ML19261D247
| ML19261D247 | |
| Person / Time | |
|---|---|
| Issue date: | 04/25/1979 |
| From: | Bennett G NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| To: | NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| References | |
| NUDOCS 7906010332 | |
| Download: ML19261D247 (32) | |
Text
F m PBf2 g
UNITED STATES
/
' ),7 NUCLEAR REGULATORY COMMisslON
- e 7 g WASHINGTON, D. C. 20555
%N a
gvv....j Those on Attached List Gentlemen:
Subject:
Summary of Briefing on Quality Assurance Introduction On February 16, 1979, members of the NRR QA Branch described a proposed graded approach on quality assurance to those RES and 00E staff involved in the programs being reviewed for QA practices. is the list of attendees and Enclosure 2 is the material handed out to each attendee. The foll wing paragraphs contain a summary of the briefing.
Summary Gary Bennett opened the meeting and described the status of the Commission-directed raview of the adequacy of QA practices on RES-sponsored programs. Meetings have been held with all RES managers of the selected programs and with DOE. Field reviews of selected LASL, Sandia and ORNL programs have been completed.
Fred Liederbach described the categories of research programs as given in the plan approved by the Commission and discussed a decision tree for choosing the level of qualib assurance to be applied to a research program.
Mr. Liederbach next described the " graded" approach to QA which allows the program manager to tailor the QA to the type of research progra.a. Graded QA would lead to a balanced application of QA in which just enough QA is applied to obtain a reasonable level of confidence in the acceptability of the research results.
Excessive QA would be avoided.
m Mr. Liederbach described a proposed QA checklist which would allow a program manager to select the necessary aspects of QA for a given program or facility. This checklist was derived from SRP 17.1 and covers the 18 elements of 10 CFR 50 Appendix B although scaled down appropriately.
790601033L 2305 001
Those on Attached List Copies of the checklist were distributed for comment (see Enclosure 2).
Mr. Liederbach listed six reasons why the QA review team proposed a graded approach to QA:
The scope and complexity of most RES programs is not as extensive as the construction of nuclear power plants.
Most RES-sponsored programs already have numerous administrative and programatic controls.
- The size of most RES-sponsored programs is smaller than the size of nuclear power plant projects.
The education and experience of researchers is relatively high.
- The attitude, motivation and dedication of RES and laboratory personnel is good.
- Most of the facilities are tools and not ends unto themselves.
There was a fair degree of discussion following the meeting. Several RES program managers observed that much of what the QA review team called QA was already being accomplished on their programs as good management practice. The treatment of QA on computer codes is still under review by the team.
Bennett said another meeting would be held if necessary to reccive comments. Otherwise, the team planned to complete its field trips by going to INEL and then draft a report of its overall review. This draft would be sent out for comment before the final version is sent to RES management.
Sincer'e /
N
/
f f
G y L. Bennptt, C ief Research Stfpport Branch Division of Reactor Safety Research
Enclosures:
as stated 2305 002
Addressees for Letter dated Saul Levine R. J. Budnitz T. E. Murley F. J. Arsenault A. R. Buhl R. M. Scroggins R. J. Mattson V. Stello H. Thornburg, IE L. S. Tong C. N. Kelber G. D. McPherson A. W. Serkiz W. D. Lanning R. Van Houten D. A. Hoatson W. C. Lyon S. Fabic L. S. Rubenstein, NRR P. Strom, NRC/ID R. E. Tiller, DOE /ID W. J. Kehew, DOE /ID B. Snyder, OPE W. Haass, NRR 2305 003 F. J. Liederbach, NRR J. W. Gilray, NRR W. R. Rutherford, IE F. Jablonski, IE-III C. Z. Serpan E. H. Davidson R. W. Barber, DOE /HQ J. Milhoan, SD M. E. Langston, DOE /HQ R. Kuhnapfel, DOE /HQ F. R. Mynatt, ORNL F. Neill, ORNL e
J. Pidkowicz, DOE /0R R. Wright, RES D. Skovholt, NRR R. Foulds T. McSpadden, DOE /HQ L. M. Shotkin G. P. Marino M. Silberberg L. J. Ybarrondo, EG&G A. W. Snyder, Sandia J. Jackson, LASL D. K. Nowlin, DOE /AL S. Scott, (2 cys for FDR)
G. P. Dix, DOE /HQ
ENCLOSURE 1 BRIEFING ON QUALITY ASSURANCE ATTENDEES February 16, 1979 Name Organization Gary L. Bennett NRC/RES R. Feit NRC/RES R. B. Foulds NRC/RES J. W. Gilray NRC/NRR W. P. Haass N RC/NRR R. Landry NRC/RES W. D. Lanning NRC/RES F. J. Liederbach NRC/NRR W. C. Lyon NRC/RES G. P. Marino NRC/RES T. McSpadden DOE /HQ J. Milhoan NRC/SD L. M. Shotkin NRC/RES M. Silberberg*
NRC/RES D. Skovholt NRC/NRR M. D. Stolzenberg NRC/RES R. Van Houten NRC/RES R. Wright NRC/RES 2305 004
- part time e
I
CATEGORIES OF RESFARO1 PROGRNE CATEGORY 1 fCSEAR01 PROGRAMS M1101 INVOLVE IDDNSTRATION TEST ARTICLES AS RElATED TO TIEIR USE IN COBERCIAL POER PLMIS.
