ML13323A488

Change Notice 35 to Amend 12 to SCE-1-A, QA Program

ML13323A488
Person / Time
Site:	San Onofre
Issue date:	10/25/1989
From:	Ray H Southern California Edison Co
To:
Shared Package
ML13322B044	List: ML13322B043 ML13323A488
References
SCE-1-A-A-12, NUDOCS 8911020045
Download: ML13323A488 (42)

Text

SOUTHERN CALIFORNIA EDISON COMPANY TOPICAL REPORT SCE-1-A CHANGE NOTICE Change Notice Number:

35 Affected Amendment:

12 Affected Pages: See attached List Description of Change:

1.

Change title of Manager of Quality Assurance to Manager of Nuclear Oversight.

2.

Change functional responsibility of Records Management from Manager of Material and Administrative Services to Manager of Budgets and Administration.

3.

Add Records Management function to NES&L.

4.

Delete CASE & add NUPIC for procurement issues.

Reason for change (including basis for concluding that the change satisfies the criteria of 10CFR50, Appendix B, and the quality assurance program commitments previously accepted by the NRC):

These changes are brought about as a result of:

1.

Change in the Manager of Quality Assurance's title to reflect a more accurate definition of his responsibilities.

2.

Transferring the function of the Document Management System from the corporate office to the nuclear generating station. This will facilitate central records management system for quality assurance records.

3.

Moving Nuclear Engineering Safety and Licensing from the corporate offices in Rosemead to Irvine established the need for drawing control at the Irvine Operations Center.

4.

Exchanging one industry organization for another.

Change ____ does X does not reduce commitments previously accepted by the NRC.

Approvals:

Manager M Nuclear Oversight VIc President Date Submitted to NRC:

October 25, 1989 0576Q 0577Q 8911020045 891025 PDR ADOCK 05000206 P

PNU

Affected Pages 17-vii 17.1-2 17.2-3

-3

-4

-3a

-5

-4

-6

-6

-7a

-8

-8

-9

-9

-10

-11

-12

-12

-15

-13

-17

-13a

-18

-16

-19

-17

-19a

-18

-21

-20

-22

-21

-24

-23

-27

-24

-28

-25

-29

-27

-35

-29

-36

-30

-37

-32

-38

-33

-39

-35

-40

-36

-41

-38

-42

-39a

-43

-39b

-44

-40

-45

-41

-45a

-42

-50

-43

-51

-44

-45

-47

-48

-49

-51

-52

-53

-54

-58

List of Effective Pages (continued)

Page No.

Amendment No.

Amendment 12 17.2-23Change Notice #35 17.2-23 5

17.2-24 5

17-vii,17-1-2 1 7.1-3..

17.2-25 12 17.1-3a,17.1-4,17.1-6 17.2-26 1

17.1-8,17.1-9,17.1-10 17.2-27 6

17.1-12,17.1-1,17.1-17 17.2-28 12 1 7.1-8,17.119,17.1-19a 17.2-29 12 17.1-21,17.122,17.1-24 17.2-30 5

17.1-27,17.128,7.1-29 17.2-31 5

17.1-35,17.136,17.137 17.2-32 5

17.1-38,17.139,17.140 17.2-33 Original 17.1-41,17.1-4217.143 17.2-34 12 17.1-44,17.1-45,17.1-45a 17.2-35 12 17.1-50,17.1-51,17.2-3, 17.2-36 12 17.2-4,17.2-,17.2-617.2-7a 17.2-37 10 17.2 8,17.2 -9,17.2 11,17.2. 12 17.2-38 10 17.2-13, 1 7.2-13a,17.2-16, 17.2-39 10 17.2-17,17.2-18,17.2-20, 17.2-39a 10 17.2-21,17.2-23,17224 17.2-39b 10 17.2-25,17.227,17.2-29 17.2-40 12 17.2-30,17.232,17.233 17.2-41 12 17.2-3,17.236,17.238 17.2-42 12 l7.2-39a,17.2-39b172-40 17.2-43 12 17.2-41,17.2-42,17.2-43 17.2-44 12 17.2-44,17.2-4,17.2-47 17.2-45 12 17.2-48,17.249,17.2.51 17.2-46 12 17.2-52,17.2-3,17.2-54 17.2-47 12 17.2-58 17.2-48 12 17.2-49 10 17.2-50 10 17.2-51 6

17.2-52 5

17.2-53 7

17.2-54 12 17.2-55 8

17.2-56 6

17.2-57 6

17.2-58 12 17.2-59 6

17.2-60 6

17.2.61 6

17.2-62 6

17.2-63 12 17.2-63a 12 17.2-64 7

17.2-65 7

17.A-1 1

17.A-2 1

17.A-3 1

17.A-4 1

17.A-5 1

17.A-6 2

17.A-7 2

17-viiAmeedente1ntN12

sp 7.1.1.2 (continued) he ultimate responsibility for design, procurement, construction testing, quality assurance, fuel supply, and 4

operations rests with the SCE Chairman of the Board. He assigns project responsibilities to the various SCE organizations involved in nuclear generating station development and operations.

A Executive Vice President reports to the Chairman of the Board and is responsible for Nuclear Engineering, Safety and Licensing, Nuclear Generation Site, and Fuel and Material Management, Power Supply, and Engineering, Planning and Research.

Senior Vice President reports to the Chairman of the Board and is responsible for Administrative Services.

12CN35 The Vice President, Nuclear Engineering, Safety and Licensing, reporting to an Executive Vice President, has been delegated the responsibility for establishment and assurance of imple mentation of the SCE Quality Assurance Program in compliance with 10CFR50, Appendix B, and other applicable regulations and standards. He is authorized to request the cooperation of all officers and management personnel of this program.

SCE corporate management is involved with quality assurance matters on a continuous basis by means of regular Officer's S

ouncil meetings. Nuclear Oversight Division weekly 12CN#35 rogress reports are prepared for the Vice President, Nuclear 7CN#7 Engineering, Safety and Licensing, and are used, as appropriate, for discussion items at these meetings.

These reports usually contain significant progress items, corrective action recommendations, and unresolved items.

In addition, a quarterly report of information suitable for assessment of the status and adequacy of the SCE Quality Assurance Program is submitted 9CN#15 to senior management by the Manager of Nuclear Oversight.

12CN#35 17.1-2 Amendment 12CN#35

7.1.1.3 Administrative Services Department A Senior Vice President is in charge of Administrative 11CN#25 Services. This Senior Vice President reports to the Executive Vice President.

The Manager of Real Properties and Administration reports directly to the Senior Vice President and is responsible for the corporate records management program. Corporate Documentation Services operates the Corporate Documentation Management (CDM) 1OCN#22 enter at the Corporate Offices which is responsible for retrieving, and storage of nuclear documentation.

12CN#35 11CN#25 17.1.1.4 Nuclear Engineering, Safety and Licensing Department The Nuclear Engineering, Safety, and Licensing Department, under the Vice President, Nuclear Engineering, Safety, and Licensing has overall responsibility for nuclear engineering, design, 12CN#31 construction, safety, licensing, nuclear fuel, and quality assurance activities associated with nuclear generating facilities. The Vice President, Nuclear Engineering, Safety, 12CN#35 eand Licensing reports directly to an Executive Vice President.

ctivities include conceptual engineering, nuclear systems 12CN#31 analyses, engineering criteria and technical assistance pertain ing to radiation protection programs, safety evaluations, emergency planning, regulatory interface with the Nuclear Regulatory Commission, procurement and shipping of nuclear fuel, engineering, construction, test program management and project management.

17.1-3 Amendment 12 CN#35

• 17.1.1.4 (continued)

The Vice President, Nuclear Engineering, Safety and Licensing, is responsible for establishment and assurance of implementa tion of SCE Quality Assurance Program in compliance with applicable regulations,codes, and standards, including those listed on Table 17.1-1. He is responsible for establishing quality assurance policies, goals, and objectives and for 7CN#7 assuring that these policies are followed and the goals and objectives are achieved.

The Vice President, Nuclear Engineering, Safety and Licensing, is responsible for apprising the Management on the effective ness of the Quality Assurance Program. The Vice President, Nuclear Engineering, Safety and Licensing is involved in the disposition of nonconformances of unusual complexity, and acts upon trending studies that indicate quality problems of a possible generic nature submitted to him by the Manager of 9CN#13 Nuclear Oversight.

The Vice President, Nuclear Engineering, Safety and Licensing, 12CN#35 exercises through the Manager of Nuclear Oversight, the Administrative Authority for the Nuclear Oversight Division.

12CN#35 Direction for implementing the Quality Assurance Program is provided to individuals and groups by the Vice President, 9CN#13 Nuclear Engineering, Safety and Licensing through the Manager of Nuclear Oversight.

12CN#35 he Manager of Nuclear Oversight, reports directly to the Vice President, Nuclear Engineering, Safety and Licensing, and has the responsibility for development, maintenance and surveil-9CN#13 lance of the Quality Assurance Program as described in quality assurance manuals. These manuals are reviewed and approved by 12CN#35 the Manager of Nuclear Oversight, and the Vice President, Nuclear Engineering, Safety and Licensing. Other SCE organizations involved with Quality Assurance Program implementation, as described in Subsection 17.1.1, review and comment on the 9CN#13 quality assurance manuals, particularly as they apply to their area of involvement. The Manager of Nuclear Oversight, is 12CN#35 responsible for identifying any conditions adverse to quality and reporting them to the Vice President, Nuclear Engineering, 9CN#13 Safety and Licensing. In addition, the Manager of Nuclear 12CN#35 Oversight, is responsible for surveillance of Quality-Affecting Activities and has the authority to Stop Work, or delegate this 9CN#13 authority in writing to other personnel.

The minimum qualification requirements-for the position of 12CN#35 Manager of Nuclear Oversight are as follows:

A. Bachelor of Science in one of the engineering 9CN#13 disciplines from an accredited college or university.

0 17.1l-3a Amendment 12CN#35

• 17.1.1.4 (continued)

B. Ten years experience in design, fabrication construction, testing, operation, or quality assurance related to the nuclear power field.

C. Management and administrative ability demonstrated by experience and training.

D. Extensive knowledge of regulatory requirements for nuclear generating stations.

9CN#13 The Nuclear Oversight Division under the direction of the Manager of Nuclear Oversight develops and administers the 12CN#35 Quality Assurance Program for the design and construction phase of SCE nuclear generating stations.

It is comprised of engineers 9CN#13 with expertise in the various disciplines required for performing quality assurance and quality control activities.

This organization audits, inspects, or otherwise verifies that activities within the scope of the SCE Quality Assurance Program are correctly performed either by SCE or other organizations delegated work.

The Nuclear Oversight Division has the authority and 12CN#35 organizational freedom to:

A. Identify quality problems.

B. Initiate, recommend, or provide solutions through 7CN#7 designated channels.

C. Verify implementation of solutions.

Additional responsibilities of "offsite" and "onsite" based 12CN#35 Nuclear Oversight Division personnel during the design and 9CN13 construction phase are listed on Table 17.1-3.

A Site Quality Assurance Manager and Corporate Office and Site 12CN#31 Quality Assurance Supervisors are assigned to each nuclear generating station under design and construction. They are responsible for directing and managing the activities of the "offsite" and "onsite" based quality assurance engineers.

9CN#13 A Site QC Manager and QC Supervisors are responsible for directing the activities of site QC personnel. QC personnel provide site inspection and surveillance of safety related items and activities and non-safety related activities when requested by Station or Project Management.

Quality Assurance and Quality Control Managers and Supervisors have the responsibility and authority, delineated in writing, to stop unsatisfactory work and to control further processing, delivery, and installation of nonconforming items.

17.1-4 Amendment 12CN#35

S 17.1.1.6 (continued) items and services (excluding nuclear fuel), material shipping, and for preparation; negotiation and administration of procurement contracts.

12CN#31 17.1.1.7 Engineering, Planning and Research Department The Environmental Affairs Division, under the direction of the Vice President, Engineering, Planning and Research, is re-12CN#31 sponsible for collection of meteorological data in support of nuclear power plant activities.

17.1.1.8 Delegated Quality Assurance Work 17CN#7 SCE retains responsibility for the Quality Assurance Program describe herein but may delegate quality assurance work to other organizations. Other organizations which may be delegated the work of establishing and executing portions of the Quality Assurance Program during the design and construction phase are as follows:

Architect-Engineer (A-E).

Nuclear Steam Supply System (NSSS) Supplier.

Other SCE Contractors and Consultants.

The quality assurance programs of these organizations and the scope of delegation are as described in the applicable contract for the work performed. A typical interface organizational relationship between SCE and other organizations delegated quality assurance work is as shown on Figure 17.1-2.

17.1.1.9 Interfaces for Delegated Quality Assurance Work 7CN#7 12CN#35 The SCE Manager of Nuclear Oversight, is responsible to 9CN#13 communicate SCE quality assurance requirements directly with management of other organizations delegated the work of establishing and executing portions of the Quality Assurance Program. Compliance with SCE quality requirements and regulatory requirements is verified by means of review and approval of these organizations' quality assurance programs as described in Subsection 17.1.2 and by means of audits as described in Subsection 17.1.18.

Management of other organizations delegated quality assurance work is required to implement a reporting system concerning the delegated quality assurance work they are performing and to regularly review the status and effectiveness of that part of the program they are executing. Further, management of these organizations is required to submit to SCE management reports oncerning correction of quality problems identified during SCE urveillance of delegated work.

17.1-6 Amendment 12 CN#35

Southern California Edison Company SCE Senior Management anager Nuclear Project Manager 12CN35 Oversigh t 1

3 I

I Typical Architect - Engineer Division Managera Manage Typical NSSS Supplier SCE QUALITY PROGRAM Legend TYPICAL INTERFACE ORGANIZATION PREOPERATIONAL AND INITIAL

-Technical/

Admi n~stratIve Authority STARTUP TES1NG AND Project Direction OPERATIONAL ECP ACTIVITIES Q.A. Functional Direction Fiue17.1-2 17.1 -8 Amendment 12 CN#35

. 17.1.2 Quality Assurance Program 17.1.2.1. Scope This subsection describes the SCE Quality Assurance Program established and implemented for the design and construction of nuclear generating stations in compliance with Regulatory Guide 1.28 (reference Table 17.1-1).

17.1.2.2 Quality Assurance Program The basic policies, goals, and objectives for quality assurance are that SCE personnel have full responsibility to assure that nuclear generating stations are designed, constructed, tested and operated in a manner to protect the health and safety of the public. In this regard, SCE has committed its Quality Assurance Program for the design and construction phase to be in compli ance with the provisions of 10CFR50, Appendix B, and the regulatory guides and standards listed on Table 17.1-1.

The SCE Quality Assurance Program described herein is applied to all activities affecting the Safety-Related 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. A listing of items designated Safety-Related is included in the PSAR for the applicable nuclear generating station. These lists are aintained and revised, as necessary, to reflect changes from he finalization of station design.

In addition, expendable.or consumable items necessary for the functional performance of Safety-Related structures, systems and components are subjected to quality assurance requirements 1

as specified in written procedures. These procedures include 421.3 provisions for review and control in accordance with industry standards and specifications and the safety-related function of the expendable or consumable items.

This program includes Safety-Related activities initiated prior to submittal of a PSAR, such as design and procurement, preparation of the PSAR, and site evaluation and preparation, and remains in effect until initiation of preoperational testing.

The program is periodically reviewed by the Nuclear Oversight 12CN#35 Division during the design and construction phase. Revisions are made in a controlled fashion, as necessary to reflect changes in the program which may be required to improve its efficiency or increase its effectiveness.

SCE quality assurance policies, goals and objectives are defined in corporate jurisdiction statements, organization plans, and quality assurance manuals and procedures. These 17.1-9 Amendment 12CN#35

7.1.2.2 (continued) documents transmit the SCE quality assurance philosophy and requirements to all levels of management and to groups and individuals involved with program implementation. Training programs, personnel certifications, meetings, review of working documents, programs, and manuals, and management directives, are some of the methods utilized to assure that these policies, goals, and objectives are properly understood and complied with.

The Manager of Nuclear Oversight, is responsible for establishing 12CN#35 and maintaining quality assurance manuals in compliance with applicable regulations and standards as listed in Table 17.1-1 and PSAR commitments. These manuals are developed by the Nuclear Oversight Division from established quality assurance 12CN#35 policies, goals, and objectives, which are mandatory require ments. Controlled distribution of quality assurance manuals is maintained by the Nuclear Oversight Division.

12CN#35 Disputes arising between departments and organizations on any quality assurance matter that cannot be resolved are referred to the Vice President, Nuclear Engineering, Safety and Licensing, I7CN#7 of if necessary to the Executive Vice President for resolution.

Written and approved procedures, instructions, and revisions thereto, necessary to activate the Quality Assurance Program originate from departments or organizations within SCE that have eurisdictional responsibility for performing specific tasks.

Wl11 procedures that support the SCE Quality Assurance Program are reviewed and approved by responsible supervision and management of the originating organization. They are also reviewed and may be approved or disapproved by the Nuclear Oversight Division. Promulgation and control of the 12CN#35 procedures and instructions developed pursuant to the Quality Assurance Program are maintained by the originating organiza tion. All procedures are included in procedure manuals maintained by the respective organizations. Table 17.1-2 presents a list of these manuals and a summary of their content.

By means of inspections and audits, Nuclear Oversight 12CN#35 Division personnel verify that these procedures are followed.

Indoctrination and training programs are established within SCE by those organizations responsible for performing Quality Affecting Activities. These programs are implemented by appropriate training plans or procedures which describe the scope and objectives. The Nuclear Oversight Division provides 12CN#35 assistance in the development and implementation of these programs, as requested, and performs periodic audits to assure effective implementation.

0 17.1-10 Amendment 12CN#35

17.1.2.2 (continued) generating station from the design and construction phase to the operations phase. Prior to actual turnover, written procedures are developed by these organizations for the control of the transfer of all portions of the nuclear generating station, including asso ciated documentation. The Nuclear Oversight Division verifies 1l2CN#36 that these procedures are developed and followed by means of inspections and audits, and assures that Quality-Affecting Activities are performed by trained and qualified personnel using specified equipment under suitable environmental conditions.

The SCE Quality Assurance Program for the design and construction phase of nuclear generating stations is described in detail in subsequent subsections of this topical report. The descriptions follow the criteria presented in 10CFR50, Appendix B.

The Vice President, Nuclear Engineering, Safety and Licensing, 7CN#7 through use of independent consultants, periodically assesses the scope, implementation, and effectiveness of the program to assure that it is meaningful and effectively complies with 10CFR50, Appendix B, criteria.

For a full-time construction project, such an assessment is made within one year following issuance of the NRC construction permit, at approximately the mid-term of the construction 1

effort and prior to commencement of major startup activities.

421.2

• ssessments will be made by qualified individuals and firms ith primary emphasis on the activities of SCE, and they result in written reports submitted to the Vice President, Nuclear 7CN#7 Engineering, Safety and Licensing. These reports may then be referred to appropriate departments for response to any findings or recommendations.

Quality-related work delegated to other organizations (A-E's),

NSSS Suppliers, and other contractor and consultants to SCE must comply with applicable provisions of 10CFR50, Appendix B.

Additionally, these programs must comply with the Regulatory Guides and ANSI Standards listed in Table 17.1-1 or acceptable alternatives must be described. The quality assurance programs must be reviewed and approved by the SCE Nuclear Oversight 12CN#35 Division. Regular planned audits of these quality assurance programs are conducted by the Nuclear Oversight Division to assure continued compliance with applicable regulatory requirements.

17.1-12 Amendment 12CN#35

7.1.3.2 (continued) ield changes requiring incorporation are incorporated in affected documentation within 20 days of approval of each field change or when 10 field changes have been accumulated, whichever occurs first.

Design documentation prepared by the A-E and NSSS Supplier are controlled in accordance with their SCE-approved quality assurance programs. Selected design documents prepared by the A-E and NSSS Supplier are reviewed and may be approved or disapproved by SCE in accordance with internal written procedures. The Project Engineer through the Project Group Leader is responsible for assuring that all comments are resolved and/or incorporated prior to acceptance by SCE.

Design controls are applied by SCE, A-E's or NSSS Suppliers, as applicable, to such activities as reactor physics, seismic, stress, thermal, hydraulic, radiation, and accident analyses.

Consultants may be utilized to review and verify the design of certain items.

Where design verification cannot be adequately accomplished by 1

the design review process, alternate calculations or 421.4 qualification testing under adverse design conditions shall be employed. These alternate methods are required to be defined in design documentation.

ecords of SCE design reviews and associated design documents are required by internal written procedures to be maintained 5

and controlled in the CDM Center.

The SCE Nuclear Oversight Division is responsible for performing 12CN#35 periodic audits, as described in Subsection 17.1.18, of SCE departments, A-E's and NSSS Suppliers to verify effective implementation of design control requirements. These audits include verification that appropriate design review records are maintained and deviations from quality standards are controlled.

17.1-15 Amendment 12CN#35

17.1.4.2 (continued) rocurement Documents prepared by SCE identify the applicable 10CFR50, Appendix B, requirements, regulatory guides, codes, and standards which must be complied with and described in suppliers' quality assurance programs. These programs are reviewed by the Nuclear Oversight Division.

12CN#35 Written procedures are established which define the sequential activities necessary for preparation, review, approval, and control of Procurement Documents. These procedures identify the responsible organizations and functions of individuals performing the Procurement Document control activities. Table 17.1-2 lists the manuals which contain these procedures.

Procurement Documents, and revisions thereto, are reviewed by responsible engineers to verify that they contain or reference technical requirements appropriate to the item or service to be 3

provided including:

0 Regulatory requirements, codes, and industry standards.

o Component and material identification requirements.

o Design requirements, including drawings and specifications.

o Test and inspection requirements.

o Special process instructions.

o Handling, storage, and shipping instructions.

o Documentation to be prepared, maintained, and submitted to SCE for review and approval.

o Records to be retained, controlled and maintained by the supplier and those to be delivered to SCE prior to use or installation of the item.

Responsible quality assurance engineers review Procurement Documents to determine that they have been prepared, reviewed and approved in accordance with SCE Quality Assurance Program requirements and to assure the adequacy of quality requirements.

This review includes, but is not limited to, verification of the following as appropriate to the item or service being provided:

3 0

Appropriate quality requirements are correctly stated and include applicable 10CFR50, Appendix B, requirements.

17.1-17 Amendment 12CN#35

7.1.4.2 (continued) o Quality requirements can be inspected and controlled.

o Adequate acceptance and rejection criteria are specified.

o Provisions are included for documenting and controlling deviations from the Procurement Document.

o Provisions are included for the right of access by the purchaser to the supplier's facilities and records for source inspection and audit.

The control measures, described herein, apply to original items as well as spare or replacement parts, and to changes to Procurement Documents. Procurement Document reviews including reviews of changes and revisions are verified by checking the signatures of assigned responsible individuals on appropriate documents. The review and approval of Procurement Documents is documented prior to release and is available for verification.

SCE, A-E's and NSSS Suppliers are required to maintain records of the review and approval of Procurement Documents. The SCE Nuclear Oversight Division is responsible for performing 12CN#35 periodic audits, as described in Subsection 17.1.18, of these participating organizations, to verify that Procurement ocuments have been prepared, reviewed, approved, controlled, and maintained in accordance with SCE Quality Assurance Program requirements.

Internal audits are also required by A-E's and NSSS Supplier's quality assurance organizations to verify that 2

these activities have been correctly performed in their 421.14 organizations and in the organizations of their suppliers, as appropriate.

17.1-18 Amendment 12CN#35

W17.1.5 INSTRUCTIONS, PROCEDURES, AND DRAWINGS 17.1.5.1 Scope This subsection describes the measures utilized by SCE to assure that activities affecting quality are prescribed by, and accomplished in accordance with, appropriate instructions, procedures, and drawings.

17.1.5.2 Instructions, Procedures, and Drawings The SCE Quality Assurance Program includes provisions which require that work be accomplished in accordance with documented instructions, procedures, and drawings.

Instructions, procedures, and drawings are prepared, reviewed, 1

approved, and controlled by organizations which implement 421.6 Quality-Affecting Activities. These documents specify the requirements and/or methods to be utilized for compliance with the requirements of the SCE Quality Assurance Program. They include appropriate qualitative and quantitative acceptance criteria, as applicable, to determine that designated activities are accomplished in a satisfactory manner.

Instructions, procedures, and drawings, including revisions, 11CN#21 thereto, prepared by SCE are reviewed are approved by organiza tions responsible for the work. The Nuclear Oversight Division 12CN#35

.Seviews and approves prior to issuance quality assurance rogrammatic procedures and procedures which define inspection 11CN#21 nondestructive examination requirements.

In addition, other quality affecting procedures are subject to review by the Nuclear Oversight Division at its discretion. Appropriate 12CN#35 surveillance and audits will be conducted by the Nuclear Oversight Division to assure that quality affecting procedures comply with the quality assurance program requirements. Maintenance, modification and inspection procedures and work order documen-12CN#35 tation are reviewed by the Nuclear Oversight Division to determine: (1) the need for inspection, identification of inspection personnel and documentation of inspection results; 11CN#21 and (2) that the inspection requirements, methods and acceptance criteria are identified. Drawings and specifications are reviewed and approved by the Nuclear Oversight Division 12CN#35 to assure inclusion of appropriate quality assurance require ments.

Changes to instructions, procedures, specifications, and draw-11CN21 ings are reviewed and approved in the same manner as original documents. Project Management personnel are responsible for assuring that instructions, procedures, and drawings, including revisions thereto, are reviewed by the appropriate SCE organi zations.

17.1-19 Amendment 12CN#35

7.1.5.2 (continued)

Instructions, procedures, and drawings, prepared by A-E's and NSSS Suppliers are controlled in accordance with their respect ive quality assurance programs as described in the applicable PSAR. Inspection plans, test, calibration, and special process procedures, drawings and specifications, and changes thereto prepared by these participating organizations may be subject to the review and approval of the SCE Nuclear Oversight Division.

12CN#35 The SCE Nuclear Oversight Division verifies by means of audits, as described in Subsection 17.1.18, that these documents are maintained and controlled by CDM in compliance 5

with established program commitments.

17.1-19a Amendment 12CN#35

7.1.6.2 (continued) hanges to instructions, procedures, and drawings, and other 4

documents are approved prior to implementation of the change.

Changes to documents can be requested by any reviewing or using organization or individual. Such requested changes are subjected to the review and approval by the same groups cognizant in the discipline affected by the change unless this work has been delegated to another organization. Where a group 2

or organization which originally was responsible for approving a particular document is no longer responsible, the group or organization to approve changes to the document shall be 1

designated and determined to be qualified by the SCE Project 421.8 Manager.

Design information transmitted from one organizational unit to another, including to organizations delegated design work, is documented and controlled by written approved procedures. These procedures require that design information transmittals identify the status of the design information or document provided and, where necessary, identification of incomplete items which require further evaluation, review or approval.

Each issuing organization prepares or delegates the preparation of a master list that identifies the latest revision number of instructions, procedures, specifications, drawings and Procurement Documents. These master lists are updated and istributed to designated responsible persons to preclude the se of obsolete or superseded documents.

SCE Project Manager personnel are responsible for assuring that selected Design Disclosure Documents developed by A-E's and NSSS Suppliers are reviewed and approved by SCE. A-E's and NSSS Suppliers are required to control the preparation and issuance of drawings and specifications in a manner approved by SCE.

The SCE Nuclear Oversight Division periodically audits 12CN#35 the document control systems of all participating organizations, as described in Subsection 17.1.18, to verify compliance with established requirements.

17.1-21 Amendment 12CN#35

W17.1.7 CONTROL OF PURCHASED MATERIAL, EQUIPMENT, AND SERVICES 7.1. 7.1 Scope This subsection describes the measures utilized by SCE to 3

control the procurement of material, equipment, and services purchased directly or through contractors and subcontractors in compliance with applicable codes and standards.

17.1.7.2 Control of Purchased Material, Equipment and Services Prior to award of purchase order or contract, suppliers to SCE are subject to technical, and quality assurance evaluations 6

as applicable by qualified SCE Engineering and Quality Assurance personnel. Quality Assurance evaluation of suppliers shall not apply to standard off-the-shelf items and basic commodities where required quality can adequately be determined by receipt inspection or post-installation checkout or test. The Quality 3

Assurance evaluation may be accomplished by one or more of the following methods:

o Review of objective evidence establishing suppliers' capability to comply with the 10CFR50, Appendix B, criteria, applicable to the type of material, equipment, or service to be procured.

0 Review of available previous records and performance of suppliers that provide similar products and services of the type to be procured.

o Review of audit/evaluation records generated by contractors, consultants, utilities/Licensees acting on behalf of SCE or organizations such as the Nuclear 12CN#35 Utilities Procurement Issues Council (NUPIC).

Prior to any award based on qualification using this method(s),

the audit/evaluation records are reviewed by SCE Nuclear Oversight to ensure applicability.

o Survey of suppliers' facilities and quality assurance programs to determine suppliers' capability to supply a product or service which meets the design, manufacturing, and quality requirements.

Results of these reviews and surveys are documented and forwarded to the Fuel and Material Management Department and to the CDM Center.

12CN#31 Surveillance of suppliers when required, is performed during 13 fabrication, inspection, testing, and shipment. This surveillance activity, as further described in Subsections 17.1.10 and 17.1.18, is planned and performed in accordance with written procedures to assure compliance to purchase order requirement. These procedures provide for the following:

17.1-22 Amendment 12CN#35

17.1.7.2 (continued)

CE may delegate the work of vendor surveillance and/or receiving inspection to A-E's quality assurance organizations.

Monitoring of this delegated work is performed by the SCE Quality Assurance Organization. Written procedures for performing delegated receiving inspection are subject to review by the SCE Nuclear Oversight Division.

1l2CN#35 Procurement specifications require suppliers to furnish the following records to SCE, as a minimum, with delivered items:

0 Certifications that specifically identify the purchased material and equipment, and the specific procurement requirements such as codes, standards, specifications, procedures, and drawings that are met by the items.

o Certifications that identify procurement requirements that were not met, together with a description of those Accept-As-Is or repair.

Certifications are reviewed and approved at receiving 6

inspection by SCE or A-E's inspectors. Quality Assurance Engineers audits these certifications for completeness and accuracy. SCE or A-E's periodically evaluate suppliers' certificates of conformance by audits, independent inspections, or tests to assure they are valid. In addition, the

1. effectiveness of the control of quality by suppliers is assessed y SCE or A-E's at intervals consistent with the importance, complexity, and quantity of the item.

The verification of the validity of supplier certificates and 2

the effectiveness of the certification system is accomplished as an integral part of the total supplier control and product acceptance program.

Spare or replacement parts of structures, systems, and components are subject to controls at least equivalent to those used for the original equipment.

Material, equipment, and services purchased through A-E's and NSSS Suppliers and controlled as specified in their quality assurance programs which are described in the PSAR.

17.1-24 Amendment 12CN#35

7.1.9 CONTROL OF SPECIAL PROCESSES 17.1.9.1 Scope This subsection describes the measures utilized by SCE to control special processes such as welding, heat treating, cleaning, and nondestructive testing in compliance with Regulatory Guides 1.31, 1.39 and 1.54 (reference Table 17.1-1).

17.1.9.2 Control of Special Processes SCE engineers and technicians performing special processes are trained, examined, and qualified in accordance with applicable codes, standards, specifications and other supplementary requirements as applicable. Procedures and equipment utilized in performing these processes are similarly qualified.

Inspection records associated with special processes include verification that the activity was performed utilizing qualified personnel, equipment, and procedures. These records, as well as current qualification records of personnel, equipment, and procedures, are filed and maintained in the CDM 5

Center.

Special process procedures, equipment, and associated personnel certifications of A-E's and NSSS Suppliers are reviewed and approved by their respective quality assurance organizations.

S

-E's, NSSS Suppliers, and SCE Suppliers are periodically audited y the SCE Nuclear Oversight Division as described in Subsection 12CN#35 17.1.18, to assure continuing compliance with special process controls of the applicable contract document or procurement specification.

17.1-27 Amendment 12CN#35

O 17.1.10 INSPECTION 17.1.10.1 Scope This subsection describes the measures utilized by SCE to control the inspection activities affecting quality in compliance with Regulatory Guides 1.30, 1.58, and 1.94, and the requirements and guidelines of ANSI N45.2.8 and N45.2.13 (reference Table 17.1-1).

17.1.10.2 Inspection The SCE Quality Assurance Program requires that activities affecting quality be inspected by individuals other than those that performed the activity being inspected. Inspection of these activities is performed for these items in accordance with written and approved procedures and inspection plans.

Approved inspection procedures, instructions, and checklists are provided to perform the inspections and contain, but are not limited to, the following:

o Identification of characteristics and activities to be inspected.

o Identification of the individuals or group(s) responsible and qualified to perform the inspection operation.

o Acceptance and rejection criteria, both qualitative and quantitative.

o Description of the inspection method.

O Recording evidence of completing and verifying a manufacturing, inspection, or test operation.

O Recording inspector or data recorder and the results of the inspection operation.

For inspections performed at a jobsite, the SCE Nuclear 12CN#35 Oversight Division has the responsibility for inspections, inspection procedures, implementation of inspection plans, and documentation of inspection findings. These inspections and associated work may be delegated to A-E's or other contractor's quality control inspection organizations provided they can demonstrate sufficient qualifications and independence from costs and schedules.

In addition, the SCE Nuclear Oversight 12CN#35 Division assigned to a jobsite periodically audits the inspection activities of SCE and other organizations delegated the inspection work to verify that:

17.1-28 Amendment 12CN#35

7.1.10.2 (continued) o Inspection procedures or instructions are developed with necessary drawings and specifications prior to performing inspection operations.

o Inspectors are qualified in accordance with appropriate codes, standards, and training programs and their qualifications are documented and maintained current.

o Modifications, repairs, and replacements are inspected in accordance with the original design and inspection requirements or acceptable alternatives.

o Inspection operations are performed and documented in compliance with the appropriate quality assurance 5

manuals and inspection records are forwarded to CDM Center.

o Source inspections are performed by SCE, or its designated agents, on a selective basis at suppliers' facilities. Designated agents may be the A-E, NSSS Supplier, or other contracted inspection agencies.

Also, source inspection, as part of the vendor sur veillance activities, may be included in the work delegated to others as described in Subsection 17.11.7.

These source inspections do not relieve the organization performing the activity being inspected from performing all the inspections required. The need for source inspection is determined by the SCE Nuclear Oversight 12CN#35 Division or other organizations delegated quality assurance work and is based on the following criteria:

o The significance of the activity to the functions of the item.

o Audit results, results of inspections or tests, lack of previous experience with the contractor or supplier, or indications from other areas that source inspections would be prudent.

Mandatory inspection hold points for witness are specified in Procurement Documents if established at the time of approval of such documents. If established during the review of contractor's or supplier's procedures or plans for manufacturing, examination, test or inspection, these witness and hold points are designated in correspondence from SCE, usually in the contract documents requiring conformance from a contractor or supplier.

17.1-29 Amendment 12CN#35

0 7.1.13 HANDLING, STORAGE, AND SHIPPING 7.1.13.1 Scope This subsection describes the measures utilized by SCE to control handling, storage, shipping, packaging, preservation, and cleaning activities in compliance with Regulatory Guide 1.38 (reference Table 17.1-1).

17.1.13.2 Handling, Storage, and Shipping The SCE Nuclear Engineering, Safety and Licensing Department and Nuclear Generation Site Department are responsible for 12CN#31 implementation of handling, packaging, preservation, storage, cleaning and shipping requirements for items delivered to a jobsite. The work associated.with these activities may be delegated to A-E's, and NSSS Suppliers; however, in all cases, the work is performed in accordance with written approved procedures by individuals qualified to perform these activities.

Special instructions, procedures, or drawings necessary to define handling, storage, shipping, packaging, preservation, and cleaning methods and requirements are prepared in accordance with design and specification requirements by SCE, A-E's, and NSSS Suppliers, as appropriate. These procedures are reviewed and approved by the originator's quality assurance

• Organization.

A-E's and NSSS Suppliers' procedures are ubject to review by SCE. The SCE Nuclear Oversight 112CN#35 Division conducts periodic audits of these organizations to assure proper implementation of these procedures.

SCE, A-E's, and NSSS Suppliers, as delegated, define handling, storage, shipping, packaging, preservation, and cleaning requirements to suppliers in procurement specifications.

Compliance with these requirements is verified by means of periodic audits conducted by their respective quality assurance organizations.

17.1-35 Amendment 12CN#35

17.1.14 INSPECTION, TEST AND OPERATING STATUS 7.1.1 4.1 Scope This subsection describes the measures utilized by SCE to indicate the status of inspections and tests and the associated clearance procedures.

17.1.14.2 Inspection, Test, and Operating Status The methods used to indicate the status of inspections and tests and for the control of status indicators are described by written procedures. These procedures are prepared and implemented by SCE, or A-E's, and NSSS Suppliers organizations delegated the work of performing the inspections and tests. The SCE Nuclear Oversight 12CN#35 Division conducts periodic audits of participating organization's activities to assure proper implementation of these procedures.

Inspection data sheets are developed to describe the inspection plan and inspection status for each item during the inspection phase. A sign-off by a cognizant inspector is required upon satisfactory completion of each inspection step which provides the record of inspection or test results.

A system of marking with stamps or tags is used to identify inspection, test, and operating status of structures, systems, components throughout manufacturing and installation. This marking system identifies the inspection status and tests erformed on individual items. Markings also indicate the

' status of nonconforming, inoperative, or malfunctioning structures, systems or.components to prevent inadvertent use.

The system for control of nonconforming items is described in Subsection 17.1.15.

Bypassing or waiving required inspections, tests, and other critical operations is controlled by written procedures that 6

require justification, approval, and documentation of the action. The Quality Assurance Supervisor or the Quality Control Supervisor or their designee approves such waivers for those activities affecting items which are under the jurisdiction of SCE.

SCE Preoperational and Startup Test Manuals establish requirements for clearances and tagging of structures, systems, and components to prevent inadvertent use during Construction and Prerequisite Testing. These manuals are independently reviewed by qualified individuals, as designated by approved procedures.

SCE, A-E's and NSSS Suppliers, as delegated, define requirements for controlling the status of inspections and tests to suppliers in procurement specifications. Compliance with these requirements is verified by means of periodic audits conducted by their espective Nuclear Oversight Division or quality assurance 112CN#35 1Aotrganizations.

17.1-36 Amendment 12CN#35

U 7.1.15 NONCONFORMING MATERIALS, PARTS, OR COMPONENTS 17.1.15.1 Scope This subsection describes the measures utilized by SCE to control materials, parts, or components that do not conform to established requirements.

17.1.15.2 Nonconforming Materials, Parts, or Components The measures used to control nonconforming items are described by written procedures. These procedures are prepared and implemented by cognizant SCE organizations performing the work of controlling nonconformances. The SCE Nuclear Oversight 12CN#35 Division conducts periodic audits to assure proper implementation of the procedures and the effectiveness of the nonconformance controls.

Deviations pertaining to a characteristic of a material, component, system or structure, from those specified in the design documents are treated as nonconformances. Procedures for processing and controlling nonconforming items contain the following requirements:

o Measures to identify the nonconforming item.

o Measures to document the nonconforming item, including cause and corrective action.

o Measures to segregate the nonconforming item 12CN#30 from acceptable items, where possible o

Method to review and disposition the nonconforming item, including approval authority.

o Method of notification to the affected organizations.

o Method for evaluating deviations to determine if reportable under the requirements of 10CFR50.55(e) 12CN#30 or 10CFR21.

Nonconformances are documented on a Nonconformance Report (NCR),

which is initiated by responsible SCE personnel when a noncon forming item is discovered at a jobsite. NCR's contain the item's identification, description of the nonconformance, cause, dispositioning activities, inspection requirements, corrective action, approval signatures, and the organizations notified of the nonconformance. An SCE nonconformance log / system is main tained and indicates the status of each nonconforming item.

12CN#30 Nonconforming items are segregated from acceptable items, where possible, and maintained in a controlled area until properly dispositioned. Nonconforming items discovered after instal ation of the item are not used until final disposition of the onconformance and associated disposition implementation.

Stamps or tags are utilized to identify the 17.1-37 Amendment 12 CN#35

917.1.15.2 (continued) nonconformance as described in Subsection 17.1.4.

Nonconforming items may be dispositioned Accept-As-Is, repair, rework, or Reject.

An Engineering Review Process is utilized to provide approval of dispositions associated with nonconforming items discovered at the jobsite where SCE is responsible for the work or where SCE technical review of the nonconformance is required. An SCE Engineering Review Board (ERB) is established on each project for Accept-As-Is and repair dispositions and is comprised of the following members who must unanimously concur on the disposition:

o Nuclear Oversight Division (NOD) Supervisor, or 12CN#35 designee.

o Project Engineer, or designee.

12CN#30 o

SCE Project Engineer or Site Nuclear Engineering Supervisor or designee o

Supplier design representative, where supplier design is involved.

When unanimous agreement cannot be reached among ERB members, the disposition will be determined jointly by the Manager of W

-uclear Oversight, and the Project Manager. The Vice President, 12CN#35 Nuclear Engineering, Safety and Licensing shall assign the disposition for a nonconformance when normal processes fail to reach a decision.

For Reject and Rework dispositions, the approval of the following individuals is required:

o NOD Supervisor, or designee.

12CN#35 o

SCE Project Engineer or Site Nuclear Engineering 12CN#30 Supervisor or designee Nonconforming items may be authorized for conditional use either prior to or after installation, providing the following conditions, as applicable, have been met:

o The NCR specifically describes the activity.

o The allowed activity does not constitute actual use in the sense that the item could be called upon to 4

perform its safety-related function of actually preventing or mitigating the consequences of postulated accidents that could cause undue risk to the health and safety of the public.

o The nonconforming condition will not adversely affect the allowed activity or implementation of the 9

disposition.

17.1-38 Amendment 12CN#35

17.1.15.2 (continued) o Identification and traceability of the item is maintained.

4 o

The authorization is approved by the same ERB members required for the disposition approval.

Depending on contract scope of work assignments, an A-E may be required to implement a similar Engineering Review Process and formulate an (ERB) to work in conjunction with the SCE (ERB).

Interface procedures are developed by both participating organizations in this event.

When the nonconformance report disposition specifies a rework or repair, these actions are accomplished in accordance with approved procedures, drawings, and instructions. The cognizant 4

SCE or A-E quality assurance organization representative verifies that acceptance of the dispositioned nonconforming item is completed by reinspection according to methods initially used. When reinspection methods differ from those initially used, methods at least equal to the original inspection are employed. Items are designated as nonconforming, and are so identified, until repair or rework and the required inspections are satisfactorily performed.

Rejected or scraped items are promptly removed from the jobsite

1. ork areas. The status of these items is displayed by 3

ppropriate tags. The cognizant SCE or A-E quality assurance organization person verifies the proper use of these tags.

The SCE or A-E design organization responsible for the affected design document reviews and approves Accept-As-Is dispositions for design impact.

For an approved disposition, the responsible design organization must issue a written justification for the deviation from the design document or revise the design document in accordance with applicable requirements.

NCR's and associated inspection records are forwarded to the SONGS CDM Center for retention purposes. Nonconformance data 5

are periodically analyzed by the SCE Nuclear Oversight Division 12CN#35 to establish quality trends. The results of these analyses are reviewed by the Manager of Nuclear Oversight, for possible 12CN#35 corrective action and referred to the Vice President, Nuclear 7

Engineering, Safety and Licensing, when a potential serious condition is determined. Deficiencies identified by 10CFR50.55(e) or 10CFR21 are reported to the NRC by the Manager 12CN#30 of Nuclear Oversight.

12CN#35 A-E's and suppliers must provide nonconformance controls that are equivalent to the controls set forth herein. The four options to disposition nonconformances as described in this subsection are required to be identified, or a suitable lternative scheme used. Nonconformances dispositioned 1

ccept-As-Is or repair by suppliers must be made part of the 421.11 17.1-39 Amendment 12CN#35

7.1.16 CORRECTIVE ACTION 7.1.16.1 Scope This subsection describes the measures utilized by SCE to assure that corrective action is promptly identified and implemented when conditions adverse to quality are determined to exist.

17.1.16.2 Corrective Action As described in Subsection 17.1.15, nonconformance and corrective action associated with material, parts, or components are controlled at a jobsite by the nonconformance reporting system. Additionally, a system for initiating corrective action associated with conditions adverse to quality is controlled by the SCE Nuclear Oversight Division by means 112CN#35 of written procedures. This system implements corrective action system forms to document conditions adverse to quality 1OCN#20 discovered by SCE personnel at the SCE General Office or jobsite, at A-E's design offices, and at NSSS Suppliers and other suppliers' facilities. This corrective action docu mentation is also used for hardware problems discovered at NSSS Supplier or other suppliers' facilities. Procurement specifications may specify the requirement for SCE approval of nonconforming hardware disposition if discovered by SCE at a supplier's facility.

he corrective action documentation provides for item or system identification, description of the adverse condition, cause of the condition, corrective action to resolve problem, and the corrective action to prevent recurrence as appropriate to the problems identified.

Corrective action documentation is promptly initiated with a request for corrective action directed to the responsible organization as a result of review, inspection, audit or surveillance activities.

The responsible organization to which corrective action docu mentation is directed determines the cause of the adverse condition, the action taken to resolve the problem, and the 1OCN#20 action to be taken to prevent recurrence as appropriate to the problems identified. They also provide dates for imple mentation of the corrective action where appropriate. The corrective action documentation is returned to the responsible SCE Nuclear Oversight Division Supervisor for review and 12CN#35 concurrence. Revised corrective action documentation is requested if corrective action proposed is unacceptable.

12CN#20 Follow-up reviews, inspections, audits, or surveillance are performed by SCE personnel to verify corrective action implementation. Significant conditions adverse to quality, the cause of the conditions and the corrective actions taken 12CN#34

.to prevent recurrence are identified by the responsible rganization and reported to cognizant levels of management for review and assessment.

17.1-40 Amendment 12CN#35

17.1.16.2 (continued) rending studies may be performed on corrective action data by 7CN#7 the SCE Nuclear Oversight Division as directed by the Vice 12CN#35 President, Nuclear Engineering, Safety and Licensing, or the Manager of Nuclear Oversight. Results of trending studies are documented and retained on file in the SONGS CDM Center. The 7CN#7 Vice President, Nuclear Engineering, Safety and Licensing, issues directives for corrective action resulting from trending studies, as necessary, and assures appropriate management involvement in correcting significant conditions adverse to quality.

In addition to the corrective action system controlled by the SCE Nuclear Oversight Division, other corrective action 12CN#35 systems may exist within other SCE organizations which provide a 1OCN#20 means for identification of the deficiency; documentation of corrective action to resolve the issue and corrective action to preclude recurrence; a means to track the status of the defi ciency; and a means to assure followup and closeout of the corrective action. When these optional systems exist, they shall be defined by written and approved procedures which con tain program elements and administrative controls which are com patible with the SCE Quality Assurance Program. These systems are periodically audited by the SCE Nuclear Oversight Division.

to determine effectiveness of implementation.

12CN#35

-E's, NSSS Suppliers, and other suppliers are required by ontract or procurement specification to implement a corrective action system equivalent to that described herein for their scope of work, including appropriate management involvement in the review and assessment of significant conditions adverse to quality.

17.1-41 Amendment 12CN#35

17.1.17 QUALITY ASSURANCE RECORDS 7.1.17.1 Scope This subsection describes the measures utilized by SCE to assure that required design documents and quality assurance records are properly stored, maintained, retained, and retrievable to provide objective evidence of activities affecting quality in compliance with Regulatory Guide 1.88 (reference Table 17.1-1).

17.1.17.2 Quality Assurance Records Corporate Documentation Management Centers (CDMC) are established at predetermined locations for indexing, storage, maintenance, and retention of quality assurance records. The 1OCN#22 CDM Centers are established and maintained by representatives of Administrative Services and Nuclear Engineering, Safety &

Licensing Services at the Corporate Offices and 12CN#35 Budget and Administration at the Nuclear Generation Site in accordance with the Quality Assurance Program.

Documents established as quality assurance records which are released for scheduled retention may be retained by designated organizations other than CDMC. Quality assurance records so 1OCN#22 retained shall be stored, maintained and controlled as required by Regulatory Guide 1.88.

The Nuclear Oversight Division 1l2CN#35 assures that the requirements for documentation imposed by SCE nd regulatory agencies are identified in a documentation ist(s) and implemented through written procedures.

Quality assurance records to be stored and maintained include, but are not limited to, the following:

o Results of reviews, inspections, tests, audits, and material analyses; o

Operating logs; o

Records of monitoring of work performance; 0

Qualifications (certifications) of personnel, procedures, and equipment; o

Specifications and drawings, including as-built drawings and stress reports or calculations; o

Procurement Documents and purchasing records; o

Calibration manuals, procedures, and reports; o

Nonconformance and corrective action reports; o

Inspection and test records which contain, as a minimum, the following; a)

A description of the type of observation; 17.1-42 Amendment 12CN#35

17.1.17.2 (continued) b)

Evidence of completion and verification of manufacturing, inspection, or test operations; c)

Date and results of inspections or tests; d)

Information related to conditions adverse to quality; e)

Inspector or data recorder identification; f)

Evidence as to the acceptability of results.

Access to quality assurance records in the CDM Centers is 1OCN#22 controlled by CDMC personnel and in the other organizations by the designated organization personnel. Access control is audited by the Nuclear Oversight Division. Access to and 12CN#35 retrieval of quality assurance records which are being main tained within scheduled retention is based on a need to know and is controlled by written procedures.

Requirements and responsibilities for record transmittals, retention, and maintenance subsequent to completion of work are consistent with applicable codes, standards, and Procurement Documents.

The review, identification, indexing, categorizing and filing f design documents and quality assurance records is accomplished 1OCN#22 in accordance with written procedures. These procedures include provisions for ready identification and retrievability of stored documents.

Documents released for scheduled retention by the responsible organization are protected against deterioration or destruction from fire, flooding, theft, and environmental conditions such as temperature and humidity.

1OCN#22 17.1-43 Amendment 12CN#35

7.1.18 AUDITS 7.1.18.1 Scope This subsection describes the measures utilized by SCE to verify compliance with, and overall effectiveness of the SCE Quality Assurance Program by means of a system of planned and periodic audits in compliance with the requirements and guidelines of ANSI N45.2.12 (reference Table 17.1-1).

17.1.18.2 Audits The SCE Quality Assurance Program requires a comprehensive system of planned and periodic audits to verify the effectiveness of the program, and evaluates compliance with applicable 10CFR50, Appendix B, criteria. Quality assurance audits are planned and performed in accordance with written procedures by Quality Assurance Engineers trained in audit techniques, or other qualified engineers or inspectors as designated by the Manager of Nuclear Oversight. Individuals performing audits are independent 12CN#35 of the areas to be audited.

Quality assurance audits provide an objective evaluation of quality-related practices, procedures, and instructions, and the effectiveness of implementation of policy directives. Audits include the evaluation of work areas, activities, processes, items, and the review of documents and records.

he Quality Assurance Supervisors are responsible for 16 assuring that sufficient audits are performed in those areas where the requirements of 10CFR50, Appendix B, are being implemented. These areas include, as a minimum, those activities associated with:

o The determination of site features which affect plant safety, such as core sampling and foundation preparation, and meteorology.

o The preparation, review, approval, and control of early procurement.

o Indoctrination and training programs.

o Interface control among the applicant and the A-E and NSSS Supplier.

The following types of audits are performed to assure that quality assurance procedures and activities are meaningful and comply with SCE Quality Assurance Program requirements:

o Internal audits conducted by SCE, A-E's and NSSS Suppliers' quality assurance organizations.

17.1-44 Amendment 12CN#35

7.1.18.2 (continued) o External audits by the SCE Nuclear Oversight 12CN#35 Division on A-E's, NSSS Suppliers, and other o

External audits by the A-E's, NSSS Suppliers, Contractors, Consultants, Utilities/Licenses 12CN#35 acting on behalf of SCE or other organizations such as NUPIC. The SCE Nuclear Oversight Division may participate in these audits, on a selective basis, as an observer or active participant.

Whenever these audits are utilized by SCE to satisfy SCE audit requirements, the results are reviewed for acceptability by Nuclear Oversight.

Each supplier's quality assurance program acceptability is 2

determined initially prior to work commencement. This 421.15 determination is made by means of:

0 Audits performed by the licensee/principal contractor, or o

evaluation of documented results of audits performed by sustaining members of the Nuclear Procurement Issues 12CN#35 Council (NUPIC).

If acceptable, the supplier is placed on the approved supplier ist.

Audits are scheduled based upon the status of work progress, importance to safety of the activities being performed, and prior experience with the organizations being audited. Audits are initiated early to assure effective quality assurance during design, procurement, and contracting activities. Audit schedules are prepared compatible with the progress of work.

These schedules provide for coverage of applicable 10CFR50, Appendix B criteria implementation.

A formal evaluation of suppliers performing continuing work is performed each year. This evaluation determines for which 2

suppliers a reaudit is required during the upcoming year. This 421.15 evaluation considers pertinent factors such as the results of other audits, history of performance of product and/or purchased service and effectiveness of implementation of the supplier's quality assurance program. In addition, the complexity of the component concerned and the degree of quality and process control required during manufacturing are considered.

This evaluation is documented and approved by the Manager of Nuclear Oversight and placed in supplier quality history files.

12CN#35 Regardless of the results of the evaluation, the suppliers 2

performing continuing work are subjected to an initial audit end are reaudited every three years. Audits of suppliers 421.15 erforming limited duration assignments are conducted at least once during the life of the contract. If at the time of the j6(CN#4) 17.1-45 Amendment 12CN#35

17.1.18.2 (continued) pre-award survey, the supplier is already implementing the same quality assurance program for other customers that he proposes (N4 to use on the auditing party's contract, then the pre-award

)

survey may serve as the first triennial audit.

The audit requirement shall not apply to standard off-the-shelf items and bulk commodities where required quality can adequately be determined by receipt inspection or post-installation checkout or test.

Results of audits conducted by the SCE Nuclear Oversight Division Nl2CN#35 are reviewed with the organization being audited during exit interviews and are documented in the formal audit reports.

Responsible management in the areas audited implement the necessary actions required to correct deficiencies.

These actions are documented and retained as part of the total audit record.

Reaudits are conducted to verify proper implementation of corrective action or until corrective action is implemented.

Audit data are summarized and analyzed by the SCE Nuclear 7

Oversight Division and reported to the Manager of Nuclear 12CN#35 Oversight, and the Vice President, Nuclear Engineering, Safety and Licensing, on a regular basis.

These reports indicate ICM#7 quality trends and the effectiveness of the SCE Quality Assurance Program. The Vice President, Nuclear Engineering, Safety and Licensing, issues directives for corrective action

• esulting from these reports, as necessary, and assures ppropriate management involvement in correcting significant conditions adverse to quality.

17.1-45a Amendment l2CN#35

TABLE 17.1-3 NUCLEAR OVERSIGHT DIVISION ACTIVITIES 12CN#35 DESIGN AND CONSTRUCTION 4

The following are "offsite" SCE Nuclear Oversight Division 12CN#35 personnel activities during the design and construction of nuclear generating stations:

4

1. Review design and procurement documents to verify incorporation of appropriate quality assurance requirements.

2. Develop quality assurance chapters for PSAR's and FSAR's and prepare quality assurance Topical Reports.

3. Prepare and maintain quality assurance manuals, procedures and instructions.

4. Review and approve quality assurance procedures and instructions developed by other internal organizations.

5. Evaluate and approve potential bidder's quality assurance manuals. Conduct internal audits of SCE organizations.

6. Initiate nonconformance reports, corrective action reports, and followup to assure proper implementation of corrective action.

12CN#35

7. Participate in and provide quality assurance training.

12CN#35

8. Provide written reports to management regarding status of 12CN#35 "offsite" activities, corrective actions required, or unresolved problems.

9. Support the Corporate Documentation Management Centers to 12CN#35 assure proper filing and retention of appropriate 5

quality assurance documentation.

17.1-50 Amendment 12CN#35

O 17.1-3 (continued)

The following are "onsite" SCE Nuclear Oversight Divisional I12CN#35 personnel activities during the design and construction of nuclear generating stations:

1. Write and maintain jobsite quality assurance procedures and instructions.

2. Review and approve jobsite quality assurance procedures and instructions developed by other organizations.

3. Perform inspection/surveillance over all Safety-Related 14 jobsite activities.

4. Conduct internal audits of SCE organizations and external audits of A-E's and other contractors' activities at the jobsite.

5. Initiate jobsite nonconformance reports, corrective action reports, and followup to assure implementation of corrective action.

6. Participate in and provide quality assurance training at the jobsite.

7. Perform quality assurance preaward surveys of bidder's 12CN#35 facilities and quality assurance programs.

8. Perform inspection/surveillance at supplier's facilities.

12CN#35

9. Conduct audits of A-E's NSSS Suppliers and other contractors and suppliers to SCE. Participate on a 12CN#35 selective basis in suppliers to SCE. Participate on a and NSSS Suppliers.

10. Provide written reports to management regarding status of "onsite" activities, corrective action required, and 12CN#35 unresolved problems.

11. Support the Corporate Documentation Management Centers 12CN#35 and Documentation Control Centers to assure proper filing and retention of quality assurance documentation.

17.1-51 Amendment 12CN#35

7.2.1.2 (continued)

Senior Vice President reports to the Chairman of the 12CN#35 Board and is responsible for Administrative Services.

12CN#31 The Vice President, Nuclear Engineering, Safety and Licensing reporting to an Executive Vice President, has been delegated 12CN#31 the responsibility for establishment and assurance of 12CN#35 implementation of the SCE Quality Assurance Program in compli ance with 10CFR50, Appendix B. and other applicable regulations and standards. He is authorized to request the cooperation of all officers and management personnel in support of this program.

SCE corporate management is involved with quality assurance matters on continuing basis by means of regular Officer Council meetings. Nuclear Oversight Division weekly 12CN#35 progress reports are prepared for the Vice President, Nuclear Engineering, Safety and Licensing, and are used, as 7CN7 appropriate, for discussion items at these meetings. These reports usually contain significant progress items, corrective action recommendations, and unresolved items.

In addition, a quarterly report of information suitable for assessment of the status and adequacy of the SCE Quality Assurance Program 1OCN#17 is submitted to senior management by the Manager of Nuclear versight.

