ML071270284

Southern Nuclear Operating Company - Quality Assurance Topical Report, ANSI N18.7-1976 Conformance Matrix, Enclosure 5

ML071270284
Person / Time
Site:	Hatch, Vogtle, Farley
Issue date:	04/30/2007
From:	George B Southern Nuclear Operating Co
To:	Office of Nuclear Reactor Regulation
References
ANSI N78.7-1976, NL-07-0835
Download: ML071270284 (162)

Text

Enclosure 5 Southern Nuclear Operating Company Quality Assurance Topical Report ANSI N-18.7-1976 Conformance Matrix ANSI N18.7-1976 Conformance Page 1 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS

1. Scope Policy Statement:

Southern Nuclear Operating Company, Inc. (SNC) shall This Standard provides maintain and operate nuclear plants in a manner that will requirements and ensure the health and safety of the public and workers.

recommendations for an Facilities shall be operated in compliance with the administrative controls and requirements of the Code of Federal Regulations, the quality assurance program applicable Nuclear Regulatory Commission (NRC) Facility necessary to provide Operating Licenses, and applicable laws and regulations of assurance that operational the state and local governments.

phase activities at nuclear power plants are carried out The SNC Quality Assurance Program (QAP) described in the without undue risk to the SNC Quality Assurance Topical Report (QATR) and health and safety of the public, associated implementing documents provides for control of The requirements of this SNC activities that affect the quality of safety related nuclear Standard apply to all activities plant structures, systems, and components and includes all affecting the safety-related planned and systematic activities necessary to provide plant structures, systems, and adequate confidence that such structures, systems, and components will perform satisfactorily in service. The QAP components. may also be applied to certain equipment and activities that are not safety related, but support safe plant operations, or where other NRC guidance establishes program requirements.

It is not intended to apply to Part I,Section 1.1:

test, mobile reactors nor and experimental reactors notpeorac This QATR applies to activities affecting the quality subject to US Nuclear performance of safety-related structures, systems, and Regulatory Commission components, including, but not limited to:

licensing. However, Designing Handling Testing applicable sections of this Constructing Refueling Receiving Standard should be used as they apply to related activities. Procuring Operating Storing Activities included are design Fabricating Training Erecting changes, purchasing, fabricating, handling, shipping, Cleaning Inspecting Installing storing, cleaning, erecting, Modifying Maintaining Repairing installing, inspecting, testing, operating, maintaining, ANSI N 18.7-1976 Conformance Page 2 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS repairing, refueling and modifying.

It is recommended that the Part I, Section 1.1: The QAP may be applied to certain administrative controls and activities where regulations other than 10CFR50 establish QA quality assurance provisions of program requirements for activities within their scope. Thus, this Standard be applied to selected elements of this QATR are applied to the "important other important plant to safety" activities of radioactive waste shipping and equipment at a level independent spent fuel storage, as defined in 10CFR71 commensurate with the Subpart H and 10CFR72 Subpart G, respectively, as allowed, importance of the equipment by 10CFR71.101 .f and 10CFR72.140.d. Accordingly, to reliable and efficient plant application of the elements of this QATR for ISFSI is as operation. However, it is defined in the respective 10 CFR 72.212 report for each site, emphasized that this Standard as applicable.

is directed primarily toward administrative controls and quality assurance associated with safety-related activities, equipment and procedures.

This Standard incorporates This is a comment on the criteria that permit a degree of format of the standard. It flexibility, since administrative establishes no requirements.

practices vary among organizations operating nuclear power plants.

ANSI N18.7-1976 Conformance Page 3 of 145 ANSI N18.7-1976 [ ASME NQA-1-1994 SNC QATR I COMMENTS The Nuclear Regulatory This is a comment on the Commission (NRC) format of the standard and the promulgates regulations necessity to differentiate applicable to many aspects of between construction and the design, construction and operation. It establishes no operation of nuclear power requirement.

reactors. This Standard contains criteria for administrative controls and quality assurance for nuclear power plants during the operational phase of plant life.

This phase is generally considered to commence with initial fuel loading, except for certain preoperational activities. Certain operating activities may commence prior to fuel loading and certain initial construction activities may extend past fuel loading.

Owner organizations should identify clearly those activities that fall in these overlapping time periods and should specify whether the activities are to be considered as operational or as construction activities.

This Standard is intended to NQA-1 was developed Part I,

Introduction:

be consistent with applicable based on ANSI N45.2. 'The QATR describes the methods and establishes quality criteria for quality assurance, assurance program and administrative control requirements including those given in Title that meet 10CFR50, Appendix B."

10 Code of Federal Regulations, Part 50, Licensing of Production and Utilization Facilities," Appendix ANSI N18.7-1976 Conformance Page 4 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS B. [1]' This Standard fully and completely describes, the general requirements and guidelines of American National Standard Quality Assurance Program Utilization Facilities," Appendix B. [1]'

guidelines of American National Standard Quality Assurance Program Requirements for Nuclear Power Plants N45.2-1971, [2]

as those requirements and guidelines apply during the operational phase of plant life.

2. Definitions 2.1 Limitations Introduction Section 4

'Terms and Definitions states "the following The definitions given below are applicable specifically to definitions are provided to assure a uniform this Standard. Other terms and their definitions are contained understanding of select terms as they are used in in American National this Part."

Standard, Quality Assurance Terms and Definitions, N45.2.10 [3]. N45.2.10 has been rescinded and replaced by NQA-1.

2.2 Glossary of Terms Introduction Section 4 Appendix D: SNC uses the definitions of terms as provided in

'Terms and Definitions" Section 4 of the Introduction of NQA-1 -1994 in interpreting the The following terms are requirements of NQA-1 -1994 and the other standards to defined: which the QATR commits. In addition, definitions are provided for the following terms not covered in NQA-1 -1994:

ANSI N18.7-1976 Conformance Page 5 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS

• administrative controls (no definition provided)

• audit. A formal, independent *audit A planned and examination with intent to documented activity verify conformance with performed to determine by established requirements investigation, examination, or evaluation of objective evidence the adequacy of and compliance with established procedures, instructions, drawings, and other applicable documents, and the effectiveness of implementation. An audit should not be confused with surveillance or inspection activities performed for the sole purpose of process control or product acceptance.

• emergency procedures (no definition provided)

• experiments (no definition provided)

• independent review (no definition provided)

• inspection. Examination, inspection - examination or observation, or measurement measurement to verify to determine the conformance whether an item or activity of materials, supplies, conforms to specified components, parts, requirements.

appurtenances, systems, personnel performance, procedures, processes or structures to predetermined requirements.

• maintenance and modification (no definition orovided)

ANSI N 18.7-1976 Conformance Paize 6 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS procedures

• nuclear power plant (no definition provided)

• off normal condition (no definition provided) procedures

• on-site operating organization (no definition provided)

• operating activities (no definition provided)

• operating procedures (no definition provided)

• operational phase (no definition provided)

• owner organization. The *owner-the person, group, organization, including the company, agency, or onsite operation organization, corporation, who has or will which has overall legal, have title to the nuclear financial and technical power plant.

responsibility for the operation of one or more nuclear power plants.

• quality assurance. All those *quality assurance - all planned and systematic those planned and actions necessary to provide systematic actions assurance that a structure, necessary to provide system, or component will adequate confidence that a perform satisfactorily in structure, system, or service. It applies to all component will perform activities associated with doing satisfactorily in service.

a job correctly as well as verifying and documenting the satisfactory completion of the work.

• review (no definition provided)

ANSI N18.7-1976 Conformance Page 7 of 145 ANSI N18.7-1976 ASME NQA-1-1994 [ SNC QATR I COMMENTS

• shall, should, and may. The shall, should - the word word "shall" is used to denote should denotes a guideline a requirement; the word (a suggested practice that is "should" to denote a not mandatory in programs recommendation; and the intended to comply with a word "may," to denote standard). The word shall permission, neither a denotes a requirement.

requirement nor a recommendation.

.supervision (no definition provided)

• surveillance testing *testing - an element of Periodic testing to verify that verification for the safety-related structures, determination of the systems, and components capability of an item to meet continue to function or are in a specified requirements by state of readiness to perform subjecting the item to a set their functions. of physical, chemical, environmental, or operating conditions.

• system (no definition provided)

• testing Performance of those testing - an element of steps necessary to determine verification for the that systems or components determination of the function in accordance with capability of an item to meet predetermined specifications. specified requirements by subjecting the item to a set of physical, chemical, environmental, or operating conditions.

r -t 3 Owner Organization 3.1 GeneralI The owner organization shall _________________jPolicy Statement:___________________

ANSI N 18.7-1976 Conformance Page 8 of 145 ANSI N18.7-11976 ASME NQA-1-1994 SNC QATR COMMENTS establish an administrative 'Southern Nuclear Operating Company, Inc. (SNC) shall controls and quality assurance maintain and operate nuclear plants in a manner that will program which complies with ensure the health and safety of the public and workers.

this Standard, The program Facilities shall be operated in compliance with the shall be in effect at all times requirements of the Code of Federal Regulations (CFR), the during the Operational phase applicable Nuclear Regulatory Commission (NRC) Facility to assure that operational Operating Licenses, and applicable laws and regulations of phase activities are carried out the state and local governments.'

without undue risk to the health and safety of the public, The program shall require that Part II, Section 2.2:

decisions affecting safety are 'SNC retains and exercises the responsibility for the scope made at the proper level of and implementation of an effective QAP. Positions identified responsibility and with the in the Organization Section of this QATR may delegate all or necessary technical advice part of the activities of planning, establishing, and and review. The owner implementing the program for which they are responsible to organization may delegate to others, but retain the responsibility for the program's other organizations the work effectiveness. Decisions affecting safety are made at the of-establishing and executing level appropriate for its nature and effect, and with any the administrative controls and necessary technical advice or review.'

quality assurance program or any parts thereof, in accordance with this Standard, but shall retain responsibility therefore.

3.2 Assignment of Authority Basic Requirement 1 Part II, Section 1: N18.7 wording in brackets are and Responsibility "Organization" states "The This Section describes the SNC organizational structure, included in this table for organizational structure, functional responsibilities, levels of authority and interfaces for completeness; they do not

[it is essential that all functional responsibilities, establishing, executing, and verifying QAP implementation, establish requirements that members of the organization levels of authority, and lines The organizational structure includes corporate functions and either NQA-1 or the SNC QATR involved in operation of of communication for onsite functions for each plant. Implementing documents would need to address.

nuclear power plants, activities affecting quality assign more specific responsibilities and duties, and define including those at the highest shall be documented." the organizational interfaces involved in conducting activities management levels, recognize and duties within the scope of this QATR. Management gives the necessity that the plants careful consideration to the timing, extent and effects of be operated under a well organizational structure changes.'

formulated and detailed administrative controls and ANSI N 18.7-1976 Conformance Page 9 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS quality assurance program to assure safety and efficiency.]

Lines of authority, responsibility and communication shall be established from the highest management level through intermediate levels and including the onsite operating organization (including those offsite organizational units assigned responsibility for procurement. design and construction, quality assurance, and technical support activities). These relationships shall be documented and updated, as appropriate, in the form of organizational charts, functional descriptions of departmental responsibilities and relationships and job descriptions for key personnel positions or in equivalent forms of documentation.

The owner organization shall Part II, Section 1 specify in writing the authority 'This Section describes the SNC organizational structure, and responsibility assigned to functional responsibilities, levels of authority and interfaces for individuals and organizations establishing, executing, and verifying QAP implementation.

involved in establishing, The organizational structure includes corporate functions and executing and measuring the onsite functions for each plant. Implementing documents administrative controls and assign more specific responsibilities and duties, and define the organizational interfaces involved in conducting activities quality assurance program and duties within the scope of this QATR. Management gives required by this Standard. careful consideration to the timing, extent and effects of organizational structure changes.'

ANSI N 18.7-1976 Conformance Page 10 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS Persons or organizations Basic Requirement 1 "The performing functions of organization structure, assuring that the functional responsibilities, administrative controls and levels of authority, and lines quality assurance program is of communication for established and implemented activities affecting quality or of assuring that an activity shall be documented, has been correctly performed Persons or organizations shall have sufficient authority responsible for assuring that and organizational freedom to: an appropriate quality identify quality problems; assurance program have initiate, recommend or provide been established and solutions, through designated verifying that activities channels; and verify affecting quality have been implementation of solutions, correctly performed shall have sufficient authority, access to work areas, and organizational freedom to:

(a) identify quality problems; (b) initiate, recommend, or provide solutions to quality problems through designated channels; (c) verify implementation of solutions;"

The organizational structure Part II, Section 2.1 Responsibilities:

and the functional 'Personnel who work directly or indirectly for SNC are responsibility assignments responsible for the achievement of acceptable quality in the shall be such that: work covered by this QATR.'

(1) Attainment of program objectives is accomplished by those who have been Part II, Section 10:

assigned responsibility for 'Inspections are carried out by properly qualified persons performing work. [This may independent of those who performed or directly supervised ANSI N18.7-1976 Conformance Page 11 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS include interim the work. Inspection results shall be documented. Where examinations, checks, and quality verification inspections at plants are performed by the inspections of the work by maintenance organization, the inspectors report to the the individual performing engineering support organization while performing inspections the work.] in order to meet the independence requirements of NQA (2) Verification of conformance 1994, Supplement 1OS-1, Section 3.1.'

to established program requirements is Part II, Section 2.3:

accomplished by a qualified person who does 'Personnel assigned to implement elements of the QAP shall not have responsibility for be capable of performing their assigned tasks. To this end performing or directly SNC establishes and maintains formal indoctrination and supervising the work. The training programs for personnel performing, verifying, or method and extent of such managing activities within the scope of the QAP to assure that verification shall be suitable proficiency is achieved and maintained.'

commensurate with the importance of the activity to plant safety and reliability.

[In structuring the organization N18.7 wording in brackets are and assigning responsibility, included for completeness; they quality assurance should be do not establish requirements recognized as an that either NQA-1 or the SNC interdisciplinary function QATR would need to address.

involving many organizational components and, therefore, should not be regarded as the sole domain of a single quality assurance group. For example, it may be more appropriate for nuclear engineers to perform reviews of plant nuclear engineering activities rather than quality assurance engineers because of the special competence required to perform these reviews. Quality assurance ANSI N 18.7-1976 Conformance Pare 12 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS encompasses many functions and activities and extends to various levels in all participating organizations, from the top executive to all workers whose activities may influence quality.]

3.3 Indoctrination and Part II, Section 2.3:

Training. 'Personnel assigned to implement elements of the QAP shall be capable of performing their assigned tasks. To this end Provisions shall be made for SNC establishes and maintains formal indoctrination and indoctrination and training of training programs for personnel performing, verifying, or those personnel in the owner managing activities within the scope of the QAP to assure that organization performing suitable proficiency is achieved and maintained.'

activities affecting quality to assure that suitable proficiency is achieved and maintained, Such personnel also shall be NQA-1 Supplement 2S-4 Part II, Section 2.3:

provided training concerning Section 3 states "Personnel 'Personnel assigned to implement elements of the QAP shall the administrative controls and shall be indoctrinated in the be capable of performing their assigned tasks. To this end quality assurance program following subjects as they SNC establishes and maintains formal indoctrination and which, as a minimum, shall relate to a particular training programs for personnel performing, verifying, or include the following areas: function: managing activities within the scope of the QAP to assure that overall company policies, (a) general criteria, including suitable proficiency is achieved and maintained.'

procedures, or instruction applicable codes, which establish the program; standards, and company procedures or instructions procedures; which implement the program related to the specific lob- (b) applicable quality related activity, assurance elements; and (c) job responsibilities and authority."

ANSI N18.7-1976 Conformance Paie 13 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS 3.4 Onsite Operating Organization 3.4.1 General

[A number of factors N18.7 wording in brackets are influence management in its included in this table for decision regarding the completeness; they do not establish requirements that establishment of an onsite operating organization. These either NQA-1 or the SNC QATR would need to address.

include the owner organization's established staffing policies, the physical size and complexity of the nuclear power plant, the number of units, the extent of assistance provided by offsite technical support organizations, the extent of reliance on consultants and the availability of qualified personnel from other sources to assist in activities, such as initial start-up, refueling, maintenance or modification work.

A nuclear power plant onsite Supplement 1S-1 Part II, Section 1 describes the organization and relationships operating organization may among the positions within the organization.

change with time. For example, the number and qualifications of personnel making up the onsite technical support-staff can generally be reduced as a plant progresses through initial operation to operational maturitv.]-- L ________________________ ,. __________________________________________________ I ___________________________

ANSI N 18.7-1976 Conformance Page 14 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS Management shall give careful consideration to the timing and extent of such changes.

3.4.2 Requirements for the Onsite Operating Organization The onsite Operating organization shall include one Part II, Section 1.2.2 "The onsite Operating organization shall or more individuals include one or more individuals knowledgeable in the knowledgeable in the following following fields: nuclear power plant operation; nuclear power fields: nuclear power plant plant, mechanical, electrical and electronic systems; nuclear operation; nuclear power engineering; chemistry and radiochemistry; radiation plant, mechanical, electrical protection; and quality assurance."

and electronic systems; nuclear engineering; chemistry and radiochemistry; radiation protection; and quality assurance.

Initial incumbents or Part II, Section 2.3 Personnel Qualifications:

replacements for members of 'Personnel assigned to implement elements of the QAP shall the onsite operating be capable of performing their assigned tasks. To this end organization and offsite SNC establishes and maintains formal indoctrination and technical support training programs for personnel performing, verifying, or organizations shall have managing activities within the scope of the QAP to assure that training and retraining tosuitable proficiency is achieved and maintained. Plant and assure that necessary support staff minimum qualification requirements are as compe is maintained in delineated in each site's Technical Specifications. Other competence is the in qualification requirements may be established but will not accordance with the provisions reduce those required by Technical Specifications. Sufficient of American National Standard managerial depth is provided to cover absences of for Selection and Training of incumbents. When required by code, regulation, or standard, Nuclear Power Plant specific qualification and selection of personnel is conducted Personnel, N18.1-1971. in accordance with those requirements as established in the I applicable SNC procedures. Indoctrination includes the ANSI N 18.7-1976 Conformance Pane 15 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS administrative and technical objectives, requirements of the applicable codes and standards, and the QAP elements to be employed. Training for positions identified in 10 CFR 50.120 is accomplished according to programs accredited by the National Nuclear Accrediting Board of the National Academy of Nuclear Training that implement a systematic approach to training. Records of personnel training and qualification are maintained.'

Personnel whose N45.2.6 = NQA-1, BR 2, Part II, Section 2.4:

qualifications do not meet Supplements 2S1, 2S-2 and In establishing qualification and training programs, SNC those specified in N18.1 and Non-mandatory Appendix commits to compliance with NQA-1 -1994, Basic Requirement who are performing inspection, 2A-1 2 and Supplements 2S-1, 2S-2, 2S-3 and 2S-4 (with examination, and testing clarifications and exception in the QATR).

activities during the operations phase of the plant, including preoperational and start-up testing shall be qualified to American National Standard Qualifications of Inspection, Examination, and Testing Personnel for the Construction Phase of Nuclear Power Plants, N45.2.6-1973 [5],

except that the QA experience cited for Levels 1,11, and Ill' should be interpreted to mean actual experience in carrying out the types of inspection, examination, or testing activity being performed.

The owner organization shall N/A Designation of the cited designate those positions in positions in site procedures the onsite operating complies with 10CFR50 and organization which shall be plant Technical Specification filled by personnel holding requirements that establish ANSI N 18.7-1976 Conformance Page 16 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS NRC reactor operator and license-holder requirements senior reactor operator and minimum staffing. Since licenses, Requirements for the these requirements are explicit minimum number of personnel and supersede N18.7 holding such licenses who statements, they are not shall be present at the plant included in the QATR.

under various operating conditions and situations shall also be specified.

The Plant Manager shall have Part II, Section 1.2.1.1.1.1 Vice President - Project The QATR states that the Vice overall responsibility for the 'The vice president-project for each Plant reports to the chief President - Project has overall execution of the administrative nuclear officer regarding operation issues and support responsibility. This reflects the controls and quality assurance matters, and is responsible for operation and maintenance of differences in responsibility that program at the plant to assure the respective Plant over which they have authority. A vice have developed since Ni18.7 safety. An individual or president-project directs the nuclear plant general manager was developed.

organizational unit (NPGM) and the nuclear support general manager (NSGM) knowledgeable and for each respective plant. The vice president - project has experienced in nuclear power overall responsibility for the execution of the administrative plant operational phase controls and quality assurance program at the respective plant activities and quality to assure nuclear safety for that plant.'

assurance practices shall be designated and assigned the responsibility to verify that the Part II, Section 18 program is being effectively implemented. 'SNC has established the necessary measures and governing procedures to implement audits to verify that activities covered by this QATR are performed in conformance with the requirements established. The audit programs are themselves reviewed for effectiveness as a part of the overall audit process. In addition to audits, SNC commits to perform surveillances as described in Appendix C to this QATR.'

ANSI N 18.7-1976 Conformance Page 17 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS

[Depending on the N18.7 wording in brackets are organizational structure, the included in this table for individual or organizational completeness; they do not unit may report functionally to establish requirements that onsite plant management or either NQA-1 or the SNC QATR an offsite organization (see would need to address.

also 3.2). Reporting to onsite plant management is preferable since such an arrangement usually results in improved communications in identifying problems and initiating corrective action.]

[The individual or organizational unit in this case Part II, Section 1, includes an organization chart showing the may receive technical reporting relationships.

guidance from offsite support groups.] This individual's or 1.2.1.1.1.2 Senior manager responsible for quality organizational unit's duties assurance and responsibilities shall be such that the required attention can be devoted, as The senior manager responsible for quality assurance is required, to verifying that the responsible for managing the QA program described in the program is being effectively QATR and for ensuring its implementation in accordance with executed. commitments shown herein. The QA organization is composed of a staff at the corporate headquarters and at each Plant site. The QA organization provides comprehensive independent audits of safety-related activities to verify that they are in compliance with the quality assurance program. The quality assurance organization also performs QA Surveillance activities as described in Appendix C of this QATR.

The individual or Part II, Section 18 organizational unit shall report 'SNC has established the necessary measures and governing on the effectiveness of the procedures to implement audits to verify that activities program to the Plant Manager covered by this QATR are performed in conformance with the and to other cognizant requirements established. The audit programs are ANSI N 18.7-1976 Conformance Page 18 of 145 ANSI N18.7-1976 ASME NQA-1 -1994 SNC QATR COMMENTS management as may be themselves reviewed for effectiveness as a part of the overall designated. Their activities audit process. In addition to audits, SNC commits to perform shall be periodically audited by surveillances as described in Appendix C to this QATR.'

designated offsite personnel.

4. Reviews and Audits 4.1 General Programs for reviews and for Part II, Sections 3, 15, and Basic Requirement 18 and Supplement 18S-1 At the time N18.7 was written, audits of activities affecting 18; Appendix B NRC reporting requirements plant safety during the included reporting in writing operational phase shall be within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> the occurrence established by the owner of certain events. These organization to:

requirements have been changed several times (10 CFR (1) Verify that these 50.72 and 50.73) such that activities are performed in reference to "reportable events" conformance with this is sufficient to establish the Standard and with company necessary requirement.

policy and rules, approved operating procedures and license provisions (2) Review significant proposed plant changes, tests and procedures (3) Verify that reportable events, which require reporting to NRC in writing within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, are promptly investigated and corrected in a manner (4) Detect trends which may not be apparent to a day-today observer.

ANSI N 18.7-1976 Conformance Pane 19 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS These programs for reviews Part II, Section 18: N18.7 wording in brackets are and audits shall, themselves, 'SNC has established the necessary measures and governing included in this table for be periodically reviewed for procedures to implement audits to verify that activities completeness; they do not effectiveness by management covered by this QATR are performed in conformance with the establish requirements that of the owner organization. requirements established. The audit programs are either NQA-1 or the SNC QATR

[The programs provided for themselves reviewed for effectiveness as a part of the overall would need to address.

reviews and for audits may audit process. In addition to audits, SNC commits to perform take different forms. For surveillances as described in Appendix C to this QATR.'

example, the owner organization may assign these functions to separate established organizational units independent of the onsite operating organization or may appoint a standing committee comprised of individuals from within or outside the owner organization to perform reviews and to exercise overview of audits.]

[Historically, a committee N18.7 wording in brackets are approach was used to provide included in this table for both review and audit completeness; they do not capability for early commercial establish requirements that nuclear power plants. This either NQA-1 or the SNC QATR approach was employed to would need to address.

make the most efficient use of personnel with pertinent experience and qualifications.

In the ensuing period, the availability of competent personnel has significantly increased as the nuclear power industry has expanded and the sources of trained manpower have ANSI N 18.7-1976 Conformance Paae 20 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS responded-to the resulting demand. This growing pool of-talent in the, aggregate, is sufficient to encourage alternative approaches to the review and audit committees commonly- used in the past.]

[In general the time required of N18.7 wording in brackets are individuals serving as included in this table for members of independent completeness; they do not review groups is a function of establish requirements that the number of nuclear power either NQA-1 or the SNC QATR plants an owner organization would need to address.

has in operation.]

[For this reason, owner N18.7 wording in brackets are organizations contemplating included in this table for rapid growth and an completeness; they do not expanding commitment to establish requirements that nuclear power should regard either NQA-1 or the SNC QATR the use of committees to meet would need to address.

the independent review functions as an interim approach for effective utilization of available technical expertise. In addition, such owner organizations should include in their expansion planning provisions for early establishment of organizational units to provide independent review, for recruitment of staff, and for an orderly transition to such an organizational structure in the event a committee approach ANSI N18.7-1976 Conformance Page 21 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS has been used previously to meet the independent review function.]

An independent offsite SNC uses a Nuclear Safety Review Board as described in organizational unit may be Appendix B to the QATR to perform this function.

assigned review responsibilities including responsibility for reviewing audit reports provided by onsite staff members, or both functions may be assigned to an organizational unit that is independent of line responsibility for operating activities.

[This Standard does not N18.7 wording in brackets are specify an organizational included in this table for structure for meeting the completeness; they do not review and audit functions, but establish requirements that in lieu thereof delineates either NQA-1 or the SNC QATR essential elements of would need to address.

satisfactorily comprehensive programs for review and for audit in the manner best suited to the owner organization involved.]

ANSI N 18.7-1976 Conformance Page 22 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS 4.2 Program Description Part II, Section 18:

Written programs for both 'SNC has established the necessary measures and governing audits and independent procedures to implement audits to verify that activities reviews contain: shall be prepared that covered by this QATR are performed in conformance with the contain tbrequirements established. The audit programs are (1) Subjects to be audited and themselves reviewed for effectiveness as a part of the overall independently reviewed. audit process. In addition to audits, SNC commits to perform surveillances as described in Appendix C to this QATR.'

(2) Responsibility and Basic Requirement 1 N18.7 wording in brackets are authority of those supervising "Organization" states included in this table for audits and conducting "Persons or organizations completeness; they do not independent review. These responsible for assuring that establish requirements that responsibilities shall include an appropriate quality either NQA-1 or the SNC QATR the identification of problems assurance program has would need to address.

and the verification of been established and corrective action. [Additional verifying that activities responsibilities may include affecting quality have been recommendations to correctly performed shall appropriate management of have sufficient authority, solutions to problems and the access to work areas, and approval or disapproval of organizational freedom to:

contemplated actions.] (a) Identify quality problems; (b) initiate, recommend, or provide solutions to quality problems through designated channels; (c) verify implementation of solutions..."

ANSI N 18.7-1976 Conformance Page 23 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS (3) Mechanisms for initiating Part II, Section 18 establishes when audits and independent audit and independent review reviews should be done.

activities.

(4) Provisions for the use of Supplement 2S-3 specialists or subgroups. 'Supplementary Requirements for the Qualification of Quality Assurance Program Audit Personnel" Section 2.1 states 'The responsible auditing organization shall establish the audit personnel qualifications and the requirements for the use of technical specialists to accomplish the auditing...'

