ML19312C144
| ML19312C144 | |
| Person / Time | |
|---|---|
| Site: | Oconee  |
| Issue date: | 02/14/1975 |
| From: | BABCOCK & WILCOX CO. |
| To: | |
| References | |
| NUDOCS 7912060709 | |
| Download: ML19312C144 (100) | |
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DUKE POWER GOMPANY
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February 14, 1975 Mr. Angelo Giambusso, Director Division of Reactor Licensing United States Nuclear Regulatory Commission Washington, D. C.
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Dear Mr. Giambusso:
Re: Topical Report on Quality Assurance DUKE-1, Amendment 2 Enclosed are three (3) signed originals and 47 copies of Amendment 2 to the Duke Power Company Topical Report, Quality Assurance Program, DUKE-1.
Amendment 2 includes the following:
1.
Resocase to a request for additional information in Mr. R. H. Vollmer's letter of December 2, 1974 (Note:
The location of individual responses is shown in Appendix B.)
2.
Organizational changes within Duke Power Company.
3 Clarification of existing information as requested by the Quality Assurance Branch of the Division of Licensing.
The enclosed copies are complete reprints of the topical report and include Amendment 2.
These copies supersede all previously transmitted versions.
Respectfully submitted, x
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W. S. Lee
s W. S. Lee being duly sworn states that he is Vice-President of Duke Power Company; that he is authorized on the part of said company to sign and file with the Nuclear Regulatory Commission this amendment to its Applications and documents appended thereto; and that all statements and matters set forth therein ere true and correct to the best of his knowledge.
W. S. Lee Senior Vice-President, Engineering and Construction ATTEST:
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QA requirements are those inspection, test, examination, certification and documentation reautrements which are imposed to provide objective evidence of the conformance of an item or activity to established design, engineering, standards and-code requirements. The establishment of design, engineering, standards, and code requirements is 'an engineering and technical support responsibility. The specification of QA requirements is a quality Assurance
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responsibility, i
l Amendment 2
7 Pcga 2 cf 3 TABLE 17.1-3 QUAllTY ASSURANCE FUNCTIONS (continued)
- 16. Assuring the resolution of va. iation notices.
- 18. Verifying correct transfer of information from purchase requisition to purchase order.
- 19. Specifying qA standards and criteria.
- 20. Writing, maintaining, contro lling, and approving QA manuals and procedures.
22.
Providing principal DRO and DOL contact on qA matters.
24.
Performing Internal company QA audits.
25 Evaluating the status and adequacy of the QA program.
- 26. Compiling data and trend analysis for QA matters for management review.
27 Providing solutions to QA problems.
28.
Collecting, maintaining, and controlling QA records.
29 Determining which documents must be controlled.
- 30. Approving the records of procedure and operator qualification of special processes.
- 31. Certification of QC Inspectors, document controllers, layout personnel and calibration personnel.
- 32. Maintaining qualification and certification records of qA and QC per,sonnel.
- 33. Reporting QA matters to management.
The following quality Assurance functions are considered Ouality Control:
- 34. Performing inspections and recording the results.
35 Performing " destructive" and " nondestructive" tests.
- 36. Performing receipt and storage inspections and reporting the results.
37 Originating nonconforming item reports and inspecting corrective action taken.
- 38. Witnessing acceptance testing in construction and operation.
- 39. Performing inspections and tests required in the qualification of special processes and personnel performing special processes.
Amendment 1
Paga 3 of 3 1
TABLE 17.1 -3 TECHNICAL FUNCTIONS Technical functions are those activities performed by engineers and technical 4
personnel in the engineering, construction, and operation of a plant.
Not all functions are listed below -- only those which are similar to or might be con-fused with QA and QC Functions.
I.
Originating and checking design documents.
2.
Originating and checking procurement documents.
3.
Determining safety-related systems and components.
4.
Approving a vendor's manufacturing and technical capabilities.
5.
Originating and resolving nonconforming item reports.
6.
Originating and resolving variation notices.
l 7
Witnessing functional tests on vendor supplied equipment.
8.
Writing construction procedures.
9 Writing functional test and operating procedures.
- 10. Writing procedures for welding and other special processes.
II, qualifying welders and welding procedures, and reporting results.
12.
Originating process control documents.
- 13. Development and approval of engineering procedures.
- 14. Determining the storage requirements for materials.
15 Controlling the distribution of drawings, specifications, and other documents used for construction and operation.
- 16. Administering the tool and gauge calibration program.
