in this part and consulting services related to the facility or activity that are safety related.
(c-1) Dedication is the evaluation process undertaken to provide reasonable assurance that a commercial grade item to be used as a basic component will perform its intended function. -
1 l
9
f 21.21(b) i (1)
If the deviation or failure to comply is discovered by a supplier of basic components, or services associated with basic components, and the supplier determines that it does not have the capability to perform the evaluation to determine if a defect exists, then the supplier must inform the purchasers or affected licensees within five working days of this determination so that the purchasers or affected licensees may evaluate the deviation or failure to comply, pursuant to i 21.21(a).
(b)(2)
The entity that performs the dedication is responsible for identifying, evaluating and reporting the deviations and failures to comply associated with substantial safety hazards of a commercial grade item.
l l
1 I
i i
10 1
...__.,,,....,_.b
~
~
j j
i i
)
TABLEI Comparison ofInitial Cost Commercially Procured From Available Appendix B-Qualified lism (Non-Safetv-Related)
(Safetv-Related)
Copper Tubing and
$242.44
$4,447.00 Brass Fittings Large Pump Motor
$29,000.00
$66,800.00 Bearings (1 set of 3 Bearings)
Two Position Keylock
$207.00
$7,548.00 Switch Assembly One Fully Threaded
$1.35
$21.15 Stud, with 2 Hex Nuts t
l 1
.I P
I
(
11 l
l s e w
i 1
)
p i
1 I
APPENDIX i
SUPPLEMENTARY ANALYSES IN SUPPORT OF THE PETITION FOR I
RULEMAKING INTRODUCTION 1
Pursuant to 10 CFR 2.80', a petition for rulemaking must set out the problem for e
which petitioners seek redress, the proposed solution identified in the rul-Mag and the j
substantive basis for the proposed solution. In tum, the NRC must evaluate the procedural and substantive merit of the proposed action against the dictates of the Atomic Energy Act and evaluate the ramifications of the proposed action against several statutes in addition to the Atomic Energy Act. Specifically, the other statutes that must be i
addressed are the National Environmental Policy Act, the Paperwork Reduction Act and -
the Regulatory Flexibility Act. Also, the NRC must draft a Regulatory Ant. lysis if certain criteria are met and determine whether 10 CFR 50.109, the backfit mie, is applicable; if i
so, an additional evaluation must be conducted. Petitioner submits the following -
information to assist the NRC in its analyses.-
l THE NATIONAL ENVIRONMENTAL POLICY ACT l
i The National Environmental Policy Act (42 U.S.C. 4321 et seq.) requires that i
federal agencies consider the expected environmental impacts of a proposed ble and any j
reasonable altematives to the action proposed.-
l The proposed modifications to Part 21 involve the sources *from which nuclear -
procurements for commercial grade items may be made, the commercial grade item dedication process, and the entities responsible for reporting to the NRC any subsequently identified defects in commercial grade items that could create a substantial safety hazard. Despite the fact that testing or other means of verification must be undertaken to dedicate a commercial grade item consistent with the proposed changes, the proposed changes do not affect either the physical or the human environment. In particular, the proposed changes to Part 21 regarding commercial grade item dedication would not cause a substantial deviation from dedication processes and techniques currently employed, but rather provide licensees with greater flexibility in ascertaining j
that a commercial grade item will perform the safety-related function for which it is -
intended.
Further, the proposed modifications to Part 21 will not create any increase in the occupational exposure to the licensee's work force. Procurement activities affected by the changes to Part 21 are performed in an office environment and the verification processes i
i i
necessary for dedication of commercial grade items are carried out outside of a licensee's controlled area. Even for those few in-service inspections or preoperational tests which i
I may follow the dedication process, occupational exposure is not expected to be affected.
4 j
'Ihus, the modifications to Part 21 proposed herein will not constitute a major federal action significantly affecting the quality of the human environment. Petitioners therefore submit that the proposed amendments have no environmental impacts and the NRC may make a formal finding of no significant impact. Based upon the nature of the proposed rule, the Commission is not required to prepare either an environmental assessment or environmental impact statement.
THE PAPERWORK RFDUCTION ACT The objective of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.) is to ensure that the OfBce of Management and Budget has the opportunity to review and approve regulatory actions that create an increased burden on the public due to additional information collection reqmrements imposed by the federal government. This statute does not apply to the instant rule== Mag.
The proposed rule amends the information collection requirements of Part 21 only to clarify the responsibility of certain entities to report defects in commercial grade items intended for use in safety-related applications. There is no increased burden on the i
remaining entities subject to the proposed Part 21 modifications as these entities are responsible for reporting defects under the current formulation of Part 21. In fact, this 4
proposed rule should have the effect of reducing the number of duplicative documents i
submitted to the NRC conceming a particular component because, under the proposed rule, reporting requirements are vested only with the entity dedicating the commercial grade item, which typically will be the utility.
REGULATORY FLEXIBILITY ACT Pursuant to the Regulatory Flexibility Act of 1980 (5 U.S.C. 605(b)), the NRC must certify that a proposed rule, it promulgated, will not have a significant impact on a substantial number of small entities. In this instance, the RC may make this l
determination because the only likely impact upon small entities would be's positive one--opening up previously closed markets and allowing small entities to compete to become vendors to supply commercial grade items to nuclear power plant licensees. This l
proposed regulation would affect nuclear power plant licensees only in their procurement and dedication of commercial grade items used in nuclear power plants. Even though there is not expected to be any adverse impact on nuclear power plant licensees, a licensee is not a small business entity as defined in Section 3 of the Small Business Act (15 U.S.C. 632), the Small Business Size Standards of the Small Business Administrator i
l l
u
i I
j (13 CFR Part 121), or the Commission's Size Standards (56 FrdL J_tgg. 56671, November l
6, 1991).
3 I
l REGULATORY ANALYSIS j
I Under certain circumstances, the NRC is required to perform a regulatory analysis.
1 j
The purpose of the analysis is to assure that the NRC obtains adequate information -
l regarding the need for and consequences of a proposed regulatory action and that.the i
NRC appropriately considers costs and benefits of alternative regulatory actions. A l
regulatory analysis must be prepared ifit is determined that the proposed action j
j contemplated by the rule will likely result in any of the following: (1) an annual effect on I
the economy of $100,000,000 or more in direct or indirect costs, or (2) a signi6 cant i
impact on health, safety or the environment, or (3) a substantial increase in the cost to '
-j NRC licensees, permit holders or applicants, to federal state or local governments, and geographic regions. Also, preparation of the analysis may be required by the l
Commission or the Executive Director of Operations. Taking the criteria seriatim, the l
following discussion supports a conclusion that the NRC is not required to do a
{
regulatory analysis on the proposed modifications to Part 21.
l First, the proposed changes to Part 21 will not have an annual effect on the i
economy of $100,000,000 or more in direct or indirect costs. To the contrary, the i
proposal is intended not only to make procurement of commercial grade items more i
j feasible; but also to allow the industry to procure these components on a significantly l
5 more cost-effective basis. Rather than resulting in an increase in the direct or indirect i
costs of obtaining commercial grade items, the approach to commercial grade items j
contained in Part 21 will allow nuclear power plant licensees to reduce the costs associated with many replacement parts.
i Second, there will be no impact on health, safety or the environment. As noted j
infra, the proposed modifications to Part 21 have three objectives: to create a more l
practical definition of commercial grade item, to allow a more flexible generic process for dedicating commercial grade items, and to clarify that the entity performing the j
dedication of commercial grade items is responsible for discovering, evaluating and i
reporting deficiencies pursuant to Part 21 reporting requirements. The achievement of i
these objectives will in no way reduce the margin of safety required for these items. The l
dedication process still must ensure that they are of high quality and will perform their
]
intended safety function. Further, delivery time for parts procured from Appendix B-qualified vendors often does not meet utility needs, i.e., equipment may remain out of '
]
service unnecessarily. Because such a circumstance could adversely affect plant
[
operations and, potentially, plant safety, allowing utilities to obtain parts more quickly l
iii i
i e
and then ensure their appropriate performance in an intended safety application will serve to promote safe plant operation.
nird, the proposed changes will not lead to a substantial increase in the cost to NRC licensees, permit holders or applicants, to federal, state or local governments, or geographic regions. To the contrary, the industry has indicated that constraints which currently exist in 10 CFR 21.3 relating to procurement of commercial grade items and their dedication add significant and unnecessary costs. Dif5culties arise because the l
mature state of the industry requires that many installed parts be replaced, focusing utility l
procurement needs on replacement parts for existing equipment rather than on the l
purchase of major new equipment. Many of the original suppliers and manufacturers no longer maintain Appendix B-quali6ed programs and replacement parts often are not l
available from other Appandir B-qualified vendors. More critically, even if parts are I
available from an Appendix B-qualified vendor, the comy-ively exorbitant cost and time delay before delivery make such procurements undesirable.
j Retaining the current formulation of Part 21 does not address the above described l
difficulties because currently, the cost of procuring an item from an Appendix B-qualified vendor is uniformly much greater than if a comparable item is procured through commercial channels. (See discussion supra, regarding data ' compiled by the New York Power Authority on comparative costs for procurement of safety related parts (Appaadiv l
B-qualified) versus commercially available (non-safety-related) items.). By modifying j
the definition of commercial grade items in 10 CFR 21.3, the regulation will allow i
commercial grade items to be procured from a greater number of sources. His will best serve the nuclear industry's need to ensure that high quality components meeting j
technical requirements for their intended safety applications can be procured and placed into service in nuclear power plants on a timely basis and at significantly less cost than achievable under the current regulations.
i THE BACKFIT RULE l
)
The proposed rule modifies the definition of commercial grade items to allow a l
l broader category ofitems, available from a greater number of sources at a lower cost, to l
be procured and dedicated as commercial grade items for use in safety-related applications. The proposed changes to Part 21 also clarify the responsibility of manufacturers and vendors for evaluating and reporting defects. Nuclear licensees would i
have substantially more flexibility in the procurement and dedication of commercial i
grade components intended for use in safety-related applications. While a licensee may now more often be the dedicating entity, the responsibility to report flaws found during dedication of commercial grade items is not a departure from current requirements.
Under the proposed modifications to 10 CFR 21.3, no new requirements are imposed l
iv
a
.4 upon licensees in the dedication process or upon the manufacturers and vendors of commercial grade items. Accordingly, the proposed rule, if promulgated, does not constitute a backfit as defined in 10 CF 50.109 and the Commission is not required to prepare a backfit analysis.
i l
\\
Y
ATTACHMENT 1 i
Topics:
EPRi NP-5652 I
Commercial grade items Project 01017 r
Dedication of parts Final Report Electnc Power Replacement of parts June 1988 Research Institute Critical charactenstics i
I 4
1 l
Guideline for the Utilization of i_...
Commercial Grade items in l
Nuclear Safety Related Applications (NCIG-07?
i l
l l
l i
i i
i f
i i
i i
Prepared by Gilbert / Commonwealth, Inc.
Reading, Pennsytvania
SUMMARhh REPORT SUBJECTS Nuclear plant operations and mantenance / Quality engmeenngiconstruction / -
Nucisar plant life extensson / Nuclear safety analysis conter TOPICS Comir idst grade items Replacement of pans Dedicahon of parts Critical charactenstics AUDIENCE Utility design engmoors / Plant opershons, procurement, and quality assurance personnel Guktoune for the UtMamion of Commenzial Grade Items in Nucteer Safety Reinted Appilcadons 90CIG47)
The reduced availability of spare and replacement parts designed specifically for nuclear safety related components has made it necessary for utilities to purchase commercial grado parts. This study, the seventh in a set.es cosponsored by the Nuclear Con-struction issues Group (NCIG),' outlines an acceptance procedure j
for ensuring that commercial grade items conform with require-q monts for their use in safety related applicahons.
BACKGROUND Most U.S. nuclear plants are now opershonal and frequently require replacement of pans, as well as complete components. Reducelone in now nuclear power plant construchon have prompted some supphers to decon-tinue 10 CFR 50, Appendix B quality aneurance programs, which had l
provuled guidance on the doengn, manufacture, and e of safety related components. Utilities now must procure quahfied replacement items from ahornative supphers or purchase replacement parts as commercial grade and dedicate them for salsty related use. With the increased use of -
commercial grade items, a guidehne is needed to ensure their conformance to regulatory requirements.-
OBJECTIVE To provide a guidehne for_ procuring and using commercial grade iterr,s in -
safety related nuclear power plant applications.
APPROACH A joint EPRI-NClG committee reviewed documents related to the use of commercial grade items in salsty related applicahons, including NRC codes,-
standards, regulations, and inspechon repons, as well as industry publica -
tions. A survey of participating NClG utilities and visits to a i+,:::, eve sample of nuclear power plants provided data on utility prachces and -
procedures related to the procurement and use of these items. The group -
also visited a representative sample of suppliers of commercial grade items. Using this information, they developed this guideline and coordinated its dissemination to utilities, regulatory forums, and industry organizations.
RESULTS The guideline contains a generic procedure for acceptance of commercial grade items, as well as four altomative acceptance methods-special tests EPRI NF-5652s
. v
and inspections, surveys of vendors supplying commercel grado co.n-l ponents, source venfication, and the recording of acceptable suppliert '
j item performance-to provide flexibility. The report desenbos the im-piementation of each method and reviews examples of situations whers t
l it could be beneficial to use more than one acceptance method.
t 4
Appendixes and exhdNts provide additional detail on selected subjects
~
presented in the guideline and examples that can assist the user in i
j employing the acceptance methods.
EPRI PERSPECTIVE The need to ensum availability of quality replacement parts for today's operating nucisar power plants in a timely manner is a concem of the industry. Since numerous replacement parts are now being purchased as commercial grade items, increased attention hoe boon focused on their procurement and use. This guidolene is intended to allenate these and other difficultos, such as lack of conesehent controis in procure-
[
ment practicos, regulatory inspection findings agemet utility control of 1
commercial grade items, and lack of quahfied replacement parts due to -
j i
discontinuation of 10 CFR 50. Appendix B quality assurance programs It facilitates industry uniformity in procuring and using commercial l
grade items.
PROJECT RPO101 ;
I l
EPRI Project Manager: Warren J. Bilanin '
j Nuclear Construction issues Group / Nuclear Power Division j
j Contractor: Gilbert / Commonwealth, Inc.
l I
i
}
1 t
l For further information on EPRI research programs, call -
EPRI Technical Information Specialists (415) 855 2411.
l
)
l J
5
Guideline for the Utilization of Commercial Grade items in Nuclear Safety Related Appbcations (NCIG-07) i NP4652 Research PrW Q101-7 Final Report. June 1988 A
f Prepared try GILBERT / COMMONWEALTH. INC.
Post Office Box 1498 Reading, Pennsy1vania 19603 '498 Principal Investigators M. P. Tulay F. J. Yurich i
F. M. Schremser, Jr.
NUCLEAR CONSTRUCTION ISSUES GROUP Commerciat Grade items Task Group l
l I
Prepared for Nuclear Construchon issues Group and Electric Power Research Instrtute 3412 Hillview Avenue Palo Atto, California 94304 EPRI Project Manager W. J. Bilanin Nuclear Power Division
1 l
ORDERING INFORMATION i
Requess for copies of this report should be chrected to Research Reports Cerver (RRC). Box 50490. Palo Alto. CA 94303, (415) 965-4081. On request RRC wnil send a catalog of EPRI reports.
I i
i
_wne Po or Reeneren in us aw Em are een<. men. W Ewe Po, Reesent in.= ine Coppnyt C 1988 Emsne Poser Roemenm emMe,Inc M nghis reserved NOTICE The roowi =es preoereo tw ine orgenmacrva) named nee. es an er.xz:xst a mort spormored ty the Eleanc Poner Reneerce trent.ma Irc (EPRf) enc the Numeer Conurutson leaues Groun Nether EPRt. mornbers d EPRt.
the km Corutrucean leeuse Groun the organusmarte) names meios. nor any person name on benen a ery d thern: (a) meses any merrenry egress or anched. wen roepea e me uma d any erformenon. oppersA rnethos_ or prooses omoosed m the report or that euen use eney nt
- rWnnge prmessy owned ngms; or (b) esasnes ery m oc respea to the une of. or tar camages re6 amo tram Ine use d. any rearmenon.
NA fnethoa, or procmas Geoomed n the report P'opered by Georvr~.~ r ire Resong. T..
r4
~
EPRI FORDdORD l
i The Nuclear Construction Issues Group (NCIG), with the support of the Electric Power Research Institute (EPRI), has prepared this guideline to provide specific direction on the utilization of commercial grade items intended for safety-related applications. This document provides methods that will reasonably assure commercial grade items are acceptable for their intended safety-related j
application. Although this document concentrates on spare / replacement commercial grade items, the same practices are applicable to commercial grade items intended for new construction or plant modifications, as well as for commercial grade services.
t The NCIG Commercial Grade Iteas Task Group responsible for developing this guideline was composed of utility and consulting personnel with experience in the j
procurement, engineering, and quality assurance disciplines. Extensive data were f
collected prior to developing the guideline to establish a meaningful document.
The first step was to develop a current and concise summary of those documents that govern or provide guidance on the use of commercial grade items in safety-related applications. This research included a review of the following j
l documents:
Requirements set forth in U. S. Nuclear Regulatory Commission e
(USKRC) Regulations.
Other regulatory type documents, including applicable USNRC Inspection Reports.
Industry publications such as consensus documents, position papers, and white papers.
The more significant and applicable of these documents are listed in the reference and bibliography sectior.s of this guideline.
The next step involved investigation of a sampling of utility practices and procedures related to the procurement and use of commercial grade items. This i
t iii J
l l
l t
I included questionnaire responses from utilities and visits to a representative sample of nuclear power plants.
The final step was to visit a representative sample of suppliers that furnish consercial grade items used in nuclear power plants. The purpose of these visits was to examine suppliers' consercial quality controls and assure that suppliers would be receptive to surveys of their practices and source verifications at their.
facilities.
From these activities, the NCIG Commercial Grade Items' Task Group developed, reviewed, and agreed upon a generic process for the acceptance of commercial grade items for use in safety-related applications. The process resulted in this document, which provides guidance and suggestions for implementation.
Warren Bilanin, Project Manager Nuclear Power Division l
i I
l iv
ACKNOWLIDGIENTS The following individuals were ongoing members of the Nuclear Construction Issues Group's Commercial Grade Items Task Group. As such, they made significant contributions to the development of this guideline by attending meetings, reviewing / commenting on various drafts, and writing portions of the document.
William E. Craig. Chairman Arizona Public Service Co.
John D. Duffin Bechtel Corp.
Walter J. Shewski Commonwealth Edison Co.
William J. Razlaff Cygna Energy Services Warren J. Bilanin Electric Power Research Institute Tom J. Mulford Electric Power Research Institute Michael P. Tulay Gilbert / Commonwealth,Inc.
Robert B. Stafford Gulf States Utilities Alan H. Miller Impe11 Corp.
Kenneth E. Peveler Iowa Electric Light & Power Co.
Larry Templeton Horthern States Power Co.
Steven M. Skidmore Pacific Gas & Electric Co.
Dennis M. O'Rourke Philadelphia Electric Co.
Robert M. Tjernlund Sargent & Lundy Engineers Kenneth L. Baldwin Southern California Edison Co.
Raymond L. Lahti Tennessee Valley Authority Jack L. Martin TU Electric Co.
Ken W. Kuechenmeister Union Electric Co.
William G. Eales Wolf Creek Nuclear Operating Corp.
In addition, acknowledgment is given to David G. Powell (Nuclear Data Services).
Philip M. Holzman (Strategic Technology and Resources), and Howard W. Newton (Southen California Edison) for their valuable review and comment on the various drafts of the guideline.
i y
l
i t
Cowiturs 1
Section ER98 1
BACKGROUND AND DOCUMENT BASIS 1-1
1.1 Background
1-1 1.1.1 Issue 1-1 1.1.2 History 1-2 j
1.1.3 Commercial Grade Items 1-3 1.2 Utilization of. Commercial Grade Items 1-4 1.3 Basic Premises of the Guideline 1-6 1.3.1 Design of Comercial Grade Items 1-6.
1.3.2 Equivalent Performance 1-6 1.3.3 Part Number Verification 1-6 1.3.4 Guideline Consistency with Regulatory Requirements 1-6 1.3.5 Uniformity and Flexibility 1-7 l
1.3.6 Acceptance Documentation 1-7 j
2 GENERIC PROCESS 2-1 i
2.1 Determining Safety Function of Ites 2-1 2.2 Confirming Item Meets Definition of Commercial Grade _
2-1 2.3 Identification of Critical Characteristics 2-3 2.3.1 Types of Critical Characteristics 2-3 2.3.2 Selection of Critical Characteristics 2-3 2.4 Selecting Appropriate Acceptance Method 2 2.5 Acceptance Delegation 28 2.6 Reportability and Traceability 2-8 3
ACCEPTANCE METHODS 3-1 3.1 Method 1 - Special Tests and Inspections 3-1 3.1.1 Explanation of Method 1 3-1 I
3.1.2 Application of Method 1 3-1 3.1.3 Employment of Method 1 3-3 vii
1 j
P,ggg j
Section 3-4 3.2 Method 2 - Commercial Grade Survey of Supplier 3-4 j
3.2.1 Explanation of Method 2 3-4 3.2.2 Application of Method 2 3-6 3.2.3 Employment of Method 2
)
3-9 3.3 Method 3 - Source Verification 3-9 l
3.3.1 Explanation of Method 3 3-11 3.3.2 Application of Method 3 3-11 3.3.3 Employment of Method 3 3-12 Method 4 - Acceptable Supplier /Ites Performance Record 3.4 3-12 3.4.1 Explanation of Method 4 3-14 3.4.2 Application of Method 8 3-14 3.4.3 Employment of Method 4 3-17 3.5 Combination of Two or More Methods 3-17 3.5.1 Explanation of Combining Two or More Methods 3-18 3.5.2 Application Example 4-1 4
REFERENCES 5-1 5
BIBLIOGRAPHY A-1 Appendix A Technical Evaluations B-1 Appendix B Part Classification C-1 Appendix C Determination of Consercial Grade item Designation Appendix 0 Establishing Procurement Requirements for Commercial 0-1 Grade items E-1 Appendix E Use of National Codes and Standards F-1 Appendix F Maintaining Seismic and Envirorunental Qualification G-1 Appendix G Specific Versus Generic Application of Commercial Grade items H-1 Appendix H Exhibits O
viii j.
4
l i
l l
i I
ILLUSTRATIONS I
U.9Et
.P998 1-1 Utilization of Comercial Grade Items 1-5 2-1 Generic Process for Acceptance of Commercial Grade Items Used in l
Safety-Related Applications 2-2 2-2 Acceptance Delegation _
2-10 1
3-1 Method 1 - Special Tests and Inspections 3-2 j
3-2 Method 2 - Commercial Grade Survey of Supplier 3-5 3-3 Method 3 - Source Verification 3-10 i
.l l
3-4 Method 4 - Acceptable Supplier / Item Performance Record 3-13
]
i A-1 Technical Evaluation A-2~
B-1 Distinctions Between Technical and Procurement Classifications B-3 l
l i
l l
i 1x
e e
i TABLES I
P,ggg T_ghlt 1-4 j
1-1 Typical Comercial Grade Products used in the Nuclear Industry 2-4
)
2-1 General Listing of Typical Critical Characteristics 1
2-2 Potential CGI Critical Characteristics for Generic Appilcation Items 2-5 2-3 Potential CGI Critical Characteristics for Specific Application Items 2-6 2-9 2-4 Acceptance Methods and Utility /Suppiter Activities-3-7 3-1 Typical Supplier Controls that Should Be Surveyed using Method 2 E-1 Examples of National Codes and Standards Associated with E-2 Commercial Grade Items l
l l
l xi
+
i P
1 I
I EXHIBITS Exhibit 1.
Example Worksheet for Parts Classification H-1 I
Exhibit 2.
Example Worksheet for Identifying Critical Characteristics-H-2 for a Commercial Grade Ites Exhibit 3.
Comercial Grade Items Supplier Survey Checklist H-3 Exhibit 4.
Application of Acceptance Methods for Typical CGIs H-7 Including Varying Procurement Scenarios i
i t
)
l i
i i
i xiii J
.-_-.~
t i
i GLOSSARY OF TERMS AND DEFINITIONS The terms presented below are referenced in various section, of this guideline and are used within the context of these definitions.
acceptable Sucolier/ Item Performance Record - A record of acceptable performance i
of a supplier's commercial' grade item which provides justification for a purchaser to accept the item for safety-related use.
AcceDtance - The employment of methods to produce objective evidence which f
i provides reasonable assurance that a comercial grade item received is the ites' specified.
j Basic Component - An ites procured either as a safety-related item or as a commercial grade item which has been accepted and dedicated for safety-related application. This ters is synonymous with " safety-related component".
Certificate of Conformance - A written statement, signed by a qualified party, certifying that the iter.s or services comply with specific requirements (definition from ANSI M45.2.10-1973).
Certificq11gn - The action of determining, verifying, and documenting that specified requirements are met.
Comercial Grade Item - An ites satisfying all three of the following cr'iteria':
1.
Not subject to design or specification requirements that are unique to nuclear facilities; Anil 2.
Used in applications other than nuclear facilities; And 3.
Is to be ordered from the manufacturer / supplier'on the basis of specifications set forth in the manufacturer's published product description (for example, a catalog) (definition from ANSI /ASME NQA-1-1986).
xv
l
^
i l'
i l
I' Commercial Grade Survey - Activities conducted by the purchaser'or its agent to 4
ify that a supplier of commercial grade items controls, through quality
.ver j
activities, the critical characteristics of specifically designated commercial.
l grade items, as a method to accept those items for safety-related use.
l Connodity ites - An item having a generic application throughout.a nuclear unit,.
which lends itself to bulk procurement (e.g, nuts. bolts, materials. 0-rings, _
i l
gaskets, indicator lights, fuses, relays, resistors, etc.).:
l 1
Conditionino - Any additional work or process imposed upon an item that makes it.
l j
different from nominally similar. items (definition from ANSI /IEEE STD 934-1987).
- l l
l Conditioning may include calibration, adjustment', tuning, selection testing, " burn-in", heat treatment, machining, and similar processes.
l
-l Critical Characteristics - Identifiable and measurable attributes / variables:of a-i commercial grade item, which once selected to' be verified ' provide reasonable -
i I
j assurance that the item received is the. item specified.
l Dedication - The point in time af ter which a commercial' grade item is accepted for 4
a safety-related application and deficiency reporting becomes the responsibility i
j of the party performing the acceptance.
Eauivalency Evaluation - A technical evaluation performed to confirm that an i
alternative item, not identical to the original ites, will satisfactorily perfom 1
its intended function once in service. This term is' synonymous with " Equal-to-or-Better-Than Evaluation".
1 j
M - Any level of unit assembly, including structures, systems, subsystems, i
subassembly, component, part, or material (definition from ANSI M45.2.10-1973).
Like-for-like Reclacement - The replacement of an ites with an ites th'at is.
~
identical.
Nonsafety Related item - An item which does not perform a safety-rel'ated function.
Part Numoer - A. supplier's assigned identifier for a commercial grade' item. Part number as used herein can also include identifiers such as model number, material type. grade Catalog reference number, etc.
xvi
a I
Post-Installation Tests Activities Conducted after installation of a Connercial grade item to verify recuired critical characteristics prior to placement in operation. An element of the "Special Tests and Inspection" method to accept an item for safety-related use.
Safety Related Component - A plant structure, system, component or part thereof, j
necessary to assure:
1.
The integrity of the reactor coolant pressure boundary, 2.
The capability to shut down the reactor and maintain it in a safe shutdown condition, or 3.
The capability to prevent or mitigate the consequences of accidents which I
could result in potential offsite radiation exposures comparable to those referred to in 10CFR Part 100,11 (definition also applies to a basic component per 10CFR21).
Source Verification - Activities witnessed at the supplier's facilities by the purchaser or its agent for specific items to verify that a supplier of a commercial grade item controls the critical characteristics of that item, as a method to accept the ites.
Special Tests and inssections - Activities conducted after receipt of a commercial grade item to verify one or more critical characteristics as a method to accept t
the item for safety-related use.
Standard Receipt inspection - Activities conducted upon receipt of items, i
including commercial grade items, in accordance with ANSI N45.2.2-1978 or ANSI /ASME NQA-1-1986 and NQA-2-1986 to check such elements as the quantity received, part number, general condition of items, and damage.
Supplier - The organization furnishing a commercial grade ites or basic component.
This could include an original equipment manuf acturer, part manufacturer, or I
distributor.
Technical Evaluation - An evaluation performed to assure that the correct requirements for an item are specified in a procurement document.
xvii
i i
i i
4
?.CRONWIS Acronyms and their meanings may not be generally known to the reader of this" document and as such, are provided as a convenience. - Acronyms ejgt have other
-j
~
i meanings in the nuclear industry. However, the meanings as given herein are as used in this document.