(5) Authority to obtain access Basic Requirement 1: Such 10CFR50, Appendix B provides to the nuclear power plant persons shall have direct the essentially the same operating records and access to responsible requirement.

operating personnel to perform management at a level audits and independent where appropriate action reviews, can be effected. Such persons or organizations shall report to a management level such that required authority and organizational freedom are provided, including sufficient independence from cost and schedule considerations.

(6) Requirements for Part II, Section 16, Significant conditions adverse to quality distribution of reports and and significant adverse trends are documented and reported ANSI N 18.7-1976 Conformance Page 24 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS other records to appropriate to responsible management.

staff members and managers in the owner organization. Appendix B, Section 6, Bullet 3, "Audit reports as described above shall be forwarded to the CNO and to the management positions responsible for the areas audited within 30 days after completion by the auditing organization.

(7) Identification of the Part II, Section 1.2.1.1.1.2 Senior manager responsible for management position (or quality assurance:

positions, reviewers if auditors and have different The senior manager responsible for quality assurance is revi chains) to which responsible for managing the QA program described in the reporting independenthQATR and for ensuring its implementation in accordance with auditors and independent commitments shown herein. The QA organization is reviewers report. composed of a staff at the corporate headquarters and at each Plant site. The QA organization provides comprehensive independent audits of safety-related activities to verify that they are in compliance with the quality assurance program. The quality assurance organization also performs QA Surveillance activities as described in Appendix C of this QATR.

(8) Provisions for assuring that NQA-1-1994 BR 18, and personnel responsible for audit Supplement 18S-1 and independent review are kept informed on a timely basis of matters within their scope of responsibility.

(9) Provisions for follow-up Supplement 18S-1, action, including re-audit of paragraph 7 Follow up deficient areas where action shall be taken to indicated, verify that corrective action is accomplished as scheduled.

ANSI N18.7-1976 Conformance Page 25 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS (10) Other provisions required Part II, Section 18 provides the audit frequency for SNC.

for effective audits and independent reviews.

4.3 Independent Review Program.

Appendix A describes the Plant Review Board and Appendix The bracketed wording is not B of the QATR describes the Nuclear Safety Review Board applicable to plants already in Activities occurring during the responsible for independent reviews. operation.

operational phase shall be independently reviewed on a periodic basis. [The independent review not applicable for plants program shall be functional already in operation. prior to initial core loading.]

4.3.1 Personnel.

Personnel assigned Appendix B:

responsibility for independent The NSRB shall be composed of members who, as a group, reviews shall be specified in provide expertise to review and audit the operation of a both number and technical nuclear power plant, and are capable of recognizing and disciplines, and shall evaluating potential nuclear safety problems and their effects.

collectively have the The Chairman and each member of the NSRB, as a minimum, experience and competence shall have a bachelor's degree in engineering or related required to review problems in sciences and five years technical experience if which at least the following areas:

three years shall be in one of the following areas:

Nuclear power plant operations (1) Nuclear power plant operations Nuclear engineering (2) Nuclear engineering Chemistry and radiochemistry (3) Chemistry and Metallurgy radiochemistry Nondestructive testing (4) Metallurgy Instrumentation and control ANSI N 18.7-1976 Conformance Page 26 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS (5) Nondestructive testing Radiological safety (6) Instrumentation and control Mechanical and electrical engineering, and (7) Radiological safety (8) Mechanical and electrical engineering, (9) Administrative controls and quality assurance practices (1 O)Other appropriate fields associated with the unique characteristics of the nuclear power plant involved

[An individual may possess Appendix B states in part: Consultants, as well as Ni18.7 wording in brackets are competence in more than one representatives from various SNC organizations, may be included in this table for specialty area.] If sufficient utilized as determined by the NSRB Chairman to provide completeness; they do not expertise is not available from expert advice to the NSRB. establish requirements that within the owner organization, either NQA-1 or the SNC QATR independent reviews shall be would need to address.

supplemented through outside consultants or organizations.

Provisions shall assure that appropriate expertise is brought to bear in reviews of operational phase activities.

4.3.2 Standing Committees Functioning as Independent Review Bodies 4.3.2.1 Committee Composition Appendix B states in part:

ANSI N18.7-1976 Conformance Page 27 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS The NSRB shall consist of at least five regular members, When a standing committee is appointed in writing by the CNO, with no more than a minority responsible for the of the members representing the onsite operating organization independent review program, of any specific plant. The minimum membership of the Board it shall be composed of no less will consist of the Vice President - Farley, the Vice President than five persons, of whom no - Hatch, the Vice President - Vogtle, the Vice President -

more than a minority are Engineering, the Nuclear Fuel Manager, and the Quality members of the onsite Assurance Manager. A Chairman and a Vice Chairman shall operating organization. be appointed by the CNO from among the plant vice Competent alternates are presidents for a term of one year.

permitted if designated in advance. The use of alternates shall be restricted to Alternate members of the NSRB shall be appointed in writing legitimate absences of by the CNO to serve on a temporary basis for a specific principals, member. The use of alternatives shall be restricted to legitimate absences of regular members. In absences of the NSRB Chairman, the Vice Chairman will assume the duties of the NSRB Chairman.

4.3.2.2 Meeting Frequency Formal meetings of personnel assigned to a standing Appendix B:

committee functioning, as an 3.0 Meetings independent review group shall be scheduled as needed. The SRB shall meet at least once per 6 months.

During the period of initial operation such meetings should be held no less frequently than once per calendar quarter.

Subsequently, the meeting frequency shall not be less than twice a year.

ANSI N 18.7-1976 Conformance Page 28 of 145 ANSI N18.7-1976 ASME NQA-1 -1994 SNC QATR COMMENTS 4.3.2.3 Quorum 3.0 Meetings The NSRB shall meet at least once per 6 months.

A quorum for formal meetings of the committee held under the provisions of 4.3.2.2 shall The quorum of the NSRB necessary for performance of the consist of not less than a NSRB review functions described below shall consist of the majority of the principals, or Chairman or Vice Chairman and at least a majority of the duly appointed alternates, and NSRB members, including alternates. No more than a shall be subject to the minority of the quorum shall have line responsibility for onsite following constraints: the operation of any specific plant and no more than two chairman (or his duly alternates shall participate as voting members in NSRB appointed alternate) shall be activities at any one time.

present for all formal meetings; and no more than a minority of the quorum shall have line responsibility for operation of the plant.

4.3.2.4 Meeting Records Minutes of all meetings of the Appendix B:

committee shall be prepared and retained. All documentary 6.0 Records material reviewed should be Records of the SRB activities shall be prepared, approved, identified. Decisions and and distributed as indicated below:

recommendations made by the committee shall be

• Minutes of each NSRB meeting shall be prepared, documented. Meeting minutes approved, and forwarded to the CNO within 14 days shall be disseminated following each meeting; promptly to appropriate a Reports or subcommittee meeting minutes of reviews as members of management described above shall be prepared, approved, and having responsibility in the forwarded to the CNO within 14 days following completion area reviewed. (See also of the review, and Section 6.2A2) a Audit reports as described above shall be forwarded to the CNO and to the management positions responsible for the areas audited within 30 days after completion by the auditing organization.

ANSI N18.7-1976 Conformance Page 29 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS 4.3.3 Organizational Units SNC uses three levels of reviews: Plant Review Board, Functioning as Independent Nuclear Safety Review Board, and Independent Reviews as Review Bodies. described in Appendices A, B, and C, respectively, in the QATR.

An organizational unit assigned primary responsibility for review of operational phase activities shall report to a designated management representative who is assigned authority and responsibility for effective functioning of the unit and who is not immediately responsible for the performance of the activities to be reviewed. The supervisor of such an organizational unit should schedule periodic formal meetings of his staff, or of appropriate subparts thereof, for the purpose of fostering interaction in reviews of specific operational phase activities.

ANSI N18.7-1976 Conformance Paze 30 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS 4.3.3.1 Documentation of SNC uses three levels of reviews: Plant Review Board, Reviews. Nuclear Safety Review Board, and Independent Reviews as described in Appendices A, B, and C, respectively, in the Written records of reviews QATR. The records for each review are as described in the shall be prepared and corresponding Appendix.

retained. All documentary material reviewed should be identified. Results of reviews conducted by the unit including recommendations and proposed actions shall be subject to approval of the supervisor of the unit, and shall be disseminated promptly to appropriate members of management having responsibility in the area reviewed. (See also Section 5.2.12.)

4.3.4 Subjects Requiring SNC uses three levels of reviews: Plant Review Board, Independent Review. The Nuclear Safety Review Board, and Independent Reviews as following subjects shall be described in Appendices A, B, and C respectively, in the reviewed by the independent QATR.

review body:

(1) Written safety evaluations of changes in the facility as described in the Safety Analysis Report, changes in procedures as described in the Safety Analysis Report and tests or experiments not described in the Safety Analysis Report which are completed without prior NRC approval under the provisions ANSI N 18.7-1976 Conformance Page 31 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS of 10 CFR 50.59(a)(1). [1] This review is to verify that such changes, tests or experiments did not involve a change in the technical specifications or an unreviewed safety question as defined in 10 CFR 50.59(a)(2).

(2) Proposed changes in procedures, proposed changes in the facility, or proposed tests or experiments, any of which involves a change in the technical specifications or an unreviewed safety question as defined in 10 CFR 50.59(c) [1]

Matters of this kind shall be referred to the independent review body by the onsite operating organization (see 4.4) following its review, or by other functional organizational units within the owner organization, prior to implementation. (3) Changes in the technical specifications or license amendments relating to nuclear safety prior to implementation, except in those cases where the change is identical to a previously reviewed proposed change.

NOTE: Regulatory Guide 1.33 states -It should be noted that proposed changes to technical specifications or license amendments should be reviewed by the independent ANSI N18.7-1976 Conformance Page 32 of 145 ANSI N18.7-1976 ASME NOA-1-1994 SNC QATR COMMENTS review body prior to their submittal to the Commission for approval."

(4) Violations, deviations and reportable events, which require reporting to the NRC in writing within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, such as:

(a) Violations of applicable codes, regulations, orders, technical specifications, license requirements or internal procedures or instructions having safety significance (b) Significant operating abnormalities or deviations from normal or expected performance of plant safety-related structures systems, or components (c) Reportable events, which require reporting to the NRC in writing within 24hours, Review of events covered under this subsection shall include the results of any investigations made and the recommendations resulting from such investigations to prevent or reduce the probability of recurrence of the event.

(5) Any other matter involving safe operation of the nuclear oower olant which an

___________________________ _________________________ .1_____________________________________________________ i ____________________________

ANSI N 18.7-1976 Conformance Page 33 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS independent reviewer deems appropriate for consideration, or which is referred to the independent reviewers by the onsite operating organization or by other functional organizational units within the owner organization.

4.4 Review Activities of the Onsite Operating Organization.

The onsite operating 1.2.2 STANDARD PLANT ORGANIZATION organization shall provide, as The onsite operating organization shall provide, as part of the part of the normal duties of normal duties of plant supervisory personnel, timely and plant supervisory personnel, continuing monitoring of operating activities to assist the timely and continuing nuclear plant general manager in keeping abreast of general monitoring of operating plant conditions and to verify that the day-to-day operating activities to assist the Plant activities are conducted safely and in accordance with Manager in keeping abreast of applicable administrative controls.'

general plant conditions and to verify that the day-to-day operating activities are conducted safely and in accordance with applicable administrative controls. [These continuing monitoring activities are considered to be an integral part of the routine supervisory function and are important to the safety of plant operation.] The onsite 4.0 Reviews operating organization shall perform reviews periodically The PRB shall be responsible for: The Plant Review Board is not and as situations demand, to responsible for planning future evaluate plant operations and activities of the plant as a ANSI N 18.7-1976 Conformance Page 34 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS to plan future activities. The (a) Review of (1) all procedures and programs required by whole, but may review future important elements of the facility Technical Specifications administrative controls plans for impact on plant reviews should be and changes thereto that require a regulatory evaluation operations and safety, such as documented. Such reviews under the facility's 10 CFR 50.59 and 10 CFR 72.48 review of refueling outage serve a useful purpose but screening program, (2) changes to the quality assurance schedules.

shall not take the place of the program description determined to be reductions in the reviews and audits described commitment under the provisions of 10 CFR 50.54(a),

in Sections 4.3 and 4.5, and (3) any other proposed procedures, programs, or respectively. The onsite changes thereto affecting facility nuclear safety as operating organization should determined by the NPGM.

screen subjects of potential concern to independent reviewers and perform (b) Review of all proposed changes to nuclear facility preliminary investigations (see Technical Specifications.

4.3.4). The Plant Manager, in carrying out his responsibility for overall safety of plant (c) Review of all proposed tests and experiments that affect operations, shall be nuclear safety.

responsible for timely referral of appropriate matters to management and independent (d) Review of all proposed changes or modifications to reviewers. systems or equipment that affect nuclear safety.

NOTE: Regulatory Guide 1.33 (e) Rendering determinations in writing or meeting minutes if replaces a number of "should" any item considered under (a) through (d) above, as statements with "shall". These appropriate and as provided by 10 CFR 50.59, 10 CFR are in Section 4.4, 5.2.3, 5.2.4, 50.92, or 10 CFR 72.48, requires a license amendment or 5.2.7.1, 5.2.13.4, 5.2.19(2), requires a significant hazards consideration 5.2.19.1, 5.3.2, 5.3.9, 5.3.9.1. determination.

These have been replaced in the first column text and have been indicated in bold. (f) Performance of special reviews and investigations and reports as requested by the Chairperson of the PRB or NPGM.

(g) Investigations of all violations of Technical Specifications, including the preparation and forwarding of reports covering evaluation and recommendations to prevent ANSI N 18.7-1976 Conformance Page 35 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS recurrence, to the NPGM, Project Vice President, the CNO, and to the Chairperson of the NSRB.

(h) Review of all nuclear facility reportable events.

(i) Review of facility operations to detect potential safety hazards 4.5 Audit Program. SECTION 18 AUDITS The amplifications of Regulatory Guide 1.33 are not specifically addressed in NQA-A comprehensive system of 'SNC has established the necessary measures and governing 1 or the QATR. The QATR planned and documented procedures to implement audits to verify that activities uses a performance based audits shall be carried out to covered by this QATR are performed in conformance with the approach to selecting topics for verify compliance with all requirements established. The audit programs are audits, based on the status, aspects of the administrative themselves reviewed for effectiveness as a part of the overall performance and safety controls and quality assurance audit process. In addition to audits, SNC commits to perform importance of the activity or program. Audits of selected surveillances as described in Appendix C to this QATR.' process being assessed.

aspects of operational phase Dynamic scheduling provides activities shall be performed for rapid focus shifts of audit with a frequency resources depending on the commensurate with their actual performance of the plant safety significance and in such and plant staff. The scheduling a manner as to assure that an approach at SNC considers the audit of all safety- related RG 1.33 elements in its overall functions is completed within a structure, but does not subject period of two years. any single area (except for those where a CFR periodicity NOTE: Regulatory Guide 1.33 requirement is imposed) to a amplifies the above defined periodicity. As has requirement "the following been shown by performance at program elements should be some plants, meeting a defined audited at the indicated assessment periodicity was not frequencies: an effective defense against significant program failures.

a. The results of actions taken SNC's approach provides for to correct deficiencies that response to both internal and affect nuclear safety and external cues to determine ANSI N 18.7-1976 Conformance Page 36 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS occur in facility equipment, what and when to assess structures, systems, or performance.

method of operation - at least once per 6 months. By letter dated June 17, 2005.

the NRC aporoved specific

b. The conformance of facility changes to the Farley, Hatch, operation to provisions and Voatle quality assurance contained within the pro-rams. These changes technical specifications and included NRC approval of applicable license standard criteria for extending conditions - at least once audit intervals. These criteria per 12 months. included the following:

c. The performance, training, A. Audits shall be performed at and Qualifications of the the intervals designated facility staff - at least once herein for each audit area.

per 12 months." Schedules shall be based Audits shall include as a on the month in which the minimum verification of audit starts.

compliance and effectiveness B. A maximum extension not of implementation of internal to exceed 25 percent of the rules, procedures (for audit interval shall be example, operating, design, allowed. That is to say that, procurement, maintenance, for audits on a 24-month modification, refueling, frequency, the maximum surveillance, test security and time between specific audits radiation control procedures shall not exceed 30 months.

and the emergency plan Likewise, audits on an regulations and license, annual (12 month) provisions, programs for frequency shall not be training, retraining & extended beyond 15 qualification and performance months.

of operating staff; corrective actions taken following C. When an audit interval abnormal occurrences; and extension greater than one observation of performance of month is used, the next operating, refueling, audit for that particular audit maintenance and modification area will be scheduled from activities, including associated the original anniversary month rather than from the ANSI N 18.7-1976 Conformance Page 37 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS record keeping. month of the extended audit.

D. Item B shall also apply to supplier audits and evaluations except that a total combined time interval for any three consecutive inspection or audit intervals should not exceed 3.25 times the specified inspection or audit interval.

In its evaluation of the proposed change, the NRC determined that the audit interval extension provision was acceptable on the basis that it:

" Conformed to the requirements of Appendix B to 10 CFR Part 50: and

• Was consistent with the staff guidance for reviewing audit programs, as delineated in Section 17.2 of NUREG-0800.

Based on the above, the Proposed use of the 25 percent grace period as described in Part II, Section 18.1 of the proposed QATR has been previously approved for Farley, Hatch. and Voatle and does not represent a change to the Farley, Hatch, or Vogtle OA program.

I. _________________________

Written reports of such audits I NQA-1-1994, Supplement ANSI N18.7-1976 Conformance Page 38 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS shall be reviewed by the 18S-1, Section 6, independent review body and Response, states by appropriate members of "Management of the audited management including those organization or activity shall having responsibility in the investigate adverse audit area audited. findings, schedule corrective action, including measures to prevent recurrence, and notify the appropriate organization in writing of action taken or planned.

The adequacy of audit responses shall be evaluated by or for the auditing organization."

Those performing the audits NQA-1-1994 Basic SNC commits in its QATR to compliance with NQA-1-1994, may be members of the Requirement 18 states Basic Requirement 18.

audited organization: however, "These audits shall be they shall not audit activities performed in accordance for which they have immediate with written procedures or responsibility. While checklists by personnel who performing the audit, they shall do not have direct not report to a management responsibility for performing representative who has the activities being audited."

immediate responsibility for the activity being audited.

Appropriate and timely follow- Supplement 18S-1, Section up action, including re-audit of 7 states: Follow-up action deficient areas, shall be taken. shall be taken to verify that corrective action is accomplished as scheduled.

ANSI N18.7-1976 Conformance Page 39 of 145 ANSI N1 8.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS Periodic review of the audit Appendix B states, "The NSRB shall review the SNC audit program shall be performed by program at least semiannually to assure that audits are being the independent review body accomplished in accordance with requirements of the SNC or by a management QATR."

representative at least semiannually to assure that audits are being accomplished in accordance with requirements of technical specifications and of this Standard.

Further guidance on Descriptive in nature. No action requirements for auditing of required.

quality assurance programs for nuclear power plants exists in draft form.

5. Program, Policies, and Descriptive in nature. No action Procedures required.

5.1 Program Description.

The total program for providing administrative controls and quality- assurance during the operational phase may be described in many diverse documents. For example, operating procedures may be compiled in one manual, maintenance procedures in a second manual and Quality Assurance procedures in a third. It is not intended that all ANSI N 18.7-1976 Conformance Page 40 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS source documents be compiled in one master document.

However, a summary The SNC QATR as a whole is intended to fill this requirement.

document shall be compiled by each owner organization to identify the sources, to index such source documents to the requirements of this Standard and to provide consolidated base for description of the program.

The owner organization shall Part I, Section 1.1 states, in part:

identify in the program 'Safety related systems, structures, and components, under description those structures, the control of the QATR, are identified for each plant.'

systems and components to be covered by the program and the major organizational Part II, Section 1:

units and their responsibilities. This section describes the SNC organizational structure, functional responsibilities, and interfaces for establishing, executing, and verifying QAP implementation.'

The program shall provide BR2 "Quality Assurance control over activities affecting Program" states 'The the quality of the structures, program shall provide systems and components to control over activities an extent consistent with their affecting quality to an extent importance to safety. The consistent with their program shall take into importance ...The program account the need for special shall provide for any special ANSI N 18.7-1976 Conformance Page 41 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS controls, processes, tests, controls, processes, test equipment, tools, and skills to equipment, tools, and skills attain the required quality and to attain the required quality the need for verification of and for verification of quality by inspections, quality."

evaluation or test.

5.2 Rules of Practice. Part II, Section 5.1 Procedure Adherence:

The SNC policy is that procedures are followed, and the The owner organization shall requirements for use of procedures have been established in establish rules and instructions administrative procedures. Where procedures cannot be pertaining to personnel followed as written, provisions are established for making conduct and control, including changes in accordance with Part II, Section 6 of this QATR.

consideration of job-related Requirements are established to identify the manner in which factors which influence the procedures are to be implemented, including identification of effectiveness of operating and those tasks that require (1) the written procedure to be maintenance personnel, present and followed step-by-step while the task is being including such factors as performed, (2) the user to have committed the procedure number of hours at duty steps to memory, (3) verification of completion of significant station, availability on call of steps, by initials or signatures or use of check-off lists.

professional and supervisory Procedures that are required to be present and referred to personnel, method of directly are those developed for extensive or complex jobs conducting operations, and where reliance on memory cannot be trusted, tasks that are preparing and retaining plant infrequently performed, and tasks where steps must be documents. These rules and performed in a specified sequence.

instructions should provide a clear understanding of operating philosophy and management policies.

5.2.1 Responsibilities and Part II, Section 1.2.2.1.1.2: Senior manager Authorities of Operating responsible for operations Personnel.

The responsibilities and The senior manager responsible for operations is responsible authorities of the plant for the safe and reliable operation of the plant. This includes support; operating personnel lshall be spreparation unit operations; day-to-day for and of outagetechnical conduct planning; related activities; and ANSI N18.7-1976 Conformance Page 42 of 145 ANSI N18.7-1976 ASME NQA-1-1994 I SNC QATR COMMENTS delineated. These shall overseeing outage work activities, surveillances, and tests.

include, as a minimum:

(1) The reactor operator's In addition, operating personnel responsibilities include:

authority and responsibility for shutting the reactor down

• The reactor operator's authority and responsibility for when he determines that the shutting down the reactor when it is determined that the safety safety of the reactor is in of the reactor is in jeopardy or when operating parameters jeopardy or when operating exceed any of the reactor protection system set-points and parameters exceed any of the automatic shutdown does not occur.

reactor protection system set-

• The responsibility to determine the circumstances, points and automatic analyze the cause, and determine that operations can proceed shutdown does not occur.

safely before the reactor is returned to power after a trip or an (2) The responsibility to unexplained or unscheduled power reduction.

determine the circumstances,

• The senior reactor operator's responsibility to be present analyze the cause, and at the plant and to provide direction for returning the reactor to determine that operations can power following a trip or an unscheduled or unexplained power proceed safely before the reduction.

reactor is returned to power

• The responsibility to believe and respond conservatively to after a trip or an unscheduled instrument indications unless they are proved to be incorrect.

or unexplained power

• The responsibility to adhere to the plant's Technical reduction. Specifications.

(3) The senior reactor

• The responsibility to review routine operating data to operator's responsibility to be assure safe operation.

present at the plant and to

• The responsibility to take action to minimize personnel provide attention for returning injury or damage to the facility and to protect the health and the reactor to power following safety of the public in the event of an emergency not covered a swing, a trip or an by approved procedures.

unscheduled or unexplained power reduction.

(4) The responsibility to believe and respond conservatively to instrument indications unless they are proved to be incorrect (5) The responsibility to adhere to the Plant's Technical Specifications.

ANSI N 18.7-1976 Conformance Page 43 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS (6) The responsibility to review routine operating data to assure safe operation.

5.2.2 Procedure Adherence Part II, Section 5:

'SNC has established the necessary measures and governing Procedures shall be followed, procedures to ensure that activities affecting quality are and the requirements for use prescribed by and performed in accordance with instructions, of procedures shall be- procedures or drawings of a type appropriate to the prescribed in writing, circumstances and which, where applicable, include quantitative or qualitative acceptance criteria to implement the QAP as described in the QATR. Such documents are prepared and controlled according to Part II, Section 6 of this QATR. In addition, means are provided for dissemination to plant staff of instructions of both general and continuing applicability, as well as those of short-term applicability.

Provisions are included for reviewing, updating, and canceling such procedures.'

Rules shall be established Part II, Section 5:

which provide methods by SNC has established the necessary measures and governing which temporary changes to procedures to ensure that activities affecting quality are approved procedures can be prescribed by and performed in accordance with instructions, made, including the procedures or drawings of a type appropriate to the designation of a person or circumstances and which, where applicable, include persons authorized to approve quantitative or qualitative acceptance criteria to implement the such changes. QAP as described in the QATR. Such documents are prepared and controlled according to Part II, Section 6 of this QATR. In addition, means are provided for dissemination to plant staff of instructions of both general and continuing applicability, as well as those of short-term applicability.

Provisions are included for reviewing, updating, and canceling such procedures.

ANSI N18.7-1976 Conformance Page 44 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS Temporary changes which Part II, Section 6.1:

clearly do not change the 'Changes to documents, other than those defined in intent of the approved implementing procedures as minor changes, are considered baproedure, shall ao miimbe as major changes and shall be reviewed and approved by the be approved by two members same organizations that performed the original review and of the plant staff approval unless other organizations are specifically knowledgeable in the areas designated. The reviewing organization shall have access to affected by the procedures. At pertinent background data or information upon which to base least one of these individuals their approval. Minor changes to documents, such as shall be the supervisor in inconsequential editorial corrections, shall not require that the charge of the shift and hold a revised documents receive the same review and approval as senior operators license on the the original documents. To avoid a possible omission of a unit affected. Such changes required review, the type of minor changes that do not require shall be documented and, if such a review and approval and the persons who can appropriate, incorporated in authorize such a decision shall be clearly delineated in the next revision of the implementing procedures.'

affected procedure. In the event of an emergency not covered by an approved procedure, operations personnel shall be instructed to take action so as to minimize personnel injury and damage to the facility and to protect health and safety.

ANSI N18.7-1976 Conformance Page 45 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS Guidance should be provided Part II, Section 5.1, Procedure Adherence:

to identify the manner in which

'The SNC policy is that procedures are followed, and the procedures are to be requirements for use of procedures have been established in implemented. Examples of administrative procedures. Where procedures cannot be such guidance include followed as written, provisions are established for making identification of those tasks changes in accordance with Part II, Section 6 of this QATR.

that require:

Requirements are established to identify the manner in which (1) The written procedure to procedures are to be implemented, including identification of be present and followed step those tasks that require: (1) the written procedure to be by step while the task is being present and followed step-by-step while the task is being performed performed, (2) the user to have committed the procedure (2) The operator to have steps to memory, (3) verification of completion of significant committed the procedural steps, by initials or signatures or use of check-off lists.

steps to memory Procedures that are required to be present and referred to directly are those developed for extensive or complex jobs (3) Verification of completion where reliance on memory cannot be trusted, tasks that are of significant steps, by initials infrequently performed, and tasks where steps must be or signatures of checkoff lists performed in a specified sequence.

Administrative procedures prescribe the methods whereby plant procedures can be temporarily revised without undue delay when the need arises. Temporary procedure revisions that do not change intent of the approved procedure may be made with the concurrence of two individuals, one of which holds a senior reactor operator's license on the affected unit.

Such revisions are documented and, if required, reviewed by the Plant Review Board and approved by the appropriate plant management within 14 days of implementation. In cases of emergency, personnel are authorized to depart from approved procedures when necessary to prevent injury to personnel or damage to the plant. Such procedures are logged describing the prevailing conditions and reasons for the action taken.'