(IN GERERAL, A DEiDNSTRATION TEST ARTICE IS AN ITD1 M1101 IS IlifB1DED TO PERFORM IN A RESEAR01 PROGr#1 AS A 01 PARABLE 1781 WQJLD RRFORM IN A C0fERCIAL NUQfAR fGER PLANT.)
CATFGORY 2 RESEAR01 PROGRAMS M1101 ARE IFFORTNIT 1D 11E SUCCESSFUL RESOLUTION OF A LIENSING TE0iNICAL ISSUE, AND MIIO1 DO TOT IIAOLVE DBETRATION TEST N$
ARTICLES.
w CD w
e AfE FACILITIES CATEWRIZED BY tRC PlRG FACILITIES TIEEELVES HAVE BEEN DEFIED BY RES AS WREIY TOOLS llSED TO OBTAIN INF0WATION AB0lff SOE PHYSICAL PIBGEON (E.G., WATER FLOW) OR ON S0fE PARTICulR TEST ARTICLE, (E.G., FIRE PROTECTIVE 00ATINGS).
U 8
a Ch
i r
e I
YES
+ USE APPLICABLE ELEMENTS OF APPENDIX B TO 10 CFR PART 50 IS TEST ARTICLE (GRADED APPROACil) z TRULY
+
PROTOTYPIC?
l NO
+ USE COLUMN 1 OF CHECKLIST YES + USE COLUMN 1 OF CHECKLIST I
IS TEST ARTICLE E
R ES CATEGORY
+
los2?
NO
+ OA NOT REQUIRED YES(POWER REACTOR FACILITY)
> USE APPLICABLE ENTER
+
ELEMENTS OF IS FACILITY APPENDIX B TO 10 CFR PART 50 3
A R E ACTOR
+
l.
FACILITY?
(GRADED APPROACH) i YES(RESEARCH REACTOR FACILITY)
> USE NRC REG I
GUIDE ON l
YES + USE COLUMN 1 OF CHECKLIST OA FOR IS NON-NUCLEAR RESEARCH m
FACILITY REACTORS f
^
INTERTWINED
+
WITH TEST ARTICLE?
N U
NO
+ USE COLUMN 2 OF CHECKLIST C
L71 YES
--h-USE COLUMN 1 OF CHECKLIST ARE TEST C
INSTRUMENTS O
& MTE USED q
IN EXPERIMENT 7 i
NO
+ OA NOT REQUIRED t
t me
}
" GRADED"_APPf0A01 TO DA A.
BALMED /PP10A01 B. LEVEL OF EFFORT Sf00LD E @KNSURATE WIT 11 ASSIGED Iff0RTANCE, E.G.,
1.
Iff0RTME OF TEST DATA OR TEST ITEM 2.
Iff0RTANE 10 RESOLUTION OF LIEtEING ISSLE C. 00 EN00GI QA TO ATTAIN REASONABLE LEVEL OF (DNFIIENE Ifl ACEPTAB EXCESSIVE QA LUISIRABLE.
D. SUBJECTIVE DETERMINATION IfNOLVED VIA COLLEGIAL EVAL ANDQAAREAS.
E. PROPOSED 04 OECKLIST lELPS f01NE SLRECTIVITY.
F. Pf0 POSED QA DECKLIST 00NSISTS OF T10 PARTS COLUMN 1 - USE FOR TEST ARTICLE, CERTAIN Mg,TE, AND ERTAIN FACILITY ITEMS (DLLM12 - USE RR FACILITY IF FACILITY ADEQUACY TESTAELE.
G. Pf0FOSED QA DECKLIST IS ALREADY PfUtED, y
u o 11. FOR TIULY PROTOTYPIC DEIONSTRATION TEST ARTICLES AND NUGEAR fGE TO 10 E R PART 50.
(I.E., 18 CRITERIA) c co
1 GRAIFD APPfM01 TO DA (QYlT'm l
m BRAN 01 STAFF FORKED TO TRIM, SLIE, 0;i, COMBINE #0 SOREN m REQUIfBERS FOR RES.
188 ELEENTS IN SRP 17.1.
ABOUT 35% OF TlDSE 188 IlERE PLUS SELECTIVE TAllDRIfE POLICY PROPOSED ONTllESE.
i N
LN O
Ln t
O l
.1 GRADED APPROA01 P3R ES Pf0GRN1S QACRITERIA SRP 17.1 TESTARTIGE TEST FACILITY
- 1. ORGANIZATION 25 4
0
- 2. PROGRNi 22 5
0
- 3. ESIGN @UROL 25 5
3
- 4. PROCURS E E 4
2 2
5.
INSTRUCTIONS / DRAWINGS 2
1 1
- 6. DOClieff CONTROL 11 9
4
- 7. C0fRROL - PUR0tASES 15 6
1 8.
IENTIFICATION CONTROLS 4
4 0
l
- 9. SRCIAL PROESSES 5
1 0
10.
INSRCTION 12 9
0
- 11. TEST ODN1TOL 8
7 7
- 12. KASURE & TEST EQUIREIT 9
7 0
- 13. lW1DLING, STORAGE, SillPPING 3
1 0
14.
INSPECTION /IEST STATUS 4
1 0
y
- 15. f0N00NFORIMNCES 5
2 0
o
- 16. CORRECTIVE ACTION 4
1 0
17.
RECORDS 15 1
0 0
- 18. AUDITS 13 3
3
R4TIORE - Wit / DOES DA REVIB1 TE#1 PROPOSE GRAID APPROA0l?
- 1. PROGRNi SIlPLICITY SCOPE AO C01PLEXITY OF TDST [S PROGMS liOT AS EXTB4SIVE AS liUCEAR PGER PLMTS.
Ill GB1ERAL, QUALITY REDUIRS1BffS RELATE TO PRWECTS INVOLVIllG EXTB4SIVE USE OF llARMfE/EQUIPfEIT AO SERVIES. Tile EXTBff 0F SUDI REDUIRBEffS IS CGiEISURATE WITil SCOPE, C01PLEXITY, A0 Ii1PORTAlE OF PRQJECT. KEEP IT SIMPE AS POSSIBE IN ALL CASES. RES PROGRMS, Ill GBiERAL, NPEAR TO E LESS CGPEX MD INVDLVE LESS EXTBiSIVE USE CF EQUIPPEff A0 SEf# ICES. TEREFORE, FEER CQfTf0LS NEEDED.
- 2. EXISTING Cd4TROLS NU1ER0LE AdilillSTRATIVE & PROGRN41ATIC CQfTROLS AIKN# EXIST IN MOST RES PROGRM ACTIVITIES V! SITED BY TIE TENi.
. Sil0RTER LIllES AU AREAS OF C0fU11CATIQ1 IliF0iHATIQ1 PROCESSli1G & INFO MIDLING PROBLBiS FAR SIfPLER
. FBER TE011ICAL & fMEtBIT IllTERFACES S
. FBER PEOPLE IlNOL\\ED
~
. MOST WORK CARRIED OUT IN A SINGE GEOGRAPfilC LOCATIG1
RATI0ilAE - WW DOES m REVIEW TFMPRDIOSE GRATFD APPRCACH (011T'D)
Lt. TYW 0F OPE Il#0LVED EVEL OF EDUCATIQ1 a EXPERIBICE OF RESEAR01ERS & 1R PERS0f1EL RELATI'El.Y HIGH COPARED TO N04-RES PR)GRN1S
- 5. ATTITUDEA UTIVATIG UDEDICATIQi TFM H/6 OBSERVED:
IIIGli DEGREE OF DEDICATIQ1 TO WORK IN RES & CQHRACTOR PERSOT1EL AND MAtNEMBE GREAT ATTITUDE, SPIRIT, DRIVE, B1ERGY, & MOTIVATI0i1
- 6. USE OF TESTIlE ITSEE AS VERIFICATI04 TOOL IF FACILITIES TliB1SELVES TESTABE, LSE OF TESTING ITSELF AS A VERIFICATIQi TECHNIQUE WOULD LESSB114EED FOR OVERLY FORMALI2ED PROGR/fMATIC a AUilllISTRATIVE 00i1TROLS.
N LT1 N
" QUALITY ASSURANCE (QA) AND ASSOCIATED LEVEL 0F EFFORT FOR NRC'S RES PROGRAMS (GRADED APPROACH TO QA)"
The level of effort and intensity of the quality assurance (QA) program for a given research program, (e.g., a program sponsored by the Office of Nuclear Regulatory Research [RES]} should be commensurate with NRC's judgment on the importance of the program (i.e., importance of the test, test data, or the structure, ystem, or component) and/or the importance of the program to the resolution of a licensitig technical issue. Thus, the QA requirements for any program should be applied in a balanced manner, an approach iat is sometines called a " graded approach." This approach of selecting only those controls that are necessary is geared to obtaining a reasonable level of confidence in the acceptability of results.
In 1970 the Commission published a set of 18 QA criteria in Appendix B to 10 CFR Part 50 for nuclear power plants.