I acronym Meanino i
AFBMA Anti-Friction Bearing Manufacturers Association j
AISI American Iron and Steel Institute AMS Aerospace Material Specification ANS American Nuclear Society ANSI American National-Standards Institute l
API American Petroleum Institute l
ASL Approved Suppliers List j
ASME American Society of Mechanical Engineers ASTM American Society for Testing and Materials:
)
CFR Code of Federal Regulations CG Commercial Grade CGI Commercial Grade Item D00 Department of Defense EPRI Electric Power Pesearch Institute
]
EQAG Equipment Qualification Advisory Group EQDB Equipment Qualification Data Bank IE Inspection and Enforcement, Office of IEEE Institute of Electrical and Electronics Engineers IMPO MPROS Institute of Nuclear Power Operations Nuclear Plant Reliability Data Summary MIL-STD Military Standard NCIG Nuclear Construction Issues Group NEMA National Electrical Manufacturers Associat'.on MP Nuclear Power NQA Mucle e Quality Assurance NSSS Nuclear' Steam Supply System xix
d Acronym MeaninQ NOGEQ Huclear Utilities Group on Equipment Qualification 3
NUREG Nuclear Regulation NUS Nuclear Utilities Service Corp.
1 PO purchase order QA
. Quality Assurance j
QC Quality Control QPL Qualified Product List SAE Society of Automotive Engineers i
l SQUG Seismic Qualification Utilities Group UL Underwriters Laboratories, Inc.
USNRC U. S. Nuclear Regulatory Counission USI unresolved safety issue l
I i
I 5
l l
j i
XX 4
t i
i j
1 i
i i
r i
l SISMARY i
j This guideline provides direction for the procurement and use of Commercial Grade j
ltems (CGI) in safety-related applications. It is divided into five major i
sections. A glossary of terms and definitions, an acronym listing, and seven j
appendices have also been included.
j The glossary defines terms used in this guideline. In certain instances, the i
definitions may be unique to this guideline. Identification of acronyms utilized-i in this guideline is also provided.
Section 1 provides a background of the commercial grade item issues facing the -
nuclear industry. It provides a historical perspective of commercial grade ites i
issues. The basic processes being addressed in this document'are reviewed.
Section 1 also summiarizes the basic premises of this guideline.
I Section 2 discusses the generic process for the acceptance of a commercial grade item for safety-related use. The benefits of evaluating the safety function of a j
part in a safety-related component are discussed. The need to confine whether an j
ites is commercial grade is addressed, as well as the need to establish critical-characteristics of a part prior to acceptance of a comunercial grade ites. The selection of acceptance methods is briefly discussed.
j 4
Section 3 defines the four distinct methods used to accept' cosanercial grade ' items I
for safety-related applications. Each acceptance method is discussed in detail l
and guidance is given on how to implement each method. The situation where it is l
beneficial to use more than one acceptance method is also reviewed with examples of using two or more methods in combination.
I l
Section 4 lists specific references that are identified in this guideline.-
Section 5 is a bibliography of documents that were considered in developing this 1
guideline, but were not directly referenced in the document.
3 j
s-1 1
l The seven appendices elaborate on certain subjects addressed in this document..
Appendices 8 through G are intended for optional use. Four exhibits are included f
which provide illustrative examples to assist'the user in employing the: acceptance methodologies.
f
^
P k
[
h a
i I
9 l
h r
s I
.I t
l:
' 5-2
.t
-l
1 i
l Section 1 BACISROUND AND 00C18ENT BASIS 1.1 BAC15ROUND l
1.1.1 11333 A challenge the nuclear industry faces is to establish a consistent guideline for the utilization of commercial grade items. The lack of specific implementation direction in existing documents has resulted in inconsistent interpretation,
)
implementation, and enforcement.
This guideline has been prepared to satisfy the following current nuclear industry -
needs:
An acceptance process which provides reasonable assurance that a e
commercial grade item received is the item specifie1.
Alternatives which provide flexibility in the selection of the most' e
prudent acceptance method on a case-by-case basis.
Acceptance methods which are definitive to minimize e
misinterpretations.
Acceptance methods which are consistent with regulatory
]
e requirements.
i 4
Factors contributing to the need for this document include:
Most nuclear plants in the United States are now in an operational e
phase. In this phase, spare and replacement parts for components, as well as complete components, are being purchased. A significant-number of these items are commercial grade itecs.
Because of the reduction in new nuclear power plant construction.-
some suppliers are discontinuing existing nuclear quality programs.
In certain instances, spare and replacement items can only be procured as comercial grade items.
1-1
.-~
j 4
I
~
I 1.1.2 Nistory When 10CFR50, Appendix B was issued, it did not specifically addres; the subject l
of commercial grade items. This regulation establishes baseline' programmatic i
requirements to assure the quality of safety-related items._ The introduction j
l to 10CFR50, Appendix B states' I
a i
I "As used in this appendix, ' quality assurance' comprises all those planned and systematic actions necessary to provide adequate confidence that a structure, system, or component will perfom satisfactorily in-service." (1) j l
C*iteria III and VII of 10CFR50. Appendix 8 establish controls to assure the i
correct safety-related items are specified and accepted. These controls are also I
applicable to comunercial grade items intended for safety-related use.
l 1
b ANSI N18.7-1976 (1), as endorsed by USNRC Regulatory Guide 1.33 (1), was the first f
riuclear standard to specifically address comunercially'"off the shelf" items. This l
standard states that spare and replacement parts found to be commercial "off the l
shelf
- may be similarly procured as the original item or part, but care must be' 4
exercised to assure at least_ equivalent performance. The care needed to be
.)
exercised is left to the purchaser's discretion.
d fhe USNRC issued 10CFR21 on June 6,'1977 (1). This document gives instructions on l
l the reporting of defects and noncompliances that could create substantial safety l
i hazards. As originally written, 10CFR21 reporting requirements applied to all parties in the procurement process, including suppliers providing commercial grade items. Each party in the procurement process was required to impose 10CFR21 on j
i its purchase orders to subtier suppliers. As purchase orders were issued invoking
[
l 10CFR21, many subtier suppliers began to reject these purchase' orders.
j i
The October 1978 revision to 10CFR21 exempted suppliers of commercial grade items l
from 10CFR21 reporting responsibilities. Despite the reporting exemption,
[
regulatory requirements still require commercial grade items used in safety-related applications to be addressed in the. purchaser's 10CFR50 Appendix B l
2 quality assurance program.
31 i
The action taken to utilize a commercial grade item in a safety-related'
]j application has commonly been called dedication by the nuclear industry. The
)
i October 1978 revision to 10CFR21 required an item to be dedicated before it could l
I 1-2 ii i
i-ll l
i 1,
i I
be used as a basic component. The term dedication defines the point in time when l
the commercial grade item becomes subject to 10CFR21 reporting requirements.
j Increased attention has been focused on cosmiercial grade item procurement practices in the nuclear industry in recent years. Reasons for this emphasis l
l include:
i Shift in procurement activity from original equipment to spare j
i e
j parts and replacement items.
f Lack of consistent controls in commercial grade item procurement e
l l
practices.
Inspection findings against utility control of commercial grade j
e
)
items.
j Difficulties encountered buying items due to suppliers j
a discontinuing 10CFR50, Appendix B quality assurance programs.
i i,
1.1.3 Comunercial Grade Items Nuclear power plants are constructed of components designated either j
safety-related or nonsafety-related. A safety-related camponent is subject to 10CFR50 Appendix B quality assurance program requirements which mandates planned-f and systematic actions to control the quality of safety-related components. These controls are achieved in the nuclear industry through utility and supplier quality i
assurance programs.
Safety-related items need not be procured from suppliers that maintain a 10CFR50, Appendix B quality assurance program, provided that the items meet the commercial j
grade item definition. The definition of a casumercial grade item is an ites:
Not subject to design or specification requirements that are unique e
to nuclear facilities, ADA Used in applications other than nuclear facilities, and l
e Is to be ordered from the manufacture,r/ supplier on the basis of i
e specifications set forth in the manufacturer's published product I
description (forexample,acatalog).
Examples of typical consnercial grade products used in the nuclear industry are as listed in Table 1-1.
I i
i I
j 1-3 l
4
i f'
i i
1 Table 1-1 l
TYPICAL C0letERCIAL GRADE PRODUCTS USED IN THE NUCLEAR INDUSTRY q
i Anchor Bolt Limit Switch Shaft Coupling l
l Ball Bearing Lubricating Grease /011 Solenoid Valve l
Bolting Material (e.g. plate, angle)- Spiral Wound Gasket l
Control Switch Motor Spring j
Cotter Pin Non-Metallic Diaphraga Temperature Switch Crane Wheel Axle 0-ring Teminal Block Drive Belt Pinion Gear
~3rminal Connector Filter Regulator Assembly Pressure Switch iorque Switch Framing Device Pump Impeller Transistor t
Fuel Oil Pump Mechanical Seal./.ssembly Transmitter 1
Fuse Relay Valve Packing Gland t
Impeller Key Resistor Valve Seal Ring Integrated Circuit Roller Bearing Valve Stem i
l Commercial grade items used in safety-related applications can be shown to be i
equivalent in quality to a safety-related.ites purchased as a basic component.
t For example, many commercial suppliers have excellent quality programs that satisfaccortly control their products. Other suppliers have satisfactory undocumented controls that assure a conforming product is supplied. Original I
equipment manufacturers select suppliers based on a variety of factors including demonstrated perfomance and reliability.
i 1.2 UTILIZATION OF CO M RCIAL GRADE ITEMS j
The utilization of commercial grade items intended for safety-related applications 4
involves two distinct processes:
I i
- )
{
A technical evaluation to assure that requirements for an
}
acceptable'ites are specified in the procurement document.
5 t
Acceptance methods to reasonably assure the item received is the
}
item wnich was specified.
4 4
1-4 j
1
i i
The technical evaluation process provides a means to specify the correct requirements for an item in a procurement document. If a supplier can furnish a f
like-for-like replacement, only a minimal technical evaluation may be required in developing procurement specifications. Reliance is placed on the engineering performed by the original equipment manufacturer during the initial design.
Identification by the part number and descriptive nomenclature is normally l
I adequate to ensure that the correct item is specified. If a supplier can only offer an alternative ites, a technical evaluation should be conducted to assure equivalency. A detailed discussion of this technical evaluation process is provided in Appendix A of this document.
The acceptance Esthods for consnercial grade items provide reasonable assurance that the item received is the item which was specified. This guideline concentrates on the acceptance process consisting of measures that assure-the correct item has been supplied. The selection.of the appropriate acceptance method and its application will vary based upon many factors which will be discussed throughout this guideline.
To utilize a conumercial grade ites in a safety-related application, reasonable actions must be taken to assure the item is appropriate for its intended application. The technical evaluation in combination with an appropriate acceptance process provides the assurance that the specified item is adequate to meet 10CFR50, Appendix B requirements. This concept is depicted in Figure 1-1.
Conumercial Grade Ites y
Technical 1
Acceptance Evaluation T
Process (See> Figure A-1)
(See Figure 2-1) n Dedicated Item Purchased as a Basic Commercial
=
Component to 10CFR50, Gr&de Item Appendix B Requirements Figure 1-1.
Utilization of Conumercial Grade Items 1-5
(
1.3 BASIC PREMISES OF THE GUIDELINE 1.3.1 Desian of Connercial Grade Items This guideline assumes that the design requirements of the ites have been satisfactorily translated into specification requirements as reflected in the procurement document. The purpose of the technical evaluation is to assure that i
the specification requirements are correct. The acceptance process reasonably I
assures that an item received is the item which was specified in the procurement.
document.
1 1.3.2 Eauivalent Performance Equivalent performance is confirmed by conducting the technical evaluation to ensure the item specified meets design requirements.. Acceptance assures that the item received is the item which was specified in the procerement document; The-combination of the two activities, therefore, assures that the item received and j
accepted will perform in an equivalent fashion to the ites being replaced.
Neither activity need be conducted with the intention of improving the expected j
performance of a replacement commercial grade ites.
1.3.3 Part Number Verification Part number verification is an integral step in the acceptance of comercial grade items and is included in each of the four acceptance methods. Verification of a part number and the utilization of the acceptance methods'in this guideline provide assurance of acceptability.
Since suppliers furnish comercial grade items for general industrial use, they may change the product design or the manufacturing process, and not the part-number. These actions are taken without concern for the nuclear end user's design l;
requirements. The methods described in this guideline provide various means to l
accept a consercial grade item without sole reliance upon part nunoer j
~
~
verification.
l l
1.3.4 Guideline.onsistency with Reaulatory Reauirements r
The methods in the guideline are in conformance with existing regulatory requirements. The methods for accepting commercial grade items are consistent with the provisions of Criterion VII of Appendix B to 10CFR50 which states:
" Measures shall be established to assure that purchased material, equipment, and services, whether purchased directly or through 1-6 l
l
l I
s contractors and subcontractors, conform to the procurement documents.
These measures shall include provisions, as appropriate, for source f
evaluation and selection (Method 21. objective evidence of quality furnished by the contractor or subcontractor [ Method 4l,-inspection at the contractor or subcontractor source [ Method 31,~ and examination of products upon delivery (Method 11." (1)
Each acceptance method in this guideline is depicted in brackets'after the specific regulatory justification for that method. The acceptance methods-provided in the guideline are:
Method 1 - Special Tests'and Inspections 1
Method 2 - Consercial Grade Survey of Supplier Method 3 - Source Verification Method 4 - Acceptable Supplier / Item Performance Record 1.3.5 Uniformity and Flexibility This fuideline provides the detailed guidance that will permit the establishment and implementation of unifor1s nuclear industry practices for the acceptance of commercial grade items. The guideline permits flexibility in the selection of the most appropriat'e method or combination'of methods to accept commercial grade items. This flexibility allows utilities to incorporate this guideline into their individual procurement, quality assurance, and engineering practices.
)
1.3.6 Acceptance Documentation This guideline emphasizes that the acceptance process and the acceptance of an item must be documented. The flow diagrams (see Section 3) for each acceptance method designate when acceptance documentation should be developed.
e,'
i C
.f -
J
$U l
1-7
i l
t t
i Section 2 GENERIC PROCESS i
The generic process for acceptance of commercial grade items contains four alternate methods. Figure 2-1 depicts,' in flowchart form, the generic process for -
accepting a commercial grade item for installation in safety-related applications.
j i
Before the appropriate acceptance method can be selected for a particular replacement / stock item, the following three fundamental issues should be addressed.
l
)
Determine the safety function of item.
e I
Confirm the item is commercial-grade Identify critical characteristics.
1 e
Although Figure 2-1 shows these fundamental issues as part of the acceptance.
l process, the purchaser may choose to address them during the technical evaluation.
l If this is accomplished, the issues need not be addressed again during the acceptance process.
2.1 DETERMINING SAFETY FUNCTION OF ITEM The first step is to perform an evaluation to determine if an item is
- )
safety-related based on its function. This evaluation is optional and need not be performed if it is assumed that the component or all items within.the component are safety-related. Appendix B of this document provides additional guidance on determining the safety function of an item.
By implementing the process discussed in Appendix B of this document, many items installed in safety-related components can be shown to have a nonsafety-related function.
j 2.2 CONFIRMING ITEM MEETS DEFINITION OF CODMERCIAL GRADE =
1 The second step is to confirm that the item meets the criteria set forth in the l
connercial grade item definition. If the' item does not meet the criteria stated in the definition, it must be procured as a basic component or by other means not 2-1
.~..
~..
...=.
=
7 e
p i
l IDENTl8Y REOUIRf D tTEM5 l l
-l BY ME AN5 OF TECHNICAL l
EVALUATION
' (See Appendis Al i
j 6
g DOE 5 tTEM
'No PROCURE ITEM PERPORM 1AFETY y
NON5AFETV f
FUtdCit0NT '
(See Sutnecten 2.1) i
'Yt3 i
5 9
I DOE 5 NO in M WET CRITERIA OF CGI j
PaoCUnfITEM A5 2
8 A5aC COMPONE NT OE8sNITIONS r
(See Subsemon 2 2) s YES 5 r c
- DENTsFY CRITICAL (5ee Sutnecten 2 3) -
CHA8.ACTERl5T4C5 i
I
, e k
I DOCUMENT aESULT5 h
s r i
SELECT (See Suteoct.pn 2 a)
ACCEPT ANCE METH00 -
[
' F t
i
.i I
COMesNAft0N OF i
METHOD METHOD METHOD METHOD TWO OR Moat 1
2
- 3 a
OF THE FOUR METHOO5 t
(See Sutnecten 3.1)
(See Sutnecten 3 2)
(See Sutnecten 3 3)
(See 5uteocton 3 4)
(See Suteocton 3 5)
I I
I
-I i
9F I
ITEM ACCEPTED
- t
- Deficiency reporting responsibility accepted.
i Figure 2-1.
Generic Process for Acceptance of Cossnercial l
i Grade Items U5ed in Safety.Related Applications T
2-2
}
t k
i
... ~..
t
i o
l I
addressed by this guideline. Appendix C of this document provides additional l
guidance for classifying items as comercial grade, j
i 2.3 IDENTIFICATION OF CRITICAL CHARACTERISTICS-l The third step is the identification of the critical characteristics to be l
verified. Critical characteristics are identifiable and measursble attributes / variables of a comercial grade ites which once verified, provide j
reasonable assurance that the ites received is the item specified.
Based on the performance and design basis for an ites, a variety of l
1 characteristics can be identified that are critical for satisfactory performance.
l However, for purposes of establishing critical characteristics for acceptance, only certain of these must be verified to provide reasonable assurance that the item specified is the item received.
l Comercial grade items which perform safety functions inherently have one or more characteristics critical to assuring equivalency to the ites it is intended to
~
replace. The item's part number by definition is a critical characteristic.
i Verification of a part number and the acceptance methods in this guideline provide assurance of acceptability. The acceptance methods in this guideline provide j
additional assurance of acceptability without sole reliance on the part number.
~
2.3.1 Troes of Critical Characteristics l
f Critical characteristics that could be identified, in addition'to the part number, are physical characteristics of an ites, identification markings, or performance characteristics of the item. A general listing of typical critical i
characteristics is provided in Table 2-1.
l 2.3.2 Selection of Critical Characteristics The selected critical characteristics are based upon the complexity, intended safety function, and performance of the commercial grade item. A listing of
)
typical comercial grade items, their intended application, and potential critical I
characteristics is provided in Tables 2-2 and 2-3.
The potential critical characteristics associated with the items in Tables 2-1, 2-2, and 2-3 are provided
~
~
~
for illustration on1y to instruct the user of this guideline. These lists are not intended to be all inclusive or exclusive of critical characteristics which may be deemed important by the purchaser to specific applications. It is only necessary to identify and verify the appropriate critical characteristics which provide reasonable assurance that the item received is the item specified..
2-3 l
i 4
l i
i Table 2-1 1
GENERAL LISTING OF TYPICAL CRITICAL CHARACTERISTICS i
l Product identification Color coding industry standard merkings Display type (scale, graduations)
Nameplate data Enclosure type Part number / unique identifier t
Phnical Characteristics j
lalance Drop point Oil / water separation I
Capacitance Ductility Permeability Cloud point Durometer hardness Plating Coating Elasticity Pc,'arity Color Fatigue resistance Pour point 4
I Composite material Flammability Purity hardness Flash point Resilience Concentration General configuration Resistance Conductivity orshape 5'olubility Continuity Hor.iogeneity Spring constant Density / specific Inductance Surface finish gravity Leathable halogen Surface hardness Dielectric strength content Tensile strength Dimensions (to within Luminescence Torque manufacturer's Material of Viscosity tolerance) construction Weight Pe formance Charactenstics Accuracy leakage Pressure drop turn-in endurance Load rating Pressure rating i
Chatter Open/ closure time.
Repeatability Current rating Operability (fall Ride out Cycle time open/close, stroke)
Rotational directior:
Deadband width Operating range Set point stability Flow rate Performance during (no drift)
Gain under voltage Speed Horsepower conditions Time / current response input / output voltage Pick up/ Drop-out Voltage rating Interrupt rating
- voltage Interrupting current Power rating 2-4
l j
I i
Table 2-2 POTENTIAL CGI CRITICAL CHARACTERISTICS FOR GENERIC APPLICATION ITEMS I
i Commercial Grade item Critical CharacteristicsW j
Seating l Configuration, dimensions, load rating, matonal, model number Bolting Configuration, dimensions, pitch, matenal, tensile strength, l
hardness, plating O-ring Dimensions, material, durometer hardness, alongation, leachable j
halogens Terminal tiock
. Configuration, voltage rating, current rating, materials, dielectric
! strength Crimped Terminal Connector Configuration, material, dimensions (wire sire, ring tong size),.
l voltage rating, continuity, tensile pullout strength, color l
Relay Configuration, pick up/ drop-out voltage, voltage rating, current rating, chatter, response time Fuse Configuration, current rating, interrupt retmg, time / current I
response, dimensions Resistor Configuration, markings, resistance, power rating Drive Belt Dimensions, cross sectional shape, ndeout, fatigue resistance, load rating, material, tensile strength Spiral Wound Gasket Configuration, dimensions, markings, style number, materials (filler and wmdings), pressure reting,leachable halogens, spiral density Cotter Pin Configuration (point type), dimensions, matenal, finish, hardness Pressure Switch Configuration, dimensions, material (pressure retaining parts),
voltage rating, response time, accur
, nameplate data, pres.sure range, wire rating, enclosure type, d'
' strength (insulation),
deadband width Temperature Switch Configuration, dimensions, material, voltage rating, response tima, accuracy, nameplate data, temperature range, were rating, enclosure type dielectric 6....ft. (insulation), deadbend width Lubricating Groase/ Oil Color,s ye gravity, viscosity, drop point, cone penetration, pour
- point, scal composroon, cloud pomt Fuel Oil Density, flash point, cloud point, pour point, kinematic viscosity, chemical composition, gtu rating Framing Device Configuration, shape, dimensions, matenal, tensile strength, coating Material (e.g., plate, Angle)
Dimensions, shape, meterial, tensile strength, hardness, ductility, markings, coating (a) Part number is a critical characteristic for each item.
Notes:
1.
These potential critical characteristics are provided for illustration only.
2.
The lists are not intended to be allinclusive or exclusive of uitical characteristics which may be deemed important by the purchaser.
2-5
l, 1
]
i Sheet 11'of 2 Table 2-3 POTENTIAL CGI CRITICAL CHARACTERISTICS FOR SPECIFIC APPLICATION ITEMS' 1
I l
Commercial Grade item CriticalNracteristicW)
(Application)lal Valve Stem (Active, low pressure Configuration, dimensions, material, tensile strength, cooling system globe valve, ductility, finish, markings, hardness sessmically and environmentally qualified).
J Pump impeller (Make-up Water -
Configuration, dimensions, matenal, hardness, balance, flow Transfer Pump) rate -
Motor (Cooling floom Fan)
Nameplate data (horsepower, speed), insulation class, frame site, materials, weight, shaft type, coupling type, bearing types Nonmetallic Diaphragm (Air operator Configurstion, dimensions, material,durometer hardness.
for a globe valve, seismically and reinforcement material j
environmentally qualified) j i
1 Solanoid Valve (Torus vacuum Configuration, size, pressure rating, materials, voltage rating, breaker) current rating, coil class, open/ closure time --
Limit Swetch (Electric motor operator Configuration, dimensions, materials (metallic and for a gate valve,seismicelly and nonmetallic), markings, operability, voltage rating, current environmentally qualified) rating Impeller Key (Auniliary Feeewater Conf 6guration, dienensions, material, hardness Pump)
Spring (Pressure relief valve, Confiouration, dimensions (free length, coil diarneter), spring _
seismically qualified) rate, finish Valve pecking Gland (Active control Conf 6gurstson, dimensions, material, tensile strength. -
valve,seismetally qualified) herdness, finish -
Filter segulator Assembly (Ifigh Configuration, dimensions, materials, flow rate, pressure.
Pressure Control Valve, seismecally range, pressure rating, temperature rating, filter micron site qualified)
Pinion Gear (5 pent fuelendge Crane Configuration, dimensions, material, hardness, pitch '
Hoist)
Crane Wheel Amle (Spent Fuel Bridge Configuration, dimensions, material, tensile strength.
Crane) hardness, finish Shaft Coupling (Diesel Generator)
Configuration, dimensions, materials, hardness Anchor Bolt (Seismically Qualified Configuration, dimensions, material, wedge hardness, pitch Concrete Anchor)
Torque Switch (Operator for globe Configuration, dimensions, materials (metallic and -
valve, seismically and nonmetallic), operability.
environmentally qualified)
PumpMechanicalSeal Assembly Configuration (completeness of assembly), materials, finish.
(Service Water Sooster Pump) leakage,leachable halogen content, dimensions -
I 2-6 i
, _. -, ~. _.... ~. - - -.. - - - - -.
- ~ - - -
J j
i i
i
(
Sheet 2 of 2 Table 2-3
)
POTENTIAL CGI CRITICAL CHARACTERISTICS FOR SPECIFIC APPLICATION ITEMS I
)
j Commercial Grade item Criticalhstid (Application)(a) 1 Valve Seal Ring (Emergency C!osed Configuration, material, dimensions, finish, leakage Coolmg System Globe valve) l Integrated Circuit (Reactor Protection Configuration, gain, input /oKput impedance, C : xy j
System) responses, operability
)
Pressure Transmitter (Main Steam Configuration, voltage rating, current output, pressure mting, Isolation Valve Air Accumulator) matenals, accuracy Control Switch (Reactor Building General configuration, contact configuration, voltage reting.
Sump Reset) current rateg, materials, dimensions, operability j
i Transistor (Uninterrupted Power Markings, gain, input / output impedance, current rating, Supply) voltage rating, operability '
1 J
l j
(a) Seismic and environmental qualification pertain to the parent component.
I (b) Part numberis a entical characteristic for each item.
i Ngitt:
2 1.
These potential critical characteristics are provided for illustration only.
- 2. The lists are not intended to be all inclusive or esclusive of critical characteristics which may be
.j deemed important by the purchaser.
I Conniercial grade items intended for it.sta11ation in seismically or envirormentally qualified applications require critical characteristics necessary to assure that the original qualification of the parent component is maintained. A discussion on -
maintaining seismic and environmental qualification is provided in Appendix F of this document.
Connercial grade items intended for generic safety-related applications rather than for installation in specific applications require special consideration when selecting critical characteristics. Critical characteristics should be selected based on the most severe conditions encountered in the generic application unless -
controls are in place to prevent inappropriate use. These controls should be sufficient to ensure that cosmiercial grade items are not used in applications for which they have not been svalvated and accepted. A discussion regarding generic and specific applications is provided in Appendix G of this document.
2-7 w
l 2.4 SELECTING APPROPRIATE ACCEPTANCE METHOD The four methods that can be used to accept commercial grade items are:
Method 1 - Special Tests and Inspections Method 2 - Commercial Grade Survey of Supplier Method 3 - Source Verification Method 4 - Acceptable Supplier / Item Performance Record.
Table 2-4 provides an overview of the four acceptance methods. It depicts the-activities the purchaser and the supplier perform when employing each acceptance-method.
The four acceptance methods provide, either individually. or in combinations, a j
means to reasonably assure that a consercial grade item which is received meets l
the requirements of the item specified. The results of employing each method i
should be documented by the purchaser.
1 The selection of a method or combination of methods for a given commercial grade l
item should be based on factors such as: (1) selected critical characteristics, (2) available supplier information, (3) quality history, and (4) degree of I
standardization.
l 2.5 ACCEPTANCE DELEGATION This document is intended for organizations responsible for accepting commercial grade items for safety-related use. This includes utilities as well as suppliers that are delegated the acceptance responsibility. In either._ case, the party responsible for acceptance of the commercial grade item must include.the -
acceptance process within its 10CFR50 Appendix B program. Figure 2-2 depicts this point.
2.6 REPORTABILITY Alm TRACEABILITY The reportability and traceability of commercial grade items accepted for use in safety-related appl 1' cations should be controlled in accordance with the i
purchaser's reportability and traceability programs applicable to other safety-related items.
r i
2-8 l
e
l t
Table 2-4 f
ACCEPTANCE METHODS AND UTILITY / SUPPLIER ACTIVITIES 1
Speofic Supplier Activities Acceptance Method Specific IJtility Activities Furnish technical design information to enable kav ermine sample sire.
e v
utility t verify critical characteristics Determine post-installation testing requirements Method I e
Determine special receipt tests and inspections.
e special Tests and Auept item via special receipt inspections.
Inspections e
Auept item via post-instaff ation testing.
implement controls necessary to verify critical E
o Conduct survey of CG program e
charatteristics.
Require the su ser to invoke the controls necessary io e
with a Certificate of Conformance f,',,
o,"ti "b
g Commercial Grade Survey Auept item based on supplier Cetlificate of Conformance y
of Supplier venfied by CG survey.
e
- Conduct source verification.
e - Implementitem-specificMp, fabrication, at\\on for Auept item based on documented source verification of E t
the c
Method 3 results.
a partitular commercial gradeitem.
Allow utility auess to facilities to conduct source
. Source Verification e
verifitation.
e Respond to CG Pr am Controls Questionnaire.
Establish documented performance record.
e (See Shtion 3. 3, item 3.e)
Monitor performance of item.
- E c
i th national codes and Method 4 e Confirm icability of independent product test results.
,'{
INPO NPR, commercial program audets/ surveys
- conducted by industry groups, utilization of national codes -
Aueptable Supplier /ttem and standares, supplier responses to CG program controls, Performance Record results of periodic maintenance surveillance, results of suuessfully employing other acceptance methods.
Auept item by issuing certification which is based on e'
supplierhtem performance record.
1 1
1
~
=
m
r l
(
i i
UTILITY PERFORMS ACCEPTANCE Item procured by utility as a commercial grade item.
e Acceptance performed by utility using Methods 1 through 4-e described in Section 3.
Acceptance controlled under utility's 10CFR50, Appendix B e
program.
L UTill!Y DFLEGATES ACCEPTANCE Acceptance perfo:med by suppliers using Methods 1 through 4.
e Acceptance controlled under supplier's'10CFR50, Appendix B i
program.
Ites procured by utility as a basic component.
l e
l Figure 2-2.
Acceptance Delegation i
6 I
2-10 4
~
l 1
j Section 3 ACCEPTANCE METH005 f
3.1 ETH001 - SPECIAL TESTS AND INSPECTIONS l
3.1.1 Exclanation of Method 1 Figure 3-1 is a schematic logic diagram for accepting a commercial grade item by conducting special tests and inspections. The special tests and inspections j
should be ccnducteo during or after receipt of an item to verify selected critical characteristics. The special tests and inspections may include post-installation tests. Although the part number is considered to be a critical characteristic, this guideline provides the purchaser the flexibility to verify it during their standard receipt inspection.
I 3.1.2 Apolication of Method 1 i
l Method 1 should be used when the purchaser desires to verify critical characteristics after the item is received. The purchaser can apply.this method 9
to all commercial grade items when sufficient data exists to perform appropriate inspections and tests. However, Method 1 is most appropriate for:
1.
Items furnished from multiple suppliers, 2.
Items that are relatively simple in nature,'and-
{
3.
Items on which post-installation tests can be conducted to' verify critical characteristics.
The critical characteristics data is generally available in existing documents f
such as specifications, drawings, instruction manuals' bills of material, and.
catalogs. Interface with the supplier may be necessary to obtain the required data. Where sufficient data to utilize Method 1 cannot be obtained.from suppliers because of proprietary considerations, other methods of acceptance must be considered.
In summary, Method 1 is valuable because the purchaser controls the verification of selected critical characteristics utilizing special tests and inspections.
j Method I should be used if the technical data are known, test facilities are 3-1 j
1 1
e
~
l
~
f rom Genent P ocess s.gwre 21 1P ESTAtuSH PunCHA5E 5 ELECT CRITICAL 5AMPUNG ORDER REQusREMENT5 CHARACTERr$ TICS to BE
' ptAN VERIFIED PROCURE ANDRECElvt
, p (STA8Lf5H ESTAtuSM SPECIAL TEST 5 4
ANO INSPECTONS 4
CONOuCT 5TANDARD YE5 PE RM)RM SPECIAL g
RECEIPT touSPECTION
.r RECElpt TESTS AND INSPECTO NS h
4 oi DOCUMENT RESUL75 CAN SPECIAL DOCUMENTRESUL75 lsu RtCEtPTTESTS AND l
9F L asc.PECTCNS VERif Y CRateCAL -
CHARACTERISTIC 5' NO V
9 r CAN CONF #RMITEM #5 TME l, VE5.
POST-4NSTALLAT:04 ur l
TEST 5 VER6FY CRITICAL CORRECT PART Fon THE INTENDED APPLICATCN CHARACTERr5tc?
h
- NSTALL CGI h
CONDUCT 5tANDARD MAINTENA8eCE TESTS ANDINSPECTONS WERESPECAL RECEIPT TEST 5 '
CON 560ER A880 M CTC NS No ALTERNATIVE t
ACCEPTANCE 7
PEmp0RM 5PECM y
METHOO5 P0$fMTALLATION CMARACTERr5 TIC 5' TE:TueG E
l DoCUMENTRE5utT5 TE5 I
J ACCEPT L
i vg ITEM g,
j (1) These documented results constitute objectio evidence to provide reasonable assurance that the CG is acceptable Ior its intended use.
(2) Each entical characteristic needs to be only verified once (at receipt or post instattation). One of i
these decision points must be answered Yf.S in order to employ Method 1. If both are NO, Method 1 cannot be used and other methods should be considered.
(3) Although part number is considered to be a critical characteristic, the purchaser may versfy it '
during their standard receiptinspection.
i Figure 3-1.
Method 1 - 5pecial Tests and. Inspections l
3-2 i
's
i available, and the items are such that inspection and tests upon receipt are adequate to verify critical characteristics. Method 1 may also be used in comDination with other acceptance methods. Combining acceptance methods is discussed in Subsection 3.5.
3.1.3 Employment of Method 1 Critical characteristics must be verified either via special receipt inspections i
and tests, or post-installation tests. These inspections and tests should be' performed in addition to, or in conjunction with, the standard receipt inspection, lo employ Method 1, critical characteristics should be verified by developirig a documented plan or checklist. This plan / checklist should include:
1.
Tests and inspections to be performed.
2.
Test methods and inspection techniques to be utilized (documented test and inspection procedures may be required as appropriate).
3.
Acceptance criteria previously derived from the technical evaluation (see Appendix A) specific to the characteristics being verified.
4.
Documentation requirements for inspection and taist results.
The test and inspections may be performed utilizing a sampling plan when appropriate.
post-installation tests may be performed as a part of standard maintenance tests
-if appropriate.
The purchaser may subcontract the special inspections and tests by utilizing the services of a purchaser approved test facility.
Once the critical characteristics are verified via special tests and inspections, the purchaser may accept the item for use in safety-related applications, j
Documenting the results of the special tests and inspections constitute objective l
evidence.
A valve stem is an example of an item for which special tests and inspections
)
could be used to accept this item. The critical characteristics to be verified j
for this item would be material of construction, dimensions, material hardness.
- -3 2
i
i I
L i
f These critical characteristics could be verified with the l
and part number.
following special tests and inspections:
i 1.
Material of Construction: Verify utilizing a spectrographic alloy analyzer.
If the dimensions are known, verify utilizing calibrated.
2.
Dimensions:
measuring devices. If the dimensions are not known, verify dimensions by.
l confirming the valve stem's fit with a post-installation test by stroking the.
valve.
i 3.
Material Hardness: Verify utilizing a hardness tester.
l Verify during the standard receipt. inspection.
j 4.
Part Nuuter:
5.
Configuration: Verify against supplier's drawing.
i 3.2 METH00 2 - C010ERCIAL GRADE SURVEY OF SUPPLIER i
3.2.1 Exclanation of Method 2 t
Figure 3-2 is a schematic logic diagram for accepting a commercial grade' item by conducting a commercial grade survey of a supplier. The survey;is a means by'-
which the purchaser can take credit for the commercial controls that the supplier f
I exercises on a given item or line of replacement items.-
!)
3.2.2 Ano11 cation of Method 2 Method 2 should be used when the purchaser desires to accept commercial grade items bssed on the merits of a supplier's commercial quality controls.- These controls may constitute quality programs, procedures,'or practices. The supplier may either be:
5
{
1.
An approved nuclear supplier maintaining both a consercial program and a 10CFR50, Appendix 8 Quality Assurance program, or-2.
A consercial grade supplier without a 10CFR50, Appendix B Quality assurance.
l p ogram.
f Consnercial grade surveys can be conducted of suppliers who are!'
f 1.
NSSS suppliers, 2.
Original equipment manufacturers, 3.
Original part manufacturers, or 4.
31stributors.
3-4
i i
r+om Generc process s.gw+e 2 '
1 CONDUCT SURVEY OF CG
$UPPLIE R CONTROL 5 mv e5 CGI CONTROLLED ai NO UNDE R SOME SUPPLif R QUALITY ACTivlTIESS h
CON 5:0E R ALTEPNATIVE 1F
'F ACCEPTANCE aL VETHOOs DO C0 5UP'L'IR NO up ACTIVtTiE5 ADEOUATELY CONTROL CRITICAL CHARACTEpiSTIC5 OF CGIS
?
vE5
,r DOCUMENT aESULT5 ESTABLISH PURCHASE ORDER
- EOutREMENTS h
PROCURE AND RECEIVE ITEM 4
CONDUCT STANDARO RECEIPT INSPECTION
,r ACCEPTITEM aA5ED ON SUPPLIER CERTIFICATE OF CONFORMANCE VE RIFIE D tV CG 50RVEY m
DOCUMENT RESULTS (1) These documented results constitute objective evidence to provide reasonable assurance that the CGl as acceptable for its intended use.
1 (2) Supplier controls may constitute commercial quality progs ams, procedures, or practices.
(3) Purchase order reavirements should invoke the programmatic control 5 necessary to assure the 1
acceptaO+tity of the CGl.
(4) Certificate of Conformance should confirm that the required Quality Control activities were invoked by the suppher.
Figure 3-2.
MethOc 2 - Comercial Grade Survey Of Supplier 3-5 I
L.
I
A comercial grade survey can be used to accept simple or ccmplex items. The-method is most appropriate in the following situations:
1.
A single supplier of the comercial grade item is _being used.
2.
Required technical information cannot be obtained from the supplier.
3.
A large group of items are repeatedly procured from a supplier for an entire line of components.
4.
The comercial grade item is an assembly of many parts.
5.
The purchaser cannot easily verify critical characteristics by inspections or tests.
i Significant technical and quality information about a' supplier s line of replacement items can be obtained during the survey. This information can-subsequently be used in other acceptance scenarios as necessary.
Where a supplier demonstrates adequate controls, only verification of the part.
nuabar and the supplier's Certificate of Confomance is required during the -
standard receipt inspection to complete item acceptance. Maximizing reliance on the supplier's controls will minimize the need to augment acceptance with Method 1 upon receipt.
3.2.3 Eanloveent of Method 2 Two basic criteria must be met when conducting a comercial grade survey. The purchaser must confirm that the selected comercial grade item's critical characteristics are controlled under the scope of comercial quality system activities. The purchaser must also be reasonably P.ssured that the comercial supplier's activities adequately control the commercial grade items supplied.
The survey criteria and the supplier controls will vary from item to ites. The survey criteria and necessary supplier controls should be determined by the purchaser and will depend on the_ number and type of. critical characteristics. -The survey should be specific to the scope of the particular. commercial grada item (s) being purchased. When many items are purchased from a supplier, a survey of representative gr'oups of commercial _ grade items can:be sufficient to demonstrate that adequate controls exist. For each ites, appropriate quality controls should be confirmed as being exercised and properly documented.
Table 3-1 provides general guidance on the types of supplier controls that should-be surveyed to assure typical critical characteristics are being controlled.
3-6
. - ~
m
-o
i Table 3-1 1
TYPICAL SUPPLIER CONTROLS THAT SHOULD BE SURVEYED USING METHOD 2 Design Control (if the design is not fixed by a national. code or standard)
Procurement Material Control Fabrication Assembly Calibration Tests Inspections Other controls may be necessary as they relate to the critical characteristics being verified..
l The results of commercial grade surveys should be documented in an approved survey plan / checklist which include:
l 1.
Item or items included within the scope of the survey.
2.
Critical characteristics to be controlled by the supplier.
3.
Supplier controls to be verified specific to the critical characteristics.
4.
Survey methods or verification activities performed with results obtained.
5.
Conclusions attesting to the adequacy of the supplier controls.
<a q
Deficiencies identified during the commercial grade survey may be' corrected by the supplier instituting additional controls, or by utilizing other acceptance methods in this guideline to verify adequacy.
1 t;,
l
- h Once a supplier's controls have been deemed to be adequate, the' purchaser should invoke or reference the observed commercial or quality controls as a part of the
{
purchase order requirements for the cosmercial grade item. Care should be taken not to impose any nuclear unique standards on purchase orders for commercial grade; items. Supplier compliance to purchase order requirements should be documented by.
J a Certificate of Conformance. Acceptance of the item will be completed by-l 3-7 t
a i
j 4
performing a standard receipt' inspection with the accompanying supplier's.-
Certificate of Conformance.
-l i
The purchaser should assess the frequency for which survey information needs to be:
reconfirmed based on supplier performance, item complexity -standard receipt
j inspection results, frequency of procurements, etc..
I An example of a like-for-like replacement of a complex item for which a survey could be used to accept the item, is a commercial' grade volume booster assembly-1 for a diaphragm control valve. A volume booster is. comprised of approximately--
20 piece-parts ranging from brass and aluminum itses to elastomers. The critical.
characteristics to be contralled are materials'of construction, dimensions,.
i operability, leakage, pressJre rating,-and part number. A survey for this item j
would be conducted as follows:
1 1.
Design Control: Review the design documents to determine if'the manufacturer.
.f has made any modifications-to the design of.the item that'was. originally
~
qualified and supplied. Design changes should be' addressed. ' Documentation-should be available to demonstrate that the supplier performed an equivalency evaluation. If there were modifications, a review should verify the adequacy.
l of the changes for the purchaser's. specific application.
2.
Procurement: Review the procurement controls the supplier exercises both on 2
raw materials to be utilized in-house;and'on procured finished parts.
Receipt inspection practices or procedures should be reviewed to verify that:
. i the supplier is assuring that the correct material and ~ items are being,
j
~
received.
3.
Material Control: Examine the supplier's' material controls in the receiving, storage, and production areas to assure the proper parts are'available for i
assembly and installation.
i 4.
Assembly: Review assembly practices to determine if changes.have been made.
l
~
5.
' Calibration: Assure the supplier calibrates' applicable measuring and testing.
equipment.
l 6.
Inspections and Tests: Investigate.the'. types and' frequency of-inspections and bench tests that are performed.- A bench test would confirm that the.
assembly was complete and the piece-parts were of.the correct dimensions.
3-8
. ~. -.
i l
i An impeller key is an example of a simple like-for-like replacement for which a commercial grade survey could be used to accept the item. The critical characteristics to be controlled for this item would be dimensions, material, and part number. A survey for this item would be conducted as follows:
j 1.
Design Control: Review the detailed design / fabrication drawing to determine if the manufacturer has made any modifications to the item's dimensions or material of construction.
2.
Procurement: Review the procurement controls the supplier exercises on the
]
l raw materials to be utilized in-house. Receipt inspection practices or 1
l procedures should be reviewed to verify the supplier is assuring that the correct materials are being received.
l 3.
Material Control: Examine the supplier's material controls in the receipt-l and machining areas.
4.
Calibration: Verify that the supplier calibrates applicable measuring'and testing equipment.
i 5.
Inspection and Tests: Confirm the types and frequency of inspections and j
j tests that are performed.
l l
In summary, by reviewing the commercial controls in several areas, reasonable I
assurance can be gained that the supplier's comunercial grade items are subject to adequate quality activities and that the supplier controls those features or characteristics deemed critical by the purchaser.
3.3 METHOD 3 - SOURCE VERIFICATION 3.3.1 Explanation of Method 3 Figure 3-3 is a schematic logic diagram for accepting a comunercial grade item by l
conducting a source verification of a supplier. Method 3 involves the g
verification of critical characteristics by witnessing quality activities before
- 4 releasing the item for shipment. The supplier may either be:
Is 1.
An approved nuclear supplier maintaining both a consnercial program and a y
10CFR50. Appendix B Quality Assurance program, or-2.
A consnercial grade item supplier without a 10CFR50, Appendix B Quality Assurance program.
k.
in 3-9
1 r,om Genenc Process Figure 21 1
E5tASLl5H PURCHASE ORDER REQUIREMENTS 1.
m r i
IMPOSE ACCE55181UTY REQUIRE ME NTS IN PURCHASE ORDER 1P CONDUCT 50URCE VERIFICATION s r DOE 5 THE SUPPLIER MUST AUGMENT ADEOVATELY CONTROL NO THE CRITICAL WITH OTHE R 2
ACCEPTANCE CHARACTE RISTICS OF THE METHOD (5)
P ARTICULAR CGI BEING IN5PECTED?
4 YES l
9r I
til DOCUMENT RESULT 5 1
l l
h 1
RELEASE ITEM BASED ON DOCUMENTED 500RCE j
VERIFICAflON RE$ULTS i
i E
RECEIVE ITEM E
CONDUCT 5TANDARD RECEIPT INSPECTION h
m I
DOCUMENT RESULT 5 1r l
l ACCEPT ITEM l
1 (1) These documented results constitute objective evidence to provide reasonable assurance that the CGlis acceptable for its intended use.
i Figure 3-3.
Method 3 - Source Verification 3-10
3.3.2 Apolication of Method 3 The source verification is best applied to a single item or shipment of items.
Although a comunercial grade survey (Method 2) is intended to qualify a supplier's entire scope of commercial grade Quality Control activities, a source verification is more suited for items procured on an infrequent or expedited basis.
When it is confirmed during a source verification that the supplier adequately controls the critical characteristics, only verification'of the part number is required upon receipt. The item is accepted upon completion of the standard receipt inspection and documentation of the source verification results.
3.3.3 Employment of Method 1 The basic purpose of conducting a source verification is to confirm that the selected commercial grade items critical characteristics are satisfactorily controlled by the supplier.
The actual controls required to be witnessed by the purchaser will vary from ites to item and should be dependent upon the number and type of critical i
characteristics. The scope of the surveillance may include witnessing fabrication and asseebly processes, nondestructive examinations, performance. tests, or final
]
inspections. It may also include confirmation of the supplier's design.
I procurement, calibration, and material control methods employed for the particular cossnercial grade item being purchased.
The results of the source verification should be documented in an approved surveillance plan / checklist which include:
4.
1.
Item or items included within the scope of-the surveillance.
.i~
2.
Critical characteristics to be controlled by the supplier.
h 3.
Supplier controls to be verified specific to the critical characteristics.
a-if:
4.
Surveillance methods or verification activities perfomed with results obtained.
kt 5.
Evaluation of the adequacy of the supplier controls.
r g.
Deficiencies identified during the source verification may be corrected by the supplier instituting additional controls, or by utilizing other acceptance methods I
in this guideline to verify adequacy.
2 3-11 4
4 Deficiencies identified during the source verification may be corrected by the j
supplier instituting additional controls, or by utilizing other acceptance methods l
in this guideline to verify adequacy.
l This documentation constitutes objective evidence that control of. specific critical characteristics was observed. Acceptance of the item is then completed by the standard receipt inspection.
A pump shaft is an example of an item for w%ich source verification could be used to accept the item. The critical characteristics to be controlled are' material of construction, hardness, surface discontinuities, dimensions, and part' number. The source verification for this item would be conducted as.follows:
1.
Material of Construction: Review the supplier's' procurement, receipt.
inspection, and material controls applicable to this item.
2.
Hardness: Witness a hardness test of the item. Alternatively,' review the applicable heat treatment procedure, heat treatment chart. and furnace calibration records.
3.
Surface Discontinuities: Witness a liquid penetrant test of the shaft.
Verify the test personnel are qualified..the procedure'is followed,'and no relevant surface indications are accepted.
4.
Dimensions: Witness a dimensional ir.spection of critical dimensions shown on the pump shaft drawing. Verify no dimensional changes have been made to the part drawing that would affect part interchangeability.
5.
Part Number: Verify during the standard receipt inspection.
3.4 ETH00 4 - ACCEPTABLE SUPPLIER /ITDI PERFORMANCE RECORD 3.4.1 Exclanation of Method si Figure 3-4 is a schematic logic diagram for accepting a coinnercial grade item by relying upon a documented acceptable supplier /ites performance record. In essence, Method 4 allows the purchaser te accept cossnercial grade items based upon a confidence in the supplied item achieved through proven performance of the item.
It also allows the purchaser to take cre(.it for item perfomance based upon historical verification gained from the successful utilization of Methods 1, 2, or 3 or pertinent industry-wide performance data. Method 4 can be applied to many commercial grade items.
3-12
From Genenc 15TA8U5M l
Proceu PURCHASE ORDER l
F gwre 21 REOuiREMENT5 DOE 5TMt
[
PERFORMANCE RE CORD PROVIDE gg ESTABLISH ASSURANCE TMAT YEI DOCUMENT PERFORMANCE 4 THE CRITICAL RESULT 5 RECORD CHARACTERISTICS AVE BEEN METT 9P'P PROCURE AND RECElVI ITEM USER MI5TORICAL PERFORMANCE 4
aE5 ULT 5Of MONITORED
- ERsORMANCE OF Ttu CONDUCT y
(See Sutnection 3 4 3.
STANDARD go aemt)
RECEIPT
- t RIODiC MAINTENANCE N5PECTION AND SURVEILLANCE TE5TS m e n.
USE R MISTOlUCAL IV ALU ATION Cog $togR DOCUMENT ALTERNATIVE RESULTS RESULT 5 FROM ACCEPTANCE tMPLOYtNG METMOD 1 METHODS 5P ACCEPflitM 8Y RE5ULTS FROM M
(See Sutnection 3 4 3.
155UtNG E MPLoviNG ME TMOD 2 item 2)
CERTiriCAitON WMiCH 15 I ASE D RE5UL75 FROM ON SUPPUEIUITEM EMPLOYING METHOD 3 PERFORMANCE RECORD WDUSTRY WIDE DERFORMANCE
- PRODUCT PE RFORMANCE/
TEST RESULT 5 84PO NPRD5
$fi$MIC EXPE RiENCE/ TEST DATA BASE 5 AND EO DATA SANit RESULT 5 FROM COMME RCLAL PROGRAM M (5+e Svanecten 3.4 3.
AUDIT 15URVEY5 CONDUCTED SY INDUSTRY GROUPS item 3)
N SUPPUER RESPON$t(5) TO CG PROGRAM CONTROL 5 l
UTILIZATSON OF NATlONAL i
CODE 5 AND STANDARD 5 TO CONTROL CGI 1
USNRC t15UED DOCUMENTS OTHER INDUSTRY DATA BASES j
(1) The5e documented reiutti conStatute objective evidence to provide reasonable a55urance that the CGli$ acceptable for it$ intended ule.
(2) Industry wide performance data must be Specific and aDolicable to the item being accepted if it i$ -
,e to be used to establaih an acceptable Supplier / item performance record.
l Figure 3-4.
Method 4 - Acceptable Supplier / Item Performance Record 3-13
+
/
o 3.4.2 Aeolication of Method 4' Method 4 is best suited for commers;;; y ade items where results of historical-performance can be compiled utilizing:
1.
Monitored performance of the ites.
2.
Industry product tests.
I 3.
National codes and standards (not specific to the nuclear industry).
4 Other 1rdustry data bases (military, aerospace, etc. - see Figure 3-4).
Method 4 is e valuable means to accept comercial grade items because it relies on proven historical performance. It negates the need for costly and time consuming activities which do not add to the quality or performance of the. item in service.
f
~
Care should be utilized in application of this method to ensure that perfomance data used is directly applicable to the verification of the critical characteristics specific to the' intended application.
3.4.3 { a lpvuent of Method 4 The purchaser can establish a documented supplier / item performance record using
{
the following sources of information (Note: Individual sources of information are not intended to stand alone as the sole means of. demonstrating satisfactory' I
performance of the it e.):
1.
User Historical Performance 4.
Results of Monitored Performance An item's performance record should be determined primarily by monitoring the performance of an item which was purchased from a particular supplier and by monitoring the performance of the parent component in which the ites was installed.
Tais performance data is normally available from maintenance records.-
Once documented, this data provides an excellent source for establishing-a performance record for a given commercial grade ites. The objective basis to support the satisfactory performance of the ccamercial grade ites in service will vary with the application, but could simply be the lack of failures during the in service period.
3-14
J I
Failure, in this sense, refers to a failure caused by some inherent defect in the item which prevents it from performing its safety-related function. It is not intended to mean:
1)
Failure of a part because of misuse or normal wearout, and 2)
Failure resulting from failures of other items.
b.
Conducting Periodic Maintenance and Surveillance Tests j
The purchaser should have dt.cumented records of maintenance and surveillance tests. These tests should demonstrate that the item j
satisfactorily performed its intended design function for the specified length of time between surveillances.
2.
User Historical Verification 1
The successful acceptance of an item using Methods 1, 2, or 3 over a period of time provides assurance that the supplier has been providing the item specified.
3.
Industry-Wide Performance j
l Industry-wide performance data must be specific and applicable to the item being accepted if it is to be used to establish a i acceptable supplier / item performance record.
1 a.
Product / Performance Test Results The supplier may test or send its product out to an independent test laboratory periodically. The results of these tests may be utilized to i
verify certain critical characteristics. Information such as j
reliability data from operating nuclear plants, suppliers, or industrial
)
j f users which support performance history of the item may also be li considered.
b.
INPO MPRDS M.
The INPO NPRDS Summaries of Component Failures in Nuclear Power Plants provide data on component failure history. Within the component failure narratives, specific items that have failea may be identified.
c.
Seismic Experience / Test Data Bases and Equipment Qualification Data Bank g,
f The nuclear industry as a result of empirical studies of earthquake I
induced failures, has developed a seismic experience data base (1, 1).
l 3-15
i Similarity by ites, category, or general type shou'd be established to
)
demonstrate an item's inherent seismic sensitivity or ruggecness.
1 EPRI has established the Equipment Qualification Data Bank (EQOB) as a remotely accessible, computerized system containing several libraries of i
information related to qualification. One library lists sumarized equipment qualification parameters for Class 1E equipment in operating-plants. Other libraries contain seismic qualification data. Another libraryhasthermalandradiationpropertiesof'nonnetallicmateriah comonly appearing in electrical-and mechanical equipment. The EQDB is administered by a commercial organization under license to EPRI, with operating costs funded by subscriber fees'(1).
Care should be exercised to ensure that the use of.these' data bases is acceptable under plant specific conditions, d.
Commercial Program Audits / Surveys Conducted by Incustry Groups To take credit for this type of information, the purchaser should assure that the audit / survey addressed the supplier quality controls applicable to the specific comercial grade item in question, and that those quality controls are still being employed by the supplier.
Supplier Response (s) to Commercial Grade Program Controls Questionnaire e.
The purchaser may determine'by a questionnaire, those controls-established by the supplier that reasonably assure the comercial grade ites furnished is equivalent to the comercial grade item supplied with the original equipment. The most important information to be obtained i
is:
~
1 1)
Changes that would result in a part number change, 2)
Material changes, and 3)
Changes to the manufacturing processes.
f.
Utilization of National Codes and Standards When taking credit for an item being manufacturec to a national-code or standard, the purchaser should assure that the item was manufactured in accordance with the code or standard. - This assurance can be obtained by:
1)
Referencing the national code or standard in the purchase order, 2)
Receiving certification from the supplier, or 3-16 1
i 3)
Researching and documenting that it is standard industry practice to manuf acture the product to this national code or standare.
4)
Verifying manufacturer testing or independent testing with certification.
Examples on tne utilization of national codes or standards are provided in Appendix E of the document.
g.
USNRC Issued Documents Inspection and Enforcement Bulletins / Notices and Licenr.ee Event Reports identify significant item failures and should be considered.
To utilize Method 4, the purchaser should perform an evaluation of the supplier /
item performance record which includes the following:
1.
Supplier / item being evaluated.
2.
Previously established critical characteristics specific to the item or supplier.
3.
Identification of utility / industry data examined to evaluate the supplier / item.
4.
Basis for determining that industry data substantiates acceptability of the supplier / item.
5.
Statement by the purchaser attesting to the acceptability of the supplier / item.
If the performance record provides reasonable assurance that the critical r
characteristics have been met, Method 4 can be used. After the establishment of an acceptable performance record, acceptance of the item utilizing Method 4 should be completed by performing a standard receipt inspection.
The supporting information should be periodically updated and reviewed to assure the supplier / item maintains an acceptable performance record.
3.5 C0peINATION OF Tid 0 OR MORE METHODS 3.5.1 Explanation of Combinino Two or More Methods The acceptance methods may be used in combinations to effectively verify critical
}
characteristics and produce the objective evidence necessary to provide reasonable assurance of acceptability. In summary, Method 1 should be used to verify 3-17
.~
critical characteristics by performing tests or' inspections upon or after receipt.
of an item. Methods 2 and 3 should be used to take credit for the controls exercised by the supplier by conducting, respectively, a supplier survey or source j
verification of the supplier. Method 4, once established and documented, should j
be used to take credit for the proven nistorical performance of the supplier / item.
3.5.2 Aeolication Example An example of combining Method I with Method 2 follows. The purchaser regularly procures a commercial grade replacement ites for a line of similar components.
i The item has been det:-mined to have a safety function. The mechanical component in which it is installec.is active. The critical characteristics of the item were I
determined to be material of co7struction, dimensions, and part number. The supplier only exercises commercial controls on this ites. The supplier machines the item and will not release the fabrication drawings to enable'the purchaser to verify dimensional conformance upon receipt. The purchaser decides to survey the supplier to verify that the ites is machined to within tolerances specified on the I
detailed design drawing. The survey confirms this, and credit can be given to the.
supplier for adequately controlling dimensions.
The survey also indicates that the supplier does not adequately control the material, nor is the supplier willing to upgrade his controls..The purchaser is j
'provided the mate i l of construction. By testing'the item upon receipt with an ra alloy analyzer, assurance is achieved that the ites is constructed of thc material specified. Method 2 is used to verify dimensions and Method I to. verify material.
The part number is verified during the standard receipt inspection.
/
.t 1
5 l
L 4
4 4
3-18
+ er
,a.
l I
i Section 4 REFERENCES The references listed have been reviewed during the course of the study and have contributed to the preparation and content of this document. Many of these references are applicable to more than one of the various subsections of this document and would have necessitated their being repeated.
1.
Quality Assurance Criteria for Nuclear Power Plants and Fuel Reorocessino Plants. 10CFR50, Appendix 8 Novemoer 1987.
2.
Administrative Controls and Ouality Assurance for the Operational Phase of Nuclear Power Plants. ANSI N18.7/ANS 3.2-1976.-
3.
Quality Asserance Procram Reauirements (Operational).. USNRC, Regulatory Guide 1.33, Rev. 2, February 1978.
4.
Reportino of Defects and Noncompliance. 10CFR21, September 1987.
5.
Seismic Oualification of Eauipment in Operatina Nuclear Power Plants. USNRC, NUREG-1030, February 1987.
6.
Reculatory Analysis for Resolution of Unresolved Safety Issue A A6.' Seismic Oualification of Ecuipment in Operatina Plants. USNRC, NUREG-1211, February 1987.
J 7.
Eauiement Qualification Data Bank. User's Manual. NUS Corp., Rev. 5..
November 1987.
1 8.
Quality Assurance Recuirements for Control of Procurement of items and Services for Nuclear Power Plants. ANSI N45.2.13-1976.
9.
Testino for Public Safety. Underwriters Laboratories. Inc.
"i 10.
Defense Standardization and Specification Procram Policies. Procedures, and Instructions.
-k 000 4120.3-M, chap. IV, Current Issue.'
- 11. Provisions Governino Oualification (Oualified Product List).
U.S. Government
)'
Printing Of fice, Washington 0.C., 50-6, November 1979.
j af
- 12. Environmental Ovalifications of Electrical Ecuioment important to Safety for g;
Nuclear Power Plants. 10CFR50.49.
4:
- 13. Environmental Oualification of Certain Electrical Ecutoment Imoortant'to t
Safety for NucIEar ?c.er Plants. USNRC, Regulatory Guide 1.89, Rev. 1, June 1984 ef f
4-1
e
- 14. Verification of Seismic Adecuacy of Mechanical and Electrical Eauipment in ODeratina Reacters. Unresolved Safety issue (USI) A-46.
USNRC, Generic j
Letter 87-02, February 1987.
- 15. Verification of Seismic Adecuacy of Mechanical and Electrical Eauipment in i
Operatina Reactors. Unresolved Safety Issue (USI) A-46.
USNRC, Generic Letter 87-03. February 1987.
- 16. Lubrication Guide. EPRI, January 1987. NP-4916.
l
- 17. Generic Seismic Ruccedness of Power Plant Eauipment. EPRI, May 1987.
NP-5223.
- 18. Generic Qualification of Rotary Hand Swite,hti. EPRI May 1983. NP-3095.
- 19. Life Eroectancy'of Motors in Mild Nuclear Plant Environments. EPRI, February 1985. NP-3887.
- 20. Correlation Between Aoina and Seismic Oualification for Nuclear Plant Electrical Components. EPRI, December 1983. NP-3326.
- 21. Seismic Ruccedness of Aced Electrical Components. EPRI, January 1987.
NP-5024.
- 22. Commercial Grade Motors in Safety Related Aeolications in Nuclear Power i
Plants. EPRI. May 1988. NP-4917.
e
?
+
B 4-2
=
4 0
O e,
f I
i i
i i
1' I
I i
l i
I APPENDIXES i
i 4
l W
i e
i j
i r
l i
I 1
i l
w l*
S%
J i
4 i
I 4
4 k
I
t l
i l
j i
4 i
l i
Section 5 d
BIBLIOGRAPHY i
i This Bibliography provides a general reading list of applicable documents which
[
may be of interest to the reader. These documents have been reviewed during the
)
i course of developing this guideline and have contributed to its preparation and content. All references to bibliographic type information in the typical manner of using footnotes throughout the guideline has been avoided.
1 Aeoarentiv improper Use of Commercial Grade Components in Safety Related Systems.
USNRC, IE Information Notice No. 83-79, November 23, 1983.
l Aeolicability of 10CFR21 to Non11censees. USNRC IE Information Notice No. 87-33, July 24, 1987.
Applicability of 10CFR21 to Swacelock Tube Fittinos as a Connercial Cataloc Material. USNRC, Letter to Crawford Fitting Co., July 17, 1984.
i Decraded Motor leads in limitoroue DC Motor Operators. USNRC, IE Information
, i Notice No. 87-08, February 4,1987.
j IEEE Standard Reauirements for Replacement Parts for Class IE Eauionent 16 Ngg1ggr
' i Power Generatino Stations. ANSI /IEEE STD 934-1987.
'l Packacino. Shippino. Receivino. Storace and Hand 11no of items for Nuclear Power
! l Plants. ANSI N45.2.2-1978.
1 l' Ouality Assurance Procram Reevirements for Nuclear Power Plants. ANSI /ASME q
4 MQA-1-1986.
4 Quality Assurance Procram Reevirements for Nuclear Power Plants. ANSI /ASME NQA-2-1986.
Ovality Assurance Reevirements for Control of Procurement of items and Services for Nuclear Power Plants. USNRC, Regulatory Guide 1.123 Rev. 1. July 1977.
)
I Quality Assurance Terms and Definitions. ANSI M45.2.10-1973.
Recommended Practices for Procurev nt of ReDlacement/ Spare Parts for Nuclear Power Plants. Atomic Industrial Forum, Inc., March 11, 1986.
Remarks Presented (Ouestions/ Answers Discussed) at Public Recional Meetinas to Discuss Reculations (10CFR Part ?ll for Reportino of Defects and NoncomDIiantes.
j July 12-16. 1977 USNRC, NUREG 302, Rev. 1.
UL A Mark of Sianificance. Compressed Air Magazine, pp. 18-23, September 1986.
5-1 c
m
Appendix A TECHNICAL EVALUATIONS Figure A-1 depicts the technical evaluation which is inherent to any commercial grade item procurement.
A commercial grade item procurement may be one of three scenarios - a like-for-like replacement, an alternative replacement, or an item required for the first time.
A.1 LIKE-FOR-LIKE REPLACEMENT If the purchaser has assurance through planned coordination with a supplier (R),
that the design of the item has not been changed by the manufacturer or supplier, a like-for-like procurement should be implemented without performing an engineering evaluation (1). Reference (1) further emphasizes:
i,
" Procedures shall be established and implemented to ensure that purchased materials and components associated with structures or systems l
important to safety are:
j Purchased to specifications and codes equivalent to those specified for J
the original equipment, or those specified by a properly reviewed and In those cases where the original item or part is h
approved revision.
'off the shelf', or without specifically identified quality assurance requirements, spare and replacement parts may be similarly procured but T
care shall be exercised to assure at least equivalent performance." (Z)
.are necessary to assure at least equivalent performance for like-for-like k.'
T h' items should be demonstrated through the appropriate acceptance method.
2 The purchaser An example of a like-for-like procurement scenario is as follows.
The original equi $ ment T
requires a replacement bearing for a safety-related pump.
manuf acturer has furnished this bearing in the past and the part number has not g
The item is procured like-for-like without performing an been changed.
g-Acceptance of the like-for-like item is still required engineering evaluation.
utilizing any of the methods discussed herein.
4-e A-1
1 e-SCea8P10 :
Lira,for-Like Commercial Grace Item Replacement i
Item A Item A is Required is Procured
.e-------------
Basic 4',, Acceptance
=
Component-e Part number is the same.
L,,,,,,,,,,,j Reasonably assured item has not been e
modified.
(See Section 3)
No special er.gineering evaltation.
e
+
e items are identical.
4 Scenario 2 Alternative Commercial Grade Item Replacement.
f f
Item A Item B is item B
$5 Specified g3 Required as an Procured e---------~~"1 Alternative 4l Acceptance
=
C nt i
Part number has changed.
e
--~~~~~-~~-
e Reason to believe item has been (See Section 3) modified.
Equivalency evaluation' required.
items are equivalent.
l e
Scenario 3 l
Initial Procurement of Commercial Grade. Item Item C ltem C is Ites C SD'Cifi'd is
--+
is' r-------------
Required for Initial Procured
.l Procurement Basic:
Acceptance
=
Component L------------
J Item required for design modification or new plart construction.
(See Section 3)
Item specified to meet design requirements.
1 Figure A-1.
Technical Evaluation l
A-2 g
7 s- - - - -
I l
A.2 ALTERMATIVE REPLACEMENT An equivalency evaluation should typically be conducted for alternative replacements caused by the following situations:
Cannot purchase original ites like-for-like.
o Technical / quality requirements of the original ites cannot be determined.
There is reason to believe the design of the item was changed.
Equivalency evaluations, typically referred to as " equal-to-or-better-than", are safety-related engineering activities and should be controlled as such by the
)
purchaser. Reference (1) additional evaluations:
"shall assure that interfaces, interchangeability, safety, fit and j
function are not adversely affected or contrary to applicable regulatory or code requirements. The results of this evaluation shall be i
documented." (1) l The equivalency evaluation in itself is not a means to accept a consercial grade s
item for safety-related use as defined herein. Rather, it is a sound engineering i
method to assure that an alternative item specified is an acceptable substitute for the originally des!gned item.
I An tumole of an alternative replacement procurement scenario is as follows. The
[
purchaser is informed that a replacement asbestos gasket is required for a S
safety-related valve.
.g^
The original equipment manufacturer has furnished this gasket in the past but has recently discontinued st;pplying asbestos materials.
The alternative gasket is constructed of a graphite base material. The manufacturer has also provided a new part number for this ites. The purchaser conducts an equivalency evaluation to confirm the alternative item meets the dt: sign conditions of the component. Additionally, the purchaser confirms that the replacement item will not adversely affect the interface, interchangeability, I
safety, fit, and function of the original component. The substitute gasket is specified with applicable technical and quality procurement requirements.
Acceptance of the alternative item is still required utilizing any of the methods discussed herein.
h I
A-3 l
i A.3 INITIAL PROCUREMENT OF A COIMERCIAL GRADE. ITEM l
A design modification or new plant construction may require the procurement of a l
new commercial grade item. In these cases, engineering determines whether the commercial grade item's design is adequate for the item to perform its intended safety functions. A technical evaluation is performed as part of the design process to ensure the appropriate technical and quality requirements are specified in the procurement documents for the ites. This evaluation, as in the alternative replacement scenario, is not a means to accept the commercial grade item for a
safety-related use.
An example of an initial procurement scenario is as follows. A solenoid valve is required for a design modification. Suppliers meeting the design requirements of l
the valve are comercial grade suppliers. A technical evaluation is conducted to develop the necessary technical and quality procurement requirements and to ensure the valve specified will satisfactorily meet the intended design conditions.
Acceptance of tne initially procured item is still required utilizing any of the methods discussed herein.
i l
r I
1
)
A-4 i
+
t Appendix 8 PART CLASSIFICATION 8.1 COMPONENT AND PART CLASSIFICATION SYSTEMS Most nuclear utilities have classified their components as being either safety-related or nonsafety-related. This information is normally maintained in a design verified document such as a Q-List or Equipment List. This listing accurately reflects the safety designation of each component as shown on the latest revision of the applicable piping flow diagram, electrical diagram, or For each component, a parts breakdown can be obtained either instrument diagram.
from the supplier's assembly drawing of the component, a bill of material, or recommended spare parts list. Each part can then be assigned a safety classification as described below.
8.2 HOW TO DETERMINE A PART'S SAFETY FUNCTION The safety function of the ites should be determined by an engineering analysis.
The analysis should be based on a logical and methodical process which addresses the following criteria:
What is the safety function of the parent component in which this e
.o item is to be installed?
Y Consideration should be given to the parent component's safety classification such as ASME Section III, Class 1, 2, or 3, or p
?
Class 1E Electrical and Qualified Associated IE Items. This safety classification was determined based on the component's and its I
nuclear system's need to perform its safety-related function.
R Consideration should also be given to the function of the
(
component, such as whether it is active or passive. For example, one could classify internal items such as a valve stem to
~
nonsafety-related if the valve was passive and its only If safety-related function was to maintain its pressure boundary.
the stem is not considered to be an ASME Section III pressure B-1
F retaining' piece, it would not be critical to the passive valve-maintaining its pressure boundary. Consideration should also be given to the original seismic or environmental qualifications of the parent component.
t e
What is the function of the ites?
It is important to understand the function of.the-item under both nomal. operating conditions and accident conditions.- This may be j
difficult to ascertain from simply examining the supplier's'
~
assembly or outline draming of the parent component, and direct 1
interface with the supplier may be' required.
i What are the various ways in which the ites could fail in actual l
e service?
Consideration should be given to failures associated with:
-- Normal operation.
-- Postulated accidents such as design basis accidents and seismic-r occurrences, 7
-- Aging,
-- Degradation due to radiation, temperature, and humidity exposure, and
-- Material compatibility (e.g., stress-corrosion fracturing of I
adjacent parts induced by the leaciting of halogens).
There may be items, by virtue of their inherent design and the design conditions of the parent components, that do not have.
t credible failure modes. In these cases, one can justify and document the non-critical nature of the item, and reclassify.the l
ites to nonsafety-related. Consideration may also be given.to f
{
whether the proposed failure is catastrophic in nature or gradual.
I
.l' Would any of the postulated failures of the ites prevent the parent; j
e component or associated components from perfoming intended' safety
{
i functiers?
l inis is the most important criteria which must be evaluated tu j
determine if the item is critica1'to function, i.e., having a
~
a safety function. There may be many cases where the postulated l
9 i,
failures of an ites would hcve no effect on the parent component or i
/
B-2 l
associated components performing satisfactorily. Typical examples l
could be non. pressure retaining items installed on passive mechanical components, items comprising handwheels or actuators installed on passive mechanical components, nameplates, or adjustment and installation hardware. Caution must be exercised in I
assuming all the preceding items can be classified as nonsafety.related for all applications.
The preceding engineering analyses should be performed by persons knowledgeable
)
with the functions of the parent component and the system in which it is-installed.
B.3 SUGGESTED CLASSIFICATIONS FOR REPLACEMENT ITEMS From a technical basis, replacement items should be assigned a safety classification of either safety-related items or nonsafety.related items. From a procurement basis, safety.related items should be further classified into those items which are considered basic components and those items meeting the definition of a commercial grade item. Figure B.1 illustrates this distinction. Methods for I
accepting commercial grade items intended for use in safety.related applications-are discussed in detail in Section 3 of this document.
Technical Safety-Related Nonsafety-Related p
Classification Item Item t.e, Procurement p
Classification M'.
Basic Coassercial Nonsafety.Related Component Grade Item item Figure B-1.
Distinctions Between Technical and Procurement Classifications t
B-3 i
I 8.4 BENEFITS OF CLASSIFYING ITDtS l
There are several benefits to capturing the information derivei from the engineering analysis which as:1gns a safety classification to an ites. First, is :
the obvious cost savings associated with procuring items nonsafety-related once they have been classified as such. The price variance between a nonsafety-related item and an identical item purchased safety-related is often significant.
Second, items that have a nonsafety-related function need not be accept'ed utilizing the methods described herein.
h Third, by clearly differentiating safety-a lated items from nonsafety-related items, and concurrently obtaining information: regarding potential end use i
applications, a utility maximizes the opportunity'for parts consolidation and part I
interchangeability among Itke components. This can enable the utility to improve plant availability and reduce the frequency with which items are reordered.
A thorough parts classification system can be integrated with the' technical'and
[
quality procurement requirements to' enable the purchaser to automate the
[
procurement process. This has been employed by identifying each replacement item with a utility specific stock code number. Using's computerized data base, the i
stock code number can be used to identify supplier part numbers, and use components, technical procurement requirements, quality procurement requirements, spe::ial tests or inspections (Method 1), and approved suppliers. The automated I
system has' eliminated the repetitiveness associated with establishing technical j
ard quality procurement requirements, r
l e-e i
Y B-4 M'!
^
r
I 1
i i
i Appendix C I
^
DETERMINATION OF CO MERCIAL GRADE ITEM DESIGNATION i
,1-i r
$}
To determine if an ites is commercial grade, the following series of questions f'[
should be asked:
D 1-1.
Is the item not subject to design or specification requirements that are i
l y:.
unique to facilities or activities licensed or regulated by the USNRC?
2 A
If NO, the item is not commercial grade.
i i.
i h
If YES, proceed to the rext question.
2.
Is the item used in applications other than facilities or activities licensed 4
or regulated by the USNRC?
If NO, the item is not commercial grade.
If YES, proceed to the next question.
t 3.
Is the ites ordered from the manufacturer / supplier on the basis of
]
specifications set forth in the manufacturer's published product description?
i If NO, the item is not commercial grade.
1
]
If YES, all three criteria have been satisfied, and the ites meets the definition of a comunercial grade ites.
Note 1 l
Components qualified to a nuclear unique standard (e.g., IEEE 344-75 and IEEE 323-74) contain commercial grade parts. These parts were not originally j
purchased from part suppliers to these nuclear unique standards.
Consequently for these items, the answer to Question 1 is YES even though the answer for the parent component is NO.
i i
C-1
Note 2 To satisfactorily answer the questions, interface with the supp'.ier or i
manufacturer should usually be considered.
Note 3 Specifications for many comeercial grade items set forth in the manufacturer's pubitshed product description or assembly drawing typically include more than the item's part number. For instance, ASTM material specifications, special processes.. material properties such as Rockwell hardness or Durometer hardness, or dimensions may be provided. Also, inherent in the design and fabrication of many commercial grade items are the perforiaance of nondestructive tests and examinations, reference:s to non-nuclear qualification reports, and prototype tests.
Invoking requirements in procurement documents, such as those discussed in the preceding paragraph, does not preclude the item from meeti%.the third criteria of the commercial grade ites definition. Furthermore, invoking tlase specifications or requesting copies of test results is recommended as a practical means of providing the purchaser with additional assurance that the correct item has been furnished.
I; C-2
Jv
- 1 J
- l Appendix 0 1
ESTABLISitING PROCUREMENT REQUIREMENTS i
FOR C000ERCIAL GRADE ITEMS i
D.1 GENERAL Before issuing a purchase order for a commercial grade ites, an evaluation should Important be performed to determine the applicable design requ1rrements.
g references can include:
Component assembly part drawings.
Component procurement specifications.
1 s
Environmental qualification reports.
t Seismic qualification reports.
f e
Supplier catalogs.
e J
5 Original component documentation packages.
l e
If an item is purchased as a commercial grade item, it must rneet the three l
In addition, the commercial grade qualifying criteria discussed in Appendix C.
appropriate procurement category should be determined and a system developed l
identify, to the purchaser's receiving personnel, the appropriate procurement This is important when a commercial grade iter is j
category for a received item.
purchased nonsafety-related, but is intended to be accepted for safety-related A method is needed to distinguish this order from one being issued for items use.
intended strictly for nonsafety-related application.
A most important parameter to be specified in the purchase order is the part 4
If the part number specified is the same as the item in the original number.
equipment, there is some assurance that an identical item is beir.g provided.
I
]
Further assurance is obtained by emp1'oyment oftre applicable acceptance method.
In addition to the part number, a descriptio'n of the item being purchased should This description could include items like the part 4
be provided to the supplier.
description, type, size, material of construction, pressure class rating, or range of operation.
4 J
D-1
1 When applicable, the appropriate material or part standards to be referenced in s
purchase orders can usually be determined from the following sources:
1 l
Component assembly drawings or bills of material.
e Part supplier or distributor catalogs.
I e
Communication with suppliers, General industry standards for a particular product.
o i
1 Requesting material and product test reports provides valuable information which can identify when an item is not in compliance with the purchase order. For example, if a material is ordered tc an ASTM Standard having a' minimal yield strength requirement and the supplied material test report shows a value below the minimum, then the nonconforming item can be identified and rejected during receipt inspection.
Providing a nuclear unique requirement is not specified in the purchase order for i
a commercial grade item, the purchaser may include requirements in addition to those contained in the supplier's product description. For example, if material test reports or product test results are requested, although they are not normally furnished with commercial orders.'this is not a nuclear unique requirement.
If a nuclear unique standard, such as 10CFR50 Appendix B. IEEE 323, or ASME Section III were specified, then the ites could no longer be considered as a commercial grade item.
The content of the purchase order will vary depending on whether it is issued to the original equipment manufacturer, the original part supplier, or a' distributor.
The purchase order requirements will also vary depending on the acceptance method chosen for a specific commercial grade part.
D.2 PURCHASE ORDER REQUIREENTS BASED ON SUPPLIER SELECTED D.2.1 Orioinal EouiDeent Manufacturer When a purchase order is issued to the original equipment manufacturer for a commercial grade item, the following should be considered for inclusion in the purchase order:
The component supplier's part number. This can normally be obtained from the component assembly drawing or bill of material.
Sometimes the supplier will not furnish part numbers on the drawing. An appropriate means to identify the item is to reference f
D-2 N
the drawing number, including revision, and tne item number en the drawing parts list.
A description of the item being purchased.
The component supplier's assembly drawing number, including revision number.
When a specific end use exists for the item, providing the serial number of the parent component will also assist the supplier in furnishing the correct ites.
C References to the applicable environmental and seismic qualification reports for the parent component (for purposes of identification).
General engineering requirements such as:
e
-- Material or part standards to which the item is manufactured (e.g.,ASME, ASTM,non-nuclearIEEE, ANSI, NEMA,AMS,SAE,AISI, y
AFBMA, API,UL) k
-- Cleanliness
-- Marking and tagging j
-- Packaging i
-- Testing i
-- Material restrictions
-- Shelf life General taality assurance requirements such as:
e
-- Rights of access j
-- Shipment release restrictions
-- Inspection hold points
-- Identification of noncompliances to the purchase order j
-- Non-substitution clauses Documentation requirements such as:
-- Material test reports or material certificates of conformance
-- Certifications of interchangeability, equivalence, and equipment i
qualification maintenance
-- Test reports
-- Reports of noncompliances to the purchase order
-- Certificate of conformance to the purchase order D-3
\\
D.2.2 Oriainal Part SuDDlier or Distributor When a purchase order is issued to the original part supplier or.a distributor rather than the original component supplier, the following should be considered for inclusion in the purchase order:
l The part supplier's part number. Caution must be exercised to e
assure the supplier's part number is equivalent to the original component supplier's part number. To do this, direct communication with the original component supplier or_ part supplier may be required. The original component supplier's assembly drawing, bill of material, or qualification reports may have to be' reviewed or physical examination of installed or stocked components may be necessary to determine the correct part number.
For base materials such as forgings and plates,'a reference to a material specification rather than a part number would be more appropriate.
A description of the item being purchased, including a catalog reference.
References to the component supplier's assembly drawing would usually be meaningless since the part suppliers and distributors have little knowledge of how their comunercial grade items' are specifically being used.
General engineering requirements such as:
-- Material or part standards to which the item is manufactured l
(e.g., ASME, ASTM, non-nuclear IEEE, ANSI, NEMA, 'JiS, SAE, AISI,
.]
AFBMA API, UL)
-- Cleanliness
.,4
-- Marking and tagging
-- Packaging k
-- Testing
{
-- Material restrictions
-- Shelf life lj1
\\o I i 1
i t
D-4 b
W
General quality assurance regt.erements such as:
-- Rights of access
-- Shipment release restrictions
-- Inspection hold points
-- Identification of noncompliances to the purchase order
-- Non-substitution clauses Documentation requirements such as:
e
-- Material test reports or material certificates of conformance
-- Test reports
-- Reports of noncompliance to the purchase order
-- Certificate of conformance to the purchase order The purchaser should determine if the component supplier did any conditioning to the part supplied with the original equipment. If conditioning was performed and is determined to affect a critical characteristic, the purchaser should evaluate if similar conditioning is still required for the replacement items. Examples of conditioning are heat treatment of metallic materials, calibration of instrumentation, burn-in, machining, an:t selection testing.
L D.3' PURCHASE ORDER REQUIREMENTS BASED ON ACCEPTANCE METH00 SELECTED L
As suggested earlier, the purchase order requirements will also vary depending on Ih the acceptance method selected for a commercial grade item. Examples are provided 1
in the following to demonstrate this point.
Method 1 - Special Tests and Inspections Because Method 1 relies on purchaser tests and inspections for acceptance, Purchase order additional purchase order requirements are not normally necessary.
references to testing, rights of access, shipment release restrictions, and If the item is manufactured to a inspection hold points may not be necessary.
national code or standard, then the purchase order'should reference the code or
]
standard.
Method 2 - Commercial Grade Survey of Supplier For items being accepted by Method 2, the purchase order should specify the applicable connercial controls the supplier implements based on the survey observations. This may consist of a reference to specific program controls, reference to a comnercial quality control manual, procedures, or standards.
D-5
.~ _
1 l
As examples in the case of a supplier of consnercially pr3duced items, the purchaser might state:
"This order shall be processed in accordance with.the design.
-i procurement, manufacturing, calibration, inspectior,'and testing l
controls observed during the survey dated
/
/
'as documented j
in Survey Report Number
'of Company X.- Any significant change in
~
the observed controls shall be identified to the Purchaser."-
or "This order shall be processed in accordance with Company X's Casumercial l
Grade Products Manual dated
/
-/
. Any revisions to this f
manual shall be forwarded to the Purchaser for review."
i or "This order shall be processed in accordance with the following Company Y procedures:
j Heat Treat Procedure XXXX, Rev..X.
f Calibration Procedure XXXX, Rev..X Product Testing Procedure XXXX, Rev. X
{
Inspection Procedure XXXX, Rev. X."
1 Method 3 - Source Verification For items being accepted by Method 3 the purchase orde should specify a.right of access to examine the supplier's product controls'in the ' areas of design,
~
procurement, manufacture, calibration, testing, and inspection, and _others as -
-l
[
applicable to the critical characteristics being verified.- In-process or final-
' inspection hold points should also be specified in the purchase order if deemed j
~
necessary to effectively conduct the source verification and witness the controls Ll necessary to verify critical characteristics.
l Method 4 Acceptable Supplier / Item Performance Record For items being accepted by Method 4, the purchase order should require the results of independent product test results the supplier has had performed on its l
product if the testing was relevant to the verification of.the item's critical f
characteristics. Also, the national codes and stande ds to which the item has' j
been manuf actured should be referenced in the purchase order. Material test-l reports, material certificates of compliance, and product test reports should be required to be submitted, as applicable, to assure the product meets these national codes and standards. The acceptable' supplier / item performance record.
provides the validity of the documentation requested and received.
D-6 i
l Appendix E USE OF MATIONAL CODES AND STANDARDS This Many commercial grade items are produced to National Codes and Standards.
fact may facilitate the acceptance of commercial grade items using Acceptance Methods 1 and 4 For Acceptance Method 1 verification of certain critical characteristics may result when a commercial grade item is manufactured to a national code or If the national code or standard includes some independent product standard.
endorsements based on qualification testing or periodic testing of selected critical characteristics, then credit can be taken for those critical characteristics being verified. When a nationat code or standard (e.g., ASTM) only establishes certain process controls and product acceptance requirements, o'tical characteristics.
the accepting party must still verify the seit a
For Acceptance Method 4, the supply of a product to a national code or standard in combination with an acceptable supplier /part performance record, provides confidence in the uniformity and quality of the ites. This is particularly true if an independent endorsement is given based on testing. Production to a national code or standard helps to justify continual acceptance of a commercial grade item by Method 4 Some typical connercial grade items and the general national codes and standards
\\
to which they can be produced are listed in Table E-1.
The credit a purchaser can take for a product manufactured to a national code or standard must be investigated on a case-by-case basis. For example, certain electrical items can be manuf actured to a UL product specification (1). These product specifications r
may require tests or controls of certain attributes that could be considered-o critical characteristics. If the connercial grade item is listed by UL, then UL will periodically test the product to assure continued product conformance.
4 E'
j l
o l
Table E-1 EXAMPLES OF NATIONAL CODES AND STANDARDS l
ASSOCIATED WITH COMERCIAL-GRADE ITEMS 1
Commercial Grade item National Code or Standard j
Bearings Anti-Friction Bearing Manufacturers Association Circuit Breakers American National Standards Institute Connectors (Lugs)
Underwriters Laboratories. Inc.
Connectors, Electric Military Standards Electrical Devices National Electrical Manufacturers' Association Electronic Devices Military Standards Fasteners American Society for Testing and Materials American Society of Mechanical Engineers Society of Automotive Engineers '
Military Standards
)
Fuses Underwriters Laboratories, Inc.
i Gaskets American Society for Testing and Materials l
Internal Wiring Underwriters Laboratories, Inc.
j Pressure and Temperature Switches Underwriters Laboratories. Inc.
Relays Underwriters Laboratories. Inc.-
Terminal Blocks Underwriters Laboratories Inc.
l l
i Many products manufactured to a military or federal specification are included on a Qualified Product List (QPL). To be added to the QPL, the product must undergo qualification testing. Upon successful qualification, the supplier's product is added to the QPL. References (12 and 11) detail:-
r Qualification requirements e
Condition. for placement and retention on the QPL j
Notification requirements should the supplier make any changes in his produr.t (design, materials, or process) after qualification Significance of the listing on'a QPL.
If credit is taken for a commercial grade item being on the QPL, then the appropriate military or federal specification must be invoked in the purchase order.
E-2
Appendix F MAINTAINING SEISMIC AND ENVIR000 ENTAL QUALIFICATION 1
)
If a conumercial grade ites is intended for installation in a seismically or environments 11y qualified component, the purchaser should be reasonably assured that the item once installed, will not adversely affect the original qualification of the component. This assurance can be obtained by performing a technical evaluation and by accepting the ites utilizing any of the four acceptance methods j
provided in this guideline.
F.1 ENVIR00 MENTAL QUALIFICATION F.1.1 Harsh Environment For devices requiring environmental qualification, the identification and verification of material type or composition of nonnetallic parts such as lubricants. 0-rings, gaskets, seals, and packing should be evaluated. The use of j
Y improper norsnetallic material could result in material decomposition, degradation, i
and failure after exposure to harsh environments. Acceptance of such casumercial grade items should include verification of correct materials of construction since they are critical to performance.
l F.1.2 Mild Environment 4
The threshold of radiation, temperature, and humidity deterioration for i
nonnetallic materials is normally above the level encountered in a mild environment (R, D). Thus, for nonmetallic comunercial grade items installed in components located in a mild environment, material verification should not be necessary.
g The need for material verification should be evaluated if the material is critical from a functional standpoint (e.g., potential degradation of an incorrect material by lubricants) or the parent component is subject to equipment qualification requirements.
2 F-1 1
ef
I F.1.3 Seismic Qualification fi The purchaser should reasonably assure that the counercial grade items will not; r
adversely affect the original seismic qualification of the' parent component in.
which they are intended for installation. Reasonable assurance for a simple metallic item can typically be achieved by verifying three critical.
characteristics - part number, material of construction, and dimensions.
Verification of these characteristics.will generally ensure that the mass, its distribution, and the strer.gth of the item are identical to the original. item.
For more complex items, modifications made to internal piece-parts sty result in a redistribution of mass.- Changes in assembly or types of materials should also be considered for complex items. These modifications could all. adverse *y affect the r
way in which the item reacts during a seismic event. Therefore, the verification
{
of design controls, modifications to internal part characteristics, and assembly procedures should be considered if maintaining seismic qualification is an issue..
I F.1.4 Develonnents in Nuclear Industry i
[;
The user should be aware that the nuclear industry is conducting. generic ongoing research in the areas of seismic qualification for critical sLfety-related-
]
The Seismic Qualification Utilities Group (SQUG), is developing components.
se'arate guidelines which the user of this document may find of value in p
addressing seismic and environmental concerns for commercial grade itcas. This t
information is based on actual seismic experience data-(1, i L4,,11). EPRI and
{
its Equipment Qualification Advisory Group (EQAG) and Nuclear Utilities Group on Equipment Qualification (NUGEQ) are also conducting research in the area of seismic and environmental qualification (1, 11 to ZZ).-
i L
E i
i i
F-2
.i
_,, _ _ _ _.,. -.... _ - -. -. ~, -
1 d
J Appendix G SPECIFIC YERSUS GENERIC APPLICATION OF C0 K RCIAL GRADE ITEMS G.1 SPECIFIC APPLICATION ITEMS Commercial grade items should be distinguished by their intended end use application. These applications may be either specific or generic. Specific application items are generally engineered items which may be installed only in specific components. Procurement of these items are nonna11y made through the original equipment manufacturer or their distributor.
When determining the safety function, procurement require *dits, and critical-characteristics for specific application items, some grouptpg of end use components is possible to increase the efficiency of perfors:ing the evaluation.
A For example, if a line of Company A's thrii.rifuga; ymps is comprised of different d
sizes, pressure classes, and materials, but pumps of the n== model'and safety
(
class are installed in the plant, one analysis may be performed foi rach like ites i
i performing the same basic function in each pump (e.g., impeller, deflectoi. wear f
rings, impeller keys, bearing housings, end covers, arvi shaft).
a Critical characteristics should be identified and be dependent upon the specific application and design function of each item.
G.2 GENERIC APPLICATION ITDt3 Generic application items are typically commodity items which have a wide range of end use applications in the plant. For instance, a carbon steel lockwasher may be a replacement ites on pumps, valves, motor operators, cranes, or the turbine.
Similarly, a Buna-N 0-ring may be installed in many types of components. When selecting critical characteristics for these generic items, then certain considerations should be made. First, because the end use ma,v not necessarily be known at the time of the analysis, a worst case scenario should be assumed. In this way, one is assured that the item can be installed in any less severe application and meet or exceed the capabilities of the ites being replaced. The
{
worst case scenario will assume that the item is safety-related, and the critical characteristics will be determined based on the most severe application.
G-1
i 4
j If a generic item is intended to be used in a more severe application than for
)
what it was originally accepted, additional critical characteristics may have to
{
be verified. For example, assume critical characteristics were established for a I
given type 0-ring based on it only being used in a mild environment. If the j
0-ring is then requested for use in a harsh environment, additional critical characteristics may have to be specified and verified before use.
i i
i I
5 4
Y 1
1 e
j h-
)
i i
l l
3-2 b
r Exhibit 1 1 of 1 EXAMPLE WORKSHEET FOR PARTS CLASSIFICATION-1.
What is the safety function of the parent component in which this item is to be installed? (Consider ASME Section III, 1E Class, seismic qualification, environmental qualification, active / passive function, etc.)
t l
f l
2.
What is the function of the item?
h k
3.
What are the ways in which the ites could fail in actual service?
4.
Would any of these postulated failures of the ites prevent the parent comporent or associated components from performing their intended safety functions?
If YES, item has a safety function.
If NO, item has a nonsafety function.
If UNSURE, assume item has a safety function.
1
+
7--.-...
~
_e,.
}
i e:
1 i
I s
)
I i
J
'li e
F
-)
i 4
Appendix H
- i EXHIBITS.
o
?
l l
9 i
i o
.i 9
.. h
.I i
t I
l i
I i
i i
}
1 o
I 1
i h
-l l
l 1
I iAs I
o Exhibit 2 1 of i EXAMPLE WORKSHEET FOR IDENTIFYING CRITICAL CHARACTERISTICS FOR A CO MERCIAL GRADE ITEM Based on the safety function of the ites, what characteristics are considered critical to ensuring it performs its safety function?
Product Identification Characteristics e
i e
e t
Physical Attributes e
e e
e e
Performance Characteristics e
e e
e 1
l I
1 i
H-2 MI l
i 1 of 4 i
Exhibit 3 CO M ERCIAL GRADE ITEMS SUPPLIER SURVEY CHECKLIST f
Supplier Dat!
Name Address i
Telephone No.
Survey Team Title Na!!g 4(
Team Leader s
{
TeamMember(s) i Personnel Contacted L
s Title Ha!!E L
w I
1 k
i P
t.
F 4
l H-3
....a.;,.....
t 7
g 9
i i
Exhibit 3 i
2 of 4 i
)
l Scope of Commercial Grade items Subject to this Survey i
l i
i t<
4 f
I i
Does this supplier furnish basic components under a 10CFR50, Appendix B program'as well as conumercial grade items (CGI)?
s l
Yes No
^!
Definition and Clarification of Terms as Used in this Checklist 1
i Commercial Grade Items An item is defined as a commercial grade ites only if it is:
1.
Not subject to design or specification requirements that are unique to facilities or activities licensed by the USNRC, and i
2.
Used in applications other than facilities.or activities licensed by the USNRC, g,n,,g 3.
To be ordered from the manufacturer / supplier on the basis of specifications set forth in the manufacturer's published product description, such as a catalog.
n 4
~
m
Exhibit 3 3 of 4 I.
ORGANIZATION Determine the number of Quality Assurance (QA) personnel in relation to the total production force.
QA No.
QC Ho.
Production No.
II.
QUALITY ASSURANCE PROGRAM i
1.
Does a documented program exist describing how commercial products are l
controlled? What areas of control (e.g., design control, inspection, procurement, calibration) are covered by this program?
2.
Are engineering, CA, and other applicable support personnel indoctrinated to the handling of commercial grade items?
III.
DESIGN CONTROL 1.
a.
Are CGIs designated differently from basic components or nonsafety items?
b.
How is this documented?
How would this supplier handle an order which invoked 10CFR50, c.
Appendix B and 10CFR21 requirements for CGIs?
2.
How are part numbers assigned to CG!s? Changes in what parameters could result in part number changes?
y 3.
How have changes to CGIS been made since the original equipment was shipped, been controlled.
4.
Does engineering do equivalency evaluations for CGIs purchased from new subsupp hers?
{
5.
Does this supplier identify critical characteristics of CGIs?
IV.
PROCUREMENT DOCINENT CONTROL 1.
Do purchase orders for CG!s adequately specify technical requirements?
2.
Who is responsible for review and acceptance of purchase orders for CGIs?
3.
If utility purchase orders are sent to salas office or headquarters, are CGI purchase order requirements being properly comunicated to the supply facility?
V.
CONTROL OF SUBSUPPLIERS 1.
Does an App *oved Suppliers List (ASL) exist for CGI subsuppliers?
2.
What methods are used for including a supplier on the CGI ASL?
3.
Where a CG'. ASL does not exist, does the system provide feedback to assure oni:t qualified subsuppliers are furnishing CGIs; e.g., periodic vendor trending?
4 Are orders for CGIs placed to a limited number of subsuppliers where a satisfacto*y history has been established, or are orders issued strictly on price?
8
(
J IIIEIT "
o O
i Exhibit 3 4 of 4 i
VI.
TEST AND INSPECTION CONTROLS 1.
Are receipt inspections performed for CGIs to procedures?
2.
Are CGI drawings available and used for receipt inspection? Where catalogs rather than drawings are applicable, are configuration checks made?
3.
What do CGI receipt inspections typically include?
i 4.
Are results of CGI receipt inspections documented and maintained?
l S.
Is material receipt testing conducted? If so, for what items?
1 6.
Are cure dates maintained, if applicable to CGIs?
)
l 7.
Does supplier have system to ensure the CGI is inspected against requirements of the utility purchase order?
l S.
Are any tests and inspections conducted to verify critical characteristics?
9.
Is test and inspection equipment used to inspect CGIs calibrated in accordance with an approved program?
- 10. For in-house manufactured CGIs, are in-process and final inspections / tests conducted to assure product conformance?
VII.
MATERIAL CONTROL Review material storage / stockroom areas to evaluate the acequacy of suppliers CG material control system.
VIII. SPECIAL PROCESSES i
Are any special processes required in the manufacture of the CGIs which are controlled?
IX.
HANDLING AND STORAGE CONTROLS 1.
Are procedures available to properly package CGIs in a:cordance with ANSI N45.2.2-1978 requirements?
i 2.
Verify CGIs pulled directly from stock are properly' controlled and
'i identified.
,i I
1 Who is responsible for inspection of CGI packaging and shipment release?
lil!
.,i d
t
- l H
h 1 of 17 Exhibit 4 APPLICATION OF ACCEPTANCE METliODS FOR TYPICAL CGIs INCLUDING VARYING PROCUREMENT SCENARIOS Included are instructive examples demonstrating hypothetical applications of the acceptance methods for six selected concercial grade items. The critical characteristics utilized in the examples are provided for illustration only.
These critical characteristics are not intended to be all inclusive or exclusive of those which may be deemed important. The examples are provided to illustrate some of the various ways a particular commercial grade item could be accepted for l
safety-related use by using the acceptance methods in this guideline.
l i
An assumption is made in each case that a technical evaluation was conducted prior to procurement to ensure the correct requirements for each ites were specified in the procurement document. It is further cssumed that the evaluation of the! items considered seismic and environmental qualification issues and identified' critical characteristics requiring verification during acceptance, to assure seisa;lc and environmental qualification is maintained.
Hypothetical procurement scenarios are also provided for each of the six examples.
The six connercial grade items selected for inclusion in this exhibit are:
i o
Pressure Switch 0-ring (nonmetallic) i e
?
e e
Valve Stem o
Resistor e
Pressure Transmitter for brevity, it is assumed that the part number is a critical characteristic for each conrnercial grade ites, and its verification is an integral part of te.h s
acceptance method.
I P
kB' L
4 e
E.
i r
l t.
H-7
i Exhibit 4 2 of 17 Description of CGI: Pressure Switch i
Application:
Mild environment, seismically qualified.
(A technical evaluation was conducted prior to procurement which assbred that the items tested, as referenced in the original test report.)specified 1
i Selected Critical Characteristics (Hypothetical Technical Data) 1.
Pressure Range (0 to 100 psi).
2.
Material, for pressure retaining parts (consercial stainless steel) 3.
Enclosure, NEMA class (NEMA 4).
a 4.
Accuracy /Deadband (12% of full scale).
5.
Electrical Ratings (120 Vac, 5 amp).
6.
Configuration (reference is made to the Supplier's catalog outline drawing)
Application of Acceptance Methods ACCEPTANCE METHOD 1:
Selected Critical Characteristics Special tests and insoections used to verify the critical enaracteristics.
1.
Pressure Range Verify the O to 100 psi pressure range as it appears on i
the nameplate.
0 to 100 psi during post-installation testing. Verify opera 2.
Material (pressure Normally this critical characteristic cannot be verified retaining parts) by Method I without disassembling the switch.
not feasible, the user must augment with anotherIf this is acceptance method.
3.
Enclosure (NEMA class)
Conduct visual inspection and nameplate check during receipt inspection.
d 4.
Accuracy /Deadband Verify accuracy is 22% of full scale during post-installation testing.
5.
Electrical Ratings t
Verify the voltage and current rating on the namep' ate and as part of post-installation testing.
E.
Configuration Dimensionally check end connections and mounting connections, visually inspect against catalog drawing, and check nameplate for proper swMch type.
j ACCEPTANCE METHOD 2.
Selected Critical Characteristics CGI Supolier's activities used to control the critical characteristics subiect to survey.
3 1.
Pressure Range and Accruacy/Deadband Examine in-process or final testing practices to 4 i determine how the Supplier verifies the pressure range of the switch.
Verify that tauipment is properly q
calibrated.
Review test records generated.
i d
H-B i
r i
Exhibit 4 3 of 17 2.
Material (pressure Examine design controls, procurement controls, receipt retaining parts) inspection activities, and material controls for commercial stainless steel.
3.
Enclosure (NEMA Examine design controls, procurement controls, receipt class) inspection activities, and material controls.
4.
Electrical Ratings Review design controls, procurement controls, electrical test practices, test equipment calibration, and test records generated.
5.
Configuration Examine design centrols, manufacturing practices, final inspection, calitration of measuring equipment, and appropriate records.
ACCEPTANCE METHOD 3:
Selected Critical Supplier's activities used to control the critical Characteristics characteristics witnessed and examined durino source surveillance.
1.
Pressure Range and Witness final testing, review test procedures, review Accuracy /Deadband final test data for acceptability, and assure test equipment is properly calibrated.
2.
Material (pressure Examine design controls, procurement controls, receipt Li retaining parts) inspection activities, and material controls applicable 3
to the switch.
F
[
- 3. _ Enclosure (NEMA Conduct visual and nameplate inspection.
class) 5 4
Electrical Ratings Visually inspect nameplate data and review applicable test records.
f 5.
Configuration Dimensionally check end connections and mounting connections, visually inspect against catalog / drawing, I
and check nameplate for proper switch type. Examine design controls.
ACCEPTANCE METHOD 4:
Selected Critical Performance information used to provide reasonable i
Characteristics assurence the critical characteristics have been met.
r 1
Pressure Range, Results from monitored performance, results from Material (pressure successfully using Method 2 that are still valid, results retaining parts),
from successfully using Method 3, periodic maintenance Enclosure (NEMA class), and surveillance tests, Supplier responses to CG program Accuracy /Deadband, controls, use of national standards, and review of USNRC j
Electrical Ratings, issued document..
and Configuration i
i H-9 c
d F EL_
l i
l f
Exhibit 4 4 of 17 i
Pressure Switch Procurement Scenarios t
l I.
Utility 1 has been buying and accepting pressure switches from Supplier A
^
i employing Method 2 for the past two years. 'During the commercial grade item surveys, the utility examined the activities listed in the preceeding application example for Method 2.
The utility has documented.results of monitored perfomance that has been acceptable. The utility considers
[
sufficient data exists to employ Method 4 and a formal evaluation is performed.
t J
During the evaluation, a USNRC. IE Bulletin is received indicating problems i
at the plants where Supplier A's pressure switches failed to perform in 6
accordance with design requirements. Based on this new input, the evaluation concludes an acceptable Supplier /perfomance record can no longer j
be justified. However, assurance that Supplier A adeguately controls the-
)
critical characteristics on a replacement switch procurement can be accomplished using a combination of Methods 2 and 3.
Method 2 is relied'
' j i
upon to accept the switch supplemented by Method 3 to assure the problem I
identified in the bulletin does not affect the switch being accepted.
]
l Utility 1 issues a purchase order to Supplier A for pressure switches, imposing rights of access, and requesting a Certificate of Conformance to the current program controls surveyed. A source verification visit is 4
conducted and the results are documented. Upon receipt of the switches, a l
Standard Receipt Inspection is performed. Utility 1 acccepts the items based on Supplier A's Certificate of Conformance to the purchase order and 1
the source verification results. Thus, a combination of Methods 2 and 3 is j
used to accept the switches.
i II.
Utility 2 has also been purchasing pressure switches from Supplier A j
(
utilizing Method 2.
Upon receipt of the USNRC, IE Bulletin, Utility 2 elects to purchase switches from a new Supplier fos which thcre is little
?
historical information. Utility 2 feels that Method 2 will provide adequate 1
I assurance for their purposes. A survey-is then conducted of the new Supplier. The selected critical characteristics Utility 2 desires to verify remain the same. Utility 2 examines the same Supplier activities'as before and determines that the new Supplier adequately controls the selected 4
i critical characteristics. A report documenting the survey results is prepared. Utility 2 issues a purchase order to Supplier 8 requesting pressure switches, and requesting a Certificate of Conformance to the program controls surveyed.
Upon receipt of the pressure switches, a Standard Receipt Inspection is l
performed. Utility 2 accepts the switches based on Supplier 8's Certificate of Conformance to the purchase order. Thus, Method 2 is used to accept the l;
switches, but consideration will be given to using Method 4 after some historical backgrocad can be developed and documented.
j I
III. Utility 3 purchases pressure switches from a number of connercial Suppliers.
l The utility does not wish to use Method 2 for each of these Suppliers..
l Instead, sufficient technical data has been gathered to permit the utility to verify critical characteristics upon receipt. The utility, selects a j
Supplier and purchases a batch of switches. Utility 3 conducts the special-i tests and inspections shown in the application example for Method 1 to-l j
verify selected critical characteristics. This assumes that the materials of construction are verified after disassembling a sample switch.' Based on i
satisfactory, documented results of the inspections and tests. Utility 3.'
accepts the switches by using Method 1.
1 H-10 b
4
~
-l w
4 i
Exhibit 4 5 of 17 Description of CGI: 0-ring (nonnetallic)
Application: Maintain a seal to prevent leakage of fluid. Mild environment.
Selected Critical Characteristics (Hypothetical Technical Data) 1.
Dimensions (ID = 5.0" (nominal) = 4.989' 10.037". cross-section diameter =
1/8" (nominal) = 0.070*
0.003").-
2.
Material (EPDM compound).
3.
Durometer Hardness (Shore A 7015).
l Application of Acceptance Methods ACCEPTANCf. METHOD 1:
Selected Critical Soecial tests and inspections used to verify the Characteristics critical characteristics.
1.
Dimentions Measure at receipt inspection using a layout cone for ID and calipers for the cross-section diameter.
2.
Material Verify color at receipt inspection against the Supplier's comparison chart, or verify chemical composition of 0-ring is that of EPDM compound.
3.
Durometer Hardness Test at receipt inspection and verify reading of Shore A 70 15 Durometer hardness.
ACCEPTANCE METHOD 2:
g..
Selected ;rjl.1,qal CGI Suoolier's activities used to control the critical Characteristics characteristics subiect to survey.
g 1.
Dimensions Examine design controls, tooling controls, in-process and final inspection practices, and measuring equipment controls to verify 0-rings are made to the correct size.
2.
Material Examine design controls, procurement controls, receipt inspection controls, processing controls, and material controls for EPDM compound.
3.
Durometer Hardness Examine in-process and final testing practices to verify i
that the Supplier controls the Durometer hardness of EPDM to Shore A 70 15. Verify test equipment is calibrated.
Review test records generated.
1 ACCEPTANC: METHOD 3:
h Selected "r.itical Supplier's activities used to control the critical Characteristics characteristics witnessed and examined durino source surveillance.
i t
1.
Dimentions l
Dimensionally inspect ID, and cross-section diameter against Supplier's fabrication drawing. Review design f
and calibration controls.
H 11
-~
m
~ ~,' ~.
. ~.
- 7....
o l
j j'.
4 a.
3 Exhibit 4 6 of 17 i
I 2.
Material Witness control of batch material from which 0-rings are
- 9 fabricated, and the mixing and fabrication processes.
j Verify color against the Supplier's comparison chart. A h
Supplier coeld be willing to conduct chemical analysis or destructive testing on a sample basis, which the 1
purchaser may also choose to witness.
g I
3.
Durameter Hardness Witness Durometer hardness test and verify reading of l
H Shore A 70 15.
H 9
Although this method is technically feasible, it may not be economically feasible 4
to maploy. For example, ordering a batch of sufficient quantity to justify a i
source verification would not be economical, since the shelf life would expire
.i scior to use of the entire batch.
ACCEPTANCE METHOD 4:
Selected Critical Perfomance information used to provide reasonable Characteristics assurance the critical characteristics have been met.
^
1.
Dime,sions Results of monitored performance, results from using other methods Supplier responses to CG program controls, CG program industry surveys.
2.
Material and Results from monitored performance, results from Durometer Hardness successfully using other methods, periodic maintenance and surveillance tests, Supplier responses to CG program controls, use of national standards, and CG program ~
industry surveys.
4 6-ring Procurement Scenarios I.
Utility 1 conducts a survey of Commercial Supplier A.
It is determined that the Supplier adequately controls the manufacture of EPDM material and tests the Durometer hardness of selected 0-rings, but has a high rate of-deficiencies in controlling the correct size of 0-rings. Utility 1 obtains 1
the. dimensional data while at the survey in order to dimensionally inspect the ID and cross-section diameter of the 0-rings upon receipt. A report is-issued documenting the survey results, including the'need to use Method 1 to verify 0-ring dimensions. Utility-1 issues a purchase order for 0-rings requesting a Certificate of Conformance to the program surveyed. Upon-receipt, a Standard Receipt Inspection is performed plus a special j
dimenstenal inspection. Utility 1 accepts the 0-rings based on Supplier A's Certificate of Conformance to the purchase order and the documented inspection results. Thus, a combination of Methods 1 and 2 is used to accept the 0-rings.
II.
Utility 2 buys 0-r1 T. from Commercial Supplier B.
A survey is conducted and credit is taken for this Supplier adequately controlling selected' critical characteristics. During the survey the utility examines in-process and final test inspection practices to verify the Supplier controls the ID and cross-section diameter of 0-rings. The utility also examines the material controls employed for EPDM compound, and verifies that the Supplier tests the Durometer hardness of EPDM. Utility 2'also performs dimensional inspections and Durometer hardness tests upon receipt of a selected sample from each batch. This practice is continued for three years after the initial survey was conducted with no reported problems in the supplied f
H-12
o Exhibit 4 7 of 17 0-rings.
Also during this time, Utility 2 documents the satisfactory performance of these 0-rings in numerous applications in the plant.
Utility 2 decides to conduct an evaluation to determine if an Acceptable Supplier / Item Performance Record can be justified.
Utility 2's historical performance results, historical verification results from using Method 1 and 2, and industry-wide perfonnance data is collected and reviewed for Supplier B's 0-rings.
Performance Record is documented. Based on the evaluation, an Acceptable Supplier / It A purchase order is issued to Supplier B for 0-rings. The 0-rings are received and subjected to a Standard Receipt Inspection.
Utility 2 accepts the 0-rings by issuing certification based on 1
the Acceptable Supplier / Item Performance Record.
Methods 1 and 2 were initially used to accept the 0-rings, then after a period of time. Method 4 was used.
III.
Utility 3 desires to use Method 1 to accept the 0-rings.
No interface is conducted with the Supplier during the procurement, and the 0-rings are received.
In developing the receipt inspection plan, the utility then requests that the Supplier furnish them with the 10 and cross-section diameter Durometer hardness, and material of construction to accceplish the special tests and inspections. The Supplier informs utility 3 that the dimensions, the chemical composition of the EPDM material, and the Durometer hardness are proprietary information and cannot be furnished.
Utility 3 cannot accept the 0-rings for safety-related use employing Method 1 without obtaining the necessary technical data from the Supplier.
I e
e h
4.
T e
1 5
- r..
l H-13 I
y v
~
9 Exhibit 4 8 of 17 Description of CGI: Torque Switch Application: Valve operators locate.1 in a harsh environment. (A technical evaluation wss conducted prior to procurement which assured that the items'specif'ed in each scenario were' identical to the item saismically and environmentally tested, as referenced in the original test report.)
SelectedCriticalCharacteristics(HypotheticalTechnicalData) i 1.
Dimensions (4.20" 20.010" width, 6.50" 20.010" depth, 2.67" to.010" height).
2.
Configuration (reference is made to the Supplier's' catalog outline drawing).
3.
Material, nonnetallic parts (phenolic, dark brown color).
4.
Operability (transfer state at 15% of applied torque).
I Applicat1*m of Acceptance Methods' i
ACCEPTANCE METHOD 1:
Selected Critical Snecial tests and insoections used to verify the Characteristics gritical characteristics.
f 1.
Dimensions Measure width, depth, and height at receipt inspection.
i 2.
Configuration Verify at receipt inspection using the catalog outline drawing as reference.
3.
Material Visually inspect for dark brown color.
j (nonmetallicparts) i 4.
Operability Manually test at receipt inspection to confirm spring i
action and air gap between contact metal bar and holder.
1 Post-installation test after torque _ setting is made to verify the switch transfers state and the valve seats properly. This also indicates that the switch is compatible with the spring pack.
ACCEPTANCE METH00 2:
Selected Critical _
CGI Suon11er's activities used to control the critical Characteristics characteristics subject to survey.
1.
Dimensions Examine design controls, measuring equipment used by the Supplier, calibration controls, and final inspection _
practices.
2.
Configuration Examine design controls'and final inspection practices.
3.
Material Examine design controls, procurement controls, receipt (nonmetallicparts) inspection activities; and material controls for phenolic material used for switch housings.
4 Operability Activities surveyed during a commercial grade survey do not lend themselves to verifying this critical characteristic. Conduct a post-installation test as described in the Method 1 appliiation to augment the survey results.
H-14.
4
i Exhibit 4 9 of 17 ACCEPTANCE METHOD 3:
Selected Critical Characteristics Jyco11er's activities used to control the critical I
characteristics witnessed and examined durina source surveillance.
1.
Dimensions and Dimensionally inspect against Supplier's assembly l
Configuration crawing.
Review design and calibration controls I
applicable to the switch.
j 2.
Material (nonmetallic parts) Examine design controls, procurement controls, receipt I
l inspection activities, and material handling controls the Supplier employs for phenolic material.
I 3.
Operability Activities witnessed during source verification.do not
'end themselves to verifying this critical characteristic. Conduct a post-installation test as described in the Method 1 application to augment the.
source verification results.-
ACCEPTANCE METHOD 4:
?
Selected Critical Characteristics Performance information used to provide reasonable ~
i I
assurance the critical characteristics have been met.
Dimensions, h
Configuration, Results from monitored performance, results from Material successfully using Method 1, periodic maintenance and (nonmetallic parts),
surveillance tests, Supplier responses to CG program and Operability controls, and review of USNRC issued documents.
i Torque Switch Procurement Scenarios i
I.
Utility I requires torque switches on~an expedited basis.-
The-switches are not an ites frequently procured. Utility 1 places an order for several torque switches and obtains the right to access the commercial Supplier's facility.
Utility 1 conducts source verification by witnessing activities A-used to control critical characteristics.
utility measures the dimensions and. verifies the configuration of theWhile at the p-switches using the Supplier's assembly drawing as a reference. The utility i
examines how the Supplier procures and handles the phenolic material used g*
for the switch casing. Finally, the utility witnesses final testing of the switches.
The switches are released for shipment by Utility 1 based on the documented source verification results.
inspection is perfo wed.
Upon receipt, a Standard Receipt of post-installation testing. Provisions are made to verify operability by means Utility 1 accepts the switches based on source verification results and the documented completion of 1, L post-installation tetting.
1 The switches are accepted using Methods 1 and 3.
t 6
k.
r
?:
H-15
9 j.
Exhibit 4 10 of 17
)
II.
Utility 2 procures a line of torque switches on a frequent basis from Commercial Supplier ABC. A survey of Supplier ABC is arranged to examine activities used to control selected critical characteristics. The Supplier
~
has a commercial Quality Assurance manual for the design and manufacture of an eittire line of switches. The survey indicates that the Supplier satisfactorily employs the controls as delineated in the manual and that these activities adequately control the dimensions, configuration, and phenolic materials of the switches. A report is issued documenting the survey results. Utility 2 issues a purchase order to Supplier ABC
]
requesting torque switches, invoking rights of access, and requesting a Certificate of Conformance to the commercial Quality Assurance manual
((1131). Upon receipt of the items, a Standard Receipt Inspection is conducted. Provisions are made to verify operability by means of post-installation testing. Utility accepts the switches based on the Supplie*'s Certificate of Conformance to the purchase order and the documented completion of post-installation testing. The switches are accepted using Methods 1 and 2.
I
{
t
)
4 l
4 3
1 H-16
i 1
!^
Exhibit 4 11 of 17 Description of CGI: Valve Sten t
Application: Installed in an active isolation valve.
Selected Critical Characteristics (Hypothetical Technical Data)
-j 1.
Dimensions (diameter = 1.663" !O.001", length = 6.250" 4.000" -0.002").
2.
Configuration (reference is arde to the Supplier's valve assembly drawing).
3.
Material (ASTM A276. Type 316 stainless steel).
4.
Hardness (Brinnell hardness 165 to 195 range as specified on Supplier's
'l drawing).
d Application of Acceptance Methods ti ACCEPTANCE METHOD 1:
Selected Critical Special tests and inspections used to verify the Characteristics critical characteristics.
1.
Dimensions If dimensional tolerances are unknown, verify dimensional acceptance by post-installation testing. Ensure stroke time is acceptable.
If dimensions are known, measure diameter and length.
p 2.
Configuration Visually inspect at receipt inspection against Supplier's valve assembly drawing.
i 3.
Material Verify the material is ASTM A276 Type 316 stainless steel with an alloy analyzer (utilizing utility, equipment or the services at an approved test facility).
4.
Hardness Verify Brinnell hardness is between 165 and 195 uti~ izing a hardness tester (utilizing utility equipment or the services at an approved test facility).
f ACCEPTANCE METHOD 2:
)
i t
Selected Critical CGI Supplier's activities used to control the criti;Al Characteristics characteristics sub.iect tc survev.
H 1.
Dimensions Examine design controls, measuring equipment, calibration controls, and final inspection practices.
2.
Configuration
. Examine design controls, manufacturing controls, arid final inspection practices.
3.
Material Examine design controls, procurement controls, receipt inspection activities, and material controls for ASTM A276 Type 316 stainless steel.
4 Hardness Examine heat treatment practices, testing, and calibration controls to verify the finished material has a Brinnell hardness between 165 and 195.
1 I
i l
4 H-17 N
t Exhibit 4 13 of 17 f'
Description of CGI: Resistor Application: Item in Class 1E Radiation Monitoring Equipment. Harsh environment.
(A technical evaluation was conducted prior to procurement. It assured that the items specified in each scenario were identical to the item installed in the component, which was seismically and environmentally qualified, as referenced in the original component test report.)
Selected Critical Characteristics (Hypothetical Technical Data) i 1.
Resistance (110% of 10,000 ohns rated resistor).
a 2.
Paar Rating (10 watts).
3.
Merkings (brown, black, orange, double space, silver).
4.
Configuration (reference is made to the Supplier's catalog outline drawing).
Application of Acceptance Methods t
ACCEPTANCE METHOD 1:
Selected Critical Special tests and inspections used to verify the Characteristics critical characteristics.
3 1.
Resistance Confirm resistance is 10,000 ches 110% utilizing test equipment.
2.
Power Rating Confirm power rating utilizing test equipment.
1 3.
Markings Verify color markings'are brown, black, orange, double space, and silver (from left to right).
4.
Configuration Visually inspect making reference to the Supplier's catalog outline drawing.
ACCEPTANCE METHOD 2:
-Selected Critical CGI Sunolier's activities used to control the critical Characteristics
. characteristics subiect to survey.
1.
Resistance Examine manufacturig controls, in-process, and final testing practices of 10,000-ohn resistors. Verify test' e.
4 equipment is properly calibrated. Review test. records generated. Examine controls of raw material.
k.
2.
Power Rating Examine design controls, manufacturing controls, and and Markings marking practices.
3.
Configuration Examine design controls, measuring equipment calibration j
F controls, and in-prJ ess/ final inspection practices.
J.
t-
- r
[*
H-15 I
Exhibit 4 12-of 17 ACCEPTANCE METHOD 3:
Selected Critical Sucolier's activities used to control the critical
)
Characteristics characte-1stics witnessed and examined durino source-L surveillance.
l 1.
Dimensions and Dimensionally. inspect against the detailed design drawing-Configuration of the stem. Review design and calibration controls' applicable to the sten.-
2.
Material Examine design controls, procurement controls, receipt inspection activities.and matertai controls for ASTM A276 Type 316 stainless steel.
3.
Hardness Review heat treatment records, calibration records, and heat treatment procedure. Alternatively, witness a.-
I hardness test to verify material Beinnell hardness is j
'between 165 and 195.
ACCEPTANCE METHOD 4:
\\
Selected Critical Performance information used to provide reasonable Characteristics assurance the critical characteristics have been met.
t Dimensions, Results of monitored performance, results from Configuration, successfully using Method 2 that are still valid, Material, and periodic maintenance and surveillance. tests INP0 MPROS.
Hardness Supplier responses to CG program controls, and USNRC issued documents.
Valve Stem Procurement Scenarios I.
Utility X procures replacement valve stems from the Original Equipment-Manufacturer. The valve assembly drawing indicates the material of i
construction and hardness of the stem, but dimensions are not provided. A i
Standard Receipt Inspection is conducted upon receipt. Utility 1 verifies-
{
the material is ASTM A276 Type 316 stainless steel by utilizing an alloy.
analyzer. Hardness is measured at 175 with a Brinnell hardness tester.
Critical dimensions are verified after_the stem is installed by stroking the-valve and ensuring its proper operation. The results of the special' receipt tests and post-installation test are documented. Utility X utilizes Method 1 to accept stems for safety-related use.'
II.
Utility 2 conducts a commercial grade ites survey in conjunction with. its l
triannual 10CFR50, Appendix B audit.. While.at the facility, it is i
determined that the Supplier controls valve stems under their:10CFR50, Appendix B program. The supplier passes the audit and remains on the utility's approved nuclear supplier list. Tne utility procures the stem as a basic component and not as a commercial grade iten.
In this case, the utility does not need to amploy commercial grade item acceptance methods because the stem is being purchased as a basic component.
j l-H-18 I
L t
a
i I
Exhibit 4 Description of CGI:
15 of 17 Pressure Transmitter Application:
1 Harsh environment, seismically qualified was conducted prior to procurament which ass (uA~ technical e specified in each scenario were identical to the ite red that the items j
and environmentally tested, as referenced in the ori i report.)
m seismically g nal test Selected Critical Characteristics (Hypothetical T 1.
Pressure Range 50 to 150 psi.
echnical Data)
Materials (comme (rcial stainles)s steel 2.
3.
Accuracy (12.5% of full scale)
, Buna-N seals).
t 4
Electrical Ratings (120 Vac, 5 amp contact 5.
Configur.ition (reference is made to the Sup lirating, 4 to 20 mA p
er's catalog outline drawing).
ACCEPTANCE METHOD 1:
Application of Acceptance Methods Selected Cri i_g t
Characteristics,1 critical characteristics.Special tests and inspectio 1.
Pressure Range the nameplate. Vet ify the 50 to 150 psi pressure range 50 to 150 pst during post-installation testiVerify 2.
Materials.
I without dise lembling a sample transmit ng.
y '4ethod 1 with other acceptance method.
3.
Accuracy Must augment i
post-installation testing. Verify accuracy is 12.5 4.
uring Electrical Ratings Verify the voltage, current rating on the nameplate, and as part of post-installati testing.
, and output amperage 5.
Configurttion on -
Dimensionall connections,y check end connections an and check nameplate data for proper transmitt ACCEPTANCE METH00 2:
er type.
$L1eeted Critigl Characterisi q_
CGI Supolier's activities used to Pressure.ange characteristics subiect to survey. control the critical 1.
determine how the Supplier verifies thExa and Accu cy ces to the transititter.
Review test records generated. Verify test caliu' t'ated.
2.
Materials Examine design controls, procurement cont inspection activities
~
the Buna-N seals.comnercial stainless s, teel p parts and H-21
e I
14 of'17' I.
Exhibit 4 l-ACCEPTANCE METHOD 3:
Se9911er's activities used to control the critical Selected Critical characteristics witnessed and examined durina source l :l Characteristics l 'l surveillance.
-Witness resistance test measures 10,000 ohns 1105.
\\
.l 1.
Resistance Examine Supplier's procedure for identifying power i
2.
Power Rating e
rat 1ng.
l
. Visually inspect l
Examine Supplier's marking' procedures.
3.
Markings color markings..
i
~Dimensionally inspect against design' drawing of 4.
Configuration 10,000-ohn resistor.
b ACCEPTANCE METH00 4:
Perfomance infomation used to orovide reasonable Selected Critical assurance the critical characteristics have been a,3,{.
Characteristics Results of successfully using Method 1, purchased to a i
Resistance, Power national standard, Supplier is on Qualified Product-List, Supplier reliability data, survey report ofmil i
Rating Markings, and Configuration
{
program controls.
l I
Resistor Procur ment Scenarios t
.l l
Utility 1 conducts a coimmercial grade item' survey of' Supplier A by e
(
manufacturing controls, in-process and final testing' practices, design l
I.
controls, manufacturing controls, and marking practices for 10,000-ohm.
j These activities are deemed adequate.to control the rated,,
resistance and power, color markings, and configuration of.the resistor.
resistors.
j Purchase order requirements are The survey results are documented.
f A Certificate of-l established which invoke the surveyed controls.Confomanc j
Quality Control activities were exercised. Inspection is required to t
{'
Thus, Utility 1 employs Method 2 to accept the resistors..
f Utility 2 conducts a commiercial grade item surv j
f-II.
i control the rated resistance of the items.
adequate marking practices and final inspection practices to control.the-.)
configuration of the resistor. These survey results are documented.
Purchase order requirements are established which invoke the surveyed j
A Certificate of Conformance is furnished by the Supplier to.
~
i confim that the required Quality Control activities were exercised. ' A-l controls.
Standard Receipt inspection is conducted upon receipt.
l i
l l
To verify the resistance, Utility 2 measure'. 10,000 ohms resistance by The results of
'I utilizing an ohn meter upon receipt of a selected sample.Thusi a combinatio l
j the special tests are documented.
l used to accept the resistors.
H-20 l
u
1 4
Exhibit 4 17 of 17
[
The Supplier furnishes Utility 1 with the necessary technical info regarding the materials of construction with'a Certificate of Confor rmation Utility 1 uses this information to verify that materials by disassembli mance.
sample transmitter and having the material of the parts tested at an ng a approved laboratory.
l Type 304 stainless steel and that the seals are Buna results confirm the data furnished on the Supplier's certification
..These remaining transmitters are accepted for safety-related use based on the
. The documented special test and inspection results.-
In this case, the utility employs Method 1 to accept the transmitters II.
Supplier does not have a cr-sercial Quality Assurance The employing various quality activitiesadequately control the select
, but does examines the Supplier's in-process an. While at the facility, Utility 2 12.5%. respectively.that the transmitter pressure range and accuracy are The utility examines how the Supplier controls desi psi and-changes to the transmitter and the material controls for stainless stee pressure retaining parts and Buna-N seals.
ratings of 120 vac, 5 amp contact rating' 4 to.20 mA ectrical configuration of a typical assembled transmitter.
, and the general' results of the survey is prepared.
A report documenting the Utility 2 issues a purchase order to Supplier X for pressure transmitt requesting a Certificate of Conformance stating the order was processed
- ers, accordance with the design control, procurement control, material contr final testing, and receipt inspection practices observed du i n
Upon receipt, a Standard Receipt Inspection is performed r ng the survey.
are accepted based on the Supplier's Certificate of Conformance to the
. The transmitters purchase order.
Utility 2 accepts the transmitters for safety-related use utilizing Method 2.
H-23
.O 16 of 17 Exhibit 4 Examine design controls, procurement controls, electrical j
test practices, test equipment calibration, and test 3.
Electrical Ratings s
records generated.
Examine design controls, manufacturing practices, final inspection, calibration of measuring equipment, and 4.
Configuration appropriate records.
ACCEPTANCE METHOD 3:
SUDDlier's activities used to control the critical Selected Critical characteristics witnessed and examined durinq source j
Characteristics surveillance.
Witness final testing, review test procedures,' review final test data for acceptability, and assure test 1.
Pressure Range and Accuracy equipment is properly calibrated.
Examine design controls, procurement controls, receipt inspection activities, and material controls fo 2.
Materials seals.
Visually inspect nameplate data and review applicable 3.
Electrical Ratings test records.
Dimensionally check end connections and mo 4.
Configuration Examine and check nameplate for proper transmitter type.
design controls.
ACCEPTANCE METHOD 4:
Performance ___information used to orovide reasonab Selected Critical assurance the critical characteristics have been met.
Characteristics Results from monitored performance, results f Pressure Range, from successfully using Method 3, periodic maintenance Materials, Accuracy, and surveillance tests, Supplier responses to CG program Electrical Ratings, controls, use of national standards, review of USNRC and Configuration issued documents, and INPO NPRDS.
Pressure Transmitter Procurement Scenarios Utility 1 procures the pressure transmitters without conducting a Method 1 is intended to be used I.
gradeitemsurveyorsourceferification.Upon receipt, a Standard Receipt Inspectio to accept the transmitters.
A bench test is conducted which verifies a 22.5% accuracy, 120 Vac, 5 amp contact rating, 4 to 20 mA output, pressure range o performed.
Because the 150 psi, and the general configuration of the transmitter.
l of traremitters is required to operate in a harsh environment, the materia conuruction of the pressure retaining and nonmeta critical.
Thus Utility 1 cannot verify under the harsh environmental conditions.that stainless steel press furnished by using a bench test.
H-22 i
NUMARC 90-13 Nuclear Procurement Program improvements October 1990 Nuclear Management and Resources Council, Inc.
1776 Eye Street, N.W.
yp p $,
Washington, DC 20006-2496
i l
l l
i i
Nuclear Procurement Program improvements October 1990 O
j l
1
t b
l t
b i
i i
NOTICE This information was prepared in connection with work sponsored by the Nuclear i
Management and Rosources Council, Inc. (NUMARC).
Neither NUMARC nor'any of its employees, members, participants, or consultants make any warranty, expressed or implied, or assume any legal liability or responsibility _for the l
accuracy, completeness or usefulness of any information, apparatus, product.or process disclosed in this document,'or represent that its use would not infringe privately-owned rights.
i The opinions, conclusions, and recommendations set forth in this document'are those of the authors and do not necessarily represent the views of. NUMARC, its employees, members, participants or consultants.
1 4
I i
I
l o
4
- o I
I-l 1
Abstract t
The NUMARC Nuclear Plant Equipment Procurement (NPEP)' Working Group..was' charged to. review nuclear ~ utility. procurement-practices and develop i
appropriate improvements for implementation through industry initiatives.
o
-l 4
The factors that-suggested a need for improvements included concerns '
l with substandard and fraudulently represented items, changing marketplace-
{
conditions, and increased obsolescence 1of installed parts.
L!
3 I
ihe " Comprehensive Procurement Initiative" summarizes'the^ areas'of-l 1
improvements specified, and references the " Nuclear Procurement Program' i
Improvements" paper. :This paper discusses the considerations of the.NPEP~
i Working Group in developing the. improvements, and describes in detail.the j
procurement process improvements specified by the industry. initiatives.. The.
j improvements are forward looking and are not intended to be applied to past' utility procurement activities.
i Overall, increased engineering involvement:in procurementlactivities is:
l called for.
Particular improvements are specified in the areas of dedication l
of commercial grade parts for nuclear safety relat~ed applications,: vendor.
J audits,. enhanced receipt inspection, obsolescence, information sharing,. and '
l general procurement. Appropriate. Electric Power Research Institute (EPRI)
I guideline documents are referenced for certain of these improvements.
1 t
i The NUMARC Board of Directors agreed with the recommendations of the_
l l
NPEP Working Group and concluded that implementation of these' industry-initiated changes will effectively address the factors describediabove i
without the need for additional regulation.. Moreover, the Board. concluded i
that the improvements should be implemented by each utility and their.overall
}
effectiveness assessed prior to further industry action.-
i t
i i
r i
e i
h i
i k
U
l 4
6 1
i 4 s F
i d
e T
4 t
t e
f 5
i i
l-1 r
b I
s T
9 1
h I
4 9
I 6
t B
E s
a 6
Ii i i s
)
't t
6 I
-i o
t i
r TABLE OF CONTENTS t
Section East l
l I.
Comprehensive Procurement Initiative.......................
I-l j
e II.
Nuclear Procurement Program Improvements..................
1 Introduction.........................................
1 Working Group' Considerations........................
2 i
Initiative on the Dedication of Commercial i
Grade Items........................................
5' Forward Looking Nature of.the Initiatives...........
6 i
Comprehensive Procurement Initiative................
7 i
Vendor Audits.......................................
7 l
Tests and/or Inspections............................
10 i
Ob s ol e s c en c e......................................... 13 Information Exchange................................
15 i
l Gene ral Procurement...................................,
Addi tional Cons iderations............................- 18 l
Conclusion..........................................
18 l
l t
iii i.
s COMPREHENSIVE PROCUREMENT INITIATIVE i
Review the " Comprehensive Procurement Initiative" section (pages 7-18) of the enclosed document, " Nuclear Procurement Program Improvements," dated June 28,-
1990, and assess your current procurement practices with respect to this document.
Provide program enhancements or upgrades where the review indicates the need for improvements. The contents of the " Nuclear' Procurement Program Improvements" document are summarized below (with corresponding page numbers from the document.) The actions indicated below in BOLD are those actions necessary to satisfy the Comprehensive Procurement Initiative.
The other items are included for information and general guidance.
This review and assessment should be complete by July 1,1991.
Implementation of the improvements should be complete by July.1,1992.
i I.
Implementation and Intent [p. 6]
The Initiatives identify improvements in utility procuretant activities that are intended to be forward looking.
It is not intended that these-1 improvements be retroactively applied to past procurement activities prior to the proposed implementation dates.
i 1
i II.
Initiative on Dedication of Commercial Grade Parts (Approved by NUMARC i
i Board of Directors in March 1989) [p. 5]-
1 1
Review and, if necessary, upgrade program to meet guidance of i
I EPRI NP-5652, relative to dedication of commercial grade parts.
III.
Comprehensive Procurement Initiative (Approved by NUMARC Board of Directors in June 1990) [pp. 7-19]_
A.
Vendor Audits [pp. 7-9]
1.
USE performance-based audits, as appropriate, for vendor audits performed by utilities and utility-based auditing organizations.
The process for performance-based audits should be consistent with EPRI NP-6630.
2.
Consider participation in joint audit activities as appropriate.
1-1 1
1 i
COMPREHENSIVE PROCUREMENT INITIATIVE (CONT) i B.
Tests and/or Inspections [pp. 10-13]
1.
Review EPRI NP-6629 relative to development of procurement requirements, acceptance methods, and engineering 1
involvement.
2.
EINANCE capability for performance of tests and/or inspections of procured items. USE tests and/or inspections, as appropriate, consistent with the information' noted in the referenced sections of EPRI NP-6629.
3.
USE guidelines for fraud detection (Appendix C to EPRI I
NP-6629) for purchases of safety related items.
l 3
C.
Obsolescence [pp.13-15]
1.
Consider alternative replacements for procurement of obsolete items, where practicable, as a~ preference to procurement from the surplus market.
If surplus market is used, ESTABLISH' product performance through traceability to l
Original Equipment Manufacturers, or performance of tests and inspections.
2.
Review EPRI NP-6406 if you identify a need to improve your technical evaluation process.
i 3.
Review EPRI NP-5638 if you identify a need to improve your i
procurement specifications.
D.
Information Exchange [pp. 15-16]
1.
Share vendor audit information through joint audit forums.
l 1
k Actively share objective procurement information through designated topics on INPO NUCLEAR NETWORK.
i E.
General Procurement [pp.16-17) 1.
Provide necessary resources (including engineering resources) to support improved procurement practices.
I-2 l
l i
i i
i COMPREHENSIVE PROCUREMENT INITIATIVE (CONT):
2.
Procure items through nor. sal supply channels (OEM or authorized distributor) where practicable.. hen procuring 1
W through other char.nels, ESTABLISH product / performance.
through traceability to Original Equipment Manufacturers, or.
performance of tests and inspections. '
3.
Where new products are desired, specify "new" on purchase-j orders.
j i
4.
Establish the acceptance method (e.g., performance based 1
audit,. tests and inspections, etc.).by assessment at the
~
front-end of the procurement process. _
1 l
Referenced EPRI Documents:
EPRI NP-5652,. Guideline for the Utilization of Commercial Grade Items in Nuclear-Safety Related Acolications (NCIG-07)
EPRI NP-6629, Guideline for the Procurement and Receipt of Items for Nuclear Power Plants (NCIG-15)
EPRI NP-6630, Guidelines for Perfomance Based Sunolier Audits 1
(NCIG-16)
EPRI NP-6406, Guidelines for the Technical Evaluation of Replacement 11gmL in Nuclear Power Plants-(NCIG-111 l
i EPRI NP-5638, Guidelines for Preparina Specifications for Nuclear Power i
Plants (NCIG-04) i l
i i
q i
1 o
I-3 j
a i
l.
I l
l 1
i i
NUCLEAR PROCUREMENT PROGRAM IMPROVEMENTS i
l l
l INTRODUCTION The NUMARC Nuclear Plant Equipment Procurement (NPEP) Working Group was formed in September 1988, at the direction of the NUMARC Board of Directors, to-address the need for general improvements to industry procurement practices.
l l
The Working Group provided a forum for unified industry discussion and j
interaction with the Nuclear Regulatory Commission (NRC) on concerns relating to industry procurement activities. The specific goals of the Working Group I
l were:
I 1)
Review utility procurement practices and consider what changes may.
be necessary to minimize the impact of fraudulent activities by i
suppliers to the industry.
l 2)
Develop and recommend long term resolution _ to industry and NRC concerns relating to procurement activities.
L 3)
Develop industry guidance as necessary to' achieve implementation of the resolution, and propose appropriate industry initiatives for consideration by the NUMARC Board of Directors.
I
i The Working Group reviewed existing procurement activities and identified elements for potential improvement. The Working Group finalized their P
determination of which improvements should be effected through the NUMARC industry initiative process.
This paper describes the total set of-improvements and provides information necessary for utility implementation of the industry initiatives.
WORKING GROUP CONSIDERATIONS At the outse'., the Working Group developed a discussion paper, " Nuclear Procuremeit Issues," which described elements of the procurement process under considerhtion for potential improvements.
These included vendor audits, receipt inspection, dedication of commercial grade items, obsolescence, fraud detection, information exchange, and general procurement. The " Nuclear I
Procurement Issues" paper was provided to both the industry and NRC. The key i
considerations of the Working Group were that:
j 1) 10 CFR 50 Appendix B was intended to ensure quality products through good faith cooperation between suppliers and utilities, and was not intended to address potentially fraudulent practices.
s 2)
In order to minimize fraud, more emphasis should be placed on technical verification of product quality, rather than relying solely on documentation reviews.
Increased engineering involvement in the front end of the procurement process will generally be needed to accomplish this.
i 1
+
2
3)
Improvements to the overall procurement process, along with j
increased awareness of the potential for fraud, provide the most effective mechanisms to counter fraud.
Changes to regulations and standards to explicitly address fraud are unlikely to be effective, since fraud can perpetrate under any~ system of controls.
)
4)
The existing system of regulations and standards provide an effective foundation for procurement activities and need not be replaced or significantly altered.
Rather, industry guideline.
1 documents should be developed to provide the.necessary l
improvements to existing practices and to address those elements of existing procurement programs needing additional emphas_is and consistency.
NRC concerns relative to ingress of potentially fraudulent and substandard parts into safety-related nuclear plant applications led to publication, in March 1989, of an Advanced Notice of Proposed Rulemaking (ANPR),'a preliminary step towards changing the regulations which affect procurement activities.
The industry response to this ANPR, developed in coordination with the Working Group, noted that self-initiated actions on the part of industry can provide
-I more effective and timely improvements than would be brought'about by revised regulations.
In addition to the concerns relative to fraudulent activities, other factors such as the diminishing number of nuclear suppliers, and I
increased obsolescence of installed items, contributed to the need for-industry to consider changes to the procurement process.
3
l
\\
The Working Group has considered each of the areas described in the " Nuclear 1
Procurement Issues" discussion paper, and has formulated two industry initiatives which encompass overall improvements to procurement practices.
The first initiative, which addresses dedication of commercial grade items for use in nuclear safety related applications, was approved by the NUMARC Board of Directors in March 1989. The second initiative, the comprehensive procurement initiative, has been recommended to the NUMARC Board of Directors for consideration, and covers the remaining areas of improvements considered l
r.ecessary.
'bese include vendor audits, tests and/or inspections, information sharing,...J,. aral procurement considerations.
The improvements delineated in the comprehensive initiative are intended to apply to the purchase of items for safety-related applications. The ccmprehensive initiative itself is brief and refers to this paper for a description of the improvements.
It should be noted that the improvements described in this paper are based on existing utility practices.
For many utilities, it is not expected that implementation of these improvements would result in major revisions to organizational structures or existing programs. However, one central element which has been identified is the need for more engineering involvement in the procurement process, to support activities such as performance based audits and tests or inspections of procured items.
The magnitude of these additional resources can be mitigated through the use of joint utility activities, such as shared vendor audits.
Further detail on this involvement is discussed in the guideline documents referenced in this paper.
It A ould be noted that long term benefits are expected to be derived from the improvements which l
would help compensate for the additional resource requirements. These 4
i
i a
l' benefits include an overall increase in quality of procured items, as well as-i a reduced potential for costly future efforts to locate and assess safety l
significance of installed items which are suspected to be potentially substandard (e.g., NRC Bulletins 88-05 and 88-10).
INITIATIVE ON THE DEDICATION OF COMMERCIAL GRADE ITEMS l
l l
A significant step towards minimizing the potential for fraudulent or substandard products is improvement in utility practices for dedication of commercial grade parts for nuclear safety related use.
Use of commercial grade parts has become increasingly common due to diminishing numbers of suppliers of safety grade items.
In March 1989, the NUMARC Board of Directors adopted an initiative calling for utilities to review and, if necessary, develop or upgrade current programs to meet the intent of the guidance provided in an EPRI guideline document, EPRI NP-5652, Guideline for the Utilization of Commercial Grade Items in Nuclear Safety Related Anolications i
(NCIG-07). Th e review and development was to be accomplished by January 1, i
1990.
In July 1989 industry workshops were held by NUMARC to provide information and discussion relative to the initiative.
The guideline document provides four methods for dedicating commercial grade items:
1.
Special tests and inspections 2.
Commercial grade survey of supplier 3.
Source verification 4.
Acceptable supplier / item performance record 5
This guideline focuses on understanding and verifying an item's critical I
charar'iristics to provide a basis for product acceptance.
NRC Generic Letter l
89-02 issued in March 1989, conditionally endorsed the EPRI document.
FORWARD LOOKING NATURE OF INITIATIVES i
With regard 'o the initiative on dedication of commercial grade items, as well as the comprehensive procurement initiative described below, it is intended that the program improvements described therein be implemented following the I
dates stated in the initiatives.
It is not intended that the improved methods be backfit to procurement activities occurring prior to the stated implementation dates.
The initiatives are intended to be " forward looking."
NUMARC's letter to the Board of Directors, dated December 26, 1989, stressed this point relative to the initiative on dedication of commercial grade items.
The fact that a utility chooses to make improvements in its current programs in accordance with the comercial grade item initiative and/or the I
comprehensive procurement initiative does not necessarily indicate previous programmatic deficiencies nor suggest that-previously purchased items are deficient.
If a utility has reason to believe that a technical deficiency exists relative to a specific item or items procured previous to the initiative implementation dates, this deficiency should be investigated, and methods as described in the initiatives may be of use to support this process.
l However, general programmatic reviews of past procurement practices with respect to the methods described in the initiatives are not warranted or intended.
6 l
t
i COMPREHENSIVE PROCUREMENT INITIATIVE The comprehensive procurement initiative was approved by the NUMARC Board of Directors in June 1990. This initiative addresses the following areas, each of which is addressed in subsequent sections of this paper:
Vendor Audits j
Tests and/or Inspections Obstscence Information Exchange General Procurement The comprehensive procurement initiative calls for utility review and assessment of the improvements discussed in the following sections of this paper by July 1,1991, and implementation of the improvements into utility programs by July 1,1992.
