ML20036C465
| ML20036C465 | |
| Person / Time | |
|---|---|
| Issue date: | 06/11/1993 |
| From: | Norrholm L Office of Nuclear Reactor Regulation |
| To: | Moyer D DRESSER INDUSTRIES, INC. |
| References | |
| REF-QA-99901227 NUDOCS 9306170120 | |
| Download: ML20036C465 (4) | |
Text
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June 11, 1993 Docket No. 99901227.
Mr. Darrell J. Moyer Dresser Pump Division Dresser Industries, Inc.
5715 Bickett Street Huntington Park, California 90255-2634
Dear Mr. Moyer:
SUBJECT:
RESPONSE TO 10 CFR PART 21 INQUIRY By letter dated October 5, 1992, you requested the U.
S.
Nuclear Regulatory Commission's assistance regarding the understanding of particular requirements of Part 21 to Title 10 of the Code of Federal Regulations.
We have addressed your four questions in to this letter.
Should you have any further questions, please contact Mr. Ronald Frahm, Jr. of my staff at (301) 504-2986 or Mr. Gregory Cwalina at (301) 504-2984.
Sincerely, Leif J. Norrholm, Chief Vendor Inspection Branch Division of Reactor Inspection and Licensee Performance Office of Nuclear Reactor Regulation
Enclosure:
1.
Response to Questions DISTRIBUTION VIB R/F
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'is June 11, 1993 P
Docket No. 99901227 Mr. Darrell J. Moyer t
Dresser Pump Division Dresser Industries, Inc.
5715 Bickett Street Huntington Park, California 90255-2634
Dear Mr. Moyer:
SUBJECT:
RESPONSE TO 10 CFR PART 21 INQUIRY By letter dated October 5, 1992, you requested the U. S. Nuclear Regulatory Commission's assistance regarding the understanding of particular requirements of Part 21 to Title 10 of the Code of Federal Regulations.
We have addressed your four questions in Enclosure I to this letter.
Should you have any further questions, please contact Mr. Ronald Frahm, Jr. of my staff at (301) 504-2986 or Mr. Gregory Cwalina at (301) 504-2984.
Sincerely,
(
i
)
(
L'eif J. I rrholm, Chief i
Vendor Inspection Branch Division of Reactor Inspection and Licensee Performance Office of Nuclear Reactor Regulation
Enclosure:
1.
Response to Questions i
-O RESPONSE TO DRESSER INDUSTRIES LETTER QUESTION (1):
When we have imposed 10-CFR-21 in our purchase order to a vendor supplying a safety related item, are we required to verify in any way that this vendor has a program in place to satisfy the requirements of 10-CFR-21? (procedure,-posting, records, etc.)
NRC RESPONSE:
L t
No.
The procuring entity's responsibility for ensuring l
compliance with the provisions of Part 21 of Title 10 of the Code of Federal Regulatiois (10 CFR Part 21) by its contractors, suppliers, and consultants is limited to the requirement that each procurement document specifies that the provisions of 10 CFR Part 21 apply, when applicable.
The NRC is responsible for evaluating the adequacy of the program.
i QUESTION (2):
i Is a vendor that accepts.our purchase order imposing 10-CFR-21 i
required to have a quality program meeting the applicable i
portions of 10-CFR-50 Appendix B?
i NRC RESPONSE:
1 i
No.
A vendor that accepts a purchase order imposing 10 CFR Part 21 is not necessarily required to have a quality program meeting i
the applicable portions of 10 CFR Part 50 Appendix B.
All " basic components," as defined by Section 21.3 of 10 CFR Part 21, are r
required to be manufactured and controlled under a 10 CFR Part 50 Appendix B program.
Therefore, if the vendor does not have a 10 CFR Part 50 Appendix B quality program, either the procuring entity or a third party must control the safety-related activities under their own 10 CFR Part 50 Appendix B program.
If the vendor is expected to supply a basic component in accordance with 10 CFR Part 50 Appendix B, this requirement should be l
clearly noted on the procurement document.
i l
i l l
i 1
QUESTION (3):
Is a vendor that accepts a purchase order that imposes 10-CFR-50, i
Appendix B automatically required to have a procedure in place to i
comply with 10-CFR-21?
l NRC RESPONSE:
i Yes.
A vendor that accepts a 10 CFR Part 50 Appendix B order has accepted a unique nuclear requirement, and would-therefore be supplying a " basic component."
Consequently, the regulations of 10 CFR Part 21.are automatically imposed for that procurement order.
Section 21.21 of 10 CFR Part 21 requires that anyone subject to the regulations in this-part adopt appropriate procedures to comply with these regulations.
Section 21.31 of 10 CFR Part 21 requires that the entity procuring the basic component specify in the procurement document that the provisions of 10 CFR Part 21 apply.
However, any vendor accepting a purchase order that imposes 10 CFR Part 50 Appendix B or any other unique nuclear requirement is required to have a 10 CFR Part 21 program whether or not the procurement document indicates that 10 CFR Part 21 applies.
P QUESTION (4):
An organization subject to the requirements of 10-CFR-21 must comply with the posting requirements described in 21.6.
Does 10-CFR-21 require training of individuals having functions described in that organizations 10-CFR-21 procedure?
. i NRC RESPONSE:
l No.
10 CFR Part 21 does not specifically address or require k
training for individuals having functions described in an l
organization's 10 CFR Part 21 procedure.
However, formal
. i training would be an effective means to assure that all individuals fully understand and comply with the requirements of 10 CFR Part 21.
Furthermore, Criterion II of 10 CFR Part 50 Appendix B requires that the quality assurance program provides for indoctrination and training of personnel performing activities affecting quality.
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