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| issue date = 04/30/2009
| issue date = 04/30/2009
| title = Supplemental Request for Additional Information Regarding Nuclear Energy Institute Technical Report 06-14A, Quality Assurance Program Description, Revision 6 (Project No. 689; TAC Q00014)
| title = Supplemental Request for Additional Information Regarding Nuclear Energy Institute Technical Report 06-14A, Quality Assurance Program Description, Revision 6 (Project No. 689; TAC Q00014)
| author name = Burton W F
| author name = Burton W
| author affiliation = NRC/NRO/DNRL/NRGA
| author affiliation = NRC/NRO/DNRL/NRGA
| addressee name = Bell R J
| addressee name = Bell R
| addressee affiliation = Nuclear Energy Institute (NEI)
| addressee affiliation = Nuclear Energy Institute (NEI)
| docket = PROJ0689
| docket = PROJ0689
| license number =  
| license number =  
| contact person = Burrows S A
| contact person = Burrows S
| case reference number = TAC Q00014
| case reference number = TAC Q00014
| document type = Letter, Request for Additional Information (RAI)
| document type = Letter, Request for Additional Information (RAI)
| page count = 5
| page count = 5
| project =
| stage = RAI
}}
}}


=Text=
=Text=
{{#Wiki_filter:April 30, 2009  
{{#Wiki_filter:April 30, 2009 Mr. Russell J. Bell, Director New Plant Licensing Nuclear Generation Division Nuclear Energy Institute 1776 I Street, NW, Suite 400 Washington, DC 20006-3708
 
Mr. Russell J. Bell, Director New Plant Licensing Nuclear Generation Division Nuclear Energy Institute 1776 I Street, NW, Suite 400 Washington, DC 20006-3708  


==SUBJECT:==
==SUBJECT:==
SUPPLEMENTAL REQUEST FOR ADDITIONAL INFORMATION REGARDING NUCLEAR ENERGY INSTITUTE TECHNICAL REPORT 06-14A, QUALITY ASSURANCE PROGRAM DESCRIPTION, REVISION 6 (PROJECT NO. 689; TAC Q00014)  
SUPPLEMENTAL REQUEST FOR ADDITIONAL INFORMATION REGARDING NUCLEAR ENERGY INSTITUTE TECHNICAL REPORT 06-14A, QUALITY ASSURANCE PROGRAM DESCRIPTION, REVISION 6 (PROJECT NO. 689; TAC Q00014)


==Dear Mr. Bell:==
==Dear Mr. Bell:==


By letter date May 7, 2008, the Nuclear Energy Institute (NEI) submitted changes to NEI Technical Report 06-14A, "Quality Assurance Program Description," Revision 5. NEI 06-14A provides a template for a quality assurance program description (QAPD) to be applied to activities affecting the quality and performance of safety-related structures, systems, and components.
By letter date May 7, 2008, the Nuclear Energy Institute (NEI) submitted changes to NEI Technical Report 06-14A, Quality Assurance Program Description, Revision 5. NEI 06-14A provides a template for a quality assurance program description (QAPD) to be applied to activities affecting the quality and performance of safety-related structures, systems, and components.
U.S. Nuclear Regulatory Commission (NRC) staff has reviewed NEI 06-14A, Revision 5, in accordance with the provisions of Draft Standard Review Plan Section 17.5, "Quality Assurance Program Description - Design Certification, Early Site Permit and New License Applicants."
U.S. Nuclear Regulatory Commission (NRC) staff has reviewed NEI 06-14A, Revision 5, in accordance with the provisions of Draft Standard Review Plan Section 17.5, Quality Assurance Program Description - Design Certification, Early Site Permit and New License Applicants.
By letter dated November 14, 2008, NEI submitted Revision 6 of NEI 06-14 that included changes that addressed questions included in the NRC staff Request for Additional Information (RAI) dated September 17, 2008. By letter dated November 20, 2008, NEI submitted the responses to each of the NRC staff questions to facilitate the staff's review. Based on our review of the RAI responses, the staff has determined that additional information is required to complete our review. Supplemental RAI is attached.
By letter dated November 14, 2008, NEI submitted Revision 6 of NEI 06-14 that included changes that addressed questions included in the NRC staff Request for Additional Information (RAI) dated September 17, 2008. By letter dated November 20, 2008, NEI submitted the responses to each of the NRC staff questions to facilitate the staffs review. Based on our review of the RAI responses, the staff has determined that additional information is required to complete our review. Supplemental RAI is attached.
On April 24, 2009, an electronic copy of the enclosed RAI was transmitted to NEI. Although this RAI has already been provided to you electronically, we will not expect a response until 30 days following the date of issuance of this letter; therefore, please let me know if you will not be able to provide your written reply within that time period.  
On April 24, 2009, an electronic copy of the enclosed RAI was transmitted to NEI. Although this RAI has already been provided to you electronically, we will not expect a response until 30 days following the date of issuance of this letter; therefore, please let me know if you will not be able to provide your written reply within that time period.


R. Bell If you have any questions or comments regarding this matter, please contact Ms. Sheryl A. Burrows by telephone at (301) 415-6086 or by e-mail at Sheryl.Burrows@nrc.gov.
R. Bell                                   If you have any questions or comments regarding this matter, please contact Ms. Sheryl A. Burrows by telephone at (301) 415-6086 or by e-mail at Sheryl.Burrows@nrc.gov.
Sincerely,    
Sincerely,
                  /RA/
                                          /RA/
William F. Burton, Chief       Rulemaking and Guidance Development Branch       Division of New Reactor Licensing       Office of New Reactors Project No. 689  
William F. Burton, Chief Rulemaking and Guidance Development Branch Division of New Reactor Licensing Office of New Reactors Project No. 689


==Enclosure:==
==Enclosure:==
As stated


R. Bell If you have any questions or comments regarding this matter, please contact Ms. Sheryl A. Burrows by telephone at (301) 415-6086 or by e-mail at Sheryl.Burrows@nrc.gov.
As stated
Sincerely,    
 
                  /RA/
R. Bell                                   If you have any questions or comments regarding this matter, please contact Ms. Sheryl A. Burrows by telephone at (301) 415-6086 or by e-mail at Sheryl.Burrows@nrc.gov.
William F. Burton, Chief       Rulemaking and Guidance Development Branch       Division of New Reactor Licensing       Office of New Reactors Project No. 689  
Sincerely,
                                          /RA/
William F. Burton, Chief Rulemaking and Guidance Development Branch Division of New Reactor Licensing Office of New Reactors Project No. 689


==Enclosure:==
==Enclosure:==
As stated Distribution
:PUBIC NRGA R/F SBurrows, NRO RRobinson, NRO RidsOgcMailCenter RidsAcrsAcnwMailCenter RidsNroDnrl RidsNroDnrlNrga RidsNroDnrlNoep RidsNroDnrlNge1 RidsNroDnrlNge2 RidsNroDnrlNwe1 RidsNroDnrlNwe2 RidsNroDnrlNmip RidsNroDcip RidsNroDcipCqvb RidsNroDcipCqvp