Inherent within Appendix B are words which allow for QA elements therein to be selectively applied. These words say, "The pertinent requirements of this Appendix apply to all activities affecting the safety-related functions of...the structures, systems, and components...to which appendix B applies," and "The quality assurance program shall provide control over activities affecting quality...to an extent consistent with their importance, etc."
Experience has taught that for the complex contracts associated with the design, construction and operations of 2305 013 commercial nuclear power plants that a relatively " full blown" Appendix B QA approach is needed r equiring extensive commitments to strict administrative and procedural controls. These controls are docketed in the license applica-tion or in topical reports from the applicant and the applicant's principal contractors; namely, the architect-engineer, constructor, construction manager, and the nuclear reactor system supplier.
By contrast with the controls invoked for commerical nuclear power plants, controls for RES programs are different, i.e., generally less complex. The RES staff is comprised of highly competent technical individuals, and as a result of their very frequent involvement and interaction with the laboratory contractors (through visits, meetings, reviews, quick-look reports and other correspondence, reporting requirements, formal presentations, and publication requirements), they and the contractors are already implementing numerous informal and formal programmatic controls.
Briefly, the nature and degree of RES program manager involvement observed by the NRC's QA review team to date denotes that, although considerable informality exists, more QA credit can be taken for RES programs than in nonresearch programs.
In fact, the NRC review team believes that a reasonable amount of informal contact is both necessary and desirable for RES programs.
The team believes that in order to better demonstrate the confidence in the acceptability of data and findings of a number of RES programs, some additional formalization is necessary. This would involve a more disciplined approach 2305 014
. in determining the required programmatic controls for RES programs and documented evidence attesting to the acceptability of test data.
This involves the selection and implementation of a balanced, i.e.,
" graded approach" to QA, recognizing the need to retain the cost effectiveness of RES programs. The NRC QA review team does not want, nor does it expect to see an " overkill in QA" on RES programs. However, refinements are in order to assure a reasonable degree of confidence is achieved in the tests and data associated with RES programs.
This is necessary in order to use such findings in the licensing process.
To this end, the enclosed suggested QA checklist has been developed to aid in determining the degree of QA effort to be applied to specific RES programs.
The checklist reflects the balanced or " graded" approach to quality assurance.
It is a considerably scaled-down version of the more extensive checklists utilized with commercial nuclear power plants.
Instructions on how to use this list are provided.
Key factors in determining what QA effort is required for a particular RES program are:
a 1.
Understanding the scope and end use objective of the RES program, the complexity of the program, and the anticipated end use of the data in the licensing process.
Example - Are the test results to be used as acceptance limits in the licensing process? Will the results from the computer codes (e.g., TRAC) be used as acceptance limits in the licensing process?
2305 015
. 2.
An evaluation of the technical issues and their importance [by technical,'ersonnel and personnel knowledgeable in QA] in order to make an intelligent selection of the requirements from the enclosed QA checklist.
Example:
If the results (e.g., computer data, pump head vs. flow curve) are going a.
to be used as acceptance limits in the licensing process, reasonable confidence in the data is needed. For such cases, we believe that most, if not all, of the elements on the checklist should apply.
Please bear in mind that the checklist has already been pared down to be brief and minimal compared to those used for nuclear power plants.
Therefore, it is suggested further trimming and pruning should be carefully guarded against. Also, it may be that more controls than identified on the checklist might be required, e.g., additional programmatic and administra-tive controls of the type found in Appendix B to 10 CFR Part 50 as clarified by Chapter 17 of NRC's Standard Review Plan for nuclear power plants may be necessary.
b.
If the data are solely for exploratory or conceptual concerns (e.g., long-term development of a concept for a rock cnssher to pulverize moon rocks),
then the extent of application of the checklist is based most heavily on the judgment of the researcher and his managers who tailor the effort to match the degree of confidence needed and/or wanted.
2305 016
. Note that the accompanying instructions for the use with the checklist address two QA catagories; namely, QA Category 1 (see column 1 of check-list) and QA Category 2 (column 2 of checklist). These categories are not to be confused with the categories developed by NRC for its confirmatory
- esearch programs, nor are they to be confused with NRC's Seismic Category I nor any other NRC categorization.
QA Category 1 (Column 1 of QA checklist) covers:
a.
RES Category 1 - Research programs which involve demonstration test articles which are not truly prototypic but which are otherwise related to their use in commercial nuclear power plants.
In general, a demonstration test article is an item which is intended to perform in a research program as a comparable item would perform in a commercial nuclear power plant.
and b.
RES Category 2 - Research porgrams which are important to e
the successful resolution of a licensing technical issue and do not involve demonstration test articles. Examples are RELAP, TRAC, and LOFT.
and Measuring and test instrumentation, including calibrating c.
equipment and devices utilized to obtain the data, and facility items directly associated with the work on the test 2305 017
. article itself.
QA Category 2 covers:
a.
