ML15348A191
| ML15348A191 | |
| Person / Time | |
|---|---|
| Site: | Summer  |
| Issue date: | 12/14/2015 |
| From: | John Klos Plant Licensing Branch IV |
| To: | Elwood T AmerenUE |
| References | |
| Download: ML15348A191 (3) | |
Text
1 NRR-PMDAPEm Resource From:
Klos, John Sent:
Monday, December 14, 2015 12:03 PM To:
Telwood@ameren.com Cc:
Klos, John
Subject:
Request for additional information: QA plan change - NEI 14-05A Mr. Elwood, Introduction By letter dated October 7, 2015, Agencywide Documents and Access and Management System (ADAMS)
Accession Number ML15280A446, Ameren Missouri submitted a QA program document which the licensee stated could be considered a reduction in commitment.
The change intends to incorporate a QA program alternative, approved by the NRCs Safety Evaluation, for Technical Report NEI 14-05, Guidelines for the Use of Accreditation in Lieu of Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services, Revision 1 (ADAMS No. ML14322A535), dated February 9, 2015.
The Nuclear Regulatory Commission staff has reviewed the submittal and determined that a request for additional information (RAI) is needed to complete its review. The draft question was sent via electronic transmission on December 1, 2015 and a clarification call was held with the licensee on December 8, 2015. The following RAI is now submitted to licensee and a response is requested in 30 days from the date of this email by Thursday January 14, 2015. The RAI is as follows; Regulatory Basis Items and services used in safety-related applications at U.S. commercial nuclear power plants are designated as basic components and are required to be provided in accordance with Appendix B to 10 CFR Part 50, which includes requirements for calibration and testing associated with basic components. The predominant criteria of Appendix B to 10 CFR Part 50 that are related to the use of accreditation in lieu of performing commercial-grade surveys for procurement of laboratory calibration and test services are Criteria 1, 4, 7, and 12.
Question 1.0 Section 4 of NEI 14-05, Guidelines for the Use of Accreditation in Lieu of Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services, Revision 1, states, in part, a Template for describing the use of the ILAC process in lieu of a commercial grade survey in a Purchasers QA Program is provided in Appendix A. Although a Purchaser is not required to use the Template in Appendix A, all of the actions and steps described in Appendix A need to be included in the Purchasers QA Program.
The first four paragraphs in Appendix A state:
Commercial Grade items (items not originally designed or manufactured as a basic component) are subject to a Commercial Grade Dedication process as defined and authorized by Engineering in accordance with procedures that meet the requirements of the U.S. NRC, before such items are approved for safety-related applications.
2 Commercial Grade Dedication also applies to a commercial grade service that is associated with basic component hardware, design certification, design approval, or information in support of an early site permit application under 10 CFR Part 52, whether these services are performed by the component supplier or others (e.g., safety-related design, analysis, inspection, testing, or fabrication that is associated with a basic component).
Procedures are established to describe the responsibilities for Engineering to perform a technical evaluation, select applicable critical characteristics, and determine an appropriate dedication method for acceptance. Procedures are also established to enhance the detection of counterfeit and fraudulent items and to minimize the likelihood of the introduction of such items in safety-related applications.
[Purchaser] may utilize commercial grade items or services in its supply of basic components in a manner consistent with the guidance in [Generic Letter (GL) 89-02, Actions to Improve the Detection of Counterfeit and Fraudulently Marked Products.
GL 89-02 documents the NRCs conditional endorsement of EPRI NP-5652, Guideline for the Utilization of Commercial grade Items in Nuclear Safety Related Applications (NCIG-07).]
[Purchaser] utilizes a commercial grade dedication process consistent with Generic Letter 89-02 and 10CFR21, for the supply of basic components. When a commercial grade item is modified, inspected, and/or tested to demonstrate compliance to requirements more restrictive than the manufacturers original specifications such item is uniquely identified as different from the commercial grade (off-the-shelf) item and traceable to documents that record the difference.
Request The proposed change to the Callaway Plant Unit 1 OQAM does not address the above requirements of Appendix A.
Please provide clarification on how Callaway Unit 1 incorporates these requirements of Appendix A in its Quality Assurance Program.
If you have any questions, please contact John Klos per the contact information below.
John Klos DORL Callaway Project Manager U.S. NRC, Office of Nuclear Reactor Regulation, Division of Operating Reactor Licensing NRC/NRR/DORL/LPL4-1, MS O8H4 Washington, DC 20555-0001 301.415.5136, 301.415.3313 (fax)
John.Klos@NRC.gov
Hearing Identifier:
NRR_PMDA Email Number:
2552 Mail Envelope Properties (37393716da1941b08961c3c4b2e2263b)
Subject:
Request for additional information: QA plan change - NEI 14-05A Sent Date:
12/14/2015 12:02:36 PM Received Date:
12/14/2015 12:02:37 PM From:
Klos, John Created By:
John.Klos@nrc.gov Recipients:
"Klos, John" <John.Klos@nrc.gov>
Tracking Status: None "Telwood@ameren.com" <Telwood@ameren.com>
Tracking Status: None Post Office:
HQPWMSMRS05.nrc.gov Files Size Date & Time MESSAGE 5072 12/14/2015 12:02:37 PM Options Priority:
Standard Return Notification:
No Reply Requested:
No Sensitivity:
Normal Expiration Date:
Recipients Received:
1 NRR-PMDAPEm Resource From:
Klos, John Sent:
Monday, December 14, 2015 12:03 PM To:
Telwood@ameren.com Cc:
Klos, John
Subject:
Request for additional information: QA plan change - NEI 14-05A Mr. Elwood, Introduction By letter dated October 7, 2015, Agencywide Documents and Access and Management System (ADAMS)
Accession Number ML15280A446, Ameren Missouri submitted a QA program document which the licensee stated could be considered a reduction in commitment.