112CN#35 The Nuclear Control Boards (NCB), which includes corporate officers and upper management personnel, are additional means by which SCE corporate management is involved with quality 7CN#7 assurance matters. As a member of the NCBs, the Vice President, Nuclear Engineering, Safety and Licensing, apprises these boards of significant quality assurance matters related to station operations and modifications.

17.2.1.3 Nuclear Generation Site Department The Nuclear Generation Site Department, under the 7CN#7 Vice President, Nuclear Generation Site, is responsible for operation of nuclear powered generating facilities.

The Vice President, Nuclear Generation Site is responsible for the safe and reliable operation, maintenance, testing, refueling, and In-service Inspection of his assigned station.

The Vice President, Nuclear Generation Site is responsible for the routine administration and implementation of the Quality Assurance Program at the station, including the following station organization functions, where appropriate:

9CN#14 17.2-3 Amendment 12CN#35

17.2.1.3 (continued) o Review and approval of Design Disclosure Documents for station modifications.

o Review and approval of Procurement Documents.

o Review and approval of administrative and technical procedures.

o Handling, Storage and Warehousing of Material and Equipment o Operation and Maintenance of plant systems and equipment o Conducting Performance Tests and In-Service Inspections and Evaluations.

o Refueling o Review of station operations and surveillance requirements of the Technical Specifications.

o Safety 9CN#14 o security o Training and examination of station personnel.

o Storage and retention of quality assurance records and 10CN22 document/drawing control at the nuclear generation site.

112CN#31 17.2.1.4 Nuclear Engineering. Safety and Licensing Department The Nuclear Engineering, Safety and Licensing Department, under the Vice President, Nuclear Engineering, Safety and Licensing is responsible for nuclear engineering, safety and licensing, nuclear fuel, corporate emergency preparedness, engineering and initial plant construction including Preoperational and Start-up testing as well as engineering, construction and start-up testing 12CN#31 associated with ECP development. Engineering responsibilities include design and drafting services, and supporting the projects in the various technical disciplines. Construction respon sibilities include technical and administrative direction over project construction personnel and construction management, and Preoperational and Start-up testing.

The Vice President, Nuclear Engineering, Safety and Licensing reports to an Executive Vice President and is responsible for 112CN#35 establishment and assurance of implementation of the SCE Quality 12CN#31 Assurance Program in compliance with applicable regulations, codes, and standards, including those listed in Table 17.2-1.

He is responsible for establishing quality assurance 7CN#7 policies, goals and objectives and for assuring that these olicies are followed and the goals and objectives are achieved.

17.2-4 Amendment 12CN#35

17.2.1.4 (continued)

The Vice President, Nuclear Engineering, Safety and Licensing, is responsible for apprising the Management of the effectiveness 7CN#7 f the Quality Assurance Program. He is involved in the disposition of nonconformances of unusual complexity, and acts upon trending studies that indicate quality problems of a possible generic nature submitted to him by the Manager of Nuclear Oversight.

12CN#35 The Vice President, Nuclear Engineering, Safety and Licensing, through the Manager of Nuclear Oversight, exercises the Adminis-I9CN#13 trative Authority for the Quality Assurance Organization.

Direction for implementing the Nuclear Oversight Division is 12CN#35 provided to individuals and groups by the Vice President, Nuclear Engineering, Safety and Licensing, through the Manager of Nuclear Oversight.

The Manager of Nuclear Oversight, reports directly to the Vice 12CN#35 President, Nuclear Engineering, Safety and Licensing, and has the responsibility for development, maintenance, and surveil lance of the Quality Assurance Program as described in Quality 9CN#13 Assurance manuals. These manuals are reviewed and approved by the Manager of Nuclear Oversight, and the Vice President, Nuclear 12CN#35 Engineering, Safety and Licensing. Other organizations involved with Quality Assurance Program implementation, as described in Subsection 17.2.1, review and comment on the Quality Assurance manuals, particularly as they apply to their area of involvement. 9CN#13 The Manager of Nuclear Oversight, is responsible for identifying any conditions adverse to quality and reporting them to the Vice 12CN#35

• resident, Nuclear Engineering, Safety and Licensing, and to he Nuclear Control Board (NCB) of which he is a member. In 9CN#13 addition, the Manager of Nuclear Oversight, is responsible for surveillance of Quality-Affecting Activities and has the 12CN#35 authority to Stop Work or delegate this authority, in writing, to other personnel.

9CN#13 The minimum qualification requirements for the position of Manager of Nuclear Oversight, are as follows:

12CN#35 o Bachelor of Science Degree in one of the engineering disciplines from an accredited college or university.

o Ten years experience in design, fabrication, construction, testing, operation, or quality 9CN#13 assurance related to the nuclear power field.

o Management and administrative ability demonstrated by experience and training.

o Extensive knowledge of regulatory requirements for nuclear generating stations.

17.2-5 Amendment 12CN#35

• l7.2.1.4 (continued)

The Quality Assurance Organization, as presented on Figure 17.2-1, under the direction of the Manager of Nuclear Oversight 12CN#35 develops and administers the Quality Assurance Program for the operational phase of nuclear generating stations.

It is comprised of engineers with expertise in the various disciplines required for performing quality assurance and quality control activities. This organization audits, inspects, or otherwise verifies that activities within the scope of the SCE Quality Assurance Program are correctly performed either by SCE or other organizations delegated the work.

The Nuclear Oversight Division has the authority and 12CN#35 organizational freedom to:

o Identify quality problems.

9CN13 o Initiate, recommend, or provide solutions through designated channels.

o Verify implementation of solutions.

Additional activities performed by "offsite" and "onsite" based Nuclear Oversight Division personnel during the operations 12CN#35 phase are listed on Table 17.2-3.

Site Quality Assurance Manager and Corporate Office and Site 12CN#31 uality Assurance Supervisors are assigned to operating nuclear generating station. They are responsible for directing and managing the activities of quality assurance personnel performing the activities described on Table 17.2-3.

A Site QC Manager and QC Supervisors are responsible for directing the activities of site QC personnel. QC personnel provide site inspection and surveillance of safety related 9CN#13 items and activities and non-safety related items and activities when requested by Station or Project Management.

The Nuclear Safety Group (NSG) and Independent Safety Engin eering Group (ISEG) Supervisors and assigned NSG and ISEG 12CN#31 personnel provide independent review of activities as defined in the station technical specifications.

Quality Assurance and Quality Control Managers and Supervisors have the responsibility and authority, delineated in writing, to 9CN#13 stop unsatisfactory work and to control further processing, delivery, and installation of nonconforming items.

The Manager of Nuclear Regulatory Affairs reports to the Vice President Nuclear Engineering, Safety and Licensing and provides licensing, corporate emergency planning, and corporate health 12CN#31 physics and environmental support for nuclear generating facil eties 17.2-6 Amendment l2CN#35

@ 17.2.1.7 Administrative Services Department A Senior Vice President is in charge of Administrative Services. The Senior Vice President reports to the 11CN#25 Executive Vice President.

The Manager of Real Properties and Administration reports directly to the Senior Vice President and is responsible for the corporate records management program. Corporate Documentation Services operates the Corporate Documentation Management (CDM) 1OCN#22 Center at the Corporate offices which is responsible for 12CN#35 retrieving and storage of nuclear documentation.

17.2.1.8 Engineering, Planning and Research The Environmental Affairs Division, under the direction of the 12CN#31 Vice President, Engineering, Planning and Research, is respon sible for collection of meteorological data, environmental monitoring support and environmental reviews in support of nuclear power plant activities.

17.2.1.9 Delegated Quality Assurance Work 17CN#7 SCE retains responsibility for the Quality Assurance Program described herein but may delegate quality assurance work to other organizations. Other organizations which may be delegated the work of establishing and executing portions of the Quality Assurance Program during the operational phase are as follows:

o Architect-Engineer (A-E,s).

o Nuclear Steam Supply System (NSSS) Supplier.

o Other suppliers contractors including consultants to SCE.

I9CN#13 The quality assurance programs of these organizations and the scope of delegated work is as described in the applicable contract for the work performed. A typical interface organizational relationship between SCE and other organizations delegated quality assurance work is as shown on Figure 17.2-2.

17.2.1.10 Interface for Delegated Quality Assurance Work I7CN#7 The SCE Manager of Nuclear Oversight, is responsible to 9CN#13 communicate SCE quality assurance requirements directly with 12CN#35 quality assurance managers of other organizations delegated the work of establishing and executing portions of the Quality Assurance Program. Compliance with SCE quality requirements and regulatory requirements is verified by means of review and approval of these organizations' quality assurance programs as described in Subsection 17.2.2 and by means of audits as described in Subsection 17.2.18.

17.2-7a Amendment 12CN#35