ML062010255
| ML062010255 | |
| Person / Time | |
|---|---|
| Site: | Calvert Cliffs, Nine Mile Point, Ginna |
| Issue date: | 07/14/2006 |
| From: | Heffley J Constellation Energy Group |
| To: | Document Control Desk, Office of Nuclear Reactor Regulation |
| References | |
| TAC MC9180, TAC MC9181, TAC MC9182, TAC MC9183, TAC MC9184 | |
| Download: ML062010255 (93) | |
Text
J. M. Heffley Chief Nuclear Officer 0
Constellation Energy-Generation Group Constellation Generation Group 1997 Annapolis Exchange Parkway Suite 310 Annapolis, MD 21401 410-897-5020 July 14, 2006 U.S. Nuclear Regulatory Commission 11555 Rockville Pike Rockville, MD 20852 ATTENTION:
SUBJECT:
Document Control Desk Calvert Cliffs Nuclear Power Plant Unit Nos. I & 2; Docket Nos. 50-317 & 50-318 Nine Mile Point Nuclear Station Unit Nos. 1 & 2; Docket Nos. 50-220 & 50-410 R.E. Ginna Nuclear Power Plant Docket No. 50-244 Response to Request for Additional Information Regarding Common Quality Assurance Program (TAC Nos. MC9180, MC9181, MC9182, MC9183, and MC9184)
(a)
Letter from J.M. Heffley (CGG) to Document Control Desk (NRC),
Request for Approval of a Common Quality Assurance Program for Constellation Generation Group, LLC, dated December 5, 2005
REFERENCES:
(b)
Letter from P.D. Milano (NRC) to J.M. Heffley (CGG), Calvert Cliffs Nuclear Power Plant, Unit Nos. 1 and 2, Nine Mile Point Nuclear Station, Unit Nos. I and 2, and R.E. Ginna Nuclear Power Plant - Request for Additional Information Regarding Common Quality Assurance Program (TAC Nos. MC9180, MC9181, MC9182, MC9183, and MC9184), dated May 15, 2006 Reference (a) submitted a common Quality Assurance Topical Report (QATR), pursuant to Title 10 of the Code of Federal Regulations 50.54(a), for Calvert Cliffs Nuclear Power Plant, Units I and 2, Nine Mile Point Nuclear Station, Units I and 2, and R.E. Ginna Nuclear Power Plant. The program described in the QATR would be applied to licensed activities under 10 CFR Parts 50, 71, and 72.
Reference (b) requested additional information to assist the Nuclear Regulatory Commission in their review of Reference (a). Attachment I to this letter provides that information. Attachment 2 provides markup pages of the revised QATR. Attachment 3 provides the revised QATR pages. Please replace pages 3 through 43 of your copy of the QATR with the attached. Attachment 4 provides a markup of the
Document Control Desk July 14, 2006 Page 2 revised version of Attachment 4 to Reference (a). Attachment 5 provides the revised Attachment 4 to Reference (a). Please replace this document in entirety.
Should you have iany questions regarding the information in this submittal, please contact Mr. L. S. Larragoite at (410) 897-5087 or Louis.S.Larragoite@constellation.com.
Very truly yours, STATE OF NEW YORK COUNTY OF WAYNE
- TO WIT 1, John M. Heffley, state that I am Chief Nuclear Officer, Constellation Generation Group, LLC, for Calvert Cliffs Nuclear Power Plant, Inc., Nine Mile Point Nuclear Station, LLC, and R. E. Ginna Nuclear Power Plant, LLC, and that I am duly authorized to execute and file this response on behalf of these companies. To the best of my knowledge and belief, the statements contained in this document are true and correct. To the extent that these statements are not based on my personal knowledge, they are based upon information provided by employees and/or consultants of the companies. Such information has been reviewed in accordance with company practice, and I believe it to be reliable.
Subscribed and sworp before me, a Notary Public, in a ofthe State of New N County of IV12OC--, this a day of.J L
.,2006.
/U6~YlYLL~
WITNESS my Hand and Notarial Seal:
My Commission Expires:
Notary Public Date JMH/EMT/j mp Attachments:
(1) Response to Request for Additional Information (2) QATR Markup (3)
Revised QATR Pages (4) Attachment 4 Markup (5)
Revised Attachment 4 Pages SHARON L MULER W9ar PWb~k State if New York 4osfabmNo. 0I1Mlo17716 CmnaExpm,,uD6 2 1.20 6'
Document Control Desk July 14, 2006 Page 3 cc:
P. D. Milano, NRC S. J. Collins, NRC Resident Inspector, NRC (Ginna)
Resident Inspector, NRC (Calvert Cliffs)
Resident Inspector, NRC (NMPNS)
T. G. Colburn, NRC R. I. McLean, Maryland DNR J. P. Spath, NYSERD P. Eddy, NYS Dept. of Public Services
ATTACHMENT (1)
Response to Request for Additional Information Constellation Generation Group, LLC July 14, 2006
Attachment (1)
Response to Request for Additional Information, Quality Assurance Topical Report
- 1.
Standard Review Plan (SRP) Section 17.3, "Quality Assurance Program Description," specifies, in Part II.A. 7, the regulatory commitments the licensee muust meet for the QATR to be found acceptable. In its QATR, CGG states that a commitment to a particular Regulatory Guide (RG) does not constitute a commnitmnent to other RGs or other standards that may be referenced therein.
Provide an explanation of how this is acceptable.
As regulatory guidance has evolved over the years, regulatory guides and endorsed standards have been revised, re-issued, and withdrawn. This has resulted in regulatory guides referencing other regulatory guides or standards that may have been superseded or revised. For instance, Regulatory Guide 1.33, Revision 2, endorses many of the regulatory guides and standards that are superseded by Regulatory Guide 1.28, Revision 3.
Our statement that a commitment to a particular regulatory guide does not constitute a commitment to other regulatory guides or other standards that may be referenced in it serves to make it clear that referenced guides and standards are not committed to by default. When we are committing to all or part of a regulatory guide, we prefer to state that specifically.
- 2.
SRP Section 17.3 specifies, in Part II.A.2, that a licensee's prograin must contain independence between persons and organizations executting perfornance activities and those executing verification and self-assessment activities.
Provide an explanation of why the use of conference calls as an alteniative means to hold meetings is acceptable for the Nuclear Safety Review Board.
Nuclear Safety Review Board (NSRB) meetings conducted using a conference call must meet the quorum/composition requirements of a formal meeting to ensure the appropriate expertise and decision making. As a conservative measure, these decisions are reviewed again by a quorum of the NSRB at the next regularly scheduled meeting.
With the communication technologies available today, personnel are able to conduct effective meetings without having to be located physically in the same room. Utilizing conference calls to conduct NSRB meetings allows flexibility to address emergent issues without making more restrictive travel arrangements.
- 3.
SRP Section 17.3 specifies, in Part ILC.2, that a program of planned and periodic assessments is to be established.
Provide the definition in the QATR for the tenns audit, self-assessment, and independent assessment.
We use the definition of audit found in NQA-l-1994 Part I, Introduction, Section 4. That definition is: "a planned and documented activity performed to determine by investigation, examination, or evaluation of objective evidence the adequacy of and compliance with established procedures, instructions, drawings, and other applicable documents, and the effectiveness of implementation. An audit should not be confused with surveillance or inspection activities performed for the sole purpose of process control or product acceptance." We commit to NQA-I-1994 Part I, Section 4 in Appendix C of the Quality Assurance Topical Report (QATR).
Attachment (1)
Response to Request for Additional Information The definition of self-assessment, as used by Constellation Generation Group, LLC (CGG) facilities, is "assessing the level of performance, or output of an activity or organization, by comparing management expectations and industry standards of excellence. Recommendations are documented to achieve improvements in the assessed area."
The definition of independent assessment, as used by CGG facilities, is expressed in Nine Mile Point Nuclear Station, R.E. Ginna Nuclear Power Plant, and Calvert Cliffs Nuclear Power Plant procedures as "the process used to provide ongoing independent evaluation-and communication of results to management on program performance, trends, and management effectiveness." We use the term independent as part of an assessment as expressed in SRP Section 17.3, Part II.C.2.
These definitions have been added to Appendix C of the QATR., Program Comparison Matrix
- 1.
The Calvert Cliffs Quality Assurance Policy states that the Plant General Manager has the final responsibility for the overall evaluation of shutting down an operating unit. The staff was not able to find this responsibility in the QATR.
Provide where the QATR has established the responsibility of shutting down an operating unit.
The intent of the QATR was to recognize the broad base of responsibility and authority held by the Plant General Managers, including the authority to shutdown an operating unit. To ensure this responsibility and authority is clearly defined, the sentence defining the Plant General Manager's authority in Section A.4 is revised to state:
"The Plant General Managers have stop work authority for all activities performed in operating their respective stations, including the final responsibility for the overall evaluation of shutting down an operating unit.", Table Comparing ANSI N18.7-1976/ANS-3.2 to NQA-1-1994 and the CGG QATR
- 1.
The CGG QATR definition for off-normal condition procedures does not have the same definition as in American National Standards Institute (ANSI) N18. 7-1976/American Nuclear Standard (ANS) 3.2.
7he QATR must adopt the ANSI N18. 7-1976/ANS-3.2 definition.
The CGG QATR definition for "off-normal condition procedures" in Appendix C is revised to match the ANSI N18.7-1976/ANS-3.2 definition. The definition now reads:
"written procedures which specify operator actions for restoring an operating variable to its normal controlled value when it departs from its range, or to restore normal operating conditions following a perturbation. Such actions are invoked following an operator observation or an annunciator alarm indicating a condition which, if not corrected, could degenerate into a condition requiring action under an emergency procedure."
2
Attachment (1)
Response to Request for Additional Information
- 2.
ANSI N18. 7-1976/ANS-3.2 states that temporary procedures shall be approved by the management representative assigned approval authority. CGG states that this statement is found in the QATR Section B.14, "Document Control." The NRC staff reviewed Section B. 14 and found only temporary changes were mentioned. In Appendix B of the QATR, the stafffound, under the definition of "Test and Inspection Procedures," a definition for "temporaty procedures."
Explain how approval of temporaty procedures are captured in the QATR.
Constellation Generation Group, LLC does not distinguish between processing permanent and temporary procedures. The paragraph in QATR Section B.14 that discusses approval authority for procedures required by Technical Specifications is applicable to temporary procedures.
From QATR Section B.14: "Procedures required by Technical Specifications shall be approved by the Plant General Manager or by cognizant managers or other supervisory personnel prior to implementation as specified by administrative requirements. The approval authority for specific procedures or classes of procedures shall be designated in writing by the Plant General Manager."
- 3.
The comments under Section 5.2.17, "Inspections, " states that "Inspection records under NQA-1, mnay be a part of the work docuaments."
Provide clarification of what is meant by this statement. Additionally, state the definition of a "work docunent, " and how this is consistent with NQA-1 Basic Requirement 17 Inspection records are not specifically addressed in NQA-1 Basic Requirement 17, Quality Assurance Records. The maintenance and inspection records storage requirements for operations phase activity records are consistent with each site's current records storage Quality Assurance requirements. As committed to in CGG QATR Appendix D, "Operations Phase Activity Records," records are required to be maintained for five years for "Records and logs of principal maintenance activities, inspections, repair, and replacement of principal items of equipment related to nuclear safety." These records are generated during maintenance activities under "work orders" or "maintenance orders," collectively called "work documents." These work documents are processed to records management as a package and can include any inspections performed.
Whether inspection records are processed as part of the work documents or separately, inspection results are documented and retained as required. While the site-specific terminology is different for the work documents, the records retention requirements are the same., Table of CGG QATR Exception and Alternatives
- 1.
For each of the exceptions and alternatives mentioned in Attachment 4, provide a basis for the applicability of the exception for each CGG facility.
Exception 1, Section A.5, Exception to NQA-1-1994 Supplement 2S-1, regarding alternative qualifications for inspectors: This exception was based on the 2005 Nuclear Management Company (NMC) fleet QATR submittal; NMC based it on a previous Palisades exception. This alternative is used by NMC to describe alternative training methods if it implemented line performance of Quality Control inspections. This alternative is acceptable for CGG because CGG would also apply it only to line personnel performing Quality Control inspections. It does not apply to Quality Assurance personnel.
3
Attachment (1)
Response to Request for Additional Information The alternative meets the requirements of 10 CFR 50, Appendix B, Criterion II, by requiring training and qualification of personnel that assures suitable proficiency in the skills necessary to perform quality verification inspections and tests is achieved and maintained. The individuals qualified in accordance with this alternative participate in an accredited SAT-based training program that meets 10 CFR 50.120.
Exception 2, Section A.5, Exception to NQA-I-1994 Nonmandatory Appendix 2A-1, regarding an alternative to three levels of qualification/certification of inspection and test personnel: This exception was based on the 2005 NMC fleet QATR submittal; NMC based it on a previous Point Beach exception. This exception establishes an alternative qualification method for independent Quality Control inspectors and is considered acceptable because it continues to satisfy the criteria of 10 CFR 50, Appendix B.
Exception 3, Section A.5, Exception to NQA-I-1994 Supplement 2S-2, regarding the alternative use of American Society of Mechanical Engineers (ASME) Boiler and Pressure Vessel Codes:
this exception was based on the 2005 NMC fleet QATR submittal. This alternative is considered acceptable because other regulations, codes and standards establish requirements for qualification of NDE personnel.
Exception 4, Section A.5, Exception to NQA-I-1994 Supplement 2S-3, regarding prospective lead auditor qualifications: As described in the "Revised Submittal of Quality Assurance Program for Station Operation, R.E. Ginna Nuclear Power Plant" dated December 21, 1998, the revised requirements for certification of lead auditors are consistent with the guidance provided by the NRC in a letter "Review of Nuclear Energy Institute Proposed Improvements to QA Programs," dated October 24, 1996. The revised requirement meets the intent of Section 3.3 of NQA-I-1994 to have the prospective lead auditor demonstrate the ability to effectively implement the audit process and to lead an audit team. Since the revised requirements meet the intent of the original requirement and the NRC has proposed this approach as an acceptable alternative, this change does not reduce the scope of the quality assurance program.
The NRC notes in their Safety Evaluation Report to R.E. Ginna Nuclear Power Plant, dated April 6, 1999, that in an October 24, 1996 letter to the Nuclear Energy Institute, the NRC staff provided its position with regards to acceptable industry proposed alternatives on quality assurance processes for qualifying auditors and for conducting annual evaluations of suppliers.
Rochester Gas and Electric's proposed alternative for certifying lead auditors, as described was consistent with the staff's position in the cited letter and is, therefore, acceptable.
Exception 5, Section A.5, Exception to NQA-l-1994 Supplement 2S-1 and 2S-3, regarding 90 day grace periods on qualifications: This was originally an exception to the provisions of Regulatory Guide 1.144, Revision 1, approved by the NRC in Safety Evaluation by the Office of Nuclear Reactor Regulation "Proposed Revision 25 to the Rochester Gas and Electric Corporation Quality Assurance Program for Station Operation, R.E. Ginna Nuclear Power Plant,"
dated July 22, 1998. The approval allowed a 90-day grace period for recertification of audit personnel. Technical Specifications allow the use of a 25% grace period for the performance of periodic surveillances. This is acceptable for all of CGG because this type of Quality Assurance program change continues to satisfy the criteria of 10 CFR 50, Appendix B.
Exception 6, Section A.7.3, Exception to Regulatory Position C of Regulatory Guide 1.28, Revision 3, regarding use of NQA-1-1994 in lieu of NQA-1-1983: this exception was based on the 2002 Exelon fleet QATR submittal. In the Code of Federal Regulations, 10 CFR 4
Attachment (1)
Response to Request for Additional Information 50.54(a)(3)(i) allows "The use of a QA standard approved by the NRC which is more recent than the standard in the licensee's current QA program at the time of the change." Although the NRC has not yet specifically endorsed NQA-I-1994 in their regulatory guides, Regulatory Guide 1.28, Revision 3, dated August 1985, endorsed NQA-I-1983. Correspondence by the NRC and related NRC Safety Evaluation Report (SER) dated December 24, 2002, for approval of Revision 70 of QATR EGC-1A, for EXELON/AMERGEN plants, subsection 3.2.1, determined that the requirements of the 1983 and 1994 editions of NQA-J are equivalent. Based on the related NRC safety evaluation, CGG's use of NQA-l-1994 is consistent with 10 CFR 50.54(a)(3)(ii), which states, 'The use of a quality assurance alternative or exception approved by an NRC safety evaluation, provided that the bases of the NRC approval are applicable to the licensee's facility" is not a reduction in commitment. EXELON has submitted a comparison of NQA-I-1983 with NQA-l-1994, used as part of the basis for the NRC approval, which applies to CGG's QATR. In addition, CGG prepared a table to compare the ANSI N 18.7 standard to NQA-I-1994 and the CGG QATR (Attachment 3 to the QATR submittal).
Exception 7, Section A.7.3, Exception to Regulatory Position C. I of Regulatory Guide 1.28, Revision 3, regarding an alternative to three levels of qualification/certification of inspection and test personnel: This Regulatory Guide endorses Non-mandatory Appendix 2A-1 of NQA-I-1994.
This alternative is considered acceptable because it continues to satisfy the criteria of 10 CFR 50, Appendix B.
Exception 8, Section A.7.3, Exception to Guide 1.28, Revision 3, Regulatory Position C.3.2, regarding external audits of vendors: this exception was based on the 2005 NMC fleet QATR submittal; NMC based it on a previous Palisades exception. NMC used this exception to establish an alternative method of auditing vendors. This alternative provides for a documented, ongoing evaluation of the supplier's performance, rather than an annual evaluation. Where applicable, this evaluation takes into account the review of supplier-furnished documents such as certificates of conformance, non-conformance notices, and corrective actions, as well as evaluating the results of previous source surveillances/verifications, audits/surveys, and receiving inspections. The alternative also provides for the review of operating experience information pertaining to equipment failures and evaluation of the results of audits from other sources (e.g.,
NUPIC audits) for their effect on supplier qualification status. As described in procedures, the results of these evaluations are reviewed and appropriate corrective action taken. Furthermore, adverse findings resulting from these evaluations are periodically reviewed to determine if, in the aggregate, they result in a significant condition adverse to quality. Additionally, the results of these evaluations are used to provide input to support supplier audit activities conducted by CGG or third party auditing organizations. If no items are received from a vendor in the course of a year, we still review industry activity using the daily download of operating experience, information from the INPO website, the NUPIC database, and the NRC's website for inspection activities and Part 21 notifications. At the NUPIC meetings, there is an ongoing agenda item to review vendor performance and to alert others to adverse trends. Internal corrective action programs at the CGG sites address vendor performance and are factored into qualification maintenance. Vendors may also be removed from the Approved Vendor's List either because of re-evaluation, which resulted in removal, or due to inactivity.
The 90-day grace period exception was taken from Ginna's Quality Assurance Program for Station Operation, Revision 32. This was originally an exception to the provisions of Regulatory Guide 1.144, Revision 1, approved by the NRC in Safety Evaluation by the Office of Nuclear Reactor Regulation "Proposed Revision 25 to the Rochester Gas and Electric Corporation Quality Assurance Program for Station Operation, R.E. Ginna Nuclear Power Plant," dated July 22, 1998.
5
Attachment (1)
Response to Request for Additional Information The approval allowed a 90-day grace period for supplier audits. This is acceptable for all of CGG because this type of Quality Assurance program change continues to satisfy the criteria of 10 CFR 50, Appendix B.
Exception 9, Section A.7.3, Exception to ANSI N45.2.4-1972 Section 6.2.1, regarding an exception to the use of calibration stickers: This exception was based on a 1998 Entergy exception that has already been approved for Calvert Cliffs and Nine Mile Point.
The alternative for this item is consistent with a QAP alternative approved by the NRC for River Bend. The intent of the alternative was to allow other methods of marking equipment with calibration information other than by tagging. The staff recognized approved alternative methods before, such as using a calibration log that is correlated with the equipment by unique identification numbers on the equipment. The staff found that alternatives to tagging equipment with calibration information are acceptable provided that the specific method implemented by the licensee meets the requirements of the above standards and found that the requirements of 10 CFR Part 50, Appendix B continue to be met. Thus, this alternative is acceptable for CGG because the calibration program continues to meet the requirements of 10 CFR 50, Appendix B.
Exception 10, Section A.7.3, Exception to Regulatory Guide 1.33, Revision 2, Regulatory Position C, regarding the incorporation of ANSI N18.7-1976 requirements into the QATR.
Constellation Generation Group recognizes that NRC Regulatory Guide 1.33, "Quality Assurance Program Requirements (Operations)" endorses ANSI Standard NI 8.7, "Administrative Controls and Quality Assurance for the Operational Phase of Nuclear Power Plants". The CGG plants have current commitments to this standard. We have concluded that the QATR, combined with our commitment to Regulatory Guide 1.28, provides an acceptable alternative to Regulatory Guide 1.33 and ANSI N18.7-1976, in that the QATR provides quality assurance and administrative control requirements consistent with that guidance, as well as a quality assurance program that meets 10 CFR 50, Appendix B. Attachment 3 to the QATR submittal is a table illustrating that the quality assurance requirements of N 18.7-1976 are addressed through our commitment to NQA-1-1994, and the administrative controls of N18.7 are addressed by inclusion of equivalent requirements within the text of the QATR.
Exception 11, Section A.7.3, Exception to Regulatory Position C.4 of Regulatory Guide 1.33, Revision 2, regarding audit frequencies: This exception is acceptable because it has been previously adopted for each CGG site and continues to satisfy the criteria of 10 CFR 50, Appendix B.
In addition, this exception contains the use of 90 day grace periods for internal audits. This was originally an exception to the provisions of Regulatory Guide 1.144, Revision 1, approved by the NRC in Safety Evaluation by the Office of Nuclear Reactor Regulation "Proposed Revision 25 to the Rochester Gas and Electric Corporation Quality Assurance Program for Station Operation, R.E. Ginna Nuclear Power Plant," dated July 22, 1998. The approval allowed a 90-day grace period for internal audits. This is acceptable for all of CGG because this Quality Assurance program change continues to satisfy the criteria of 10 CFR 50, Appendix B.
Exception 12, Section A.7.3, Exception to Regulatory Guide 1.39, September 1977, Regulatory Positions C. 1, C.2 and C.3, regarding the use of NQA-1-1994, Subpart 2.3 in lieu of ANSI N45.2.3: this exception was based on the 2005 Dominion fleet QATR submittal.
Dominion used this exception to establish an alternative program for housekeeping requirements.
This is acceptable for CGG because the NRC staff found that wording of NQA-1-1994 6
Attachment (1)
Response to Request for Additional Information Subpart 2.3 contains equivalent requirements to Regulatory Guide 1.39, September 1977, and ANSI N45.2.3-1973. This alternative is acceptable based on providing an equivalent level of control over housekeeping activities.
Exception 13, Section A.7.3, Exception to Regulatory Guide 1.116, May 1977, regarding the substitution of NQA-I-1994, Subpart 2.8 for ANSI N45.2.8: This exception was based on the 2005 Dominion fleet QATR submittal. Dominion used this exception to establish an alternative program for installation, inspection, and testing of mechanical equipment and systems. The NRC staff found that NQA-1-1994 Subpart 2.8 contains equivalent requirements to Regulatory Guide 1.116, May 1977, and ANSI N45.2.8-1975. This alternative is acceptable based on providing an equivalent level of control over housekeeping activities.
Exception 14, Section A.7.3, Exception to Regulatory Guide 4.15, Revision 1, February 1979, regarding various exceptions in implementing the regulatory guide: This exception was developed within CGG, and was not based on any previous NRC approval of another utility's alternative. The basis for applicability is described in Attachment 4 to the QATR.
Exception 15, Section A.7.3, Exception to Generic Letter 82-21, regarding fire protection audit frequencies: this exception was based on previously approved Ginna and Calvert Cliffs submittals. The difference in the 12-month, 24-month and 36-month audits is the use of an outside consultant. The use of the consultant on a 24-month basis is acceptable to CGG.
Exception 16, Section B.4, Exception to NQA-I-1994 Supplement 4S-1, Section 2.3, regarding the use of alternative standards for procurement documents: This exception was based on the 2005 NMC fleet QATR submittal; NMC based it on a previous Palisades exception. Nuclear Management Company used this exception to establish alternative standards on which to base procurement documents. For existing long-term plant purchases that have imposed ANSI N45.2, or other NRC endorsed quality standards that can be shown to be equivalent to NQA-I, CGG is not required to change the procurement document. For new procurement documents, CGG will specify the requirements of NQA-1 or Appendix B to 10 CFR Part 50. However, CGG may accept vendors implementing another NRC endorsed standard that has shown to be equivalent to NQA-I or Appendix B to 10 CFR Part 50. This alternative is acceptable because we continue to meet the requirements of 10 CFR 50, Appendix B.
Exception 17, Section B.4, Exception to NQA-1-1994 Supplement 4S-1 and Supplement 7S-1, regarding an alternative for procurement of commercial grade items: this exception was based on the 2005 NMC fleet QATR submittal, NMC based it on a previous Palisades exception. Nuclear Management Company used this exception to establish alternative standards for the purchase of commercial grade items. The standard NQA-I-1994 does not address commercial grade dedication adequately, therefore an exception to NQA-l-1994 Supplements 4S-1 and 7S-I is needed. The NRC staff conditionally endorses EPRI NP-5652, "Guideline for the Utilization of Commercial Grade Items in Nuclear Safety Related Applications (NCIG-07)," in Generic Letter 89-02, "Actions to Improve the Detection of Counterfeit and Fraudulently Marketed Products."
This alternative is acceptable for CGG to assure the quality of procured vendor products.
Exception 18, Section B.4, Exception to NQA-I-1994 Supplement 7S-1, Section 8.1, regarding when procurement documentation shall be available on site: this exception was based on the 2005 NMC fleet QATR submittal; NMC based it on a previous Palisades exception. This alternative is acceptable for CGG because it still ensures that safety-related equipment will meet 10 CFR 50, Appendix B requirements for control of purchased items prior to their being made operable.
7
Attachment (1)
Response to Request for Additional Information Exception 19, Section B.4, Exception to NQA-I-1994 Supplement 7S-1 Paragraph 8.2.4, regarding establishment of post-installation test requirements: This alternative was based on a previously approved Nine Mile Point submittal. This alternative is acceptable for CGG because it places the primary responsibility on the CGG plants, in consultation with the supplier.
Exception 20, Section B.7, Exception to NQA-2-1983, regarding the scope of applicability of NQA-2 requirements at Nine Mile Point only: this exception is acceptable because it continues a pre-approved NRC exception previously granted to Nine Mile Point Nuclear Station. It does not extend the exception to other CGG sites.
Exception 21, Section B.7, Exception to NQA-I-1994 Subpart 2.3, regarding the five-level housekeeping zone designation: this exception was based on the 2005 NMC fleet QATR submittal; NMC based it on a previous Palisades exception. Nuclear Management Company used this exception to establish alternative administrative controls for housekeeping. This alternative is acceptable based on providing an equivalent level of control over housekeeping activities.
Exception 22, Section B. 15, Exception to NQA-I -1994 Supplement 17S-1, section 4.2(b),
regarding methods of records storage: this exception was based on the 2005 NMC fleet QATR submittal; NMC based it on a previous Palisades exception. Nuclear Management Company used this exception to establish alternative standards for records storage. This alternative is acceptable for CGG as it still ensures adequate protection of records and meets the requirements of 10 CFR 50, Appendix B.
Exception 23, Section B.15, Exception to NQA-1-1994 Supplement 17S-1 Section 4.4, regarding alternative storage locations: this exception is based on an existing Calvert Cliffs exception for alternative storage location requirements. The alternative is acceptable for CGG because it provides equivalent storage requirements to NQA-1-1994 and continues to meet the storage requirements of 10 CFR 50, Appendix B.
Exception 24, Section B.15, Exception to NQA-l-1994 Supplement 17S-1, Section 4.4.1(a),
regarding alternative records vault construction requirements at Calvert Cliffs only: this exception is acceptable because it continues a pre-approved NRC exception previously granted to Calvert Cliffs Nuclear Power Plant. It does not extend the exception to other CGG sites.
- 2.
Exception to Supplement 2S-1 states that, "Inspections, examinations and tests mnay be perforned by individuals in the samne organization as that which performed the work,..."
Explain why this exception is taken under personnel training and qualification and not under inspection.