ADAMS Accession Number: ML091140483     NRO-002 OFFICE PM:DNRL/NRGA LA:DNRL/NRGABC:DCIP/CQVB BC:DCIP/CQVP BC:DNRL/NRGA NAME SBurrows RRobinson JNakoski JPeralta WBurton DATE     4/29/2009 4/28/2009     4/30/2009   4/30/2009 4/30/2009 OFFICIAL RECORD COPY NEI 06-14 Supplemental Requests for Additional Information Enclosure During the review of the request for additional information (RAI) responses, the U.S. Nuclear Regulatory Commission (NRC) staff identified areas where additional clarification was needed. These areas included the following: 1. With respect to RAI #1, which requested additional guidance on organizational structure, the NRC staff acknowledged the additional guidance provided. However, the organizational description and charts provided in Section 1 of NEI 06-14A still needs to include:   a. More detail of the responsibilities and quality relationships during construction phase and operation phase is needed, including a description for the transition of responsibilities from construction to the operational phase. b. An organizational description that includes management levels that implement quality activities. c. The organizational descriptions and charts for the operations phase, including both onsite and offsite management and the independent review function. d. The commitment to the regulatory change process established by Title 10 of the Code of Federal Regulations 50.54(a) when incorporating organization information from other sections of the Final Safety Analysis Report (FSAR) by reference. 2. In response to RAI #2, which addresses the use of generic titles, NEI 06-14, Revision 6 was revised to add a statement explaining that generic titles can be used throughout the quality assurance program description (QAPD) if they are used consistently. However, Revision 6 of NEI 06-14 needs to clearly state that generic titles should be consistent with those used in the Organization section. 3. In response to RAI #4, which suggests a more appropriate reference be used to illustrate commercial grade dedication, NEI 06-14, Revision 6 replaced the reference to Regulatory Issue Summary 2002-22 with a reference to Electric Power Research Institute (EPRI) Topical Report (TR) 106439. However, the use of EPRI TR-106439 is limited to digital instrumentation and control (I&C). The staff requests that the reference be removed from the template and placed in implementing procedures specific to digital I&C. 4. In response to RAI #5, which addresses the use of generic brackets to inspection controls applied to non-safety-related structures, systems, and components, NEI 06-14, Revision 6 removed the bracket and changed the qualification requirements. Instead of requiring the inspection personnel to be "at a minimum as qualified as the person who performed the activity," the revised requirement states that "inspections are performed by knowledgeable personnel.Please provide justification on the change to the qualification requirements. 5. The NRC staff noted that the following regulatory guides (RGs) are referenced in FSAR Chapter 1 of applications submitted by combined license (COL) applicants, as commitments with exceptions, pointing to the QAPD for clarification. NEI 06-14 should be revised to address how QAPDs submitted by early site permit and COL applicants will either commit to these RGs or take exceptions from them.
As stated Distribution:
* RG 1.8, Revision 3, May 2000, "Qualification and Training of Personnel for Nuclear Power Plants"
PUBIC                                              RidsNroDnrlNge1 NRCA R/F                                          RidsNroDnrlNge2 SBurrows, NRO                                      RidsNroDnrlNwe1 RRobinson, NRO                                    RidsNroDnrlNwe2 RidsOgcMailCenter                                  RidsNroDnrlNmip RidsAcrsAcnwMailCenter                            RidsNroDcip RidsNroDnrl                                        RidsNroDcipCqvb RidsNroDnrlNrga                                    RidsNroDcipCqvp RidsNroDnrlNoep ADAMS Accession Number: ML091140483                                         NRO-002 OFFICE     PM:DNRL/NRCA    LA:DNRL/NRCA BC:DCIP/CQVB         BC:DCIP/CQVP BC:DNRL/NRCA NAME       SBurrows         RRobinson       JNakoski           JPeralta     WBurton DATE         4/29/2009       4/28/2009       4/30/2009         4/30/2009     4/30/2009 OFFICIAL RECORD COPY
* RG 1.28, Revision 3, August 1985, "Quality Assurance Program Requirements (Design and Construction)"
 
* RG 1.33, Revision 2, February 1978, "Quality Assurance Program Requirements (Operations)" 6. NEI 06-14A, Revision 6, Section 2, Subsection 2.7, "Independent Review," Option I, needs to address the qualification for the independent review staff. The qualification requirements for these personnel should meet or exceed those described in Section 4.7 of ANSI/ANS-3.1-1978 and the regulatory position of RG 1.8, Revision 3.}}
NEI 06-14 Supplemental Requests for Additional Information During the review of the request for additional information (RAI) responses, the U.S. Nuclear Regulatory Commission (NRC) staff identified areas where additional clarification was needed.
These areas included the following:
: 1. With respect to RAI #1, which requested additional guidance on organizational structure, the NRC staff acknowledged the additional guidance provided. However, the organizational description and charts provided in Section 1 of NEI 06-14A still needs to include:
: a. More detail of the responsibilities and quality relationships during construction phase and operation phase is needed, including a description for the transition of responsibilities from construction to the operational phase.
: b. An organizational description that includes management levels that implement quality activities.
: c. The organizational descriptions and charts for the operations phase, including both onsite and offsite management and the independent review function.
: d. The commitment to the regulatory change process established by Title 10 of the Code of Federal Regulations 50.54(a) when incorporating organization information from other sections of the Final Safety Analysis Report (FSAR) by reference.
: 2. In response to RAI #2, which addresses the use of generic titles, NEI 06-14, Revision 6 was revised to add a statement explaining that generic titles can be used throughout the quality assurance program description (QAPD) if they are used consistently. However, Revision 6 of NEI 06-14 needs to clearly state that generic titles should be consistent with those used in the Organization section.
: 3. In response to RAI #4, which suggests a more appropriate reference be used to illustrate commercial grade dedication, NEI 06-14, Revision 6 replaced the reference to Regulatory Issue Summary 2002-22 with a reference to Electric Power Research Institute (EPRI)
Topical Report (TR) 106439. However, the use of EPRI TR-106439 is limited to digital instrumentation and control (I&C). The staff requests that the reference be removed from the template and placed in implementing procedures specific to digital I&C.
: 4. In response to RAI #5, which addresses the use of generic brackets to inspection controls applied to non-safety-related structures, systems, and components, NEI 06-14, Revision 6 removed the bracket and changed the qualification requirements. Instead of requiring the inspection personnel to be at a minimum as qualified as the person who performed the activity, the revised requirement states that inspections are performed by knowledgeable personnel. Please provide justification on the change to the qualification requirements.
: 5. The NRC staff noted that the following regulatory guides (RGs) are referenced in FSAR Chapter 1 of applications submitted by combined license (COL) applicants, as commitments with exceptions, pointing to the QAPD for clarification. NEI 06-14 should be revised to address how QAPDs submitted by early site permit and COL applicants will either commit to these RGs or take exceptions from them.
Enclosure
* RG 1.8, Revision 3, May 2000, Qualification and Training of Personnel for Nuclear Power Plants
* RG 1.28, Revision 3, August 1985, Quality Assurance Program Requirements (Design and Construction)
* RG 1.33, Revision 2, February 1978, Quality Assurance Program Requirements (Operations)
: 6. NEI 06-14A, Revision 6, Section 2, Subsection 2.7, Independent Review, Option I, needs to address the qualification for the independent review staff. The qualification requirements for these personnel should meet or exceed those described in Section 4.7 of ANSI/ANS-3.1-1978 and the regulatory position of RG 1.8, Revision 3.}}