VENDOR AUDITS Improved vendor audits provide one method of increased assurance against the 4
ingress of fraudulent or substandard parts.
Program audits, which have been standard practice for implementing Appendix B requirements, review administrative controls and interfaces to assess the adequacy of written Quality Assurance programs to industry standards and regulatory requirements.
These audits rely primarily on review of paperwork, while hardware, or 7
l
L performance based, audits assess manufacturing process controls, design, inspection and test activities. A performance based audit generally involves the participation of individuals on the audit team who possess technical expertise relative to the item being procured.
Industry use of performance based audits, as appropriate, is called for as part of the comprehensive procurement initiative.
Use of performance based audits is intended primarily for application to suppliers with approved Appendix B programs; however, performance based elements could be considered for commercial grade surveys or source verifications (Methods 2 and 3 of the CGI Guideline) to support procurement of commercial grade items.
Improvements in auditing can come from incorporation of performance based elements into the audit process.
Information applicable to performance based supplier audits can be found in EPRI NP-6630, Guidelines For Performance Based Sucolier Audits (NCIG-16). The decision to use performance based audit methods is at the discretion of the utility or auditing organization and is based on a number of factors, including vendor history, item complexity and function, and the extent to which other verification methods (such as receipt testing or post installation testing) would be performed.
Generally, performance based audits would provide more value for more complex items, while simpler items will lend themselves to tests and/or inspections, as described in the next section.
This does not imply that one or the other of these methods must always be useo. Acceptance methods which do not rely on performance based audits or tests and/or inspections may be appropriate, based on item function and vendor performance record.
8 u
n
~
Initially, performance based elements would augment, rather than replace, i
existing programmatic audit methods.
However, as the application of performance based audits becomes more widespread and experience is gained, it is expected that satisfactory results of a performance based audit will provide a basis to conclude that supplier quality assurance programs are acceptable.
This comprehensive initiative also endorses the concept of. joint audits and sharing of audit information. Joint and shared audits provide for efficient l
utilization of resources and availability of appropriate technical expertise i
to support performance based audits.
In this regard, NUMARC supported the.
merger of the Nuclear Section of CASE (Coordinating Agency for Supplier l
Evaluation) and NSQAC (Nuclear Supplier Quality Assurance Committee) into a t
single nuclear utility joint audit group known as NUPIC (Nuclear Procurement IssuesCommittee). NUPIC will continue the functions of both CASE (shared l
audit results) and NSQAC (joint audits) and will additionally provide a forum for utility discussion of procurement audit issuas and findings and for timely dissemination of information relative to audit findings. Utilities should become aware of the functions of NUPIC and assess the benefits it provides to support utility procurement programs.
It is also recognized thht other joint audit groups (such as those of an equipment specific nature or affiliated with a Reactor Manufacturer Owners Group) may be utilized as well.
1 1
j l
TESTS AND/0R INSPECTIONS
?
The experiences with fraudulent or substandard materials have resulted in an increased need to consider appropriate post-receipt verification testing or inspection to assure quality and performance capability of purchased items.
These tests and/or inspections ce in addition to the standard receipt inspection and can include post installation functional testing. While tests and/or inspections can provide increased assurance of quality as well as a
{
deterrent to fraudulent activities, it would be' impractical to require universal testing and/or inspection of all received items.
Rather, this testing and/or inspection should be viewed in the overall context of the I
procurement process, and the decision to perform testing and/or inspection should be based on item function, safety significance, supplier history, supply thannels, and other factors. Tests and/or inspections can support l
procurement from Appendix B suppliers, or procurement of commercial grade items in accordance with Method 1 of the CGI Guideline document.
Generally, the availability of a performance based audit for a given' supplier and product j
should be considered in establishing the need for special tests and/or j
inspections, as the performance based audit alone can provide the technical assurance of product performance. However, absent a performance based audit, l
industry utilization of tests and/or inspections may be appropriate, l
particularly when dealing with suppliers which are not either original equipment manufacturers-(0EM) or distributors authorized by the OEM.
For OEMs or authorized distributors, the product and supply history should be considered in determining whether and to what degree performance based audits-l 10 l
l I
l
a a
+ > -.
--.=e-a--
e a.
i or tests and/or inspections should be used. The NPEP Working Group reviewed and endorsed sections of an EPRI document which provides guidance for tests and/or inspections. As part of this comprehensive procurement initiative, utilities should consider this document, EPRI NP-6629, Guidelines for the Procurement and Receiot of Items for Nuclear Power Plants,.as a useful j
reference.
Certain portions of this document addressing tests and/or j
inspections (as noted in the following paragraphs), should be. implemented into 1
1 utility programs. The remaining information in the document should be
^
considered to support program improvements as necessary, but is not required to be implemented under the comprehensive industry initiative. While the-primary purpose of the document is t.,, ivide information relative to tests and/or inspections, it also provides information relative to other aspects of procurement, such as the development of technical and quality requirements.
These provide a sound basis for item acceptance using ter ing or other acceptance methods. This document provides information relative to the need for engineering involvement in the delineation of procurement requirements,.
I and in the planning of tests and the review of test results.
Engineering involvement, particularly in the front end of the procurement process, is a central consideration in the improvement of procurement programs. The document also provides guidelines for detection of potentially fraudulent or substandard items, as well as potential test equipment considerations for the
)
purposes of tests and/or inspections.
Utility implementation of this document under 'the comprehensive procurement initiative involves the following:
11
l l
l 1.
In order to improve utility practices in the araa of tests and/or 1
inspections, the guidance contained in the following sections of l
the document should be reviewed and assessed against existing utility programs:
4.4.2.2, " Receiving Inspection and Testing" 4.4.2.2.1, " Standard Receiving Inspection" 4.4.2.2.2, " Quality Control Receiving Inspection" 4.4.2.3, " Post-Installation Testing"
'l I
Appendices B, C, and D of the document provide ~ additional supporting information with respect to the above areas. Appendix B provides an example of a data sheet which could be used for the i
j performance of tests and/or inspectio'ns. Appendix D provides l
examples of test and inspection equipment that can be considered on an individual utility basis. Use of the Appendix B data-sheet, i
or use of the particular types of test equipment listed in j
i Appendix D, is discretionary, as these are intended as examples j
only.
i 2.
Appendix C of the document provides useful guidance to assist in the identification of potentially substandard or fraudulent items. This guidance is an important element of the overall~
procurement improvement effort.
This guidance should be applied-to the purchase of all safety-related items, and may be 12
considered, at utility discretion, for' application to purchases of certain non safety-related items.
3.
The sections noted above provide guidance directly addressing the conduct of tests and/or inspections. The remainder of Section.4 of the document, "The Procurement Process," includes infonnation addressing various other aspects of the procurement. process.
This information relates to activities which support the proper conduct of tests and/or inspections as well as' the appropriate use of engineering involvement in the procurement process.
These are-t' important areas, and this information should be carefully considered. However, implementation of this information.into utility programs is discretionary.
4.
Section 5 of the document, "Other Factors Affecting Quality."
discusses factors such as training and communications within the utility. Use of this information is also discretionary.
OBSOLESCENCE Obsolescence is another concern which is affecting procurement of replacement parts. When the need arises to replace an obsolete component, two methods have historically been available. The first method is to perform a technical i
evaluation to justify an alternative replacement, and, where necessary, to; 1
utilize the design change process to effect the change. The second method 13 I
which has been used is to obtain a replace.nent item from the surplus market.
The Working Group recognizes that the surplus product market offers direct savings in continuing the use of manufacturer's outdated designs while at the same time allowing end user utilities to sustain previously established design approval. However, this surplus market has been a primary arena for fraudulent business practices, namely refurbishing surplus products for resale as new. An example of the impact of these practices is provided by recent events relative to molded case circuit breakers where some utilities were purchasing outdated models.
It is recommended that the first method above, using an alternative replacement and the design change process, should be I
considered where practicable.
If the surplus market is used for the purchase of replacement parts, appropriate caution must be employed.
Establishment of traceability to the original manufacturer, or performance of tests and inspections, as appropriate, is generally necessary to ensure product quality when dealing in the surplus market.
The NPEP Working Group reviewed an EPRI document that provides information relative to establishing technical requirements for replacement items, including like-for-like replacement, alternative replacement, and initial procurement for modifications.
This document, EPRI NP-6406, Guideline for the Technical Evaluation of Replacement Items in Nuclear Power Plants (NCIG-11),
is acknowledged by the Working Group as providing a sound process for a l
technical evaluation.
Other existing utility processes have been identified which may differ from the EPRI methodology, but which are technically sound.
Therefore, EPRI NP-6406 provides useful information, i>ut industry usage of l
l 14 i
l
i i
this document is not required as part of the comprehensive procurement-initiative.
The Working Group additionally reviewed an EPRI document that provides information relative to preparing specifications. This document, EPRI NP-5638, Guidelines for Preparina Specifications for Nuclear Power Plants (NCIG-04), has been acknowledged by the Working Group as providing a useful source of information to utilities in developing ' specifications for replacement items. As with the EPRI NP-6406 document above, this initiative does not call for industry usage of the specification document, but rather acknowledges that i
the information contained therein may be useful as a source referenco.
1 INFORMATION EXCHANGE Exchange of procurement information facilitates better utilization of utility i
resources, and provides a mechanism for timely notification of potentially substandard items and procurement audit experiences.
Several mechanisms are available to facilitate information exchange. The first is through joint audit organizations, which provide a forum for sharing of audit problems, findings, and exchange of general procurement information.
In addition, other information networks are currently in use for sharing of_
j procurement and parts information.
i i
The second major mechanism for information exchange is INP0 NUCLEAR NETWORK.
Utilities should use this industry computer network to exchange' procurement i
15
and quality information. Two NETWORK topics are available for this purpose.
A topic entitled " Parts and Materials Information Exchange" has recently been established. The purpose of this topic is to facilitate the exchange of parts and materials-related information. Typical uses of this topic include requests for availability of needed parts, exchange of information regarding methods of dedication of commercial grade items, exchange of information regarding problems with parts (e.g., 10 CFR Part 21 notices, vendor bulletins, NRC information), and exchange of other information relative to parts and materials. A NETWORK topic also exists for the purpose of exchange of quality assurance information. The " Nuclear Quality Assurance Information Exchange" topic may be used to exchange information regarding quality assurance audit problems and results, vendor experiences, and exchange of other information relative to quality assurance issues.
~
Information exchange through either of the above mechanisms must be of an appropriate nature due to possible restraint of trade concerns. Objective, factual information can be exchanged.
Subjective assessments should be avoided.
GENERAL PROCUREMENT Minor changes to several key aspects of general procurement practices can be significant in improving product quality and minimizing the impact of fraudulent practices. The comprehensive procurement initiative addresses the following additional areas of general procurement:
16
i 1.
The participation of necessary~ engineering and other technical personnel in-the audit and inspection processes is important to assure the technical performance' capability;of purchased items.-
f 1
This commitment is implicit in industry adoption of guidance in.
i q
the above-referenced EPRI documents (or sections thereof).
.i addressing dedication of commercial grade items, procurement and-receipt, and performance based auditing. These documents offer
'l considerations for engineering involvement in various aspects;of.
I the procurement' process..
2.
The decision as to which method will be,used (and the extent-of application) to provide. the basis for product acceptance (e.g.,
~
performancebasedaudit,testsand/orinspections,ftraceability, or other basis) should, to'the extent possible, be'made at the i
front end of the procurement process, and~ factored-into the 1
initial procurement requisitions and specifications.
q 3.
Items should be procured through normal -supply channels where practicable.
This involves direct procurement and' shipment from the manufacturer or through authorized distributors.
Items-procured through other channels should be treated with caution-and-should generally be subject to traceability to the original manufacturer or performance of tests and/or inspections as
appropriate.
Items should be specified as "new" on purchase -
orders, to avoid unwanted substitution'of used or. refurbished:
items.
I i
17 i
i l
- i L.. - -
i l
e l
ADDITIONAL CONSIDERATIONS I
For either OEMs or suppliers authorized by the OEM with a proven performance record, implementation of the improved procurement methods discussed in this paper need not be put into place until completion of.the audit cycle which exists at the time of implementation of the comprehensive procurement initiative.
In other words, existing audits or other documentation providing a basis for procurement from the above sources remain valid at the time of initiative implementation.
1 i
Overall, these improvements should be considered as a whole, with the individual areas of improvement, as discussed _in this paper, applied as necessary to procurement of a given item.
It is not intended that all of the improved practices be applied universally to all purchased. items.
Reasonable asrarance remains the key consideration in determining which methods should be used for procurement of a given item, taking into account factors such as item function, safety significance, and supplier history.
CONCLUSION NUMARC believes the above improvements, implemented as a whole through the industry initiative process, will provide significant improvement to the.
procurement process, and will adequately address the problem of potentially fraudulent or substandard components.
Implementation of these changes should-j obviate the need for changes in the regulations at this time. Moreover,~these 18 i
self-initiated improvements should be implemented and the effects assessed prior to determination of the need for any further industry action.
1 19
s 7
\\
verreoents:
6 i
[
NUCLEAR REOULATORY confMl8810N l
ans== sten e.s. asses s
March 21.1989 ALL HOLSEtt 0F OptRATIRS LICENSES AND cot $TRUCTION PElBitTS FOR TO:
NUCLEAR POWER REACTDAS ACTIORS 70 INPIOVE THE DETECTION OF COUNTERFEIT AIS F
SUBJECT:
MARETED PRODUCTS (GEEERIC LETTER 89 08)
Recent instances of counterfeit and fraudulently marketed vender predests have heightened the NRC's cancerns for licensees' capability to assere the geality of precured preaucts and te reduce the Itks11 heed of the use of esenterfeit er fraudulent predocts in nuclear peser plants. During recent Ric inspections of licensees and weeders, the NRC has observed a onde variety of practices and recatetinspection,testinganddedicationofequip-programs for procurement
.related applicattees.
De purposa of this gener.it ment and asterial for sa letter is te share with al licensees seas of the elements of programs that appear te be effective-in providing the capability te detect counterfeit er-fraudulently marketed predetts and in assurieg the quality of vender products.
The staff is aware of and oncestages the industry working group efforts to develop guidance in these areas.
Three characteristics of effective procurement and dedication progrees have been identified during these NRC inspections. These characteristics are (1) the involvement of engineering staff in the procurement and product acceptance pre.
cess, (2) effective source inspection, receipt inspection, and testing pre 0 rams, and (3) thorough, engineering based, programs for review, testing ans setten.
tien of commercial-grada products for suitability for use in safety-related' kRC has found that programs that subodied the above three ele-applications.
monts were generally effective in providing enhancad capab precared products, both in safety.related and other plant systems.
Licensees may want talconsiderlthe applicability of these characteristics to their programs to reduce the like11hees of the introduction of counterfeit er fraudulent protects into their plants and to assure the quality of procured.
vender pegesets.
- s should be noted that the Rtc staff conditionally endorses the guidelines
' Guideline for the Utilisation of Commercial-Grade contained in EPRI RP-55$2, lated Applications (llCIG-07)
- that was issued by items in Nuttaar $sfety-Re EPRI in June 1988 for evaluating commercial grade predocts for suitability for use in safety-related applications.
Backaroun,d:
Numerous instances have been identified by th: NRC during the past 2 years in which the nuclear industry received, accepted, and installed itens of hardware h
V
- ty, o : e o se ' : z_
e t -
304 ec-t4-az.wo-suusn
4 l
l Multiple Addressess
-t=
that were not of the quality purported by the manefacturer er supplier due to apparent sisrepresentaties. Significant deficiencies have aise been identified l
in the programs for dedicattag commercial-grade products for ese in safety-related applications.
j The use in nuclear facilities of products which are seanterfeit er freedulently 1
i marketed increases the likeliheed that eene plast equipment any not portrors as espected. (see the entlesed list of NRC leformation Nettees and Bulletins j
regardingthismatter.)
1 Rigggjg:
procurement gustity assurance (S) controls for products to be used in safety.
related applications are established in Appendix 8 to 10 CFR part 50, and in Regulatory Guides 1.28, 1.33, and 1.123. It is recognized that Appendix g pre-vides criteria for S programs and does not specifically address fraudulent-activitten benever, se effectively implenested licensee S program would increase the likelihood of detecting fraudulently marketed vender products.'
l Altheegh a properly implemseted E program any more rettily detect substandard l
products than will the commercial-grade mapenest upgrade process, a licensee's cannercial-grade dedication process as described in paragraph C., will greatly e
enhance the effectiveness of current upgrada practices.- The actions described in paragraphs A. and g. have also proved usefel in esteettag sekstandard, 4
countarf ait er fraudulently marketed products intenced for use in systems needed for the safe.eparation ef.the facility.
A.
Eneineerine Involvener.t in tne Precurement process Appropriate engineering involvement is warranted during the procurement and product acceptance processes, including testing, for predects used in nuclear power plants. Inaseguate sagineering involvement has been a common weakness in licensees' precurement programs, particularly when con-mercial-grade procurements were involved. Involvement of a Itcensee's engineering staff in an effective precurement process would normally include (1) development of specifications to be used for the procurement of products to be used in the plant, (t) determinatten of the critical characteristics of the selected products that are to be verified during product acceptance, (3) determination of specific testing reestrements applicable to the selected products, and (4) evaluation of test results.
Tae entent of necessary. engineering involvement is dependent on the nature and use of the products inystved.
D.
product Accostance #rearene Experience indicates that reliance on part num6er verification and certi.
fication documentation is insufficient to ensure the quality of procured-1.icensees with effective product acceptance programs have products.
included receipt / source inspection and appropriate testing criteria.
effective vender audits, special tests and inspecticas and post-installa-tien tests in their programs. These licensees have applied os inspection r
~
a xv*o:ec ee
't2 cc 4
cea sc-ta-44mo-==
se.
l
I i
.i Multiple Addressess
-3 and testing artesets to products procused for use in safety.related systems and for al i maaersial grade gradecas treing evaluated for seitan111ty for ese in safety.velsend systees. fte tempeetten and testing criteria aise have required identificatten and verification of the predetts' critical l
tharacteristics. In selecting the eritical ektracteritties te be verified, consideration may be given to the safety significance souplaattyle (A pro.
and ForsuppliceswIthacceptab applicaties of the earious products.
as esafirmed by liseases audits sampling plass are eften ett'ised grams, form tks togeived inspecticas and tests. la additten to these to per reest t/ source tespections and tests, opfective 11eensee programs normally vert the tracombility to the aristeal sensfacturers of procured -
and seaponents in these cases where original j
aster alt, equipment manufacturer'ssortificationsareelemsatasfthesafety-relatedpre-curement er asumerstal-grade dedication progras. Effective audits have included considerastes of audit approacA depth of sedit, and audit taas compositten and have tacladed appropriate engineering / technical represen-tattves. Comprehenaite multi-licanese audit teens have aise seen found to be effective.
~
C.
Dedication preerens It is each licensea's responsibility to provide reasonable assurance that nonconforming products are not intredeced into their plants. Dedication programs that ensure the adequacy of critical parameters of products used in safety-related applications can aise centribute to the identification of counterfeit er fraudulantly marketed vender products.-
The NRC staff tralieves that licensees who see motheos similar to those described in EPRI kP 4652 " Guideline for the Utilization of Cosmarcial-Grade Items in Nuclear safety-Related Aeplications (NCIC.07),"-to verify the critical characteristics cf ceumarcial. grade items intended for safety.
related applications have the basis for effective dedication prograss.
Properly implemented, 'the TPRI guidelines, as modified below, estabitsh methods which satisfy existing requirements of Appendix 8 to 10 CFA part 50 as they apply se the assication process of commercial grade items.
1.
Acceptance tiethod 2, 'Casmarcial-Grade. Survey of Supplier,'
should not be amployed sh the basis for steepting items free suppliers with vneocumented commercial que11 control pre-grams or with programs.that de not effective 1 implement their esa necessary centrols. Likeutee, Method 2 s euld not be 1 eyed as t5 haats for accepting items from distributors 9un ass the servey taciadas the part manufacturer (s) and the survey sentiras adequate centrals ty both *the distributor and the part ranufacturer(s).
2.
Acceptance Method 4. "Actwytable supplier /tten Performance Record.' should not te employed alone maless:
ny,c ec es tz cc
+ca sc-: 4 - x 4 u.c - w n s..
O Multiple Addressess.
The estabitshed historical record is bases on industry.
a.
wide perfemassa sata Gat is directly applisable to tas item's crittsal characteristics and the intended safety.
related applications and The manufacturer's measures for the control of des 10n.le-6.
process, and asterial changes hava teen adequately sap seated as verified V aedit (emiti.10 censes team audits are seseptable).
,j The NRC staff believes that if 11censees' promesmant programs effectively l'-['h' inlement the elements discussed in paragraphs. A.
8.. and C.. they wil) reduce the itkalthood of the introsection of causterfeit er fraudulent pre.
ducts into that'r plants.
Although ne responsa to this letter is recutred if you have any euestions regaraing this matter, please contact the technical contact listu below.
I j
Sincerely.
. e... 4 a
- ~
fitvenl.' V Acting Assectate etter for Projects l
Office of Nuclear Reactor Regulation l
Ecclosures:
- 1. List of Bulletins saa information Notices
- 2. List of Recently Issutd Generic Letters CONTACT:
E. W1111em Brach. HRR (301) 492-0961 1
i
- <v,c ec es
.z ce sea sc-4-gauc-aensn j
f' i
i l
[.
j i
f' Eaclosure 1 i
BULLTTIN5 AND INFORMATION NOTICES CONCERN!N8 NONCONFO l
MATERIALS AND IQU1PMENT AND INSTANCES OF INADt0UATE l
M DICATION OF EQUIPMENT FOR SAFETT RELAftD APPLICATI i
i
- gQe, Su11stin No.
Tj{Q, l
11/05/87 Fastener Testing to Determine Confermance l
87-Ot*
with Applicable Materitl Specifications 04/22/88 i
S7-42. Supplement 1*
08/10/88 87-02. Supplement 2*
05/08/88 Monconfoming Materials Supplied by Piping 88-05*
Suppites. Inc., at Folsus. Neu Jersey, and West Jersey Manufacturing Company at i
Williamstown. New Jersey i
06/15/88 88 05. Supplement l' 08/03/88 t
l 88-05. Supplement 2*
11/22/88 Nonconforming Molded-Cese Circuit treakers 88-10'
- j InformationNotlesNo.
12/21/87 In6ppropriate Application of Commercial-Grade 3
t 87-66 Components 04/26/88
.i Questionable certification of Class IE 48-19' Camponents i
06/02/88 Inadeguate Licensee Perfomed vendor Audits 88-35 j
Licensee Report of Defective Refurbished 07/08/88 J
88 4G*
Circuit treakers i) 07/21/88
)
86-46. Supplement 1*
12/30/88 88-46. Supplement t' j;
Licensee Report of Defective Refurbished Valves 07/12/88 4
88-48*
j 08/24/88 88 48. Supplement 1*
i 12/15/88 Potentially Substandard Yalve Replacement Parts 88-97
- These items mflect instances in which suppliers and manufactu ers of safety-j related material may have intentionally eluded QA reeutrements to misrepresent In the instances rarked by an asterisk, the pro-the quality of their products.blem was brought to NRC's attention by atther e
~,c e=
us c
f.
taelosura 2 i
LIST OF RECENTLY !$$UED S B D !C LETTERS i
i SeneHe Otts of.
j Letter No.
Subject ta ^^ - ;
tansed Te 1
89 01 IWLEMENTATION OF 1/31/89 RL LICER$tts MDLDINS i
PMEAMATIC CONTRES OPERRTIM LIC M St3 I
POR RADIOLOGICAL EFFLUENT.
A S CO NTW CTI M i
TECMICAL SPECIFICATIONS PEMIT5 PS WCLEAR Is THE AORIRISTRATIVE' PSER REACTM FACILITIES.
CONTRE 5 stCTIN OF THE-TECWICAL SPECIFICATIONS i
AND TE RELOCATION OF PROCI WRAL DETAILS OF l
RETS TO THE OFFS!Tt 00$t CALCEAT!0N MNUAL OR TO THE PMCESS CONTRS. PROSRAM.
08-20 INDIV!OURL PLANT 11/13/88 ALL L!CBSH 5 NOLDING j
EXAN! NATION PON SEVERE OP R ATIRE LIC M SES i
i ACC10mf YULMERABILIT!Es.
Ano Ce nTRUCTION 1
10CPR60.64(f)
Pt m!T5 PR NUCLIAR PORR REACTOR FACILIT!!5, i
i j
88-19 ust 0F OtanLY FORCE BY
-10/28/88 -
ALL' FUEL CYCLE FACILITT i
LICEN5tt 80ARDS TO PRtVENT LICS$tt$ WND POS$tss.
UEE. ! WORT EXPORT.
THEFT OF SPECIAL W CLEAR OR M FtW WLA MitR!AL OuANTIT!!s 0F STRAfts!C i
-SPECIAL RUCLEAR MAffRIAL
/,
l 88-18 PLANT RECORD STD4 Alt GN 10/10/88 ALL L!CS$tt5 0F 0FTICAL DISK 5 OPERAT!bG REACTORS Am N0LDERS OF C 557RUCTION PERMITS 88 17 LOS5 OF DECAT NEAT REMOVAL 10/17/88 ALL N0Lep5 0F 10CFR50.54(f)
OPERATIRB LICB$ts a CONSTRUCTION PtW ITS FOR PRESSUR12tB WATS REACTORS 88 16 RENOVAL OF CYCLt SPICIFIC 10/M/88 ALL POWER REACTOR PARAMETER 11Mt71 FROM LICEN$tts A W TECHNICAL' SPECIFICATIONS APPLICANT 5 j
j 88 16 ELECTRIC P WER SYSTENS.
09/11/88 ALL POWER REACTDR INADEQUATE CONTROL C'itz LICm$tt! AND l
Ots!GN PN0 Cts 5E5 APPLICANTS 1
I l
l t
_e, s e _ : a - u m e u. e.
m+c ec as
- =
ce j
] -
.p ancy['g 5
UNITED STATES f
NUCLEAR REGULATORY COMMISSION l
y g
1 s
cj wAssimoTON, D. C. 20555 l
April 9, 1991
~
t T0:
ALL HOLDERS OF OPERATING LICENSES AND CONSTRUCTION PERMITS FOR l
NUCLEAR POWER REACTORS
SUBJECT:
LICENSEE COMMERCIAL-GRADE PROCUREMENT AND DEDICATION PROGRAMS l
(GENERICLETTER91-05) l This generic letter notifies the industry of the' staff's pause in conducting j
certain procurement inspection and enforcement activities and identifies a number of failures in licensees' connercial-grade dedication programs -
l' identified during recent team inspections performed by the U.S. Nuclear Regulatory Commission (NRC). The pause, which began in March of 1990, will end in late sunner of 1991. The purpose of the pause is to allow licensees sufficient time to fully understand and implement guidance developed by industry to improve procurement and commercial-grade dedication programs.
This generic letter expresses staff positions regarding certain aspects of 1
licensee commercial-grade procurement and dedication programs which would i
provide acceptable methods to meet. regulatory requirements.
During the period from 1986 to 1989, the NRC conducted 13 team inspections of' the licensees' procurement and commercial-grade dedication prograsis. During these inspections, the NRC staff identified a common.. programmatic deficiency l
in the licensees' control of the procurement and-dedication process of commercial-grade items for safety-related applications.
In a nud er of. cases, j
the staff found that licensees had failed to adequately maintain programs as i
required by 10 CFR Part 50, Appendix B, to assure the suitability of commercially procured and dedicated equipment for its intended safety-related applications.
In addition, the staff identified _ equipment of indeterminate quality installed in the licensees' facilities.
' i Because of a decrease in the number of qualified nuclear-grade. vendors, the NRC staff is aware that there has been a change in the industry's ~ procurement practices. Ten years ago, licensees procured major asses 611es from approved
.i vendors who maintained quality assurance programs pursuant to Appendix B of-l Part 50 of Title 10 of the Code of Federal' Regulations (10 CFR). Currently.,
i due to the reduction in the number of qualified nuclear-grade vendors,.
licensees are increasing the numbers of commercial-grade replacement parts l
that they procure and dedicate for use in safety-related applications.~ This
]
i is a substantial change from the environment in which 10 CFR Pari 50, Appendix B was promulgated. This has necessitated an increased emphasis by licensees and the NRC staff to maintain' procurerent and dedication programs that adhere to the requirements of 10 CFR~Part 50, Appendix B, and thus' assure the quality of items purchased and installed in safety-related applications.
Therefore, dedication processes for commercial-grace parts have increased-in importance and NRC inspections have determined that a number of licensees have not satisfactorily performed this procurement and dedication process.
l
(
==
i t
i GENERIC LETTER 91-05 i i
1 The industry has been made fully aware of the NRC's concerns in this program In the past, escalated enforcement cases have provided notice to the area.
affected licensees and to the industry of NRC's findings, concerns, and i
expectations in the implementation of procurement and dedication programs.
l Further, the NRC staff continues to participate in numerous industry meetings f
and conferences at which the NRC's positions in this area have been presented.