Non-nuclear facilities that are in and of themselves merely supportive tools used to obtain infonnation (i.e., which can be in and of themselves tested to confirm their adequacy; example, old quonset hut at Sandia utilized to house cable trays and ignition source to start a fire in cable that is utilized in obtaining data on effects of fires).
Precautionary notes are to be observed as follows:
1.
If the demonstration test article is truly prototypic of that which is to be installed in a nuclear power plant, Appendix B to 10 CFR Part 50 must be applied.
(See accompanying definitions and instructions). Also, note that Appendix B to 10 CFR Part 50 contains language therein that allows a balanced, graded and tailored approach, yet one that is far more stringent from that advocated in this document.
i 2.
If the facility involves a nuclear power reactor or another kind of 0A effort which is subject to the NRC licensing process, contact the QA Branch of NRC for advice on procedural matters. NRC requires implementation of Appendix B to 10 CFR Part 50 for nuclear power plants and fuel reprocessing plants.
NRC has issued a regulatory guide on QA for nuclear research reactors.
2305 018
. In summary, the NRC QA review team does not want an " overkill" QA approach applied to RES programs. The greater the truly ethical, yet informal work that is conducted, the better. The only reason, yet a good reason that QA exists, is that people make mistakes and good people have a desire /want/need to do things right the first time around.
Rather,the QA review team wants a well-balanced, efficiently implemented QA program that provides the necessary confidence in results of RES programs. This does not cost in the long run!
It pays!
We propose that the QA checklist or an amended version thereof be published and included into NRC programs and procedures manuals.
Each RES program manager would be expected to fill out and sign the checklist or otherwise enclose it with a formal memo to his immediate manager signifying that he has reviewed each checklist item and has made a personal determination as to which elements of the enclosed checklist do or do not apply.
In certain situations the program manager might ask the contractor to propose the QA controls to be applied. This effort should also be appropriately documented.
i Tentative Conclusions by NRC Review Tear
- 1.
The NRC QA review team came to the conclusion that significant differences usually exist between QA requirements for nuclear power plants vs. those for RES research programs, namely:
- The NRC QA Review Team is approximately midway through its review, discussions, and investigation as required by the Memorandum and Order from the NRC Commissioners.
The above tentative conclusions may be subject to revision pending the outcome of ongoing work by the team.
2305 019
. a.
Size of program - number of people involved.
b.
Level of dedication / education / experience of technical and managerial personnel.
Use of testing itself as a verification technique as opposed c.
to prognostication on what happens during a LOCA, i.e., where test of an actual LOCA in a commercial nuclear power reactor is both unwise and prohibited.
This led to the development of the graded QA approach (note enclosed checklist).
2.
We propose that the QA requirements for a given RES program be determined by the RES program manager, and if necessary, with assistance by the author of the user's request; and furnished to the contractor or laboratory as part of the request for proposal (RFP). Alternatively, the RFP might simply. request that the contractor / lab include a proposed QA program plan in its proposal to NRC.
In this case, the enclosed checklist would aid RES program managers in deciding whether or not the QA effort' proposed ~~
by the contractor is inadequate, acceptable, or excessive.
i 3.
We recommend that NRC management develop a policy statement on QA for RES programs.
Such statement would be included in the forthcoming report to the NRC Commissioners. Such statement would hava the concurrence of management one layer removed from the Commissioners.
This statement should require that QA controls be an integral part of each RES program and that each RES program manager use the enclosed checklist in deciding whether or not the QA effort proposed by the contractor / lab is :ceptable.
2305 020
CHECKLIST - GRADED QA FOR RES PROGRAMS Instructions for Use:
1.
Column 1 of the " graded approach" checklist deals with items in QA Category 1.
QA Category 1 should be considered for and encompasses both RES program Categories 1 and 2 unless the demonstration test article is truly prototypic.
(See RES definitions.) Thus, consider Column 1 of the checklist for 1) demonstration test article (s);
- 2) facility item (s) (if any) directly associated with test objectives; and 3) for the instrumentation and measuring and testing devices used in bbtaining the data.
In general, consider Column 1 (QA Category 1) of the checklist as a baseline for QA for all RES Categories 1 and 2 programs involving facilities other than nuclear facilities and for a demonstration test article that is not an exact duplicate of the item to be installed in a commercial nuclear power plant.
If it is to be a duplicate or an identical prototype (e.g., truly prototypic) of an item to be installed in a commercial nuclear power plant, the checklist will not suffice, and the QA provisions of Appendix B to 10 CFR Part 50 (as embodied in Chapter 17.1 of NRC's Standard Review Plan for Nuclear Power Plants) apply.
2.
Column 2 (QA Category 2) represents minimum checklist items to be considered for non-nuclear research facilities. When the acceptability of the non-nuclear test facility per se cannot be established by functional testing of the facility, the graded QA program in Column 1 should be applied.
When the test facility involves a nuclear research reactor or a nuclear power reactor: such facilities require far more stringent QA practice and become involved in the NRC licensing process. For such cases, the QA Branch of NRC should be contacted for applicable requirements.
2305 021
Graded Kpproach 1
2 1.
The Organization elements responsible for the QA program are acceptable if:
1.1 Organization charts identify the organizational elements which function under the cognizance of the QA program (such as design engineering, procurement, manufacturing, construction, inspection, test, instrumentation and control, nuclear engineering, X
etc.) and the lines of responsibility.
1.2 The Qt responsibilities of each of the organizational el eme -
noted on the organization charts are desem bed.
X' l.3 Verification of conformance to selected requirements is accomplished by individuals or groups who do not have direct responsibility for performing the work X
being verified.
1.4 NRC evaluates the performance of work by the organizations identified in 1.1 Note - The proposed frequency and method for performing this evaluation must be specified in writing and found acceptable to NRC. At least an annual evaluation is performed, although a longer cycle is acceptable provided other ongoing evaluations of work elements occur.
y 2.
Activities related to Quality Assurance Program are acceptable if the scope of the QA program include:
2.1 A commitment that activities affecting safety-related structures, systems and components will be subject to the applicable controls of the QA program.
X 2.2 The identification of structures, systems, and components and related consumables covered by the 0A program and controlled measures identifying personnel authorized to approve changes to this list and describing methods controlling its distribution.
X 2305 022
Graded Approach 1
2 Provisions are established to assure that procedures 2.3 required to implement the QA program are consistent with QA program connitments and NRC policies and are properly documented, controlled, and made mandatory through a policy statement or equivalent x
document signed by the responsible official.
An indoctrination and training program is established 2.4 such that:
Personnel responsible for performing quality-a.
affecting activities are instructed as to the purpose, scope, and implementation of the quality-related manuals, instructions, and X
procedures.
Personnel verifying activities affecting quality b.
are trained in the principles, techniques, and requirements of the activity being performed and X
their proficiency maintained.
Activities related to Design Control _ are acceptable if:
3.
The scope of the design control program includes all 3.1 design activities associated with the preparation and review of design documents including the correct translation of applicable requirements and X
design bases into design, procurement and procedural
.documen ts.
Organizational responsibilities are described for 3.2 preparing, reviewing, approving, and verifying design documents such as system descriptions, design input and criteria, design drawings, design X
analyses, computer programs, specifications, and procedures.
Guidelines or criteria are established and described 3.3 for determiningthe method of design verification X
X (design review, alternate calculations, or tests),
Procedures are established and described for design 3.4 verification activities which assure the following:
The verifier is qualified and is not directly a.
responsible for the design (i.e., neither the performer or his immediate supervisor).
In X
X exceptional circumstances, the designer's immediate supervisor can perform the verification.
2305 023 Page 2 of 10
Graded Approach b.
The responsibilities of the verifier, the areas 1
2 to be verified, the pertinent considerations to be verified, and the extent of documentation X
X are identified in procedures.
4.
Activities related to Procurement Document Control are acceptable if:
4.1 Procedures are established for the review of procurement documents to determine that quality requirements are correctly stated, inspectable, and controllable; there are adequate acceptance and rejection criteria; and procurement documents have been prepared, reviewed, and approved in accordance with QA program requirements.
To the extent necessary, procurement documents should require contractors and subcontractors to provide an acceptable quality assurance program. The review and X
X concurrence of the adequacy of quality requirements stated in procurement documents is performed by personnel qualified in QA practices.
4.2 Procedures are established to assure that procurement documents identify applicable regulatory, technical, administrative, and reporting requirements; drawings; specifications; codes and industrial standards; test and inspection requirements; and special process X
X instructions that must be complied with by suppliers.
5.
Activities related to Instructions, Procedures, and Drawings are acceptable if:
5.1 Activities affecting quality are (1) prescribed by documented instructions, procedures, drawings, and (2) accomplished through implementation of these X
X documents by qualified individuals.
t 6.
Activities related to Document Control are acceptable if:
6.1 The scope of the document control program is described, and the types of controlled documents are identified. As a minimum, controlled documents include:
a.
Design documents (e.g., calculations, drawings, specifications, analyses) including documents X
X related to computer codes.
b.
X X
. Page 3 of 10 2305 024
Graded Approach Instructions and procedures for such activities 1
2 c.
as fabrication, constructica, modification,in-X stallation, test, and inspection.
X X
d.
As-built drawings.
Quality assurance and quality control manuals or X
e.
equivalent.
X f.
Nonconformance reports.
6.2 Procedures for'the review, approval, and issuance of documents and changes thereto are established and described to assure technical adequacy and inclusion X
X of appropriate quality requirements prior to implementation.