Supplement 2S-1 pertains to qualification of independent quality assurance inspectors. This exception allows maintenance personnel who meet the qualifications stated in the QATR to also perform inspections. Therefore, the portion of the exception to the training requirements of Supplement 2S-1 that states, "Inspections, examinations and tests may be performed by individuals in the same organization as that which performed the work,..." is only related to training and qualification of the inspection staff and not to inspection performance, does not require an exception to NQA-I-1994 Basic Requirement 10, and is in accordance with 10 CFR Part 50, Appendix B.
8
Attachment (1)
Response to Request for Additional Information Additionally, the QATR states in Section B. 10, "Inspections, " that "inspections are carried out by properly qualified persons independent of those who performed or directly supervised the work."
Explain why this statement is not in conflict with the exception.
The exception to Supplement 2S-1 is related to the training of inspection personnel. Title 10 CFR Part 50, Appendix B requires inspections to be performed by individuals other than those who performed the activity. Likewise, NQA-I-1994, Basic Requirement 10 adds that inspection for acceptance shall be performed by persons other than those who performed or directly supervised the activity. We committed to these requirements in QATR Section B.12. Individuals and supervisors in the same organization that performed an activity may perform the inspections, as long as they are not the persons who performed or supervised the activity.
- 3.
For the exception taken under Supplement 2S-1 regarding the three levels of qualification/certification of inspectors, provide the initial qualification requirements for inspectors. Refer to Dominion QA Consolidation submittal, Attachment 2, "Description of Changes," and the associated supplemental document dated August 24, 2004, and May 5, 2005, respectively, for an example.
The three levels of qualification are addressed in Nonmandatory Appendix 2A-1.
The initial qualification requirements for inspection personnel under this exception are that (1) the inspector will be required to posses qualifications equal to or better than those required for performing the task being verified; and (2) will be required to have the necessary skills and/or have the verification requirements specified in procedures.
This exception meets the requirements of 10 CFR Part 50, Appendix B, Criterion II, by requiring training and qualification of personnel that assures suitable proficiency in the skills necessary to perform quality verification inspections.
- 4.
The Supplement 2S-2 alternative regarding the qualification of non-destructive examination personnel should also specify Section III of the American Society of Mechanical Engineers Boiler and Pressure Vessel Code.
Section III of the American Society of Mechanical Engineers Boiler and Pressure Vessel Code is added to the Supplement 2S-2 alternative. The alternative now reads:
"In lieu of Supplement 2S-2, CGG will follow the applicable standard cited in the latest version(s) of Sections III and XI of the ASME Boiler and Pressure Vessel Code approved by the NRC for use at CGG sites for qualification of nondestructive examination personnel."
- 5.
For the Supplement 2S-3 alternative regarding the requirenments for lead auditors, CGG mentions that this alternative is consistent iwith the approved alternative for tile Nuclear Management Company (NMQ. Thie NMC basis for this alternative was taken from the Palisades Quality Program Description, Revision 21, approved by the staff on April 18, 1997. The approval of this alternative was based on the following requirements: (1) the prospective lead auditor effectively demonstrates ability to lead and implement audit process; (2) the licensee describes the demonstration process in written procedures; and (3) the prospective lead auditor shall have participated in at least one nuclear audit in the last year. In addition, this alternative was based 9
Attachment (1)
Response to Request for Additional Information on individuals that have related experience and are capable of demonstrating the ability to lead audits in fewer than five audits.
Provide an explanation of your basis for this exception, and how its relates to the approved basis.
Note that in order to use this alternative all bases need to be ntet and the statement must read:
"The prospective lead auditor shall demonstrate his/her ability to properly implement the audit process, as implemented accordingly to Section C.2 of the QATR, to effectively organize and report results, inchlding participation in at least one nuclear audit with in tde year preceding tde date of qualification."
The alternative to NQA-I-1994 Supplement 2S-3 is revised to read:
For Supplement 2S-3: The requirement that prospective Lead Auditors have participated in a minimum of five (5) audits in the previous three (3) years is replaced by the following, "The prospective lead auditor shall demonstrate his/her ability to effectively lead and implement the audit process, as implemented according to Section C.2 of the QATR, and to effectively organize and report results, including participation in at least one nuclear audit within the year preceding the date of qualification. CGG describes this process in written procedures and shall evaluate and document the results of the demonstration."
The revised alternative aligns closer to the existing exceptions under the current site's Quality Assurance programs. As described in the "Revised Submittal of Quality Assurance Program for Station Operation, R.E. Ginna Nuclear Power Plant" dated December 21, 1998, the revised requirements for certification of lead auditors are consistent with the guidance provided by the NRC in a letter "Review of Nuclear Energy Institute Proposed Improvements to QA Programs,"
dated October 24, 1996.. The revised requirement meets the intent of Section 3.3 of NQA-I-1994 to have the prospective lead auditor demonstrate the ability to effectively implement the audit process and to lead an audit team. Since the revised requirements meet the intent of the original requirement and the NRC has proposed this approach as an acceptable alternative, this change does not reduce the scope of the quality assurance program.
The NRC notes in their Safety Evaluation Report to R.E. Ginna Nuclear Power Plant, dated April 6, 1999, that in an October 24, 1996 letter to the Nuclear Energy Institute, the NRC staff provided its position with regards to acceptable industry proposed alternatives on quality assurance processes for qualifying auditors and for conducting annual evaluations of suppliers.
Rochester Gas and Electric's proposed alternative for certifying lead auditors, as described was consistent with the staff's position in the cited letter and is, therefore, acceptable.
- 6.
For the alternative to RG 1.28, Revision 3, Regulatory Position C.3.2.2 regarding annual supplier evaluation, provide an explanation for the evaluation of a supplier to which no periodic (nore than a year) supplies are received in order to implement an ongoing receipt inspection, operating experience, and a supplier evaltation program.
The basis for this alternative is revised to read:
"This alternative provides for a documented ongoing evaluation of the supplier's performance, rather than an annual evaluation. Where applicable, this evaluation takes into account the review of supplier-furnished documents such as certificates of conformance, non-conformance notices, and corrective actions, as well as evaluating the results of previous source surveillances/verifications, audits/surveys, and receiving inspections. The alternative also 10
Attachment (1)
Response to Request for Additional Information provides for the review of operating experience information pertaining to equipment failures and evaluation of the results of audits from other sources (e.g., NUPIC audits) for their effect on supplier qualification status. As described in procedures, the results of these evaluations are reviewed and appropriate corrective action taken. Furthermore, adverse findings resulting from these evaluations are periodically reviewed to determine if, in the aggregate, they result in a significant condition adverse to quality. Additionally, the results of these evaluations are used to provide input to support supplier audit activities conducted by CGG or third party auditing organizations. If no items are received from a vendor in the course of a year, we still review industry activity using the daily download of operating experience information from the INPO website, the NUPIC database, and the NRC's website for inspection activities and Part 21 notifications. At the NUPIC meetings, there is an ongoing agenda item to review vendor performance and to alert others to adverse trends. Internal corrective action programs at the sites address vendor performance and are factored into qualification maintenance. Vendors may also be removed from the Approved Vendor's List either because of re-evaluation, which resulted in removal, or due to inactivity."
- 7.
For the exception to RG 1.116, Regulatory Position C.3, provide the basis for using RG 1.116 as an alternative to RG 1.68. Additionally, for the new reactor licensing process, RG 1.68 must be utsed.
The exception to Regulatory Guide 1.116, Regulatory Position C.3, states "Regulatory Position C.3 recommends using Section 5 of N45.2.8 in conjunction with Regulatory Guide 1.68 for pre-operational, cold functional, and hot functional testing. While Section 5 of NQA-1, Subpart 2.8 provides the same requirements, it is anticipated that CGG plants, since they are already beyond these tests, will not need to implement Regulatory Guide 1.68. If testing in accordance with Regulatory Guide 1.68 becomes necessary, CGG will comply with the guidance of the Regulatory Guide 1. 116 position."
The exception to Regulatory Guide 1.116, Regulatory Position C.3, does not propose using Regulatory Guide 1.1 16 as an alternative to Regulatory Guide 1.68. The licensed plants to which the CGG QATR applies have completed their pre-operational, cold functional, and hot functional testing. Thus, there is no need for these Licensees to commit to Regulatory Guide 1.68. We agree that for the new reactor licensing process, Regulatory Guide 1.68 must be used. The statement from the above exception "If testing in accordance with Regulatory Guide 1.68 becomes necessary, CGG will comply with the guidance of the Regulatory Guide 1.116 position,"
was inserted specifically to show that for new reactor licensing, Regulatory Guide 1.68 will be used.
- 8.
For the Supplement 4S-1, Section 2.3 alternative regarding procurement documents applying other NRC endorsed standards, CGG's basis for this alternative must be that for existing long-term plant purchases that have imposed ANSI N45.6, or other endorsed quality standards that can be shown to be equivalent to NQA-1, the licensee is not required to change the procurement document. For new procurement documents, the licensee must specify the requirements of NQA-1 or Appendix B to 10 CFR Part 50. However, the licensee may accept vendors implementing another NRC endorsed standard that are shown to be equivalent to NQA-1 or Appendix B to 10 CFR Part 50 program.
We have revised our basis for this alternative consistent with this guidance. The revised basis now reads:
11
Attachment (1)
Response to Request for Additional Information "For existing long-term plant purchases that have imposed ANSI N45.2, or other NRC endorsed quality standards, that can be shown to be equivalent to NQA-l, CGG is not required to change the procurement document. For new procurement documents, CGG will specify the requirements of NQA-1 or Appendix B to 10 CFR Part 50. However, CGG may accept vendors implementing another NRC endorsed standard that has shown to be equivalent to NQA-1 or Appendix B to 10 CFR Part 50. This alternative is acceptable because we continue to meet the requirements of 10 CFR 50, Appendix B."
- 9.
The NRC staff described in Generic Letters (GLs) 89-02 and 91-05 the expectations for an effective commercial-grade dedication program. GL 91-05 discusses the characteristics of effective procurement and dedication prograins previously discussed in GL 89-02 and provides examples of specific failures by licensees to effectively implement these characteristics for dedicating and ensuring the suitability of commercial-grade products for safety-related applications. For the alternative to Supplement 4S-1 and Supplement 7S-1 regarding the use of the guidance contained in GL 89-02 to procure commercial grade items, the NRC staff recommends adding the guidance contained in GL 91-05.
We have added the guidance contained in GL 91-05 to the alternative to Supplement 4S-1 and Supplement 7S-1 in Section B.4. The alternative now reads:
"For Supplement 4S-1 and Supplement 7S-1, CGG will use the guidance contained in Generic Letters 91-05 and 89-02/EPRI NP-5652 to procure Commercial Grade Items in lieu of these requirements."
We also added a commitment to GL 91-05 in Section A.7.3, which reads:
"Generic Letter 91-05 (April 1991) - CGG commits to compliance with the guidance regarding licensee commercial-grade procurement and dedication programs."
12
ATTACHMENT (2)
QATR Markup Constellation Generation Group, LLC July 14, 2006
QUALITY ASSURANCE TOPICAL REPORT Revision 0 the work shall be stopped and the plant placed in a safe condition. Work shall not resume until the procedure is changed to reflect correct work practices.
In addition, operating personnel responsibilities include:
I.
The reactor operator's authority and responsibility for shutting down the reactor when it is determined that the safety of the reactor is in jeopardy or when operating parameters exceed any of the reactor protection system set-points and automatic shutdown does not occur.
- 2.
The responsibility to determine the circumstances, analyze the cause, and determine that operations can proceed safely before the reactor is returned to power after a trip or an unexplained or unscheduled power reduction.
- 3.
The senior reactor operator's responsibility to be present at the plant and to provide direction for returning the reactor to power following a trip or an unscheduled or unexplained power reduction.
- 4.
The responsibility to believe and respond conservatively to instrument indications unless they are proved to be incorrect.
- 5.
The responsibility to adhere to the plant's Technical Specifications.
- 6.
The responsibility to review routine operating data to assure safe operation.
- 7.
The responsibility to take action to minimize personnel injury or damage to the facility and to protect the health and safety of the public in the event of an emergency not covered by approved procedures.
In establishing quality assurance program responsibilities, CGG commits to compliance with NQA-I-1994, Basic Requirement I and Supplement IS-I.
A.4 AUTHORITY Persons or organizations who are delegated responsibility for planning, establishing, or implementing any part of the CGG quality assurance program also have the authority to carry out those responsibilities.
Nuclear operations and support organization personnel are empowered to take stop work action on their own activities if they determine that continuing the activity would preclude identifying and correcting a condition adverse to quality or lead to an unsafe condition. Designated independent inspection and audit personnel have the authority to stop work within nuclear operations and support organizations, and at supplier locations. The Plant General Managers have stop work authority for all activities performed in operating their respective stations, including the final resnonsibility for the overall evaluation of shuttin,.
Deleted:.
down an operating unit.
In establishing quality assurance program authorities, CGG commits to compliance with NQA-1-1994, Basic Requirement I and Supplement IS-I.
A.5 PERSONNEL TRAINING AND QUALIFICATION Personnel assigned to implement elements of the QA program must be capable of performing their assigned tasks. To this end, CGG establishes and maintains formal indoctrination and training programs for personnel performing, verifying or managing activities within the scope of the QA program to assure that suitable proficiency is achieved and maintained.
Generating site and support staff minimum qualification requirements are as delineated in each site's Technical Specifications. Other qualification requirements may be established but will not reduce those required by Technical Specifications.
Sufficient managerial depth is provided to cover absences of incumbents. When required by code, Page 9 of 45
QUALITY ASSURANCE TOPICAL REPORT Revision 0 regulation, or standard, specific qualification and selection of personnel is conducted in accordance with those requirements as established in the applicable COG procedures.
Indoctrination includes the administrative and technical objectives, requirements of the applicable codes and standards, and the QA program elements to be employed. Training for positions identified in IOCFR50.120 is accomplished according to programs accredited by the National Nuclear Accrediting Board of the National Academy of Nuclear Training that implement a systematic approach to training. Records of personnel training and qualification are maintained.
In establishing qualification and training programs, COG commits to compliance with NQA-1-1994 Basic Requirement 2 and Supplements 2S-1, 2S-2, 2S-3 and 2S-4, with the following alternatives and exceptions:
- 1.
For Supplement 2S-1: Inspections, examinations or tests may be performed by individuals in the same organization as that which performed the work, provided that (a) the qualifications of the inspector for an activity are equal to or better than the minimum qualifications for persons performing the activity, (b) the work is within the skills of personnel and/or is addressed by procedures, and (c) if work involves breaching a pressure-retaining item, the quality of the work can be demonstrated through a functional test. When a, b and c are not met, inspections, examinations or tests are carried out by individuals certified in accordance with Supplement 2S-
- 1. Individuals performing visual inspections required by the ASME Boiler and Pressure Vessel Code are qualified and certified according to Code requirements.
- 2.
In lieu of Nonmandatory Appendix 2A-1, COG need not establish levels of qualification/
certification for inspection and test personnel. Instead, COG may establish initial qualification requirements and determines individual qualification through evaluation of education, training and experience, and through demonstration of capability in performing the type of inspections expected on the job.
- 3.
In lieu of Supplement 2S-2, CGG will follow the applicable standard cited in the latest version(s) of Sections III and Xi of the ASME Boiler and Pressure Vessel Code approved by the NRC for use at CGG sites for qualification of nondestructive examination personnel.
- 4.
For Supplement 2S-3: The requirement that prospective Lead Auditors have participated in a minimum of five (5) audits in the previous three (3) years is replaced by the following, "The requirement that prospective Lead Auditors have participated in a minimum of five (5) audits in the previous three (3) years is replaced by the following, "The prospective lead auditor shall demonstrate his/her ability to effectively lead and implement the audit process, as implemented according to Section C.2 of the OATR, and to effectively organi7e and report results, includine participation in at least one nuclear audit with in the year preceding the date of qualification.
COG describes this process in written procedures and shall evaluate and document the results of the demonstration." ---------------------------------------------------
- 5.
A grace period of 90 days may be applied to the performance of annual evaluations of inspection, examination and testing personnel qualifications defined in Supplement 2S-1, and annual lead auditor recertifications described in Supplement 2S-3. The grace period does not allow the "clock" for a particular activity to be reset forward. However, the "clock" for an activity is reset backwards by performing the activity early.
Deleted: The prospective lead auditor shall demonstrate his/her ability to properly implement the independent assessment (audit) process, as implemented by CGG according to
.section C.2 of this QATR. to effectively lead an assessment team. and to effectively organize and report results.
including participation in at least one independent assessment or audit within the year preceding the date of qualification Page 10 of 45
QUALITY ASSURANCE TOPICAL REPORT Revision 0
- a.
In lieu of plotting background parameters and setting predetermined control values for gamma spectroscopy instrumentation as described in Regulatory Position C.6.2, background results may be logged and evaluated to ensure the background does not bias reported results.
- b.
The NRC's independent sampling and analysis program described in Regulatory Position C.6.3.2 may not be performed.
- c.
In lieu of performing source check calibrations at least once per 18 months as described in Regulatory Position C.7, CGG may perform these calibrations at least once per refueling interval.
- 21.
Regulatory Guide 7.10, Revision 1, June 1986, "Establishing Quality Assurance Programs for Packaging Used in the Transport of Radioactive Material" - CGG commits to implement the quality assurance guidance for activities related to the packaging and transport of radioactive material that are under its control. Quality Assurance for the design, fabrication and licensing of shipping containers is the responsibility of the container certificate holders.
- 22.
Regulatory Issue Summary 2000-18, October 2000, "Guidance on Managing Quality Assurance Records in Electronic Media" - Should CGG choose electronic media storage as a means of maintaining required records, CGG will comply with the guidance of this Regulatory Issue Summary.
- 23.
Generic Letter 82-21, "Technical Specifications for Fire Protection Audits," In lieu of the 12-month, 24-month and 36-month fire protection and loss prevention audits, CGG will combine the scope of the three audits into one by performing a biennial audit of the facility fire protection program and implementing procedures.
The biennial requirement includes a fire protection equipment and program implementation inspection and audit utilizing either a qualified offsite licensed fire protection engineer or an outside qualified fire protection consultant.
- 24.
Generic Letter 91-05 (April 1991) - CGG commits to compliance with the guidance regarding licensee commercial-grade procurement and dedication proerams.
Page 16 of 45
QUALITY ASSURANCE TOPICAL REPORT Revision 0 continue to provide acceptable products and services. Source inspection (surveillance), certificate of conformance, receipt inspection, and pre-or post-installation testing are methods that are considered for item acceptance. The extent of the acceptance methods and associated verification activities will vary depending upon the relative importance and complexity of the purchased item or service and the supplier's past performance.
The contents of procurement documents vary according to the item and/or service being purchased and its function in the plant. Procurement documents include the following, as applicable:
I.
Material description and/or scope of work to be performed.
- 2.
Technical requirements with reference to applicable drawings, specifications, codes and standards identified by title, document number, revision and date. Any required procedures, such as special process instructions, are identified in such a way as to indicate source and need.
- 3.
Regulatory, administrative and reporting requirements. This includes IOCFR21 requirements, specifications, codes, standards, tests, inspections, and special processes.
(The QA programmatic requirements of ASME NQA-I or ANSI N45.2 may be used, where appropriate.)
- 4.
A requirement for a documented QA program.
- 5.
A requirement for the supplier to invoke applicable quality requirements on subtier suppliers.
- 6.
Provisions for access to supplier and subtier suppliers' facilities and records for inspections, surveillances and audits.
- 7.
Identification of documentation to be provided by the supplier.
- 8.
Provisions for documentation and dispositioning of nonconformances.
Spare and replacement parts are procured in accordance with the following provisions to assure that their performance and quality are at least equivalent to those of the parts that will be replaced:
- 1.
Specifications and codes referenced in procurement documents for spare or replacement items are the same or equivalent to those for the original items or to the reviewed and approved revisions;
- 2.
Where quality requirements for the original items cannot be determined, requirements and controls are established by an engineering evaluation; and
- 3.
Any additional or modified design criteria imposed after previous procurement of the item(s), are identified and incorporated.
Appropriate controls are imposed for the selection, determination of suitability for intended use (critical characteristics), evaluation, receipt, and quality evaluation of commercial grade items or services to ensure that they will perform satisfactorily in service.
In establishing controls for procurement, CGG commits to compliance with NQA-l, 1994, Basic Requirements 4 and 7, and Supplements 4S-I and 7S-1, with the following exceptions:
I.
For Supplement 4S-1, Section 2.3, which requires procurement documents to require a quality program that complies with NQA-I, CGG may apply other nationally recognized and NRC endorsed quality standards, such as N45.2 or IOCFR50 Appendix B, as appropriate to the circumstances of the procurement.
- 2.
For Supplement 4S-1 and Supplement 7S-I, CGG will use the guidance contained in Generic Letters 91-05 and 89-02/EPRI NP-5652 to procure Commercial Grade Items in lieu of these requirements.
- 3.
For Supplement 7S-1, Section 8.1, documentary evidence that items conform to procurement requirements need not be available at the site prior to item installation, but will be available at the site prior to placing reliance on the item for its intended safety function.
Page 20 of 45
QUALITY ASSURANCE TOPICAL REPORT Revision 0 APPENDIX C DEFINITIONS CGG uses the definitions of terms as provided in Section 4 of the Introduction of NQA-l-1994 in interpreting the requirements of NQA-l and the other standards to which the QATR commits.
In addition, definitions are provided for the following terms not covered in NQA-l:
Administrative controls: rules, orders, instructions, procedures, policies, practices and designations of authority and responsibility.
Audit:, A planned and documented activity performed to determine by investigation. examination, or....
evaluation of obiective evidence the adequacy of and compliance with established procedtres.
instructions, drawines, and other applicable documents, and the effectiveness of implementation.
An
,audit should not be confused with surveillance or inspection activities performed for the sole purpose of process control or product acceptance
'Formatted:
Font: Not Bold Emergency procedures: see Appendix B.
Experiments: performance of plant operations carried out under controlled conditions in order to establish characteristics or values not previously known.
Independent Assessment:
the process used to provide ongoing independent evaluation and communication of results to manacement on program performance, trends, and management effectiveness Independent Review: review completed by personnel not having direct responsibility for the work function under review regardless of whether they operate as part of an organizational unit or as individual staff members.
Maintenance and modification procedures: written procedures defining the policies and practices by which structures, mechanical, electrical and instrumentation and control systems, and components thereof, are kept in a condition of good repair or efficiency so that they are capable of performing their intended functions.
Nuclear power plant: any plant using a nuclear reactor to produce electric power, process steam or space heating.
{Formatted: Font: Not Bold Off-normal condition procedures: written procedures which specify operator actions for restoring an operating variable to its normal controlled value when it departs from its range, or to restore normal operating conditions following a perturbation. Such actions are invoked following an operator observation or an annunciator alarm indicating a condition which, if not corrected, could degenerate into a condition renuirine action under an emereencv nrocedure.
-- Deleted: (%fay be called Abnormal.
Off-normal or other terms conveying the same intent.)
a condition reouirini! action tinder an emcmencv nrocedure X -
On-site operating organization: on-site personnel concerned with the operation, maintenance and certain technical services.
Operating activities: work functions associated with normal operation and maintenance of the plant, and technical services routinely assigned to the on-site operating organization.
Operating procedures: written procedures defining the normal methods, means and limits of operation of the nuclear power plant, a plant system or systems, or processes, including actions to be taken by operating personnel for removal from and return to service equipment on which maintenance is to be or has been performed.
Operational phase: that period of time during which the principal activity is associated with normal operation of the plant. This phase of plant life is considered to begin formally with commencement of initial fuel loading, and ends with plant decommissioning.
Page 41 of 45
QUALITY ASSURANCE TOPICAL REPORT Revision 0 Review: a deliberately critical examination, including observation of plant operation, evaluation of assessment results, procedures, certain contemplated actions, and after-the-fact investigations of abnormal conditions.
Self-Assessment:
assessine the level of performance, or output of an activity or organization, by comparing management expectations and industry standards of excellence. --------------------
Supervision: direction of personnel activities or monitoring of plant functions by an individual responsible and accountable for the activities they direct or monitor.
Surveillance testing: periodic testing to verify that safety related structures, systems and components continue to function or are in a state of readiness to perform their functions.
System: an integral part of nuclear power plant comprising components which may be operated or used as a separate entity to perform a specific function.
Formatted: Font: Not Bald Page 42 of 45
ATTACHMENT (3)
Revised QATR Pages Constellation Generation Group, LLC July 14, 2006
QUALITY ASSURANCE TOPICAL REPORT Revision 0 TABLE OF CONTENTS Section Title Page A
MANAGEMENT A.1 Methodology 4
A.2 Organization 5
A.3 Responsibility 8
A.4 Authority 9
A.5 Personnel Training and Qualification 9
A.6 Corrective Action I I A.7 Regulatory Commitments II B
PERFORMANCE VERIFICATION B. 1 Methodology 17 B.2 Design Control 17 B.3 Design Verification 18 B.4 Procurement Control 19 B.5 Procurement Verification 21 B.6 Identification and Control of Items 21 B.7 Handling, Storage, and Shipping 21 B.8 Test Control 22 B.9 Measuring and Test Equipment Control 23 B.10 Inspection, Test, and Operating Status 23 B.1 1 Special Process Control 24 B.12 Inspection 24 B.13 Corrective Action 24 B. 14 Document Control 25 B.15 Records 26 B.16 Plant Maintenance 27 B.17 Computer Software Control 28 C
ASSESSMENT C. I Methodology 29 C.2 Assessment 29 APPENDICES A
Review Functions of the PORC, NSRB, and ISEG.
32 B
Procedures 37 C
Definitions 41 D
Operations Phase Activity Records 43 E
Organizational Relationships of Key Management and Functional Groups 44 Page 3 of 45
QUALITY ASSURANCE TOPICAL REPORT Revision 0 A.
MANAGEMENT A.1 METHODOLOGY The President of Constellation Generation Group, LLC (CGG), establishes the CGG quality assurance policy. This policy is set forth in the CGG Corporate Statement of Quality Assurance Policy and is binding on all organizations and individuals performing CGG quality affecting activities. The policy is implemented under the overall direction of the Senior Vice President and Chief Nuclear Officer, CGG.
The quality assurance program comprises those planned and systematic actions necessary to provide confidence that structures, systems, and components will perform their intended safety functions. The quality assurance program consists of the NRC approved regulatory document that describes the quality assurance program elements (the QATR) along with the associated corporate, fleet, and site implementing documents. Appropriate sections in the QATR contain a "Quality Standard Reference" which describes applicable commitments to related NQA-1-1994 sections.
The Quality Standard referenced in each section will be reviewed in addition to the QATR when determining station quality requirements.
Nuclear directives establish high-level responsibilities and authority for carrying out important functions. Fleet procedures establish common practices for certain activities such that the activity is controlled and carried out in a manner that meets quality assurance program requirements.
Site and department procedures establish detailed implementation requirements and methods, and may be used to implement nuclear directives and fleet procedures or be unique to particular functions or work activities. In addition, to provide a clear understanding of CGG operating philosophy, CGG establishes rules of practice pertaining to personnel conduct and control, including consideration of job related factors which can influence the effectiveness of operating and maintenance personnel, including such factors as number of hours at duty station, availability on-call of professional and supervisory personnel, method of conducting operations, and preparing and retaining plant documents. Such rules are contained within appropriate implementing documents.
The quality assurance program applies to activities affecting the performance of safety-related structures, systems and components, including, but not limited to, design; construction; procurement; fabrication; installation; modification; maintenance; repair; refueling; operation; training, inspection; tests; and decommissioning.
A list or other means of identification, of safety-related Systems, Structures, and Components (SSC) under the control of the quality assurance program is established and maintained for each operating plant. The technical aspects of the items are considered when determining program applicability, including, as applicable, the item's design safety function, the ASME Code and the other references cited in section A.7.3 of this QATR. The quality assurance program is also applied to certain activities where regulations other than 10CFR50 establish quality assurance program requirements for activities within their scope. Thus, this QATR is applied to the "important to safety" activities of radioactive waste shipping and independent spent fuel storage, as defined in those NRC regulations, as allowed by I OCFR7 I. 101 (f) and IOCFR72.140(d).
It is CGG's policy to assure a high degree of availability and reliability of its nuclear plants while ensuring the health and safety of the public and its workers. To this end, selected elements of the quality assurance program are also applied to certain equipment and activities that support safe and reliable plant operations, or where other non-CFR NRC guidance establishes program requirements. These include, but may not be limited to, emergency preparedness, security, radiation protection and fire protection.
Implementing documents establish program element applicability.
Activities affecting quality are prescribed by and performed according to documents (such as instructions, procedures or drawings) of a type appropriate to the circumstances and which, where applicable, include quantitative or qualitative acceptance criteria. Such documents are prepared and controlled according to section B.14. In addition, means are provided for dissemination to plant staff of instructions of both general and continuing applicability (e.g., dealing with job turnover and relief, designation of confines of the control room, limitations on access to certain areas), as well as those of Page 4 of 45
QUALITY ASSURANCE TOPICAL REPORT Revision 0 short-term applicability (e.g., dealing with short-term operating conditions, publications, personnel actions). Provisions are included for review, updating, and cancellation of such instructions.
In establishing, implementing and maintaining the QATR, CGG commits to compliance with ASME NQA-I-1994, Basic Requirement 2. QATR revisions are reviewed by site and corporate management, and approved by the Chief Nuclear Officer. Changes to this QATR will be governed by and made in compliance with IOCFR50.54(a).
In establishing procedural controls, CGG commits to compliance with NQA-I, 1994, Basic Requirement
- 5. In addition, as stated in position C.1 of Regulatory Guide 1.33, Revision 2, CGG commits to use Appendix A of Regulatory Guide 1.33 as guidance for establishing the types of procedures that are necessary to control and support plant operation. Requirements specific to procedures are also provided in Appendix B of this QATR.
A.2 ORGANIZATION This section describes the CGG organizational structure, functional responsibilities, and levels of authority and interfaces for establishing, executing, and verifying quality assurance program implementation. The organizational structure includes corporate functions and onsite functions at each plant. Corporate management is responsible for overall management of the Company's nuclear facilities through all the phases from siting to decommissioning. Support groups provide management, technical, and oversight support for activities such as design, construction, operation, modification, and decommissioning and report to corporate management.
These support groups may be located at corporate offices or at a nuclear facility site. The onsite operations groups are responsible for overall operational activities of assigned nuclear facilities in accordance with the facility license. The operations groups are typically assigned responsibility for one or more nuclear power station units and any associated Independent Spent Fuel Storage Installations at a particular site. Decisions affecting safety are made at the level appropriate for its nature and effect and with any necessary technical advice for review.
Implementing documents assign more specific responsibilities and duties, and define the organizational interfaces involved in conducting activities and duties within the scope of this QATR. As the amount of certain activities changes, such as construction or decommissioning, the organizational structure may change and will be reflected in a change to these descriptions.
A.2.1 CORPORATE ORGANIZATION The following positions have the described corporate functional responsibilities (See Appendix E):
A.2.1.1 President, CGG This position is responsible for overall corporate policy and provides executive direction and guidance for the corporation as well as promulgates corporate policy through the Company's senior management staff. Overall responsibility for the implementation of the quality assurance program is delegated to the Senior Vice President and Chief Nuclear Officer, CGG.
A.2.1.2 Senior Vice President and Chief Nuclear Officer, CGG (CNO)
This position reports to the President, CGG and has overall responsibility for the safe and reliable operation of the Company's nuclear stations including management oversight and support of the day-to-day operations of the stations. This is the senior executive responsible for setting and implementing policies, objectives, expectations, and priorities to ensure activities are performed in accordance with the quality assurance program and other requirements. The CNO oversees activities of the Nuclear Safety Review Board (NSRB).
Page 5 of 45
QUALITY ASSURANCE TOPICAL REPORT Revision 0 A.2.1.3 Operations Support An executive management position for operations support reports to the CNO and provides direction to the nuclear security, emergency preparedness,
- training, and fleet procedures departments.
Responsibilities for nuclear security include facility physical security, nuclear access programs, and fitness for duty programs.
Emergency preparedness responsibilities include development and maintenance of the company radiological emergency plans and coordination with off-site radiological emergency response groups for the nuclear facilities. Training ensures qualified personnel operate and support the nuclear facilities and administers the fleet corrective action, self-assessment, and industry operating experience programs.
The fleet procedures department ensures that fleet procedures are prepared in accordance with applicable regulatory requirements, industry quality standards, and this QATR.
Additionally, corporate oversight and support is provided in the areas of operations, maintenance, refueling services, radiation protection, chemistry, and work management. Some of these responsibilities may be assigned to Site Vice President(s) at the discretion of the CNO.
A.2.1.4 Technical Services An executive management position for technical services reports to the CNO and provides direction to corporate engineering, licensing, nuclear fuel services, and probabilistic risk assessment (PRA) departments.
Additionally, corporate oversight and support is provided for site engineering.
This position is responsible for the engineering functions supporting design and construction activities and long-term nuclear operations, providing for regulatory compliance and licensing support through NRC communications, and activities related to safety and management of nuclear fuel.
Some of these responsibilities may be assigned to the Site Vice President(s) at the discretion of the CNO.
A.2.1.5 Quality and Performance Assessment (Q&PA)
A senior management position reporting to the CNO is responsible for the verification of effective Company and Supplier quality assurance program development, documentation, and implementation.
This position is independent of cost and scheduling concerns associated with construction, operations, maintenance, modification, and decommissioning activities for performing quality assurance program verification. Where implementation of any or all of these functions is delegated to Suppliers, procedures require the establishment of interface documents including defining lines of communication and authorities as appropriate for the delegated functions. However, this senior management position retains responsibility for the scope and effective implementation of the quality assurance program for those functions. This management position has the necessary authority and responsibility for verifying quality achievement; identifying quality problems, recommending solutions and verifying implementation of the solutions; and escalating quality problems to higher management levels. This position has the authority to suspend unsatisfactory work and control further processing or installation of non-conforming materials. The authority to stop work delegated to Q&PA personnel is delineated in procedures.
Q&PA is responsible for the evaluation of Suppliers' quality programs through a system of external audits, evaluations, and reviews of Supplier performance in accordance with quality assurance requirements. A list of approved Suppliers is maintained. Q&PA is responsible for assuring Company compliance with this QATR through administration of a comprehensive and systematic internal audit program.
Q&PA is also responsible for the Employee Concerns Program, and developing and maintaining an appropriate quality verification inspection program where not provided for in the facility construction or operating organization functions.
A.2.1.6 Project Management A senior management position reporting to the CNO is responsible for the implementation of large projects for the nuclear facilities. Implementation includes development of the detailed scope, estimate, schedule, cost, design procurement, construction, testing, and closeout of each project.
Project management also oversees siting and construction activities. Focus is on defined projects separate from Page 6 of 45
QUALITY ASSURANCE TOPICAL REPORT Revision 0 ongoing routine engineering projects. Some of these responsibilities may be assigned to the Site Vice President(s) at the discretion of the CNO.
A.2.1.7 Supply Chain Supply Chain is responsible for material management, purchasing, procurement engineering, and receipt inspection. This position has the authority to control further processing or installation of nonconforming materials. This authority is delegated to inspection personnel as delineated in procedures.
A.2.1.8 Information Technology Information Technology is responsible for network infrastructure maintenance and upgrade; network and application security; network operations; automation strategy; application development and support, automation training; development and maintenance of the software control program; and oversight, maintenance, and repair of the Emergency Offsite Facility Computer System.
A.2.2 SITE ORGANIZATION The overall structure of the organization described herein is applied for all facilities, however, there may be slight variations in responsibilities between facilities, but the overall reporting relationships remain.
Depending on the scope of the activities, one or more individuals may be assigned the described management responsibilities.
The on-site operating organization includes one or more individuals knowledgeable in the following fields: nuclear power plant operation; nuclear power plant mechanical, electrical and electronic systems; nuclear engineering; chemistry and radiochemistry; radiation protection; and quality assurance. Site procedures provide detailed organizational descriptions. The site organization is depicted in Appendix E.
A.2.2.1 Site Vice President (SVP)
This position reports to the CNO and is responsible for overall plant nuclear safety and implementation of the Company's quality assurance program. This position is responsible for the station's compliance with its NRC Operating License, governmental regulations, and ASME Code requirements. Areas of responsibility also include site engineering and training. This position provides day-to-day direction and management oversight of activities associated with the safe and reliable operations of a nuclear station.
A.2.2.2 Plant General Manager This position reports to the SVP and is responsible for plant operations and maintenance. This position assures the safe, reliable, and efficient operation of the plant within the constraints of applicable regulatory requirements, Operating License, and the quality assurance program. The Plant General Manager, in carrying out the responsibility for overall safety of plant operations, is responsible for timely referral of appropriate plant matters to management and independent reviewers. Areas of responsibility also include chemistry activities, health physics/radiological protection, operations and support, work management, records management, maintenance and production planning, and related procedures and programs. The Plant Operating Review Committee (PORC) reports to the Plant General Manager.
A.2.2.3 Training A site management position reports to the SVP and functionally to a corporate management position (offsite), and is responsible for the training of personnel who operate or support the nuclear facilities.
Training responsibilities include determining the need for training based on information provided by the various groups, developing performance-based training programs, implementing training programs to support employee and facility needs, and evaluating training programs. Certain functional groups may be assigned responsibility for the development and conduct of their own training programs provided these groups are not required to have a systems approach to training under 10 CFR 50.120. This position is Page 7 of 45
QUALITY ASSURANCE TOPICAL REPORT Revision 0 also responsible for administration of the corrective action, self-assessment and industry operating experience programs.
A.2.2.4 Engineering A site management position reports to the SVP and functionally to a Corporate Vice President (offsite),
and is responsible for day-to-day engineering support activities including design engineering, engineering programs, equipment reliability, and system engineering.
A.2.2.5 Q&PA A site management position reports to the corporate management position (offsite) responsible for Q&PA and functionally to the SVP, and is responsible for site Q&PA activities. Significant safety or quality issues requiring escalated action are directed through this position to corporate Q&PA management, as necessary. Responsibilities include conducting independent assessments of line and support activities; monitoring and assessing day-to-day station activities; stop work authority at the site; periodic reporting on the status and adequacy of the quality program; providing quality verification and inspections; and the Employee Concerns Program.
In establishing its organizational structure, CGG commits to compliance with NQA-I, 1994, Basic Requirement I and Supplement IS-I.
A.3 RESPONSIBILITY All employees of CGG involved in the operation of the fleet nuclear power plants and associated support activities have full personal and corporate responsibility to assure that the plant is operated, maintained, tested, inspected, and modified in a safe and reliable manner. This responsibility includes assuring that an effective quality assurance program is implemented.
Although authority for development and execution of specified parts of the program may be delegated to others (e.g. suppliers), CGG retains overall responsibility.
The QA program status, scope, adequacy and compliance with IOCFR50 Appendix B are regularly reviewed by CGG management through reports, meetings, review of audit results, and documented assessments performed by management teams. The NSRB reviews the status and adequacy of the QA program at each site at least once every two years to assure that it is meaningful and effectively complies with corporate policy and 10CFR50, Appendix B.
This review consists of an audit, or a review equivalent to an audit, performed by company personnel or outside organizations.
CGG is responsible for ensuring that the applicable portions of the QA program are properly documented, approved, and implemented (people are trained and resources are available) before an activity with the scope of the QA program is undertaken by CGG or by others. Individual managers ensure that personnel working under their cognizance are provided the necessary training and resources to accomplish their assigned tasks. Managers and supervisors are responsible for timely and continuing monitoring of performance to verify that day-to-day activities are conducted safely and in accordance with applicable requirements.
The QA program is implemented through procedures prepared and maintained by the responsible organization and approved for use by their designated manager. Quality affecting activities are performed in accordance with these procedures, utilizing sufficiently trained personnel and necessary resources to accomplish the work.
Adherence to procedures is vital to the safe and reliable operation of CGG's Nuclear Power Plants.
Personnel are responsible for adhering to established procedures, interpreting them conservatively in case of doubt, and recommending changes when necessary. Procedures with the potential to affect nuclear or personnel safety shall be strictly adhered to. When an activity controlled by such procedures cannot be Page 8 of 45
QUALITY ASSURANCE TOPICAL REPORT Revision 0 accomplished as described or accomplishment of such activity would result in an undesirable situation, the work shall be stopped and the plant placed in a safe condition. Work shall not resume until the procedure is changed to reflect correct work practices.
In addition, operating personnel responsibilities include:
I.
The reactor operator's authority and responsibility for shutting down the reactor when it is determined that the safety of the reactor is in jeopardy or when operating parameters exceed any of the reactor protection system set-points and automatic shutdown does not occur.
- 2.
The responsibility to determine the circumstances, analyze the cause, and determine that operations can proceed safely before the reactor is returned to power after a trip or an unexplained or unscheduled power reduction.
- 3.
The senior reactor operator's responsibility to be present at the plant and to provide direction for returning the reactor to power following a trip or an unscheduled or unexplained power reduction.
- 4.
The responsibility to believe and respond conservatively to instrument indications unless they are proved to be incorrect.
- 5.
The responsibility to adhere to the plant's Technical Specifications.
- 6.
The responsibility to review routine operating data to assure safe operation.
- 7.
The responsibility to take action to minimize personnel injury or damage to the facility and to protect the health and safety of the public in the event of an emergency not covered by approved procedures.
In establishing quality assurance program responsibilities, CGG commits to compliance with NQA-I-1994, Basic Requirement I and Supplement I S-I.
A.4 AUTHORITY Persons or organizations who are delegated responsibility for planning, establishing, or implementing any part of the CGG quality assurance program also have the authority to carry out those responsibilities.
Nuclear operations and support organization personnel are empowered to take stop work action on their own activities if they determine that continuing the activity would preclude identifying and correcting a condition adverse to quality or lead to an unsafe condition. Designated independent inspection and audit personnel have the authority to stop work within nuclear operations and support organizations, and at supplier locations. The Plant General Managers have stop work authority for all activities performed in operating their respective stations, including the final responsibility for the overall evaluation of shutting down an operating unit.
In establishing quality assurance program authorities, CGG commits to compliance with NQA-l-1994, Basic Requirement 1 and Supplement IS-1.
A.5 PERSONNEL TRAINING AND QUALIFICATION Personnel assigned to implement elements of the QA program must be capable of performing their assigned tasks. To this end, CGG establishes and maintains formal indoctrination and training programs for personnel performing, verifying or managing activities within the scope of the QA program to assure that suitable proficiency is achieved and maintained.
Generating site and support staff minimum qualification requirements are as delineated in each site's Technical Specifications. Other qualification Page 9 of 45
QUALITY ASSURANCE TOPICAL REPORT Revision 0 requirements may be established but will not reduce those required by Technical Specifications.
Sufficient managerial depth is provided to cover absences of incumbents.
When required by code, regulation, or standard, specific qualification and selection of personnel is conducted in accordance with those requirements as established in the applicable CGG procedures.
Indoctrination includes the administrative and technical objectives, requirements of the applicable codes and standards, and the QA program elements to be employed. Training for positions identified in 10CFR50.120 is accomplished according to programs accredited by the National Nuclear Accrediting Board of the National Academy of Nuclear Training that implement a systematic approach to training. Records of personnel training and qualification are maintained.
In establishing qualification and training programs, CGG commits to compliance with NQA-1-1994 Basic Requirement 2 and Supplements 2S-1, 2S-2, 2S-3 and 2S-4, with the following alternatives and exceptions:
- 1.
For Supplement 2S-1: Inspections, examinations or tests may be performed by individuals in the same organization as that which performed the work, provided that (a) the qualifications of the inspector for an activity are equal to or better than the minimum qualifications for persons performing the activity, (b) the work is within the skills of personnel and/or is addressed by procedures, and (c) if work involves breaching a pressure-retaining item, the quality of the work can be demonstrated through a functional test. When a, b and c are not met, inspections, examinations or tests are carried out by individuals certified in accordance with Supplement 2S-
- 1. Individuals performing visual inspections required by the ASME Boiler and Pressure Vessel Code are qualified and certified according to Code requirements.
- 2.
In lieu of Nonmandatory Appendix 2A-1, CGG need not establish levels of qualification/
certification for inspection and test personnel. Instead, CGG may establish initial qualification requirements and determines individual qualification through evaluation of education, training and experience, and through demonstration of capability in performing the type of inspections expected on the job.
- 3.
In lieu of Supplement 2S-2, CGG will follow the applicable standard cited in the latest version(s) of Sections III and XI of the ASME Boiler and Pressure Vessel Code approved by the NRC for use at CGG sites for qualification of nondestructive examination personnel.
- 4.
For Supplement 2S-3: The requirement that prospective Lead Auditors have participated in a minimum of five (5) audits in the previous three (3) years is replaced by the following, "The requirement that prospective Lead Auditors have participated in a minimum of five (5) audits in the previous three (3) years is replaced by the following, "The prospective lead auditor shall demonstrate his/her ability to effectively lead and implement the audit process, as implemented according to Section C.2 of the QATR, and to effectively organize and report results, including participation in at least one nuclear audit with in the year preceding the date of qualification.
CGG describes this process in written procedures and shall evaluate and document the results of the demonstration.."
- 5.
A grace period of 90 days may be applied to the performance of annual evaluations of inspection, examination and testing personnel qualifications defined in Supplement 2S-1, and annual lead auditor recertifications described in Supplement 2S-3. The grace period does not allow the "clock" for a particular activity to be reset forward. However, the "clock" for an activity is reset backwards by performing the activity early.
Page 10 of 45
QUALITY ASSURANCE TOPICAL REPORT Revision 0 A.6 CORRECTIVE ACTION CGG management, at all levels, fosters a non-punitive ("no-fault") attitude toward the identification of conditions adverse to quality. This includes failures, malfunctions, deficiencies, deviations, defective material and equipment, abnormal occurrences, nonconformances, and out-of-control processes, including the failure to follow procedures.
CGG implements a corrective action program to promptly identify, control, document, classify, and correct conditions adverse to quality.
In addition, for significant conditions adverse to quality, the program provides for cause evaluation and corrective actions to prevent recurrence. Provisions are also made to ensure that corrective actions for significant conditions adverse to quality are completed as intended.
Results of evaluations of conditions adverse to quality are analyzed to identify trends.
Significant conditions adverse to quality and significant adverse trends are documented and reported to responsible management.
Prior to installation, nonconforming items, services or activities are reviewed and accepted, rejected, repaired, or reworked, and are identified and controlled to prevent their inadvertent test, installation or use.
In establishing requirements for corrective action, CGG commits to compliance with NQA-1-1994, Basic Requirements 15 and 16, and Supplement 15S-1.
The Employee Concerns Program provides CGG and contractor employees an opportunity to communicate their quality concerns regarding operation, maintenance or modification while keeping their identity confidential, if they desire, and to receive feedback regarding the results of investigations with respect to their concerns. Quality concerns determined to be valid are acted upon by the responsible organization, and the actions are verified prior to closeout.
A.7 REGULATORY COMMITMENTS A.7.1 Through the QATR, CGG commits to compliance with the following:
I.
IOCFR50, Appendix B, "Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants"
- 2.
10CFR Part 71, Subpart H, "Quality Assurance for Packaging and Transportation of Radioactive Material"
- 3.
10CFR Part 72, Subpart G, "Quality Assurance for Licensing Requirements for the Independent Storage of Spent Nuclear Fuel and High-Level Radioactive Waste,"
- 4.
10CFR Part 21, "Reporting of Defects and Non-Compliance"
- 5.
General Design Criterion 1, of Appendix A to 10 CFR Part 50
- 6.
10CFR50.55a, "Codes and standards"
- 7.
1 OCFR50.59, "Changes, Tests and Experiments"
- 8.
10CFR55, "Operators' Licenses" A.7.2 When applicable, for Class 1, 2, and 3 items covered by Section III of the ASME Boiler and Pressure Vessel Code, the code Quality Assurance requirements are supplemented by the guidance of applicable regulatory guides and this QATR.
Page 11 of 45
QUALITY ASSURANCE TOPICAL REPORT Revision 0 A.7.3 Through this QATR, CGG commits to compliance with the regulatory guidance and industry standards governing quality assurance as described below along with any exceptions or alternatives described within this QATR. Commitment to a particular Regulatory Guide does not constitute commitment to Regulatory Guides or other standards that may be referenced therein, unless otherwise noted.
I1.
Regulatory Guide 1.8, Revision (site-specific), "Qualification and Training of Personnel for Nuclear Power Plants" - CGG commitments regarding qualification and training of personnel are described in Section A.5 of this QATR, which states that staff qualification requirements are as delineated in each site's Technical Specifications, and that training for positions identified in IOCFR50.120 is accomplished according to programs accredited by the National Nuclear Accrediting Board of the National Academy for Nuclear Training.
- 2.
Regulatory Guide 1.16, Revision (site-specific), "Reporting of Operating Information" - The commitment to this Regulatory Guide is site-specific as described in the approved Safety Analysis Report (SAR) or License for each nuclear facility. Where items do not conform to the requirements of the Regulatory Guide, they are addressed in the applicable facility's SAR.
- 3.
Safety/Regulatory Guide 1.26, Revision (site-specific), "Quality Group Classifications and Standards for Water-, Steam-, and Radioactive Waste-Containing Components of Nuclear Power Plants" - Commitment to Safety/Regulatory Guide 1.26 is site-specific, as required by the approved SAR/License at each nuclear facility.
Sites may use this guidance to assist in establishing the lists of equipment to which this QA program applies, or for other purposes.
- 4.
Regulatory Guide 1.28, Revision 3, August 1985, "Quality Assurance Program Requirements (Design and Construction)" (ASME NQA-1, 1983a) - CGG will implement the requirements and guidance of the standard and Regulatory Guide during the design and construction phases of the facilities subject to the following:
- a.
Regulatory Position C endorses the basic and supplementary requirements of ANSI/
ASME NQA-1-1983 and the ANSI/ASME NQA-la-1983 Addenda.
In place of the specific edition and addenda of NQA-1 addressed in the Regulatory Guide, CGG commits to implement the requirements of NQA-1-1994 Part I. CGG's commitment to these requirements and any exceptions/alternatives to these requirements are addressed in this QATR.
- b.
CGG does not commit to compliance with Regulatory Position C.1 of this Regulatory Guide; instead of establishing three levels of qualification provided in Nonmandatory Appendix 2A-1, CGG may establish initial qualification requirements and determine individual qualification through evaluation of education, training and experience, and through demonstration of capability in performing the type of inspections expected on the job.
- c.
CGG uses the list of records in position C.2 (Table 1) to establish the types of records that will be created and retained in support of plant operation. Table I addresses design, construction and initial start-up records and will be applied to operating and decommissioning phase records that are similar in nature to the construction records.
Additional operations phase records and their retention periods are identified in Appendix D to this QATR.
- d.
The guidance in Regulatory Position C.3.2 regarding external audits will also be implemented during the operational phase. CGG complies with Regulatory Position C.3.2 with the exception that for Regulatory Position C.3.2.2, CGG may review the information described therein as it becomes available through its ongoing receipt inspection, operating experience, and supplier evaluation programs, in lieu of performing a specific evaluation on an annual basis.
The results of the reviews are promptly considered for effect on a supplier's continued qualification and adjustments made as necessary (including corrective actions, adjustments of supplier audit plans, and input to third party auditing entities, as warranted).
Additionally, results are reviewed Page 12 of 45
QUALITY ASSURANCE TOPICAL REPORT Revision 0 periodically to determine if, as a whole, they constitute a significant condition adverse to quality requiring additional action. A grace period of 90 days may be applied to the performance of triennial supplier audits described in Regulatory Position 3.2.1.
The grace period does not allow the "clock" for a particular activity to be reset forward.
However, the "clock" for an activity is reset backwards by performing the activity early.
- 5.
Safety/Regulatory Guide 1.29, Revision (site-specific) "Seismic Design Classification" - CGG plants may have been designed, constructed and licensed based on criteria available prior to this Regulatory Guide being issued.
The specific design criteria and seismic designations are reflected in each plant's SAR, and in other docketed analysis.
Thus, the commitment to Safety/Regulatory Guide 1.29 is site-specific, as required by the approved SAR/License at each CGG site. Sites may use this guidance to assist in establishing the lists of equipment to which this QA program applies, or for other purposes.
- 6.
Regulatory Guide 1.30, August 1972, "Quality Assurance Requirements for the Installation, Inspection and Testing of Instrumentation and Electric Equipment," (ANSI N45.2.4-1972/IEEE 336-1971):
- a.
CGG commits to ANSI N45.2.4-1972/IEEE 336-1971 in its commitment to Position C of Regulatory Guide 1.30.
- b.
As noted in Regulatory Position C.1, ANSI N45.2.4-1972 is being used in conjunction with NQA-I-1994, Part I, which replaced ANSI N45.2.
- c.
As noted in Regulatory Position C.2, other industry standards may be referenced. The commitment in this QATR to ANSI N45.2.4-1972 includes commitment to those standards to the extent necessary to implement ANSI N45.2.4-1972 requirements.
If NRC guidance applies to those referenced standards, it is followed.
- d.
Consistent with Regulatory Position C.3, the requirements of the endorsed standard are also considered applicable during the operation phase of the nuclear power plant.
- e.
In lieu of the requirements of the last paragraph of ANSI N45.2.4-1972 Section 6.2. 1, the calibration program at CGG does not use calibration stickers on installed plant instrumentation that contain the date of calibration and identity of person that performed the calibration. Calibrations of instruments are scheduled and tracked by a computer database.
- 7.
Regulatory Guide 1.33, Revision 2, February 1978, "Quality Assurance Program Requirements (Operation)" (ANSI NI 8.7-1976/ANS-3.2):
- a.
NQA-1-1994 Part I contains quality assurance requirements equivalent to those of ANSI N18.7-1976/ANS-3.2, and CGG has included in this QATR the remaining "administrative controls" elements from ANSI N18.7-1976/ANS-3.2. Therefore, CGG does not commit to compliance with the requirements of ANSI N-18.7-1976/ANS-3.2.
- b.
As recommended by Regulatory Position C.1, CGG uses Appendix A of Regulatory Guide 1.33, Revision 2, as guidance in establishing the types of procedures required for plant operation and support.
- c.
CGG's commitment to the applicable Regulatory Guides and associated standards listed in Regulatory Position C.2 is addressed within this QATR.
A number of these Regulatory Guides and standards have been incorporated into NQA-I-1994 Part I.
- d.
CGG complies with Regulatory Position C.3, as described in Appendix A of this QATR.
- e.
In lieu of the six and twelve month audit frequencies specified in Regulatory Position C.4, CGG audits selected aspects of operational phase activities at a frequency commensurate with their safety significance in such a manner as to assure an audit of all safety-related functions is completed within a period of two years. (except as otherwise required in regulations) CGG's audit program includes the elements listed in Regulatory Position C.4. A 90-day grace period may be applied to the 24-month frequency for Page 13 of 45
QUALITY ASSURANCE TOPICAL REPORT Revision 0 performing internal audits. The grace period does not allow the "clock" for a particular activity to be reset forward. However, the "clock" for an activity is reset backwards by performing the activity early.
- f.
In lieu of compliance with Regulatory Position C.5, CGG has established appropriate equivalent requirements within this QATR.
- 8.
Regulatory Guide 1.36, Revision (site-specific), "Nonmetallic Thermal Insulation for Austenitic Stainless Steel" - CGG plants may have been designed, constructed and licensed based on criteria available prior to this Regulatory Guide being issued. Regulatory Guide 1.36 may be used for plant modifications on a case-by-case basis, but this QATR makes no generic commitment thereto.
- 9.
Regulatory Guide 1.37, Revision (site-specific), "Quality Assurance Requirements for Cleaning of Fluid Systems and Associated Components of Water-Cooled Nuclear Power Plants," (ANSI N45.2.1-1973) - The commitment to this Regulatory Guide is site-specific as described in the approved SAR or License for each nuclear facility.
Where items do not conform to the requirements of the Regulatory Guide, they are addressed in the applicable facility's SAR.
- 10.
Regulatory Guide 1.38, Revision (site-specific), "Quality Assurance Requirements for Packaging, Shipping, Receiving, Storage, and Handling of Items for Water-Cooled Nuclear Power Plants," (ANSI N45.2.2-1972) - The commitment to this Regulatory Guide is site-specific as described in the approved SAR or License for each nuclear facility. Where items do not conform to the requirements of the Regulatory Guide, they are addressed in the applicable facility's SAR.
This alternative applies to Nine Mile Point Nuclear Station (NMPNS). NMPNS commits to ANSI/ASME NQA-2-1983 Part 2.2, "Quality Assurance Requirements for Packaging, Shipping, Receiving, Storage, and Handling of Items for Nuclear Power Plants," for nuclear safety-related activities pertaining directly to permanent plant modifications only. NQA-2-1983 Section 7.1 refers to NQA-2-1983 Part 2.15 for requirements related to handling of items. The scope of Part 2.15 includes hoisting, rigging and transporting of items for nuclear power plants. This scope exceeds the scope of the NRC's original endorsement of ANSI N45.2.2 in Regulatory Guide 1.38, and establishes requirements for which there is no NRC regulatory position. In lieu of compliance with Part 2.15, NMPNS is committed to the requirements of applicable heavy load reports for Nine Mile Point Units 1 and 2 that have been approved by the NRC. Unit 2's report is a part of the SAR (Appendix 9C). Unit I's is a separate report.
- 11.
Regulatory Guide 1.39, Revision 2, September 1977, "Housekeeping Requirements for Water-Cooled Nuclear Power Plants," (ANSI N45.2.3-1973) - CGG substitutes NQA-I-1994, Subpart 2.3 for N45.2.3 in its commitment to Regulatory Guide 1.39. As noted in Regulatory Position C.1, other industry standards may be referenced; the commitment in this QATR to NQA-I, Subpart 2.3 includes commitment to those standards to the extent necessary to implement Subpart 2.3 requirements. If NRC guidance applies to those referenced standards, it is followed.
Regulatory Position C.2 indicates that the provisions of section 3.2.3 of N45.2.3 are not part of the Regulatory endorsement. As NQA-1, Subpart 2.3, section 3.2.3 has the same wording as N45.2.3; the Regulatory Position is applicable and will be followed in CGG's implementation of Subpart 2.3. Regulatory Position C.3 indicates that the endorsed standard is "applicable for housekeeping activities during the operations phase that are comparable to those occurring during construction." This is addressed in section B.7 of this QATR, which also establishes any necessary exceptions or alternatives to the provisions of Subpart 2.3.
- 12.
Regulatory Guide 1.54, Revision (site-specific), "Quality Assurance for Protective Coatings Applied to Nuclear Power Plants" (NIOI.4-1972) - The commitment to this Regulatory Guide is site-specific as described in the approved SAR or License for each nuclear facility. Where items do not conform to the requirements of the Regulatory Guide, they are addressed in the applicable facility's SAR.
Page 14 of 45
QUALITY ASSURANCE TOPICAL REPORT Revision 0
- 13.
Regulatory Guide 1.68, Revision (site-specific), "Preoperational and Initial Startup Test Programs for Water-Cooled Power Reactors," - The commitment to this Regulatory Guide is site-specific as described in the approved SAR or License for each nuclear facility. Where items do not conform to the requirements of the Regulatory Guide, they are addressed in the applicable facility's SAR.
- 14.
Regulatory Guide 1.94, Revision (site-specific), "Quality Assurance Requirements for Installation, Inspection, and Testing of Structural Concrete and Structural Steel During the Construction Phase of Nuclear Power Plants," (ANSI N45.2.5-1974) - CGG plants may have been designed, constructed and licensed based on criteria available prior to this Regulatory Guide being issued. The specific installation, inspection, and testing criteria are reflected in each plant's SAR, and in other docketed analysis. Thus, the commitment to Regulatory Guide 1.94 is site-specific, as required by the approved SAR/License at each CGG site. Sites may use this guidance to assist in establishing the equipment to which this QA program applies, or for other purposes.
- 15.
Regulatory Guide 1.116, Revision O-R, May 1977, "Quality Assurance Requirements for Installation, Inspection, and Testing of Mechanical Equipment and Systems," (ANSI N45.2.8-1975) - CGG substitutes NQA-I-1994, Subpart 2.8 for N45.2.8 in its commitment to Regulatory Guide 1.116. As noted in Regulatory Position C.1, other industry standards may be referenced; the commitment in this QATR to NQA-1, Subpart 2.8 includes commitment to those standards to the extent necessary to implement Subpart 2.8 requirements. If NRC guidance applies to those referenced standards, it is followed. Regulatory Position C.3 recommends using Section 5 of N45.2.8 in conjunction with Regulatory Guide 1.68 for pre-operational, cold functional, and hot functional testing. While Section 5 of NQA-1, Subpart 2.8 provides the same requirements, it is anticipated that CGG plants, since they are already beyond these tests, will not need to implement Regulatory Guide 1.68. If testing in accordance with Regulatory Guide 1.68 becomes necessary, CGG will comply with the guidance of the Regulatory Guide 1.116 position.
Regulatory Position C.2 indicates that the endorsed standard should be "followed for those applicable operations phase activities that are comparable to activities occurring during the construction phase." This is addressed in section B.12 of this QATR.
- 16.
Regulatory Guide 1.143, Revision (site-specific), "Design Guidance for Radioactive Waste Management Systems, Structures and Components Installed in Light-water-Cooled Nuclear Power Plants" Commitment to Regulatory Guide 1.143 is site-specific, as required by the approved SAR at each CGG site. Sites may use this guidance to assist in establishing the lists of equipment to which this QA program applies, or for other purposes.
- 17.
Regulatory Guide 1.152, Revision 0, November 1985, "Criteria for Programmable Digital Computer System Software in Safety-Related Systems of Nuclear Power Plants" - CGG does not make a commitment to Regulatory Guide 1.152. CGG commits to Generic Letter 95-02, and its endorsement of NUMARC/EPRI Report TR-102348, "Guidelines on Licensing Digital Upgrades."
- 18.
Generic Letter 89-02/EPRI-NP-5652 (June 1988) - CGG commits to compliance with the endorsed industry guidance regarding selection and qualification of commercial grade suppliers and dedication of commercial grade items for use in safety related applications.
- 19.
Branch Technical Position CMEB 9.5-1, Revision 2, July 1981 (Positions C.2 and C.4) - None of the current CGG plants are committed to CMEB 9.5-1.
CGG plants are committed to the guidance in Appendix A to Branch Technical Position APCSB 9.5-1, "Guidelines for Fire Protection for Nuclear Power Plants Docketed Prior to July 1, 1976." However, application of the requirements is site-specific as described in the applicable facility SAR, Fire Protection Program, and License documents.
- 20.
Regulatory Guide 4.15, Revision 1, February 1979, "Quality Assurance for Radiological Monitoring Programs (Normal Operations) - Effluent Streams and the Environment" - CGG commits to compliance with the Regulatory Positions of Section C with the following alternatives/exceptions:
Page 15 of 45
QUALITY ASSURANCE TOPICAL REPORT Revision 0
- a.
In lieu of plotting background parameters and setting predetermined control values for gamma spectroscopy instrumentation as described in Regulatory Position C.6.2, background results may be logged and evaluated to ensure the background does not bias reported results.
- b.
The NRC's independent sampling and analysis program described in Regulatory Position C.6.3.2 may not be performed.
- c.
In lieu of performing source check calibrations at least once per 18 months as described in Regulatory Position C.7, CGG may perform these calibrations at least once per refueling interval.
- 21.
Regulatory Guide 7.10, Revision 1, June 1986, "Establishing Quality Assurance Programs for Packaging Used in the Transport of Radioactive Material" - CGG commits to implement the quality assurance guidance for activities related to the packaging and transport of radioactive material that are under its control. Quality Assurance for the design, fabrication and licensing of shipping containers is the responsibility of the container certificate holders.
- 22.
Regulatory Issue Summary 2000-18, October 2000, "Guidance on Managing Quality Assurance Records in Electronic Media" - Should CGG choose electronic media storage as a means of maintaining required records, CGG will comply with the guidance of this Regulatory Issue Summary.
- 23.
Generic Letter 82-21, "Technical Specifications for Fire Protection Audits," In lieu of the 12-month, 24-month and 36-month fire protection and loss prevention audits, CGG will combine the scope of the three audits into one by performing a biennial audit of the facility fire protection program and implementing procedures.
The biennial requirement includes a fire protection equipment and program implementation inspection and audit utilizing either a qualified offsite licensed fire protection engineer or an outside qualified fire protection consultant.
- 24.
Generic Letter 91-05 (April 1991) - CGG commits to compliance with the guidance regarding licensee commercial-grade procurement and dedication programs.
Page 16 of 45
QUALITY ASSURANCE TOPICAL REPORT Revision 0 B.
PERFORMANCE VERIFICATION B.1 METHODOLOGY Personnel who work directly or indirectly for CGG are responsible for the achievement of acceptable quality in the work covered by this QATR.
This includes design, engineering, procurement, manufacturing, construction, installation, start-up, maintenance, modifications, operations, and decommissioning.
CGG personnel performing verification activities are responsible for verifying the achievement of acceptable quality. Activities governed by the QA program are performed as directed by documented instructions, procedures and drawings that are of a detail appropriate for the activity's complexity and effect on safety. Instructions, procedures and drawings specify quantitative or qualitative acceptance criteria as applicable or appropriate for the activity, and verification is against these criteria.
Provisions are established to designate or identify the proper documents to be used in an activity, and to ascertain that such documents are being used.
B.2 DESIGN CONTROL Station modifications are accomplished in accordance with approved designs and procedures.
The controls apply to preparation, review and revision of design documents, including the correct translation of applicable regulatory requirements and design bases into design, procurement and procedural documents.
Configuration changes, including temporary changes, are implemented utilizing design control measures at least commensurate with those applied to the original design. Changes to design output documents, including field changes, are controlled in a manner commensurate with that used for the original design.
Information on approved changes is transmitted to affected organizations.
In addition, temporary design changes (temporary modifications), such as temporary bypass lines, electrical jumpers and lifted leads, and temporary trip-point settings, are controlled by procedures that include requirements for appropriate installation and removal verifications and status tracking.
Engineering has overall control of design documents. Design output documents, and revisions thereto, are controlled by the design office (architect-engineer, supplier, contractor, consultant or engineering) responsible for the design work. Each design organization controls design documents in accordance with approved procedures that provide for development, review, approval, distribution, document control and revision.
Design control measures are defined and implemented by trained and qualified personnel through approved procedures and instructions. These procedures and instructions assure that:
I.
Design inputs are appropriately specified on a timely basis and correctly translated into design documents.
- 2.
Design interfaces are identified and controlled.
- 3.
The design is suitable for its intended application.
- 4.
Personnel other than those who performed the design verify design adequacy.
- 5.
Design changes, including field changes, are governed by control measures.
- 6.
Deviations and nonconformances are controlled.
- 7.
Design records are identified, controlled, and retrievable.
Design inputs (such as design bases, performance requirements, regulatory requirements, codes, and standards) and changes to design inputs are identified, documented, reviewed and approved, and controlled.
Design documents, including drawings and specifications, are prepared and technically reviewed by qualified personnel.
The technical reviewer ensures that the design document is in accordance with the design concept, incorporates appropriate design inputs, and conforms to approved procedures and instructions. Appropriate management or supervision approves design change packages prior to release for implementation. Design interfaces, both internal and external, are formally identified, Page 17 of 45
QUALITY ASSURANCE TOPICAL REPORT Revision 0 and design activities are coordinated among the participating organizations to ensure that design inputs and outputs are properly developed, reviewed, approved, and distributed. Multi-discipline changes are reviewed to ensure integration of design outputs.
Design databases, documents, and procedures are revised to reflect changes installed in the plant. Design records are identified, indexed, and controlled to allow for retrievability of design basis information and to provide evidence of appropriate design controls.
In establishing its program for design control, CGG commits to compliance with NQA-I, 1994, Basic Requirement 3, and Supplement 3S-1, Sections 1, 2, 3, 5, 6, and 7.
B.3 DESIGN VERIFICATION Design verification is the process of reviewing, confirming, or substantiating the design to assure the acceptability of the design inputs; adherence to the design process; that design inputs are reflected in the design outputs; and that design changes are implemented under controls commensurate with those applied to the initial design. The extent of and methods used for design verification are documented.
Methods for design verification include evaluation of the applicability of standardized or previously proven designs, alternate calculations, qualification testing and design reviews. These methods may be used singly or in combination, depending on the needs for the design under consideration. When design verification is done by evaluating standardized or previously proven designs, the applicability of such designs is confirmed. Any differences from the proven design are documented and evaluated for the intended application.
Design reviews are performed by individuals, or by interdisciplinary or multi-organizational groups, as appropriate. Unless otherwise stated, the verification of design addresses the information conveyed by the design document. When the verification is limited to certain areas or features, the scope or extent and any limitations on the verification are documented.
Qualification testing of prototypes, components, or features is used when the ability of an item to perform an essential safety function cannot otherwise be adequately substantiated.
This testing is performed before Station equipment installation where possible, but always before reliance upon the item to perform a safety-related function. Qualification testing is performed under conditions that simulate the most adverse design conditions as determined by analysis, considering relevant operating modes.
Test requirements, procedures and results are documented.
Results are evaluated to assure that test requirements have been satisfied. Modifications are made if shown to be necessary through testing.
Following modification, any necessary retesting or other verification is performed. Scaling laws are established and verified when applicable. Test configurations are documented.
Persons representing applicable technical disciplines are assigned to perform design verifications. These persons are qualified by appropriate education or experience and are not directly responsible for the design being verified.
The originator's supervisor may perform this verification, provided (1) the supervisor did not specify a singular design approach or rule out certain design considerations, and did not establish the design inputs used in the design; or (2) the supervisor is the only individual in the organization competent to perform the verification, and receives written approval by the appropriate engineering manager.
When designs must be released for use before they have been completed or before they have been verified, the incomplete or unverified parts of the design and the hold point to which work may proceed are identified, and design output documents based on unverified data are identified and controlled. This hold point occurs before the work becomes irreversible or before the item is relied on to perform a safety-related function. Justification for such early release is documented.
Page 18 of 45
QUALITY ASSURANCE TOPICAL REPORT Revision 0 Procedures define acceptable verification methods and controls, design parameters subject to verification, acceptance criteria, and verification documentation and records requirements.
In establishing its program for design verification, CGG commits to compliance with NQA-l, 1994, Basic Requirement 3, and Supplement 3S-1, Section 4.
B.4 PROCUREMENT CONTROL Procurement documents define the characteristics of items or services to be procured, identify applicable regulatory and industry codes or standards requirements, and specify supplier QA program requirements to the extent necessary to assure adequate quality.
Prospective suppliers of safety-related items and services are evaluated to assure that only qualified suppliers are used. Qualified suppliers are periodically evaluated to assure they continue to provide acceptable products and services. Industry programs, such as those applied by ASME, NUPIC, or other established utility groups, are used as input or the basis for supplier qualification whenever appropriate.
In addition, CGG commits to Position C.3.2 of Regulatory Guide 1.28, Revision 3, for auditing and evaluation of suppliers, with the exception that for position C.3.2.2, CGG will review the information described therein as it becomes available through its ongoing receipt inspection, operating experience, and supplier evaluation programs, in lieu of performing a specific evaluation on an annual basis. The results of the reviews are promptly considered for effect on a supplier's continued qualification and adjustments made as necessary (including corrective actions, adjustments of supplier audit plans, and input to third party auditing entities, as warranted). In addition, results are reviewed periodically to determine if, as a whole, they constitute a significant condition adverse to quality requiring additional action.
A grace period of 90 days may be applied to the performance of triennial supplier audits described in Regulatory Guide 1.28, Revision 3, Regulatory Position 3.2.1. The grace period does not allow the "clock" for a particular activity to be reset forward. However, the "clock" for an activity is reset backwards by performing the activity early. CGG considers that other 10 CFR 50 licensees, Authorized Nuclear Inspection Agencies, National Institute of Standards and Technology, or other State and Federal agencies which may provide items or services to CGG plants are not required to be evaluated or audited.
Procurement of safety-related items and services from suppliers is permitted when CGG has performed a documented evaluation of their capability to provide the items or services specified by procurement documents. However, such evaluation for items or services specified may not necessarily result in the supplier being placed on the Approved Vendors List (AVL). In instances where an identified supplier is the only practical source, procurement may be authorized subject to satisfactory surveillance of the processes and characteristics identified in items (1.) and (2.) below:
- 1.
The supplier is capable of meeting specific procurement document requirements by virtue of their ability to control critical manufacturing and functional processes and characteristics identified by engineering; and
- 2.
Methods have been identified and documented which will verify conformance to these requirements.
When required by operational considerations, an order may be placed with a supplier prior to completion of the evaluation and approval process only after obtaining approval from the nuclear site individual responsible for the procurement function.
CGG's acceptance of basic component items or services provided by an unapproved supplier is contingent on the subsequent Q&PA evaluation and approval of the supplier as stated above.
Procurement planning by procuring organizations consists of determining the supplier of choice, methods to be used for acceptance of the item or service, and provisions for ensuring that qualified suppliers Page 19 of 45
QUALITY ASSURANCE TOPICAL REPORT Revision 0 continue to provide acceptable products and services. Source inspection (surveillance), certificate of conformance, receipt inspection, and pre-or post-installation testing are methods that are considered for item acceptance. The extent of the acceptance methods and associated verification activities will vary depending upon the relative importance and complexity of the purchased item or service and the supplier's past performance.
The contents of procurement documents vary according to the item and/or service being purchased and its function in the plant. Procurement documents include the following, as applicable:
- 1.
Material description and/or scope of work to be performed.
- 2.
Technical requirements with reference to applicable drawings, specifications, codes and standards identified by title, document number, revision and date. Any required procedures, such as special process instructions, are identified in such a way as to indicate source and need.
- 3.
Regulatory, administrative and reporting requirements. This includes IOCFR21 requirements, specifications, codes, standards, tests, inspections, and special processes.
(The QA programmatic requirements of ASME NQA-I or ANSI N45.2 may be used, where appropriate.)
- 4.
A requirement for a documented QA program.
- 5.
A requirement for the supplier to invoke applicable quality requirements on subtier suppliers.
- 6.
Provisions for access to supplier and subtier suppliers' facilities and records for inspections, surveillances and audits.
- 7.
Identification of documentation to be provided by the supplier.
- 8.
Provisions for documentation and dispositioning of nonconformances.
Spare and replacement parts are procured in accordance with the following provisions to assure that their performance and quality are at least equivalent to those of the parts that will be replaced:
- 1.
Specifications and codes referenced in procurement documents for spare or replacement items are the same or equivalent to those for the original items or to the reviewed and approved revisions;
- 2.
Where quality requirements for the original items cannot be determined, requirements and controls are established by an engineering evaluation; and
- 3.
Any additional or modified design criteria imposed after previous procurement of the item(s), are identified and incorporated.
Appropriate controls are imposed for the selection, determination of suitability for intended use (critical characteristics), evaluation, receipt, and quality evaluation of commercial grade items or services to ensure that they will perform satisfactorily in service.
In establishing controls for procurement, CGG commits to compliance with NQA-I, 1994, Basic Requirements 4 and 7, and Supplements 4S-1 and 7S-1, with the following exceptions:
I.
For Supplement 4S-1, Section 2.3, which requires procurement documents to require a quality program that complies with NQA-I, CGG may apply other nationally recognized and NRC endorsed quality standards, such as N45.2 or IOCFR50 Appendix B, as appropriate to the circumstances of the procurement.
- 2.
For Supplement 4S-1 and Supplement 7S-1, CGG will use the guidance contained in Generic Letters 91-05 and 89-02/EPRI NP-5652 to procure Commercial Grade Items in lieu of these requirements.
- 3.
For Supplement 7S-1, Section 8.1, documentary evidence that items conform to procurement requirements need not be available at the site prior to item installation, but will be available at the site prior to placing reliance on the item for its intended safety function.
Page 20 of 45
QUALITY ASSURANCE TOPICAL REPORT Revision 0
- 4.
Supplement 7S-1 Paragraph 8.2.4 states "...post-installation test requirements and acceptance documentation shall be mutually established by the Purchaser and Supplier."
In exercising ultimate responsibility for its QA Program, CGG establishes post-installation test requirements, giving due consideration to supplier recommendations.
B.5 PROCUREMENT VERIFICATION CGG establishes and implements measures to verify the quality of purchased items and services, whether purchased directly or through contractors, at intervals and to a depth consistent with the item's or service's importance to safety, complexity, quantity and the frequency of procurement. Verification actions include testing, as appropriate, during design, fabrication and construction activities associated with plant maintenance or modifications.
Verifications occur at the appropriate phases of the procurement process, including, as necessary, verification of activities of suppliers below the first tier.
When suppliers perform work under their own QA programs, those programs are reviewed for compliance with the applicable requirements of IOCFR50 Appendix B and the contract.
In establishing procurement verification controls, CGG commits to compliance with NQA-I, 1994, Basic Requirement 7 and Supplement 7S-1.
B.6 IDENTIFICATION AND CONTROL OF ITEMS CGG establishes and implements provisions for the identification and control of items to prevent the use of incorrect or defective items. This includes controls for consumable materials and items with limited shelf life. The identification of items is maintained throughout fabrication, erection, installation and use so that the item can be traced to its documentation, consistent with the item's effect on safety. Marking locations and methods are selected so as not to affect the function or quality of the item.
In establishing provisions for identification and control of items, CGG commits to compliance with NQA-I-1994, Basic Requirement 8 and Supplement 8S-I.
B.7 HANDLING, STORAGE, AND SHIPPING CGG establishes and implements provisions to control the handling, storage, shipping, cleaning and preservation of items to prevent inadvertent damage, loss or deterioration. These provisions include specific procedures, when required to maintain acceptable quality, for cleaning, handling, storage, packaging, shipping and preserving items important to safety.
Items are appropriately marked and labeled during packaging, shipping, handling and storage to identify, maintain and preserve the item's integrity and indicate the need for special controls. Special controls (such as containers, shock absorbers, accelerometers, inert gas atmospheres, specific moisture content levels and temperature levels) are provided when required to maintain acceptable quality.
In establishing provisions for handling, storage and shipping, CGG commits to compliance with NQA-I-1994, Basic Requirement 13 and Supplement 13S-1. CGG sites also commit to items I or 2 below:
I.
Regulatory Guide 1.38, Revision (site-specific), "Quality Assurance Requirements for Packaging, Shipping, Receiving, Storage, and Handling of Items for Water-Cooled Nuclear Power Plants," (ANSI N45.2.2-1972) - The commitment to this Regulatory Guide is site-specific as described in the approved SAR or License for each nuclear facility. Where items do not conform to the requirements of the Regulatory Guide, they are addressed in the applicable facility's SAR.
Page 21 of 45
QUALITY ASSURANCE TOPICAL REPORT Revision 0
- 2.
This alternative applies to Nine Mile Point Nuclear Station (NMPNS).
NMPNS commits to ANSI/ASME NQA-2-1983 Part 2.2, "Quality Assurance Requirements for Packaging, Shipping, Receiving, Storage, and Handling of Items for Nuclear Power Plants," for nuclear safety-related activities pertaining directly to permanent plant modifications only. NQA-2-1983 Section 7.1 refers to NQA-2-1983 Part 2.15 for requirements related to handling of items. The scope of Part 2.15 includes hoisting, rigging and transporting of items for nuclear power plants. This scope exceeds the scope of the NRC's original endorsement of ANSI N45.2.2 in Regulatory Guide 1.38, and establishes requirements for which there is no NRC regulatory position. In lieu of compliance with Part 2.15, NMPNS is committed to the requirements of applicable heavy load reports for Nine Mile Point Units 1 and 2 that have been approved by the NRC. Unit 2's report is a part of the SAR (Appendix 9C). Unit l's is a separate report.
Housekeeping practices during normal operations and maintenance activities, including refueling, are established to account for the control of radiation zones and other conditions or environments that could affect the quality of structures, systems and components within the plant. This includes control of cleanness of facilities and materials, fire prevention and protection, disposal of combustible material and debris, control of access to work areas, protection of equipment, radioactive contamination control and storage of solid radioactive waste. Housekeeping practices assure that only proper materials, equipment, processes and procedures are used and that the quality of items is not degraded as a result. Necessary procedures or work instructions, such as for electrical bus and control center cleaning, cleaning of control consoles, and radioactive decontamination are developed and used.
In addition, CGG commits to compliance with the requirements of NQA-I-1994, Subpart 2.3, to establish appropriate provisions for housekeeping; with the following exception:
- 1.
In lieu of the five-level zone designation in Subpart 2.3, CGG may base its control over housekeeping activities on a consideration of what is necessary and appropriate for the activity involved. The controls are effected through procedures or instructions. Factors considered in developing the procedures and instructions include cleanliness control, personnel safety, fire prevention and protection, radiation control and security. The procedures and instructions make use of standard janitorial and work practices to the extent possible.
CGG establishes appropriate cleanliness controls for work on safety related equipment to minimize introduction of foreign material and maintain system/component cleanliness throughout maintenance or modification activities, including documented verification of absence of foreign materials prior to system closure. In addition, CGG commits to compliance with the requirements of Regulatory Guide 1.37, March 1973, "Quality Assurance Requirements for Cleaning of Fluid Systems and Associated Components of Water-Cooled Nuclear Power Plants," (ANSI N45.2.1-1973) - The commitment to this Regulatory Guide is site-specific as described in the approved SAR or License for each nuclear facility.
Where items do not conform to the requirements of the Regulatory Guide, they are addressed in the applicable facility's SAR.
B.8 TEST CONTROL CGG establishes and implements testing programs to demonstrate that items subject to the provisions of this QATR will perform satisfactorily in service, that the plant can be operated safely and as designed, and that the coordinated operation of the plant as whole is satisfactory.
This testing involves the operation of all items in a system or partial system to assure that operation is in accordance with the design criteria and functional requirements.
These programs include criteria for determining when testing is required, such as proof tests before installation, pre-operational tests, post-maintenance tests, post-modification tests, inservice tests, and operational tests (such as surveillance tests required by Plant Technical Specifications), to demonstrate that performance of plant systems is in accordance with design intent. Programs also include provisions for establishing and adjusting test schedules and maintaining status for periodic or recurring tests.
Tests are performed according to applicable procedures that Page 22 of 45
QUALITY ASSURANCE TOPICAL REPORT Revision 0 include, consistent with the effect on safety, (I) instructions and prerequisites to perform the test, (2) use of proper test equipment, (3) acceptance criteria, and (4) mandatory verification points as necessary to confirm satisfactory test completion. Test results are documented and evaluated by the organization performing the test and reviewed by the appropriate authority having responsibility for the item being tested. If acceptance criteria are not met, retesting is performed as needed to confirm acceptability following correction of the system or equipment deficiencies that caused the failure.
In establishing provisions for testing, CGG commits to compliance with NQA-l, 1994, Basic Requirement I I and Supplement 1 IS-1.
B.9 MEASURING AND TEST EQUIPMENT CONTROL CGG establishes and implements provisions to control the calibration, maintenance, and use of measuring and test equipment. The provisions cover equipment such as instruments and gages, tools, reference and transfer standards, and nondestructive examination equipment. The provisions assure that:
- 1.
Measuring and test equipment is calibrated at specified intervals on the basis of the item's required accuracy, intended use, frequency of use, and stability characteristics or other conditions affecting its performance. Alternatively, equipment may be calibrated immediately before and after use if a defined interval is not appropriate.
- 2.
Measuring and test equipment is labeled, tagged or otherwise controlled to indicate its calibration status and provide traceability to calibration test data or records.
- 3.
Calibrations are performed against standards that have an accuracy of at least four times the required accuracy of the equipment being calibrated. When this is not possible, an evaluation of the uncertainty is performed to ensure the equipment being calibrated will be within the required tolerance.
- 4.
Where possible, calibration standards are traceable to appropriate national standards. Calibration standards have greater accuracy than the standards being calibrated, except where the same accuracy as the instruments being calibrated can be shown to be adequate for the service requirements.
- 5.
Measuring and test equipment found out of calibration is tagged or segregated and not used until it is successfully re-calibrated. An evaluation is performed to determine the acceptability of any items measured, inspected or tested with an out-of-calibration device from the time of the previous calibration.
In establishing provisions for control of measuring and test equipment, CGG commits to compliance with NQA-1, 1994, Basic Requirement 12, Supplement 12S-1.
B. 10 INSPECTION, TEST, AND OPERATING STATUS CGG establishes and implements measures to identify the inspection, test and operating status of items and components subject to the provisions of this QATR in order to maintain personnel and reactor safety and avoid unauthorized operation of equipment. Procedures require control measures such as locking, tagging, marking, logging or other suitable means to secure and identify equipment in a controlled status.
Where necessary to preclude inadvertent bypassing of inspections or tests, or to preclude inadvertent operation, these measures require the inspection, test or operating status be verified before release, fabrication, receipt, installation, test or use.
Authority for the application and removal of status indicators or labels is controlled by procedures.
Page 23 of 45
QUALITY ASSURANCE TOPICAL REPORT Revision 0 In establishing measures for control of inspection, test and operating status, CGG commits to compliance with NQA-1, 1994, Basic Requirement 14.
B.1 1 SPECIAL PROCESS CONTROL CGG establishes and implements provisions to assure that special processes that require interim process controls to assure quality, such as welding, heat treating, chemical cleaning, and nondestructive examination, are controlled. These provisions include assuring that special processes are accomplished by qualified personnel using qualified procedures and equipment. Special processes are performed in accordance with applicable codes, standards, specifications, criteria or other specially established requirements. Special processes are those where the results are highly dependent on the control of the process or the skill of the operator, or both, and for which the specified quality cannot be fully and readily determined by inspection or test of the final product.
In establishing measures for the control of special processes, CGG commits to compliance with NQA-I, 1994, Basic Requirement 9 and Supplement 9S-1, as well as the applicable ASME Boiler and Pressure Vessel Code provisions established via 10CFR50.55a.
B. 12 INSPECTION CGG establishes and implements provisions for inspections to assure that items, services and activities affecting safety meet established requirements and conform to applicable documented instructions, procedures and drawings. Inspection may also be applied to items, services and activities affecting plant reliability. Types of inspections may include those verifications related to procurement, as discussed in Sections B.4 and B.5, such as source, in-process, final, and receipt inspection, as well as maintenance, modification, in-service, and operational activities. Inspections are carried out by properly qualified persons independent of those who performed or directly supervised the work.
Inspection planning (for those activities subject to inspection) identifies the characteristics and activities to be inspected, the inspection techniques, the acceptance criteria and the organization responsible for performing the inspection. Inspection planning identifies required hold points, beyond which work is not to proceed without the consent of the inspection organization. Provisions for ASME Boiler and Pressure Vessel Code Authorized Inspections are included when required.
Inspection results are documented by the inspector and approved by authorized personnel. If acceptance criteria are not met, corrected areas are reinspected.
In establishing inspection requirements, CGG commits to compliance with NQA-I-1994, Basic Requirement 10, Supplement 1OS-1. In addition, for situations comparable to original construction, CGG commits to compliance with the requirements of Subpart 2.8 for establishing appropriate inspection requirements.
B. 13 CORRECTIVE ACTION CGG establishes and implements provisions to assure that personnel have both the responsibility and authority to identify conditions adverse to quality, and the opportunity to suggest, recommend or provide solutions to resolve the condition. Provisions also include verification of resolution of significant issues (see also section A.6). Reworked, repaired and replacement items are inspected and tested to meet the Page 24 of 45
QUALITY ASSURANCE TOPICAL REPORT Revision 0 original inspection or test requirements, or appropriately specified alternatives (see also sections B.8 and B.12).
If evidence indicates that common components in safety related systems have performed unsatisfactorily, compensatory or corrective measures are planned prior to replacement or repair of such components.
Replacement components receive adequate testing or are of a design for which experience indicates a high probability of satisfactory performance. Consideration is given to phased replacement to permit inservice performance to be evaluated and minimize the possibility of systemic failure.
Issues are periodically analyzed for the identification of adverse quality trends. The existence of an adverse quality trend is resolved in accordance with this section. A trend report is issued to management at intervals specified in approved procedures.
Nonconforming items may be conditionally released for installation, test, energization, pressurization, or use if the conditional release will not adversely affect nor preclude identification and correction of the nonconformance. Dispositions of conditionally released items are resolved before the items are relied upon to perform their safety-related functions.
Conditional release evaluations are documented, reviewed, and approved prior to implementation.
In establishing provisions for corrective action and control of non-conforming items, CGG commits to compliance with NQA-I, 1994, Basic Requirements 15 and 16, and Supplement 15S-I.
B.14 DOCUMENT CONTROL CGG establishes and implements provisions to specify the format and content (see Appendix B for procedures), and control the development, review, approval, issue, use and revision, of documents that specify quality requirements or prescribe activities affecting quality or safe operation to assure the correct documents are being employed. These provisions assure that specified documents are reviewed for adequacy, approved prior to use by authorized persons, and distributed according to current distribution lists and used at the location where the prescribed activity takes place. Procedures governing generating site activities (see Appendix B) are reviewed by qualified persons, other than the originator or preparer. Such procedure review includes determination whether additional cross-discipline reviews are required. Provisions include establishing levels of use, such as requiring the document to be present at the work location. Documents subject to control provisions include, but are not limited to, drawings (design, as-built), engineering documents (calculations, analyses, specifications, computer codes, Safety Analysis Reports, facility Technical Specifications), and procedures (administrative, operating, emergency operating, maintenance, calibration, surveillance, inspection, test). Other documents, such as those related to procurement, corrective actions, and assessments, are controlled as defined by the provisions and commitments cited in those sections of this QATR. Controlled copies of instructions and procedures are made available to and used by the persons performing the activity covered. New or revised controlled documents are made available in a timely fashion to support ongoing work and preclude use of incorrect information.
Superseded documents are identified or removed from availability.
Each site maintains documentation that describes how implementing documents are maintained to assure that quality assurance program requirements are met and are not inadvertently removed in later revisions.
Revisions to controlled documents are reviewed for adequacy and approved for release by the same organization(s) as originally did so, or by other designated organizations that are qualified and sufficiently knowledgeable of the requirements and intent of the original document.
CGG also establishes programmatic procedure preparation, review and usage controls that ensure procedures are technically and administratively correct.
These controls ensure that procedures are reviewed when pertinent source material is revised (such as when Technical Specifications are revised), when unusual incidents occur, when plant modifications are made, and when significant deficiencies are identified.
Page 25 of 45
QUALITY ASSURANCE TOPICAL REPORT Revision 0 Procedures may also be reviewed because industry experience reviews, use during job execution or training, self-assessments, or independent assessments identify deficiencies or opportunities for improvement. Revisions are made as necessary.
Temporary changes to approved procedures that do not change the intent are approved by two members of plant staff knowledgeable in the areas affected by the procedure. Temporary changes to procedures identified in Appendix B are approved by two members of plant staff knowledgeable in the areas affected by the procedure, at least one of whom is a person holding an active senior reactor operator's license.
Temporary changes are documented, reviewed by the PORC or by a Qualified Reviewer, and approved by the designated approval authority within 14 days of implementation.
The Plant General Manager may designate specific procedures or classes of procedures in writing to be reviewed by Qualified Reviewers in lieu of review by the PORC. Review by Qualified Reviewers shall be in accordance with implementing procedures. In addition, IOCFR50.59 and/or 10CFR72.48 reviews are performed on designated procedures, including subsequent changes, to determine if NRC review and approval is required prior to implementing the procedures/changes.
Procedures required by Technical Specifications shall be approved by the Plant General Manager or by cognizant managers or other supervisory personnel prior to implementation as specified by administrative requirements. The approval authority for specific procedures or classes of procedures shall be designated in writing by the Plant General Manager.
In establishing provisions for document control, CGG commits to compliance with NQA-1, 1994, Basic Requirement 6 and Supplement 6S-1.
B.15 RECORDS CGG establishes and implements provisions to ensure that sufficient records of items and activities affecting quality are generated and maintained to reflect completed work. Such records may include, but are not limited to, design, engineering, procurement, manufacturing, construction, inspection, test, installation, modification, operations, maintenance, decommissioning, corrective action, assessment, and associated reviews.
The provisions establish requirements for records administration, including generation, receipt, preservation, storage, safekeeping, retrieval and final disposition. For activities governed by IOCFR71 or 72, these provisions address the specific requirements of sections 71.135 and 72.174.
CGG uses the list of records in IOCFR71.135, 10CFR72.174, and Regulatory Guide 1.28, Revision 3, position C.2 (Table 1) to establish the types of records that will be created and retained in support of plant operation. Regulatory Guide 1.28, Revision 3, Table 1 addresses design, construction and initial start-up records and will be applied to operating and decommissioning phase records that are similar in nature to the construction records. Additional operations phase records and their retention periods are identified in Appendix D to this QATR. In those cases where local or State retention requirements are more restrictive than the regulatory guidance, the more restrictive requirements are met. In addition, should CGG choose electronic media storage as a means of maintaining required records; CGG will comply with NRC guidance in RIS 2000-18.
In establishing provisions for records, CGG commits to compliance with NQA-I, 1994, Basic Requirement 17 and Supplement 17S-1, with the following exceptions:
I.
Supplement 17S-1, section 4.2(b) requires records to be firmly attached in binders or placed in folders or envelopes for storage in steel file cabinets or on shelving in containers. For hard-copy records maintained by CGG, the records are suitably stored in steel file cabinets or on shelving in Page 26 of 45
QUALITY ASSURANCE TOPICAL REPORT Revision 0 containers, except that methods other than binders, folders or envelopes may be used to organize the records for storage.
- 2.
In lieu of the storage facility requirements of Supplement 17S-I Section 4.4, CGG allows the following alternative storage requirements for organizations other than the records management organization.
Organizations that originate records and do not transfer them to the records management within 30 days of completion shall establish one of the following three controls as alternatives to the requirements specified for the records management organization:
I)
Duplicate Storage - Either A or B.
A.
Within 30 days of completion of a record, a duplicate record file shall be established. This activity shall be controlled by procedures which provide for the following: (a) Assignment of responsibility for records; (b) Description of storage area; (c) Description of filing system; (d) An index of the filing system; (e) Rules governing access to and control of files; (f) Methods for maintaining control of and accountability for records removed from the file; (g) Method for filing supplemental information and disposing of superseded or obsolete records; (h) Method for preserving records to prevent deterioration; (i) Method for maintaining specially processed records that are sensitive to light, pressure, or temperature; (j) Transfer of duplicates to the records management organization within two years of completion of records.
B.
Make arrangements with at least one other department that receives a copy of each document to subject this other copy to the controls specified above.
- 2)
Fire-resistant Building Storage - Records shall be stored in steel cabinets located in a non-combustible building with a fire suppression system.
The procedural controls defined for duplicate storage shall be applied.
- 3)
Non-fire-resistant Building Storage - Within non-fire-iesistant facilities, records shall.be stored in UL one-hour-minimum fire-rated storage cabinets and be subject to the procedural controls defined for duplicate storage.
CGG defines a non-combustible Building as follows: A facility constructed to resist the initiation or spreading of fire; non-combustible materials used; building construction evaluated by fire protection consultant or engineer and found to be in accordance with requirements of applicable building construction code for "non-combustible" construction.
- 3.
This alternative applies to Calvert Cliffs Nuclear Power Plant. In lieu of the reinforced concrete, concrete block, masonry, or equal construction requirements of Supplement 17S-1, Section 4.4.1(a), the records vault is entirely enveloped by a structurally sound, non-combustible building. Second, the vault rests on a reinforced slab on grade and its walls extend fully to the underside of the structural deck. Third, the walls of the vault are constructed of gypsum wallboard on metal studs per Underwriters Laboratory Test Number U412, assuring the equivalent of 2-hour fire resistant construction. This is equal construction to concrete block in terms of fire protection.
The walls carry no structural load; hence, they provide equivalent structural integrity to that needed of concrete block. Supplement 17S-1 Section 4.4.1(b) requires floor and roof drainage control. If a floor drain is provided, a check valve (or equal) shall be included. In lieu of this requirement, the vault is contained within an environmentally protected building. As such, it has no roof, or need for floor drain.
B. 16 PLANT MAINTENANCE CGG establishes controls for the maintenance or modification of items and equipment subject to this QATR to ensure quality at least equivalent to that specified in original design bases and requirements, such that safety-related structures, systems and components are maintained in a manner that assures their Page 27 of 45
QUALITY ASSURANCE TOPICAL REPORT Revision 0 ability to perform their intended safety function(s). A preventative maintenance program prescribes the frequency and type of maintenance to be performed. Adjustments are made where necessary to improve equipment performance.
Maintenance activities (both corrective and preventive) are scheduled and planned so as not to unnecessarily compromise the safety of the plant. Permission to release equipment or systems for maintenance is granted by designated operating personnel who are responsible to verify that the equipment or system can be released and determine how long it may be out of service. This includes attention to the potentially degraded degree of protection when one subsystem of a redundant safety system has been removed for maintenance. The release is also documented. When equipment is ready to be returned to service, operating personnel place the equipment in operation and verify and document its functional acceptability. In completing maintenance and restoring equipment, attention is given to restoration of normal conditions, such as removal of jumpers or signals used in maintenance or testing, or such as returning valves, breakers or switches to proper operating positions. Inspections (verifications) of maintenance or modification activities are established, conducted and documented as required by Section B.12 to establish a suitable level of confidence in affected structures, systems, or components.
B.17 COMPUTER SOFTWARE CONTROL CGG establishes and implements provisions to assure that computer software used in applications affecting safety is prepared, documented, verified and tested, and used such that the expected output is obtained and configuration control maintained.
To this end, CGG commits to compliance with the requirements of NQA-I 1994, Supplement 1 IS-2 to establish the appropriate provisions.
Page 28 of 45
QUALITY ASSURANCE TOPICAL REPORT Revision 0 C.
ASSESSMENT C.1 METHODOLOGY Personnel responsible for the self-assessment function, including onsite and offsite nuclear safety review committee activities, audits, and other independent assessments are cognizant of day-to-day activities so that they can act in a management advisory function. Self-assessment activities are technically and performance oriented, with the primary focus on the quality of the end product and a secondary focus on procedures and processes. Self-assessments are accomplished using instructions, procedures, or other appropriate means that are of a detail commensurate with the activity's complexity and importance to safety.
Ongoing and periodic self-assessments are used to identify safety concerns and improve performance.
Self-assessments compare actual performance to management expectations, performance of other high-performing organizations, industry standards of excellence, and regulatory requirements.
- Skilled, knowledgeable internal and external personnel perform self-assessments. Improvement needs identified by self-assessments are assigned for action and tracked through completion.
Benchmarking is used to identify options for solving problems, improving performance, and emulating best practices. Managers and coworkers frequently observe work and training activities to recognize strong performance and identify needed improvements. Performance measures are used to identify areas of strong performance, areas needing improvement, and precursors to significant problems.
The organization supports and learns from participation in self-assessments and evaluations at other facilities.
Results of self-assessments, observations, corrective actions, and independent oversight assessments are reviewed for underlying problems that need resolution. Self-assessment and corrective action program effectiveness is periodically assessed and the programs are adjusted.
C.2 QUALITY AND PERFORMANCE ASSESSMENT A program of planned and periodic assessments is established and implemented to confirm that activities affecting quality comply with the QA program and that the QA program has been implemented effectively. Assessments provide comprehensive independent evaluation of activities and procedures.
Monitoring and assessment activities are conducted in sufficient depth to identify potentially significant nuclear safety problems. Planning activities identify the characteristics and activities to be assessed and the acceptance criteria. Assessments are conducted using the predetermined acceptance criteria. Use of relevant industry and in-house operating experience information is reviewed during periodic assessments.
Scheduling and resource allocation are based on the status and safety importance of the activity or process being assessed. Scheduling is dynamic to allow for additional assessments in areas where QA program effectiveness is in doubt.
Activities of groups performing independent monitoring and assessment are coordinated to encompass all matters relevant to nuclear safety and reliability.
Audits of selected aspects of operational phase activities are performed with a frequency commensurate with their strength of performance and safety significance and in such a manner as to assure that an audit of all safety-related functions is completed within a period of two years. Audits may also be used to meet the periodic review requirements of the code for the Security, Emergency Preparedness, and Radiological Protection programs within the provisions of the applicable code. Audits and assessment activities may be conducted continuously.
Page 29 of 45
QUALITY ASSURANCE TOPICAL REPORT Revision 0 The audits performed within a period of two years will include, as a minimum, activities in the following areas:
I.
The results of actions taken to correct deficiencies that affect nuclear safety and occur in facility equipment, structures, systems, or method of operation.
- 2.
The conformance of facility operation to provisions contained within the technical specifications and applicable license conditions, including administrative controls.
- 3.
The performance, training, and qualifications of the facility staff.
- 4.
The performance of activities required by the QA program to meet the criteria of 10CFR50, Appendix B.
- 5.
Observation of performance of operating, refueling, maintenance and modification activities.
- 6.
The Fire Protection Program and implementing procedures. A fire protection equipment and program implementation inspection and audit utilizing either a qualified offsite fire protection engineer or an outside qualified fire protection consultant.
- 7.
The radiological environmental monitoring program and the results thereof;
- 8.
The Offsite Dose Calculation Manual and implementing procedures;
- 9.
The Process Control Program and implementing procedures for processing and packaging of radioactive wastes;
- 10.
The performance of activities required by the QA program for effluent and environmental monitoring; and
- 11.
Other activities and documents considered appropriate by the NSRB or the CNO.
A grace period of 90-days is applied to the audits listed above. The grace period does not allow the "clock" for a particular period to be reset forward. For example, if a biennial audit is due on June 15 of a particular year, but is not performed until August 13, the next due date for that audit will be June 15 of the second year following. However, the clock for an activity is reset backwards by performing the activity early. The 90-day grace period does not apply to audits specified in regulations (i.e. Emergency Preparedness, Security, and Fitness for Duty).
Assessment results are documented and reviewed by the assessor's management and by management having responsibility in the area assessed. Actions to address issues identified through independent monitoring and assessment activities are tracked and completed in a timely manner. Follow-up action, including a re-look at deficient areas, is initiated as necessary.
When work carried out under the requirements of the QA program is delegated to others, implementation of that work is assessed by CGG.
If a difference of opinion arises between Q&PA personnel and those of other Sections or Departments, the dispute is resolved as follows: The site management position responsible for Q&PA first tries to resolve the matter with the organization responsible for conducting the activity. If a resolution cannot be obtained, the matter is referred up through the following management personnel until it is resolved:
- 1.
The site management position responsible for Q&PA and the site management position responsible for performing the activity. NOTE: If the dispute is internal to Q&PA, the site management position responsible for Q&PA will settle the issue.
- 2.
The fleet management position responsible for Q&PA and the appropriate Site Vice President
- 3.
The Senior Vice President and Chief Nuclear Officer Individuals assigned to perform independent monitoring and assessments have the necessary experience, training, and authority to conduct the reviews, audits, or analyses.
Individuals assigned to perform independent monitoring and assessments do not have line responsibility for the area being assessed.
Assessment resources may be supplemented with technical specialists as needed.
Page 30 of 45
QUALITY ASSURANCE TOPICAL REPORT Revision 0 The effectiveness of independent monitoring and assessments are evaluated every two years by an independent organization such as the Nuclear Industry Evaluation Program (NIEP). Results are reported to senior management, and corrective actions are implemented as needed.
In establishing the independent assessment program, CGG commits to compliance with NQA-I-1994, Basic Requirement 18 and Supplement 18S-1.
Page 31 of 45
QUALITY ASSURANCE TOPICAL REPORT Revision 0 APPENDIX A REVIEW FUNCTIONS OF THE PORC, NSRB, AND ISEG CGG ensures that operational phase activities of the facilities are independently reviewed on a periodic basis. The purpose of these reviews is to: (I) verify that operational phase activities are performed in accordance with this QATR and CGG administrative controls, procedures, and license provisions; (2) review significant proposed plant changes, tests, and procedures; (3) verify that events that are reportable to the NRC are promptly investigated and corrected so as to reduce the probability of recurrence; and (4) detect trends that may not be apparent to a day-to-day observer.
These review functions are performed through a combination of independent review bodies and internal audits. This appendix describes the review program implemented by the independent review bodies.
The internal audit program is addressed in Section C.2 of this QATR. The review programs of this appendix ensure that the personnel performing this review collectively have the experience and competence necessary to review problems in the following areas:
- 1.
Nuclear power plant operations
- 2.
Nuclear engineering
- 3.
Chemistry and radiochemistry
- 4.
Metallurgy
- 5.
Nondestructive testing
- 6.
Radiological safety
- 7.
Mechanical engineering
- 8.
Electrical engineering
- 9.
Instrumentation and control
- 10.
Administrative controls and quality assurance practices
- 11.
Training
- 12.
Emergency plans and related procedures and equipment An individual may possess competence in more than one specialty area. The established administrative controls contain provisions to assure the appropriate expertise is applied to the independent reviews, including the use of consultants when necessary Personnel performing the independent review functions meet the qualification requirements of ANS-3. I -
1993, subsection 4.7, as clarified in NRC Regulatory Guide 1.8, Revision 3, and this QATR.
The provisions of Section 4.1.1.1 of ANS-3.1-1993 may be applied. Independent review personnel shall also complete the required qualification training for the function they are performing.
Page 32 of 45
QUALITY ASSURANCE TOPICAL REPORT Revision 0 1.0 PLANT OPERATIONS REVIEW COMMITTEE (PORC) 1.1 FUNCTION The PORC shall function to advise the Plant General Manager on all matters related to nuclear safety for their assigned Company facilities.
1.2 COMPOSITION The PORC shall be composed of a minimum of five members, including the Chairperson. The Plant General Manager shall appoint members in writing, including the PORC Chairperson and Vice Chairpersons drawn from the committee members.
1.3 ALTERNATES Alternate members shall be appointed in writing by the PORC Chairperson to serve on a temporary basis.
Each alternate shall meet the minimum qualifications for regular PORC members, and shall have the same area of expertise as the member being replaced.
1.4 MEETING FREQUENCY The PORC shall meet at least once per calendar month and as convened by the PORC Chairperson or one of the designated Vice Chairpersons.
1.5 QUORUM A quorum of the PORC shall include the Chairperson or one of the designated Vice Chairpersons and two members or designated alternates. However, a maximum of one third of the voting membership may be designated alternates. For any PORC decision affecting site-wide issues, the Chairperson shall ensure appropriate representation.
1.6 RESPONSIBILITIES The PORC shall be responsible for:
- a.
Review of (1) all procedures and programs required by facility Technical Specifications administrative controls and changes thereto that require a regulatory evaluation under the facility's 10CFR50.59 and IOCFR72.48 screening program, (2) changes to the quality program determined to be reductions in the commitment to quality under the provisions of IOCFR50.54(a), and (3) any other proposed procedures, programs, or changes thereto affecting facility nuclear safety as determined by the Plant General Manager.
- b.
Review of all proposed tests and experiments that affect nuclear safety.
- c.
Review of all proposed changes to Technical Specifications or the Operating License prior to their submittal to the NRC.
- d.
Review of all proposed changes or modifications to systems or equipment that affect nuclear safety.
- e.
Rendering determinations in writing or meeting minutes if any item considered under (a) through (d) above, as appropriate and as provided by 10CFR50.59, IOCFR50.92, or IOCFR72.48 requires a license amendment or requires a significant hazards consideration determination.
Page 33 of 45
QUALITY ASSURANCE TOPICAL REPORT Revision 0
- f.
Investigation of all violations of the Technical Specifications including the preparation and forwarding of reports covering evaluation and recommendations to prevent recurrence to the Plant General Manager, the Site Vice President, the CNO, and to the Chairperson of the Nuclear Safety Review Board.
- g.
Review of all Reportable Events.
- h.
Review of unit operations to detect potential hazards to nuclear safety.
- i.
Performance of special reviews, investigations or analyses and reports thereon as requested by the Plant General Manager or the Chairperson of the Nuclear Safety Review Board.
1.7 AUTHORITY The Plant Operations Review Committee shall:
- a.
Recommend to the approval authority approval or disapproval of procedures considered under 1.6.a above.
- b.
Recommend to the Plant General Manager written approval or disapproval in meeting minutes of items considered under Responsibilities 1.6.a through i above. The Plant General Manager will report any issues that require higher level of authority to the Site Vice President.
- c.
Evaluate root causes and recommended actions to prevent recurrence for items considered under 1.6.f through g above.
- d.
Provide written notification within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> to the Site Vice President and the Chairperson of the Nuclear Safety Review Board of disagreement between the Plant Operations Review Committee and the Plant General Manager; however, the Plant General Manager shall have responsibility for resolution of such disagreements pursuant to Technical Specifications.
1.8 RECORDS The Plant Operations Review Committee shall maintain written minutes of each meeting and copies shall be provided to the Site Vice President, Chairperson of the Nuclear Safety Review Board, and the Plant General Manager.
Records of the minutes shall be maintained in accordance with Section B.15 of this QATR. Open items shall be assigned, tracked and resolved.
Page 34 of 45
QUALITY ASSURANCE TOPICAL REPORT Revision 0 2.0 NUCLEAR SAFETY REVIEW BOARD (NSRB)
The NSRB shall ensure that periodic independent reviews and audits of activities are conducted by qualified individuals free from the pressures of plant operations. For new nuclear power plant construction, the NSRB shall be functional at least one year prior to initial core loading. The NSRB serves in an advisory capacity to the CNO.
2.1 REVIEW RESPONSIBILITIES The NSRB shall ensure periodic independent reviews and audits of activities as stated in the facility Technical Specifications and this QATR are performed. Review of events shall include the results of any investigations made and the recommendations resulting from such investigations to prevent or reduce the probability of recurrence of the event. Additional review activities by the NSRB should be performed to verify adequate organizational response to adverse performance trends.
The NSRB should monitor the results of audits, evaluations, and assessment activities to ensure that items that could affect plant safety are reviewed. The NSRB may delegate review functions to subcommittees, that may include NSRB members, provided that the subcommittees report the results of their reviews to the NSRB.
2.2 COMPOSITION The NSRB shall be composed of at least five members, including the Chairperson, of whom no more than a minority are members of the onsite operating organization. The CNO shall appoint, in writing, a Chairperson.
The Chairperson shall appoint, in writing, a minimum of four members to the NSRB and shall designate from this membership, in writing, a Vice Chairperson.
Consultants should be utilized as determined by the NSRB Chairperson to provide expert advice to the NSRB.
2.3 ALTERNATES Alternates shall be designated in advance, but their use shall be restricted to legitimate absences of principals.
2.4 MEETING FREQUENCY The NSRB shall meet at least once per six months.
During initial operation of a newly constructed power plant, the meeting frequency shall be at least once per calendar quarter.
NSRB decisions should be made at formal meetings. However, in extenuating circumstances where it is impractical to convene a quorum for a formal meeting within a necessary time constraint, alternative means such as a conference call may be used. In such cases, action taken shall be reviewed by a quorum of the NSRB at its next regularly scheduled meeting.
2.5 QUORUM The quorum of the NSRB necessary for the performance of the NSRB review and audit functions shall consist of a majority of regular members, including the Chairperson or Vice Chairperson.
No more than a minority of the quorum shall have line responsibility for operation of a Company nuclear facility.
Page 35 of 45
QUALITY ASSURANCE TOPICAL REPORT Revision 0 2.6 RECORDS Minutes of all NSRB meetings shall be prepared and retained. All documents reviewed should be identified.
Decisions and recommendations made by the NSRB shall be documented.
Minutes of each NSRB meeting shall be disseminated promptly to appropriate members of management having responsibility in the area reviewed. Records of meeting minutes shall be retained in accordance with Section B.15 of this QATR.
3.0 INDEPENDENT SAFETY ENGINEERING GROUP (ISEG)
Independent safety review is performed to meet the individual unit's commitment to NUREG-0737,Section I.B.1.2, "Independent Safety Engineering Group," as described in the unit's safety analysis report, if applicable.
Page 36 of 45
QUALITY ASSURANCE TOPICAL REPORT Revision 0 APPENDIX B PROCEDURES CGG uses procedures to provide an approved, preplanned method of conducting activities affecting safety. As stated in position C. I of Regulatory Guide 1.33, Revision 2, CGG commits to use Appendix A of Regulatory Guide 1.33 as guidance for establishing the types of procedures that are necessary to control and support plant operation. Procedures are sufficiently detailed for a qualified individual to perform the required function without direct supervision, but may not provide a complete description of the system or plant process.
Guidance is established to identify the manner in which procedures are to be implemented, including identification of those tasks that require (I) the written procedure to be present and followed step by step while the task is being performed, (2) the user to have committed the procedure steps to memory, (3) verification of completion of significant steps, as by initials or signatures or use of check-off lists.
Procedures that are required to be present and referred to directly are those developed for extensive or complex jobs where reliance on memory cannot be trusted, tasks that are infrequently performed, and tasks where steps must be performed in a specified sequence. When documentation of an action is specified, the necessary data is recorded as the task is performed.
The format of procedures may vary from plant to plant within CGG; however, procedures include the following elements, as appropriate to the purpose or task covered. These elements are not intended to imply a specific format is required:
Title/status: each procedure is given a title descriptive of the work or subject it addresses, and includes a revision number and/or date and an approval status.
Purpose/Statement of applicability: the purpose for which the procedure is intended is clearly stated (if not clear from the title).
References:
applicable references, including reference to appropriate Technical Specifications, are included. References are included within the body of the procedure when the sequence of steps requires other tasks to be performed (according to the reference) prior to or concurrent with a particular step.
Prerequisites: identifies those independent actions or procedures that must be accomplished and plant conditions which must exist prior to performing the procedure. A prerequisite applicable to only a specific portion of a procedure is so identified.
Precautions: alert the user to those important measures to be used to protect equipment and personnel, including the public, or to avoid an abnormal or emergency situation during performance of the procedure. Cautionary notes applicable to specific steps are included in the main body of the procedure and are identified as such.
Limitations and actions: limitations on the parameters being controlled and appropriate corrective measures to return the parameter to the normal control band are specified.
Main body: contains the step-by-step instructions in the degree of detail necessary for performing the required function or task.
Acceptance criteria: the quantitative or qualitative criteria against which the success or failure (as of a test-type activity) of the step or action would be judged.
Checkoff lists: complex procedures use checkoff lists. These lists may be included as part of the procedure or may be appended to the procedure.
Page 37 of 45
QUALITY ASSURANCE TOPICAL REPORT Revision 0 Certain types of procedures governing generating site activities are common to all plants. Individual plant terminology may vary from the following, and some procedure types may be combined. Sufficient procedures are maintained to provide appropriate direction for these activities. In amplification to the appropriate elements above, such procedures are further defined as follows:
System Procedures: contain instructions for energizing, filling, venting, draining, starting up, shutting down, changing modes of operation and other instructions appropriate for operations of systems related to the safety of the plant. Separate procedures may be developed for correcting off-normal conditions for those events where system complexity may lead to operator uncertainty. System procedures contain check-off lists where appropriate.
Start-up Procedures: contain instructions for starting the reactor from cold or hot conditions and establishing power operation. This includes documented determination that prerequisites have been met, including confirmation that necessary instrumentation is operable and properly set; necessary system procedures, tests and calibrations have been completed; and required approvals have been obtained. The main body includes the major steps of the start-up sequence, including reference to appropriate systems procedures. Start-up procedures contain check-off lists where appropriate.
Shutdown Procedures: contain instructions for operations during controlled shutdown and following reactor trips, and include instructions for establishing or maintaining hot standby or cold shutdown conditions, as applicable. The major steps involved in shutting down the plant are specified, including instructions for such actions as monitoring and controlling reactivity, load reduction, cooldown rates, activating or deactivating equipment, and provisions for decay heat removal. Check-off lists are used, as appropriate, for confirming completion of major steps in proper sequence.
Power Operation and Load Changing Procedures: contain instructions for steady-state power operation and load changing that include provisions for use of control rods, chemical shim, coolant flow channel control, or for any other system available for short-or long-term control of reactivity, making deliberate load changes and adjusting operating parameters.
Process Monitoring Procedures: contain instructions for monitoring performance of plant systems to assure that core thermal margins and coolant quality are maintained in acceptable status at all times, that integrity of fission product barriers is maintained, and that engineered safety features and emergency equipment are in a state of readiness to keep the plant in a safe condition if needed. Maximum and minimum limits for process parameters are appropriately identified.
Fuel Handling Procedures: contain instructions for core alterations, accountability of fuel and partial or complete refueling operations that include, for example, continuous monitoring of neutron flux throughout core loading, periodic data recording, audible annunciation of abnormal flux increases, and evaluation of core neutron multiplication to verify safety of loading increments. Procedures are also provided for receipt and inspection of new fuel, and for fuel movements in the spent fuel storage areas.
Fuel handling procedures include prerequisites to verify the status of systems required for fuel handling and movement; inspection of replacement fuel and control rods; designation of proper tools, proper conditions for spent fuel movement, proper conditions for fuel cask loading and movement; and status of interlocks, reactor trip circuits and mode switches. These procedures provide requirements for refueling, including proper sequence, orientation and seating of fuel and components, rules for minimum operable instrumentation, actions for response to fuel damage, verification of shutdown margin, communications between the control room and the fuel handling station, independent verification of fuel and component locations, criteria for stopping fuel movements, and documentation of final fuel and component serial numbers and locations.
Maintenance Procedures: contain instructions in sufficient detail to permit maintenance work to be performed correctly and safely, and include provisions for conducting and recording results of required inspections or tests.
Appropriate referencing to other procedures or vendor manuals is provided.
Instructions are also provided, although not necessarily in Maintenance Procedures, for equipment Page 38 of 45
QUALITY ASSURANCE TOPICAL REPORT Revision 0 removal and return to service, and appropriate radiation protection measures (such as protective clothing and radiation monitoring).
Radiation Control Procedures: contain instructions for implementation of program requirements necessary to meet regulatory commitments, including acquisition of data and use of equipment to perform necessary radiation surveys, measurements and evaluations for the assessment and control of radiation hazards. These procedures provide requirements for monitoring both external and internal exposures of employees, utilizing accepted techniques; routine radiation surveys of work areas; environmental monitoring in the vicinity of the plant; radiation monitoring of maintenance and special work activities, and for maintaining records demonstrating the adequacy of measures taken to control radiation exposures to employees and others.
Calibration and Test Procedures: contain instructions for periodic calibration and testing of safety related instrumentation and control systems, and for periodic calibration of measuring and test equipment used in activities affecting the quality of these systems.
These procedures provide for meeting surveillance requirements and for assuring measurement accuracy adequate to keep safety related parameters within operational and safety limits.
Chemistry-radiochemistry Control Procedures: contain instructions for chemical and radiochemical activities such as the nature and frequency of sampling and analyses; maintaining coolant quality within prescribed limits; limitations on concentrations of agents that could cause corrosive attack, foul heat transfer surfaces or become sources of radiation hazards due to activation; control, treatment and management of radioactive wastes and control of radioactive calibration sources, including shipping.
Emergency Procedures: contain instructions for response to potential emergencies so that a trained operator will know in advance the expected course of events that will identify an emergency and the immediate actions that should be taken in response. Format and content of emergency procedures are based on regulatory and Owner's Group(s) guidance that identify potential emergency conditions and generally require such procedures to include a title, symptoms to aid in identification of the nature of the emergency, automatic actions to be expected from protective systems, immediate operator actions for operation of controls or confirmation of automatic actions, and subsequent operator actions to return the reactor to a normal condition or provide for a safe extended shutdown period under abnormal or emergency conditions.
Emergency Plan Implementing Procedures: contain instructions for activating the Emergency Response Organization and facilities, protective action levels, organizing emergency response actions, establishing necessary communications with local, state and federal agencies, and for periodically testing the procedures, communications and alarm systems to assure they function properly. Format and content of such procedures are such that requirements of each site's NRC approved Emergency Plan are met.
Test and Inspection Procedures: contain the objectives, acceptance criteria, prerequisites for performing the test or inspection, limiting conditions, and appropriate instructions for performing the test or inspection. These procedures also specify any special equipment or calibrations required to conduct the test or inspection and provide for appropriate documentation and evaluation by responsible authority to assure test or inspection requirements have been satisfied. Where necessary, hold or witness points are identified within the procedures and require appropriate approval for the work to continue beyond the designated point. These procedures provide for recording the date, identification of those performing the test or inspection, as-found condition, corrective actions performed (if any), and as-left condition, as appropriate for the subject test or inspection.
While not specifically a procedure type, Temporary Procedures may be used to direct operations during testing, refueling, maintenance and modifications; to provide guidance in unusual situations not within the scope of normal procedures; and to insure orderly and uniform operations for short periods when the plant, a system, or a component of a system is performing in a manner not covered by existing detailed Page 39 of 45
QUALITY ASSURANCE TOPICAL REPORT Revision 0 procedures, or has been modified or affected in such manner that portions of existing procedures do not apply. Temporary Procedures include designation of the period of time during which they may be used.
Page 40 of 45
QUALITY ASSURANCE TOPICAL REPORT Revision 0 APPENDIX C DEFINITIONS CGG uses the definitions of terms as provided in Section 4 of the Introduction of NQA-I-1994 in interpreting the requirements of NQA-I and the other standards to which the QATR commits. In addition, definitions are provided for the following terms not covered in NQA-l:
Administrative controls: rules, orders, instructions, procedures, policies, practices and designations of authority and responsibility.
Audit: A planned and documented activity performed to determine by investigation, examination, or evaluation of objective evidence the adequacy of and compliance with established procedures, instructions, drawings, and other applicable documents, and the effectiveness of implementation.
An audit should not be confused with surveillance or inspection activities performed for the sole purpose of process control or product acceptance Emergency procedures: see Appendix B.
Experiments: performance of plant operations carried out under controlled conditions in order to establish characteristics or values not previously known.
Independent Assessment:
the process used to provide ongoing independent evaluation and communication of results to management on program performance, trends, and management effectiveness.
Independent Review: review completed by personnel not having direct responsibility for the work function under review regardless of whether they operate as part of an organizational unit or as individual staff members.
Maintenance and modification procedures: written procedures defining the policies and practices by which structures, mechanical, electrical and instrumentation and control systems, and components thereof, are kept in a condition of good repair or efficiency so that they are capable of performing their intended functions.
Nuclear power plant: any plant using a nuclear reactor to produce electric power, process steam or space heating.
Off-normal condition procedures: written procedures which specify operator actions for restoring an operating variable to its normal controlled value when it departs from its range, or to restore normal operating conditions following a perturbation. Such actions are invoked following an operator observation or an annunciator alarm indicating a condition which, if not corrected, could degenerate into a condition requiring action under an emergency procedure.
On-site operating organization: on-site personnel concerned with the operation, maintenance and certain technical services.
Operating activities: work functions associated with normal operation and maintenance of the plant, and technical services routinely assigned to the on-site operating organization.
Operating procedures: written procedures defining the normal methods, means and limits of operation of the nuclear power plant, a plant system or systems, or processes, including actions to be taken by operating personnel for removal from and return to service equipment on which maintenance is to be or has been performed.
Operational phase: that period of time during which the principal activity is associated with normal operation of the plant. This phase of plant life is considered to begin formally with commencement of initial fuel loading, and ends with plant decommissioning.
Review: a deliberately critical examination, including observation of plant operation, evaluation of assessment results, procedures, certain contemplated actions, and after-the-fact investigations of abnormal conditions.
Page 41 of 45
QUALITY ASSURANCE TOPICAL REPORT Revision 0 Self-Assessment:
assessing the level of performance, or output of an activity or organization, by comparing management expectations and industry standards of excellence.
Supervision: direction of personnel activities or monitoring of plant functions by an individual responsible and accountable for the activities they direct or monitor.
Surveillance testing: periodic testing to verify that safety related structures, systems and components continue to function or are in a state of readiness to perform their functions.
System: an integral part of nuclear power plant comprising components which may be operated or used as a separate entity to perform a specific function.
Page 42 of 45
QUALITY ASSURANCE TOPICAL REPORT Revision 0 APPENDIX D OPERATIONS PHASE ACTIVITY RECORDS The following table provides a list of operations phase nonpermanent and lifetime records and their respective retention times. These records retention requirements are in addition to those described in Section B. 15 of this QATR.
Records Description Retention Time Records and drawing changes reflecting unit design modifications made to systems Lifetime and equipment described in the SAR.
Records of new and irradiated fuel inventory, fuel transfers, and assembly bumup Lifetime histories.
plus 3 years Records of radiation exposure for all individuals entering radiation control areas.
Lifetime Records of gaseous and liquid radioactive material released to the environs.
Lifetime Records of transient or operational cycles for those unit components designed for a Lifetime limited number of transients or cycles.
Records of reactor tests and experiments.
Lifetime Records of training and qualification for current members of the unit staff.
Lifetime Records of in-service inspections performed pursuant to the Technical Specifications.
Lifetime Records of evaluations performed for changes made to procedures or equipment or Lifetime evaluations of tests and experiments pursuant to 10CFR50.59 or 10CFR72.48.
Records of meetings of the PORC and the NSRB.
Lifetime Records of offsite environmental monitoring surveys.
Lifetime Records of unit radiation and contamination surveys.
Lifetime Records of secondary water sampling and water quality.
Lifetime Records of the service lives of all snubbers, including the date at which the service Lifetime life commences and associated installation and maintenance records. (Does not apply to NMP Unit 1)
Records of QA activities required by this QATR and not otherwise listed.
Lifetime Records and logs of unit operation covering time interval at each power level.
5 years Records and logs of principal maintenance activities, inspections, repair, and 5 years (except replacement of principal items of equipment related to nuclear safety.
ISFSI activities are Lifetime)
All Reportable Events submitted to the Commission.
5 years Records of surveillance activities, inspections, and calibrations required by the 5 years Technical Specifications.
Records of changes made to the procedures required by Technical Specifications.
5 years Records of radioactive shipments.
5 years Records of sealed source and fission detector leak tests and results.
5 years Records of annual physical inventory of all sealed source material of record.
5 years Page 43 of 45
QUALITY ASSURANCE TOPICAL REPORT Revision 0 APPENDIX E ORGANIZATION RELATIONSHIPS OF KEY MANAGEMENT AND FUNCTIONAL GROUPS CORPORATE AND TECHNICAL SUPPORT Chief Executive Officer Constellation Energy I
Project Management Executive Management Position Responsible for Operations Support Executive Management Position Responsible for Technical Services Senior Management Position Responsible for Quality & Performance Assessment Radiation Protection Chemistry Maintenance
-t Operations I
g 4 Refueli LServic' I
services ng ISite es Engineering Doffed lines represent matrixed relationships Page 44 of 45
QUALITY ASSURANCE TOPICAL REPORT Revision 0 APPENDIX E ORGANIZATION RELATIONSHIPS OF KEY MANAGEMENT AND FUNCTIONAL GROUPS SITE ORGANIZATION Site Vice President
[
Plant Operations Plant General Management Position Management Reviw CmmiteeMangerResponsible for Position Review Committee Manager Engineering Responsible for Training I
II Training Ra lIntegrated Design Protection &
Operations Maintenance Work Engineering Chemistry Management Engineering Action Programs Records Modifications Management E
IEquipment Sl Reliability Assessment Engineering Experience r- -- -- -- --------- -- -- -- -- -- -- -- -- -- ------
- L-- - --- -- -- -- -- -- ---------------------.
Supply Chain Information Emergency Licensing Security Performancial Technology Preparedness c
S rformasneFnnc V A ssePseroma Dotted lines represent matrixed relationships verification &
Ae ssm ent Page 45 of 45
ATTACHMENT (4) Markup Constellation Generation Group, LLC July 14, 2006
CGG QATR EXCEPTIONS/ALTERNATIVES SOURCE/BASIS FOR ACCEPTANCE A.5 Personnel Training and Qualification For NQA-1-1994 Supplement 2S-1: Inspections, examinations or tests This alternative is consistent with the provisions approved by the NRC may be performed by individuals in the same organization as that in Safety Evaluation Report by the Office of Nuclear Reactor which performed the work, provided that (a) the qualifications of the Regulation, "Change to the Quality Assurance Program, Quality inspector for an activity are equal to or better than the minimum Assurance Program Consolidation," dated March 24, 2005 for Nuclear qualifications for persons performing the activity, (b) the work is within Management Company.
the skills of personnel and/or is addressed by procedures, and (c) if work involves breaching a pressure-retaining item, the quality of the This alternative is used by NMC to describe altemative training work can be demonstrated through a functional test. When a, b and c methods if it implemented line performance of Quality Control are not met, inspections, examinations or tests are carried out by inspections. This alternative is acceptable for CGG because CGG individuals certified in accordance with Supplement 2S-1. Individuals would also apply it only to line personnel performing Quality Control performing visual inspections required by the ASME Boiler and inspections. It does not apply to Quality Assurance personnel.
Pressure Vessel Code are qualified and certified according to Code requirements.
The alternative meets the requirements of 10 CFR 50, Appendix B, Criterion II, by requiring training and qualification of personnel that assures suitable proficiency in the skills necessary to perform quality verification inspections and tests is achieved and maintained. The individuals qualified in accordance with this alternative participate in an accredited SAT-based training program that meets 10 CFR 50.120.
In lieu of NQA-1-1994 Nonmandatory Appendix 2A-1, CGG need This alternative is consistent with the provisions approved by the NRC not establish levels of qualification/certification for inspection and test in Safety Evaluation Report by the Office of Nuclear Reactor personnel. Instead, CGG may establish initial qualification Regulation, "Change to the Quality Assurance Program. Quality requirements and determines individual qualification through Assurance Program Consolidation," dated March 24, 2005 for Nuclear evaluation of education, training and experience, and through Management Company.
demonstration of capability in performing the type of inspections expected on the job.
This exception establishes an alternative qualification method for independent Quality Control inspectors and is considered acceptable because it continues to satisfy the criteria of 10 CFR 50, Appendix B.
In lieu of NQA-1-1994 Supplement 2S-2, CGG will follow the This alternative is consistent with the provisions approved by the NRC applicable standard cited in the latest version(s) of Section XI of the in Safety Evaluation Report by the Office of Nuclear Reactor ASME Boiler and Pressure Vessel Code approved by the NRC for use Regulation, "Change to the Quality Assurance Program, Quality at CGG sites for qualification of nondestructive examination personnel.
Assurance Program Consolidation," dated March 24, 2005 for Nuclear Management Company.
Deleted: 12
[Deleted: 9 I - Table of CGG QATR Exceptions/Alternatives Page I of 1_A,
CGG QATR EXCEPTIONS/ALTERNATIVES SOURCE/BASIS FOR ACCEPTANCE This alternative is considered acceptable because other regulations, codes and standards establish requirements for qualification of NDE personnel.
For NQA-l-1994 Supplement 2S-3: The requirement that prospective This alternative is consistent with the provisions approved by the NRC Lead Auditors have participated in a minimum of five (5) audits in the in Safety Evaluation Reprt by the Office of Nuclear Reactor previous three (3) years is replaced by the following:
Regulation, "Change to the Quality Assurance Program, Quality "The prospective lead auditor shall demonstrate his/her ability to Assurance Program Consolidation," dated March 24, 2005 for Nuclear properly implement the independent assessment (audit) process, as Management Company.
implemented by CGG according to section C.2 of this QATR, to effectively lead an assessment team, and to effectively organize and As described in the "Revised Submittal of Quality Assurance Program report results, including participation in at least one independent for Station Operation, R.E. Ginna Nuclear Power Plant" dated assessment or audit within the year preceding the date of qualification."
December 21, 1998, the revised requirements for certification of lead auditors are consistent with the guidance provided by the NRC in a letter "Review of Nuclear Energy Institute Proposed Improvements to QA Programs," dated October 24, 1996. The revised requirement meets the intent of Section 3.3 of NOA-1 -1994 to have the prospective lead auditor demonstrate the ability to effectively implement the audit process and to lead an audit team. Since the revised requirements meet the intent of the original requirement and the NRC has proposed this approach as an acceptable alternative, this change does not reduce the scope of the quality assurance program.
The NRC notes in their Safety Evaluation Report to R.E. Ginna Nuclear Power Plant, dated April 6, 1999, that in an October 24, 1996 letter to the Nuclear Energy Institute, the NRC staff provided its position with regards to acceptable industry proposed alternatives on quality assurance processes for qualifying auditors and for conducting annual evaluations of suppliers. Rochester Gas and Electric's proposed alternative for certifying lead auditors, as described was consistent with dte staffs position in the cited letter and-is, therefore, acceptable.
A grace period of 90 days may be applied to the performance of annual This was originally an exception to the provisions of Regulatory Guide evaluations of inspection, examination and testing personnel 1.144, Revision I, approved by the NRC in Safety Evaluation by the qualifications defined in NQA-1-1994 Supplement 2S-1, and annual Office of Nuclear Reactor Regulation "Proposed Revision 25 to the lead auditor recertifications described in Supplement 2S-3. The grace Rochester Gas and Electric Corporation Quality Assurance Program period does not allow the "clock" for a particular activity to be reset for Station Operation, R.E. Ginna Nuclear Power Plant," dated July 22.
forward. However, the "clock" for an activity is reset backwards by 1998.
The approval allowed a 90-day grace period for recertification Deleted: 'This exception was taken from Ginna's Quality Assurance Program for Station Operation, Revision 32. This was originally an exception to the provisions of ANSI N45.2.6-1978 (RG 1.58 Revision 1) and ANSI N45.2.23-1978 (RG 1.146 Revision 0) approved by the NRC in Safety Fvaluation by the Office of Nuclear Reactor Regulation "Proposed Revision 25 to the Rochester Gas and Electric Corporation Quality Asstrance Program for Station Operation. R.E.
Ginna Nuclear Power Plant." dated July
- 22. 1998 Deleted: 12 I
Deleted:9 - Table of CGG QATR Exceptions/Altematives Page 2 of
CGG QATR EXCEPTIONS/ALTERNATIVES SOURCE/BASIS FOR ACCEPTANCE performing the activity early, of audit personnel. Technical Specifications allow the use of a 25%
grace period for the performance of periodic surveillances. This is acceptable for all of CGG because this type of Quality Assurance program change continues to satisfy the criteria of 10 CFR 50, Appendix B.
A.7.3 Regulatory Position C of Regulatory Guide 1.28, Revision 3, CGG is adopting ASME NQA-1-1994 Part I consistent with the endorses the basic and supplementary requirements of ANSI/ASME provisions approved by the NRC in Safety Evaluation by the Office of NQA-1-1983 and the ANSI/ASME NQA-I a-1983 Addenda. In place Nuclear Reactor Regnlation "Proposed Change to the Quality of the specific edition and addenda of NQA-I addressed in the Assurance Program, Quality Assurance Program Consolidation, Exelon Regulatory Guide, CGG commits to implement the requirements of Generation Company, LLC and Amergen Energy Company, LLC,"
NQA-I-1994 Part I.
dated December 24, 2002. CGG's conformance to NQA-1-1994 Part I is documented in CGG QATR.
In the Code of Federal Regulations, 10 CFR 50.54(a)(3)(i) allows "The use of a OA standard approved by the NRC which is more recent than the standard in the licensee's current QA program at the time of the change." Although the NRC has not yet specifically endorsed NQA-I-1994 in their regulatory guides, Regulatory Guide 1.28, Revision 3, dated August 1985, endorsed NOA-1-1983. Correspondence by the NRC and related NRC Safety Evaluation Report (SER) dated Decenber 24, 2002, for approval of Revision 70 of QATR EGC-I A, for EXELON/AMERGEN plants, subsection 3.2.1, determined that the requirements of the 1983 and 1994 editions of NOA-I are equivalent.
Based on the related NRC safety evaluation, CGG's use of NOA-I -
1994 is consistent with 10 CFR 50.54(a)(3)(ii), which states, "The use of a quality assurance alternative or exception approved by an NRC safety evaluation, provided that the bases of the NRC approval are applicable to the licensee's facility" is not a reduction in commitment.
EXELON has submitted a comparison of NQA-1-1983 with NQA-I-1994, used as part of the basis for the NRC approval, which applies to CGG's OATR. In addition, CGG prepared a table to compare the ANSI N 18.7 standard to NOA-I-1994 and the CGG OATR (Attachment 3 to the OATR submittal).
CGG does not commit to compliance with Regulatory Position C.1 of This exception is consistent with the provisions approved by the NRC A Deleted-12
/,, Deleted: 9 - Table of CGG QATR Exceptions/Alternatives Page 3 of I,,
CGG QATR EXCEPTIONS/ALTERNATIVES SOURCE/BASIS FOR ACCEPTANCE Regulatory Guide 1.28, Revision 3; instead of establishing three in Safety Evaluation Report by the Office of Nuclear Reactor levels of qualification provided in NQA-I-1994 Nonmandatory Regulation, "Change to the Quality Assurance Program, Quality Appendix 2A-I, CGG may establish initial qualification requirements Assurance Program Consolidation," dated March 24, 2005 for Nuclear and determine individual qualification through evaluation of education, Management Company. This Regulatory Guide endorses Non-training and experience, and through demonstration of capability in mandatory Appendix 2A-1 of NOA-I-1994. This alternative is performing the type of inspections expected on the job.
considered acceptable because it continues to satisfy the criteria of 10 CFR 50, Appendix B.
The guidance of Regulatory Guide 1.28, Revision 3, Regulatory This exception is consistent with the provisions approved by the NRC Position C.3.2, regarding external audits will also be implemented in in Safety Evaluation Report by the Office of Nuclear Reactor the operational phase. CGG complies with Regulatory Position C.3.2 Regulation, "Change to the Quality Assurance Program, Quality with the exception that for Regulatory Position C.3.2.2, CGG may Assurance Program Consolidation," dated March 24, 2005 for Nuclear review the information described therein as it becomes available Management Company.
through its ongoing receipt inspection, operating experience, and supplier evaluation programs, in lieu of performing a specific This alternative provides for a documented ongoing evaluation of the evaluation on an annual basis. The results of the reviews are promptly supplier's performance, rather than an annual evaluation. Where considered for effect on a supplier's continued qualification and applicable, this evaluation takes into account the review of supplier-adjustments made as necessary (including corrective actions, furnished documents such as certificates of conformance, non-adjustments of supplier audit plans, and input to third party auditing conformance notices, and corrective actions, as well as evaluating the entities, as warranted). Additionally, results are reviewed periodically results of previous source surveillances/verifications, audits/surveys.
to determine if, as a whole, they constitute a significant condition and receiving inspections. The alternative also provides for the review adverse to quality requiring additional action. A grace period of 90 of operating experience information pertaining to equipment failures days may be applied to the performance of triennial supplier audits and evaluation of the results of audits from other sources (e.G., NUPIC described in Regulatory Position C.3.2.1. The grace period does not audits) for their effect on supplier qualification status. As described in allow the "clock" for a particular activity to be reset forward.
procedures, the results of these evaluations are reviewed and However, the "clock" for an activity is reset backwards by performing appropriate corrective action taken. Furthermore, adverse findings the activity early.
resulting from these evaluations are periodically reviewed to determine if, in the aggregate, they result in a significant condition adverse to quality. Additionally, the results of these evaluations are used to provide input to support supplier audit activities conducted by CGG or third party auditing organizations. If no items are received from a vendor in the course of a year, we still review industry activity using the daily download of operating experience information from the INPO website, the NUPIC database, and the NRC's website for inspection activities and Part 21 notifications. At the NUPIC meetings, there is an ongoing agenda item to review vendor performance and to alert others to adverse trends. Internal corrective action programs at the CG sites address vendor performance and are factored into qualification IDeleted: 12 Deleted: 9 - Table of CGG QATR Exceptions/Alternatives Page 4 of I
J
CGG QATR EXCEPTIONS/ALTERNATIVES SOURCE/BASIS FOR ACCEPTANCE maintenance. Vendors may also be removed from the Approved Vendnr'~ T ki either hec'm~e of re-evaluation, which re~uultefl in Vendor's...L..t ei e
be
.c..
se e-tio which..............
removal, or due to inactivity.
The 90-day grace period exception was taken from Ginna's Quality Assurance Program for Station Operation, Revision 32. This was originally an exception to the provisions of Regulatory Guide 1.144, Revision 1, approved by the NRC in Safety Evaluation by the Office of Nuclear Reactor Regulation "Proposed Revision 25 to the Rochester Gas and Electric Corporation Quality Assurance Program for Station Operation, R.E. Ginna Nuclear Power Plant," dated July 22, 1998. Tile approval allowed a 90-day grace period for supplier audits. This is acceptable for all of CGG because this type of Quality Assurance nrmernm chance cnntinuueq to vatikfv the criteria of 10 C~FR 50.
program chanpe continues to satisfv the criteria of 10 CFR 50I Appendix B.
-t In lieu of the requirements of the last paragraph of ANSI N45.2.4-1972 Section 6.2.1, the calibration program at CGG does not use calibration stickers on installed plant instrumentation that contain the date of calibration and identity of person that performed the calibration.
Calibrations of instruments are scheduled and tracked by a computer database.
This alternative is consistent with the provisions approved by the NRC in Safety Evaluation Report "Entergy Operations, Inc, Quality Assurance Program Consolidation," dated November 6, 1998. This alternative is also consistent with the current quality assurance programs for Calvert Cliffs and Nine Mile Point.
The alternative for this item is consistent with a QAP alternative approved by the NRC for River Bend. The intent of the alternative was to allow other methods of marking equipment with calibration information other than by tagging. The staff recognized approved alternative methods before, such as using a calibration log that is correlated with the equipment by unique identification numbers on the equipment. The staff found that alternatives to tacging equipment with calibration information are acceptable. provided that the specific method implemented by the licensee meets the requirements of the above standards and found that the requirements of 10 CFR Part 50, Appendix B continue to be met. Thus, this alternative is acceptable for CGG because die calibration program continues to meet the requirements of 10 CFR 50, Appendix B.
NQA-1-1994 Part I contains quality assurance requirements equivalent This alternative is consistent with the provisions approved by the NRC to those of ANSI N1 8.7-1976/ANS-3.2, and CGG has included in this I in Safety Evaluation Report by the Office of Nuclear Reactor
° i
Deleted: 12
,.{Deleted: 9 - Table of CGG QATR Exceptions/Altematives Page 5 of A1___
CGG QATR EXCEPTIONS/ALTERNATIVES SOURCE/BASIS FOR ACCEPTANCE CGG QATR EXCEPTIONS/ALTERNATIVES SOURCE/BASIS FOR ACCEPTANCE QATR the remaining "administrative controls" elements from ANSI NI8.7-1976/ANS-3.2. Therefore, CGG does not commit to compliance with the requirements of ANSI N-18.7-1976/ANS-3.2 as endorse by Regulatory Guide 1.33, Revision 2, Regulatory Position C.
CGG's commitment to the applicable Regulatory Guides and associated standards listed in Regulatory Position C.2 of Regulatory Guide 1.33, Revision 2, is addressed within the CGG QATR. A number of these Regulatory Guides and standards have been incorporated into NQA-I-1994 Part I.
In lieu of compliance with Regulatory Position C.5 of Regulatory Guide 1.33, Revision 2, CGG has established appropriate equivalent requirements within this QATR.
Regulation, "Change to the Quality Assurance Program. Quality Assurance Program Consolidation," dated March 24, 2005 for Nuclear Management Company.
Constellation Generation Group recognizes that NRC Regulatory Guide 1.33, "Quality Assurance Program Requirements (Operations)'
endorses ANSI Standard N1 8.7. "Administrative Controls and Quality Assurance for the Operational Phase of Nuclear Power Plants". The CGG plants have current commitments to this standard. We have concluded that the OATR. combined with our commitment to Regulatory Guide 1.28, provides an acceptable alternative to Regulatory Guide 1.33 and ANSI N 18.7-1976, in that the QATR provides quality assurance and administrative control requirements consistent with that guidance, as well as a quality assurance proeram that meets 10 CFR 50, Appendix B. Attachment 3 to the QATR submittal is a table illustrating that the quality assurance requirements of N 18.7-1976 are addressed through our commitment to NOA-I-1994, and the administrative controls of N 18.7 are addressed by inclusion of equivalent requirements within the text of the OATR.
+
In lieu of the six and twelve month audit frequencies specified in Regulatory Position C.4 of Regulatory Guide 1.33, Revision 2, CGG audits selected aspects of operational phase activities at a frequency commensurate with their safety significance in such a manner as to assure an audit of all safety-related functions is completed within a period of two years. (except as otherwise required in regulations)
CGG's audit program includes the elements listed in Regulatory Position C.4. In addition, A 90-day grace period may be applied to the 24-month frequency for performing internal audits. The grace period does not allow the "clock" for a particular activity to be reset forward.
However, the "clock" for an activity is reset backwards by performing the activity early.
Each CGG site currently has an exception to the six and twelve month audit frequencies specified in Regulatory Position C.4. The NRC most recently approved this exception for the Fitzpatrick and Indian Point Unit 3 Nuclear Plants in a Safety Evaluation by the Office of Nuclear Reactor Regulation, dated March 25, 1999.
This exception is acceptable because it has been previously adopted for each CGG site and continues to satisfy the criteria of 10 CFR 50, Appendix B.
In addition, this exception contains the use of 90 day grace periods for internal audits. This was originally an exception to the provisions of Regulatory Guide 1.144, Revision 1. approved by the NRC in Safety Evaluation by the Office of Nuclear Reactor Regulation "Proposed Revision 25 to the Rochester Gas and Electric Corporation Quality Assurance Program for Station Operation, R.E. Ginna Nuclear Power Plant," dated July 22, 1998. The appmval allowed a 90-day crace period for internal audits. This is acceptable for all of CGG because this Quality Assurance program change continues to satisfy the criteria st
/
Deleted: 12 Deleted: 9 - Table of CGG QATR Exceptions/Alternatives Page 6 of A_ _ -1, '
CGG QATR EXCEPTIONS/ALTERNATIVES SOURCE/BASIS FOR ACCEPTANCE of 10 CFR 50, Appendix B.
CGG substitutes NQA-I-1994, Subpart 2.3 for N45.2.3 in its CGG is adopting ASME NQA-I-1994 Subpart 2.3 consistent with the commitment to Regulatory Guide 1.39, September 1977. As noted in provisions approved by the NRC in Safety Evaluation of Proposed Regulatory Position C.1, other industry standards may be referenced; Change to the Quality Assurance Program, Quality Assurance Program the commitment in this QATR to NQA-1, Subpart 2.3 includes Consolidation for Dominion Nuclear Connecticut, Inc. and Virginia commitment to those standards to the extent necessary to implement Electric and Power Company, dated September 9, 2005. The NRC Subpart 2.3 requirements. If NRC guidance applies to those referenced staff found that NQA-I-1994 Subpart 2.3 contains equivalent standards, it is followed. Regulatory Position C.2 indicates that the requirements to Regulatory Guide 1.39, September 1977, and ANSI provisions of section 3.2.3 of N45.2.3 are not part of the Regulatory N45.2.3-1973.
endorsement. As NQA-l, Subpart 2.3, section 3.2.3 has the same wording as N45.2.3; the Regulatory Position is applicable and will be This alternative is acceptable based on providing an equivalent level of followed in CGG's implementation of Subpart 2.3. Regulatory control over housekeeping activities.
Position C.3 indicates that the endorsed standard is "applicable for housekeeping activities during the operations phase that are comparable to those occurring during construction." This is addressed in section B.7 of the QATR, which also establishes any necessary exceptions or alternatives to the provisions of Subpart 2.3.
CGG substitutes NQA-1-1994, Subpart 2.8 for N45.2.8 in its CGG is adopting ASME NQA-1-1994 Subpart 2.8 consistent with the commitment to Regulatory Guide 1.116, May 1977. As noted in provisions approved by the NRC in Safety Evaluation of Proposed Regulatory Position C.1, other industry standards may be referenced; Change to the Quality Assurance Program, Quality Assurance Program the commitment in this QATR to NQA-I, Subpart 2.8 includes Consolidation for Dominion Nuclear Connecticut, Inc. and Virginia commitment to those standards to the extent necessary to implement Electric and Power Company, dated September 9, 2005. The NRC Subpart 2.8 requirements. If NRC guidance applies to those referenced staff found that NQA-I-1994 Subpart 2.8 contains equivalent standards, it is followed. Regulatory Position C.3 recommends using requirements to Regulatory Guide 1.116, May 1977, and ANSI Section 5 of N45.2.8 in conjunction with Regulatory Guide 1.68 for N45.2.8-1975.
pre-operational, cold functional, and hot functional testing. While Section 5 of NQA-1, Subpart 2.8 provides the same requirements, it is This alternative is acceptable based on providing an equivalent level of anticipated that CGG plants, since they are already beyond these tests, control over housekeeping activities will not need to implement Regulatory Guide 1.68. If testing in accordance with Regulatory Guide 1.68 becomes necessary, CGG will comply with the guidance of the Regulatory Guide 1.116 position.
Regulatory Position C.2 indicates that the endorsed standard should be "followed for those applicable operations phase activities that are comparable to activities occurring during the construction phase." This is addressed in section B.12 of this QATR, which also establishes any necessary exceptions or alternatives to the provisions of Subpart 2.8.
Deleted: The 90.-day grace period exception was taken from Ginna's Quality Assurance Program for Station Operation. Revision 32. This was originally an exception to the provisions of ANSI N18.7-1972 approved by the NRC in Safety Evaluation by the Office of Nuclear Reactor Regulation "Proposed Revision 25 to the Rochester Gas and Electric Corporation Quality Assurance Program for Station Operation. R.E.
Ginna Nuclear Power Plant." dated July
- 22. 1998.
'I Deleted: 12 Deleted: 9 f * - Table of CGG QATR Exceptions/Altematives Page 7 of A- _
CGG QATR EXCEPTIONS/ALTERNATIVES SOURCE/BASIS FOR ACCEPTANCE CGG QATR EXCEPTIONS/ALTERNATIVES SOURCE/BASIS FOR ACCEPTANCE
- 1.
CGG commits to Regulatory Guide 4.15, Revision 1, February 1979, "Quality Assurance for Radiological Monitoring Programs (Normal Operations) - Effluent Streams and the Environment," with the following alternatives/exceptions:
In lieu of plotting background parameters and setting predetermined control values for gamma spectroscopy instrumentation as described in Regulatory Position C.6.2, background results may be logged and evaluated to ensure the background does not bias reported results.
The NRC's independent sampling and analysis program described in Regulatory Position C.6.3.2 may not be performed.
In lieu of performing source check calibrations at least once per 18 months as described in Regulatory Position C.7, CGG may perform these calibrations at least once per refueling interval.
CGG establishes a commitment to Regulatory Guide 4.15 in the QATR. Three exceptions are taken consistent with existing QA programs for radiological Monitoring Programs for effluent streams and the environment:
Counting room procedures are based on industry best practices. CGG plots (i.e., graph paper) and trends backgrounds on all laboratory instrumentation with the exception that an alternate method may be used for gamma spectroscopy. In this case, an alternate but equally effective method may be implemented: Gamma isotopic backgrounds are counted routinely, and all nuclides are checked for the presence of contamination (i.e. a peak) to ensure each background for each nuclide does not impact any analysis result. If contamination is detected (i.e., a peak is identified), remedial action is taken. Adequacy and accuracy of results are checked in an Interlaboratory test program. Interlaboratory and Intmlaboratory test data are carefully evaluated to determine bias.
The NRC has previously evaluated this method of counting room performance for gamma spectroscopy and found it acceptable.
The exception from the NRC's independent sampling and analysis program reflects the discontinuance of their Confirmatory Measurements Program.
Regulatory Position C.7, "Quality Control for Continuous Effluent Monitoring Systems," states that sources that have been related to initial calibration should be used to check this initial calibration at least once per 18 months (normally during refueling outages). The typical industry refueling outage today is at a 24-month frequency. This change of frequency allows source check calibrations consistent with Technical Specification amendments such as the "Twenty Four Month Cycle Technical Specification Amendments for Calvert Cliffs Nuclear Power Plants Units I and 2," issued November 3, 1987 in the Safety Evaluation by the Office on Nuclear Reactor Regulation, and the intent of this Regulatory Guide.
In lieu of the 12-month, 24-month and 36-month fire protection and loss prevention audits described in Generic Letter 82-21, CGG will This was originally an alternative reviewed and accepted by the NRC combine the scope of the three audits into one by performing a biennial staff for Revision 21 of Ginna's QAPSO in the "10 CFR 50.54 Quality audit of the facility fire protection program and implementing Assurance Program Change Review" dated March 22, 1995.
Deleted: This alternative is consistent with Ginna's Quality Assurance Program I for Station Operation (QAPSO). Revision 32, and CCNPP's Quality Assurance Policy (QAP). Revision 59.i
_I Deleted: 12 I
/
/
4 Deleted: 9 I - Table of CGG QATR Exceptions/Alternatives Page 8 of
CGG QATR EXCEPTIONS/ALTERNATIVES SOURCE/BASIS FOR ACCEPTANCE procedures. The biennial requirement includes a fire protection equipment and program implementation inspection and audit utilizing The annual fire protection audit requirement was incorporated into the either a qualified offsite licensed fire protection engineer or an outside biennial fire protection audit at CCNPP in Revision 43 to the QAP.
qualified fire protection consultant.
CCNPP's revised QAP was reviewed and accepted by the NRC staff in the "10 CFR 50.54 Quality Assurance Program Change Review" dated September 25, 1996.
The difference in the 12-month, 24-month and 36-month audits is the use of an outside consultant. The use of the consultant on a 24-month basis is acceptable to CGG.
B.4 Procurement Control For NQA.1-1994 Supplement 4S-1, Section 2.3, which requires This alternative is consistent with the provisions approved by the NRC procurement documents to require a quality program that complies with in Safety Evaluation Report by the Office of Nuclear Reactor NQA-I, CGG may apply other nationally recognized and NRC Regulation, "Change to the Quality Assurance Program. Quality endorsed quality standards, such as N45.2 or 10CFR50 Appendix B, as Assurance Program Consolidation," dated March 24, 2005 for Nuclear appropriate to the circumstances of the procurement.
Management Company.
For existing long-term plant purchases that have imposed ANSI N45.2, or other NRC endorsed quality standards, that can be shown to be equivalent to NOA-l. CGG is not required to change the procurement document. For new procurement documents, CGG will specify the requirements of NOA-I or Appendix B to 10 CFR Part 50. However, CGG may accept vendors implementing another NRC endorsed standard that has shown to be equivalent to NQA-I or Appendix B to 10 CFR Part 50. This alternative is acceptable because we continue to meet the requirements of 10 CFR 50, Appendix B.
For NQA-1-1994 Supplement 4S-I and Supplement 7S.1, CGG will The standard NOA-1-1994 does not address commercial grade use the guidance contained in Generic Letter 89-02/EPRI NP-5652 to dedication adequately, therefore an exception to NOA-I-1994 procure Commercial Grade Items in lieu of these requirements.
Supolements 4S-I and 7S-1 is needed. The NRC staff conditionally endorses EPRI NP-5652, "Guideline for the Utilization of Commercial Grade Items in Nuclear Safety Related Applications(NCIG-07)," in Generic Letter 89-02, "Actions to Improve the Detection of Counterfeit and Fraudulently Marketed Products," This alternative is acceptable for CGG to assure the quality of procured vendor products.
,I Deleted: 12 Deleted-9 Page 9 of I - Table of CGG QATR Exceptions/Alternatives
CGG QATR EXCEPTIONS/ALTERNATIVES SOURCE/BASIS FOR ACCEPTANCE For NQA-1-1994 Supplement 7S-1, Section 8.1, documentary This alternative is consistent with the provisions approved by the NRC evidence that items conform to procurement requirements need not be in Safety Evaluation Report by the Office of Nuclear Reactor available at the site prior to item installation, but will be available at the Regulation, "Change to the Quality Assurance Program, Quality site prior to placing reliance on the item for its intended safety function.
Assurance Program Consolidation," dated March 24, 2005 for Nuclear Management Company.
This alternative is acceptable for CGG because it still ensures that safety-related equipment will meet 10 CFR 50, Appendix B requirements for control of purchased items prior to their being made operable.
For NQA-1-1994 Supplement 7S-1 Paragraph 8.2.4 states "...post-This alternative was taken from Nine Mile Point Nuclear Station's installation test requirements and acceptance documentation shall be Quality Assurance Program Topical Report, Revision 18. This mutually established by the Purchaser and Supplier." In exercising alternative was originally related to NQA-1-1983 and was approved by ultimate responsibility for its QA Program, CGG establishes post-the NRC on 12/31/1985 with revision I to Niagara Mohawk Power installation test requirements, giving due consideration to supplier Corporation QA Topical Report, NMPC-QATR-1. This alternative is recommendations.
acceptable for CGG because it places the primary responsibility on the CGG plants, in consultation with the supplier.
B.7 Handling, Storage, and Shipping This alternative applies to Nine Mile Point Nuclear Station (NMPNS).
This alternative was taken from Nine Mile Point Nuclear Station's NMPNS commits to ANSI/ASME NQA-2-1983 Part 2.2, "Quality Quality Assurance Program Topical Report, Revision 18. This Assurance Requirements for Packaging, Shipping, Receiving, Storage, alternative was originally related to NQA-1-1983 and was approved by and Handling of Items for Nuclear Power Plants," for nuclear safety-the NRC on 12/31/1985 with revision I to Niagara Mohawk Power related activities pertaining directly to permanent plant modifications Corporation QA Topical Report, NMPC-QATR-1.
only. NQA-2-1983 Section 7.1 refers to NQA-2-1983 Part 2.15 for requirements related to handling of items. The scope of Part 2.15 This exception is acceptable because it continues a pre-approved NRC includes hoisting, rigging and transporting of items for nuclear power exception previously granted to Nine Mile Point Nuclear Station. It plants. This scope exceeds the scope of the NRC's original does not extend the exception to other CGG sites.
endorsement of ANSI N45.2.2 in Regulatory Guide 1.38, and establishes requirements for which there is no NRC regulatory position.
In lieu of compliance with Part 2.15, NMPNS is committed to the requirements of applicable heavy load reports for Nine Mile Point Units I and 2 that have been approved by the NRC. Unit 2's report is a part of the SAR (Appendix 9C). Unit l's is a separate report.
In lieu of the five-level zone designation in NQA-1-1994 Subpart 2.3, This alternative is consistent with the provisions approved by the NRC A Deleted: 12
~'A-Deleted: 9 I - Table of CGG QATR Exceptions/Alternatives Page 10 of I
CGG QATR EXCEPTIONS/ALTERNATIVES SOURCE/BASIS FOR ACCEPTANCE CGG may base its control over housekeeping activities on a in Safety Evaluation Report by the Office of Nuclear Reactor consideration of what is necessary and appropriate for the activity Regulation, "Change to the Quality Assurance Program, Quality involved. The controls are effected through procedures or instructions.
Assurance Program Consolidation," dated March 24, 2005 for Nuclear Factors considered in developing the procedures and instructions Management Company.
include cleanliness control, personnel safety, fire prevention and protection, radiation control and security. The procedures and This alternative is accentable based on providing an equivalent level of instructions make use of standard janitorial and work practices to the control over housekeeping activities.
extent possible.
B.15 Records NQA-1-1994 Supplement 17S-1, section 4.2(b) requires records to be This alternative is consistent with the provisions approved by the NRC firmly attached in binders or placed in folders or envelopes for storage in Safety Evaluation Report by the Office of Nuclear Reactor in steel file cabinets or on shelving in containers. For hard-copy records Regulation, "Change to the Quality Assurance Program, Quality maintained by CGG, the records are suitably stored in steel file cabinets Assurance Program Consolidation," dated March 24, 2005 for Nuclear or on shelving in containers, except that methods other than binders, Management Company.
folders or envelopes may be used to organize the records for storage.
This alternative is acceptable for CGG as it still ensures adequate pmtection of records and meets the requirements of 10 CFR 50, Appendix B.
In lieu of the storage facility requirements of NQA-1.1994 This alternative was taken from Calvert Cliffs Nuclear Power Plant's Supplement 17S-1 Section 4.4, CGG allows the following alternative Quality Assurance Policy, Revision 59. This alternative was originally storage requirements for organizations other than the records related to ANSI N45.2.9-1976 and has been a part of Calvert Cliffs QA management organization. Organizations that originate records and do Policy since Revision 2, dated March 4, 1974.
not transfer them to the records management within 30 days of completion shall establish one of the following three controls as This exception is based on an existing Calvert Cliffs exception for alternatives to the requirements specified for the records management alternative storage location requirements. The alternative is acceptable organization:
for CGG because it provides equivalent storage requirements to NOA-I )
Duplicate Storage - Either A or B.
1-1994 and continues to meet the storage requirements of 10 CFR 50, A.
Within 30 days of completion of a record, a duplicate record Appendix B.
file shall be established. This activity shall be controlled by procedures which provide for the following: (a) Assignment of responsibility for records; (b) Description of storage area; (c) Description of filing system; (d) An index of the filing system; (e) Rules governing access to and control of files; (f) Methods for maintaining control of and accountability for records removed from the file; (g) Method for filing supplemental information and disposing of superseded or obsolete records; (h) Method for preserving records to prevent deterioration: (i)
Method for maintaining specially processed records that are sensitive to
,f Deleted: 12 5Deleted: 9 - Table of CGG QATR Exceptions/Alternatives Page I I of A- _,,-
I.
J
CGG QATR EXCEPTIONS/ALTERNATIVES SOURCE/BASIS FOR ACCEPTANCE CGG QATR EXCEPTIONS/ALTERNATIVES SOURCE/BASIS FOR ACCEPTANCE light, pressure, or temperature; (j) Transfer of duplicates to the records management organization within two years of completion of records.
B.
Make arrangements with at least one other department that receives a copy of each document to subject this other copy to the controls specified above.
- 2)
Fire-resistant Building Storage - Records shall be stored in steel cabinets located in a fire-resistant building or a non-combustible building with a fire suppression system. The procedural controls defined for duplicate storage shall be applied.
- 3)
Non-fire-resistant Building Storage - Within non-fire-resistant facilities, records shall be stored in UL one-hour-minimum fire-rated storage cabinets and be subject to the procedural controls defined for duplicate storage. CCNPP defines a Fire-resistant Building as follows:
A facility constructed to resist the initiation or spreading of fire; non-combustible and/or fire-suppressive materials used; building certified as fire-resistant by a person who specializes in the technical field of fire prevention and fire extinguishing.
This alternative applies to Calvert Cliffs Nuclear Power Plant. In lieu of the reinforced concrete, concrete block, masonry, or equal construction requirements of NQA-1-1994 Supplement 17S-1, Section 4.4.1(a), the records vault is entirely enveloped by a structurally sound, fire resistive building. Second, the vault rests on a reinforced slab on grade and its walls extend fully to the underside of the structural deck.
Third, the walls of the vault are constructed of gypsum wallboard on metal studs per Underwriters Laboratory Test Number U412, assuring the equivalent of 2-hour fire resistive construction. This is equal construction to concrete block in terms of fire protection. The walls carry no structural load; hence, they provide equivalent structural integrity to that needed of concrete block. Supplement 17S-1 Section 4.4.1(b) requires floor and roof drainage control. If a floor drain is provided, a check valve (or equal) shall be included. In lieu of this requirement, the vault is contained within an environmentally protected building. As such, it has no roof, or need for floor drain.
These responses have been forwarded to the NRC by the CCNPP letter dated 02/11/83 from Robert G. Nichols, Sr. Facilities Project Administrator, Real Estate and Office Services Department, to Terry L.
Harpster, Chief QA Branch, Division of QA, Safeguards and Inspection Programs, IE, USNRC. These responses have also been accepted by the NRC in their letter dated 04/22/83 from Walter P. Haass, Deputy Chief, QA Branch, Division of Quality Assurance, Safeguards, and Inspections Programs, Office of Inspection and Enforcement.
This exception is acceptable because it continues a pre-approved NRC exception previously granted to Calvert Cliffs Nuclear Power Plant. It does not extend the exception to other CGG sites Deleted: 12 Deleted: 9 - Table of CGG QATR Exceptions/Alternatives Page 12 of I
ATTACHMENT (5)
Revised Attachment 4 Pages Constellation Generation Group, LLC July 14,2006
CGG QATR EXCEPTIONS/ALTERNATIVES SOURCE/BASIS FOR ACCEPTANCE A.5 Personnel Training and Qualification For NQA-1-1994 Supplement 2S-1: Inspections, examinations or tests This alternative is consistent with the provisions approved by the NRC may be performed by individuals in the same organization as that in Safety Evaluation Report by the Office of Nuclear Reactor which performed the work, provided that (a) the qualifications of the Regulation, "Change to the Quality Assurance Program, Quality inspector for an activity are equal to or better than the minimum Assurance Program Consolidation," dated March 24, 2005 for Nuclear qualifications for persons performing the activity, (b) the work is within Management Company.
the skills of personnel and/or is addressed by procedures, and (c) if work involves breaching a pressure-retaining item, the quality of the This alternative is used by NMC to describe alternative training work can be demonstrated through a functional test. When a, b and c methods if it implemented line performance of Quality Control are not met, inspections, examinations or tests are carried out by inspections. This alternative is acceptable for CGG because CGG individuals certified in accordance with Supplement 2S-1. Individuals would also apply it only to line personnel performing Quality Control performing visual inspections required by the ASME Boiler and inspections. It does not apply to Quality Assurance personnel.
Pressure Vessel Code are qualified and certified according to Code requirements.
The alternative meets the requirements of 10 CFR 50, Appendix B, Criterion II, by requiring training and qualification of personnel that assures suitable proficiency in the skills necessary to perform quality verification inspections and tests is achieved and maintained. The individuals qualified in accordance with this alternative participate in an accredited SAT-based training program that meets 10 CFR 50.120.
In lieu of NQA-1-1994 Nonmandatory Appendix 2A-1, CGG need This alternative is consistent with the provisions approved by the NRC not establish levels of qualification/ certification for inspection and test in Safety Evaluation Report by the Office of Nuclear Reactor personnel. Instead, CGG may establish initial qualification Regulation, "Change to the Quality Assurance Program, Quality requirements and determines individual qualification through Assurance Program Consolidation," dated March 24, 2005 for Nuclear evaluation of education, training and experience, and through Management Company.
demonstration of capability in performing the type of inspections expected on the job.
This exception establishes an alternative qualification method for independent Quality Control inspectors and is considered acceptable because it continues to satisfy the criteria of 10 CFR 50, Appendix B.
In lieu of NQA-1-1994 Supplement 2S-2, CGG will follow the This alternative is consistent with the provisions approved by the NRC applicable standard cited in the latest version(s) of Sections III and XI in Safety Evaluation Report by the Office of Nuclear Reactor of the ASME Boiler and Pressure Vessel Code approved by the NRC Regulation, "Change to the Quality Assurance Program, Quality for use at CGG sites for qualification of nondestructive examination Assurance Program Consolidation," dated March 24, 2005 for Nuclear personnel.
Management Company. - Table of CGG QATR Exceptions/Alternatives Page I of 12
CGG QATR EXCEPTIONS/ALTERNATIVES SOURCE/BASIS FOR ACCEPTANCE This alternative is considered acceptable because other regulations, codes and standards establish requirements for qualification of NDE personnel.
For NQA-1-1994 Supplement 2S-3: The requirement that prospective Lead Auditors have participated in a minimum of five (5) audits in the previous three (3) years is replaced by the following:
"The requirement that prospective Lead Auditors have participated in a minimum of five (5) audits in the previous three (3) years is replaced by the following, "The prospective lead auditor shall demonstrate his/her ability to effectively lead and implement the audit process, as implemented according to Section C.2 of the QATR, and to effectively organize and report results, including participation in at least one nuclear audit within the year preceding the date of qualification. CGG describes this process in written procedures and shall evaluate and document the results of the demonstration."
This alternative is consistent with the provisions approved by the NRC in Safety Evaluation Report by the Office of Nuclear Reactor Regulation, "Change to the Quality Assurance Program, Quality Assurance Program Consolidation," dated March 24, 2005 for Nuclear Management Company.
As described in the "Revised Submittal of Quality Assurance Program for Station Operation, R.E. Ginna Nuclear Power Plant" dated December 21, 1998, the revised requirements for certification of lead auditors are consistent with the guidance provided by the NRC in a letter "Review of Nuclear Energy Institute Proposed Improvements to QA Programs," dated October 24, 1996. The revised requirement meets the intent of Section 3.3 of NQA-1-1994 to have the prospective lead auditor demonstrate the ability to effectively implement the audit process and to lead an audit team. Since the revised requirements meet the intent of the original requirement and the NRC hasproposed this approach as an acceptable alternative, this change does not reduce the scope of the quality assurance program.
The NRC notes in their Safety Evaluation Report to R.E. Ginna Nuclear Power Plant, dated April 6, 1999, that in an October 24, 1996 letter to the Nuclear Energy Institute, the NRC staff provided its position with regards to acceptable industry proposed alternatives on quality assurance processes for qualifying auditors and for conducting annual evaluations of suppliers. Rochester Gas and Electric's proposed alternative for certifying lead auditors, as described was consistent with the staff's position in the cited letter and is, therefore, acceptable.
i A grace period of 90 days may be applied to the performance of annual evaluations of inspection, examination and testing personnel qualifications defined in NQA-l-1994 Supplement 2S-1, and annual lead auditor recertifications described in Supplement 2S-3. The grace period does not allow the "clock" for a particular activity to be reset forward. However, the "clock" for an activity is reset backwards by This was originally an exception to the provisions of Regulatory Guide 1.144, Revision 1, approved by the NRC in Safety Evaluation by the Office of Nuclear Reactor Regulation "Proposed Revision 25 to the Rochester Gas and Electric Corporation Quality Assurance Program for Station Operation, R.E. Ginna Nuclear Power Plant," dated July 22, 1998. The approval allowed a 90-day grace period for recertification - Table of CGG QATR Exceptions/Alternatives Page 2 of 12
CGG QATR EXCEPTIONS/ALTERNATIVES SOURCE/BASIS FOR ACCEPTANCE performing the activity early, of audit personnel. Technical Specifications allow the use of a 25%
grace period for the performance of periodic surveillances. This is acceptable for all of CGG because this type of Quality Assurance program change continues to satisfy the criteria of 10 CFR 50, Appendix B.
A.7.3 Regulatory Position C of Regulatory Guide 1.28, Revision 3, endorses the basic and supplementary requirements of ANSI/ASME NQA-1-1983 and the ANSI/ASME NQA-la-1983 Addenda. In place of the specific edition and addenda of NQA-1 addressed in the Regulatory Guide, CGG commits to implement the requirements of NQA-I- 1994 Part I.
CGG is adopting ASME NQA-I-1994 Part 1 consistent with the provisions approved by the NRC in Safety Evaluation by the Office of Nuclear Reactor Regulation "Proposed Change to the Quality Assurance Program, Quality Assurance Program Consolidation, Exelon Generation Company, LLC and Amergen Energy Company, LLC," dated December 24, 2002. CGG's conformance to NQA-I-1994 Part I is documented in CGG QATR.
In the Code of Federal Regulations, 10 CFR 50.54(a)(3)(i) allows "The use of a QA standard approved by the NRC which is more recent than the standard in the licensee's current QA program at the time of the change." Although the NRC has not yet specifically endorsed NQA-I-1994 in their regulatory guides, Regulatory Guide 1.28, Revision 3, dated August 1985, endorsed NQA-I-1983. Correspondence by the NRC and related NRC Safety Evaluation Report (SER) dated Decenber 24, 2002, for approval of Revision 70 of QATR EGC-I A, for EXELON/AMERGEN plants, subsection 3.2.1, determined that the requirements of the 1983 and 1994 editions of NQA-I are equivalent.
Based on the related NRC safety evaluation, CGG's use of NQA-I-1994 is consistent with 10 CFR 50.54(a)(3)(ii), which states, "The use of a quality assurance alternative or exception approved by an NRC safety evaluation, provided that the bases of the NRC approval are applicable to the licensee's facility" is not a reduction in commitment.
EXELON has submitted a comparison of NQA-I-1983 with NQA 1994, used as part of the basis for the NRC approval, which applies to CGG's QATR. In addition, CGG prepared a table to compare the ANSI N 18.7 standard to NQA-I -1994 and the CGG QATR (Attachment 3 to the QATR submittal). - Table of CGG QATR Exceptions/Alternatives Page 3 of 12
CGG QATR EXCEPTIONS/ALTERNATIVES SOURCE/BASIS FOR ACCEPTANCE CGG does not commit to compliance with Regulatory Position C.1 of This exception is consistent with the provisions approved by the NRC Regulatory Guide 1.28, Revision 3; instead of establishing three in Safety Evaluation Report by the Office of Nuclear Reactor levels of qualification provided in NQA-1-1994 Nonmandatory Regulation, "Change to the Quality Assurance Program, Quality Appendix 2A-1, CGG may establish initial qualification requirements Assurance Program Consolidation," dated March 24, 2005 for Nuclear and determine individual qualification through evaluation of education, Management Company. This Regulatory Guide endorses Non-training and experience, and through demonstration of capability in mandatory Appendix 2A-I of NQA-l-1994. This alternative is performing the type of inspections expected on the job.
considered acceptable because it continues to satisfy the criteria of 10 CFR 50, Appendix B.
The guidance of Regulatory Guide 1.28, Revision 3, Regulatory Position C.3.2, regarding external audits will also be implemented in the operational phase. CGG complies with Regulatory Position C.3.2 with the exception that for Regulatory Position C.3.2.2, CGG may review the information described therein as it becomes available through its ongoing receipt inspection, operating experience, and supplier evaluation programs, in lieu of performing a specific evaluation on an annual basis. The results of the reviews are promptly considered for effect on a supplier's continued qualification and adjustments made as necessary (including corrective actions, adjustments of supplier audit plans, and input to third party auditing entities, as warranted). Additionally, results are reviewed periodically to determine if, as a whole, they constitute a significant condition adverse to quality requiring additional action. A grace period of 90 days may be applied to the performance of triennial supplier audits described in Regulatory Position C.3.2.1. The grace period does not allow the "clock" for a particular activity to be reset forward.
However, the "clock" for an activity is reset backwards by performing the activity early.
This exception is consistent with the provisions approved by the NRC in Safety Evaluation Report by the Office of Nuclear Reactor Regulation, "Change to the Quality Assurance Program, Quality Assurance Program Consolidation," dated March 24, 2005 for Nuclear Management Company.
This alternative provides for a documented ongoing evaluation of the supplier's performance, rather than an annual evaluation. Where applicable, this evaluation takes into account the review of supplier-furnished documents such as certificates of conformance, non-conformance notices, and corrective actions, as well as evaluating the results of previous source surveillances/verifications, audits/surveys, and receiving inspections. The alternative also provides for the review of operating experience information pertaining to equipment failures and evaluation of the results of audits from other sources (e.g., NUPIC audits) for their effect on supplier qualification status. As described in procedures, the results of these evaluations are reviewed and appropriate corrective action taken. Furthermore, adverse findings resulting from these evaluations are periodically reviewed to determine if, in the aggregate, they result in a significant condition adverse to quality. Additionally, the results of these evaluations are used to provide input to support supplier audit activities conducted by CGG or third party auditing organizations. If no items are received from a vendor in the course of a year, we still review industry activity using the daily download of operating experience information from the INPO website, the NUPIC database, and the NRC's website for inspection activities and Part 21 notifications. At the NUPIC meetings, there is an ongoing agenda item to review vendor performance and to alert others - Table of CGG QATR Exceptions/Alternatives Page 4 of 12
to adverse trends. Internal corrective action programs at the CG sites address vendor performance and are factored into qualification maintenance. Vendors may also be removed from the Approved Vendor's List either because of re-evaluation, which resulted in removal, or due to inactivity.
The 90-day grace period exception was taken from Ginna's Quality Assurance Program for Station Operation, Revision 32. This was originally an exception to the provisions of Regulatory Guide 1.144, Revision I, approved by the NRC in Safety Evaluation by the Office of Nuclear Reactor Regulation "Proposed Revision 25 to the Rochester Gas and Electric Corporation Quality Assurance Program for Station Operation, R.E. Ginna Nuclear Power Plant," dated July 22, 1998. The approval allowed a 90-day grace period for supplier audits. This is acceptable for all of CGG because this type of Quality Assurance program change continues to satisfy the criteria of 10 CFR 50, Appendix B.
- 2*
In lieu of the requirements of the last paragraph of ANSI N45.2.4-1972 Section 6.2.1, the calibration program at CGG does not use calibration stickers on installed plant instrumentation that contain the date of calibration and identity of person that performed the calibration.
Calibrations of instruments are scheduled and tracked by a computer database.
This alternative is consistent with the provisions approved by the NRC in Safety Evaluation Report "Entergy Operations, Inc, Quality Assurance Program Consolidation," dated November 6, 1998. This alternative is also consistent with the current quality assurance programs for Calvert Cliffs and Nine Mile Point.
The alternative for this item is consistent with a QAP alternative approved by the NRC for River Bend. The intent of the alternative was to allow other methods of marking equipment with calibration information other than by tagging. The staff recognized approved alternative methods before, such as using a calibration log that is correlated with the equipment by unique identification numbers on the equipment. The staff found that alternatives to tagging equipment with calibration information are acceptable provided that the specific method implemented by the licensee meets the requirements of the above standards and found that the requirements of 10 CFR Part 50, Appendix B continue to be met. Thus, this alternative is acceptable for CGG because the calibration program continues to meet the requirements of 10 CFR 50, Appendix B.
NQA-I-1994 Part I contains quality assurance requirements equivalent This alternative is consistent with the provisions approved by the NRC - Table of CGG QATR Exceptions/Alternatives Page 5 of 12
to those of ANSI N I8.7-1976/ANS-3.2, and CGG has included in this QATR the remaining "administrative controls" elements from ANSI N18.7-1976/ANS-3.2. Therefore, CGG does not commit to compliance with the requirements of ANSI N-18.7-1976/ANS-3.2 as endorsed by Regulatory Guide 1.33, Revision 2, Regulatory Position C.
CGG's commitment to the applicable Regulatory Guides and associated standards listed in Regulatory Position C.2 of Regulatory Guide 1.33, Revision 2, is addressed within the CGG QATR. A number of these Regulatory Guides and standards have been incorporated into NQA-I-1994 Part I.
In lieu of compliance with Regulatory Position C.5 of Regulatory Guide 1.33, Revision 2, CGG has established appropriate equivalent requirements within this QATR.
in Safety Evaluation Report by the Office of Nuclear Reactor Regulation, "Change to the Quality Assurance Program, Quality Assurance Program Consolidation," dated March 24, 2005 for Nuclear Management Company.
Constellation Generation Group recognizes that NRC Regulatory Guide 1.33, "Quality Assurance Program Requirements (Operations)"
endorses ANSI Standard N18.7, "Administrative Controls and Quality Assurance for the Operational Phase of Nuclear Power Plants". The CGG plants have current commitments to this standard. We have concluded that the QATR, combined with our commitment to Regulatory Guide 1.28, provides an acceptable alternative to Regulatory Guide 1.33 and ANSI N18.7-1976, in that the QATR provides quality assurance and administrative control requirements consistent with that guidance, as well as a quality assurance program that meets 10 CFR 50, Appendix B. Attachment 3 to the QATR submittal is a table illustrating that the quality assurance requirements of N18.7-1976 are addressed through our commitment to NQA-l-1994, and the administrative controls of N1 8.7 are addressed by inclusion of equivalent requirements within the text of the QATR.
In lieu of the six and twelve month audit frequencies specified in Regulatory Position C.4 of Regulatory Guide 1.33, Revision 2, CGG audits selected aspects of operational phase activities at a frequency commensurate with their safety significance in such a manner as to assure an audit of all safety-related functions is completed within a period of two years. (except as otherwise required in regulations)
CGG's audit program includes the elements listed in Regulatory Position C.4. In addition, A 90-day grace period may be applied to the 24-month frequency for performing internal audits. The grace period does not allow the "clock" for a particular activity to be reset forward.
However, the "clock" for an activity is reset backwards by performing the activity early.
Each CGG site currently has an exception to the six and twelve month audit frequencies specified in Regulatory Position C.4. The NRC most recently approved this exception for the Fitzpatrick and Indian Point Unit 3 Nuclear Plants in a Safety Evaluation by the Office of Nuclear Reactor Regulation, dated March 25, 1999.
This exception is acceptable because it has been previously adopted for each CGG site and continues to satisfy the criteria of 10 CFR 50, Appendix B.
In addition, this exception contains the use of 90 day grace periods for internal audits. This was originally an exception to the provisions of Regulatory Guide 1.144, Revision 1, approved by the NRC in Safety Evaluation by the Office of Nuclear Reactor Regulation "Proposed Revision 25 to the Rochester Gas and Electric Corporation Quality Assurance Program for Station Operation, R.E. Ginna Nuclear Power Plant," dated July 22, 1998. The approval allowed a 90-day grace period for internal audits. This is acceptable for all of CGG because this Quality Assurance program change continues to satisfy the criteria of 10 CFR 50, Appendix B. - Table of CGG QATR Exceptions/Alternatives Page 6 of 12
CGG substitutes NQA-I-1994, Subpart 2.3 for N45.2.3 in its commitment to Regulatory Guide 1.39, September 1977. As noted in Regulatory Position C.1, other industry standards may be referenced; the commitment in this QATR to NQA-1, Subpart 2.3 includes commitment to those standards to the extent necessary to implement Subpart 2.3 requirements. If NRC guidance applies to those referenced standards, it is followed. Regulatory Position C.2 indicates that the provisions of section 3.2.3 of N45.2.3 are not part of the Regulatory endorsement. As NQA-1, Subpart 2.3, section 3.2.3 has the same wording as N45.2.3; the Regulatory Position is applicable and will be followed in CGG's implementation of Subpart 2.3. Regulatory Position C.3 indicates that the endorsed standard is "applicable for housekeeping activities during the operations phase that are comparable to those occurring during construction." This is addressed in section B.7 of the QATR, which also establishes any necessary exceptions or alternatives to the provisions of Subpart 2.3.
CGG is adopting ASME NQA-1-1994 Subpart 2.3 consistent with the provisions approved by the NRC in Safety Evaluation of Proposed Change to the Quality Assurance Program, Quality Assurance Program Consolidation for Dominion Nuclear Connecticut, Inc. and Virginia Electric and Power Company, dated September 9, 2005. The NRC staff found that NQA-I-1994 Subpart 2.3 contains equivalent requirements to Regulatory Guide 1.39, September 1977, and ANSI N45.2.3-1973.
This alternative is acceptable based on providing an equivalent level of control over housekeeping activities.
CGG substitutes NQA-I-1994, Subpart 2.8 for N45.2.8 in its commitment to Regulatory Guide 1.116, May 1977. As noted in Regulatory Position C.1, other industry standards may be referenced; the commitment in this QATR to NQA-I, Subpart 2.8 includes commitment to those standards to the extent necessary to implement Subpart 2.8 requirements. If NRC guidance applies to those referenced standards, it is followed. Regulatory Position C.3 recommends using Section 5 of N45.2.8 in conjunction with Regulatory Guide 1.68 for pre-operational, cold functional, and hot functional testing. While Section 5 of NQA-I, Subpart 2.8 provides the same requirements, it is anticipated that CGG plants, since they are already beyond these tests, will not need to implement Regulatory Guide 1.68. If testing in accordance with Regulatory Guide 1.68 becomes necessary, CGG will comply with the guidance of the Regulatory Guide 1. 116 position.
Regulatory Position C.2 indicates that the endorsed standard should be "followed for those applicable operations phase activities that are comparable to activities occurring during the construction phase." This is addressed in section B.12 of this QATR, which also establishes any necessary exceptions or alternatives to the provisions of Subpart 2.8.
CGG is adopting ASME NQA-1-1994 Subpart 2.8 consistent with the provisions approved by the NRC in Safety Evaluation of Proposed Change to the Quality Assurance Program, Quality Assurance Program Consolidation for Dominion Nuclear Connecticut, Inc. and Virginia Electric and Power Company, dated September 9, 2005. The NRC staff found that NQA-1-1994 Subpart 2.8 contains equivalent requirements to Regulatory Guide 1. 116, May 1977, and ANSI N45.2.8-1975.
This alternative is acceptable based on providing an equivalent level of control over housekeeping activities CGG commits to Regulatory Guide 4.15, Revision 1, February 1979, CGG establishes a commitment to Regulatory Guide 4.15 in the "Quality Assurance for Radiological Monitoring Programs (Normal QATR. Three exceptions are taken consistent with existing QA Operations) - Effluent Streams and the Environment," with the programs for radiological Monitoring Programs for effluent streams - Table of CGG QATR Exceptions/Alternatives Page 7 of 12
following alternatives/exceptions:
and the environment:
following altematives/exceptions:
and the environment:
In lieu of plotting background parameters and setting predetermined control values for gamma spectroscopy instrumentation as described in Regulatory Position C.6.2, background results may be logged and evaluated to ensure the background does not bias reported results.
The NRC's independent sampling and analysis program described in Regulatory Position C.6.3.2 may not be performed.
In lieu of performing source check calibrations at least once per 18 months as described in Regulatory Position C.7, CGG may perform these calibrations at least once per refueling interval.
Counting room procedures are based on industry best practices. CGG plots (i.e., graph paper) and trends backgrounds on all laboratory instrumentation with the exception that an alternate method may be used for gamma spectroscopy. In this case, an alternate but equally effective method may be implemented: Gamma isotopic backgrounds are counted routinely, and all nuclides are checked for the presence of contamination (i.e. a peak) to ensure each background for each nuclide does not impact any analysis result. If contamination is detected (i.e., a peak is identified), remedial action is taken. Adequacy and accuracy of results are checked in an Interlaboratory test program. Interlaboratory and Intralaboratory test data are carefully evaluated to determine bias.
The NRC has previously evaluated this method of counting room performance for gamma spectroscopy and found it acceptable.
The exception from the NRC's independent sampling and analysis program reflects the discontinuance of their Confirmatory Measurements Program.
Regulatory Position C.7, "Quality Control for Continuous Effluent Monitoring Systems," states that sources that have been related to initial calibration should be used to check this initial calibration at least once per 18 months (normally during refueling outages). The typical industry refueling outage today is at a 24-month frequency. This change of frequency allows source check calibrations consistent with Technical Specification amendments such as the "Twenty Four Month Cycle Technical Specification Amendments for Calvert Cliffs Nuclear Power Plants Units I and 2," issued November 3, 1987 in the Safety Evaluation by the Office on Nuclear Reactor Regulation, and the intent of this Regulatory Guide.
In lieu of the 12-month, 24-month and 36-month fire protection and loss prevention audits described in Generic Letter 82-21, CGG will combine the scope of the three audits into one by performing a biennial audit of the facility fire protection program and implementing procedures. The biennial requirement includes a fire protection equipment and program implementation inspection and audit utilizing either a qualified offsite licensed fire protection engineer or an outside qualified fire protection consultant.
This was originally an alternative reviewed and accepted by the NRC staff for Revision 21 of Ginna's QAPSO in the "10 CFR 50.54 Quality Assurance Program Change Review" dated March 22, 1995.
The annual fire protection audit requirement was incorporated into the biennial fire protection audit at CCNPP in Revision 43 to the QAP.
CCNPP's revised QAP was reviewed and accepted by the NRC staff in the "10 CFR 50.54 Quality Assurance Program Change Review" dated - Table of CGG QATR Exceptions/Alternatives Page 8 of 12
September 25, 1996.
The difference in the 12-month, 24-month and 36-month audits is the use of an outside consultant. The use of the consultant on a 24-month basis is acceptable to CGG.
4 B.4 Procurement Control 4
For NQA-1-1994 Supplement 4S-1, Section 2.3, which requires procurement documents to require a quality program that complies with NQA-1, CGG may apply other nationally recognized and NRC endorsed quality standards, such as N45.2 or IOCFR50 Appendix B, as appropriate to the circumstances of the procurement.
This alternative is consistent with the provisions approved by the NRC in Safety Evaluation Report by the Office of Nuclear Reactor Regulation, "Change to the Quality Assurance Program, Quality Assurance Program Consolidation," dated March 24, 2005 for Nuclear Management Company.
For existing long-term plant purchases that have imposed ANSI N45.2, or other NRC endorsed quality standards, that can be shown to be equivalent to NQA-l, CGG is not required to change the procurement document. For new procurement documents, CGG will specify the requirements of NQA-1 or Appendix B to 10 CFR Part 50. However, CGG may accept vendors implementing another NRC endorsed standard that has shown to be equivalent to NQA-I or Appendix B to 10 CFR Part 50. This alternative is acceptable because we continue to meet the requirements of 10 CFR 50, Appendix B.
For NQA-1-1994 Supplement 4S-1 and Supplement 7S-1, CGG will The standard NQA-1-1994 does not address commercial grade use the guidance contained in Generic Letters 91-05 and 89-02/EPRI dedication adequately, therefore an exception to NQA-I-1994 NP-5652 to procure Commercial Grade Items in lieu of these Supplements 4S-I and 7S-1 is needed. The NRC staff conditionally requirements.
endorses EPRI NP-5652, "Guideline for the Utilization of Commercial Grade Items in Nuclear Safety Related Applications(NCIG-07)," in Generic Letter 89-02, "Actions to Improve the Detection of Counterfeit and Fraudulently Marketed Products." This alternative is acceptable for CGG to assure the quality of procured vendor products.
For NQA-1-1994 Supplement 7S-1, Section 8.1, documentary This alternative is consistent with the provisions approved by the NRC evidence that items conform to procurement requirements need not be in Safety Evaluation Report by the Office of Nuclear Reactor available at the site prior to item installation, but will be available at the Regulation, "Change to the Quality Assurance Program, Quality site prior to placing reliance on the item for its intended safety function.
Assurance Program Consolidation," dated March 24, 2005 for Nuclear Management Company. - Table of CGG QATR Exceptions/Alternatives Page 9 of 12
This alternative is acceptable for CGG because it still ensures that safety-related equipment will meet 10 CFR 50, Appendix B requirements for control of purchased items prior to their being made operable.
For NQA-1-1994 Supplement 7S-1 Paragraph 8.2.4 states "...post-This alternative was taken from Nine Mile Point Nuclear Station's installation test requirements and acceptance documentation shall be Quality Assurance Program Topical Report, Revision 18. This mutually established by the Purchaser and Supplier." In exercising alternative was originally related to NQA-I-1983 and was approved by ultimate responsibility for its QA Program, CGG establishes post-the NRC on 12/31/1985 with revision I to Niagara Mohawk Power installation test requirements, giving due consideration to supplier Corporation QA Topical Report, NMPC-QATR-1. This alternative is recommendations.
acceptable for CGG because it places the primary responsibility on the CGG plants, in consultation with the supplier.
B.7 Handling, Storage, and Shipping This alternative applies to Nine Mile Point Nuclear Station (NMPNS).
This alternative was taken from Nine Mile Point Nuclear Station's NMPNS commits to ANSI/ASME NQA-2-1983 Part 2.2, "Quality Quality Assurance Program Topical Report, Revision 18. This Assurance Requirements for Packaging, Shipping, Receiving, Storage, alternative was originally related to NQA-1-1983 and was approved by and Handling of Items for Nuclear Power Plants," for nuclear safety-the NRC on 12/3 1/1985 with revision 1 to Niagara Mohawk Power related activities pertaining directly to permanent plant modifications Corporation QA Topical Report, NMPC-QATR-1.
only. NQA-2-1983 Section 7.1 refers to NQA-2-1983 Part 2.15 for requirements related to handling of items. The scope of Part 2.15 This exception is acceptable because it continues a pre-approved NRC includes hoisting, rigging and transporting of items for nuclear power exception previously granted to Nine Mile Point Nuclear Station. It plants. This scope exceeds the scope of the NRC's original does not extend the exception to other CGG sites.
endorsement of ANSI N45.2.2 in Regulatory Guide 1.38, and establishes requirements for which there is no NRC regulatory position.
In lieu of compliance with Part 2.15, NMPNS is committed to the requirements of applicable heavy load reports for Nine Mile Point Units I and 2 that have been approved by the NRC. Unit 2's report is a part of the SAR (Appendix 9C). Unit l's is a separate report.
In lieu of the five-level zone designation in NQA-1-1994 Subpart 2.3, This alternative is consistent with the provisions approved by the NRC CGG may base its control over housekeeping activities on a in Safety Evaluation Report by the Office of Nuclear Reactor consideration of what is necessary and appropriate for the activity Regulation, "Change to the Quality Assurance Program, Quality involved. The controls are effected through procedures or instructions.
Assurance Program Consolidation," dated March 24, 2005 for Nuclear Factors considered in developing the procedures and instructions Management Company.
include cleanliness control, personnel safety, fire prevention and protection, radiation control and security. The procedures and This alternative is acceptable based on providing an equivalent level of - Table of CGG QATR Exceptions/Alternatives Page 10 of 12
instructions make use of standard janitorial and work practices to the control over housekeeping activities.
extent possible.
B.15 Records NQA-1-1994 Supplement 17S-1, section 4.2(b) requires records to be This alternative is consistent with the provisions approved by the NRC firmly attached in binders or placed in folders or envelopes for storage in Safety Evaluation Report by the Office of Nuclear Reactor in steel file cabinets or on shelving in containers. For hard-copy records Regulation, "Change to the Quality Assurance Program, Quality maintained by CGG, the records are suitably stored in steel file cabinets Assurance Program Consolidation," dated March 24, 2005 for Nuclear or on shelving in containers, except that methods other than binders, Management Company.
folders or envelopes may be used to organize the records for storage.
This alternative is acceptable for CGG as it still ensures adequate protection of records and meets the requirements of 10 CFR 50, Appendix B.
In lieu of the storage facility requirements of NQA-1-1994 This alternative was taken from Calvert Cliffs Nuclear Power Plant's Supplement 17S-1 Section 4.4, CGG allows the following alternative Quality Assurance Policy, Revision 59. This alternative was originally storage requirements for organizations other than the records related to ANSI N45.2.9-1976 and has been a part of Calvert Cliffs QA management organization. Organizations that originate records and do Policy since Revision 2, dated March 4, 1974.
not transfer them to the records management within 30 days of completion shall establish one of the following three controls as This exception is based on an existing Calvert Cliffs exception for alternatives to the requirements specified for the records management alternative storage location requirements. The alternative is acceptable organization:
for CGG because it provides equivalent storage requirements to NQA-
- 1)
Duplicate Storage - Either A or B.
1-1994 and continues to meet the storage requirements of 10 CFR 50, A.
Within 30 days of completion of a record, a duplicate record Appendix B.
file shall be established. This activity shall be controlled by procedures which provide for the following: (a) Assignment of responsibility for records; (b) Description of storage area; (c) Description of filing system; (d) An index of the filing system; (e) Rules governing access to and control of files; (f) Methods for maintaining control of and accountability for records removed from the file; (g) Method for filing supplemental information and disposing of superseded or obsolete records; (h) Method for preserving records to prevent deterioration; (i)
Method for maintaining specially processed records that are sensitive to light, pressure, or temperature; (0) Transfer of duplicates to the records management organization within two years of completion of records.
B.
Make arrangements with at least one other department that receives a copy of each document to subject this other copy to the controls specified above.
- 2)
Fire-resistant Building Storage - Records shall be stored in steel cabinets located in a fire-resistant building or a non-combustible building with a fire suppression system. The procedural controls - Table of CGG QATR Exceptions/Alternatives Page I I of 12
defined for duplicate storage shall be applied.
- 3)
Non-fire-resistant Building Storage - Within non-fire-resistant facilities, records shall be stored in UL one-hour-minimum fire-rated storage cabinets and be subject to the procedural controls defined for duplicate storage. CCNPP defines a Fire-resistant Building as follows:
A facility constructed to resist the initiation or spreading of fire; non-combustible and/or fire-suppressive materials used; building certified as fire-resistant by a person who specializes in the technical field of fire prevention and fire extinguishing.
This alternative applies to Calvert Cliffs Nuclear Power Plant. In lieu of the reinforced concrete, concrete block, masonry, or equal construction requirements of NQA-1-1994 Supplement 17S-1, Section 4.4.1(a), the records vault is entirely enveloped by a structurally sound, fire resistive building. Second, the vault rests on a reinforced slab on grade and its walls extend fully to the underside of the structural deck.
Third, the walls of the vault are constructed of gypsum wallboard on metal studs per Underwriters Laboratory Test Number U412, assuring the equivalent of 2-hour fire resistive construction. This is equal construction to concrete block in terms of fire protection. The walls carry no structural load; hence, they provide equivalent structural integrity to that needed of concrete block. Supplement 17S-I Section 4.4.1 (b) requires floor and roof drainage control. If a floor drain is provided, a check valve (or equal) shall be included. In lieu of this requirement, the vault is contained within an environmentally protected building. As such, it has no roof, or need for floor drain.
These responses have been forwarded to the NRC by the CCNPP letter dated 02/11/83 from Robert G. Nichols, Sr. Facilities Project Administrator, Real Estate and Office Services Department, to Terry L.
Harpster, Chief QA Branch, Division of QA, Safeguards and Inspection Programs, IE, USNRC. These responses have also been accepted by the NRC in their letter dated 04/22/83 from Walter P. Haass, Deputy Chief, QA Branch, Division of Quality Assurance, Safeguards, and Inspections Programs, Office of Inspection and Enforcement.
This exception is acceptable because it continues a pre-approved NRC exception previously granted to Calvert Cliffs Nuclear Power Plant. It does not extend the exception to other CGG sites. - Table of CGG QATR Exceptions/Alternatives Page 12 of 12