The Nuclear Utility Management and Resources Council (NLMARC) Board of Direc-tors recently approved a comprehensive procurement initiative as described in NUMARC 90-13, " Nuclear Procurement Program Improvements," which commits
(
licensees to assess their procurement programs and take specific action to l
enhance or upgrade the program if they are determined to be inadequate. The initiative on the dedication of commercial-grade items, which is part of-NUMARC 90-13, was to be implemented by January 1,1990.. The staff is monitor-ing implementation of licensee program improvements by conducting assessments of their procurement and commercial-grade dedication programs and maintaining close interaction with the nuclear industry through participation in confer-ences, panels, and meetings.
The staff will continue to perform reactive inspections relating to plant.
]
specific operaticnal events or to defective equipment and, as required, will continue to initiate resultant enforcement actions.- In addition,~the staff J
will continue to perform inspections of vendors. The staff expects to resusc j
procurement and dedication inspection activities.in the late summer of 1991.
These resumed inspections will be conducted using 10 CFR Part 50, Appendix B (not the NUMARC initiatives) as the applicable regulatory requirement.
j Licensee programs must assure the suitability of comercially procured and j
dedicated equipment for its intended safety-related application.
The staff position is that the staff will not initiate enforcew nt action in i
cases of past programmatic violations that have been adequately corrected.
In addition, the staff does not expect licensees to review all; past procurements.
However, if during current procurement activities,' licensees identify shortcomings in the form, fit, or function of specific vendor products. or if failure experience or current information on supplier adequacy indicates that a component may not be suitable for service, corrective actions are required for all such installed and stored items in accordance with Criterion XVI of'10 CFR Part 50, Appendix B.
Also in accordance with Criterion XVI, licensees must determine programatic causes when actual deficiencies in several products from different vendors are identified during current procurement activities and these deficiencies lead to the replacement of installed items as part of the
-l corrective action.
In such cases, a further sampling of previously procured comercial-grade items may be warranted.
In NRC Generic Letter (GL) 89-02, " Actions to Improve the Detection of Counterfeit and Fraudulently Marketed Products," the staff described its perspective on good practices in procurement and dedication and provided the NRC's conditional A
/
.=-
GENERIC LETTER 91- 05 !
l endorsement of an industry standard (EPRI NP-5652) on methods of commercial-grade procurement and dedication. A number of recent inspection fir. dings, as discussed in Enclosure 1, indicate that licensees have failed to include certain key activities, as appropriate, in the implementation of the dedication The NRC staff's positions on the successful implementation of process.
licensees' programs for comercial-grade dedication with respect to critical (These are also characteristics and like-for-like replacements are as follows.
includedinEnclosure1.)
The term " critical characteristics" is not contained in Appendix 8 an'd has no special regulatory significance beyond its use.and definition in various industry guides and standards. The NRC first used the term critical characteristics in GL 89-02 as constituting those characteristics which need to be identified and verified during product acceptance as part of the procurement The NRC has not taken the position that all design requirements must process.
be considered to be critical characteristics as defined and used in EPRI HP-5652. Rather, as stated in Appendix B, Criterion III, licensees must assure the suitability of all parts, materials, and services for their. intended safety-related applications (i.e., there needs to be_ assurance that the item The licensee is will perform its intended safety function when required).
l responsible for identifying the important design, material, and perfonnance-characteristics for each part, material, and service intended for safety-l related applications, estr.blishing acceptance criteria, and providing reasonable assurance of the conformance of items to these criteria.
A like-for-like replacement is defined as the replacement of an item with an item that is identical. For example, the replacement item would be identical l'
if it was purchased at the same time from the same vendor as the item it is replacing, or if the user can verify that there have been no changes in the
~,
design, materials, or manufacturing process since procurement of-the item being If differences from the original item are identified in the replaced.
replacement item, then the item is not identical, but similar to the item being replaced, and an evaluation is necessary to determine if any changes in design, material, or the manufacturing process could impact the functional characteristics and ultimately the component's ability to perform its required safety function.
If the licensee can demonstrate that the replacement item is identical, then the licensee need not identify the safety function or review and verify the design requirements and critical characteristics. Engineering involvement is necessary in the above activities. Reliance on part number verification and certification documentation is insufficient to ensure the quality of comercially procured products.
The other matters discussed in Enclosure 1 do not constitute NRC staff positions, but provide information on inspection findings and clarify the characterization of effective procurement and dedication programs previously described in GL 89-02.
BACKFIT DISCUSSION:
Based on past inspection findings and the resulting enforcement actions, the i
HRC staff has determined that licensee commercial-grade procurement and I
~
o e
GENERIC LETTER 91-05 dedication programs needed to be improved to comply'with the existing NRC requirements as described in 10 CFR Part 50, Appendix B, Criterion III-(Design Control), IV (Procurement Document Control), VII (Control of Purchased Material, Equipment and Services), and XVIII (Audits). Specifically, licensees have f&iled to adequately maintain programs to assure the suitability of concercially procured and dedicated equipment for its intended safety-related application. Since the generic letter presents staff positions regarding implementation of existing regulatory requirements, as contained in Appendix B to 10 CFR Part 50, the staff has concluded, that this is a compliance backfit and has prepared the generic. letter in accordance with 10 CFR 50.109 (a)(4)(i).
In light of the inadeque.cies identified in the procurement and dedication
~
programs of a large number of licensees, the issuance of this generic letter is necessary to express the staff's position on the key element that licensees must include as part of the dedication process,.specifically that commercial-grade procurement and d(;dication programs must assure the suitability of equipment for its intended safety-related application. This generic letter is also intended to clarify.the elements of effective procurement and connercial-grade dedication programs that were previously provided to licensees' in GL 89-02. Since licensees procurement and dedication programs may contain progranaatic deficiencies, the staff has. included in the generic letter the necessary licensee corrective action to address shortcomings identified in specific vendor products or components that directly-lead to the component not being suitable for safety-related service.
Although no response to this letter is required, if you have any questions regarding this matter, please contact the persons listed below.
Sincerely,
\\.h. x
& mes G. Partlow As sociate Director for Pro,jects Office of Nuclear Reactor Regulation
Enclosures:
1.
Characteristics of Effective Consercial-Grade Procurement and Dedication Programs 2.
List of Recently Issued Generic Letters Technical Cont 6 cts: Richard P. McIntyre, NRR (301)492-3215 Uldis Potapovs, NRR (301)492-0959
l i-i CHARACTERISTICS OF EFFECTIVE COMMERCIAL-GRADE PROCUREMENT AND DEDICATION PROGRAMS l
Background
2 Appendix B to 10 CFR Part 50 contains the NRC's regulations for procurement quality assurance (QA) and quality control (QC) for products to be used in safety-related applications.
In addition, the NRC has provided further l
guidance in Regulatory Guides 1.28, 1.33, and 1.123. These requirements and j
guides, if properly implemented, provide a measure of assurance for the i
suitability of equipment, including cosumercial-grade items for use in-safety-related systems. Criterion III of Appendix B requires licensees to-i select and review for suitability of application materials, parts, equipment,~
j and processes that are essential to the safety-related functions of the '
structures, systems, and components.- Criterion IV requires that procurement documents specify the applicable requirements necessary to ensure functional I
performance. Criterion VII requires licensees to assure that'the following are i
sufficient to identify whether specification requirements for the purchased material and equipment have been met:.- source evaluation and selection, objective evidence of quality, inspection of the source, and examination of.
j products upon delivery. The process used to satisfy these requirements when upgrading commercial-grade items for safety-related applications is commonly-l called " dedication." The process of ensuring compliance with 10 CFR Part 50, I
Appendix B, must include all those activities necessary to establish ~and i
confirm the quality and suitability of commercially procured and dedicated-equipment for its intended safety-related application. Some of the dedication activities may occur early in the procurement-cycle}~ before the item isGeneric Letter (
i I
accepted from the manufacturer.
the Detection of Counterfeit and Fraudulently Marketed Products," discussed i
comunercial-grade dedication in terms of engineering involvement in the i
procurement process, product acceptance,:and the dedication process as i
identified in the EPRI NP-5652 guidelines. This enclosure further discusses j
the characteristics of effective procurement and dedication programs previously
(
discusses in GL 89-02 and provides examples of specific failures by licensees:
l to effectively implement these characteristics for dedicating and ensuring.the suitability of commercial-grade products for safety-related applications. _
a l
Appropriate implementation of these characteristics would have avoided many of...
the failures to meet 10 CFR Part 50, Appendix B requirements in licensee t
[
procurement and commercial-grade dedication programs which were < identified-during past NRC inspections.
j Inspection Observations'and Findings From 1986 to 1989, headquarters and regional personnel conducted 13 team' inspections of licensees' procurement and dedication programs.- TheseLinspec-tions have' identified a ' common, broad programmatic deficiency ~in licensees' control over the process of procurement' and dedication of comunercialagrade
.3
. items.
In a number of cases, licensees have not maintained programs to ensure the suitability of equipment for use in safety-related applications as required by 10 CFR Part 50, Appendix B, Criterion III. These 13 inspections resulted in findings with significant safety implications. The staff identified eight findings that were considered to be Severity Level III violations and three findings that were Severity Level IV violations. At one plant, the staff did not assign a severity level to individual violations.
Instead, the e'.ff considered the entire group to be a Severity Level III problem and used enforce-ment discretion, as provided under the enforcement policy, based on the licensee's corrective actions (see 10 CFR Part 2, Appendix C, Section V.G.2).
Only one of the plants that were inspected did not receive violations in this program area.
In GL 89-02, the hRC has conditionally endorsed the dedication methods described in EPRI NP-5652 guidelines. The staff believes that licensees who implement these dedication methods, in accordance with the NRC's endorsement, can establish a basis for satisfying the existing requirements of Appendix 5 to 10 CFR Part 50 as these requirements apply to the dedication process for commercial-grade items. An effective commercial-grade dedication program must include provisions to demonstrate that a dedicated item is suitable for safety-related applications. For a licensee to adequately establish suitabil-ity, certain key activities must be performed, as appropriate, as part of the dedication process. This generic letter is intended to clarify the dedication approaches described in GL 89-02.
During each of the 13 inspections, the staff identified a cosson element in each of the inspection findings. This element was the failure of the licensee-to assure that a commercially procured and dedicated item was suitable for the intended safety-related application.
A dedicated comunercial-grade item must be equivalent in its ability to perform its intended safety function to the same item procured under a 10 CFR Part 50, Appendix B QA program. The follow-ing is a list of the 13 licensees inspected and.the inspection report numbers.
A susocry of the general inspection findings and NRC observations on these findings follows the list of licensee inspections.
LICENSEE and PLANT INSPECTION REPORT NO.
1.
Tennessee Valley Authority (Sequoyah) 50-327/86-61 50-328/86-61 2.
SouthernChliforniaEdison(SanOnofre) 50-206/87-02 50-361/87-03 50-362/87-04 3.
Alabama Power (Farley) 50-348/87-11 50-364/87-11 4.
Louisiana Power and Light (Waterford) 50-382/87-19 1
.~.-
e i
i i
)
LICENSEE and PLANT INSPECTION REPORT NO.
j i
j 5.
Sacramento Municipal Utility District (Rancho Seco).
50-312/88-02 6.
Maine Yankee Atomic Power (Maine Yankee) 50-309/88-200 t
i 7.
Northern States Power (Prairie Island) 50-282/88-201 50-306/88-201 1
8.
PortlandGeneralElectric(Trojan) 50-344/88-39 50-344/88-46 1
i 9.
Connecticut Yankee Atomic Power (Haddam. Neck) 50-213/89-200
- 10. Washington Public Power'S.pply System (WNP-2) 50-397/89-21 50-397/89-28 j
j
- 11. Florida Power (Crystal River) 50-302/89-200 1
2
- 12. GulfStatesUtilities(River 8end) 50-458/89-200
- 13. CommonwealthEdison(Zion) 50-295/89-200 50-304/89-200 1l
)
1.
Inspection Findings a.
Failure to identify the methods and. acceptance criteria for verify-ing the critical characteristics, such as during receipt inspection, j
dedication process, or post-installation testing.
)
b.
Failure to establish verifiable, documented traceability of complex 1
consnercial-grade items to their original equipmer.t manufacturers in those cases where the dedication program cannot verify the critical j
characteristics.
c.
Failure to recognize that some comunercial-grade items cannot be fully dedicated once received on site. Certain items are manufac-i tured using special processes, such as welding and heat treating.
l Dedication testing of these items as finished products would destroy L
them. For these items, licensees may need to conduct. vendor sur-veillances or to witness certain activities during the manufacturing process.
Discussion The NRC staff has met on several occasions with NUMARC and licensee representatives to discuss " critical characteristics" as used in the context of commercial-grade procurement and dedication. The ters."criti-:
cal characteristics" is.not contained.in Appendix B and has no special regulatory significance beyond its use and definition-in various industry
i o-j 0
i j ;
4 guides and standards. The NRC first used the term critical characteris-i l
tics in GL 89-02 as constituting those characteristics which need to be identified and verified during product acceptance as part of the-j procurement process. The NRC has not taken the position that all design-j requirements must be considered to be critical characteristics as defined 1
and used in EPRI NP-5652. Rather, as stated in Appendix B, Criterion III, j
licensees must assure the suitability of all parts, materials, and
~
services for their intended safety-related applications (..e., there needs i
.I to be assurance that the item will perform its intended safety function-when required). The licensee.is responsible for identifying the important j
design, material, and performance characteristics for each part, material, j
j and service intended for safety-related applications, establishing 1
acceptans criteria, and providing reasonable assurance of the conformance.
j of items to these criteria. There is no minimum or maximum nud er of critical characteristics that need to be verified. Further, the critical characteristics for an item may vary from application to application l
~
depending on the design and performance-requirements unique to each l
application.
A licensee may take different approaches for the verification of the l
ciitical characteristics, depending on the complexity of the item. -In sany cases, the licensee can verify the critical characteristics of_ each -
j item during receipt inspection testing. However, for a complex item with internal parts which receive special processing during manufacturing, i
i the licensee may need to conduct a source verification of the manu-j facturer during production to verify the critical characteristics 1
identified as necessary for the item to perform its safety function. When l
5 l
these methods cannot verify the critical characteristics related to special processes and tests, certification cy the original equipment i
manufacturer may be an acceptable alternative provided' documented,'
j verified traceability to the original equipment manufacturer has been established and the purchaser has verified by audit or survey that the a
l original equipment manufacturer has implemented adequate quality controls for the activity being certified.
i For items with critical characteristics that can be verified for the nest severe or limiting plant application, the licensee might prefer to identify and verify the item's critical characteristics to qualify that i
item for all possible plant applications.
For complex items that would be-purchased for specific plant applications, it may be appropriate to address the acceptance criteria for each ites individually. Engineering 4
involvement is important in either method because the technical. evaluation will ider.tify-the critical characteristics, acceptance criteria, and the methods to be used for verification.
2.
Inspection Findings a.
Failure to demonstrate that a like-for-like replacement item is identical in form, fit, and function to the item it is replacing.
j Part number verification is not sufficient because of the probability of undocumented changes in the design, material,~or fabrication i
of comercial-grade items using the same part number.
i f
i
=
uu-
.. ~
w -
-(
. i l
b.
Failure to evaluate changes in the design, mcterial,-or manufactur-l ing process for the effect of these changes on safety function
~
P performance (particularly under design basis event conditions) of replacement items that are similar as opposed to identical to the :
l items being replaced.
c.
Failure to ensure that itesis will function under all design require-J ments. On some occasions, licensees only ensured that the commercial grade item would function under normal operation conditions.
d.
Failure to verify the validity of certificates of.conformance received from vendors not on the licensee's list of approved vendors /
suppliers. An unverified certificate of.conformance from a cossnercial-i grade vendor is not sufficient.
Discussion A like-for-like replacement is defined as the replacement of an. iteu with an item that is identical. For example, the replacement item would be identical if it was purchased at the same time from the'same vendor as the item it is replacing, or if the user can verify that there have been no changes in the design, materials, or manufacturing process since procurement of the item being replaced.
If differences from the original iten are identified in the replacement item, then the item is'not identical, but similar to the item being replaced,'anc' evaluation.is necessary to determine if any changes in design, material, or the manufacturing process could impact the functional characteristics and ultimately the cosiponent's ability to perform its required safety func-tion.
If the licensee can demonstrate that the replacement item is identical, then the licensee need not-identify the safety function or review and verify the design requirements and critical characteristics.
Engineering involvement is necessary in the above activities. The extent of this involvement is dependent on the nature, complexity, and use of the items to be dedicated. Participation of engineering personnel is appropriate in the procurement process, and product acceptance, to develop purchase specifications, determine specific testing _ requirements applicable to the products, and evaluate the test results.- When engi-neering personnel specify design requirements for inclusion on the purchase documents for replacement components,.they need _not reconstruct and reverify design adequacy for procurement purposes, but need only -
ensure that the existing design requirements (which may. reference the original design basis) are properly translated into the purcha:e order.
Reliance on part number verification and certification documentation is insufficient to ensure the quality of commercially procured products.
Effective product aceptance programs have as elements, receipt and source inspection, appropriate testing criteria, effective vendor audits'and-1 surveillances (including witness / hold points as appropriate),.special tests and inspections, and post-installation tests.
Procedures and adequate qualifications and training for implementing personnel are'also necessary factors in successful implenentation._
~.
l 1
l
[7590-01-P]
j NUCLEAR REGULATORY COMMISSION 10 CFR PART 21
[ Docket No. PRM-21-2)
Nuclear Management'and Resources Council; i
Receipt of Petition for Rulemaking.
f AGENCY:
Nuclear Regulatory Commission._
j I
ACTION:
Petition for rulemaking;_ Notice-of receipt.
j
SUMMARY
The Nuclear Regulatory Commission (NRC)- is publishing for public comment a notice of receipt of a-petition for rulemaking, dated June 21, 1993, which was filed with the f
Commission by the Nuclear Management and Resources Council.
The
. i l
Li petition was docketed by the NRC on June 22, 1993,'and has'been assigned Docket No. PRM-21-2.
The petitioner requests that the l
NRC amend its regulations (1) to revise the definition of.the i
term " commercial grade item"; (2) to include a flexible g4#.*,eric process for dedication of commercial' grade itemsjfor safety--
l related use; and-(3) to clarify that the-entity performing,the
~i dedication of a commercial grade' item _is responsible for.
}
t discovering, evaluating, and reporting deficienciesfas required:
i by NRC's regulations.
i r
1-9kest9sudbip?sv7" 6
1
l DATE:
Submit comments by (75 days after publication in the Federal Register).
Comments received after this date will be considered if it is practical to do so, but the Commission is able to assure consideration only for comments received on or before this date.
l ADDRESSES:
Submit written comments to the Secretary of the Commission, U.S.
Nuclear Regulatory Commission, Washington, DC 20555, Attention: Docketing and Service Branch.
Hand deliver comments to:
11555 Rockville Pike, Rockville, Maryland, between 7:45 a.m.
and 4:15 p.m. Federal workdays.
l l
For a copy of the petition, write the Rules Review and I
Directives Branch, Division of Freedom of Information and Publications Services, Office of Administration, U.S.
Nuclear Regulatory Commission, Washington, DC 20555.
The petition and copies of comments received may be inspected and copied for a fee at the NRC Public Document Room, 2120 L Street, NW. (Lower Level), Washington, DC.
FOR FURTHER INFORMATION CONTACT:
Michael T.
Lesar, Chief, Rules Review Section, Rules Review and Directives Branch, Division of Freedom of Information and Publications Services, Office of Administration, U.S.
Nuclear Regulatory Commission, Washington, DC 20555, Telephone:
301-492-7758 or Toll Free:
800-368-5642.
2 l
l l
M,
l l
l SUPPLEMENTARY INFORMATION:
Petitioner The Nuclear Manageme.nt and Resources Council (NUMARC) is an organization of the nuclear power industry.
NUMARC is responsible for coordinating the combined efforts of all utilities licensed by the NRC to construct or operate nuclear power plants, and of other nuclear industry organizations, in all matters involving generic regulatory policy issues and regulatory-aspects of generic operational and technical issues affecting the nuclear power industry.
NUMARC's members include all utilities responsible for constructing or operating a commercial nuclear power plant in the United States, major architect / engineering l
firms, and all of the major nuclear steam supply system vendors.
l
Background
Section 206 of the Energy Reorganization Act of 1974, as amended, requires that all licensees, as well as nonlicensees who construct facilities for licensees, supply basic components to licensees, and provide services associated with basic' components to licensees, report defects that could create a substantial safety hazard.
The NRC regulations that implement Section 206 are contained in 10 CFR Part 21.
This part, in conjunction with 10 CFR Part 50, Appendix B, also covers the procurement of parts for nuclear power plants, including basic components and commercial grade items to be used in safety-related applications.
3
)
l l
1 l
l t
\\
l
l i
The petitioner has focused this petition on the procurement of parts described as commercial grade items because, according to the petitioner, the current procurement environment is different from the environment extant when Part 21 was adopted.
The petitioner states that because nuclear power plants have been operating for several years, many pieces of equipment now require replacement or refurbishment of their components.
According to the petitioner, current nuclear utility procurement needs primarily involve replacement parts for existing equipment rather than the purchase of major new pieces of equipment.
- However, many of the original suppliers and manufacturers no longer' maintain Appendix B-qualified programs because of the diminished market, because no new plants are being ordered or are currently under construction, and because of the burden of maintaining such a quality assurance program.
Frequently, replacement parts are not available from original or other Appendix B-qualified vendors.
The combined effect of the decreased availability of parts from Appendix B-qualified vendors and the greater expense of obtaining these parts is that licensees are increasingly forced to procure cominercial grade replacement parts and dedicate tPmm for use in safety-related applications.
Discussion According to the petitioner, the provisions of Part 21 that relate to commercial grade items, the dedication of these' items for use in safety-related applications, and the reporting 4
l t
L
i I
requirements associated with these items that are imposed on l
l manufacturers, suppliers, and sub-tier suppliers are unworkabJe, l
ineffective, and may be counterproductive.
The petitioner states that safety may be adversely affected by delay caused by the inability to obtain the replacement parts needed for use as basic components.
The petitioner believes that Part 21, as it relates to I
commercial grade items and their dedication, is not accomplishing its intended objectives effectively.
The petitioner believes that the current Part 21 regulations involving posting, document l
retention, and deficiency evaluation and reporting make the implementation of these regulations unnecessarily burdensome and create substantial liability for licensees subject to Part 21.
The petitioner believes that the effect of these provisions has been to discourage vendors frs
'aintaining Appendix B-qualified programs.
l l
Although Part 21 provided a reasonable foundation for regulating procurement and imposing reporting requirements at the time it was promulgated, the petitioner believes that the current requirements of Part 21 often impede a utility's ability to obtain the highest quality part available for use in a safety-i related application in a cost-and time-efficient manner.
The inability to procure appropriate parts promptly could adversely
)
affect plant safety.
5 l
.b The petitioner discusses several options available to nuclear utilities in procuring replacement. parts, most of which i
have serious drawbacks directly or. indirectly related to the current regulatory approach set out under Part 21..These options l
and drawbacks, as discussed by the petitioner, are as follows:
1.
Nuclear utilities could procure' items from a supplier who maintains an Appendix B-qualified program,'.but the. cost of.
procuring an item from such a source is much higher than if.
comparable items are procured through commercial channels.
2.
Nuclear utilities could procure replacement' parts that' are slightly different than the original parts,'but even if
'I replacement parts are obtained from an Appendix B-qualified supplier, a design change is likely.to be required to' justify _the use of the proposed replacement parts.
[
3.
Nuclear utilities could obtain the item from the surplus market or another utility, but this option may: be j
impossible if the product does not fit into the basicLcomponent-
~
~
or commercial grade definitions.
L 1
4.
Nuclear utilities could procure the item as commercial-l grade, but it may be difficult to meet all of the definitional i
requirements of Part 21.
i
.i 5.
Nuclear utilities may file an application for an-
)
exemption, but this process is impractical because of the. time generally required to obtain a decision.
6 i
I s
a The petitioner believes _that the substitution of a more i
practicable definition of.the term " commercial grade item" and.
the addition of a flexible generic process for dedication would~
assist in resolving many of the drawbacks cited for the' options i
available to a nuclear utility, j
The petitioner states that its suggested change to the NRC's regulations would' broaden the definition of commercial grade item j
under 10 CFR 21.3 (a) (4) and (a-1).
The petitioner also states that Part 21 does not allow an' item to qualify as-commercial' grade unless the item meets all three of.the. requirements defined, in 10 CFR 21.3 (a) (4) and (a-1).
Because many of the1 replacement parts needed are no longer available from the-origindl manufacturers or suppliers who maintain Appendix B-qualified programs, the petitioner believes'that the current definition of the term " commercial grade item" presents a significant' obstacle for licensees in procuring appropriate parts in.the most' cost-and time-efficient manner.
According to the petitioner,-the I
proposed changes would expand the definition of 'icommercial grade
{
f item" to include any item obtained on the open market.
Under the petitioner's suggested amendment, it would lxa incumbent upon:the dedication process to provide rearonable assurance that the item will perform its intended function i.a the safety-related application and upon.the dedication entity to report any deficiencies covered under Part 21.
+
i I
6 f
7 l
.i 4
h
\\
The petitioner believes that allowing commercially available items to qualify as commercial grade items would provide i
significant benefits without any adverse impact on safe plant operation.
According to the petitioner, the suggested amendment not only allows procurement from the original manufacturer or supplier even if that entity no longer maintains an Appendix B-qualified program, as well as from other commercial sources, but it also reduces the potential need for design changes and permits a more reasonable price and delivery time.
In the petitioner's suggested amendment, the regulations l
would define the dedication process as one that will provide recsonable assurance that the commercial grade item will perform its intended function.
According to the petitioner, the following are ways to assure that the commercial grade item will perform its intended function:
i (1) Testing and/or inspection; (2) Surveying the commercial grade supplier to determine that the appropriate quality control is in place; (3) Observing the manufacturing process; and (4) Analyzing the historical record of the item for acceptable performance.
The petitioner indicates that other methods of verification for dedication may exist that are acceptable to the NRC and that should be considered in evaluating whether the reasonable assurance standard is met in this context.
l l
8 i
t
l l
The petitioner also proposes that the dedication eistity I
maintain documentation of the dedication process for the purpose e
of an audit or inspection.
The petitioner believes that the primary benefit of establishing the dedication. process suggested l
in the petition is that the user or other party performing the
- I dedication, who understands the safety significance of the
{
1 proposed component and, therefore,.is better able.to identify the characteristics necessary to perform-its. intended function than j
the manufacturer,. is responsible for the quality of the commercial grade item.
In order for the dedication entity to l
maintain documentation of the dedication' process for the purpose of an audit or inspection, the -'ility party performing the dedication would have to evaluate the suitability of the i
component by analyzing the effect of the commercial grade item on l
the component's performance in a safety-related application.
The petitioner believes that it is appropriate to place the responsibility for reporting deficiencies in commercial grade i
i items with the entity performing the dedication process.
The 1
petitioner believes that suppliers and sub-tier suppliers do not i
j necessarily know whether a commercial grade item is destined for a safety-related application.
The petitioner also indicates that no time limitation exists on the Part 21 reporting responsibility.
for suppliers.
The petitioner recommends-that language be added to S 21.21(b) to make clear that the entity performing the dedication of a commercial. grade item is responsible for discovering, evaluating, and reporting deficiencies.
9 1
+
The Suggested Amendments The petitioner believes that Part 21 should be modified to accommodate the current procurement needs of the nuclear power l
l industry.
The petitioner recommends changes to 10 CFR 21.3 to 1
l broaden the definition of a commercial grade item and to define I
l and set out a standard for the dedication process.
The petitioner believes that all parties would benefit from the inclusion of language in 10 CFR 21.21(b) clarifying the responsibility associated with dedication.
According to the petitioner, the recommended changes would not have any adverse l
l impact on safety as the use of properly dedicated commercially available parts neither decreases equipment performance nor affects safe plant operation.
The changes requested by the petitioner are set out as follows:
1.
In S 21.3, paragraphs (a-1) and (c-1) are revised to i
read as follows:
S 21.3 Definitions l
(a-1) Commercial crade item means any item that has not 1
been dedicated for use as a basic component.
(c-1)
Dedication is the evaluation process undertaken to provide reasonable assurance that a commercial grade item to be used as a basic component will perform its intended function.
l 10 i
i i
2.
In S 21.21, the existing text of paragraph (b) is-
[
j redesignated as paragraph (b)(1) and a paragraph (b) (2) is added to read as follows:
S21.21 Notification of. failure to comply;or existence ~of a i
defect and its evaluation, j
l (b) t (2)
The entity that performs the dedication'is responsible l
for identifying, evaluating, and reporting.the deviations'and l
failures to comply associated with substantial safety. hazards of' a commercial grade item.
i t
n$
~
day of 0ctober 1993..
l Dated at Rockville, Maryland, this l i
or the Nuclear Regulatory _ Commission.,
Samuel J.
drlk,
Secretary of-the Commissl n.~
i
'I m
'l 11 l
r---