ANSI N 18.7-1976 Conformance Page 46 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS The types of procedures that Part II, Section 5.2: N18.7 wording in brackets are shall be present and referred In establishing procedural controls, SNC commits to included in this table for to directly are those developed compliance with NQA-1-1994, Basic Requirement 5. In completeness; they do not for extensive or complex jobs addition, as stated in position CA of Regulatory Guide 1.33, establish requirements that where reliance on memory Revision 2, SNC commits to use Appendix A of Regulatory either NQA-1 or the SNC QATR cannot be trusted, e.g., reactor Guide 1.33 as guidance for establishing the types of Guiea133-sugidacetorsstalisingthetypsro would need to address.

start-up, tasks which are procedures that are necessary to control and support plant infrequently performed, and operation. Appendix E of this QATR provides additional tasks in which operations must details regarding procedures developed and implemented by be performed in a specified SNC.

sequence. [Procedural steps for which actions should be committed to memory include, for example, immediate actions in emergency procedures. Routine procedural actions that are repeated may not require the procedure to be present.]

Copies of all procedures shall SNC commits to NQA-1-1994 Supplement 6S-1 for Document be available to appropriate Control. The Supplement requires that the Company maintain members of the plant staff. If a document control system. The definition of Document documentation of an action is Control in the Supplement is "The act of assuring that required, the necessary data documents are reviewed for adequacy, approved for release shall be recorded as the task by authorized personnel, and distributed to and used at the is performed. [Examples of location where the prescribed activity is performed."

procedures requiring verification are furnished in 5.3.4.1 and 5.3.4.2.]

5.2.3 Operating Orders. Part II, Section 5:

"SNC has established the necessary measures and governing A mechanism shall be procedures to ensure that activities affecting quality are provided for dissemination to prescribed by and performed in accordance with instructions, the plant staff of instructions of procedures or drawings of a type appropriate to the general and continuing circumstances and which, where applicable, include applicability to the conduct of quantitative or qualitative acceptance criteria to implement the ANSI N 18.7-1976 Conformance Page 47 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS business, Such instructions, QAP as described in the QATR. Such documents are sometimes also referred to as prepared and controlled according to Part II,Section 6 of this standing orders or standard QATR. In addition, means are provided for dissemination to operating procedures, should plant staff of instructions of both general and continuing deal with job turnover and applicability, as well as those of short-term applicability.

relief designation of confines Provisions are included for reviewing, updating, and canceling of control room, definition of such procedures."

duties of operators and others, transmittal of operating data to management, filing of charts, Appendix E:

limitations on access to certain "This appendix contains a description of the various types of areas and equipment, shipping procedures used by SNC to govern the design, operation, and and receiving instructions, or maintenance of its nuclear generating plants. Each procedure other such matters. Provisions shall be sufficiently detailed for a qualified individual to shall be made for periodic perform the required function without direct supervision, but review and updating of need not provide a complete description of the system or plant standing orders. process."

5.2.4 Special Orders. Appendix E: "Special Orders A mechanism shall be Management instructions, which have short-term applicability provided for issuing and require dissemination, are issued to encompass special management instructions operations, housekeeping, data taking, publications and their which have short-term distribution, plotting process parameters, personnel actions, applicability and which require or other similar matters. Provisions are made for periodic dissemination. Such review, updating, and cancellation of these documents, where instructions sometimes appropriate.

referred to as a special orders, should encompass special operations, housekeeping, data taking, publications and their distribution, plotting process parameters, personnel actions, or other similar matters. Provisions shall be made for periodic review, updating and ANSI N 18.7-1976 Conformance Pa~e 48 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS cancellation of special orders.

5.2.5 Temporary Appendix E: "Temporary Procedures" Procedures.

Temporary procedures may be used to direct operations Temporary procedures may be during testing, refueling, maintenance, and modifications to issued during the operational provide guidance in unusual situations not within the scope of phase: to direct operations the normal procedures. These procedures ensure orderly and during testing, refueling, uniform operations for short periods when the plant, a system, maintenance and or a component of a system is performing in a manner not modifications; to provide covered by existing detailed procedures or has been modified guidance in unusual situations or extended in such a manner that portions of existing not within the scope of the procedures do not apply. Temporary Procedures include normal procedures; and to designation of the period of time during which they may be insure orderly and uniform used and are subject to the procedure review process as operations for: short periods applicable.

when the plant, a system, or a component of a system is performing in a manner not covered by existing detailed procedure or has been modified or extended in such a manner that portions of existing procedures do not apply. Temporary procedures shall include designation of the period of time during which they may he used and shall be subject to the review process prescribed in 4.3 and 5.2.15 as applicable.

ANSI N 18.7-1976 Conformance Page 49 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS Temporary procedures shall Part II, Section 6 Document Control be approved by the SNC has established the necessary measures and governing management representative procedures to control the preparation of, issuance of, and assigned approval authority, changes to documents that specify quality requirements or prescribe how activities affecting quality are controlled to assure that correct documents are being employed. Such documents, including changes thereto, shall be reviewed for adequacy and approved for release by authorized personnel.

5.2.6 Equipment Control.

Permission to release NQA-1, Subpart 2.18, equipment or systems for Paragraph 2.5, maintenance shall be granted "(a) Procedures shall be by designated operating established for the personnel. Prior to granting authorization of permission, such operating maintenance work....

personnel shall verify that the (b)The work authorization equipment or system can be shall contain (4) approval by released, and determine how authorized personnel. (c) long it may be out of service. Interface concerns such as Granting of such permission plant operations, ... shall be shall be documented. considered for applicability Attention shall be given to the by authorized individuals potentially degraded degree of prior to approval of the work protection when one subsystem of a redundant authorizing document."

safety system has been removed for maintenance, ANSI N18.7-1976 Conformance Page 50 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS After permission has been Part II, Section 14: "SNC has established the necessary granted to remove the measures and governing procedures to identify the inspection, equipment from service, it test, and operating status of items and components subject to shall be made safe to work on. the provisions of this QATR in order to maintain personnel Measures shall provide for and reactor safety and avoid unauthorized operation of protection of equipment and equipment. Where necessary to preclude inadvertent workers. Equipment and bypassing of inspections or tests, or to preclude inadvertent systems in a controlled status operation, these measures require the inspection, test or shall be clearly identified. operating status be verified before release, fabrication, Strict control measures for receipt, installation, test or use.

such equipment shall be enforced.

[Conditions to be considered NQA-1 Subpart 2.18, N18.7 wording in brackets is in preparing equipment for Paragraph 2.3 states, "(a) included in this table for maintenance include, for Controls to minimize the completeness; it does not example: shutdown margin; introduction of foreign establish requirements that method of emergency core materials and to maintain either NQA-1 or the SNC QATR cooling; establishment of a cleanness during would need to address.

path for decay heat removal; maintenance shall be in temperature and pressure of accordance with Subpart the system; valves between 2.1 ...Verification methods work and hazardous material; shall be established to venting, draining and flushing; ensure these requirements entry into closed vessels; are met. (b) Immediately hazardous atmospheres; prior to closure of handling hazardous materials; equipment, the absence of and electrical hazards.] When foreign materials shall be entry into a closed system is verified. The results of the required, control measures verification shall be shall be established to prevent documented."

entry of extraneous material and to assure that foreign material is removed before the system is reclosed.

ANSI N18.7-1976 Conformance Pare 51 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS Procedures shall be provided NQA-1 BR 14 'Status for control of equipment as indicator shall also provide necessary, to maintain for indicating operating personnel and reactor safety status of systems and and to avoid unauthorized components of the nuclear operation of equipment. These facility, such as by tagging procedures shall require valves and switches, to control measures such as prevent inadvertent locking or tagging to secure operation.

and identify equipment in a controlled status. The procedures shall require independent verifications, where appropriate, to ensure that necessary measures, such as tagging equipment have been implemented correctly.

Temporary modifications, such NQA-1 Subpart 2.18 Section Part II, Section 3 states, in part:

as temporary bypass lines, 2.1 (h) states 'the 'In addition, temporary design changes (temporary electrical jumpers, lifted development of provisions modifications), such as temporary bypass lines, electrical electrical leads, and temporary for installation and removal jumpers and lifted wires, and temporary trip-point settings, are trip point settings, shall be of temporary conditions controlled by approved (e.g., jumpers, transferring controlled by procedures that include requirements for procedures which shall include of control switch position, appropriate installation and removal verifications and status a requirement for independent etc.) and returning tracking.'

verification. A log shall be equipment and systems to maintained of the current service."

status of such temporary modifications.

ANSI N18.7-1976 Conformance PaNe 52 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS The procedures shall also NQA-1 BR 14 'The status of N18.7 wording in brackets are require that the status of inspection and test activities included in this table for inspections and tests shall be identified either on completeness; they do not performed upon individual items or in documents establish requirements that items on the nuclear power traceable to the items where either NQA-1 or the SNC QATR plant be indicated by use of it is necessary to assure that would need to address.

markings such as stamps, required inspections and tags, labels, routing cards, or tests are performed and to other suitable means. assure that items which

[Suitable means include have not passed the identification numbers which required inspections and are traceable to records of the tests are not inadvertently status of inspections and installed, used, or operated.

tests.] Status shall be maintained through indicators, such as physical location and tags, markings, shop travelers, stamps, inspection records, or other suitable means.

Procedures shall also provide NQA-1 BR 8 "Controls shall Part II, Section 8: The sum of the requirements for the identification of items be established to assure SNC has established the necessary measures and governing from NQA-1 and the QATR which have satisfactorily that only correct and procedures to identify and control items to prevent the use of accomplish the N 18.7 intent.

passed required inspections accepted items are used or incorrect or defective items.

and tests, where necessary to installed preclude inadvertent bypassing of such inspections NQA-1 BR 14 "The status of Part II, Section 14:

and tests. In cases where inspection and test activities required documentary shall be identified either on Where necessary to preclude inadvertent bypassing of evidence is not available, the the items or in documents inspections or tests, or to preclude inadvertent operation, associated equipment or traceable to the items where these measures require the inspection, test or operating materials must be considered it is necessary to assure ttat status be verified before release, fabrication, receipt, nonconforming in accordance itqis necessaynt asu installation, test or use.

with Section 5.2.14. Until tests are performed and to suitableassure that items which evidence is available to show ase that te the the equipment orr material theequpmnt ateia is in isin have requirednspinspections and Part II, Section 7.1:

ANSI N18.7-1976 Conformance PaNe 53 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS conformance, affected tests are not inadvertently Acceptance actions are completed to ensure that systems shall be considered to installed, used, or operated. procurement, inspection, and test requirements, as applicable, be inoperable and reliance have been satisfied before relying on the item to perform its shall not be placed on such intended safety function.

systems to fulfill their intended safety functions.

When equipment is ready to Appendix E: "Maintenance Procedures be returned to service, operating personnel shall These documents contain instructions insufficient detail to permit place the equipment in maintenance work to be performed correctly and safely, and include operation and verify and provisions, such as hold or witness points, for conducting and document its functional recording results of required inspections or tests. These documents may include applicable inspection or test instructions subject to the acceptability. Attention shall requirements for test and inspection procedures below. Appropriate be given to restoration of referencing to other procedures, standards, specifications, or supplier normal conditions such as manuals is provided. When not provided through other documents, removal of jumpers or signals instructions for equipment removal and return to service, and used in maintenance or testing applicable radiation protection measures (such as protective clothing or such as returning valves, and radiation monitoring) will be included. Additional maintenance breakers or switches to proper procedure requirements are addressed in NQA-1 -1994, Subpart 2.18, start-up or operating positions Section 2.2, Procedures."

from "test or "manual" positions. When placed into service, the equipment should receive additional surveillance during the running period.

5.2.7 Maintenance and Appendix E: "Maintenance Procedures Modifications These documents contain instructions in sufficient detail to permit maintenance work to be performed correctly and safely, and include Maintenance or modifications provisions, such as hold or witness points, for conducting and which may affect functioning of recording results of required inspections or tests. These documents safety-related structures; may include applicable inspection or test instructions subject to the systems, or components shall requirements for test and inspection procedures below. Appropriate be performed in a manner to referencing to other procedures, standards, specifications, or supplier ensure quality at least manuals is provided. When not provided through other documents, instructions for equipment removal and return to service, and ANSI N18.7-1976 Conformance Page 54 of 145 ANSI N1i8.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS equivalent to that specified in applicable radiation protection measures (such as protective clothing original design bases and and radiation monitoring) will be included. Additional maintenance requirements, materials procedure requirements are addressed in NQA-1 -1994, Subpart 2.18, specifications and inspection Section 2.2, Procedures."

requirements. A suitable level of confidence in structures, systems or components on which maintenance or modifications have been performed shall be attained by appropriate inspection and performance testing (see also 5.2.17 and 5.3.5).

Maintenance or modification of NQA-1 Subpart 2.18 Appendix E: "Maintenance Procedures N18.7 wording in brackets are equipment shall be preplanned "Quality Assurance These documents contain instructions insufficient detail to permit included in this table for and performed in accordance Requirements for maintenance work to be performed correctly and safely, and include completeness; they do not with written procedures, Maintenance of Nuclear provisions, such as hold or witness points, for conducting and recording establish requirements that documented instructions or Facilities" states in Section results of required inspections or tests. These documents may include either NQA-1 or the SNC QATR drawings appropriate to the 2.2(a) "Procedures and/or applicable inspection or test instructions subject to the requirements for would need to address.

circumstances which conform written instructions shall be test and inspection procedures below. Appropriate referencing to other to the applicable codes, established for performance procedures, standards, specifications, or supplier manuals is provided.

standards, specifications, and of maintenance activities..." When not provided through other documents, instructions for equipment removal and return to service, and applicable radiation criteria, protection measures (such as protective clothing and radiation

[Skills normally possessed by monitoring) will be included. Additional maintenance procedure qualified maintenance requirements are addressed in NQA-1 -1994, Subpart 2.18, Section 2.2, personnel may not require Procedures."

detailed step-by-step delineations in a written procedure.]

ANSI N 18.7-1976 Conformance Pane 55 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS Means for assuring quality of NQA-1 Subpart 2.18 Part II, Section 10:

maintenance and modification "Quality Assurance SNC has established the necessary measures and governing activities (for example, Requirements for procedures to implement inspections that assure items, inspections, measurements, Maintenance of Nuclear services and activities affecting safety meet established tests, welding, heat treatment, Facilities" states in Section requirements and conform to applicable documented cleaning, nondestructive 2.1 "Responsibilities shall be specifications, instructions, procedures, and design examination and worker assigned.. .the conduct of documents. Inspection may also be applied to items, services qualifications in accordance the program of maintenance and activities affecting plant reliability and integrity. Types of with applicable codes and activities and other inspections may include those verifications related to standards) and measures to inspections and tests as procurement, such as source, in-process, final, and receipt document the performance necessary to verify inspection, as well as maintenance, modification, in-service, thereof shall be established. satisfactory performance...'

and operational activities. Inspections are carried out by This documentation shall be and Section 2.2d states properly qualified persons independent of those who retained as specified in "Provisions shall be made performed or directly supervised the work.

Section 5.2.12. Measures shall for documenting data to be established and assist in ensuring documented to identify the satisfactory completion of Part II, Section 17:

inspection and test status of the work. Such data shall SNC has established the necessary measures and governing items to be used in include, as applicable..." procedures to ensure that sufficient records of items and maintenance and modification activities affecting quality are developed, reviewed, approved, activities. Normally, the point issued, used, and revised to reflect completed work.

of control for such items should be the plant storage area. Part II, Section 14:

Where necessary to preclude inadvertent bypassing of inspections or tests, or to preclude inadvertent operation, these measures require the inspection, test or operating status be verified before release, fabrication, receipt, installation, test or use.

ANSI N18.7-1976 Conformance Page 56 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS The following standards NQA-1 was developed QATR Part III provides a listing contain useful guidance based on ANSI/ASME of other documents, such as concerning design and N45.2-1977; ANSI N46.2; NRC Regulatory Guides that construction-related activities and seven daughter endorsed the older ANSI associated with modifications standards of ANSI/ASME Standards, and establishes the and shall be applied to those N45.2: nature and level of SNC activities occurring during the N45.2.6 commitment thereto.

operational phase that are N45.2.9 comparable in nature and extent to related activities N45.2.1 0 occurring during initial plant N45.2.1 1 design and construction:

American National Standard N45.2.12 Installation, Inspection and N45.2.13 Testing of Instrumentation and Electric Equipment During the N45.2.23 Construction of Nuclear Power Generation Station. In addition, other daughters N45.2.4-1972 (IEEE 336- were made into subparts, 1972); American National these included:

Standard Supplementary N45.2.1 =Subpart 2.1 Quality Assurance Requirements for Installation, N45.2.2 =Subpart 2.2 Inspection and Testing of N45.2.3 =Subpart 2.3 Structural Concrete and Structural Steel During the N45.2.4 =Subpart 2.4 Construction Phase of Nuclear N45.2.5 =Subpart 2.5 Power Plants, N45.2.5-1 974; American National Standard N45.2.8 =Subpart 2.8 Qualifications of Inspection, N45.2.15 = Subpart 2.15 Examination and Testing N45.2.16 = Subpart 2.16 Personnel for the Construction Phase of Nuclear Power Plans N45.2.18 = Subpart 2.18 N45.2.6-1 973; American N45.2.20 = Subpart 2.20 National Standard Supplementary Quality Assurance Requirements for Installation, Inspection and ANSI N 18.7-1976 Conformance Page 57 of 145 I ANSI N18.7-1976 ASME NQA-1 -1994 SNC QATR I COMMENTS Testing of Mechanical Equipment and Systems for Construction Phase of Nuclear Power Plants, N45.2.8-1 975 American National Standard Quality Assurance Requirements for the Design of Nuclear Power Plants, N45.2.1 1- 1974; and American National Standard Quality Assurance for Protective Coating Applied to Nuclear Facilities N1101.4-1972.

[Considerable care is required N18.7 wording in brackets are in assessing which operational included in this table for phase activities are completeness; they do not comparable in nature and establish requirements that extent to activities normally either NQA-1 or the SNC QATR associated with design and would need to address.

construction.]

5.2.7.1 Maintenance SECTION 14 INSPECTION, Appendix E: "Maintenance Procedures Programs. A maintenance TEST, AND OPERATING STATUS These documents contain instructions in sufficient detail to permit program shall be developed to maintain safety-related maintenance work to be performed correctly and safely, and include structures, systems and provisions, such as hold or witness points, for conducting and recording results of required inspections or tests. These documents components at the quality SNC has established the may include applicable inspection or test instructions subject to the required for them to perform necessary measures and requirements for test and inspection procedures below. Appropriate their intended functions. governing procedures to referencing to other procedures, standards, specifications, or supplier Maintenance shall be identify the inspection, test, manuals is provided. When not provided through other documents, scheduled and planned so as and operating status of instructions for equipment removal and return to service, and not to compromise the safety items and components applicable radiation protection measures (such as protective clothing of the plant. and radiation monitoring) will be included. Additional maintenance subject to the provisions of procedure requirements are addressed in NQA-1-1994, Subpart 2.18, this QATR in order to Section 2.2, Procedures."

maintain personnel and ANSI N18.7-1976 Conformance Page 58 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS reactor safety and avoid unauthorized operation of equipment. Where necessary to preclude inadvertent bypassing of inspections or tests, or to preclude inadvertent operation, these measures require the inspection, test or operating status be verified before release, fabrication, receipt, installation, test or use.

These measures also establish the necessary authorities and controls for the application and removal of status indicators or labels.

Planning shall consider the NQA-1, Subpart 2.18, possible safety consequences Paragraph 2.5 of concurrent or sequential "(a) Procedures shall be maintenance, testing or established for the operating activities, Equipment authorization of required to be operable for the maintenance work....

prevailing mode shall be (b)The work authorization available, and maintenance shall contain (4) approval by shall be performed in a authorized personnel.

manner such that license limits are not violated. Planning for (c) Interface concerns such maintenance shall include as plant operations, shall be evaluation of the use of considered for applicability special processes, equipment, by authorized individuals and materials in performance prior to approval of the work of the task, including authorizing document."

assessment of potential hazards to personnel and equipment.

ANSI N 18.7-1976 Conformance Page 59 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS

[General rules for the NQA-1 Subpart 2.18 Quality Part II, Section 5: N18.7 wording in brackets are development of procedures Assurance Requirements for 'SNC has established the necessary measures and governing included in this table for under a maintenance program Maintenance of Nuclear procedures to ensure that activities affecting quality are completeness; they do not which is consistent with the Facilities' Section 2.2a prescribed by and performed in accordance with instructions, establish requirements that provisions of 5.2.7 shall be states 'Procedures and/or procedures or drawings of a type appropriate to the either NQA-1 or the SNC QATR written before start- up.] These written instructions shall be circumstances and which, where applicable, include would need to address.

general rules shall form the established for performance quantitative or qualitative acceptance criteria to implement the basis for developing the repair of maintenance activities. QAP as described in the QATR.'

or replacement procedures at Requirements for procedure the time of failure. [Procedures format and content shall be required for maintenance of established equipment expected to require recurring maintenance should be written prior to plant operation. As experience is gained in operation of the plant, routine maintenance should be altered to improve equipment performance, and procedures for repair of equipment shall be improved as appropriate.] Approved procedures shall be available for repair of safety-related equipment prior to the performance of such repairs (see also Sections 5.2.2 and 5.2.7).

A preventive maintenance NQA-1 Subpart 2.18 'Quality program including procedures Assurance Requirements for as appropriate for safety- Maintenance of Nuclear related structures, systems Facilities' Section 3 states and components shall be 'Plans and procedures shall established and maintained be developed to identify the which prescribes the equipment which requires frequency and type of preventive maintenance, to ANSI N18.7-1976 Conformance PaLe 60 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS maintenance to be performed. establish the frequency and kind of preventive maintenance to be performed on the equipment, and to document those actions.'

[A preliminary program based N18.7 wording in brackets are on service conditions and included in this table for experience with comparable completeness; they do not equipment should be establish requirements that developed prior to fuel loading, either NQA-1 or the SNC QATR The would need to address.

program should be revised and updated as experience is gained with the equipment.]

The causes of malfunctions NQA-1 Subpart 2.18 'Quality shall be promptly determined, Assurance Requirements for evaluated and recorded (see Maintenance of Nuclear also Sections 4.3 and 4.4). Facilities" Sections 4.2 and Experience with the 4.3 state 'Procedures shall malfunctioning equipment and be established for promptly similar components shall be identifying the failed item reviewed and evaluated to and controlling it to preclude determine whether a its inadvertent use; replacement component of the documenting and reporting same type can be expected to of failures, in accordance perform its function reliably. If with pre-established evidence indicates that criteria.. .An assessment of common components in failure cause and required safety-related systems have maintenance shall be made performed unsatisfactorily, consistent with the type of corrective measures shall be item failure and the planned prior to replacement importance of the item. The or repair of all such assessment shall also components. Replacement include, as appropriate, the components shall have possibility of similar failure in ANSI N18.7-1976 Conformance Paie 61 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS received adequate testing or other items.'

should be of a design for which experience indicates a high probability of satisfactory performance. Consideration shall be given to phased replacement to permit inservice performance of the new component to be evaluated and thereby minimize the possibility of a hidden deficiency producing a systematic failure.

[An augmented testing and N18.7 wording in brackets are inspection program should be included in this table for implemented following a large completeness; they do not scale component replacement establish requirements that (or repair) until such time as a either NQA-1 or the SNC QATR suitable level of performance would need to address.

has been demonstrated.]

5.2.7.2 Modifications. Design N45.2.11 was incorporated activities associated with into NQA-1.

modifications of safety relate structures, systems and components shall be accomplished in accordance with N45.2.11-1974.

5.2.8 Surveillance Part II, Section 11:

Testing and Inspections 'SNC has established the necessary measures and governing Schedule. procedures to demonstrate that items subject to the provisions of this QATR will perform satisfactorily in service, that the A surveillance testing and plant can be operated safely and as designed, and that the inspection program shall be I ANSI N 18.7-1976 Conformance Page 62 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS prescribed to insure that coordinated operation of the plant as a whole is satisfactory.'

safety-related structures, systems, and components will Part II, Section 10:

continue to operate, keeping parameters within normal 'SNC has established the necessary measures and governing bounds, or will act to put the procedures to implement inspections that assure items, plant in a safe condition if they services and activities affecting safety meet established exceed normal bounds. requirements and conform to applicable documented specifications, instructions, procedures, and design documents.'

Appendix D:

Surveillance testing: periodic testing to verify that safety related structures, systems, and components continue to function or are in a state of readiness to perform their functions, and to provide assurance that failures or substandard performance do not remain undetected and that the required reliability of safety related systems is maintained.

Such functions include keeping parameters within normal bounds or acting to put the plant in a safe condition if they exceed normal bounds.

Provisions shall be made for Part II, Section 11:

performing surveillance required 'SNC has established the necessary measures and governing testing and inspections including inservice procedures to demonstrate that items subject to the provisions inspections Such provisions of this QATR will perform satisfactorily in service, that the inspectionsluch provisions plant can be operated safely and as designed, and that the shall include the establishment coordinated operation of the plant as a whole is satisfactory.

of a master surveillance These programs include criteria for determining when testing schedule reflecting the status is required, such as proof tests before installation, pre-of all planned in plant operational tests, post-maintenance tests, post-modification tests, in-service tests, and operational tests (such as inspections. surveillance tests required by Plant Technical Specifications),

to demonstrate that performance of plant systems is in accordance with design. Programs also include provisions for establishing and adjusting test schedules and maintaining status for periodic or recurring tests.'

ANSI N 18.7-1976 Conformance Page 63 of 145 ANSI N1i8.7-11976 ASME NQA-1 -1994 SNC QATR COMMENTS Part II, Section 10:

'SNC has established the necessary measures and governing procedures to implement inspections that assure items, services and activities affecting safety meet established requirements and conform to applicable documented specifications, instructions, procedures, and design documents. Inspection may also be applied to items, services and activities affecting plant reliability and integrity.'

Frequency of surveillance Part II, Section 11:

tests and inspections may be 'Programs also include provisions for establishing and related to the results of adjusting test schedules and maintaining status for periodic or reliability analyses, the recurring tests. Tests are performed according to applicable frequency and type of service, procedures that include, consistent with the effect on safety, or age of the item or system, (1) instructions and prerequisites to perform the test, (2) use as appropcate. Additional of proper test equipment, (3) acceptance criteria, and (4) control procedures shall be mandatory verification points as necessary to confirm instituted, as necessary, to satisfactory test completion. Test results are documented and assure timely conduct of evaluated by the organization performing the test and speil and appropriate reviewed by a responsible authority to assure that the test inspections ropriate requirements have been satisfied. If acceptance criteria are documentation, reporting, and not met, retesting is performed as needed to confirm acceptability following correction of the system or equipment deficiencies that caused the failure.'

5.2.9 Plant Security and Security and visitor control Visitor Control. provisions at SNC plants comply with 10CFR73 and Procedures shall be other NRC orders, and with the developed to supplement approved Security and features and physical barriers Safeguards Contingency Plans.

designed to control access to N18.7 requirements are the plant and, as appropriate, considered superseded by to vital areas within the plant. these documents, although ANSI N 18.7-1976 Conformance Paze 64 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS Information concerning they generally provide for specific design features and compliance with the N1 8.7 administrative provisions of intent.

the plant security program shall be confidential and thus accorded limited distribution.

The security and visitor control procedures should consider, for example, physical provisions, such as: fences and lighting; lock controls for doors, gates and compartments containing sensitive equipment; and provisions for traffic and access control. Also to be considered are administrative provisions, such as: visitor sign-in and sign-out procedures; escorts and badges for visitors; emphasis on inspection, observation and challenging of strangers by operating crews; and a program of pre-employment screening for potential employees. See American National Standard Industrial Security (or Nuclear Power Plants, N1 3.17-1 973, for guidance and provisions for security measures adequate to protect nuclear power plants.