Latest revision as of 07:46, 14 November 2019

Supplemental Request for Additional Information Regarding Nuclear Energy Institute Technical Report 06-14A, Quality Assurance Program Description, Revision 6 (Project No. 689; TAC Q00014)
ML091140483
Person / Time
Site: Nuclear Energy Institute
Issue date: 04/30/2009
From: William Burton
NRC/NRO/DNRL/NRGA
To: Bell R
Nuclear Energy Institute
Burrows S
References
TAC Q00014
Download: ML091140483 (5)


Text

April 30, 2009 Mr. Russell J. Bell, Director New Plant Licensing Nuclear Generation Division Nuclear Energy Institute 1776 I Street, NW, Suite 400 Washington, DC 20006-3708

SUBJECT:

SUPPLEMENTAL REQUEST FOR ADDITIONAL INFORMATION REGARDING NUCLEAR ENERGY INSTITUTE TECHNICAL REPORT 06-14A, QUALITY ASSURANCE PROGRAM DESCRIPTION, REVISION 6 (PROJECT NO. 689; TAC Q00014)

Dear Mr. Bell:

By letter date May 7, 2008, the Nuclear Energy Institute (NEI) submitted changes to NEI Technical Report 06-14A, Quality Assurance Program Description, Revision 5. NEI 06-14A provides a template for a quality assurance program description (QAPD) to be applied to activities affecting the quality and performance of safety-related structures, systems, and components.

U.S. Nuclear Regulatory Commission (NRC) staff has reviewed NEI 06-14A, Revision 5, in accordance with the provisions of Draft Standard Review Plan Section 17.5, Quality Assurance Program Description - Design Certification, Early Site Permit and New License Applicants.

By letter dated November 14, 2008, NEI submitted Revision 6 of NEI 06-14 that included changes that addressed questions included in the NRC staff Request for Additional Information (RAI) dated September 17, 2008. By letter dated November 20, 2008, NEI submitted the responses to each of the NRC staff questions to facilitate the staffs review. Based on our review of the RAI responses, the staff has determined that additional information is required to complete our review. Supplemental RAI is attached.

On April 24, 2009, an electronic copy of the enclosed RAI was transmitted to NEI. Although this RAI has already been provided to you electronically, we will not expect a response until 30 days following the date of issuance of this letter; therefore, please let me know if you will not be able to provide your written reply within that time period.

R. Bell If you have any questions or comments regarding this matter, please contact Ms. Sheryl A. Burrows by telephone at (301) 415-6086 or by e-mail at Sheryl.Burrows@nrc.gov.