The change intends to incorporate a QA program alternative, approved by the NRCs Safety Evaluation, for Technical Report NEI 14-05, Guidelines for the Use of Accreditation in Lieu of Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services, Revision 1 (ADAMS No. ML14322A535), dated February 9, 2015.
The Nuclear Regulatory Commission staff has reviewed the submittal and determined that a request for additional information (RAI) is needed to complete its review. The draft question was sent via electronic transmission on December 1, 2015 and a clarification call was held with the licensee on December 8, 2015. The following RAI is now submitted to licensee and a response is requested in 30 days from the date of this email by Thursday January 14, 2015. The RAI is as follows; Regulatory Basis Items and services used in safety-related applications at U.S. commercial nuclear power plants are designated as basic components and are required to be provided in accordance with Appendix B to 10 CFR Part 50, which includes requirements for calibration and testing associated with basic components. The predominant criteria of Appendix B to 10 CFR Part 50 that are related to the use of accreditation in lieu of performing commercial-grade surveys for procurement of laboratory calibration and test services are Criteria 1, 4, 7, and 12.
Question 1.0 Section 4 of NEI 14-05, Guidelines for the Use of Accreditation in Lieu of Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services, Revision 1, states, in part, a Template for describing the use of the ILAC process in lieu of a commercial grade survey in a Purchasers QA Program is provided in Appendix A. Although a Purchaser is not required to use the Template in Appendix A, all of the actions and steps described in Appendix A need to be included in the Purchasers QA Program.
The first four paragraphs in Appendix A state:
Commercial Grade items (items not originally designed or manufactured as a basic component) are subject to a Commercial Grade Dedication process as defined and authorized by Engineering in accordance with procedures that meet the requirements of the U.S. NRC, before such items are approved for safety-related applications.
2 Commercial Grade Dedication also applies to a commercial grade service that is associated with basic component hardware, design certification, design approval, or information in support of an early site permit application under 10 CFR Part 52, whether these services are performed by the component supplier or others (e.g., safety-related design, analysis, inspection, testing, or fabrication that is associated with a basic component).
Procedures are established to describe the responsibilities for Engineering to perform a technical evaluation, select applicable critical characteristics, and determine an appropriate dedication method for acceptance. Procedures are also established to enhance the detection of counterfeit and fraudulent items and to minimize the likelihood of the introduction of such items in safety-related applications.
[Purchaser] may utilize commercial grade items or services in its supply of basic components in a manner consistent with the guidance in [Generic Letter (GL) 89-02, Actions to Improve the Detection of Counterfeit and Fraudulently Marked Products.
GL 89-02 documents the NRCs conditional endorsement of EPRI NP-5652, Guideline for the Utilization of Commercial grade Items in Nuclear Safety Related Applications (NCIG-07).]
[Purchaser] utilizes a commercial grade dedication process consistent with Generic Letter 89-02 and 10CFR21, for the supply of basic components. When a commercial grade item is modified, inspected, and/or tested to demonstrate compliance to requirements more restrictive than the manufacturers original specifications such item is uniquely identified as different from the commercial grade (off-the-shelf) item and traceable to documents that record the difference.
Request The proposed change to the Callaway Plant Unit 1 OQAM does not address the above requirements of Appendix A.
Please provide clarification on how Callaway Unit 1 incorporates these requirements of Appendix A in its Quality Assurance Program.
If you have any questions, please contact John Klos per the contact information below.
John Klos DORL Callaway Project Manager U.S. NRC, Office of Nuclear Reactor Regulation, Division of Operating Reactor Licensing NRC/NRR/DORL/LPL4-1, MS O8H4 Washington, DC 20555-0001 301.415.5136, 301.415.3313 (fax)
John.Klos@NRC.gov
Hearing Identifier:
NRR_PMDA Email Number:
2552 Mail Envelope Properties (37393716da1941b08961c3c4b2e2263b)
Subject:
Request for additional information: QA plan change - NEI 14-05A Sent Date:
12/14/2015 12:02:36 PM Received Date:
12/14/2015 12:02:37 PM From:
Klos, John Created By:
John.Klos@nrc.gov Recipients:
"Klos, John" <John.Klos@nrc.gov>
Tracking Status: None "Telwood@ameren.com" <Telwood@ameren.com>
Tracking Status: None Post Office:
HQPWMSMRS05.nrc.gov Files Size Date & Time MESSAGE 5072 12/14/2015 12:02:37 PM Options Priority:
Standard Return Notification:
No Reply Requested:
No Sensitivity:
Normal Expiration Date:
Recipients Received: