NOC-AE-09002460, Submittal of Operations Quality Assurance Plan Change QA-069

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Submittal of Operations Quality Assurance Plan Change QA-069
ML092790556
Person / Time
Site: South Texas  STP Nuclear Operating Company icon.png
Issue date: 09/24/2009
From: Halpin E
Southern Nuclear Operating Co
To:
Document Control Desk, Office of Nuclear Reactor Regulation
References
G09.19, NOC-AE-09002460, STI: 32532614, U7-C-STP-NRC-090026
Download: ML092790556 (50)


Text

Nuclear Operating Company South Texas Pmrect E/ectnrc Gencibng Staton P.. Box 289 Wadsworth, Texas 77483 A -

September 24, 2009 NOC-AE-09002460 File No.: G09.19 10CFR50.54(a)

STI: 32532614 U. S. Nuclear Regulatory Commission Attention: Document Control Desk One White Flint North 11555 Rockville Pike Rockville, MD 20852-2738 South Texas Project Units 1 and 2 Docket Nos. STN 50-498 and STN 50-499 Submittal of Operations Quality Assurance Plan Change QA-069

Reference:

Letter, S. Head to Document Control Desk, "Initial and Revised Responses for Additional Information," dated April 2, 2009 (U7-C-STP-NRC-090026)

The STP Nuclear Operating Company (STPNOC) submits the attached change to revision 18 of the Operations Quality Assurance Plan (OQAP). These changes provide the necessary revision to the applicable chapters of the OQAP to remove the control and performance of safety-related and quality-related activities associated with Early Site Permitting/COL Application activities for additional units (3 & 4) at the STPEGS from the scope of the OQAP.

The NRC has been formally informed of Units 3 & 4 intention to begin implementation of the Quality Assurance Program Description on September 30, 2009 by the noted reference.

This change does not reduce any element of or responsibilities for implementation of the QA program for Units 1 and 2. This change therefore does not represent a reduction in commitment and does not require NRC approval prior to implementation in accordance with the provisions of 10CFR50.54(a)(3).

There are no commitments in this letter.

If there are any questions regarding this matter, please contact Ms. D. I. Towler at (361) 972-7222 or me at (361) 972-7849.

E. D. ýalpýin Executive Vice President and Chief Nuclear Officer

Attachment:

Operations Quality Assurance Plan change QA-069

NOC-AE-09002460 Page 2 of 2 cc:

(paper copy) (electronic copy)

Regional Administrator, Region IV A. H. Gutterman, Esquire U. S. Nuclear Regulatory Commission Morgan, Lewis & Bockius LLP 612 East Lamar Blvd, Suite 400 Arlington, Texas 76011-4125 Mohan C. Thadani U. S. Nuclear Regulatory Commission Mohan C. Thadani Kevin Howell Senior Project Manager Catherine Callaway U.S. Nuclear Regulatory Commission Jim von Suskil One White Flint North (MS 7 D1) NRG South Texas LP 11555 Rockville Pike Rockville, MD 20852 Ed Alarcon Senior Resident Inspector J. J. Nesrsta U. S. Nuclear Regulatory Commission R. K. Temple P. 0. Box 289, Mail Code: MNl 16 Kevin Polio Wadsworth, TX 77483 City Public Service Jon C. Wood C M. Canady Cox Smith Matthews City of Austin Electric Utility Department C. Mele 721 Barton Springs Road City of Austin Austin, TX 78704 Richard A. Ratliff Texas Department of'State Health Services Alice Rogers Texas Department of State Health Services

CHANGE QA-069

SUMMARY

OF CHANGES Page 1 of 4 ALL CHANGES ARE IN BOLD TYPE CHAPTER LOCATION ACTION TEXT TOC CH 1.0 INSERT QA-069 CH 2.0 INSERT QA-069 CH 7.0 INSERT QA-069 CH 15.0 INSERT QA-069 CH 1.0 5.5 DELETE The STPNOC (Units 3 & 4) includes the Vice President, Oversight & Regulatory Affairs, the Vice President Engineering & Construction, Plant General Manager, and General Manager Support Services. The senior management of these groups report to the Senior Vice President.

The Senior Vice President reports to the President and Chief Executive Officer.

INSERT The Manager, Quality (Units 3 & 4) is responsible for vendor oversight activities for Units 1 & 2. In the performance of this function, the Manager, Quality (Units 3 & 4) reports to the General Manager, Oversight (Units 1 & 2).

5.5.1 DELETE The Senior Vice President is responsible for implementing quality program requirements applicable to the overall efforts associated with the activities related to Early Site Permit/Construction Operating License.

INSERT The Manager, Quality, (Units 3 & 4) has unfettered access to the President and Chief Executive Officer and the Board of Directors.

5.5.2 DELETE The Vice President, Oversight & Regulatory Affairs is responsible for implementing quality program requirements applicable to the following functions including: regulatory affairs (licensing and probabilistic risk assessment) and quality. The senior management of these functions report to the Vice President, Oversight

& Regulatory Affairs.

INSERT The Manager, Quality, (Units 3 & 4) has the authority to stop work for cause related to vendor oversight activities for Units 1 & 2. This authority has been granted by the Executive Vice President and Chief Nuclear Officer.

CHANGE QA-069

SUMMARY

OF CHANGES Page 2 .of4 ALL CHANGES ARE D4 BOLD TYPE CHAPTER LOCATION ACTION TEXT CH 1.0 5.5.2.1 DELETE The Manager, Quality has the independence to conduct Quality activities without undue pressure of cost or schedule and is responsible for the following: Development, maintenance, and independent verification of implementation of the STP Quality Program; making periodic reports on its effectiveness; review of selected documents which control activities within its scope; and preparation, control, and approval of the OQAP and revisions thereto; Identify, initiate, recommend, or provide solutions to quality-related problems and verify the implementation and effectiveness of the solutions; and Independent oversight activities, including audits, independent assessments, evaluations, surveillances, performance monitoring. Vendor oversight activities for Units 1 through 4. For those vendor oversight activities specifically related to Units 1 & 2, the Manager, Quality reports to the General Manager, Oversight (Units 1 & 2).

5.5.2.2 DELETE The Vice President, Oversight & Regulatory Affairs and the Manager, Quality at their discretion, have unfettered access to the President and Chief Executive Officer and the Board of Directors.

5.5.2.3 DELETE The Senior Vice President, the Vice President, Oversight & Regulatory Affairs, and the Manager, Quality have the authority to stop work for cause. This authority has been granted by the President and Chief Executive Officer.

6.1 DELETE and safety-related and quality-related activities associated with Early Site Permitting/COL Application activities for additional units (3 & 4) at STP

CHANGE QA-069

SUMMARY

OF CHANGES Page 3 of 4 ALL CHANGES ARE IN BOLD TYPE CH 2.0 2.3 DELETE The QA Program provides the basis for the control and performance of safety-related and quality-related activities associated with Early Site Permitting/COL Application activities for additional units (3 & 4) at the STPEGS.

Controls, as currently stated in the OQAP, will be extended to specific activities associated with the new units by inserting an applicability statement in the Purpose and Scope of station procedures. These specific QA Program controls for the new units remain in effect until the Nuclear Regulatory Commission approves a Quality Program specific to the new units, and the associated implementing procedures are in place.

5.1.2 DELETE for Units 1 & 2. The Vice President Oversight &

Regulatory Affairs is responsible for the development and maintenance of the OQAP for Units 3 & 4.

5.8.2 DELETE The Vice President Oversight & Regulatory Affairs or the Manager, Quality for Units 3 & 4 shall present the problem to the Senior Vice President. For quality problems associated with vendor oversight activities for Units 1 through 4, the General Manager, Oversight (Units 1 & 2) or Manager, Quality (Units 3 & 4) shall present the problem to the Executive Vice President and Chief Nuclear Officer or the Senior Vice President respectively.

INSERT For quality problems associated with vendor oversight activities for Units 1 & 2, the General Manager, Oversight or Manager, Quality (Units 3 & 4) shall present the problem to the Executive Vice President and Chief Nuclear Officer.

CH 7.0 5.4.1.6 DELETE (Units 1 & 2) and the Vice President Oversight &

Regulatory Affairs (Units 3 & 4) and may approve exceptions for Units 1 through 4 5.4.2.1 DELETE (Units 1 & 2) and by direction of the Vice President Oversight & Regulatory Affairs for Units 3 & 4. and may direct removal of vendor for activities related to Units 1 through 4

CHANGE QA-069

SUMMARY

OF CHANGES Page 4 of 4 ALL CHANGES ARE IN BOLD TYPE CH 7.0 5.4.3.2 DELETE (Units 1 & 2) and by the Vice President Oversight

& Regulatory Affairs for Units 3 & 4. and may waive inspections for Units 1 through 4 CH 15.0 5.2.1.11 DELETE , the Senior Vice President (for Units 3 & 4) 5.2.3.1 DELETE and the Vice President Oversight & Regulatory Affairs for Units 3 & 4 5.2.5.6 DELETE , the Senior Vice President (for Units 3 & 4),

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TABLE 18 OF OPERATIONS QUALITY ASSURANCE PLAN OF CONTENT TABLE OF CONTENTS PAGE 1OF2 EFFECTIVE DATE 02-01-08 Chapter Title Effective Effective Change Number Chapter Revision Date Notice No.

Definitions 9 2-1-02 1.0 Organization 14 2-1-08 QA-067, 068, 069 2.0 Program Description 16 2-1-08 QA-067, 068, 069 3.0 Conduct of Plant Operations 7 2-1-98 4.0 Qualification, Training, and 6 2-1-98 Certification of Personnel 5.0 Maintenance, Installation of 5 2-1-98 Modifications, and Related Activities 6.0 Design and Modification Control 9 2-1-06 7.0 Procurement 11 2-1-08 QA-069 8.0 Control and Issuance of 6 2-1-98 Documents 9.0 Control of Material 6 2-1-98 10.0 Inspection 11 2-1-08 11.0 Test Control 8 2-1-08 12.0 Instrument and Calibration 6 2-1-98 Control 13.0 Control Of Conditions Adverse 12 2-1-08 QA-068 to Quality 14.0 Records Control 8 2-1-06

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OPERATIONS QUALITY ASSURANCE PLAN TABLE 18 OF CONTENT TABLE OF CONTENTS PAGE 2 OF 2 EFFECTIVE DATE 02-01-08 Chapter Title Effective Effective Change Number Chapter Revision Date Notice No.

15.0 Quality Oversight 11 2-1-08 QA-067, 068, 069 Activities 16.0 Independent Technical 10 2-1-08 QA-067, 068 Review 17.0 ASME Code Section XI - 8 2-1-08 QA-067 Repairs and Replacements 18.0 ASME Code Section XI - 9 2-1-08 QA-067 Inservice Inspection and Testing 19.0 Administrative Controls 3 2-1-08 QA-067, 068

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OPERATIONS QUALITY ASSURANCE PLAN 1.0 14 ORGANIZATION PAGE 1 OF 4 EFFECTIVE DATE 02-01-08 1.0 PURPOSE 1.1 The purpose of this chapter is to describe the organizational structure as related to quality assurance and to establish the responsibilities of organizations for the South Texas Project (STP). C?

2.0 SCOPE 2.1 STP Nuclear Operating Company (STPNOC), as licensee, has the Quality responsibility for design, engineering, procurement, fabrication, modification, maintenance, repair, in-service inspection, refueling, testing, and operation of the STP.

3.0 DEFINITIONS 3.1 None

4.0 REFERENCES

4.1 , None 5.0 RESPONSIBILITIES 5.1 The STPNOC (Units 1 & 2) includes the Senior Vice President and the Vice President Shared Services. The senior management of these groups report 00 to the Executive Vice President and Chief Nuclear Officer. The Executive Vice President and Chief Nuclear Officer reports to the President and Chief o' Executive Officer.

5.2 The Executive Vice President and Chief Nuclear Officer has overall 0\

responsibility for the implementation of the Operations Quality Assurance Program and approving the Operations Quality Assurance Plan (OQAP) and revisions thereto. The Executive Vice President and Chief Nuclear Officer shall designate those members of senior management to function as the Senior Management Team.

5.3 The Senior Vice President is responsible for implementing quality program requirements applicable to staffing STP with qualified personnel and acquiring and coordinating the assistance of internal and external 9 organizations for the following functions including: engineering, plant general management, projects & outages, and oversight. The senior management of these functions report to the Senior Vice President.

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OPERATIONS QUALITY ASSURANCE PLAN 1.0 14 ORGANIZATION PAGE 2 OF 4 EFFECTIVE DATE 02-01-08 5.3.1 The Vice President Engineering is responsible for implementing quality program requirements applicable to the following functions including: 00 fuels & analysis, engineering (testing/programs, design engineering, systems engineering, maintenance engineering), and administrative support. The senior management of these functions report to the Vice President Engineering.

5.3.2 The Plant General Manager has prime responsibility for the safe operations of the units. The plant staff, under the direction of the Plant General Manager, develop detailed procedures and instructions for testing, operation, modification, and maintenance of the STP.

5.3.3 The Plant General Manager is responsible for implementing quality program requirements applicable to the following functions including:

operations, maintenance, chemistry, environmental, health physics, and work control. The senior management of these functions report to the Plant General Manager.

5.3.4 The General Manager, Oversight is responsible for implementing quality program requirements applicable to the following functions including:

licensing, quality, risk management, performance improvement, and training. The senior management of these functions report to the General <

Manager, Oversight.

5.3.4.1 The Manager, Quality has the independence to conduct Quality activities without undue pressure of cost or schedule and is responsible for the following:

Development, maintenance, and independent verification of implementation of the STP Quality Program; making periodic reports on its effectiveness; review of selected documents which control activities within its scope; and preparation, control, and approval of the OQAP and revisions thereto; <

CY Identify, initiate, recommend, or provide solutions to quality-related problems and verify the implementation and effectiveness of the solutions; and Independent oversight activities, including audits, independent assessments, evaluations, surveillances, performance monitoring; inspections, independent oversight of NDE examinations, and administration of organizational unit

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OPERATIONS QUALITY ASSURANCE PLAN 1.0 14 ORGANIZATION PAGE 3 OF 4 EFFECTIVE DATE 02-01-08 independent review activities. (see section 5.5.2.1 for vendor oversight responsibilities) 5.3.4.2 General Manager, Oversight and the Manager, Quality, at their discretion, have unfettered access to the President and Chief Executive Officer and the Board of Directors.

5.3.4.3 The General Manager, Oversight and the Manager, Quality have the authority to stop work for cause. This authority has 00 been granted by the Executive Vice President and Chief Nuclear Officer. The Quality organization, including the inspection staff, is based upon the anticipated Quality involvement in operations, modification, and maintenance activities.

5.3.4.4 The Manager, Risk Management is responsible for activities related to the Comprehensive Risk Management Program, including oversight of Probabilistic Safety Assessment activities. The Comprehensive Risk Management Expert Panel guides the implementation of the Comprehensive Risk Management. Program and is composed of a Chairman and additional senior level management designated by the o Executive Vice President and Chief Nuclear Officer. V 5.3.5 The General Manager, Projects & Outages is responsible for implementing quality program requirements applicable to the following functions:

engineering projects, project alliance, replacement reactor vessel head, outage management, and projects. The senior management of these functions report to the General Manager, Projects & Outages.

5.4 The Vice President, Shared Services is responsible for implementing quality program requirements applicable to the following functions: plant protection (emergency response, access authorization, and security), supply chain, records management system, and information technology. The senior <i management of these functions report to the Vice President, Shared Services.

5.5 The Manager, Quality (Units 3 & 4) is responsible for vendor oversight activities for Units 1 & 2. In the performance of this function, the Manager, o Quality (Units 3 & 4) reports to the General Manager, Oversight (Units 1 &

2).

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OPERATIONS QUALITY ASSURANCE PLAN 1.0 14 ORGANIZATION PAGE 4 OF 4 EFFECTIVE DATE 02-01-08 5.5.1 The Manager, Quality, (Units 3 & 4) has unfettered access to the President and Chief Executive Officer and the Board of Directors.'

00D 06 0

5.5.2 The Manager, Quality, (Units 3 & 4) has the authority to stop work for cause related to vendor oversight activities for Units 1 & 2. This authority has been granted by the Executive Vice President and Chief Nuclear Officer.

6.0 REQUIREMENTS 6.1 The fundamental responsibility for implementing quality program requirements is assigned to all personnel performing activities affecting the 00*

06 safe and reliable operation of STP. These personnel and their management 0 are responsible for implementing through approved procedures and other work documents, the quality assurance program controls described in the OQAP. Line organizational details and responsibilities for Units 1 & 2 are further described in STP UFSAR Chapter 13.1.

7.0 DOCUMENTATION 7.1 None 8.0 ATTACHMENTS 8.1 None

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OPERATIONS QUALITY ASSURANCE PLAN 2.0 16 PROGRAM DESCRIPTION PAGE 1 OF 18 EFFECTIVE DATE 02-01-08 1.0 PURPOSE 1.1 The purpose of this chapter is to define criteria and establish administrative controls for implementation of the Quality Assurance (QA) Program for the South Texas Project (STP).

2.0 SCOPE 2.1 The QA Program is implemented and controlled in accordance with the Operations Quality Assurance Plan (OQAP) and is applicable to structures, systems, and components to an extent consistent with their importance to safety, and complies with the requirements of 10CFR50, Appendix B and other program commitments as appropriate.

2.2 The QA Program will also extend, as applicable and/or determined by STP management, to programs including 10CFR71, Subpart H (except design and fabrication of NRC certified radioactive waste shipping casks), ASME Boiler and Pressure Vessel Code, Sections III and XI; and to quality-related areas as defined herein including the Fire Protection Program, Emergency Plan, Radiological Environmental Monitoring Program, Radwaste Management Program, Computer Program Verification and Control, Seismic and Environmental Equipment Qualification Programs, Radiation Protection Program, and Station Blackout (SBO) systems and equipment.

3.0 DEFINITIONS< CY 3.1 Comprehensive Risk Management - A process by which the change in risk to station personnel, the public's health and safety are evaluated as a result of changes in commitments, processes, activities, and human and equipment performance.

3.2 Graded Quality Assurance - The process by which risk-based methodology [iLe.,

Probabilistic Safety Assessment (PSA)] and deterministic and performance-based information analyses are combined to establish appropriate levels of programmatic controls for SSCs and appropriate levels of first line and independent oversight needed to provide the necessary assurance that SSCs will operate safely.

3.3 Full program controls - The highest levels of controls and oversight applied to safety-related SSCs categorized as High Safety Significant (HSS), as prescribed in Table I to this chapter and throughout individual OQAP chapters.

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OPERATIONS QUALITY ASSURANCE PLAN 2.0 16 PROGRAM DESCRIPTION, PAGE 2 OF 18 EFFECTIVE DATE 02-01-08 3.4 Basic program controls - Levels of control and oversight, lower than in the Full Program, applied to safety-related SSCs categorized as Medium Safety Significant (MSS), as prescribed in Table I to this chapter and throughout individual OQAP chapters.

3.5 Targeted program controls - Selected program controls applied to certain non-safety-related SSCs categorized as either HSS or MSS.

3.6 Limited program controls- Limited controls applied to safety-related SSCs categorized as either Low Safety Significant (LSS) or Non-Risk Significant (NRS).

4.0 REFERENCES

4.1 10CFR50, Appendix B 4.2 10CFR71, Subpart H 4.3 ASME B&PV Code 4.4 OQAP Chapter 14.0, Records Control 4.5 10CFR50.63, Loss of All Alternating Current Power 4.6 10CFR50.54(a) 4.7 Updated Final Safety Analysis Report 4.8 Safety Evaluation on Exemption Requests from Special Treatment Requirements of 10 CFR Parts 21, 50, and 100 (TAC NOS. MA6057 AND MA6058) 5.0 REQUIREMENTS 5.1 General Program Requirements 5.1.1 The OQAP shall be prepared and maintained to prescribe the STP QA Program. The OQAP reflects the quality program policies to be implemented. The OQAP describes the organization and responsibilities for attainment of quality objectives and verification of conformance to established requirements. The QA Program shall be in effect throughout the operating life of the STP.

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OPERATIONS QUALITY ASSURANCE PLAN 2.0 16 PROGRAM DESCRIPTION PAGE 3 OF 18 EFFECTIVE DATE 02-01-08 5.1.2 The Executive Vice President and Chief Nuclear Officer has overall responsibility for quality assurance. The General Manager, Oversight is responsible for the development and maintenance of the OQAP.

5.1.3 The operations phase of the STP includes design, procurement, fabrication, repair, testing, operation, maintenance, refueling, inspection, o' independent oversight, modification, and other activities as discussed Table I to this chapter and throughout the OQAP. STP and its vendors are required, as appropriate, to comply with the criteria established by 10CFR50, Section 50.55a; 10CFR50, Appendix A, General Design Criterion (GDC) 1; 10CFR50, Appendix B, and 10CFR71, Sub-Part H (except design and fabrication of NRC certified radioactive waste shipping casks). These regulations are not applicable to LSS and NRS safety-related components, to the extent that the Nuclear Regulatory Commission has granted STP an exemption from the regulations as described in Reference 4.8.

STP will implement, as specified, the Regulatory Guides (RG) and implementing American National Standards Institute (ANSI) standards contained in Table I of this chapter.

5.1.4 STP shall maintain the OQAP as an effective and meaningful document to provide programmatic direction for the station. Changes to the OQAP shall be accomplished as prescribed by 10CFR50.54(a).,When changes are made in the OQAP to the organizational elements only, appropriate notification will be made to the NRC within 30 days of implementation.

5.2 Organizational Independence 5.2.1 The reporting arrangement utilized by the Quality organization ensures that those personnel performing independent oversight have the organizational freedom to:

5.2.1.1 Identify quality problems.

5.2.1.2 Initiate, recommend, or provide solutions.

5.2.1.3 Verify implementation of solutions.

5.2.2 Personnel verifying compliance with quality requirements do not have direct responsibility for the performance of or directly supervise the activity being verified.

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Chapter OPERATIONS QUALITY ASSURANCE PLAN 2.0 16 PROGRAM DESCRIPTION PAGE 4 OF 18 EFFECTIVE DATE 02-01-08 5.3 Graded Quality Assurance 5.3.1 Graded Quality Assurance (GQA) is fundamental to the STP QA Program.

It is described in more detail in the implementing procedure for the STP Comprehensive Risk Management (CRM) Program.

5.3.2 GQA is a process by which risk-based methodology [i.e., Probabilistic Safety Assessment (PSA)], deterministic insights, and performance-based information are combined and analyzed to determine what levels of programmatic controls are needed for structures, systems, and components (SSCs) and what levels of first line and independent oversight are needed to provide assurance that items will operate safely and activities are accomplished as prescribed.

5.3.3 Selected systems are evaluated, at the component level, by a cross-discipline Expert Panel comprised of high level station management.

Initial evaluations are performed by the Working Group.

5.3.4 These recommendations are developed in consideration of the risk significance of system functions, components' contribution to core damage frequency and large early release frequency, components' critical attributes (needed to support risk significant system functions),

performance, regulatory/QA requirements, and other deterministic considerations as prescribed in the Comprehensive Risk Management procedures.

5.3.5 Program control recommendations are developed by the Working Group and ultimately approved by the Expert Panel and forwarded to the site for implementation. Controls are implemented in four graded applications (i.e., "Full", "Basic", "Targeted", and "Limited").

5.3.6 "Full" program controls are applied to safety-related SSCs categorized as HSS. These "Full" levels of controls and oversight are designed to provide a high degree of confidence that SSCs perform safely and activities are performed as expected. Table I to the OQAP chapter prescribes the program commitments applicable to "Full" program activities.

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OPERATIONS QUALITY ASSURANCE PLAN 2.0 16 PROGRAM DESCRIPTION PAGE 5 OF 18 EFFECTIVE DATE 02-01-08 5.3.7 "Basic" program controls are applied to safety- related SSCs categorized as MSS. These are lower levels of control and oversight, designed to maintain/preserve those identified critical attributes of SSCs needed to support risk significant system functions. These controls are intended to reflect economical and efficient business practices. Table I to the OQAP chapter prescribes the program commitments applicable to "Basic" program activities.

5.3.8 "Limited" program controls are applied to safety-related SSCs categorized as either LSS or NRS. Only specific program controls related to the activities listed in the following subparagraphs are applicable to these SSCs. The other chapters of the OQAP are not applicable to safety-related LSS and NRS SSCs. Instead, the treatment processes applicable to these SSCs are described in the Updated Final Safety Analysis Report Section 13.7.3.3 and implementing procedures:

5.3.8.1 Those elements in Chapter 1.0 that are needed to implement and control activities described above; 5.3.8.2 Applicable requirements in this Chapter; 5.3.8.3 Modification/design activities as described in Chapter 6.0; and 5.3.8.4 Corrective action as described in Chapter 13.0.

5.3.9 "Targeted" program controls are applied to non-safety related SSCs, for which 10CFR50, Appendix B is not applicable, categorized as HSS or MSS. Specific program controls consistent with applicable portions of the "full" and "basic" program controls are applied to those items in a selected manner, "targeted" at those characteristics or critical attributes that render the SSC risk significant.

5.3.10 Safety-related components that are highly reliable, yet whose failure would result in a significant increase in risk, will receive Full program coverage, or will be evaluated based on their risk significance to ensure that Full program controls are applied to their critical attributes.

5.3.11 SSCs governed by the OQAP shall retain their current program coverage until such time as prescribed risk-informed, performance-based analyses are completed and approved, and they are placed into the graded program categories (i.e., "Full", "Basic", "Targeted", or "Limited") as appropriate.

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OPERATIONS QUALITY ASSURANCE PLAN 2.0 16 PROGRAM DESCRIPTION PAGE 6 OF 18 EFFECTIVE DATE 02-01-08 5.3.12 A vital element of the GQA program is the "feedback" loop. On a periodic basis, and as prescribed in the Comprehensive Risk Management procedure, the GQA Working Group and Expert Panel shall review any changes to the PSA information and performance/operating experience that could result in recategorization of an SSC. These reviews are also used to assess the effectiveness and appropriateness of in-place quality program controls. Adjustments shall be made as determined necessary.

5.4 Delegation of QA Functions 5.4.1 The OQAP may be executed in whole or part by subcontract personnel.

However, STP will retain responsibility for the total quality assurance program, and Quality organization personnel will perform appropriate oversight activities of subcontracted activities.

5.5 Identification of Safety Significant Structures, Systems, and Components 5.5.1 The program described herein is applied to activities affecting the safety functions of those structures, systems, and components which prevent, or mitigate the consequences of postulated accidents that could cause undue risk to the health and safety of the public. The structures, systems, and components controlled are listed in UFSAR Section 3.2, along with their associated fire protection systems. UFSAR Section 3.2 also identifies those structures, systems, and components which may not represent a safety significant/risk important concern but to which the STP OQAP is applied.

5.5.2 The fire protection QA Program is part of the overall STP Operations QA Program. Fire protection QA Program criteria are implemented as part of the Operations QA Program.

5.5.3 Expendable or consumable items necessary for the functional performance

'of structures, systems, and components are subjected to quality assurance requirements as specified in written procedures. These procedures include provisions for review and control in accordance with industry standards and specifications.

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OPERATIONS QUALITY ASSURANCE PLAN 2.0 16 PROGRAM DESCRIPTION PAGE 7 OF 18 EFFECTIVE DATE 02-01-08 5.6 QA Program Documents 5.6.1 The QA Program shall be implemented with documented instructions, procedures, and drawings which include appropriate quantitative and qualitative acceptance criteria for determining that prescribed activities have been satisfactorily accomplished. Procedures shall include the control of the sequence of required inspections, tests, and other operations when important to quality. To change these controls, the individual procedure must be changed and shall require the same level of review and approval given to the original procedure. Such instructions, procedures, and drawings are reviewed and approved for compliance with requirements appropriate to their safety significance by individuals qualified to do so.

5.7 Personnel Indoctrination and Training 5.7.1 General indoctrination and training programs shall be provided for site personnel to assure that they are knowledgeable regarding quality programs and requirements. The training requirements for STP personnel are described in UFSAR Section 13.2. Personnel performing complex, unusual, or potentially hazardous work shall be instructed in special indoctrination or briefing sessions. Emphasis shall be on special requirements for safety of personnel, radiation control and protection, unique features of equipment and systems, operating constraints, and control requirements in effect during performance of work. Where required by codes and standards, personnel are trained, qualified, and certified according to written procedures in the principles and techniques of performing specific activities.

5.8 Policies and Goals 5.8.1 STP policy is to assure that the design, procurement, construction, testing, and operation of the STP are in conformance with specifications, procedures, codes, commitments and Nuclear Regulatory Commission (NRC) regulations to the extent not exempted. The responsibility of each organization supporting the STP is to ensure that the requirements stated in this QA Program are incorporated into procedures. Adherence to those procedures is mandatory for all STP organizations and contractors or vendors providing items or services covered by the QA Program.

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OPERATIONS QUALITY ASSURANCE PLAN 2.0 16 PROGRAM DESCRIPTION PAGE 8 OF 18 EFFECTIVE DATE 02-01-08 5.8.2 The OQAP identifies activities and establishes requirements for procedures which identify, report, and verify the resolution of quality problems. The implementing procedures call for the resolution of quality problems at the lowest possible authorized level. However, if a dispute is encountered in the resolution of a quality problem which cannot be resolved at lower levels, the General Manager, Oversight or Manager, Quality for Units 1 & 2 shall present the problem to the Executive Vice C, President and Chief Nuclear Officer for resolution. For quality problems o 00 associated with vendor oversight activities for Units 1 & 2, the General Manager, Oversight or Manager, Quality (Units 3 & 4) shall present the problem to the Executive Vice President and Chief Nuclear Officer.

0 5.9 Control of Activities 5.9.1 The OQAP requires Quality department review and/or approval of procedures which control selected activities. These procedures shall require the use of the proper equipment, completion of prerequisites. for starting an activity, and suitable environment for performing the activity.

Procedures will comply with the appropriate standards.

5.9.2 STP personnel attend planning, scheduling, and status meetings as necessary to assure adequate quality coverage and program application exists.

5.10 Management Review 5.10.1 The implementation of both line and OQAP requirements shall be verified through independent oversight activities. The Quality organization shall conduct independent oversight activities of the operating plant and of the interfacing organizations' activities.

5.10.2 Independent oversight of the implementation of the OQAP is conducted under the cognizance of the Senior Management Team and results are o transmitted to appropriate line and senior management, including the' Executive Vice President and Chief Nuclear Officer for review and/or action. 0' 5.10.3 STP may use the services of architect-engineer firms, Nuclear Steam Supply System (NSSS) suppliers, fuel fabricators, constructors, and others which provide or augment STP efforts during operations. As applicable, the QA programs of such contractors or consultants shall be subject to review, evaluation, and acceptance by the Quality organization before initiation of activities affected by the program.

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OPERATIONS QUALITY ASSURANCE PLAN 2.0 16 PROGRAM DESCRIPTION PAGE 9 OF 18 EFFECTIVE DATE 02-01-08 5.11 Computer Code Programs 5.11.1 The development, maintenance, and use of computer code programs will be controlled. Prior to use of a computer code program, the appropriateness of the program shall be verified. In addition, all such programs shall be appropriately certified for use.

6.0 DOCUMENTATION 6.1 Procedures which are generated as required by this chapter shall identify the records which are required to implement and document those activities. The records shall be controlled in accordance with Reference 4.4.

7.0 ATTACHMENTS 7.1 Table I - Program Commitments

TABLE I PROGRAM COMMITMENTS R.G./ANSI STANDARD FULL PROGRAM BASIC PROGRAM R.G. 1.8, rev. 1 (9/75) No exceptions taken. No exceptions taken.

ANSI N 18.1, 1971 4.2.2-The Operations Manager requirements regarding holding a Senior Reactor Same as full.

Operator license are met by the Unit Operations Managers.

R.G. 1.28, rev. 0 (6/72) This R.G. is not applicable to operations phase activities. Same as full.

ANSI 45.2, 1971 This standard is not applicable to operations phase activities. Same as full.

R.G. 1.33, rev. 2 (2/78) C.2 - the specific revisions of the listed standards to which STP is committed are Same as full.

in this table and are not necessarily the "latest" revision.

C.4 - Chapter 15.0 of the STP OQAP describes the audit program at STP that Same as full.

meets the intent of R.G. 1.33, rev. 2, position C.4 regarding frequency of audits C.4.a.b.c - STP performs these audits in accordance with a nominal biennial Same as full.

frequency.

ANSI NI8.7 - 1976/ANS 3.2 3.4.2 - refer to R.G. 1.8 regarding Operations Manager holding a Senior Reactor Same as full.

Operator license.

3.4.2 refer to R.G. 1.58 regarding use of personnel not qualified in accordance with ANSI N45.2.6.

4.5 - refer to R.G. 1.33 coverage regarding audit frequency. Same as full.

5.2.6 (5th paragraph) - independent verification may be concurrent with (same Same as full.

time as) work performance.

Operations Quality Assurance Plan, Chapter 2.0, Revision 16 Page 10 of 18

TABLE I PROGRAM COMMITMENTS R.GoIANSI STANDARD I FULL PROGRAM BASIC PROGRAM ANSI N18.7/ANS 3.2 (cont'd) 5.2.7 (1st paragraph) - STP will use current approved design bases as opposed to Same as full.

original design bases.

5.2.7 - STP will perform inspection as deemed necessary, based on the relative complexity of the work.

5.2.7.1 (5th paragraph) - STP takes exception to use of the word "promptly" with Same as full.

regard to determining, evaluating and recording the causes of malfunctions. The STP Corrective Action Program includes the elements with regard to timeliness of action associated with causal analyses.

5.2.7.2 - refer to table coverage of ANSI N45.2.11, 1974.

5.2.13 (1st paragraph) - refer to table coverage of ANSI N45.2.13, 1976.

5.2.13.1 (1st paragraph) - refer to table coverage of ANSI N45.2, 1971.

5.2.13.4 (5th paragraph) - refer to table coverage of ANSI N45.2.2, 1972.

5.2.15 (4th paragraph) - Chapter 8.0 of the OQAP describes the requirements for Same as full.

control and issuance of documents, which meets the intent of R.G. 1.33, rev. 2.

The intent of the biennial review is accomplished by other controls that assure that procedures are appropriately reviewed and revised to incorporate information based on plant operations, design changes, regulatory requirements, industry experience and other conditions that may impact plant procedures.

Operations Quality Assurance Plan, Chapter 2.0, Revision 16 Page I I of 18

TABLE I PROGRAM COMMITMENTS R.G./ANSI STANDARD FULL PROGRAM BASIC PROGRAM ANSI N18.7/ANS 3.2 (cont'd) 5.2.17 (3rd paragraph) - STP may not implement the requirement for conduct of inspections in a manner similar to that associated with construction phase activities (i.e.,

regarding use of personnel not qualified to ANSI N45.2.6)

R.G. 1.38, rev. 2 (5/77) No exceptions taken. No exceptions taken.

ANSI N45.2.2, 1972 2.4 - Audit personnel are qualified in accordance with STP's commitment to R.G. Same as full.

1.146/ANSI 45.2.23.

2.4 - Offsite oversight of vendors of items in the Basic category will only be performed as deemed necessary.

5.2.1 - These activities do not constitute an "inspection" as defined in Same as Full ANSIASME NQA-1, 1983, Supplement S-1, Terms and Definitions. Therefore, the requirements for qualification to ANSI N45.2.6 as stated in Section 2.4 do not apply to personnel performing these activities.

R.G. 1.58, rev. 1 (9/80) C.2 - STP is committed to ASNT-TC-lA, 1980. STP treats the recommendation Same as full.

("should") of the 1980 edition as requirements ("shall").

ANSI N45.2.6, 1978 1.2 (1st paragraph) - with the exception of receipt inspection, personnel may perform inspections, examinations and tests provided they are experienced, task qualified journeymen, or supervisors, who did not perform or directly supervised the activity being inspected, examined or Operations Quality Assurance Plan, Chapter 2.0, Revision 16 Page 12 of 18

TABLE I PROGRAM COMMITMENTS R.G./ANSI STANDARD FULL PROGRAM BASIC PROGRAM ANSI N45.2.6, 1978 (cont'd) tested. These individuals shall also receive training to the applicable inspection procedure, processes, methods in accordance with a Quality approved training program; and Quality will provide periodic oversight of the inspection activities.

1.2 (3rd paragraph) - refer to table coverage of R.G. 1.28. Same as full.

1.4.4 - refer to table coverage of R.G. 1.74/ANSI N45.2.10. Same as full.

Personnel performing the activities stated in ANSI N45.2.2, Section 5.2.1 do not Same as Full require qualification to this Standard. (see exception to ANSI N45.2.2)

R.G. 1.64, rev. 2 (6/76) No exceptions taken. C.2 - STP may implement the requirement regarding design verification as prescribed in ANSI N45.2.11, 1974, 6.1, second paragraph/second sentence, as opposed to R.G. wording.

ASNI N45.2.11, 1974 No exceptions taken. 3.2 (1st paragraph) - STP will require personnel to consider items 1 through

.28, but a documented checklist may not be required.

Operations Quality Assurance Plan, Chapter 2.0, Revision 16 Page 13 of 18

TABLE I PROGRAM COMMITMENTS R.G./ANSI STANDARD FULL PROGRAM BASIC PROGRAM ANSI N45.2.11, 1974 (Con't.) 6.3 - Verification and checking of design may be accomplished through supervisory or management review/approval as provided for in 6.1.

Personnel will be required to consider items 1 through 19, but a documented checklist may not be required.

R.G. 1.74 (2/74) Not applicable to STP. STP uses ANSI/ASME NQA-1-1983 for Quality Same as full.

Assurance Terms and Definitions.

ANSI N45.2.10, 1973 Same as R.G. 1.74 above. Same as full.

R.G. 1.88, rev. 2 (10/76) No exceptions taken. Same as full.

ANSI N45.2.9, 1974 Section 5.6 - supplement the provisions of this section by providing for alternate Same as full.

temporary storage of records. Allow the use of 1-hour fire rated cabinets to store records that are awaiting processing (e.g., processing into Optical Disk Storage).

Storage of these records in 1-hour fire rated cabinets will be controlled by procedure which specify a maximum allowable time limit. Cabinets housing these records shall be controlled for access and shall be located in an area protected by sprinklers.

R.G. 1.123, rev. 1 (7/77) C.6.b.and e. -The referenced section of ANSI N45.2.13 will be implemented as written.

ANSI N45.2.13, 1976 Various sections refer to ANSI N45.2. Refer to table coverage of R.G. 1.28 and Same as full.

ANSI N45.2.

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TABLE I PROGRAM COMMITMENTS R.G./ANSI STANDARD FULL PROGRAM BASIC PROGRAM ANSI N45.2.13, 1976 (cont'd) 3.2.3 - When purchasing commercial-grade calibration services from calibration Same as full laboratories accredited by a nationally-recognized accrediting body, the procurement documents are not required to impose a quality assurance program consistent with 10CFR50, Appendix B. In such cases, accreditation may be accepted in lieu of the Purchaser imposing a QA Program consistent with 10CFR50, Appendix B, provided all of the following are met:

1) The accreditation is to ANSI/ISO/IEC 17025
2) The accrediting body is either the National Voluntary Laboratory Accrediting Program (NVLAP) administered by the National Institute of Standards and Technology (NIST) or American Association for Laboratory Accreditation (A2LA). The A2LA accreditation is recognized by NVLAP through the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA).
3) The published scope of accreditation for the calibration laboratory covers the needed measurement parameters, ranges, and uncertainties. This requires the supplier to provide a measurement of collective uncertainty and obviates the need to impose the four-to-one ratio requirement discussed in NIST Information Report (NISTIR) 6989.
4) The purchase documents impose additional technical and administrative requirements, as necessary, to satisfy STPNOC QA Program and technical requirements. This requires the calibration certificate/report include identification of the laboratory equipment/standards used.
5) Purchase documents require reporting as-found calibration data when calibrated items are found to be out-of-tolerance.

5.3 and 5.4 - Provision are established for, in special cases and with management Same as full.

approval, completion of these activities after award of contract.

9.0 - This section will be implemented based on the scope, complexity and safety Same as full.

significance of the items being procured.

_________ I______________________ .j. __________

4 +

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TABLE I I PROGRAM COMMITMENTS R.G.IANSI STANDARD FULL PROGRAM BASIC PROGRAM ANSI N45.2.13, 1976 (cont'd) 10.3.1 - This section will only be implemented as deemed necessary.

12 - This section will only be implemented as deemed necessary for audits of suppliers.

R.G. 1.144, rev. 1 (9/80) C. 1 - refer to table coverage of R.G. 1.28 and ANSI N45.2. Same as full.

C.3a(1) -refer totable coverageof R.G. 1.33 regarding audit frequency. Same as full.

C.3.b(2) - When purchasing commercial-grade calibration services from Same as full for commercial-grade calibration laboratories accredited by a nationally-recognized accrediting body, calibration services the accreditation process and accrediting body may be credited with carrying out a portion of the Purchaser's duties of verifying acceptability and effective STP will audit vendors only as deemed implementation of the calibration service supplier's quality assurance program. necessary. STP will perform biennial evaluations.

In lieu of performing an audit, accepting an audit by another licensee, or performing a commercial-grade survey, a documented review of the supplier's accreditation shall be performed by the Purchaser. This review shall include, at a minimum, verification of the following:

1)The accreditation is to ANSIIISO/IEC 17025

2) The accrediting body is either NVLAP or A2LA. The A2LA accreditation is recognized by NVLAP through the ILAC MRA.
3) The published scope of accreditation for the calibration laboratory covers the needed measurement parameters, ranges, and uncertainties. This requires the supplier to provide a measurement of collective uncertainty and obviates the need to impose the four-to-one ratio requirements discussed in NISTIR 6989.

The licensee is responsible for ensuring that the procured services are within the accredited scope of the NVLAP and A2LA certificates.

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TABLE I PROGRAM COMMITMENTS R.G./ANSI STANDARD FULL PROGRAM BASIC PROGRAM ANSI N45.2.12, 1977 No exceptions taken. STP will audit vendors only as deemed necessary. These audits will be conducted as unplanned/unscheduled audits.

R.G. 1.146, rev. 0 (8/80) C.1 - refer to table coverage of R.G. 1.28 and ANSI N45.2.

Refer to table coverage of R.G. 1.74 and ANSI N45.2.10 Same as full.

ANSI N45.2.23, 1978 1.2 - refer to table coverage of R.G. 1.28. Same as full.

1.4 - refer to table coverage of R.G. 1.74. Same as full.

2.21 - refer to table coverage of R.G. 1.28. Same as full.

2.3.3.1 - refer to table coverage of R.G 1.28. Same as full.

2.3.4 - In lieu of the requirements of section 2.3.4 of ANSI N45.2.23-1978 Same as full the following alternative is acceptable:

Prospective lead auditors shall demonstrate their ability to properly implement the audit process and effectively lead an audit team. This demonstration process will be described in implementing procedures and will include the evaluation and documentation of the results of the demonstration. Regardless of the methods used for the demonstration, the prospective lead auditor is required to participate in at-least one nuclear quality assurance audit within the year preceding the individual's effective date of qualification. Upon successful demonstration of the ability to effectively implement the audit process and effectively lead audits, and having met the other provisions of Section 2.3 of ANSI N45.2.23-1978, the individual may be certified as being qualified to lead audits.

Operations Quality Assurance Plan, Chapter 2.0, Revision 16 Page 17 of 18

TABLE I PROGRAM COMMITMENTS For Regulatory Guides addressed by the table, and unless specific clarification or exception is indicated, STP will implement the Regulatory Guide positions, including recommendations.

For ANSI Standards addressed by this table, and unless specific clarification or exception is indicated, STP will treat ANSI requirements (i.e., "shall")

as such - except in instances where the standard itself provides optionsor requires a graded approach - this notwithstanding the general applicability statements found in many standards (i.e., section 1.0)

Operations Quality Assurance Plan, Chapter 2.0, Revision 16 Page 18 of 18

SOUTH TEXAS PROJECT ELECTRIC GENERATING STATION NUMBER REV.

Chapter NO.

OPERATIONS QUALITY ASSURANCE PLAN 7.0 11 PROCUREMENT PAGE 1 OF 13 EFFECTIVE DATE 02-01-08 1.0 PURPOSE 1.1 The purpose of this chapter is to establish the requirements for procurement of items and services for the South Texas Project Electric Generating Station (STP).

2.0 SCOPE 2.1 This chapter applies to the procurement of items and services for use at STP which are subject to the controls of this Quality program. These activities include procurement document control, bid evaluation, vendor evaluation, verification of vendor activities and receiving inspection.

3.0 DEFINITIONS 3.1 None

4.0 REFERENCES

4.1 10CFR50, Appendix B 4.2 10CFR21, Reporting of Defects and Noncompliance 4.3 OQAP Chapter 2.0, Table I 4.4 EPRI NP-5652 (NCIG-07), Guideline for the Utilization of Commercial Grade Items in Nuclear Safety Related Application 4.5 OQAP Chapter 4.0, Qualification, Training and Certification of Personnel 4.6 OQAP Chapter 13.0, Control of Conditions Adverse to Quality 4.7 OQAP Chapter 14.0, Records Control 4.8 Generic Letter 89-02, Actions to Improve the Detection of Counterfeit and Fraudulent Marketed Products

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Chapter NO.

OPERATIONS QUALITY ASSURANCE PLAN 7.0 11 PROCUREMENT PAGE 2 OF 13 EFFECTIVE DATE 02-01-08 5.0 REQUIREMENTS 5.1 Procurement Document Preparation, Review and Control 5.1.1 Responsibility for procurement is a joint effort of all the departments within the STP Nuclear Operating Company (STPNOC). The department requesting the material or service provides technical content and quality requirements. Engineering/Supply Chain is responsible to provide input to the requesting department on technical content and quality requirements, as requested. Quality will concur with all changes to quality requirements.

5.1.2 The sequence of preparation, review, approval, and. issuance of procurement documents is generally as follows:

5.1.2.1 Purchase Requisitions

  • Purchase requisition forms shall be used to initiate the procurement of materials, parts, components, and services.

Procurement may be initiated by any STPNOC personnel.

Purchase requisitions shall include material and component identification requirements, drawings, specifications, standards, inspection and test requirements, and special process instructions as appropriate.

Purchase requisitions for materials, parts, components, or services shall be reviewed by the cognizant technical organization to verify that adequate technical and quality requirements have been specified.

The reviews for technical and quality requirements shall be performed by someone other than the originator of the requisition. Quality will concur with all changes to quality requirements.

5.1.2.2 Purchase Orders and Contracts Purchase orders and contracts are prepared and issued by Supply Chain and establish for the suppliers the technical and quality requirements which must be met.

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OPERATIONS QUALITY ASSURANCE PLAN 7.0 11 PROCUREMENT PAGE 3 OF 13 EFFECTIVE DATE 02-01-08 Purchase orders and contracts shall accurately reflect the technical and quality requirements established by the purchase requisition. If, during the bid negotiations with the supplier, it becomes necessary or commercially desirable to change the technical or quality requirements, such changes shall be presented for approval to the cognizant technical organization which approved the original requirements.

5.1.2.3 Change Controls Changes to procurement document quality and technical requirements shall require a review and approval equivalent to that of the original document. Commercial consideration changes not affecting the technical or quality requirements do not require review and 'concurrence by the originator.

5.1.3 For the procurement of spare or replacement parts, equipment, materials, and services, the quality and technical requirements shall be equal to or greater than the design basis requirements for the original part, equipment, materials or services; except where less stringent quality or technical requirements may be established based on specific evaluations and justification. The cognizant technical organization shall document such justification.

5.1.3.1 Items may be procured as Commercial Grade Items (CGIs) if a documented engineering evaluation indicates the CGI will provide equivalent performance. CGI dedication will comply with established procedures designed to satisfy the requirements of References 4.2 and 4.8.

5.1.3.2 The cognizant technical organization shall verify that quality requirements are correctly stated, verifiable, and controllable; that acceptance/rejection criteria are included; and that the documents have been prepared, reviewed, and approved in accordance with STP Quality Program requirements.

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7.0 11 OPERATIONS QUALITY ASSURANCE PLAN PROCUREMENT PAGE 4 OF 13 EFFECTIVE DATE 02-01-08 5.2 Procurement Document Content 5.2.1 Procurement document control measures shall assure that appropriate regulatory requirements, design bases, and other requirements are included in the procurement process. The following shall be included or invoked by reference in procurement documents as appropriate:

5.2.1.1 Applicable regulatory, code, and design requirements, including material and component identification requirements, drawings, specifications, standards, inspection and test requirements, special process instructions and handling, preservation, cleaning, storage, packaging and shipping requirements. These requirements shall equal or exceed the original requirements (unless changed by established design control processes).

5.2.1.2 Extent that supplier QA program shall comply with 10CFR50, Appendix B or the QA program requirements of other nationally recognized codes and standards, as applicable; or for CGIs to be dedicated for safety related use by STPNOC based on the results of a survey of the vendor's controls, the vendor's STPNOC approved and/or surveyed program.

5.2.1.3 Requirements for supplier documents, such as instructions, procedures, drawings, specifications, inspection and test records, and suppliers' QA records to be prepared, submitted, or be made available for review and/or approval by STP personnel.

5.2.1.4 Requirements for suppliers to maintain the status of required inspections or tests throughout the manufacturing process to preclude inadvertent bypassing of inspections and tests.

5.2.1.5 Requirements for STPNOC's right of access to suppliers' facilities and work documents for, inspection and audit.

5.2.1.6 Requirements for extending applicable STP procurement requirements to lower-tier suppliers and subcontractors, including STPNOC's access to facilities and records.

5.2.1.7 Requirements for supplier reporting to STP nonconformances to procurement document requirements and conditions for their disposition.

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OPERATIONS QUALITY ASSURANCE PLAN 7.0 11 PROCUREMENT PAGE 5 OF 13 EFFECTIVE DATE 02-01-08 5.2.1.8 Requirements for the retention, control, and maintenance of supplier QA records that are not maintained by STPNOC.

Supplier-furnished records shall include:

" Documentation (e.g., certification) that identifies the purchased item and the specific procurement requirements (e.g.,' codes, standards, and specifications) met by the item.

  • Documentation identifying any procurement requirements that have not been met.
  • A description of those nonconformances from procurement requirements dispositioned "accept-as-is" or "repair".

5.2.1.9 Requirement for the supplier to submit a copy of its QA program description (does not apply for CGIs).

5.2.1.10 Requirements for the performance of maintenance and receipt, inspection checks where applicable.

5.2.1.11 Applicability of 10CFR21 reporting requirements.

  • The reporting requirementsof 10CFR21 do not apply to vendors of CGIs to be dedicated for use by STPNOC.

" The reporting requirements of 1 OCFR21 do not apply to suppliers of commercial-grade calibration services.

5.2.2 When purchasing commercial-grade calibration services from calibration laboratories accredited by a nationally-recognized accrediting body, the procurement documents are not required to impose a quality assurance program consistent with 10CFR50, Appendix B.

5.2.2.1 In such cases, accreditation may be accepted in lieu of imposing a QA Program consistent with 10CFR50, Appendix B, provided all of the following are met:

  • The accreditation is to ANSI/ISO/IEC 17025

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OPERATIONS QUALITY ASSURANCE PLAN 7.0 11 PROCUREMENT PAGE 6 OF 13 EFFECTIVE DATE 02-01-08

  • The accreditation body is either the National Voluntary Laboratory Accrediting Program (NVLAP) administered by National Institute of Standards and Technology (NIST) or American Association for Laboratory Accreditation (A2LA). The A2LA accreditation is recognized by NVLAP through the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA).
  • The published scope of accreditation for the calibration laboratory covers the needed measurement parameters, ranges, and uncertainties. This requires the supplier to provide a measurement of collective uncertainty and obviates the need to impose the four-to-one ratio requirement discussed in NIST Information Report (NISTIR) 6989.
  • The purchase documents impose additional technical and administrative requirements, as necessary, to satisfy STPNOC QA Program and technical requirements. This requires the calibration certificate/report include identification of the laboratory equipment/standards used.

" Purchase documents require reporting as-found calibration data when calibrated items are found to be out-of-tolerance.

5.3 Bid Evaluation 5.3.1 Bid Evaluations shall be performed to evaluate adherence to technical and quality assurance requirements.

5.4 Supplier Selection 5.4.1 Suppliers of items (for CGIs, when basis for dedication includes commercialgrade survey) or services shall be required to submit copies of their QA program description for evaluation prior to the issuance of a purchase order or execution of a contract, and acceptability shall be documented. The process by which suppliers are judged as being a capable procurement source is described as follows:

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OPERATIONS QUALITY ASSURANCE PLAN 7.0 11 PROCUREMENT PAGE 7'OF 13 EFFECTIVE DATE 02-01-08 5.4.1.1 Procurement source evaluation and selection involves Engineering, Quality, Supply Chain, and STP plant personnel, as appropriate. These organizations participate in the qualification evaluation of suppliers in accordance with written procedures.

5.4.1.2 Measures for the evaluation and selection of procurement sources shall be specified in procedures and may vary depending upon the complexity and risk significance of the item or service. When procurement source evaluations are performed, the information to be considered shall include one or more of the following:

  • Experience of users of identical or similar products of the prospective supplier, other utility or approved contractor audits/evaluations, audits/evaluations by cooperative utility groups, American Society of Mechanical Engineers (ASME) Certificates of Authorization, STP records accumulated in previous procurement actions, and STP product operating experience may be used in this evaluation. When other utiljty, contractor or cooperative utility audits/evaluations are used, the documentation will be obtained and reviewed. Supplier history shall reflect recent capability. Previous favorable experience with suppliers may be an adequate basis for judgments attesting to suppliers' capability.

" An evaluation of the suppliers' current quality records supported by documented qualitative and quantitative information which can be objectively evaluated. This may include review and evaluation of the suppliers' QA Program Manual, procedures, and responses to questionnaires, as appropriate. -

  • A source evaluation of the suppliers' technical and quality capability as determined by a direct evaluation of facilities and personnel (audit, survey, or surveillance) and quality program implementation. Resolution or a commitment to resolve unacceptable technical or quality requirements identified by the bid evaluation or vendor evaluation shall be obtained prior to the award of a purchase order or contract.

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OPERATIONS QUALITY ASSURANCE PLAN 7.0 11 PROCUREMENT PAGE 8 OF 13 EFFECTIVE DATE 02-01-08 5.4.1.3 Procurement source evaluations involve a review of technical and quality considerations to an extent considered appropriate by each participant. Technical considerations include the design or manufacturing capability and technical ability of suppliers to produce or provide the design, service, item or component. Quality considerations include one of the previously stated methods of supplier evaluation and a consideration of a suppliers' current quality program or capabilities.

5.4.1.4 A documented quality assurance evaluation of a vendor's quality program shall be performed to assure it meets the appropriate requirements of 10CFR50 Appendix B, or where applicable, other nationally recognized codes and standards, or, for CGIs, to assure the program provides adequate control over established critical characteristics.

5.4.1.5 Vendors may be placed on the Approved Vendors List after passing this evaluation.

5.4.1.6 A vendor shall not be issued a purchase order or contract unless they have been accepted for placement on the Approved Vendors List or an exception has been approved by the General Manager, Oversight or the Manager, Quality (Units 3 & 4).

5.4.1.7 Service organizations which will supply only manpower and no other service are not required to be on the Approved Vendors List or have an STP approved quality assurance program as long as the supplied personnel are trained and work under the auspices of the STP Operations Quality Assurance Plan.

cy 5.4.2 Each vendor on the Approved Vendors List shall be periodically evaluated by Quality as provided by Reference 4.3 (i.e., annually for "Full" program, biennially for "Basic" program).

5.4.2.1 A vendor may be removed from the Approved Vendors List if evaluation determines the vendor is unacceptable, the vendor requests removal or by direction of the General Manager, Oversight or the Manager, Quality (Units 3 & 4).

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OPERATIONS QUALITY ASSURANCE PLAN 7.0 11 PROCUREMENT PAGE 9 OF 13 EFFECTIVE DATE 02-01-08 5.4.3 Planning of verification activities to be employed for item or service acceptance shall begin during the purchase requisition or contract preparation and review stage. The extent of the verification activities will vary and be a function of the relative safety significance, complexity of the purchased item or service, and the supplier's past performance. The verification activities may include vendor surveillance, receipt inspection, or post-installation testing. Verification activities are planned to assure conformance to procurement document requirements. Procedures shall establish the organizational responsibilities for identifying required verifications and methods, performing and documenting the verification activities.

5.4.3.1 Verification activities shall be performed using plans developed in accordance with procedures with appropriate input from the cognizant technical organization. The plan shall specify the characteristics or processes to be witnessed, inspected or verified.

5.4.3.2 Specified source inspections may be waived by General Manager, Oversight or the Manager, Quality (Units 3 & 4).

5.4.3.3 Vendor related reports shall be evaluated to determine the effectiveness of the vendor's quality assurance program.

5.5 Receiving Activities 5.5.1 Received purchased items shall be observed for shipping damage and the requirements of ANSI N45.2.2 Section 5.2.1. (This activity does not constitute an inspection and does not require qualification in accordance with Reference 4.5).

5.5.2 Receiving inspection shall be coordinated with verification activities. If source inspection is not performed or did not address all applicable attributes, receipt inspection shall be performed and shall include the applicable additional attributes listed in ANSI N45.2.2 Section 5.2.2, except for commercial grade items dedicated by survey which shall be receipt inspected as required by the procurement document.

5.5.3 Receiving inspection checklists shall be developed using the requirements specified in the procurement documents and applicableattributes of ANSI N45.2.2.

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OPERATIONS QUALITY ASSURANCE PLAN 7.0 11 PROCUREMENT PAGE 10OF 13 EFFECTIVE DATE 02-01-08 5.5.4 Statistical sampling methods may be used for groups of similar items.

Sampling shall comply with nationally recognized methods or approved engineering alternates.

5.5.5 Receiving inspections shall be performed by personnel trained and qualified in accordance with Reference 4.5. Technical assistance shall be provided by Supply Chain or Engineering as applicable.

5.5.6 Receiving inspection activities shall include:

5.5.6.1 Identifying materials, parts, and components and their status upon receipt by tagging or other acceptable means of identification, or segregating and controlling items in receiving hold areas separate from the storage facilities for acceptable items. Identification of items shall correspond to the identification required by procurement documents'and be noted on receiving documentation..

5.5.6.2 Verification of items for acceptance includes correctness of identification and specified quality documentation.

5.5.6.3 Inspecting or testing using approved procedures and calibrated tools, gauges, and measuring equipment for verification acceptance of items, including off-the-shelf items.

5.5.6.4 Items determined to be acceptable for use shall be identified with an "accept" tag or other acceptable means of identification prior to release for storage or use.

5.5.6.5 Received items which do, not conform to procurement documents are controlled and segregated (if practical) and processed in accordance with Reference 4.6.

5.5.7 Acceptance by post-installation test may be utilized following one of the preceding verification methods. Post-installation testing may be used for acceptance verification when it is difficult to verify item quality characteristics, the item requires an integrated system checkout or test, or the item cannot demonstrate its ability to perform when not in use.

Engineering specifications shall be used for developing post-installation test instruction requirements and acceptance documentation. Post-.

installation testing is the responsibility of the Plant General Manager and is witnessed by Engineering or Quality personnel at specified hold points.

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OPERATIONS QUALITY ASSURANCE PLAN 7.0 11 PROCUREMENT PAGE 11 OF 13 EFFECTIVE DATE 02-01-08 5.5.8 Acceptance of Procured Items and Services 5.5.8.1 Acceptance of items and services shall be based on one or more of the following:

Written certifications (Note: This shall not be the sole method of acceptance for items in the "Basic" program)

Surveillance/Audit of procured service Source verification Receiving inspection/testing Commercial Grade Item dedication Vendor surveillance Post-installation test 5.5.9 Documented evidence from the supplier that procured items meet procurement quality requirements, when required, such as codes, standards, or specifications will be maintained at the plant site. Such evidence shall be provided by the supplier, at the time of source or receipt inspection, for review and verification before acceptance. The documented evidence will be retrievable and available at the plant site prior to installation or use of the procured item, unless otherwise controlled in accordance with Reference 4.6.

5.6 Vendor Surveys, Surveillance and Audit 5.6.1 For items in the Full Program, Suppliers Certificates of Conformance; shall be periodically evaluated by audits, independent inspections, surveys, or tests to assure that they are valid and results are documented.

When acceptance is based upon source inspection, documented evidence shall be furnished to the plant receiving organization.

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OPERATIONS QUALITY ASSURANCE PLAN 7.0 11 PROCUREMENT PAGE 12OF13 EFFECTIVE DATE 02-01-08 5.6.1.1 Acceptance by source inspection may be considered when the item or service is vital to plant safety; or the quality characteristics are difficult to verify after receipt; or the item or service is complex in design, manufacture, inspection, or test.

Vendor surveillance/source inspection involves a physical presence to monitor, by observation, designated activities for the purpose of evaluating supplier performance and product acceptance (source inspection only).

5.6.2 The STP survey and audit program provide for periodic scheduled audits or surveys of suppliers, the site procurement program, contractors, subcontractors, and others performing work. The audit and survey schedule is prepared and updated by Quality. Frequency of these surveys and audits is based upon the safety, complexity, and quality requirements, and as a minimum shall be in compliance with Reference 4.3.

5.6.3 When purchasing commercial-grade calibration services from calibration laboratories accredited by a nationally-recognized accrediting body, the accreditation process and accrediting body may be credited with carrying out a portion of the STPNOC's duties of verifying acceptability and effective implementation of the calibration service supplier's quality assurance program.

In lieu of performing an audit, accepting an audit by another licensee, or performing a commercial-grade survey, a documented review of the supplier's accreditation shall be performed by STPNOC. This review shall include, at a minimum, verification of the following:

0 The accreditation is to ANSI/ISO/IEC 17025

  • The accrediting body is either NVLAP or A2LA. The A2LA accreditation is recognized by NVLAP through the ILAC MRA.
  • The published scope of accreditation for the calibration laboratory covers the needed measurement parameters, ranges, and uncertainties.

This requires the supplier to provide a measurement of collective uncertainty and obviates the need to impose the four-to-one ratio requirement discussed in NISTIR 6989.

  • STPNOC is responsible for ensuring that the procured services are within the accredited scope of the NVLAP and A2LA certificates.

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OPERATIONS QUALITY ASSURANCE PLAN 7.0 11 PROCUREMENT PAGE 13OF13 EFFECTIVE DATE 02-01-08 6.0 DOCUMENTATION 6.1 Procedures which are generated as required by this chapter shall identify the records which are required to implement and document those activities. The records shall be controlled in accordance with Reference 4.7.

7.0 ATTACHMENTS 7.1 None

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15.0 OPERATIONS QUALITY ASSURANCE PLAN QUALITY OVERSIGHT ACTIVITIES PAGE 1OF7 EFFECTIVE DATE 02-01-08 10 PURPOSE 1.1 The purpose of this chapter is to establish requirements for a system of N independent oversight activities of quality assurance programs for the South Texas Project (STP).

2,0 SCOPE 2.1 This chapter provides for implementing a program of independent oversight activities which includes audits, assessments, evaluations, performance monitoring, and surveillances to ensure the requirements of the Operations Quality Assurance Program are being properly implemented.

3.0 DEFINITIONS 3.1 None

4.0 REFERENCES

4.1 OQAP Chapter 2.0, Table I 4.2 OQAP Chapter 4.0, Qualification, Training and Certification of Personnel 4.3 OQAP Chapter 7.0, Procurement 4.4 OQAP Chapter 13.0, Control of Conditions Adverse to Quality 4.5 OQAP Chapter 14.0, Records Control 5.0 REQUIREMENTS 5.1 Independent Oversight Activities 5.1.1 Procedures shall be developed to control independent oversight activities.

These activities include, but are not limited to, audits, assessments, evaluations, performance monitoring, and surveillances. These activities shall be used to observe and verify that activities are accomplished in accordance with prescribed requirements.

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OPERATIONS QUALITY ASSURANCE PLAN 15.0 11 QUALITY OVERSIGHT ACTIVITIES PAGE 2 OF 7 EFFECTIVE DATE 02-01-08 5.2 Audits 5.2.1 A comprehensive audit program in compliance with Reference 4.1 shall be established and implemented by STP Nuclear Operating Company (STPNOC) to verify internal and external quality activity compliance with the Quality Program. The audit program shall assure that applicable elements of the program have been developed, documented, and are effectively implemented and shall provide for reporting and reviewing audit results by appropriate levels of management. These audits shall encompass:

5.2.1.1 The conformance of unit operation to provisions contained within the Technical Specifications and applicable license conditions; 5.2.1.2 The training and qualification of the unit staff; 5.2.1.3 Actions taken to correct deficiencies occurring in equipment, structures, systems, components, or method of operation that affect nuclear safety; 5.2.1.4 The performance of activities required by the Operational Quality Assurance Program to meet the criteria of Appendix B, 10CFR50; 5.2.1.5 The fire protection programmatic controls including the implementing procedures; 5.2.1.6 The fire protection equipment and program implementation utilizing either a qualified offsite licensee fire protection engineer or an outside independent fire protection consultant; 5.2.1.7 The Radiological Environmental Monitoring Program and the results thereof; 5.2.1.8 The OFFSITE DOSE CALCULATION MANUAL and implementing procedures; 5.2.1.9 The PROCESS CONTROL PROGRAM and implementing procedures for processing and packaging of radioactive wastes;

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OPERATIONS QUALITY ASSURANCE PLAN 15.0 11 QUALITY OVERSIGHT ACTIVITIES PAGE 3 OF 7 EFFECTIVE DATE 02-01-08 5.2.1.10 The performance of activities required by the Quality Assurance Program for effluent and environmental monitoring; and 00 5.2.1.11 Other activities and documents as requested by the Senior C)

Management Team or the Executive Vice President and Chief 0 Nuclear Officer.

5.2.2 Qualified personnel assigned auditing responsibilities shall be independent of any direct responsibility for the performance of the activities which they audit; shall be experienced or trained commensurate with the scope, complexity, or special nature of the activities to be audited; and shall be qualified in accordance with the requirements of Reference 4.2.

5.2.2.1 An audit team consists of one (or more) qualified person(s). A qualified lead auditor shall be appointed as the audit team leader. The audit team leader shall be responsible for the written plans, checklists, team orientation, audit notification, pre-audit conference, audit performance, post-audit conference, reporting, and follow-up, activity to assure corrective action.

The audit team leader shall promptly report conditions requiring immediate corrective action to the appropriate management of the audited organization. Other audit findings will be identified to the audited organization at the post-audit conference.

5.2.2.2 Other qualified personnel may assist in the conduct of audits, such as technical specialists or management representatives.

5.2.3 Internal Audits

-5.2.3.1 Internal audits shall be conducted by the Quality Department and performed with a frequency commensurate with their safety significance, past performance and regulatory requirements. Audits are scheduled on a nominal biennial frequency, except those audits whose frequency is specifically governed by regulation.

If a decision is made to extend an audit beyond that nominal frequency, the basis for that decision shall be documented.

Decisions shall be approved by the Manager, Quality and notifications made to the General Manager, Oversight and the Senior Management Team.

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OPERATIONS QUALITY ASSURANCE PLAN 15.0 11 QUALITY OVERSIGHT ACTIVITIES PAGE 4 OF 7 EFFECTIVE DATE 02-01-08 5.2.3.2 Review of the audit program shall be performed at least semiannually by the Senior Management Team or by a management representative to verify that audits are being accomplished in accordance with the requirements of the Quality Program.

5.2.3.3 Audit results shall be reviewed periodically by the Quality organization for quality trends and overall audit program effectiveness. The results of these reviews shall be reported to appropriate management in periodic summary reports.

5.2.3.4 Audited organizations are responsible for providing timely corrective action including action to prevent recurrence for programmatic problems identified by an audit.

5.2.4 Supplemental audits shall be conducted when:

5.2.4.1 Significant changes are made to the quality assurance program.

5.2.4.2 It is necessary to determine the root cause of problem areas which may impact the effectiveness of the quality assurance program.

5.2.4.3 A systematic, independent assessment of program effectiveness is necessary.

5.2.4.4 Requested by appropriate management.

5.2.5 Audit implementation shall include the following:

5.2.5.1 Written notification to the audited organization of the audit, if an announced audit.

5.2.5.2 Development of an individual audit plan/scope. The audit plan and any necessary reference documents shall be available to the audit team members.

5.2.5.3 A pre-audit and post-audit conference with responsible organizational management.

5.2.5.4 Use of a checklist or procedure as a guide during the performance of the audit.

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OPERATIONS QUALITY ASSURANCE PLAN 15.0 11 QUALITY OVERSIGHT ACTIVITIES PAGE 5 OF 7 EFFECTIVE DATE 02-01-08 5.2.5.5 Identifying and documenting conditions adverse to quality.

5.2.5.6 Audit reports shall be prepared and submitted to the audited organization, Senior Management Team and the Executive Vice President and Chief Nuclear Officer within thirty days after the post-audit conference. The audit report shall address those items required by Reference 4.1.

5.2.5.7 Audited organizations provide timely and thorough corrective action and recurrence control to discrepancies identified during the audit. In the event that corrective action cannot be completed within thirty days, the audited organization's response shall include a scheduled date for the corrective action. Earlier dates for corrective action may be established if circumstances dictate.

5.2.5.8 Evaluation of corrective action for conditions adverse to quality and follow-up verification as appropriate.

5.3 Surveillance/Quality Performance Monitoring 5.3.1 Procedures and/or instructions shall be developed to control surveillance/quality performance monitoring activities.

Surveillance/quality performance monitoring activities shall be used to observe and verify that activities are accomplished in accordance with prescribed procedures.

5.3.2 Surveillance/quality performance monitoring activities will be performed during refueling outages, startup activities, and normal and off-normal operational activities. Areas to be monitored will be determined based on safety significance, past performance, regulatory requirements, and customer request.

5.3.3 The frequency of surveillance/quality performance monitoring activities is based upon the complexity of the activity, importance of the activity, and severity level of conditions noted during previous oversight activities.

5.3.4 Surveillance/quality performance monitoring results shall be documented and a summary shall be prepared and transmitted to responsible management.

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OPERATIONS QUALITY ASSURANCE PLAN 15.0 11 QUALITY OVERSIGHT ACTIVITIES PAGE 6 OF 7 EFFECTIVE DATE 02-01-08 5.4 Assessments/Evaluations 5.4.1 Assessments are conducted on a nominal biennial frequency in accordance with written procedures to assess the Quality organization's implementation of the Operations Quality Assurance Plan.

5.4.1.1 These assessments will be conducted by organizations independent of the activities performed to assure the STPNOC OQAP is being properly implemented.

5.4.1.2 The Senior Management Team shall review the scope and schedule of the assessment.

00 5.4.1.3 Theresults of these assessments will be transmitted to the Executive Vice President and Chief Nuclear Officer and the Senior Management Team.

5.4.2 Other assessments/evaluations may be performed to verify activities are accomplished in accordance with applicable requirements and prescribed procedures.

5.4.2.1 These assessments/evaluations will be performed on areas based on their safety significance, past performance, regulatory requirements, and customer request.

5.4.2.2 Assessment/evaluation results shall be documented and transmitted to appropriate management.

5.5 An approved oversight plan shall be issued annually to include:

5.5.1 Activities/organizations to receive independent oversight.

5.5.2 Time frame in which the oversight activity will be conducted.

5.6 Conditions adverse to quality identified during an independent oversight activity shall be documented in accordance with Reference 4.4.

5.7 Personnel performing independent oversight activities shall be trained and qualified in accordance with Reference 4.2.

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Chapter OPERATIONS QUALITY ASSURANCE PLAN 15.0 11 QUALITY OVERSIGHT ACTIVITIES PAGE 7 OF 7 EFFECTIVE DATE 02-01-08 6.0 DOCUMENTATION 6.1 Procedures which are generated as required by this chapter shall identify the records which are required to implement and document those activities. The records shall be controlled in accordance with Reference 4.5.

7.0 ATTACHMENTS 7.1 None