6.3 Procedures are established to assure that changes to documents are reviewed and approved by the same organizations that performed the initial review and approval or by other qualified responsible organizations X
delegated by the applicant.
6.4 Procedures are established and described to assure that obsolete or superseded documents are removed and replaced by applicable revisions in work areas X
in a timely manner.
7.
Activities related to Control of Purchased Material, Equipment, and Services are acceptable if:
7.1 Verification of suppliers' activities during fabrication, inspection, testing, and shipment of materials, equipment, and components is planned and performed, as required, X
in accordance with written procedures to assure conformance to the purchase order requirements.
7.2 5 election of suppliers is documented and filed.
X a
7.3 Receiving inspection is performed to assure:
The material, component, or equipment is properly a.
identified and corresponds to the identification on the purchase document and the receiving X
X documentation.
b.
Material, components, equipment, and acceptance records satisfy the inspection instructions X
prior to installation or use.
2305 025 Page 4 of 10
Graded Approach 7.4 The supplier furnishes the following records to 1
2 the purchaser:
a.
Documentation that identifies the purchased item and the specific procurement requirements (e.g.,
codes, standards, and specifications) met by x
the item.
b.
Documentation identifying any procurement X
requirements that have not been met.
8.
Activities related to Identification and Control of_
Materials, Parts, and Components are acceptable if:
8.1 Controls are established and described to identify and control materials (including consumables),
parts, and components including partially fabricated X
subassemblies. The description should include organizational responsibilities.
8.2 Procedures are established which assure that identification is maintained either on the item or on records traceable to the items to preclude X
use of incorrect or defective items.
8.3 Identification of materials and parts important to the function of the item can be traced to the appropriate documentation such as drawings, specifications, purchase orders, manufacturing and inspec^. ion documents, deviation reports, and X
physical and chemical mill test reports.
1 8.4 Correct identification of material, parts, and components is verifled and documented' prior to release for fabrication, assembling, shipping, and X
installation.
9.
Activities related to Control of Special Processes are acceptable if:
9.1 Procedures, em'ipment, and personnel associated with special pract' as such as welding, NDT, etc., are qualified and are in conformance with applicable X
codes standards, QA procedures, and specifications.
- 10. Activities related to Inspection are acceptable if:
10.1 The scope of the inspection program is described that indicates an effective inspection program has been X
established. Program procedures provide criteria Page 5 of 10 2305 026
Graded Approach for determining the accuracy requirements of inspection 1
2 equipment, and criteria for determining when inspections are required or define how and when inspections are y
performed.
10.2 Organizational responsibilities for inspection are described.
Individuals performing inspections for determining acceptability of an item are other than those who performed or directly supervised the activity being inspected and do not report directly to the immediate supervisors who are responsible X
for the activity being inspected.
10.3 Inspection procedures, instructions, or checklists provide, as required, for the following:
Identification of characteristics and activities X
a.
to be inspected.
b.
Identification of the individuals or groups responsible for performing the inspection operation.
X Acceptance and rejection criteria.
c.
d.
Identification of required procedures, X
drawings and specifications and revisions.
Recording inspector or data recorder and the X
e.
results of the inspection operation.
f.
Specifying, when applicable, necessary measuring and test equipment including their accuracy X
requirements.
10.4 Inspection results are documented, evaluated and their acceptability determined by a responsible X
individual or group.
- 11. Activities related to Test Control _ are acceptable if:
11.1 The description of the scope of the test control program indicates an effective test program has been established for tests including proof tests prior to installation and preoperational tests. Program procedures provide criteria for determining the accuracy requirements of test equipment and criteria for determining when a test is required or how and X
X when testing activities are performed.
11.2 Test procedures or instructions provide as required
'^r the following:
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Graded Kpproach 1
2 The requirements and acceptance limits contained a.
in applicable design and procurement documents.
X X
X X
b.
Instructions for performing the test.
Test prerequisites such as calibrated instrumen-c.
tation, adequate test equipment and instrumenta-tion including their accuracy requirements, completeness of item to be tested, suitable and controlled environmental conditions, and X
X provisions for data collection and storage.
X X
d.
Acceptance and rejection criteria.
e.
Provisions for assuring test prerequisites X
have been met.
11.3 Test results are documented, evaluated, and their acceptability determined by a responsible individual X
X or group.
- 12. Activities related to Control of Measuring and Test Equipment are acceptable if:
12.1 The scope of the program for the control of measuring and test equipment is described and the types of equipment to be controlled are established.
This information indicates an effective calibration X
X program has been established.
'2.2 Procedures are established and described for calibration (technique and frequency), main-tenance, and control of the measuring and test equipment (instruments, tools, gages, fixtures, reference and transfer standards, and nondestruc-tive test equipment) that is used in the measure-ment, inspection, and monitoring of safety-X related structures, systems, and components.
12.3 Measuring and test equipment is identified and X
traceable to the calibration test data.