[11]

ANSI N 18.7-1976 Conformance Page 65 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS 5.2.10 Housekeeping and Part II, Section 13.1:

Cleanliness Control. 'Housekeeping practices during normal operations and maintenance activities, including refueling, are established to Housekeeping practices shall account for conditions or environments that could affect the be utilized recognizing quality of structures, systems and components within the requirements for the control of plant. This includes control of cleanness of facilities and radiation zones and the control materials, fire prevention and protection, disposal of of work activities, conditions combustible material and debris, control of access to work and environments that can areas, protection of equipment, radioactive contamination affect the quality of important control and storage of solid radioactive waste. Housekeeping parts of the nuclear plant. practices help assure that only proper materials, equipment, Housekeeping encompasses processes and procedures are used and that the quality of all activities related to the items is not degraded. Necessary procedures or work control of cleanness of instructions, such as for electrical bus and control center facilities materials, equipment cleaning, cleaning of control consoles, and radioactive fire prevention and protection decontamination are developed and used.'

including disposal of combustible material and debris and control of access to areas, protection of equipment, radioactive contamination control and storage of solid radioactive waste.

Housekeeping practices shall Part II, Section 13.2 assure that only proper 'Housekeeping practices help assure that only proper materials, equipment, materials, equipment, processes and procedures are used processes and procedures are and that the quality of items is not degraded. Necessary utilized and that the quality of procedures or work instructions, such as for electrical bus and items is not degraded as a control center cleaning, cleaning of control consoles, and result of housekeeping radioactive decontamination are developed and used.'

practices or techniques.

Where necessary procedures and work instructions needed to assure compliance with specific requirements shall be available: e.g., inspection and ANSI N 18.7-1976 Conformance Page 66 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS cleaning of electrical bus and control centers, cleaning of control consoles, radioactive decontamination.

Particular attention should be Part II, Section 13.1:

given to housekeeping in work 'Housekeeping practices during normal operations and important items are handled maintenance activities, including refueling, are established to and stored to preclude account for conditions or environments that could affect the dmand sore tontprecludenquality of structures, systems and components within the damage or contamination, plant. This includes control of cleanness of facilities and materials, fire prevention and protection, disposal of combustible material and debris, control of access to work areas, protection of equipment, radioactive contamination control and storage of solid radioactive waste. Housekeeping practices help assure that only proper materials, equipment, processes and procedures are used and that the quality of items is not degraded. Necessary procedures or work instructions, such as for electrical bus and control center cleaning, cleaning of control consoles, and radioactive decontamination are developed and used.'

American National Standard ANSI N45.2.3 = NQA-1 Part II, Section 13.2:

Housekeeping During the Subpart 2.3 'In addition, SNC commits to compliance with the Construction Phase of Nuclear requirements of NQA-1-1994, ... Subpart 2.3, to establish Power Plants. N-45.2.3.1973 appropriate provisions for housekeeping; with the following shall be applied to those clarifications and exceptions...'

activities occurring during the operational phase that are comparable in nature and extent to related activities occurring during construction.

ANSI N 18.7-1976 Conformance Page 67 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS During maintenance or NQA-1 Subpart 2.18 Section modification activities, certain 2.3 states "(a) controls to portions of safety- related minimize the introduction of systems may be subject to foreign materials and to potential contamination with maintain cleanness during foreign materials. To prevent maintenance shall be in such contamination, control accordance with Subpart 2.1 measures, including measures of this Part. (Part II).

for access control, shall be Verification methods shall established. Immediately prior be established to ensure to closure an inspection shall these requirements are met.

be conducted to assure (b) Immediately prior to cleanness and the result of closure of equipment, the such inspection shall be absence of foreign materials documented. shall be verified. The results of the verification shall be documented."

American National Standard ANSI N45.2.1 = NQA-1 Part II, Section 13.2:

Cleaning of Fluid Systems and Subpart 2.1 'In addition, SNC commits to compliance with the Associated Components requirements of NQA-1-1994, Subpart 2.1, to establish during Construction Phase of appropriate provisions for the cleaning of fluid systems and Nuclear Power Plant. N45.2.1 - associated components; and Subpart 2.3, to establish 1973 [13] shall be applied to appropriate provisions for housekeeping; with the following activities occurring during the clarifications and exceptions...'

operational phase that are comparable in nature and extent to related activities occurring during construction.

[Measures for minimizing the N18.7 wording in brackets are introduction of foreign included in this table for materials during maintenance completeness; they do not or modification, or cleaning establish requirements that following maintenance or either NQA-1 or the SNC QATR modification of radioactively would need to address.

contaminated systems or of equipment of high radiation ANSI N 18.7-1976 Conformance Pa e 68 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS fields require special consideration.]

5.2.11 Corrective Actions. BR 16 "Corrective Action" Part II, Section 16.1:

The program shall provide states "Conditions adverse In establishing provisions for corrective action, SNC commits measures to ensure that to quality shall be identified to compliance with NQA-1-1994, Basic Requirement 16.

conditions adverse to plant promptly and corrected as safety, such as failure, soon as practical. In the malfunctions, deficiencies, case of a significant deviations, defective material condition adverse to quality, and equipment, abnormal the cause of the condition occurrences, and shall be determined and nonconformances are corrective action taken to promptly identified and preclude recurrence. The corrected. In the case of identification, cause, and significant conditions adverse corrective action for to safety, the measures shall significant conditions assure that the cause of the adverse to quality shall be condition is determined and documented and reported to corrective action taken shall appropriate levels of be documented and reported management; follow-up to appropriate levels of action shall be taken to management and for verify implementation of this independent review in corrective action."

accordance with Section 4.3.

5.2.12 Plants Records Part I1,Section 17:

Management. Provisions shall 'SNC has established the necessary measures and governing be made for preparation and procedures to ensure that sufficient records of items and retention of plant records as activities affecting quality are developed, reviewed, approved, appropriate, issued, used, and revised to reflect completed work.'

ANSI N 18.7-1976 Conformance Page 69 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS The responsibility for Part II, Section 17:

maintaining records and 'The provisions of such procedures establish the scope of the storing them at a specified records retention program for SNC and include requirements location or locations shall be for records administration, including receipt, preservation, assigned. retention, storage, safekeeping, retrieval, and final disposition.'

Retention periods of sufficient Part II, Section 17.1:

duration to assure the ability to 'Records of activities for design, engineering, procurement, reconstruct significant events manufacturing, construction, inspection and test, installation, and satisfy any statutory pre-operation, startup, operations, maintenance, modification, requirements which apply shall decommissioning, and audits include the appropriate content be specified. requirements of NQA-1-1 994, Parts I and II. Such records and their retention times are based on Regulatory Position C.2, Table 1, of Regulatory Guide 1.28, Revision 3. This table addresses design, construction, and initial start-up records and will be applied to operating and decommissioning phase records that are similar in nature to the construction records.

Additional operations phase records and their retention periods are identified in the respective FSAR for each plant.

In addition, SNC uses the list of records in 10 CFR 71.135 and 10 CFR 72.174 to establish the types of records that will be created and retained in support of transportation and storage operations governed by 10 CFR Part 71 and Part 72, respectively. In all cases where state, local, or other agencies have more restrictive requirements for record retention, those requirements will be met.'

American National Standard NQA-1 was developed Part II, Section 17.3:

Requirements for Collection, based on ANSI N45.2.9. 'In establishing provisions for records, SNC commits to Storage and Maintenance of See BR 17 and 17S-1. compliance with NQA-1 -1994, Basic Requirement 17 and Quality Assurance Records for Supplement 17S-1, with the following clarifications and Nuclear Power Plants, exceptmens:

N45.2.9-1974 shall be used for exceptions:

management of plant records ANSI N 18.7-1976 Conformance Page 70 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS during the operational phase. NQA-1-1994, Supplement 17S-1 Supplement 17S-1, Section 4.2(b) requires records to be firmly attached in binders or placed in folders or envelopes for storage in steel file cabinets or on shelving in containers. For hard-copy records maintained by SNC, the records are suitably stored in steel file cabinets or on shelving in containers, except that methods other than binders, folders or envelopes may be used to organize the records for storage.'

5.2.13 Procurement and NQA-1 BR 4 "Procurement Part II, Section 4:

Materials Control. Measures Document Control" states 'SNC has established the necessary measures and governing shall be provided for "Applicable design bases procedures to assure that purchased items (components, procurement, documentation and other requirements spares and replacement parts necessary for plant design, and control of those materials necessary to assure construction, operation, refueling, maintenance and and components including adequate quality shall be modifications) and services are subject to quality and spare and replacement parts included or referenced in technical requirements at least equivalent to those specified necessary for plant operation, documents for procurement for original equipment or specified by properly reviewed and refueling, maintenance and of items and services." approved revisions to the original requirements to assure the modification. items are suitable for the intended service, and are of NQA-1 Supplement 4S-1 acceptable quality, consistent with their effect on safety.'

Section 2.7 states "The procurement documents shall require the identification of appropriate spare and replacement parts or assemblies..."

These measures shall utilize NQA-1 was developed Part II, Section 4.2:

American National Standard based on ANSI N45.2.13. In establishing controls for procurement, SNC commits to Quality Assurance See BR 4 and 4S-1, and BR compliance with NQA-1 -1994, Basic Requirements 4 and Requirements for the Control 7 and 7S-1. Supplements 4S-1, with the following clarifications and of Procurement of Items and exceptions:

Services for Nuclear Power Plants, N45.2.13-1 976. The NQA-1-1994, Supplement 4S-1 Appendix to N45.2.13 is Section 2.3 of Supplement 4S-1 includes a requirement particularly useful in that procurement documents require suppliers to have a determining the quality documented quality assurance program that implements ANSI N 18.7-1976 Conformance Page 71 of 145 ANSI N1 8.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS assurance requirements NQA-1-1994, Part 1. In lieu of this requirement, SNC may depending on the complexity require suppliers to have a documented supplier quality or safety of the item. assurance program that is determined to meet the applicable requirements of 10 CFR 50, Appendix B, as appropriate to the circumstances of the procurement.

With regard to service performed on a plant site by a supplier, SNC procurement documents may allow the supplier to work under the SNC quality assurance program, including implementing procedures, in lieu of the supplier having its own quality assurance program.

etenlsdan i2of Supplhmet n t 4e rceuaspures mdgovernt documents to be aretiawd pror to bid or aamrd of conetact.

The quality asnuranacoement rts ecessaroat d esigen, aatiefid through roVieW of the aPPlingab miOtennceRant sPodification),including the teshical and quality prouremnt roquiFrometG, prior to bid-orFaw.ard of contmcnt.

Procedures shall be Part 11,Section 4:

established and implemented tSNC has established the necessary measures and governing to ensure that purchased procedures to assure that purchased items (components, materials and components spares and replacement parts necessary for plant design, associated with safety-related construction, operation, refueling, maintenance and structures or systems are: modifications) and services are subject to quality and (1) Purchased to specifications technical requirements at least equivalent to those specified and codes equivalent to those for original equipment or specified by properiy reviewed and specified for the original approved revisions to the original requirements to assure the equipment or those specified items are suitable for the intended service, and are of by a properly reviewed and acceptable quality, consistent with their effect on safety.'

approved revision, ANSI N 18.7-1976 Conformance Page 72 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS In those cases where the Part II, Section 4:

original item or part is found to Where original technical or quality assurance requirements be commercially "off the shelf," cannot be determined, an engineering evaluation is conducted or without specifically and documented by qualified staff to establish appropriate identified quality assurance requirements and controls to assure that interfaces, requirements, spare and interchangeability, safety, fit and function, as applicable, are replacement parts may be not adversely affected or contrary to applicable regulatory similarly procured but care requirements.'

shall be exercised to assure at least equivalent performance.

(In those cases where the QA Part II,Section 4:

requirements of the original Where original technical or quality assurance requirements item cannot be determined, an cannot be determined, an engineering evaluation is conducted engineering evaluation shall and documented by qualified staff to establish appropriate be conducted by qualified requirements and controls to assure that interfaces, individuals to establish uand cetrols.the tinterchangeability, safety, fit and function, as applicable, are requirements and controls. not adversely affected or contrary to applicable regulatory This evaluation shall assure requirements.'

that interfaces, interchangeability, safety, fit and function are not adversely affected or contrary to applicable regulatory or code requirements. The results of this evaluation shall be documented)

(2) Produced or fabricated Part II, Section 4:

under requirements at least 'SNC has established the necessary measures and governing equivalent to that of the procedures to assure that purchased items (components, original equipment, or those spares and replacement parts necessary for plant design, specified by a properly construction, operation, refueling, maintenance and reviewed and approved modifications) and services are subject to quality and revision; technical requirements at least equivalent to those specified for original equipment or specified by properly reviewed and approved revisions to the original requirements to assure the ANSI N 18.7-1976 Conformance Page 73 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS items are suitable for the intended service, and are of acceptable quality, consistent with their effect on safety.'

(3) Packaged and transported NQA-1 BR 13 "Handling, Part II, Section 13:

in a manner that will ensure storage, cleaning, 'SNC has established the necessary measures and governing that the quality is not degraded packaging, shipping and procedures to control the handling, storage, packaging, during transit; preservation of items shall shipping, cleaning, and preservation of items to prevent be controlled to prevent inadvertent damage or loss, and to minimize deterioration.

damage or loss and to minimize deterioration." These provisions include specific procedures, when required to maintain acceptable quality of the items important to safety.

Items are appropriately marked and labeled during packaging, shipping, handling and storage to identify, maintain, and preserve the item's integrity and indicate the need for special controls. Special controls (such as containers, shock absorbers, accelerometers, inert gas atmospheres, specific moisture content levels and temperature levels) are provided when required to maintain acceptable quality.'

(4) Properly documented to NQA-1 Supplement 4S-1 show compliance with states "....these applicable specifications, requirements shall be codes and standards; specified by reference to specific drawings, specifications, codes, standards, regulations, procedures, or instructions.

(5) Properly inspected, NQA-1 BR 13 "Handling, identified and stored to protect storage, cleaning, against damage, deterioration packaging, shipping and or misuse; preservation of items shall be controlled to prevent damage or loss and to minimize deterioration."

ANSI N 18.7-1976 Conformance Page 74 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS (6) Properly controlled to NQA-1 BR 15 "Items that do Control, use and shipment of ensure the identification, not conform to specified special nuclear material is segregation and disposition of requirements shall be subject to NRC regulations and nonconforming material, controlled to prevent applicable license conditions Special nuclear material and inadvertent installation or which are not repeated in the sources shall be shipped and use. Controls shall provide QATR.

stored as specified in the U.S. for identification, Nuclear Regulatory documentation, evaluation, Commission (NRC) fuel segregation when practical, license and other applicable and disposition of non-regulatory documents. conforming items..."

5.2.13.1 Procurement NQA-1 BR4 'Procurement Document Control. Document Control" states Measures shall be provided to "Applicable design bases assure that applicable and other requirements regulatory documents, design necessary to assure quality bases and other requirements shall be included or which are necessary to assure referenced in documents for quality are included or procurement of items and referenced in the procedures services. To the extent for procurement of items and necessary, procurement services. To the extent documents shall require necessary, procurement Suppliers to have a quality documents shall require assurance program suppliers to provide a quality consistent with the assurance program consistent applicable requirements of with the pertinent this part.

requirements of American National Standard Quality Assurance Program ANSI N 18.7-1976 Conformance PaNe 75 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS Requirements for Nuclear Power Plants, N45.2-1971.

[2] Where changes are made NQA-1 Supplement 4S-1 to procurement documents, Section 4 states they shall be subject to the 'Procurement document same degree of control as was changes shall be subject to used in the preparation of the the same degree of control original documents. as utilized in the preparation of the original documents.'

Procurement documents shall NQA-1 Supplement 4S-1 Part II, Section 4:

include provisions for the Section 2 states 'Applicable technical, regulatory, administrative, quality and following, as applicable: 'Procurement documents reporting requirements (such as specifications, codes, (1) Supplier Quality Assurance issued at all tiers of standards, tests, inspections, special processes, and Program. Identification of procurement shall include standare inspection processes and quality assurance provisions for the following, 10CFR21) are invoked for procurement of items and services.'

requirements applicable to the as deemed necessary by items or services procured. the Purchaser...

2.3 Quality Assurance Program Requirements

'Procurement documents shall require that the Supplier have a documented quality assurance program...'

(2) Basic Technical NQA-1 Supplement 4S-1 Requirements. Section 2 states Where specific technical 'Procurement documents requirements apply, such as issued at all tiers of drawings, specifications, and procurement shall include industrial codes and provisions for the following, standards, they shall be as deemed necessary by identified by titles and dates of the Purchaser...

ANSI N 18.7-1976 Conformance Page 76 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS issue in such a way as to clearly set forth the applicable 2.2 Technical Requirements documents. Where procedural requirements apply, in such Technical requirements areas as test and inspection shall be specified in the needs, fabrication, cleaning, procurement documents.

erecting, packaging, handling, Where necessary, these shipping and storage, they too, requirements shall be shall be identified clearly and specified by reference to in such a way as to avoid specific drawings, uncertainty as to source and specifications, codes, need. standards, regulations, procedures, or instructions...

(3) Source Inspection and NQA-1 Supplement 4S-1 Audit. Provisions for access to Section 2 states the supplier's facilities and 'Procurement documents records for source inspection issued at all tiers of and audit when the need for procurement shall include such inspection or audit has provisions for the following, been determined, as deemed necessary by the Purchaser...

2.4 Right of Access At each tier of procurement, the procurement documents shall provide for access to the Supplier's plant facilities and records for inspection or audit..."

ANSI N18.7-1976 Conformance Page 77 of 145 ANSI N1 8.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS (4) Documentation NQA-1 Supplement 4S-1 Requirements. Records to be Section 2 states prepared, maintained, "Procurement documents submitted or made available issued at all tiers of for review, such as drawings, procurement shall include specifications, procedures, provisions for the following, procurement documents, as deemed necessary by inspection and test records, the Purchaser...

personnel and procedure qualifications, and material, 2.5 Documentation chemical, and physical test Requirements results. Instruction on record retention and disposition shall be provided, The procurement documents at all tiers shall identify the documentation required to be submitted for information, review, or approval by the Purchaser.

The time of submittal shall also be established. When the Purchaser requires the Supplier to maintain specific quality assurance records, the retention times and disposition requirements shall be prescribed."

(5) Lower Tier Procurement. NQA-1 Supplement 4S-1 Provisions for extending Section 2 states applicable requirements to "Procurement documents lower tier subcontractors and issued at all tiers of suppliers, including procurement shall include purchasers access to facilities provisions for the following, and records, as deemed necessary by the Purchaser...

ANSI N 18.7-1976 Conformance Page 78 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS 2.3 Quality Assurance Program Requirements The procurement documents shall require the Supplier to incorporate appropriate quality assurance program requirements in subtier procurement documents."

2.4 Right of Access "At each tier of procurement, the procurement documents shall provide for access to the Supplier's plant facilities and records..."

5.2.13.2 Control of NQA-1 -1994 BR 7 states Part II, Section 7.2:

Purchased Material, 'The procurement of items 'In establishing procurement verification controls, SNC Equipment and Services. or services shall be commits to compliance with NQA-1-1994, Basic Requirement Measures shall be provided to controlled to assure 7 and Supplement 7S-1, with the following clarifications and assure that purchased items conformance with specified exceptions...'

and services, whether requirements."

purchased directly or through contractors, conform to the procurement documents.

ANSI N 18.7-1976 Conformance Page 79 of 145 ANSI Ni 8.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS These measures shall include Supplement 7S-1 Part II,Section 18.1 By letter dated June 17, 2005, provisions, as appropriate, for 'Supplementary the NRC approved specific

'Audit of supplier activities shall be performed at 36 month changes to the Farley, Hatch, source evaluation and Requirements for Control of intervals, and evaluations shall be performed at 12 month and Voc.tle quality assurance selection, objective evidence Purchased Items and intervals. A maximum extension not to exceed 25% of the programs. These changes of quality furnished by the Services' states 'Such audit or evaluation interval shall be allowed. The combined included NRC approval of contractor, inspection and control shall provide for the time interval for any three consecutive audit or evaluation standard criteria for extending audit at the source and following as appropriate:

intervals should not exceed 3.25 times the specified audit or audit intervals. These criteria examination of items upon source evaluation and evaluation interval.' included the following:

delivery, selection, evaluation of objective evidence of quality A. Audits shall be performed at furnished by the Supplier, the intervals designated source inspection, audit, herein for each audit area.

and examination of items or Schedules shall be based services upon delivery or on the month in which the completion.' audit starts.

B. A maximum extension not to exceed 25 Percent of the audit interval shall be allowed. That is to say that, for audits on a 24-month frequency. the maximum time between specific audits shall not exceed 30 months.

Likewise, audits on an annual (12 month) freauency shall not be extended beyond 15 months.

C. When an audit interval extension greater than one month is used, the next audit for that particular audit area will be scheduled from the original anniversary month rather than from the month of the extended audit.

ANSI N 18.7-1976 Conformance Page 80 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS D. Item B shall also apply to supplier audits and evaluations exceot that a total combined time interval for any three consecutive inspection or audit intervals should not exceed 3.25 times the specified inspection or audit interval.

In its evaluation of the proposed chance, the NRC determined that the audit interval extension provision was acceptable on the basis that it:

• Conformed to the requirements of Appendix B to 10 CFR Part 50: and

" Was consistent with the staff guidance for reviewing audit proarams, as delineated in Section 17.2 of NUREG-0800.

Based on the above, the proposed use of the 25 percent grace period as described in Part II. Section 18.1 of the proposed QATR has been previously approved for Farley, Hatch, and Voatle and does not represent a change to the Farley, Hatch, or Vootle QA program.

ANSI N18.7-1976 Conformance Page 81 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS Measures for evaluation and Supplement 7S-1 Section 3 selection of procurement states 'Measures for sources include the use of evaluation and selection of historical quality performance procurement sources... shall data, source surveys or audits, include one or more of (a) or source qualification through (c) below:

programs.

(a) evaluation of the Supplier's history of providing an identical or similar product which performs satisfactorily in use...

(b) Supplier's current quality records supported by documented qualitative and quantitative information which can be objectively evaluated; (c) Supplier's technical and quality capability as determined by a direct evaluation of his facilities and personnel and the implementation of his quality assurance program.

Source inspection or audit Supplement 7S-1 Section shall be performed as 8.2.2 states "When source necessary to assure the verification is used, it shall required quality of an item. be performed at intervals Source inspection or audit consistent with the may not be necessary when importance and the quality of the item can be complexity..."

ANSI N 18.7-1976 Conformance Page 82 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS verified by review of test reports, inspection upon receipt, or other means.

Where required by code, NQA-1, 7S-1, Paragraph 8.1 Part II, Section 7.2: Exception to NQA-1 taken.

regulation, or contract states, "Where required by In establishing procurement verification controls, SNC requirements documentary code, regulation, or contract commits to compliance with NQA-1-1994, Basic Requirement evidence that items conform to requirement, documentary 7 and Supplement 7S-1, with the following clarifications and procurement requirements evidence that items conform exceptions:

shall be available at the to procurement documents nuclear power plant site prior shall be available at the to installation or use of such nuclear power facility site NQA-1-1994, Supplement 7S-1 items. prior to installation or use."

- 'SNC considers that other 10 CFR 50 licensees, Authorized Nuclear Inspection Agencies, National Institute of Standards and Technology, or other State and Federal agencies which may provide items or services to SNC plants are not required to be evaluated or audited.

- When purchasing commercial grade calibration services from a calibration laboratory, procurement source evaluation and selection measures need not be performed provided each of the following conditions are met:

(1) The purchase documents impose any additional technical and administrative requirements, as necessary, to comply with the SNC QA program and technical provisions. At a minimum, the purchase document shall require that the calibration certificate/report include identification of the laboratory equipment/standard used.

ANSI N18.7-1976 Conformance Pagae 83 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS (2) The purchase documents require reporting as-found calibration data when calibrated items are found to be out-of-tolerance.

(3) A documented review of the supplier's accreditation shall be performed and shall include a verification of each of the following:

The calibration laboratory holds ao domestic accreditation by the National Voluntary Laboratory Accreditation Program (NVLAP) or by the American Association for Laboratory Accreditation (A2LA) as recognized by NVLAP through athe International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA).

The accreditation is based on ANS/ISO/IEC 17025.

The published scope of accreditation for the calibration laboratory covers the necessary measurement parameters, ranges, and uncertainties.

For Section 8.1, SNC considers documents that may be stored in approved electronic media under SNC control and not physically located on the plant site but which are accessible from the respective nuclear facility site as meeting the NQA-1 requirement for documents to be available at the site.

In lieu of the requirements of Section 10, Commercial Grade Items, controls for commercial grade items and services are established in SNC documents using the guidance of EPRI NP-5652 as discussed in Generic Letter 89-02 and GL 91-05.'

ANSI N 18.7-1976 Conformance Page 84 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS This documentary evidence Part II, Section 7.2:

shall be retrievable and shall In establishing procurement verification controls, SNC be sufficient to identify the commits to compliance with NQA-1 -1994, Basic Requirement specific requirements such as 7 and Supplement 7S-1, with the following clarifications and codes, standards and exceptions:

specifications met by the purchased item.

NQA-1-1994, Supplement 7S-1

- SNC considers that other 10 CFR 50 licensees, Authorized Nuclear Inspection Agencies, National Institute of Standards and Technology, or other State and Federal agencies which may provide items or services to SNC plants are not required to be evaluated or audited.

- When purchasing commercial grade calibration services from a calibration laboratory, procurement source evaluation and selection measures need not be performed provided each of the following conditions are met:

(1) The purchase documents impose any additional technical and administrative requirements, as necessary, to comply with the SNC OA program and technical provisions. At a minimum, the purchase document shall require that the calibration certificate/report include identification of the laboratory equipment/standard used.

(2) The purchase documents require reporting as-found calibration data when calibrated items are found to be out-of-tolerance.

(3) A documented review of the supplier's accreditation shall be performed and shall include a verification of

Enclosure 5 ANSI N18.7-1976 Conformance Pagre 85 of 145

[ ANSI N18.7-1976 I ASME NQA-1-1994 [ SNC QATR COMMENTS each of the following:

• The calibration laboratory holds a#A domestic accreditation by the National Voluntary Laboratory Accreditation Program (NVLAP) or by the American Association for Laboratory Accreditation (A2LA) as recognized by NVLAP through a-the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA).

" The accreditation is based on ANS/ISO/IEC 17025.

• The published scope of accreditation for the calibration laboratory covers the necessary measurement parameters, ranges, and uncertainties.

- For Section 8.1, SNC considers documents that may be stored in approved electronic media under SNC control and not physically located on the plant site but which are accessible from the respective nuclear facility site as meeting the NQA-1 requirement for documents to be available at the site.

- For Section 10, Commercial Grade Items, Controls for commercial grade items are established in SNC documents using the guidance of EPRI NP-5652 as discussed in Generic Letter 89-02 and Generic Letter 91-05.

ANSI N 18.7-1976 Conformance Page 86 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS Where not precluded by other Supplement 7S-1 Section requirements, such 8.2 states "When a documentary evidence may Certificate of Conformance take the form of written is used, the minimum certifications of conformance criteria of (a) through (f) which identify the shall be met.

requirements met by the items, provided means are (f) means shall be provided available to verify the validity to verify the validity of of such certifications. Supplier certificates and the effectiveness of the certification system..."

The effectiveness of the Supplement 7S-1 Section 5 control of quality shall be states "The Purchase of assessed by the purchaser at items and services shall intervals consistent with the establish measures to importance, complexity and interface with the Supplier quality of the item or service. and to verify Suppliers performance as deemed necessary by the Purchaser.

The measures shall include (a) through (f) below:

5.1 The extent of verification activities.., shall be a function of relative importance, complexity, and quantity of the item or services procured and the Supplier's quality performance."

ANSI N 18.7-1976 Conformance Page 87 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS 5.2.13.3 Identification and NQA-1, 8S-1, Paragraph 2.1 Part II, Section 8:

Control of Materials, Parts states, "Items of production 'SNC has established the necessary measures and governing and Components. (batch, lot, component, part) procedures to identify and control items to prevent the use of Measures shall he provided for shall be identified from the incorrect or defective items. This includes controls for the identification and control of initial receipt and fabrication consumable materials and items with limited shelf life. The materials, parts and of the items up to and identification of items is maintained throughout fabrication, components including partially including installation and erection, installation and use so that the item can be traced to fabricated subassemblies. use." its documentation, consistent with the item's effect on safety.

Identification locations and methods are selected so as not to affect the function or quality of the item.'

These procedures shall be BR8 "Identification and implemented to provide Control of Items" states insurance that only correct and "Controls shall be accepted items are used and established to assure that installed, and relating an item only correct and accepted of production (batch, lot, items are used or installed."

component, part) at any stage, from initial receipt through Supplement 8S-1 fabrication, installation, repair "Identification and Control of or modification, to an Items" Section 2.1 states applicable drawing, "Items of production (batch, specification, or other pertinent lot, component, part) shall technical document. be identified from the initial receipt and fabrication of the items up to and including installation and use. The identification shall relate an item to an applicable design or other pertinent specifying document."

ANSI N18.7-1976 Conformance Page 88 of 145 ANSI N18.7-1976 ASME NaA-1-1994 SNC QATR COMMENTS Physical identification shall be Supplement 8S-1 Section used to the maximum extent 2.2 states "Physical possible. Where physical identification shall be used identification is either to the maximum extent impractical or insufficient, possible. Where physical physical separation, identification on the item is procedural control or other either impractical or appropriate means shall be insufficient, physical employed, separation, procedural control or other appropriate means shall be employed.

Identification may be either on BR8 "Identification and the item or on records Control of Items" states traceable to the item, as "Identification shall be appropriate. maintained on the items or in documents traceable to the item..."

Where identification marking is Supplement 8S-1 Section The NQA-1 requirements are employed, the marking shall 2.3 states "Identification better stated.

be clear, unambiguous and markings, when used, shall indelible, and shall be applied be applied using materials in such a manner as not to and methods which provide affect the function of the item. a clear and legible identification and do not detrimentally affect the function or service life of the item."

ANSI N 18.7-1976 Conformance Page 89 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS Markings shall be transferred Supplement 8S-1 Section to each part of an item when 2.3 states "Markings shall subdivided and shall not be be transferred to each part obliterated or hidden by of an identified item when surface treatment or coatings subdivided and shall not be unless other means of obliterated or hidden by identification are substituted. surface treatment or coatings unless other means of identification are substituted."

When standards or Supplement 8S-1 Section specifications require 3.1 states 'When specified traceability of materials, parts by codes, standards or or components to specific specifications that include inspection or test records, the specific identification or program shall be designed to traceability requirements provide such traceability, (such as identification or traceability of the item to applicable specification and grade of material; heat, batch, lot, part, or serial number; or specified inspection, test, or other records), the program shall be designed to provide such identification and traceability control."

5.2.13.4 Handling, Storage BR13 "Handling, Storage, and Shipping. Measures shall and Shipping" states be provided to control "Handling, storage, handling, storage and cleaning, packaging, shipping, including cleaning, shipping, and preservation packaging and preservation of of items shall be controlled material and equipment in to prevent damage or loss ANSI N18.7-1976 Conformance Page 90 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS accordance with established and to minimize instructions, procedures or deterioration."

drawings, to prevent damage, deterioration and loss.

When necessary for particular Supplement 13S-1 Part II, Section 13:

items, special coverings, "Supplementary 'Special controls (such as containers, shock absorbers, special equipment and special Requirements for Handling, accelerometers, inert gas atmospheres, specific moisture protective environments, such Storage, and Shipping" content levels and temperature levels) are provided when as inert gas atmosphere, Section 3.1 states "When specific moisture content required for particular items, required to maintain acceptable quality.'

levels and temperature levels special equipment (such as shall be specified, provided, containers, shock and their existence verified,, absorbers, and accelerometers) and special protective environments (such as inert gas atmosphere, specific moisture content levels, and temperature levels) shall be specified, provided, and their existence verified."

For critical, sensitive, Supplement 8S-1 Section perishable or high-value 3.2 states "When required articles, specific written for critical, sensitive, procedures for handling, perishable or high-value storage, packaging, shipping articles, specific procedures and preservation should be for handling, storage, used. packaging, shipping and preservation shall be used."

Special handling tools and Supplement 8S-1 Section equipment shall be provided 3.3 states "Special handling and controlled as necessary to tools and equipment shall ANSI N18.7-1976 Conformance Page 91 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS ensure safe and adequate be utilized and controlled as handling, necessary to ensure safe and adequate handling."

Special handling tools and Supplement 8S-1 Section equipment shall be inspected 3.3 states "Special handling and tested in accordance with tools and equipment shall written procedures and at be inspected and tested in specified times, to verify that accordance with procedures the tools and equipment are and at specified time adequately maintained, intervals to verify that the tools and equipment are adequately maintained."

Attention shall be given to Supplement 8S-1 Section 4 providing adequate states 'Instructions for instructions for marking and marking and labeling for labeling of items for packaging, shipment, packaging, shipment and handling, and storage of storage. Marking shall be items shall be established adequate to identify, maintain as necessary to adequately and preserve the shipment, identify, maintain and including indication of the preserve the item, including presence of special indication of the presence of environments or the need for special environments or the special control. need for special controls."

American National Standard ANSI N45.2.2 = NQA-1 Part II, Section 13.2:

for Packaging. Shipping, Subpart 2.2 'In establishing provisions for handling, storage and shipping, Receiving, Storage and SNC commits to compliance with NQA-1-1994, Basic Handling of Items for Nuclear Requirement 13 and Supplement 13S-1. SNC also commits Construction Phase), N45.2.2- to compliance with the requirements of NQA-1 -1994, Subpart 1972, shall be applied to those 2.2, with the clarifications and exceptions shown below.'

activities occurring during the ANSI N 18.7-1976 Conformance Page 92 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS operational phase that are comparable in nature and extent to related activities occurring during construction.

5.2.14 Nonconforming Items. BR15 'Control of Measures shall be provided to Nonconforming Items" control items, services or states 'Items that do not activities which do not conform conform to specified to requirements (see also requirements shall be Section 5.2.6). controlled to prevent inadvertent installation or use."

These procedures shall BR 15 "Control of include as appropriate, Nonconforming Items" instructions for identification, states "Controls shall documentation, segregation, provide for instructions for disposition and notification to identification, affected organizations. documentation, evaluation, segregation when practical, and disposition of nonconforming items, and for notification to affected organizations."

Nonconforming items shall be Supplement 15S-1 Section reviewed and accepted, 4.1 states "Nonconforming rejected, repaired or reworked characteristics shall be in accordance with reviewed and recommended documented procedures. dispositions of nonconforming items shall be proposed and approved ANSI N 18.7-1976 Conformance Page 93 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS in accordance with documented procedures."

The responsibility and Supplement 15S-1 Section authority for the disposition of 4.2 states "The nonconforming items shall be responsibility and authority defined, for the evaluation and disposition of nonconforming items shall be defined."

Repaired and reworked items Supplement 15S-1 Section NQA-1 uses a more shall be reinspected in 4.5 states 'Repaired or encompassing word, accordance with applicable reworked items shall be reexamined," in lieu of procedures. reexamined in accordance "reinspected" with applicable procedures...'

Measures which control further Supplement 15S-1 Section processing, delivery, or 4.1 states 'Further installation of a nonconforming processing, delivery, or defective item pending a installation or use of a decision on its disposition shall nonconforming item shall be be established and controlled pending an maintained, evaluation and an approved disposition..

ANSI N 18.7-1976 Conformance Page 94 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS Nonconforming items may be Supplement 15S-1 Section disposed of by acceptance 'as 4.4 states "The disposition, is," by scrapping or repairing such as use-as-is, reject, the defective item, or by repair, or rework, of rework to complete or correct nonconforming items shall to a drawing or specification. be identified and Such measures shall provide documented.

assurance that the item is identified as nonconforming Technical justification for the and controlled. The measures shall require documentation acceptability of a verifying noncnfomin the acceptability ites wich of nonononforming dispositioned item, or use repair nonconforming items which as is shall be documented.'

have the disposition of "repair' or "use as is."

A description of the change, Supplement 15S-1 Section waiver or deviation that has 4.4 states The as-built been accepted shall be records, if such records are documented to record the required, shall reflect the change and denote the as- accepted deviation.'

built condition.

As a guideline, control of Supplement 15S-1 Section nonconforming items by 2 states 'Identification of tagging, marking or other nonconforming items shall means of identification is be by marking, tagging, or acceptable where physical other methods...

segregation is not practical. Supplement 15S-1 Section although physical segregation 3 states 'Nonconforming and marking are preferred. items shall be segregated, when practical..

ANSI N18.7-1976 Conformance Page 95 of 145 ANSI N18.7-1976 ASME NQA-1 -1994 SNC QATR COMMENTS 5.2.15 Review, Approval and BR6 'Document Control' Control of Procedures The states 'The preparation, administrative controls and issue, and change of quality assurance program documents that specify shall provide measures to quality requirements or control and coordinate the prescribe activities affecting approval and issuance of quality shall be controlled to documents including changes assure that correct thereto, which prescribe all documents are being activities affecting quality, employed. Such documents, including changes thereto, shall be reviewed for adequacy and approved for release by authorized personnel.'

Such documents include those Part II, Section 5:

which describe organizational 'SNC has established the necessary measures and governing interfaces, or which prescribe procedures to ensure that activities affecting quality are activities affecting safety- prescribed by and performed in accordance with instructions, related structures, systems, or procedures or drawings of a type appropriate to the components. These circumstances and which, where applicable, include documents also include quantitative or qualitative acceptance criteria to implement the operating and special orders, QAP as described in the QATR. Such documents are operating procedures, test prepared and controlled according to Part II, Section 6 of this procedures, equipment control QATR. In addition, means are provided for dissemination to procedures, maintenance or plant staff of instructions of both general and continuing refueling, and material control applicability, as well as those of short-term applicability.

Provisions are included for reviewing, updating, and canceling procedures. such procedures.'

ANSI N18.7-1976 Conformance Page 96 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS These measures shall assure Part II, Section 6:

that documents, including 'SNC has established the necessary measures and governing revisions or changes, are procedures to control the preparation of, issuance of, and reviewed for adequacy by changes to documents that specify quality requirements or appropriately qualified prescribe how activities affecting quality are controlled to personnel and approved for assure that correct documents are being employed. Such release by authorized documents, including changes thereto, shall be reviewed for personnel; and are distributed adequacy and approved for release by authorized personnel.

in accordance with current The control system shall be documented and shall provide for distribution lists and used by (a) through Lep) below:

the personnel performing the prescribed activity, and that (a) identification of documents to be controlled and their procedures are provided to specified distribution; avoid the misuse of outdated (b) identification of assignment of responsibility for preparing, or inappropriate documents. reviewing, approving, and issuing documents; (c) review of documents for adequacy, completeness, and correctness prior to approval and issuance.'

(d) coordinating and controlling interface documents and procedures- and (e) a method for providing feedback from users to continually improve procedures and work instructions.

[Procedures for operational Part II, Section 6.1: N18.7 wording in brackets is phase activities of a nuclear 'Changes to documents, other than those defined in included in this table for power plant reflect the implementing procedures as minor changes, are considered completeness; it does not conditions that exist at the as major changes and shall be reviewed and approved by the establish requirements that time the procedures are same organizations that performed the original review and either NQA-1 or the SNC QATR written. Procedures for approval unless other organizations are specifically would need to address.

operational phase ant of designated. The reviewing organization shall have access to a nuclear power plant reflect pertinent background data or information upon which to base the conditions that exist at the their approval. Minor changes to documents, such as time the procedures are inconsequential editorial corrections, shall not require that the include the technical revised documents receive the same review and approval as information available, industry the original documents. To avoid a possible omission of a experience, and in the case of required review, the type of minor changes that do not require ANSI N 18.7-1976 Conformance Page 97 of 145 ANSI NI 8.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS the initial procedures for a new such a review and approval and the persons who can plant assumptions made authorize such a decision shall be clearly delineated in regarding the detailed implementing procedures.'

behavior of the plant that may not be fully known prior to operation.] In order to ensure Part II, Section 5:

that the procedures in current 'Such documents are prepared and controlled according to use provide the best possible Part II, Section 6 of this QATR. In addition, means are instructions for performance of provided for dissemination to plant staff of instructions of both the work involved, systematic general and continuing applicability, as well as those of short-review and feedback of term applicability. Provisions are included for reviewing, information based on use is updating, and canceling such procedures.'

required.

Part II, Section 6:

SNC has established the necessary measures and governing procedures to control the preparation of, issuance of, and changes to documents that specify quality requirements or prescribe how activities affecting quality are controlled to assure that correct documents are being employed. Such documents, including changes thereto, shall be reviewed for adequacy and approved for release by authorized personnel.

The control system shall be documented and shall provide for (a) through (e) below:

(a) identification of documents to be controlled and their specified distribution:

(b) identification of assignment of responsibility for orepadnn, reviewina, approvina, and issuing documents:

(c) review of documents for adequacy, completeness, and correctness prior to approval and issuance:

(d) coordinating and controlling interface documents and procedures: and (e) a method for providing feedback from users to continually improve procedures and work instructions.

ANSI N18.7-1976 Conformance Pare 98 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS Each procedure shall be Part II, Section 6.1:

reviewed and approved prior 'Changes to documents, other than those defined in to initial use. implementing procedures as minor changes, are considered as major changes and shall be reviewed and approved by the same organizations that performed the original review and approval unless other organizations are specifically designated.'

The frequency of subsequent Part II, Section 5:

reviews shall be specified and 'Such documents are prepared and controlled according to may vary depending on the Part II, Section 6 of this QATR. In addition, means are type and complexity of the provided for dissemination to plant staff of instructions of both activity involved, and may vary general and continuing applicability, as well as those of short-with time as a given plant term applicability. Provisions are included for reviewing, reaches operational maturity, updating, and canceling such procedures.'

Applicable procedures shall be Part II, Section 5:

reviewed following an unusual 'Such documents are prepared and controlled according to incident, such as an accident, Part II, Section 6 of this QATR. In addition, means are an unexpected transient, provided for dissemination to plant staff of instructions of both significant operator error, or general and continuing applicability, as well as those of short-equipment malfunction. term applicability. Provisions are included for reviewing, Applicable procedures shall be updating, and canceling such procedures.'

reviewed following any modification to a system. Plant procedures shall be reviewed by an individual knowledgeable in the area affected by the procedure no less frequently than every two years to determine if changes are necessary or desirable. A revision of a procedure constitutes a procedure review.

ANSI N18.7-1976 Conformance Page 99 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS Procedures shall be approved Part II, Section 6.1:

as designated by the owner 'Changes to documents, other than those defined in Rules shall be established implementing procedures as minor changes, are considered which clearly delineate the as major changes and shall be reviewed and approved by the review of procedures by same organizations that performed the original review and knowledgeable personnel approval unless other organizations are specifically other than the originator and designated. The reviewing organization shall have access to the approval of procedures pertinent background data or information upon which to base and procedure changes by their approval. Minor changes to documents, such as authocrized i s, byinconsequential hndivid editorial corrections, shall not require that the authorized individuals, revised documents receive the same review and approval as the original documents. To avoid a possible omission of a required review, the type of minor changes that do not require such a review and approval and the persons who can authorize such a decision shall be clearly delineated in implementing procedures.'

Changes to documents shall Part II, Section 6.1:

be reviewed and approved by 'Changes to documents, other than those defined in the same organizations that implementing procedures as minor changes, are considered perform the original review as major changes and shall be reviewed and approved by the and approval unless the owner same organizations that performed the original review and anoteriqalioeddrgaizatonapproval unless other organizations are specifically another qualified organization, designated. The reviewing organization shall have access to pertinent background data or information upon which to base their approval. Minor changes to documents, such as inconsequential editorial corrections, shall not require that the revised documents receive the same review and approval as the original documents. To avoid a possible omission of a ANSI N18.7-1976 Conformance Paie 100 of 145 ANSI N18.7-1976 ASME NQA-1 -1994 SNC QATR COMMENTS required review, the type of minor changes that do not require such a review and approval and the persons who can authorize such a decision shall be clearly delineated in implementing procedures.'

The reviewing organizations Supplement 6S-1, Section shall have access to pertinent 3.1 states, "The reviewing background information upon organization shall have which to base its approval and access to pertinent shall have adequate background data or understanding of requirements information upon which to and intent of the original base their review."

document.

Those participating in any Part II, Section 5:

activity shall be made aware of 'SNC has established the necessary measures and governing and use, proper and current procedures to ensure that activities affecting quality are instructions, procedures, prescribed by and performed in accordance with instructions, drawings and engineering procedures or drawings of a type appropriate to the requirements for performing circumstances and which, where applicable, include the activity, Participating quantitative or qualitative acceptance criteria to implement the organizations shall have QAP as described in the QATR. Such documents are procedures for control of the prepared and controlled according to Part II, Section 6 of this documents and changes QATR. In addition, means are provided for dissemination to thereto to preclude the plant staff of instructions of both general and continuing possibility or use of outdated applicability, as well as those of short-term applicability.

or inappropriate documents. Provisions are included for reviewing, updating, and canceling such procedures.'

Document control measures Supplement 6S-1 Section 2 Part II, Section 6.2: In response to NRC RAI, shall provide for: states 'The control system NQA-1 -1994 Commitment Question 7. SNC has (1) Identification of individuals shall be documented and incorporated the ANSI N18.7-or organizations responsible shall provide for (a) through !In establishing provisions for document control, SNC commits 1976 requirement for ANSI N 18.7-1976 Conformance Page 101 of 145 ANSI N18.7-1976 ASME NQA-1 -1994 SNC QATR COMMENTS for preparing, reviewing, (c) below: to compliance with NQA-1 -1994, Basic Requirement 6 and coordinating and controlling approving, and issuing Supplement 6S-1. Additionally, Section 6 of the proposed interface documents and documents and revisions (a) identification of QATR incorporates the following requirements from ANSI procedures into the proposed thereto documents to be controlled N18.7-1976, not included in NQA-1-1994:-! SNC QATR to suoplement the (2) Identifying the proper and their specified 1. Coordinating and controllinq interface documents and document control requirements documents to be used in distribution; procedures, and of ASME NOA-1-1994.

performing the activity (3) (b) identification of 2. a method for providina feedback from users to Coordination and control of assignment of responsibility continually improve procedures and work instructions.

interface documents for preparing, reviewing, (4) Ascertaining that proper approving, and issuing documents are being used (5) documents Establishing current and (c) review of documents for updated distribution lists adequacy, completeness, and correctness prior to approval and issuance."

5.2.16 Measuring and Test Supplement 12S-1 Equipment. "Supplementary Requirements for Control of The method and interval of Measuring and Test calibration for each installed Equipment" Section 3.2 instrument and control device states "The method and shall be defined and shall be interval of calibration for based on the type of each item shall be defined, equipment, stability and based on the type of reliability characteristics, equipment, stability required accuracies and other characteristics, required conditions affecting calibration, accuracy, intended use, and other conditions affecting measurement control."

ANSI N18.7-1976 Conformance Paze 102 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS Tools, instruments, testing BRI 2 "Control of Measuring equipment and measuring and Test Equipment" states devices used for "Tools, gages, instruments, measurements, tests and and other measuring and calibration shall be of the test equipment used for proper range and type and activities affecting quality shall be controlled, calibrated shall be controlled and at and adjusted and maintained specified periods calibrated at specified intervals or prior to and adjusted to maintain use to assure the necessary accuracy within necessary accuracy of calibrated devices, limits."

Supplement 12S-1 Section 2 states "Selection of measuring and test equipment shall be controlled to assure that such items are of proper type, range, accuracy, and tolerance..."

When calibration, testing, or Supplement 12S-1 Section Part II, Section 12:

other measuring devices are 3.2 states "When measuring 'Measuring and test equipment found out of calibration is found to be out of calibration, and test equipment is found tagged or segregated and not used until it is successfully re-an evaluation shall be made to be out of calibration, an calibrated. An evaluation is performed to determine the and documented concerning evaluation shall be made acceptability of any items measured, inspected or tested with the validity of previous tests and documented of the an out-of-calibration device from the time of the previous and the acceptability of validity of previous calibration.'

devices previously tested from inspection or test results the time of the previous and of the acceptability of calibration. If any calibration, items previously inspected testing or measuring device is or tested... Ifany measuring consistently found to be out of or test equipment is calibration, it shall be repaired consistently found to be out or replaced. of calibration, it shall be repaired or replaced."

ANSI N18.7-1976 Conformance Page 103 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS It is not the intent of this Supplement 12S-1 Section Standard to imply a need for 3.3 states "Calibration and special calibration and control control measures may not measures on rulers, tape be required for rulers, tape measures, levels and other measures, levels and other such devices if normal such devices, if normal commercial practices provide commercial equipment adequate accuracy. provides adequate accuracy.

Special calibration shall be Supplement 12S-1 Section performed when the accuracy 3.2 states "A calibration of either installed or calibrating shall be performed when the equipment is questionable. accuracy of the equipment is suspect.

Records shall be made and Supplement 12S-1 Section equipment suitably marked to 5 states 'Records shall be indicate calibration status. maintained and equipment shall be suitably marked to indicate calibration status."

American National Standard ANSI N45.2.4 = NQA-1 Part II, Section 10.1:

N45.2.4-1972 shall be applied Subpart 2.4 'In establishing inspection requirements, SNC commits to to those activities occurring compliance with NQA-1-1994, Basic Requirement 10, during the operational phase Supplement 1OS-1 and Subpart 2.4, with the clarification that that are comparable in nature follows below. In addition, for situations comparable to and extent to related activities original new plant construction, SNC commits to compliance occurring during construction with the requirements of Subparts 2.5 and 2.8 for establishing

[6]. appropriate inspection requirements.'

ANSI N 18.7-1976 Conformance Page 104 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS 5.2.17 Inspections. A Part II, Section 10:

program for inspection of 'SNC has established the necessary measures and governing activities affecting safety shall procedures to implement inspections that assure items, be established and executed services and activities affecting safety meet established by or for the organization requirements and conform to applicable documented performing the activity to verify specifications, instructions, procedures, and design conformance with applicable documents. Inspection may also be applied to items, services documented instructions, and activities affecting plant reliability and integrity. Types of procedures, and drawings. inspections may include those verifications related to procurement, such as source, in-process, final, and receipt inspection, as well as maintenance, modification, in-service, and operational activities. Inspections are carried out by properly qualified persons independent of those who performed or directly supervised the work.'

Inspections, examinations, NQA-1, 12S-1, Paragraph measurements, or tests of 6.1 states, "Inspection of material, products, or activities items in- process or under shall be performed for each construction shall be work operation where performed for work activities necessary to assure quality, where necessary to verify quality."

Such inspections shall be BR1O 'Inspection' states Part II, Section 10:

performed by qualified "Inspection for acceptance 'Inspections are carried out by properly qualified persons individuals other than those shall be performed by independent of those who performed or directly supervised who performed or directly persons other than those the work.'

supervised the activity being who performed or directly inspected, supervised the work being inspected."

ANSI N 18.7-1976 Conformance Page 105 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS Inspection of operating BR10 "Inspection" states Part II,Section 10:

activities (work functions "Inspection for acceptance 'Inspections are carried out by properly qualified persons associated with normal shall be performed by independent of those who performed or directly supervised operation of the plant, routine persons other than those the work. Inspection results shall be documented. Where maintenance, and certain who performed or directly quality verification inspections at plants are performed by the technical services routinely supervised the work being maintenance organization,, the inspectors report to the assigned to the onsite inspected." engineering support organization while performing inspections operating organization) may in order to meet the independence requirements of NQA be conducted by second-line 1994, Supplement 1OS-1, Section 3.1.'

supervisory personnel or by other qualified personnel not assigned first-line supervisory responsibility for conduct of the work.

These independent BR 10 'Inspection" states Part II,Section 2.1:

inspections i.e., those "Inspection for acceptance 'Personnel who work directly or indirectly for SNC are performed by individuals not shall be performed by responsible for the achievement of acceptable quality in the assigned first-line supervisory persons other than those work covered by this QATR.'

responsibility for the conduct who performed or directly of the work, are not intended supervised the work being to dilute or replace the clear inspected."

responsibility of first-line supervisors for the quality of work performed under their supervision.

For modifications and non- Part II,Section 10.1:

routine maintenance, 'In establishing inspection requirements, SNC commits to inspections shall be conducted compliance with NOA-1-1994, Basic Requirement 10, in a manner similar Supplement 1OS-1 and Subpart 2.4, with the clarification that (frequency, type, and follows below. In addition, for situations comparable to inspections) to that associated original new plant construction, SNC commits to compliance with construction phase with the requirements of Subparts 2.5 and 2.8 for establishing activities (see also Section appropriate inspection requirements.'

5.2.7).

ANSI N18.7-1976 Conformance Page 106 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS Inspections of safety- related Supplement 1OS-1 Section Part II, Section 10.1:

activities shall be performed in 2 "Supplementary 'In establishing inspection requirements, SNC commits to accordance with appropriate Requirements for compliance with NQA-1-1994, Basic Requirement 10, written, procedures, which set Inspection" states Supplement 1OS-1 and Subpart 2.4, with the clarification that forth the requirements and "Inspection requirements follows below. In addition, for situations comparable to acceptance limits and specify and acceptance criteria shall original new plant construction, SNC commits to compliance the inspection responsibilities, include specified with the requirements of Subparts 2.5 and 2.8 for establishing requirements contained in appropriate inspection requirements.'

applicable design documents or other pertinent technical documents... Inspection activities shall be documented and controlled by instructions, procedures, drawings, checklists, travelers, or other appropriate means."

If mandatory inspection hold Supplement 1OS-1 Section Part II, Section 10.1:

points are required, the 4 states "If mandatory 'In establishing inspection requirements, SNC commits to specific hold points shall be inspection hold points are compliance with NQA-1-1994, Basic Requirement 10, indicated in appropriate required... the specific hold Supplement 1OS-1 and Subpart 2.4, with the clarification that documents. points shall be indicated in follows below. In addition, for situations comparable to appropriate documents." original new plant construction, SNC commits to compliance with the requirements of Subparts 2.5 and 2.8 for establishing appropriate inspection requirements.'

Information concerning, Supplement 1OS-1 Section Part II, Section 10.1:

inspection shall be obtained 2 states "Inspection 'In establishing inspection requirements, SNC commits to from the related design requirements and compliance with NQA-1-1994, Basic Requirement 10, drawings, specifications acceptance criteria shall Supplement 1OS-1 and Subpart 2.4, with the clarification that and/or, other controlled include specified follows below. In addition, for situations comparable to documents. requirements contained in original new plant construction, SNC commits to compliance the applicable design with the requirements of Subparts 2.5 and 2.8 for establishing documents or other ANSI N18.7-1976 Conformance Page 107 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS pertinent technical appropriate inspection requirements.'

documents..."

When inspection techniques Supplement 1OS-1 Section Part II, Section 10.1:

require specialized 3.2 states "Each person who 'In establishing inspection requirements, SNC commits to qualifications or skills, verifies conformance of compliance with NQA-1-1994, Basic Requirement 10, personnel performing the work activities for purposes Supplement 1OS-1 and Subpart 2.4, with the clarification that inspection shall meet of acceptance shall be follows below. In addition, for situations comparable to applicable licensing qualified to perform the original new plant construction, SNO commits to compliance requirements, codes, and assigned inspection task." with the requirements of Subparts 2.5 and 2.8 for establishing standards appropriate to the appropriate inspection requirements.'

discipline involved (see also Sections 5.2.7, 5.2.6 and 5.3.10).

If inspection is impossible or Supplement 10S-1 Section Part II, Section 10.1:

disadvantageous, indirect 6.1 states "If inspection of 'In establishing inspection requirements, SNC commits to control by monitoring processed items is compliance with NQA-1 -1994, Basic Requirement 10, processing methods, impossible or Supplement 1OS-1 and Subpart 2.4, with the clarification that equipment and personnel shall disadvantageous, indirect follows below. In addition, for situations comparable to be provided, control by monitoring of original new plant construction, SNC commits to compliance processing methods, with the requirements of Subparts 2.5 and 2.8 for establishing equipment and personnel appropriate inspection requirements.

shall be provided."

Both inspection and process Supplement 1OS-1 Section Part II, Section 10.1:

monitoring shall be provided 6.1 states "Both inspection 'In establishing inspection requirements, SNC commits to when control is inadequate and process monitoring compliance with NQA-1-1994, Basic Requirement 10, without both. shall be provided when Supplement 1OS-1 and Subpart 2.4, with the clarification that control is inadequate without follows below. In addition, for situations comparable to both." original new plant construction, SNC commits to compliance with the requirements of Subparts 2.5 and 2.8 for establishing appropriate inspection requirements.'

[In cases where documented N18.7 wording in brackets are verification of quality implied included in this table for ANSI N 18.7-1976 Conformance Page 108 of 145 ANSI N1 8.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS by the above requirements is completeness; they do not not possible or feasible, the establish requirements that extent of inspection or either NQA-1 or the SNC QATR performance testing to verify would need to address.

adequacy of structures, systems or components for service should be, in general, greater than otherwise required.]

The owner organization shall Supplement 10S-1 Section Part II, Section 11:

evaluate inspection results 7.3 states "The acceptance 'SNC has established the necessary measures and governing along with test results (see of the item shall be procedures to demonstrate that items subject to the provisions Section 5.2.19) to determine documented and approved of this QATR will perform satisfactorily in service, that the whether the individual by authorized personnel." plant can be operated safely and as designed, and that the inspection and test programs coordinated operation of the plant as a whole is satisfactory.'

demonstrate that the plant can Supplement 11S-1 Section be operated safely and as 4 "Supplementary designed. Requirements for Test Control" states "Test results shall be documented and evaluated by a responsible authority to assure that test requirements have been satisfied."

Records shall be kept in Supplement 10S-1 Section Part II, Section 10.1:

sufficient detail to permit 9 states "Records shall, as 'In establishing inspection requirements, SNC commits to adequate confirmation of the a minimum, identify (a) compliance with NQA-1-1994, Basic Requirement 10, inspection program. The through (f) below: Supplement 1OS-1 and Subpart 2.4, with the clarification that person recording the data as follows below. In addition, for situations comparable to well as the person approving (c) inspector" original new plant construction, SNC commits to compliance the inspection results shall be with the requirements of Subparts 2.5 and 2.8 for establishing identified. appropriate inspection requirements.'

ANSI N 18.7-1976 Conformance Paye 109 of 145 I ANSI N18.7-1976 I ASME NQA-1-1994 SNC QATR COMMENTS I Deviations, their cause, and Supplement 1OS-1 Section Part II, Section 16 any corrective action 9 states "Records shall, as 'SNC has established the necessary measures and governing completed or planned as a a minimum, identify (a) procedures to promptly identify, control, document, classify.

result of the deviations shall through (f) below:

and correct conditions adverse to quality. SNC procedures be documented. Inspection (f) reference to information require personnel to identify known conditions adverse to records shall be identified as on action taken in quality and assure that corrective actions are documented and such and shall be retrievable connection with initiated in accordance with regulatory guidance and (see also Section 5.2.12). nonconformances."

applicable auality standards. When complex issues arise BR 15 "...Controls shall where it cannot be readily determined if a condition adverse to provide for identification, quality exists, SNC documents establish the requirements for documentation, evaluation, documentation and timely evaluation of the issue. Results of segregation when practical, evaluations of conditions adverse to Quality are analyzed to and disposition of identify trends. Significant conditions adverse to quality and nonconforming items,..." significant trends are documented and reported to responsible BR 16 'The identification, management.'

cause, and corrective action for significant conditions Part II, Section 17.1:

adverse to quality shall be documented..." 'Records of activities for design, engineering, procurement, manufacturing, construction, inspection and test, installation, pre-operation, startup, operations, maintenance, modification, decommissioning, and audits include the appropriate content requirements of NQA-1-1994, Parts I and II. Such records and their retention times are based on Regulatory Position C.2, Table 1, of Regulatory Guide 1.28, Revision 3. This table addresses design, construction, and initial start-up records and will be applied to operating and decommissioning phase records that are similar in nature to the construction records.

Additional operations phase records and their retention periods are identified in the respective FSAR for each plant.

In addition, SNC uses the list of records in 10 CFR 71.135 and 10 CFR 72.174 to establish the types of records that will be created and retained in support of transportation and storage operations governed by 10 CFR Part 71 and Part 72, respectively.'

L I _____________________________

ANSI N18.7-1976 Conformance Page 110 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS 5.2.18 Control of Special Part II, Section 9:

Processes. 'SNC has established the necessary measures and governing procedures to assure that special processes that require Measures shall be interim process controls to assure quality, such as welding, established and documented heat treating, and nondestructive examination, are controlled.

to assure that special These provisions include assuring that special processes are processes accomplished accomplished by qualified personnel using qualified under controlled conditions in procedures and equipment. Special processes are performed accordance with applicable in accordance with applicable codes, standards, codes, standards, specifications, criteria or other specially established specifications, criteria, and requirements. Special processes are those where the results other special requirements, are highly dependent on the control of the process or the skill use qualified personnel and of the operator, or both, and for which the specified quality procedures. cannot be fully and readily determined by inspection or test of the final product.'

Qualification of personnel, Supplement 9S-1 Section procedures, and equipment 3.1.1 "Supplementary shall comply with the Requirements for Control of requirements of applicable Processes" states codes and standards. "Qualification of personnel, procedures, and equipment shall comply with specified requirements."

Special processes are those Part II, Section 9:

that require interim in- process SNC has established the necessary measures and governing controls in addition to final procedures to assure that special processes that require inspection to assure quality interim process controls to assure quality, such as welding, including such processes as heat treating, and nondestructive examination, are controlled.

welding, heat treating, These provisions include assuring that special processes are chemical cleaning, and accomplished by qualified personnel using qualified nondestructive examination. procedures and equipment. Special processes are performed in accordance with applicable codes, standards, specifications, criteria or other specially established ANSI N 18.7-1976 Conformance Pane 111 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS requirements. Special processes are those where the results are highly dependent on the control of the process or the skill of the operator, or both, and for which the specified quality cannot be fully and readily determined by inspection or test of the final product.

For special processes not Supplement 9S-1 Section covered by existing codes or 3.4 states "For special standards, or where item processes not covered by quality requirements exceed existing codes or standards the requirements of or where quality established codes or requirements specified for standards, the necessary an item exceed those of qualifications of personnel, existing codes or standards, procedures, or equipment the necessary requirements shall be defined, for qualifications of personnel, procedures, or equipment shall be specified or referenced in the procedures or instructions."

5.2.19 Test Control. Part II, Section 11:

'SNC has established the necessary measures and governing A test program shall be procedures to demonstrate that items subject to the provisions established to assure that of this QATR will perform satisfactorily in service, that the testing required to plant can be operated safely and as designed, and that the demonstrate that the item will coordinated operation of the plant as a whole is satisfactory.'

perform satisfactorily in service is identified and documented, and that the testing is performed in accordance with written test procedures which incorporate or reference the requirements and acceptance limits contained in applicable design ANSI N18.7-1976 Conformance Page 112 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS documents.

The test program shall cover NQA-1 Subpart 2.8 Section Part II, Section 11:

all required tests including: 5.2 "Quality Assurance 'SNC has established the necessary measures and governing (1) Tests during the Requirements for procedures to demonstrate that items subject to the provisions preoperational period to Installation, Inspection, and of this QATR will perform satisfactorily in service, that the demonstrate that isperformance of plant systems in Testing Equipment of Mechanical and Systems for plant patcnbcan be operated prtdsfl safely and n assdsgeadta designed, and that the h

ofcoplant ssthdemsisgin inte qNuipent Pwandytems. f coordinated operation of the plant as a whole is satisfactory.

accordance with design intent Nuclear Power Plants" These programs include criteria for determining when testing and that the coordinated states (Preoperational is required, such as proof tests before installation, pre-ope ration of the plant as a Tinvolvestig Thsteting operational tests, post-maintenance tests, post-modification whole is satisfactory, to the involves the operation of all tests, in-service tests, and operational tests (such as extent feasible. items in a system(s) or surveillance tests required by Plant Technical Specifications),

partial system(s) to assure to demonstrate that performance of plant systems is in that operation is in accordance with design. Programs also include provisions for accordance with the design establishing and adjusting test schedules and maintaining criteria and functional status for periodic or recurring tests. Tests are performed requirements." according to applicable procedures that include, consistent with the effect on safety, (1) instructions and prerequisites to perform the test, (2) use of proper test equipment, (3) acceptance criteria, and (4) mandatory verification points as necessary to confirm satisfactory test completion. Test results are documented and evaluated by the organization performing the test and reviewed by a responsible authority to assure that the test requirements have been satisfied. If acceptance criteria are not met, retesting is performed as needed to confirm acceptability following correction of the system or equipment deficiencies that caused the failure.'

(2) Tests during the initial Part II, Section 11:

operational phase to 'SNC has established the necessary measures and governing demonstrate the performance procedures to demonstrate that items subject to the provisions of systems that could nor be of this QATR will perform satisfactorily in service, that the tested prior to operation and to plant can be operated safely and as designed, and that the confirm those physical coordinated operation of the plant as a whole is satisfactory.

parameters, hydraulic or These programs include criteria for determining when testing ANSI N 18.7-1976 Conformance Page 113 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS mechanical characteristics that is required, such as proof tests before installation, pre-need to be known, but which operational tests, post-maintenance tests, post-modification could not be predicted with the tests, in-service tests, and operational tests (such as required accuracy, and to surveillance tests required by Plant Technical Specifications),

confirm that plant behavior to demonstrate that performance of plant systems is in conforms to design criteria. accordance with design. Programs also include provisions for establishing and adjusting test schedules and maintaining status for periodic or recurring tests. Tests are performed according to applicable procedures that include, consistent with the effect on safety, (1) instructions and prerequisites to perform the test, (2) use of proper test equipment, (3) acceptance criteria, and (4) mandatory verification points as necessary to confirm satisfactory test completion. Test results are documented and evaluated by the organization performing the test and reviewed by a responsible authority to assure that the test requirements have been satisfied. If acceptance criteria are not met, retesting is performed as needed to confirm acceptability following correction of the system or equipment deficiencies that caused the failure.'

The initial start-up test These requirements apply to program shall be planned to initial start-up testing. The SNC permit safe fuel loading and QATR is intended to cover start-up; to increase power in initial start u testing, if a safe increments; and to decision is made to design and perform major testing at build a new plant. At this time, specified power plateaus. If this section is not applicable to tests require the variation of SNC's scope of responsibilities.

operating parameters outside of their normal range, the limits within which such variation is permitted shall be prescribed. Prerequisites and record keeping shall be given attention and the scope of the testing shall demonstrate insofar as practicable that the plant is capable of ANSI N 18.7-1976 Conformance Page 114 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS withstanding the design transients and accidents. The suitability of plant operating procedures shall be checked to the maximum extent possible during the preoperational and initial start-up test programs.

(3) surveillance test during, the Part II,Section 11:

operational phase to provide 'SNC has established the necessary measures and governing assurance that failures or procedures to demonstrate that items subject to the provisions substandard performance do of this QATR will perform satisfactorily in service, that the that the required reliability of plant can be operated safely and as designed, and that the sat related rel is coordinated operation of the plant as a whole is satisfactory.

safety- ated systemsis These programs include criteria for determining when testing maintained (see Section is required, such as proof tests before installation, pre-5.2.8). operational tests, post-maintenance tests, post-modification tests, in-service tests, and operational tests (such as surveillance tests required by Plant Technical Specifications),

to demonstrate that performance of plant systems is in accordance with design. Programs also include provisions for establishing and adjusting test schedules and maintaining status for periodic or recurring tests. Tests are performed according to applicable procedures that include, consistent with the effect on safety, (1) instructions and prerequisites to perform the test, (2) use of proper test equipment, (3) acceptance criteria, and (4) mandatory verification points as necessary to confirm satisfactory test completion. Test results are documented and evaluated by the organization performing the test and reviewed by a responsible authority to assure that the test requirements have been satisfied. If acceptance criteria are not met, retesting is performed as needed to confirm acceptability following correction of the system or equipment deficiencies that caused the failure.'

ANSI N18.7-1976 Conformance Paze 115 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS (4) Tests during design, Part II, Section 11:

fabrication and construction

'SNC has established the necessary measures and governing activities associated with plant procedures to demonstrate that items subject to the provisions maintenance and of this QATR will perform satisfactorily in service, that the modifications during the plant can be operated safely and as designed, and that the operational phase and the coordinated operation of the plant as a whole is satisfactory.

demonstration satisfactory These programs include criteria for determining when testing performance following plant is required, such as proof tests before installation, pre-maintenance and operational tests, post-maintenance tests, post-modification modifications or procedural tests, in-service tests, and operational tests (such as changes (see Section 5.2.7).

surveillance tests required by Plant Technical Specifications),

to demonstrate that performance of plant systems is in accordance with design. Programs also include provisions for establishing and adjusting test schedules and maintaining status for periodic or recurring tests. Tests are performed according to applicable procedures that include, consistent with the effect on safety, (1) instructions and prerequisites to perform the test, (2) use of proper test equipment, (3) acceptance criteria, and (4) mandatory verification points as necessary to confirm satisfactory test completion. Test results are documented and evaluated by the organization performing the test and reviewed by a responsible authority to assure that the test requirements have been satisfied. If acceptance criteria are not met, retesting is performed as needed to confirm acceptability following correction of the system or equipment deficiencies that caused the failure.'

Part II, Section 7.1:

'SNC establishes and implements measures to verify the quality of purchased items and services, whether purchased directly or through contractors, at intervals and to a depth consistent with the item's or service's importance to safety, complexity, quantity and the frequency of procurement.

Verification actions include testing, as appropriate, during design, fabrication and construction activities, including those associated with plant maintenance or modifications.

Verifications occur at the aDorooriate ohases of the ANSI N 18.7-1976 Conformance Page 116 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS procurement process, including, as necessary, verification of activities of suppliers below the first tier.'

5.2.19.1 Preoperational N18.7 wording in brackets are Tests. included inthis table for completeness; they do not

[Preoperational tests are establish requirements that generally performed either NQA-1 or the SNC QATR sequentially in accordance would need to address.

with written procedures.]

Procedures shall ensure that Supplement 11S-1 prerequisites steps for "Supplementary equipment testing, such as Requirements for Test completion of necessary Control" Section 3 states construction, prior testing, "Test procedures shall safety precautions, and include or reference test measures to preserve objectives and provisions for equipment status have been assuring that prerequisites or will be performed (see also for the given test have been Sections 5.217 and 5.3.10). met...Prerequisites shall include the following, as applicable: calibrated instrumentation, appropriate equipment, trained personnel, condition of test equipment..."

A detailed prescribed physical NQA-1, Subparts 2.4, 2.5 Part II,Section 10.1:

inspection of equipment and 2.8 provide for such 'In establishing inspection requirements, SNC commits to components and facilities shall inspections and testing. compliance with NOA-1-1994, Basic Requirement 10, be performed to ensure Supplement 1OS-1 and Subpart 2.4, with the clarification that readiness for operation. follows below. In addition, for situations comparable to Typical items to be covered original new plant construction, SNC commits to compliance include cleanliness, with the requirements of Subparts 2.5 and 2.8 for establishing lubrication, setting of limit _________________________________________________________

ANSI N 18.7-1976 Conformance Page 117 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS switches, calibration of appropriate inspection requirements.'

instruments and presence of safety devices. The test procedure shall list the checks to be made and include acceptance criteria and reference sources, such as vendor's literature, engineering drawings or plant specifications.

A component test is a NQA-1, Subparts 2.4, 2.5 Part II, Section 10.1:

functional, operational or and 2.8 provide for such 'In establishing inspection requirements, SNC commits to performance test of an inspections and testing. compliance with NQA-1-1994, Basic Requirement 10, individual piece of equipment Supplement 1OS-1 and Subpart 2.4, with the clarification that or unit system under follows below. In addition, for situations comparable to prescribed conditions. Typical original new plant construction, SNC commits to compliance parameters to be examined with the requirements of Subparts 2.5 and 2.8 for establishing are direction of rotation, appropriate inspection requirements.'

bearing temperatures, vibration, time delays, and ability to operate with remote and local controls. The procedure shall list checks to be made and provide acceptance criteria.

Consideration should also be given to providing a run- in period to minimize early failures during operation of the plant.

Individual system tests NQA-1, Subparts 2.4, 2.5 Part II, Section 10.1:

establish the functional and 2.8 provide for such 'In establishing inspection requirements, SNC commits to adequacy by operation under testing. compliance with NQA-1 -1994, Basic Requirement 10, prescribed conditions. The Supplement 1OS-i and Subpart 2.4, with the clarification that tests shall be designed to Supplement_10S-1_andSubpart_2.4,_withtheclarificationthat ANSI N 18.7-1976 Conformance Page 118 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS permit evaluation of system follows below. In addition, for situations comparable to performance including, for original new plant construction, SNC commits to compliance example the measurement of with the requirements of Subparts 2.5 and 2.8 for establishing flow, temperature, pressure, appropriate inspection requirements.'

response time and vibration, transfer of power supply to emergency power and accuracy and response of control devices.

The preoperational testing NQA-1, Subparts 2.4, 2.5 Part II, Section 10.1:

program should demonstrate, and 2.8 provide for such 'In establishing inspection requirements, SNC commits to as nearly as can be testing. compliance with NQA-1-1994, Basic Requirement 10, practicably simulated, the Supplement 1OS-1 and Subpart 2.4, with the clarification that overall integrated operation of follows below. In addition, for situations comparable to the plant systems at rated original new plant construction, SNC commits to compliance conditions, including with the requirements of Subparts 2.5 and 2.8 for establishing simultaneous operation of appropriate inspection requirements.'

auxiliary systems. It may be necessary to defer portions of these tests until nuclear heat is available. The procedures used should be similar to those discussed in 5.3.3 and 5.3.4, and they should be modified to require variation in control parameters, such as pump stops and restarts, cycling valves and varying flows so that system performance can be evaluated.

For additional requirements in ANSI N45.2.8 = NOA-1 Part II, Section 10.1:

matters relating to Subpart 2.8 'In establishing inspection requirements, SNC commits to preoperational test programs. compliance with NQA-1-1994, Basic Requirement 10, American National Standard ANSI N18.7-1976 Conformance Page 119 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS N45.2.8- 1975 is generally Supplement 1oS-1 and Subpart 2.4, with the clarification that applicable. [8] follows below. In addition, for situations comparable to original new plant construction, SNC commits to compliance with the requirements of Subparts 2.5 and 2.8 for establishing appropriate inspection requirements.'

5.2.19.2 Tests Prior to and Part II, Section 11:

During Initial Plant 'SNC has established the necessary measures and governing Operation. procedures to demonstrate that items subject to the provisions of this QATR will perform satisfactorily in service, that the Prior to placing a nuclear plant can be operated safely and as designed, and that the power plant into operation, a coordinated operation of the plant as a whole is satisfactory.

preoperational test program These programs include criteria for determining when testing shall be performed to is required, such as proof tests before installation, pre-demonstrate the functional operational tests, post-maintenance tests, post-modification adequacy of- plant tests, in-service tests, and operational tests (such as components systems and surveillance tests required by Plant Technical Specifications),

structures. to demonstrate that performance of plant systems is in accordance with design. Programs also include provisions for establishing and adjusting test schedules and maintaining status for periodic or recurring tests. Tests are performed according to applicable procedures that include, consistent with the effect on safety, (1) instructions and prerequisites to perform the test, (2) use of proper test equipment, (3) acceptance criteria, and (4) mandatory verification points as necessary to confirm satisfactory test completion. Test results are documented and evaluated by the organization performing the test and reviewed by a responsible authority to assure that the test requirements have been satisfied. If acceptance criteria are not met, retesting is performed as needed to confirm acceptability following correction of the system or equipment deficiencies that caused the failure.'

Following fuel loading an initial Part II, Section 11:

start-up test program shall be 'SNC has established the necessary measures and governing conducted to evaluate plant procedures to demonstrate that items subject to the provisions ANSI N18.7-1976 Conformance Page 120 of 145 ANSI NI 8.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS performance as the start-up of this QATR will perform satisfactorily in service, that the progresses. plant can be operated safely and as designed, and that the coordinated operation of the plant as a whole is satisfactory.

These programs include criteria for determining when testing is required, such as proof tests before installation, pre-operational tests, post-maintenance tests, post-modification tests, in-service tests, and operational tests (such as surveillance tests required by Plant Technical Specifications),

to demonstrate that performance of plant systems is in accordance with design. Programs also include provisions for establishing and adjusting test schedules and maintaining status for periodic or recurring tests. Tests are performed according to applicable procedures that include, consistent with the effect on safety, (1) instructions and prerequisites to perform the test, (2) use of proper test equipment, (3) acceptance criteria, and (4) mandatory verification points as necessary to confirm satisfactory test completion. Test results are documented and evaluated by the organization performing the test and reviewed by a responsible authority to assure that the test requirements have been satisfied. If acceptance criteria are not met, retesting is performed as needed to confirm acceptability following correction of the system or equipment deficiencies that caused the failure.'

Responsibilities. The Part II, Section 11:

ultimate responsibility for the 'SNC has established the necessary measures and governing preparation and execution of procedures to demonstrate that items subject to the provisions adequate preoperational and of this QATR will perform satisfactorily in service, that the initial start-up test programs plant can be operated safely and as designed, and that the organization. If design or coordinated operation of the plant as a whole is satisfactory.

construction is performed by These programs include criteria for determining when testing costheructinte oerf d is required, such as proof tests before installation, pre-other than the owner operational tests, post-maintenance tests, post-modification organization, design tests, in-service tests, and operational tests (such as organizations involved should surveillance tests required by Plant Technical Specifications),

participate in definition of the to demonstrate that performance of plant systems is in programs, and the accordance with design. Programs also include provisions for construction organization ______________ _____________________________

ANSI N 18.7-1976 Conformance Page 121 of 145 ANSI N18.7-1976 ASME NOA-1-1994 SNC QATR COMMENTS involved may supply establishing and adjusting test schedules and maintaining manpower or supervision for status for periodic or recurring tests. Tests are performed execution of part or all of the according to applicable procedures that include, consistent program, but the owner with the effect on safety, (1) instructions and prerequisites to organization shall determine perform the test, (2) use of proper test equipment, (3) that the program is adequate acceptance criteria, and (4) mandatory verification points as and that the results are necessary to confirm satisfactory test completion. Test results satisfactory. are documented and evaluated by the organization performing the test and reviewed by a responsible authority to assure that the test requirements have been satisfied. If acceptance criteria are not met, retesting is performed as needed to confirm acceptability following correction of the system or equipment deficiencies that caused the failure.'

Scheduling. A schedule shall Part II, Section 11:

be provided and maintained to 'SNC has established the necessary measures and governing provide assurance that all nrovideessarytesare performeprocedures to demonstrate that items subject to the provisions necessary tests are performed of this QATR will perform satisfactorily in service, that the and properly evaluated on a plant can be operated safely and as designed, and that the timely basis. Testing shall be scheduled so that the safety of coordinated operation of the plant as a whole is satisfactory.

These programs include criteria for determining when testing the plant is never dependent is required, such as proof tests before installation, pre-on the performance of an operational tests, post-maintenance tests, post-modification untested system (see also tests, in-service tests, and operational tests (such as Section 5.2.8). surveillance tests required by Plant Technical Specifications),

to demonstrate that performance of plant systems is in accordance with design. Programs also include provisions for establishing and adjusting test schedules and maintaining status for periodic or recurring tests. Tests are performed according to applicable procedures that include, consistent with the effect on safety, (1) instructions and prerequisites to perform the test, (2) use of proper test equipment, (3) acceptance criteria, and (4) mandatory verification points as necessary to confirm satisfactory test completion. Test results are documented and evaluated by the organization performing the test and reviewed by a responsible authority to assure that the test requirements have been satisfied. If acceptance ANSI N 18.7-1976 Conformance Paze 122 of 145 ANSI N18.7-1976 ASME NQA-1 -1 994 SNC QATR COMMENTS criteria are not met, retesting is performed as needed to confirm acceptability following correction of the system or equipment deficiencies that caused the failure.'

5.2.19.3 Tests Associated Part II, Section 11:

with Plant Maintenance, 'SNC has established the necessary measures and governing Modifications or procedures to demonstrate that items subject to the provisions Procedure Changes. of this QATR will perform satisfactorily in service, that the plant can be operated safely and as designed, and that the Tests shall be performed coordinated operation of the plant as a whole is satisfactory.

following plant modifications or These programs include criteria for determining when testing significant changes in is required, such as proof tests before installation, pre-operating procedures to operational tests, post-maintenance tests, post-modification confirm that the modifications tests, in-service tests, and operational tests (such as or changes reasonably surveillance tests required by Plant Technical Specifications),

produce expected results and to demonstrate that performance of plant systems is in that the change does not accordance with design. Programs also include provisions for reduce safety of operations. establishing and adjusting test schedules and maintaining status for periodic or recurring tests. Tests are performed according to applicable procedures that include, consistent with the effect on safety, (1) instructions and prerequisites to perform the test, (2) use of proper test equipment, (3) acceptance criteria, and (4) mandatory verification points as necessary to confirm satisfactory test completion. Test results are documented and evaluated by the organization performing the test and reviewed by a responsible authority to assure that the test requirements have been satisfied. If acceptance criteria are not met, retesting is performed as needed to confirm acceptability following correction of the system or equipment deficiencies that caused the failure.'

5.3 Preparation of BR5 "Instructions, Part I, Section 1:

Instructions and Procedures, and Drawings" The QATR describes the methods and establishes quality Procedures. states "Activities affecting assurance program and administrative control requirements quality shall be prescribed that meet 10 CFR 50, Appendix B.'

The administrative controls by and performed in ANSI N 18.7-1976 Conformance Page 123 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS and quality assurance accordance with program shall be carded out documented instructions, Part II, Section 5:

throughout plant life in procedures, or drawings of a 'SNC has established the necessary measures and governing accordance with written type appropriate to the pccoroancedrs Actvithwittes actig c prcu taes thes procedures to ensure that activities affecting quality are procedures. Activities affecting circumstances. These prescribed by and performed in accordance with instructions, safety at nuclear power plants documents shall include or procedures or drawings of a type appropriate to the shall be described by written reference appropriate circumstances and which, where applicable, include procedures of a type quantitative or qualitative quantitative or qualitative acceptance criteria to implement the appropriate to the acceptance criteria for QAP as described in the QATR. Such documents are circumstances and shall be determining that prescribed prepared and controlled according to Part II, Section 6 of this accomplished in accordance activities have been QATR. In addition, means are provided for dissemination to with these instructions and satisfactorily plant staff of instructions of both general and continuing procedures. These procedures accomplished." applicability, as well as those of short-term applicability.

shall include appropriate Provisions are included for reviewing, updating, and canceling quantitative or qualitative such procedures.'

acceptance criteria for determining that important activities have been Part II, Section 6:

satisfactorily accomplished. 'SNC has established the necessary measures and governing These procedures shall procedures to control the preparation of, issuance of, and provide an approved changes to documents that specify quality requirements or preplanned method of prescribe how activities affecting quality are controlled to conducting operations. assure that correct documents are being employed. Such Procedures shall be prepared documents, including changes thereto, shall be reviewed for and approved prior to adequacy and approved for release by authorized personnel.'

implementation as required by 4.3 and 5.2.15.

5.3.1 Procedure Scope. Appendix E:

T'his appendix contains a description of the various types of Each procedure shall be procedures used by SNC to govern the design, operation, and sufficiently detailed for a maintenance of its nuclear generating plants. Each procedure qualified individual to perform shall be sufficiently detailed for a qualified individual to the required function without perform the required function without direct supervision, but direct supervision, but need need not provide a complete description of the system or plant not provide a complete process.'

description of the system or plant process.

ANSI N 18.7-1976 Conformance Page 124 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS 5.3.2 Procedure Content. Appendix E:

Procedure format and content may vary from one location to The format of procedures may the other. However, procedures include the following vary from plant to plant, elements as appropriate to the purpose or task to be depending on the policies of described.

the owner organization.

However, procedures shall include, as appropriate, the following elements:

(1) Title. Each procedure shall contain a title descriptive of the work or system or unit to which it applies, a revision number or date, and an approval status.

(2) Statement of Applicability.

The purpose for which the procedure is intended shall be clearly stated; for example, for use during reactor or plant startup. If the purpose is not clear from the title, a separate statement of applicability should be provided, which may identify the reasons for particular operations. (3)

Reference. References, including reference to technical specifications, shall be included in procedures as applicable. References shall be identified within the body of procedures when the sequence of steps requires other tasks to be performed prior to or concurrent with a particular step within that task.

(4) Prereauisites. Each a _____________________________________________________ .i.. ____________________________

ANSI N 18.7-1976 Conformance Page 125 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR I COMMENTS procedure shall identity those independent actions or procedures which shall be completed and plant conditions which shall exist prior to its use. Prerequisites applicable only to certain sections of a procedure shall be so identified.

(5) Precautions. Precautions shall be established to alert the individual performing the task of those important measures which shall be used to protect equipment and personnel, including the public, or to avoid an abnormal or emergency situation. It may be convenient to specify precautions separately.

Cautionary notes as applicable to specific steps in the procedure shall be included in the main body of the procedure and shall be identified as such.

(6) Limitations and Actions.

Limitations on the parameters being controlled and appropriate corrective measures to return the parameter to the normal control band shall be specified. It may be convenient to specify limitations and setpoints in a separate section. Where appropriate, quantitative control guides should be ANSI N18.7-1976 Conformance Page 126 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS provided; for example, an appropriate step of a procedure should say "Manually adjust the feedwater flow controller to maintain the reactor water level at x feet,"

rather than "Manually adjust the feedwater flow to maintain water level."

(7) Main Body. The main body of a procedure shall contain step-by-step instructions in the degree of detail necessary for performing a required function or task.

(8) Acceptance Criteria.

Procedures shall contain, where applicable, acceptance criteria against which the success or failure of test-type activity would be judged. In some cases there would be qualitative criteria, i.e., a given event does or does not occur.

In other cases quantitative values would be designated.

(9) Checkoff Lists. Complex procedures shall have checkoff lists. These lists may be included as part of the procedure or may be appended to the procedure.

5.3.3 System Procedures. Appendix E:

System Procedures Instructions for energizing, 'These documents contain instructions for energizing, filling, filling, venting, draining,__________________________________________ _______________

ANSI N 18.7-1976 Conformance PaLe 127 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS starting up, shutting down, venting, draining, starting up, shutting down, changing modes changing modes of operation of operation, and other instructions appropriate for operations and other instructions of systems related to the safety of the plant. Separate appropriate for operations of procedures may be developed for correcting off-normal systems related to the safety conditions for those events where system complexity may of the plant shall be delineated lead to operator uncertainty. Appropriate procedures will also in system procedures. be developed for the fire protection program.'

Procedures for correcting off-normal conditions shall be developed for those events where system complexity may lead to operator uncertainty.

System procedures shall contain checkoff lists where appropriate.

5.3.4 General Plant N18.7 wording in brackets are Procedures. included in this table for completeness; they do not

[General plant procedures establish requirements that provide instructions for the either NQA-1 or the SNC QATR integrated operations of the would need to address.

plant. In addition to the characteristics of procedures presented in 5.3.1 and 5.3.2 details conceming specific general plant procedures are emphasized in the following sections.]

5.3.4.1 Start-up Appendix E:

Procedures. Start-up Procedures Start-up procedures shall be 'These documents contain instructions for starting the reactor provided that include starting from cold or hot conditions and establishing power operation.

the reactor from cold or hot This includes documented determination that prerequisites conditions and establishing have been met, including confirmation that necessary ANSI N18.7-1976 Conformance Page 128 of 145 ANSI Ni 8.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS power operation, with the instruments are operable and properly set; valves are properly generator synchronized to the aligned, necessary system procedures, tests and calibrations line. Recovery from reactor have been completed; and required approvals have been trips shall be- in accordance obtained.'

with the startup procedure and shall be subject to the determinations set forth in 5.2.1.

(I) Prerequisites. Start-up procedures shall include provisions for documented determination that.

Prerequisites have been met, including confirmation that necessary instruments are operable and properly set; valves are properly aligned:

necessary systems procedures, tests and calibrations have been completed; and required approvals have been obtained.

Checkoff lists are normally used for this purpose.

(2) Main Body. The main body of the start-up procedures shall include the major steps of the start-up sequence, including reference to appropriate system procedures. Such major steps shall include or reference detailed instructions for their performance, for example, minimum instrumentation requirements, coverage of control rod withdrawal sequence or soluble poison dilution. maniDulation of ANSI N 18.7-1976 Conformance Paie 129 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS controls, establishment of feed and steam flow and turbine start-up and synchronization.

Checkoff lists should be used for the purpose of confirming completion of major steps in proper sequence.

5.3.4.2 Shutdown Appendix E:

Procedures. Shutdown Procedures Shutdown procedures shall 'These documents contain guidance for operations during be provided to guide controlled shutdown and following reactor trips, including operations during and instructions for establishing or maintaining hot following controlled shutdown shutdown/standby or cold shutdown conditions, as applicable.

or reactor trips and shall The major steps involved in shutting down the plant are include instructions for specified, including instructions for such actions as monitoring establishing or maintaining hot and controlling reactivity, load reduction and cooldown rates, standby or cold shutdown sequence for activating or deactivating equipment, conditions, as applicable. The requirements for prompt analysis for causes of reactor trips or major steps involved in abnormal conditions requiring unplanned controlled shutting down the plant shall shutdowns, and provisions for decay heat removal.'

be specified, including detailed instructions for the performance of such actions as monitoring and controlling reactivity, load reduction and cooldown rates, sequence of activating or deactivating equipment, requirements for prompt analyses of causes of reactor trips or abnormal conditions requiring unplanned controlled shutdowns, and provisions for decay heat removal. Checkoff lists should be used for the purpose of ANSI N18.7-1976 Conformance Page 130 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS confirming completion of major steps in proper sequence.

5.3.4.3 Power Operation and Appendix E:

Load Changing Procedures. Power Operation and Load Changing Procedures Procedures for steady-state 'These documents contain instructions for steady-state power power operation and load operation and load changing. These type documents include, changing shall be provided as examples, provisions for use of control rods, chemical that include, for example, shim, coolant flow control, or any other system available for provisions for use of control short- or long-term control of reactivity, making deliberate load rods, chemical shim, coolant changes, responding to unanticipated load changes, and flow control or any other adjusting operating parameters.'

system available for long- or short-term control of reactivity, making deliberate load changes, responding to unanticipated load changes and adjusting operating parameters.

5.3.4.4 Process Monitoring Appendix E:

Procedures. Process Monitoring Procedures Procedures for monitoring 'These documents contain instructions for monitoring performance of plant systems performance of plant systems to assure that core thermal shall be required to assure margins and coolant quality are maintained in acceptable that core thermal margins and status at all times, that integrity of fission product barriers is coolant quality are maintained maintained, and that engineered safety features and at all times, that integrity of emergency equipment are in a state of readiness to keep the fission product barriers is plant in a safe condition if needed. Maximum and minimum maintained at all times and limits for process parameters are appropriately identified.

that engineered safety Operating procedures address the appropriate nature and features and emergency frequency of this monitoring.'

equipment are in a state of readiness to maintain the plant in a safe condition if needed.

ANSI N18.7-1976 Conformance Page 131 of 145 ANSI N18.7-1976 ASME NOA-1-1994 SNC QATR COMMENTS The limits (maximum and minimum) for significant process parameters shall be identified. 'The nature and frequency of this monitoring shall be covered by operating procedures, as appropriate.

5.3.4.5 Fuel-Handling Fuel Handling Procedures N18.7 wording in brackets are Procedures. included in this table for

'These documents contain instructions for core alterations, completeness; they do not accountability of fuel and partial or complete refueling establish requirements that Fuel-handling operations shall operations that include, for example, continuous monitoring of either NQA-1 or the SNC QATR be performed in accordance with written procedures. These neutron flux throughout core loading, periodic data recording, would need to address.

audible annunciation of abnormal flux increases, and procedures shall specify evaluation of core neutron multiplication to verify safety of actions for core alterations, loading increments. Procedures are also provided for receipt accountability of fuel and partial or complete refueling and inspection of new fuel, and for fuel movements in the spent fuel storage areas. Fuel handling procedures include operations that include, for prerequisites to verify the status of systems required for fuel example, continuous handling and movement; inspection of replacement fuel and monitoring of the neutron flux throughout core loading, control rods; designation of proper tools, proper conditions for periodic recording of data, spent fuel movement, proper conditions for fuel cask loading and movement; and status of interlocks, reactor trip circuits audible annunciation of and mode switches. These procedures provide requirements abnormal flux increases and evaluation of core neutron for refueling, including proper sequence, orientation and multiplication to the safety of seating of fuel and components, rules for minimum operable loading increments. Provisions instrumentation, actions for response to fuel damage, verification of shutdown margin, communications between the shall be made for preparing specific procedures for each control room and the fuel handling station, independent verification of fuel and component locations, criteria for refueling outage and for stopping fuel movements, and documentation of final fuel and receipt and shipment of fuel.

[Plant procedures should, component serial numbers (or other unique identifiers) and locations.'

nonetheless, prescribe the general preplanning for the fuel- handling program and its associated safety measures ANSI N 18.7-1976 Conformance Page 132 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS and should identify those aspects of the program for which procedures are to be prepared for each refueling outage.]

(1) Prerequisites.

Prerequisites shall be provided in the fuel- handling procedures that include, for example, the status of plant systems required for refueling; inspection of replacement fuel, control rods, poison curtains and internals: designation of proper tools; proper conditions for spent fuel movement; proper conditions for fuel cask loading and movement; and status of interlocks, reactor trip circuits and mode switches.

(2) Main Body. The main body of fuel-handling procedures shall include requirements for refueling for example, the status of the core, instructions for proper sequence, orientation and seating of fuel and components, rules for minimum operable instrumentation, actions to' be followed in the event of fuel damage rules for periods when refueling is interrupted, verification of the shutdown margin and the frequency-of determination, communications between control room and the fuel loadina station, independent ANSI N18.7-1976 Conformance Page 133 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS verification of fuel and component location, criteria for stopping refueling and for reducing the size of the fuel loading increment, and a containment evacuation plan and its associated safety measures. Documentation of final fuel and component serial numbers and locations shall be maintained.

5.3.5 Maintenance Appendix E:

Procedures. Maintenance Procedures Maintenance procedures shall 'These documents contain instructions in sufficient detail to contain applicable items listed permit maintenance work to be performed correctly and under 5.3.2 and, in addition, safely, and include provisions, such as hold or witness points, measures to cover the for conducting and recording results of required inspections or features of maintenance tests. These documents may include applicable inspection or described below. test instructions subject to the requirements for test and (1) Preparation for inspection procedures below. Appropriate referencing to other Maintenance. Maintenance procedures, standards, specifications, or supplier manuals is procedures shall reflect provided. When not provided through other documents, considerations listed under instructions for equipment removal and return to service, and 5.2.6. Adherence to applicable applicable radiation protection radiation Protection measures raiall bProtescti. Theasues measures (such as protective clothing and radiation shall be prescribed. These monitoring) will be included. Additional maintenance measures shall specify procedure requirements are addressed in NQA-1-1994, radiation monitoring needed to Subpart 2.18, Section 2.2, Procedures.'

assure safety.

(2) Performance of Maintenance. The procedures shall contain enough detail to permit the maintenance work to be performed correctly and ANSI N 18.7-1976 Conformance Page 134 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS safely, and shall include provisions for conducting and recording results of required tests and inspections.

References should be made to vendor manuals, plant procedures, drawings and other sources as applicable.

(3) Post Maintenance Check Out and Return to Service.

Instructions shall be included or referenced, for returning the equipment to its normal operating status.

(4) Supporting Maintenance Documents. Where appropriate sections of related documents, such as vendor manuals, equipment operating and maintenance instructions, or sip-proved drawings with acceptance criteria provide adequate instructions to assure the required quality of work, the applicable sections of the related documents shall be referenced in the procedure or may, in some cases, constitute adequate procedures in themselves.

Such procedure shall receive the same level of review and approval as operating procedures.

5.3.6 Radiation Control Appendix E:

Procedures. Radiation Control Procedures ANSI N18.7-1976 Conformance Paze 135 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS Procedures shall be provided 'These documents contain instructions for implementation of for implementation of a the radiation control program requirements necessary to meet radiation control program to regulatory commitments, including acquisition of data and use meet applicable program of equipment to perform necessary radiation surveys, requirements. The radiation measurements and evaluations for the assessment and control program involves the control of radiation hazards. These procedures provide acquisition of data and requirements for monitoring both external and internal provision of equipment to exposures of employees, utilizing accepted techniques; perform necessary radiation routine radiation surveys of work areas; effluent and surveys, measurements and environmental monitoring in the vicinity of the plant; radiation evaluations for the monitoring of maintenance and special work activities, and for assessment and control of maintaining records demonstrating the adequacy of measures radiation hazards associated taken to control radiation exposures to employees and others.'

with a nuclear power plant.

Procedures shall be developed and implemented for: monitoring both external and internal exposures of employees, utilizing, accepted techniques, routine radiation surveys of work areas; environmental monitoring in the vicinity of the plant; radiation monitoring of maintenance and special work activities; and for maintaining records demonstrating the adequacy of measures taken to control radiation exposures of employees and others.

5.3.7 Calibration and Test Appendix E:

Procedures. Calibration and Test Procedures Procedures shall be provided 'These documents contain instructions for periodic calibration for periodic calibration and and testing of instrumentation and control systems, and for ANSI N18.7-1976 Conformance Page 136 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS testing of safety-related periodic calibration of measuring and test equipment used in instrumentation and control activities affecting the quality of these systems. These systems. Procedures shall documents provide for meeting surveillance requirements and also be provided for periodic for assuring measurement accuracy adequate to keep safety-calibration of measuring and related parameters within operational and safety limits.'

test equipment used in activities affecting the quality of these systems. The procedures shall provide for meeting surveillance schedules and for assuring measurement accuracy adequate to keep safety-related parameters within operational and' safety limits.

5.3.8 Chemical- Appendix E:

Radiochemical Control Chemical and Radiochemical Control Procedures Procedures.

'These documents contain instructions for chemical and Procedures shall be provided radiochemical control activities and include: the nature and for chemical and frequency of sampling and analyses; instructions for radiochemical control maintaining coolant quality within prescribed limits; and activities. They should include, limitations on concentrations of agents that could cause for example, the nature and corrosive attack, foul heat transfer surfaces, or become frequency of sampling and sources of radiation hazards due to activation. These analyses; instructions for documents also provide for the control, treatment and maintaining coolant quality management of radioactive wastes, and control of radioactive within prescribed limits: and calibration sources.'

limitations on concentrations of agents that could cause corrosive attack, foul heat transfer surfaces or become sources of radiation hazards due to activation, Procedures shall also be provided for the control, treatment and ANSI N 18.7-1976 Conformance Page 137 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS management of radioactive wastes and control of radioactive calibration sources.

5.3.9 Emergency Appendix E: N18.7 wording in brackets are Procedures. included in this table for Emergency Operating Procedures completeness; they do not Procedures shall be provided 'These documents contain instructions for response to establish requirements that to guide operations during potential emergencies so that a trained operator will know in either NQA-1 or the SNC QATR potential emergencies. They would need to address.

advance the expected course of events that will identify an shall he written such that a emergency and the immediate actions that should be taken in trained operator will know in response. Format and content of emergency procedures are advance the expected course based on regulatory and Owner's Group(s) guidance that of events that will identify an identify potential emergency conditions and generally require emergency and the immediate such procedures to include a title, symptoms to aid in action he shall take. [Since identification of the nature of the emergency, automatic emergencies may not follow actions to be expected from protective systems, immediate anticipated, patterns, the operator actions for operation of controls or confirmation of procedures should provide, automatic actions, and subsequent operator actions to return sufficient flexibility to the reactor to a normal condition or provide for a safe accommodate variations. extended shutdown period under abnormal or emergency Emergency procedures that conditions.'

cover actions for manipulations of controls to prevent accidents or lessen their consequences should be based on a general sequence of observations and actions.

Emphasis should be placed on operator responses to observations and indications in the control room; that is, when immediate operator actions are required to prevent or mitigate the consequences of a serious condition, ANSI N18.7-1976 Conformance Page 138 of 145 ANSI N18.7-1976 ASME NQA-1-1994 [ SNC QATR COMMENTS procedures require that those actions be implemented promptly. The emergency procedure format given in 5.3.9.1 provides a basis for coping with emergencies and is an acceptable format for prescribing operator observations and actions.

Emergency procedures may contain supplemental background information to further aid operators in taking proper emergency actions, but this information shall be separated from the procedural actions. It is extremely difficult to distinguish between procedures prepared for the purpose of correcting off-normal conditions which in themselves do not constitute actual emergency situations, but which conceivably can degenerate into true emergencies in the absence of positive corrective action, and procedures required for coping with true emergencies that have already occurred. Some owner organizations choose the term "Off normal Procedures" for the same purpose that others choose Emergency Procedures."

When initially' available intelligence provided to operating personnel via instrument readings, physical ANSI N18.7-1976 Conformance Page 139 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS conditions, and personal observations may not clearly indicate the difference between a simple operational problem and a serious emergency, the actions outlined in the emergency procedures shall be based on a conservative course of action by the operating crew.

Considerable judgment on the part of competent personnel is required before departing from the emergency procedure.]

t +

5.3.9.1 Emergency Appendix E:

Procedure Format and Emergency Operating Procedures Content.

'These documents contain instructions for response to Emergency procedures shall potential emergencies so that a trained operator will know in include as appropriate, the advance the expected course of events that will identify an following elements: emergency and the immediate actions that should be taken in (1) Title. The title shall be response. Format and content of emergency procedures are descriptive of the emergency based on regulatory and Owner's Group(s) guidance that for which the procedure is identify potential emergency conditions and generally require provided. (2) Symptoms. such procedures to include a title, symptoms to aid in Symptoms shall be included identification of the nature of the emergency, automatic to aid in the identification of actions to be expected from protective systems, immediate the emergency. They should operator actions for operation of controls or confirmation of include alarms, operating automatic actions, and subsequent operator actions to return conditions and probable the reactor to a normal condition or provide for a safe magnitudes of parameter extended shutdown period under abnormal or emergency changes. If a condition is conditions.'

peculiar only to an emergency under consideration, it should be listed first.

(3) Automatic Actions. The ANSI N18.7-1976 Conformance Page 140 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS automatic actions that will probably occur as a result of the emergency shall be identified.

(4) Immediate Operator Actions. These steps shall specify immediate actions for operation of controls or confirmation of automatic actions that are required to stop the degradation of conditions and mitigate their consequences. Examples include the following:

(a) The verification of automatic actions. This step is based on equipment operating as designed and the sequence of events following an expected course. Since variations from the expected course may occur, operators should be prepared to manipulate controls as necessary to cope with the problem. However, the procedure should caution the operator not to place systems in "manual" unless misoperation in "automatic" is apparent and should require him to make frequent checks for proper operation of systems placed in manual control. (b) Assurance that reactor is in a safe condition.

This step usually means shutdown of the reactor with sufficient reactivity marQin and ANSI N18.7-1976 Conformance Paee 141 of 145 ANSI N1 8.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS establishment of required core cooling. (c) Notification to plant personnel of the nature of the emergency. (d) Determination that the reactor coolant system pressure boundary is intact.

(e) Confirmation of the availability of adequate power sources. (f) Confirmation that containment and exhaust systems are operating properly in order to prevent uncontrolled release of radioactivity. (5) Subsequent Operator Actions. Steps shall be included to return the reactor to a normal condition or to provide for a safe extended shutdown period under abnormal or emergency conditions 5.3.9.2 Events of Potential Appendix E:

Emergency. Emergency Operating Procedures Potential emergency 'These documents contain instructions for response to conditions shall be identified potential emergencies so that a trained operator will know in and procedures for coping with advance the expected course of events that will identify an them shall be prepared. The emergency and the immediate actions that should be taken in following categories of events response. Format and content of emergency procedures are may, depending upon the based on regulatory and Owner's Group(s) guidance that design of the plant, be identify potential emergency conditions and generally require considered as examples of such procedures to include a title, symptoms to aid in potential emergencies for identification of the nature of the emergency, automatic which procedures are written actions to be expected from protective systems, immediate and for which immediate operator actions for operation of controls or confirmation of action is indicated: (1) Loss of automatic actions, and subsequent operator actions to return ANSI N18.7-1976 Conformance Page 142 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS coolant from identified and the reactor to a normal condition or provide for a safe unidentified sources, from extended shutdown period under abnormal or emergency small loss to design basis conditions.'

accident loss (2) Reactor transients and excursions (3)

Failure of vital equipment. (4)

Loss or degradation of vital power sources (5) Civil disturbances (6) Abnormally high radiation levels (7)

Excessive release of' radioactive liquid or gaseous effluent (8) Malfunction of reactivity control system (9)

Loss of containment integrity (10) Conditions that require use of standby liquid poison systems (11) Possible natural occurrences (12) Fires 5.3.9.3 Procedures for Appendix E:

Implementing Emergency Emergency Plan Implementing Procedures Plan.

'These documents contain instructions for activating the Implementing procedures for Emergency Response Organization and facilities, protective emergency plan actions shall action levels, organizing emergency response actions, contain, as appropriate, the establishing necessary communications with local, state and following elements: federal agencies, and for periodically testing the procedures, (1) Individual assignment of communications and alarm systems to assure they function authorities and properly. Format and content of such procedures are such responsibilities for that requirements of each facility's NRC approved Emergency performance of specific tasks Plan are met.'

to specific individuals or staff positions.

(2) Protective action levels and protective measures outlined for the emergency identified.

ANSI N 18.7-1976 Conformance Pa2e 143 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS (3) Specific actions to be taken by coordinating support groups.

(4) Procedures for medical treatment and handling of contaminated individuals.

(5) Special equipment requirements for items such as medical treatment, emergency personnel removal, specific radiation detection, personnel dosimetry and rescue operations, procedures for making this equipment available, plus operating instructions for such equipment, and provisions for its periodic inspection and maintenance.

(6) Identification of emergency communications network.

Including communications required for personnel identification and effective coordination of all support groups.

(7) Description of alarm signals in each facility. At sites with multiple units, alarm signals should be consistent from one unit to another.

(Signals for initiating protective measures should be clear and distinct from process or operational alarm system to avoid confusion.)

(8) Procedures required to restore the plant to normal conditions following an ANSI N 18.7-1976 Conformance Page 144 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS emergency.

(9) Requirements for periodically testing of procedures, communications network and alarm systems to assure that they function properly. See also U.S.

Nuclear Regulatory Commission (NRC) "Guide to the Preparation of Emergency Plans for Production and Utilization Facilities." [17]

5.3.10 Test and Inspection Appendix E:

Procedures.

Test and Inspection Procedures Test and inspection procedures shall contain a 'These documents provide the necessary measures to assure description of objectives; quality is achieved and maintained for the nuclear facilities.

acceptance criteria that will be The instructions for tests and inspections may be included used to evaluate the results; within other procedures, such as installation and maintenance prerequisites for performing procedures, but will contain the objectives, acceptance the tests or inspections criteria, prerequisites for performing the test or inspection, including any special limiting conditions, and appropriate instructions for performing conditions to be used to the test or inspection, as applicable. These procedures also simulate normal or abnormal specify any special equipment or calibrations required to operating conditions; limiting conduct the test or inspection and provide for appropriate conditions; and the test or documentation and evaluation by responsible authority to inspection procedure. This assure test or inspection requirements have been satisfied.

procedure shall also specify Where necessary, hold or witness points are identified within any special equipment or the procedures and require appropriate approval for the work calibrations required to to continue beyond the designated point. These procedures conduct the test or inspection. provide for recording the date, identification of those Test and. inspection results performing the test or inspection, as-found condition, shall be documented and corrective actions performed (if any), and as-left condition, as evaluated by responsible appropriate for the subject test or inspection.'

authority to assure that test and insDection reauirements ANSI N 18.7-1976 Conformance Paze 145 of 145 ANSI N18.7-1976 ASME NQA-1-1994 SNC QATR COMMENTS have been satisfied. Where tests and inspections are to be witnessed, the procedure shall identify hold points in the testing sequence to permit witnessing. The procedure shall require appropriate approval for the work to continue beyond the designated hold point. The test and inspection procedures shall require recording the date, identification of those performing the test or inspection, as-found condition, corrective actions performed, if any, and as- left condition.

~1- t

6. References Because most references from N18.7 have been superseded, and the QATR Section 3.1 establishes the nature and level of commitment to certain references, this section is not addressed in this matrix.

Enclosure 6 Southern Nuclear Operating Company Quality Assurance Topical Report Response to NRC RAI dated February 1, 2007 Response to Draft NRC RAI dated February 1, 2007 Page 1 of 15 ENCLOSURE 1 SOUTHERN NUCLEAR OPERATING COMPANY QUALITY ASSURANCE TOPICAL REPORT PART I INTRODUCTION NRC QUESTION

1. Part I, Section 1.4 of the QATR commits to compliance with NQA-1-1994, Part I, Introduction, Section 4. SNC utilizes the terms and definitions provided in NQA 1994 with the exception of the term "verification." Appendix D to the QATR provides additional definitions of terms used in the QATR that are not contained in the NQA 1994 definitions.

" The QATR proposes to use the terms "independent verification" and "concurrent verification" instead of the term "verification" provided in NQA 1994. Provide the bases for the proposed definitions of "independent verification" and "concurrent verification," and why they are acceptable.

• The terms "independent verification" and "concurrent verification" that are proposed to be used instead of the term "verification" included in NQA 1994 are not included in Appendix D to the QATR. The staff recommends adding the definitions of "independent verification" and "concurrent verification" to the Appendix D to the QATR.

SNC RESPONSE The use of the terms "independent verification" and "concurrent verification" were intended by SNC to provide clarification for the term "verification" as opposed to replacing the term "verification" defined by ASME NQA-1-1994. SNC has determined that this clarification is not necessary and as a result, has deleted the terms "independent verification" and "concurrent verification" from Part I,Section I, Paragraph 1.4 of the proposed QATR. This deletion will result in SNC's commitment to the term "verification" as defined in NQA-1-1994. In addition, the following conforming changes have been incorporated into the QATR submittal to reflect the above described change:

• Enclosure 2, Section 4.2.1, has been modified to delete the proposed definitions of "independent verification" and "concurrent verification" intended to provide clarification of the term "verification" defined by NQA-1 -1994.

° Enclosure 4, Part I, Section 1.4, has been modified to delete references to "independent verification" and "concurrent verification" and reflect SNC conformance with the definitions contained in NQA-1-1994, Part I, Section 1.4.

Response to Draft NRC RAI dated February 1, 2007 Page 2 of 15 PART II QAPD DETAILS SECTION 1 ORGANIZATION NRC QUESTION

2. The Three Mile Island (TMI)-related requirements contained in 10 CFR 50.34(f)(3)(iii)(F) requires ensuring that the size of the QA organization is commensurate with its duties and responsibilities. Clarify how the QATR provides for ensuring that the QA organization is sized commensurate with its duties and responsibilities.

SNC RESPONSE As stated in 10 CFR 50.34(f), the requirement of 10 CFR 50.34(f)(3)(iii)(F) associated with sizing of the QA staff commensurate with its duties and responsibilities is applicable to licensees whose applications for a construction permit or manufacturing license were pending as of February 16, 1982. A specific list of plants to which the requirements of 10 CFR 50.34(f) apply is provided in the regulation and does not include Farley, Hatch, or Vogtle. Accordingly, the requirement of 10 CFR 50.34(f)(3)(iii)(F) does not apply to SNC operating plants.

SECTION 2 QUALITY ASSURANCE PROGRAM NRC QUESTION

3. The QATR proposes an alternative to Supplement 2S-1 that would allow a qualified engineer to plan an inspection, evaluate the capabilities of an inspector, or evaluate the training program for inspectors. Provide a bases for why the use of an engineer to perform these functions is acceptable.

SNC RESPONSE NQA-1 -1994, Appendix 2A-1, Nonmandatory Guidance on the Qualifications of Inspection and Test Personnel, may be used in conjunction with Basic Requirement 2 and Supplement 2S-1 of NQA-1 -1994, Part I, for the qualification of inspection and test personnel. Appendix 2A-1 identifies three levels of qualification that may be used depending on the complexity of the functions involved with the qualifications for Level I inspectors being the least restrictive and Level III inspectors being the most restrictive.

Appendix 2A-1, Paragraph 2.2 states that a Level II inspector should have, among other things, all of the capabilities of a Level I inspector. Similarly, Appendix 2A-1, Paragraph 2.3 states that a Level III inspector should have the capabilities of a Level II inspector. In addition, Paragraph 2.3 states that the Level III inspector should also be capable of evaluating the adequacy of specific programs used to train and certify inspection and test personnel whose qualifications are covered by this Appendix.

Appendix 2A-1, Section 3, provides education and experience qualification recommendations for Levels 1,11, and II1. Section 3.3 provides four options for qualification of personnel as a Level II1. Paragraph 3.3.4 provides the following option for qualification of a Level III inspector.

Response to Draft NRC RAI dated February 1, 2007 Page 3 of 15 Graduationfrom a 4 year college plus 5 years of relatedexperience in equivalent inspection or testing activities with at least 2 years of this experience associatedwith nuclearfacilities - or, if not, at least sufficient trainingto be acquainted with the relevant quality assuranceaspects of a nuclear facility.

Accordingly, SNC's use of a qualified engineer as described in Part II, Section 2.4, of the proposed QATR to plan inspections, evaluate capabilities of other inspectors, and evaluate the training program for inspectors assures conformance with the recommendations of Appendix 2A-1, Paragraph 3.3.4, for Level III inspectors.

NRC QUESTION

4. Section 2.4 of the QATR establishes a commitment to NQA-1 -1994, Basic Requirement 2 and its supplements with clarifications and exceptions to these requirements. As an exception the QATR proposes that nondestructive examination (NDE) personnel will follow the applicable standard cited in the version(s) of ASME Section Xl. Provide a bases for why the Supplement 2S-2 alternative regarding the qualification of NDE personnel does not include Section III of the ASME Boiler and Pressure Vessel Code.

SNC RESPONSE SNC has revised the exception to the requirements of NQA-1 -1994, Supplement 2S-2, described in Section 2.4 of the proposed QATR to include Section III of the ASME Boiler and Pressure Vessel Code as follows:

In lieu of Supplement 2S-2, for qualificationof nondestructive examination personnel, SNC will follow the applicablestandardcited in the version(s) of Section //I and Section X1 of the ASME Boiler and Pressure Vessel Code approvedby the NRC for use at SNC sites.

Conforming changes to the supplemental information provided with the proposed SNC QATR have been incorporated as follows:

" Enclosure 2, Section 4.2.3 has been modified to include the qualification requirements of ASME Section II1. Additionally, the citation provided in this section of prior NRC approval for the proposed exception to NQA-1 -1994 has been modified to reflect the deviation from the information contained in the NMC QATR.

• Enclosure 4,Section II, Basic Requirement 2, Supplement 2S-2, has been modified to include the qualification requirements of ASME Section II1. For consistency with Enclosure 2, Section 4.2.3, the reference in the "Basis for Acceptance" for this exception has been modified to reflect consistency with the NMC QATR, as modified by the NRC-requested addition of the reference to ASME Section III in response to this RAI question, and approved by NRC SER dated March 24, 2005.

Response to Draft NRC RAI dated February 1, 2007 Page 4 of 15 SECTION 3 DESIGN CONTROL NRC QUESTION

5. The TMI-related requirements contained in 10 CFR 50.34(f)(iii)(C) requires that QA personnel are included in the documented review and concurrence of quality-related procedures associated with design, construction, and installation. Clarify how the QATR implements measures to control the documented review and concurrence of quality-related procedures.

SNC RESPONSE As stated in 10 CFR 50.34(f), the requirement of 10 CFR 50.34(f)(3)(iii)(C) associated with QA personnel inclusion in the documented review and concurrence of quality-related procedures is applicable to licensees whose applications for a construction permit or manufacturing license were pending as of February 16, 1982.

A specific list of plants to which the requirements of 10 CFR 50.34(f) apply is provided in the regulation and does not include Farley, Hatch, or Vogtle.

Accordingly, the requirement of 10 CFR 50.34(f)(3)(iii)(C) does not apply to SNC operating plants.

SECTION 4 PROCUREMENT DOCUMENT CONTROL NRC QUESTION

6. Section 4.2 of the QATR establishes a commitment to NQA-1 -1994, Basic Requirement 4 and Supplement 4S-1, and includes clarification and exceptions to these requirements. As an exception, the QATR proposes that "the quality assurance review of procurement documents is satisfied through review of the applicable procurement specifications, including the technical and quality procurement requirements, prior to bid or award of contract." This exception does not specify if procurement documents as well as changes to procurement documents will be part of the proposed quality assurance review. Clarify how the proposed quality assurance review of procurement documents includes reviews of procurement document changes.

SNC RESPONSE SNC has revisited its proposed clarification to Section 3 of Supplement 4S-1 contained in Section 4.2 of the proposed QATR and determined the clarification is unnecessary. Accordingly, this clarification has been deleted from the proposed QATR provided in Enclosure 1, and references thereto have been deleted from Enclosures 2, 4, and 5.

Section 3 of Supplement 4S-1 provides the requirements for procurement document reviews. The proposed SNO QATR provided in Enclosure 1 does not include an exception to, or clarification of, the requirements of Supplement 4S-1, Section 3.

Accordingly, SNO commitments to NQA-1-1994, Basic Requirement 4 and Supplement 4S-1, with the clarifications and exceptions provided in Section 4.2 of the proposed QATR, provide appropriate controls for the review of procurement documents.

Response to Draft NRC RAI dated February 1, 2007 Page 5 of 15 Section 4 of NQA-1 -1994, Supplement 4S-1, requires that "procurement document changes shall be subject to the same degree of control as utilized in the preparation of the original documents." The proposed SNC QATR does not include an exception to, or clarification of, the requirements of Supplement 4S-1, Section 4. Accordingly, SNC commitments to NQA-1 -1994, Basic Requirement 4 and Supplement 4S-1, with the clarifications and exceptions provided in Section 4.2 of the proposed QATR, provide appropriate controls for the review of procurement document changes.

SECTION 6 DOCUMENT CONTROL NRC QUESTION

7. ANSI Standard N1 8.7-1976, "Administrative Controls and Quality Assurance for the Operational Phase of Nuclear Power Plants," (ANSI N1 8.7) specifies that there should be coordination and control of interface documents. The QATR no longer commits to the requirements of ANSI N18.7. Clarify how the QATR addresses the coordination and control of interface documents.

SNC RESPONSE SNC has revised Section 6 of the proposed QATR to include the following component from Section 5.2.15 of ANSI N18.7-1976 in the document control system:

- coordinatingand controlling interface documents and procedures.

Conforming changes to the supplemental information provided with the proposed SNC QATR have been incorporated as follows:

• Enclosure 4, Section Basic Requirement 6, Supplement 6S-1, was modified to reflect the additional requirement of ANSI N1 8.7-1976 for coordinating and controlling interface documents not addressed by ASME NQA-1-1994.

• Enclosure 5, Section 5.2.15 was modified to reflect the additional requirement for coordinating and controlling interface documents and procedures in the column titled, SNC QATR.

SECTION 7 CONTROL OF PURCHASED MATERIAL, EQUIPMENT, AND SERVICES NRC QUESTION

8. Section 7.2 of the QATR proposes to use an alternate method for procurement of commercial-grade calibration services for safety-related applications in lieu of performing a supplier audit, commercial-grade survey, or in-process surveillance for calibration laboratory accredited by NVLAP or A2LA as recognized by NVLAP through a Mutual Recognition Arrangement (MRA).

An MRA is a generic term referring to a conformity assessment process. For assessment of calibration laboratories, the NRC has found the ILAC MRA to be an acceptable alternative. The alternative previously approved by the NRC does not include MRAs administered under other programs. Clarify which MRA the QATR proposes to use.

Response to Draft NRC RAI dated February 1, 2007 Page 6 of 15 The NRC has approved this alternative only to be used with domestic accredited calibration service suppliers. Clarify how the QATR will implement the procurement of commercial-grade calibration services consistent with the previously approved alternative.

SNC RESPONSE SNC will limit the use of MRAs associated with the procurement of commercial-grade calibration services for safety-related applications to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA). Use of this alternative will be limited to domestic accredited calibration service suppliers.

Section 7.2 of the proposed QATR has been modified to include the following:

The calibrationlaboratoryholds a domestic accreditationby the National Voluntary LaboratoryAccreditation Program(NVLAP) or by the American Association for LaboratoryAccreditation (A2LA) as recognizedby NVLAP through the InternationalLaboratory Accreditation Cooperation(ILAC) Mutual Recognition Arrangement (MRA).

Conforming changes to the supplemental information provided with the proposed SNC QATR have been incorporated as follows:

• Enclosure 2, Section 4.2.6, has been modified to reflect domestic accreditation by the NVLAP and the ILAC MRA described above.

• Enclosure 4, Part II, Basic Requirement 7, has been modified to reflect domestic accreditation by the NVLAP and the ILAC MRA described above.

• Enclosure 5, Section 5.2.13.2, has been modified to reflect domestic accreditation by the NVLAP and the ILAC MRA described above.

SECTION 16 CORRECTIVE ACTION NRC QUESTION

9. Section 3.2 of ANSI N1 8.7 specifies that the corrective action program shall include provisions for all personnel to identify conditions that are adverse to quality. The QATR no longer commits to the requirements of ANSI N18.7. Clarify how the QATR provides for all personnel to identify conditions that are adverse to quality.

SNC RESPONSE Part II, Section 16, of the proposed SNC QATR states, "SNC has established the necessary measures and governing procedures to promptly identify, control, document, classify, and correct conditions adverse to quality." To clarify the scope of this statement, Section 16 of the proposed QATR has been revised to state:

SNC procedures require personnel to identify known conditions adverse to quality and assure that corrective actions are documented and initiatedin accordance with regulatoryguidance and applicable quality standards.

Conforming changes to the supplemental information provided with the proposed SNC QATR have been incorporated as follows:

Response to Draft NRC RAI dated February 1, 2007 Page 7 of 15 Enclosure 5, Section 5.2.17, which addresses the inspection requirements of ANSI N18.7-1976, has been modified to provide a cross reference to the corrective action requirements contained in NQA-1-1994 and the proposed SNC QATR.

SECTION 18 AUDITs NRC QUESTION

10. NRC's previously approved provision states that "a general grace period of 90 days may be applied to provisions that are required to be performed on a periodic basis unless otherwise noted. Annual evaluations and audits that must be performed on a triennial basis are examples where the 90 day general grace period could be applied.

The grace period does not allow the "clock" for a particular activity to be reset forward. The "clock" for an activity is reset backwards by performing the activity early." Section 18.1 of the QATR provides provisions for the performance of audits.

The QATR incorporates a grace period of 25% be applied to provisions that are required to be performed on a periodic basis. Describe the bases and acceptability of the provision for the 25% grace period stated in the QATR.

SNC RESPONSE By letter dated June 17, 2005, the NRC approved specific changes to the Farley, Hatch, and Vogtle quality assurance programs. These changes included NRC approval of standard criteria for extending audit intervals. These criteria included the following:

A. Audits shall be performed at the intervals designated herein for each audit area. Schedules shall be based on the month in which the audit starts.

B. A maximum extension not to exceed 25 percent of the audit interval shall be allowed. That is to say that, for audits on a 24-month frequency, the maximum time between specific audits shall not exceed 30 months.

Likewise, audits on an annual (12 month) frequency shall not be extended beyond 15 months.

C. When an audit interval extension greater than one month is used, the next audit for that particular audit area will be scheduled from the original anniversary month rather than from the month of the extended audit.

D. Item B shall also apply to supplier audits and evaluations except that a total combined time interval for any three consecutive inspection or audit intervals should not exceed 3.25 times the specified inspection or audit interval.

In its evaluation of the proposed change, the NRC determined that the audit interval extension provision was acceptable on the basis that it:

• Conformed to the requirements of Appendix B to 10 CFR Part 50; and

• Was consistent with the staff guidance for reviewing audit programs, as delineated in Section 17.2 of NUREG-0800.

Based on the above, the proposed use of the 25 percent grace period as described in Part II, Section 18.1 of the proposed QATR has been previously approved for Response to Draft NRC RAI dated February 1, 2007 Page 8 of 15 Farley, Hatch, and Vogtle and does not represent a change to the Farley, Hatch, or Vogtle QA program.

SNC has incorporated the above information regarding grace period for provisions that are required to be performed on a periodic basis into the ANSI N18.7-1976 conformance matrix provided in Enclosure 5. In addition, SNC has modified the Enclosure 5 to include the headings for the table columns inadvertently omitted from the original submittal.

NRC QUESTION

11. Section 18.1 of the QATR provides measures and frequencies for audits and evaluations of suppliers. The QATR provides a 36-month interval for audits of supplier activities, and 12-month interval for evaluation of supplier activities. In addition, the QATR allows for a maximum extension not to exceed 25% of the audit or evaluation [interval]. The combined time interval for any three consecutive audit or evaluation intervals should not exceed 3.25 times the specified audit or evaluation interval.

• Clarify what is included in an evaluation of a supplier and if the evaluation will be documented.

• Provide bases for the allowed extension period provided in the QATR for audits and evaluations of suppliers.

SNC RESPONSE Evaluation of suppliers is described in Section 7.1 of the proposed SNC QATR which states:

Prospectivesuppliers of safety-related items and services are evaluated to assure that only qualified suppliers are used. Qualified suppliers are auditedon a triennialbasis. SNC may utilize audits conducted by outside organizationsfor supplierqualification provided the scope and adequacy of the audits meet SNC requirements.

Documented annual evaluations are performed for qualifiedsuppliers to assure they continue to provide acceptableproducts and services.

Industry programs,such as those applied by ASME, Nuclear ProcurementIssues Committee (NUPIC), or other established utility groups, are used as input or the basis for supplier qualification whenever appropriate. The results of the reviews are promptly considered for effect on a supplier's continued qualificationand adjustments are made as necessary (includingcorrective actions, adjustments of supplieraudit plans, and input to third party auditing entities, as warranted). In addition, results are reviewed periodically to determine if, as a whole, they constitute a significant condition adverse to quality requiringadditionalaction.

Accordingly, the requested information regarding evaluation of suppliers is provided in the proposed QATR, as originally submitted.

Response to Draft NRC RAI dated February 1, 2007 Page 9 of 15 See the response to NRC Question 10 above for the basis for the extension period for audits and evaluation of suppliers described in the QATR. SNC has incorporated the information regarding extension period for audits and evaluations of suppliers into the ANSI N18.7-1976 conformance matrix, Section 5.2.13.2, provided in Enclosure 5.

NRC QUESTION

12. Section 3.1 of ANSI N18.7 specifies that when any work carried out under the requirements of the QA program is delegated to others, the work is to be audited by the QA audit program. Clarify how the QATR will provide measures to address the audit of QA program delegated to others.

SNC RESPONSE The information contained in Part II, Section 2, of the proposed QATR has been modified to include the following:

Delegatedresponsibilitiesmay be performed under a supplier'sor principalcontractor'sQA program,provided that the supplieror principle contractorhas been approved as a supplierin accordance with the QA TR. Periodicaudits and assessments of supplier QA programsare performed to assure compliance with the supplier's or principle contractor'sQA program and implementing procedures. In addition, routine interfaces with project personnelassure that quality expectations are met.

NRC QUESTION

13. NRC Regulatory Guide 1.33, "Quality Assurance Program Requirements," Revision 2, provides a frequency of 12 months for audits of facilities conformance with Technical Specifications and for audits of performance, training, and qualifications of the facility personnel. Provide the bases for the proposed extended audit frequencies provided in Section 18.1.

SNC RESPONSE As stated in Part III of the proposed QATR, SNC considers the quality assurance requirements of the proposed QATR and the QA requirements of NQA-1-1994 to be equivalent to ANSI N1 8.7-1976/ANS-3.2 and Regulatory Guide 1.33, Revision 2.

Consequently, SNC does not commit to ANSI N18.7-1976, or to Regulatory Guide 1.33, except that Appendix A of Regulatory Guide 1.33 will be used as guidance for establishing the procedures required for plant operational phase activities.

Notwithstanding, NRC letter dated June 17, 2005, approved specific changes to the Farley, Hatch, and Vogtle quality assurance programs. These changes included NRC approval of a maximum 24-month audit interval, except where noted.

Response to Draft NRC RAI dated February 1, 2007 Page 10 of 15 When the review and audit requirements for SNC's plants were relocated from the technical specifications to the QA program under the Improved Technical Specification Program, the relocations were performed in accordance with NRC Administrative Letter (AL) 95-06. Administrative Letter 95-06 states that audit frequencies may be revised by implementation of a performance-based schedule (schedule adjusted according to objective evaluation of plant functional area performance), provided that the maximum audit interval does not exceed the 24-month interval specified in ANSI N1 8.7. Exceptions to the allowable use of performance-based audit frequencies are those audit intervals defined by regulations, such as regulations governing the emergency and security plans.

The NRC found the SNC proposed change to the maximum audit intervals to be acceptable based on:

• A similar change in maximum audit intervals, based on performance-based audit scheduling, has been previously approved by the NRC staff; and

• The proposed implementation of a maximum 24-month interval for the specified audits is consistent with the guidance of AL 95-06 and is, therefore, acceptable.

Based on the above, the proposed use of a maximum 24-month interval for specific audits specified in the proposed QATR has been previously approved for SNC and as a result, does not represent a change to the Farley, Hatch, or Vogtle quality assurance requirements.

Enclosure 5, Section 4.5, of the SNC QATR submittal has been revised to provide the above described bases for the SNC exception to the audit frequencies contained in Regulatory Guide 1.33, Revision 2.

ENCLOSURE 2 DESCRIPTION OF PROPOSED CHANGE/BASIS FOR CONCLUDING THE REVISED PROGRAM CONTINUES TO SATISFY 10 CFR 50. APPENDIX B NRC QUESTION

14. As stated in 10 CFR 50.54(a)(3)(ii), the use of a quality assurance alternative, clarification or exception approved by an NRC safety evaluation, provided that the bases of the NRC approval are applicable to the licensee's facility, is not considered to be a reduction in commitment. The staff needs to understand how the bases of the NRC approval is applicable to the licensee's individual facilities. A statement that the bases are met is not adequate. For each alternative, clarifications and exceptions mentioned in Enclosure 2, Sections 4.2 and 4.3 provide a bases for each affected operating nuclear facility.

Response to Draft NRC RAI dated February 1, 2007 Page II of 15 The licensee may refer to Dominion's QA Consolidation submittal, Attachment 2, "Description of Changes," and the associated supplemental document dated August 24, 2004, and May 05, 2005, respectively, and Constellation's Common QATR, Attachment 4, and the associated supplemental documents dated December 5, 2005, and September 1, 2006, respectively, for examples of how to address providing a bases for the proposed alternative, clarification or exception. It would help the staff if the bases could provide information for each of the alternatives, clarifications or exceptions on the current commitment for each facility and explain why it is acceptable.

SNC RESPONSE The provisions of 10 CFR 50.54(a)(3) cited by the NRC allow licensees to make changes to a previously accepted QA program without prior NRC approval provided the change does not reduce commitments in the program description as accepted by the NRC. 10 CFR 50.54(a)(3) defines specific changes that are not considered to be reductions in commitments. Specifically, 10 CFR 50.54(a)(3)(ii) allows licensees to use quality assurance program alternatives or exceptions approved by an NRC safety evaluation, provided the bases of the NRC approval are applicable to the licensee's facility.

During development of the SNC QATR, consideration was given to changing the existing Farley, Hatch, and Vogtle QA programs to the QATR without prior NRC review and approval in accordance with the provisions of 10 CFR 50.54(a)(3).

However, at the direction of the NRC Staff, SNC submitted the proposed QATR in accordance with the provisions of 10 CFR 50.54(a)(4). SNC citation of prior NRC approval of alternatives and exceptions contained in the QATR is provided, not to state that the alternative or exception is applicable to SNC plants but instead, to facilitate NRC review of the proposed QATR.

The quality assurance topical report for nuclear power reactors describes quality assurance program requirements at a very high level with the detail necessary for implementation provided in detailed procedures. Licensees of commercial nuclear power reactors are required to have quality assurance programs that meet the requirements of 10 CFR 50, Appendix B, and are subject to routine NRC inspection of the QA program implementation. Accordingly, methods found to be acceptable by the NRC for meeting the requirements of 10 CFR 50, Appendix B, for a specific site should also be acceptable for other sites required to comply with the same requirement.

As stated above, SNC submitted the proposed QATR in accordance with the provisions of 10 CFR 50.54(a)(4) for NRC approval. Accordingly, the requirements of 10 CFR 50.54(a)(3) do not apply.

Response to Draft NRC RAI dated February 1, 2007 Page 12 of 15 NRC QUESTION

15. Paragraphs 4.2.7(b) and 4.2.8 of Enclosure 2 provide an alternate method for items requiring labeling and tagging. Provide an explanation of why the same alternative is taken for two different applications, and why it is acceptable.

SNC RESPONSE As stated in Section 4.2.7(b) and 4.2.8, SNC will utilize appropriate measures necessary to provide means for identification of equipment so that appropriate controls may be implemented. Regardless of the alternative selected in lieu of labeling or tagging, appropriate measures for assuring appropriate controls, including calibration of equipment, will be provided.

ENCLOSURE 3 EXISTING QA PROGRAMS VS. QATR COMPARISON MATRIX NRC QUESTION

16. In the Enclosure 3 of the QATR, SNC proposes moving Vogtle QA program section 17.2.17.1, "Record Retention," to FSAR Chapter 13, "Conduct of Operations."

Section 17 of the proposed QATR has a commitment to Regulatory Guide 1.28 under Record Retention, which includes guidance on the retention period for the different types of documents. The staff finds that these details would be appropriate to include in implementing procedures instead of Chapter 13. Explain the bas[e]s for moving this information to Chapter 13 of the FSAR and why taking this information out of the FSAR could result in a change to the license design bases.

SNC RESPONSE The proposed relocation of the record retention requirements for Vogtle described in FSAR Section 17.2.17.1 to Vogtle FSAR Section 13.7.1 is required to be consistent with Farley and Hatch. Section 13.6.2 of the Farley FSAR and Section 13.6.5 of the Hatch Unit 2 FSAR provide record retention requirements similar to those currently contained in Vogtle FSAR 17.2.17.1.

Part II, Section 17 of the proposed QATR provides controls to establish the necessary measures and governing procedures to ensure that sufficient records of items and activities affecting quality are developed, reviewed, approved, issued, used, and revised to reflect completed work. These procedures establish the scope of the records receipt, preservation, retention, storage, safekeeping, retrieval, and final disposition.

As stated in Part II, Section 17, records of activities for design, engineering, procurement, manufacturing, construction, inspection and test, installation, pre-operation, startup, operations, maintenance, modification, decommissioning, and audits include the appropriate content of NQA-1-1994, Parts I and II, and are based on the list of records and their retention times provided in Regulatory Position C.2, Table 1, of Regulatory Guide 1.28, Revision 3. Part II, Section 17 of the proposed QATR continues by stating, "Additional operations phase records and their retention periods are identified in the respective FSAR for each plant."

Response to Draft NRC RAI dated February 1, 2007 Page 13 of 15 Based on the above, the list of additional operations phase records that are proposed to be relocated from Vogtle FSAR Section 17.2.17.1 to Vogtle FSAR Section 13.7.1 are incorporated into the proposed SNC QATR by reference and as such, changes to the list of records or their retention period are subject to the controls of 10 CFR 50.54(a). Accordingly, relocation of the list of records does not represent a reduction in commitments contained in the existing Vogtle QA program.

SNC has modified Enclosure 3, Section 3, of the proposed QATR submittal associated with Section 17.2.17.1 of the Vogtle FSAR to reflect that the relocation of the list of records and their corresponding retention period does not constitute a reduction in the commitments contained in the quality assurance program. That is, changes to the list of records and their retention period will be subject to the provisions of 10 CFR 50.54(a).

ENCLOSURE 5 ANSI N18.7-1976 CONFORMANCE MATRIX NRC QUESTION

17. Regulatory Guide 1.33 specifies a minimum audit frequency of 6-month[s] for audits of corrective actions affecting safety-related equipment, 12-month[s] for audits of facilities conformance with Technical Specifications, and 12-month[s] for audits of performance, training, and qualifications of the facility personnel. In order for the staff to determine the acceptability of the proposed audit program, describe the bases for scheduling audits with the proposed performance-based program, as outlined in Section 4.3 of Enclosure 5 and how it comparts [sic] with the audit program outlined in Section 18.1 of Enclosure 1.

SNC RESPONSE See response to NRC Question 13 above.

NRC QUESTION

18. Section 5.2.15 of ANSI N18.7, "Review, Approval and Control of Procedures,"

specifies the following:

• In order to ensure that the procedures in current use provide the best possible instructions for performance of the work involved, systematic review and feedback of information based on use is required. The proposed QATR submittal, as stated in the comparison to ANSI N1 8.7 in Enclosure 5, does not appear to address procedure feedback.

" Plant procedures shall be reviewed by an individual knowledgeable in the area affected by the procedure no less than every two years to determine if changes are necessary or desirable. The proposed QATR submittal, as outlined in the comparison to ANSI N1 8.7 in Enclosure 5, does not appear to address the two-year procedure review.

Provide additional information describing how these requirements of ANSI N18.7 are met by the proposed QATR.

Response to Draft NRC RAI dated February 1, 2007 Page 14 of 15 SNC RESPONSE

• In order to address the need to provide systematic review and feedback regarding procedure use, SNC has incorporated the following in Section 6 of the proposed QATR:

(e) a method for providing feedback from users to continually improve procedures and work instructions.

(Note - Item (d) was added to the list provided in Section 6 of the proposed QATR in response to RAI Question 7 above.)

• By letters dated October 29, 1991, August 11, 1993, and July 21, 1992, the NRC reviewed and found acceptable the SNC proposed deletion of the biennial review of procedures for Farley, Hatch, and Vogtle, respectively. SNC's commitment to perform biennial reviews of procedures was replaced by a commitment to perform biennial quality assurance audits of the administrative controls for procedures utilizing a representative sampling process. The NRC found SNC's proposed alternative to be acceptable for Farley and Hatch based on the above.

During the NRC review of the change for Vogtle, the NRC included an additional requirement that non-routine procedures (i.e., emergency operating procedures and abnormal operating procedures) continue to be reviewed at least once every 2 years by a knowledgeable individual to determine whether changes are necessary or desirable.

As a result, SNC committed to continue to review emergency operating procedures and abnormal operating procedures for Vogtle at least once every two years by a knowledgeable individual to determine whether changes are necessary or desirable and modified Vogtle FSAR Section 13.5.1.1 to reflect his requirement. Based on its review, the NRC determined that the proposed change to the respective quality assurance program provided an acceptable alternative and that the programs continued to meet the requirements of 10 CFR 50, Appendix B.

Part II, Section 18.1, of the proposed QATR includes a requirement to perform audits of facility activities that include the performance of activities required by the quality assurance program to meet the criteria of 10 CFR 50, Appendix B, at least once per 24 months. Use of procedures is required by Part II, Section 5, of the proposed QATR titled, "Instructions, Procedures, and Drawings." Accordingly, the proposed SNC QATR includes a requirement for the biennial review of the administrative controls for procedures utilizing a representative sampling process. In addition, Section 13.5.1.1 of the Vogtle FSAR will retain the requirement to perform a review of emergency operating procedures and abnormal operating procedures at least once every two years.

Response to Draft NRC RAI dated February 1,2007 Page 15 of 15 Based on the above, the NRC basis for deletion of the review of procedures for SNC plants once every 24 months remains valid and therefore, the alternative also remains valid.