Sincerely,

/RA/

William F. Burton, Chief Rulemaking and Guidance Development Branch Division of New Reactor Licensing Office of New Reactors Project No. 689

Enclosure:

As stated

R. Bell If you have any questions or comments regarding this matter, please contact Ms. Sheryl A. Burrows by telephone at (301) 415-6086 or by e-mail at Sheryl.Burrows@nrc.gov.

Sincerely,

/RA/

William F. Burton, Chief Rulemaking and Guidance Development Branch Division of New Reactor Licensing Office of New Reactors Project No. 689

Enclosure:

As stated Distribution:

PUBIC RidsNroDnrlNge1 NRCA R/F RidsNroDnrlNge2 SBurrows, NRO RidsNroDnrlNwe1 RRobinson, NRO RidsNroDnrlNwe2 RidsOgcMailCenter RidsNroDnrlNmip RidsAcrsAcnwMailCenter RidsNroDcip RidsNroDnrl RidsNroDcipCqvb RidsNroDnrlNrga RidsNroDcipCqvp RidsNroDnrlNoep ADAMS Accession Number: ML091140483 NRO-002 OFFICE PM:DNRL/NRCA LA:DNRL/NRCA BC:DCIP/CQVB BC:DCIP/CQVP BC:DNRL/NRCA NAME SBurrows RRobinson JNakoski JPeralta WBurton DATE 4/29/2009 4/28/2009 4/30/2009 4/30/2009 4/30/2009 OFFICIAL RECORD COPY

NEI 06-14 Supplemental Requests for Additional Information During the review of the request for additional information (RAI) responses, the U.S. Nuclear Regulatory Commission (NRC) staff identified areas where additional clarification was needed.

These areas included the following:

1. With respect to RAI #1, which requested additional guidance on organizational structure, the NRC staff acknowledged the additional guidance provided. However, the organizational description and charts provided in Section 1 of NEI 06-14A still needs to include:
a. More detail of the responsibilities and quality relationships during construction phase and operation phase is needed, including a description for the transition of responsibilities from construction to the operational phase.
b. An organizational description that includes management levels that implement quality activities.
c. The organizational descriptions and charts for the operations phase, including both onsite and offsite management and the independent review function.
d. The commitment to the regulatory change process established by Title 10 of the Code of Federal Regulations 50.54(a) when incorporating organization information from other sections of the Final Safety Analysis Report (FSAR) by reference.
2. In response to RAI #2, which addresses the use of generic titles, NEI 06-14, Revision 6 was revised to add a statement explaining that generic titles can be used throughout the quality assurance program description (QAPD) if they are used consistently. However, Revision 6 of NEI 06-14 needs to clearly state that generic titles should be consistent with those used in the Organization section.
3. In response to RAI #4, which suggests a more appropriate reference be used to illustrate commercial grade dedication, NEI 06-14, Revision 6 replaced the reference to Regulatory Issue Summary 2002-22 with a reference to Electric Power Research Institute (EPRI)

Topical Report (TR) 106439. However, the use of EPRI TR-106439 is limited to digital instrumentation and control (I&C). The staff requests that the reference be removed from the template and placed in implementing procedures specific to digital I&C.

4. In response to RAI #5, which addresses the use of generic brackets to inspection controls applied to non-safety-related structures, systems, and components, NEI 06-14, Revision 6 removed the bracket and changed the qualification requirements. Instead of requiring the inspection personnel to be at a minimum as qualified as the person who performed the activity, the revised requirement states that inspections are performed by knowledgeable personnel. Please provide justification on the change to the qualification requirements.
5. The NRC staff noted that the following regulatory guides (RGs) are referenced in FSAR Chapter 1 of applications submitted by combined license (COL) applicants, as commitments with exceptions, pointing to the QAPD for clarification. NEI 06-14 should be revised to address how QAPDs submitted by early site permit and COL applicants will either commit to these RGs or take exceptions from them.

Enclosure

  • RG 1.8, Revision 3, May 2000, Qualification and Training of Personnel for Nuclear Power Plants
  • RG 1.28, Revision 3, August 1985, Quality Assurance Program Requirements (Design and Construction)
  • RG 1.33, Revision 2, February 1978, Quality Assurance Program Requirements (Operations)
6. NEI 06-14A, Revision 6, Section 2, Subsection 2.7, Independent Review, Option I, needs to address the qualification for the independent review staff. The qualification requirements for these personnel should meet or exceed those described in Section 4.7 of ANSI/ANS-3.1-1978 and the regulatory position of RG 1.8, Revision 3.