12.4 Measuring and test equipment is labeled or tagged or otherwise controlled to indicate due date of the next calibration. The method of "otherwise control" X
should be described.
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Graded Approach 12.5 Measuring and test equipment is calibrated at 1
2 specified intervals based on the required accuracy, purpose, degree of usage, stability characteristics and other conditions affecting the measurement.
Calibration of this equipment should be against standards that have an accuracy of at least four times the required accuracy of the equipment being calibrated or, when this is not possible, have an accuracy that assures the equipment being calibrated will be within required tolerance and that the basis of acceptance is documented and authorized by responsible management.
X 12.6 Calibrating standards have greater accuracy than standards being calibrated. Calibrating standards with the same accuracy raay be used if it can be shown to be adequate for the requirements and the basis of acceptance is documented and authorized by responsible management.
X 12.7 Reference and transfer standards are traceable to nationally recognized standards;. where national standards to not exist, provisions are established to document the basis for calibration.
y
- 13. Activities related to Handling, Storage, and Shipping are acceptable if:
13.1 Special handling, preservation, storage, cleaning, packaging, and shipping requirements are established and accomplished by suitably trained individuals in accordance with predetermined work and inspection instructions.
x
- 14. Activities related to Inspection, Test, and Operating Status are acceptable if:
14.1 Procedures are established to indicate the inspection, i
test, and operating status of structures, systems, and components throughout fabrication, installation, and test.
x 15.
Activities related to Nonconforming Materials, Parts, or Components are acceptable if:
2305 029 Page 8 of 10
Graded Approach 18.3 Audits are performed in accordance with pre-established written procedures or checklists and conducted by trained personnel having no direct responsibilities X
X in the areas being audited.
2305 030 t
Page 10 of 10 Definitions Category 1 Research Programs Research programs which involve demonstration test articles as related to their use in commercial nuclear power plants.
In general, a demonstration test article is an item which is intended to perform in a research program as a comparable item would perform in a comnercial nuclear power plant.
As such, Category 1 research programs are subject to the applicable provisions of Appendix B to 10 CFR Part 50.
Category 2 Research Programs Research programs which are important to the successful resolution of a licensing technical issue and which do not involve demonstration test articl es.
jlA - abbreviation for quality assurance QJ: - abbreviation for quality control Quality assurance - All those planned and systematic actions necessary to provide adequate confidence that a structure, system, or component will perform satisfactorily in service. Quality assurance includes, per NRC definition, the term quality control.
Quality control - Those quality assurance actions related to the physical characteristics of a material, structure, component, or system which provide a means to control the quality of the~ material, structure, component, or system to predetermined requirements.
Appendix B to 10 CFR Part 50 The NRC's regulation on quality assurance entitled, " Quality Assurance for Nuclear Power Plants and Fuel Reprocessing Plants." This regulation contains a set of 18 criteria established as requirements for the design, construction, and operation of structures, systems, and canponents that prevent or mitigate the consequences of postulated accidents that could cause undue risk to the health and safety of the public. Appendix B states "The pertinent requirements of - - Appendix B to 10 CFR Part 50 - - apply to all activities affecting the safety-related functions of those structures, systems, and components. Appendix B further states "The quality assurance program shall provide control over activities affecting the quality of the identified structures, systems, and components to an extent consistent with their importance to safety."
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Demonstration test article An item which is intended to perform in a research program as a comparable item would perform in a cormlercial nuclear power plant.
If the demonstration article is a " carbon copy" or truly prototype of the item in the commercial nuclear power plant, the applicable QA provisions of Appendix B to 10 CFR Part 50 must be applied.
If this is not the case,- it is acceptable to consider, as a minimum, the QA provisions included in the checklist identified as QA Category 1 in this report.
Prototype - A full scale functional form of a new product identical to the items to be massed produced based on "as-built" drawings of it, e.g., a control rod drive mechanism for a nuclear power plant.
Graded approach A balanced approach in which the type, level, and stringency of prograrmiatic and administrative (QA) controls vary dependent on the kind of project or item, its complexity, importance relative to safety, and, for example, its use in the ligensing process.
QA Category 1 See QA checklist. Applfps to Category 1 and Category 2 RES programs and associated test and measuring instrumentation used in obtaining data on the test article. However, if the test article is truly prototypic of a nuclear power plant item, the pertinent provisions of Appendix B to 10 CFR Part 50 or equivalent must be applied. (Please see notes on checklist.)
QA Category 2 See QA checklist. Applies to test facilities if the facilities are testable, e.g., simple heat transfer loops or facility used in fire protection qualifi-cation tests of cable. Note that if the facility is not testable (e.g., LOCA's are not simulated in an actual reactor), more stringent QA program provisions would apply, e.g., those of QA Category 1 or, more stringent, those judged on a case-by-case basis.
(Please see notes on checklist).
2305 032
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