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4 Amendment 1
DUKE POWER COMPANY CORPORATE ORGANIZATION FOR QUALITY ASSURANCE Executive Vice-President
& General Manager 7
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I Senior Senior Director of Nuclear Vice-President Vice-President Purchases &
Safety Engineering Production &
President Review
& Construction Transmission Mill Power Board (s)
Supply Company Corporate Vice-President Vice-President Quality Construction Design Vice-President Assurance Engineering Steam Manager Production TOPICAL REPORT QUALITY ASSURANCE PROGRAM Figure 17.l-1 An.endment 2 i
DESIGN ENGINEERING DEPARTMENT ORGANIZATION CHART Vice-President Design Engineering Manager Engineering Manager Services General Services I
Chief Chief Engineer Chief Civil.
Engineer Engineer Environmental Electrical Mec n cal l
i TOPICAL REPORT QUALITY ASSURANCE PROGRAM FIGURE 17.1-2 Amendment 2 l
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f HECHANICAL-NUCLEAR DIVISION ORGAdlZATION CHART
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CHIEF ENGINEER HECH-NUCLEAR DIVISION STAFF
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ENGINEER SYSTEMS AND MECHANICAL NUCLEAR AND EQUIPMENT DESIGN COMPUTER PROJ ENGINEERS ENGINEERS ENGINEERS DESIGNERS DESIGNERS DESIGNERS TOPICAL REPORT QUALITY ASSURANCE PROGRAM FIGURE 17.1-3 l
Amendment I
C I V I L-ENV I RONt' TAL DIVIS10t1 ORGANIZATION CHART CHI EF ENGINEF's CIVIL-ENV DIVISION l
STAFF ENGINEER CIVIL civil PROJECTS PROJECTS STRUCTURAL ARCHITECTURAL ENVIRONMENTAL LICENSING &
SPECIAL ASS IGNMENTS ENGINEERS
! ENGINEERS ENGINEERS ENGINEERS ENGINEERS DESI NERS DESIGNERS DESIGNERS DESIGNERS SCIEN IFIC DESIGNERS PERSONNEL TOPICAL REPORT QUALITY ASSILA!!CE PROGRAM FIGURE 17.1-4 Amendment 1 I
ELECTR ICA' DIVISION ORGANIZATION CHART CHIEF ENGINEER ELECTRI CAL DIVISION i
RELAYlhG AND POWER POWER SYSTEMS CONTROL AND CONTROL AND SWITCHING DESIGN AND COMPUTER EQUlPMENT INSTRUMENTATION INSTRUMENTATION STATION APPLICATIONS DESIGN SYSTEMS ENGINEERS ENGINEERS ENGINEERS ENGINEERS ENGINEERS ENGINEERS DESIGNERS DESIGNERS DESIGNERS DESIGNERS DESIGNERS DESIGNERS TOPICAL REPORT QUALITY ASSURANCE PROGRAM FIGU.lE 17.1-5 Amendment 1 I
CONSTRUCTION DEPARTMENT ORGANIZATION CHART Vice-President Construction l
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Supervisor Of ng neer Employee Relations
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Oconee McGuire Catawba C reek Senior Mount Holly Manager l
Project Project Project P roject P roj ect Store Yard Constructicrl Manager Manager Manager Manager Engineer Resident Services I.)
TOPICAL REPORT QUALITY ASSURANCE PROGRAM FIGURE 17.1-6 Amendment 2
TYPICAL CONSTRUCTION DEPARTMENT PROJECT ORGANIZATION Project Manager General Project Resident Superintendent Engineer Cashier Senior Senior Senior Construction Quality Planning and Control Facilities Eng i r.ee r Engineer Engineer i
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FIGURE 17 1-7 Amendment I
QUALITY A55UAANCE OEFAAIMENT - ORCANilATION CHAAT Corporate CA Manager I
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CA Manager, QA Manager, CA Manager, CA Manager.
Audits and Con s t ruc t ion Engineering Operations tendors Training and Services I
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Audits Set.Ior QA g
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Clerical Senior I
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_________.J Typical Project QA Organtration hotet This chart shows the total Quality Assurance organization, et varicus stages dur!ng icotementation of the cew organlaatton or a new nuclear project all positions may not be filled.
hnendment 2 TOPICAL REPORT QUALITY ASSURANCE PROGRAM FIGURE 17.1-8 i
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17.2 OPERATIONAL QUALITY ASSURANCE 17.2.1 ORGANIZATION 17 2.1.1 Corporate organization The Duke Power Company corporate organization for quality assurance is shown in Figure 17.l-1.
The Executive Vice President and General Manager has overall responsibility for planning, design, construction and operation of the Company's generation and transmission facilities.
Reporting to the Executive Vice President and General Manager are the Senior Vice President, Engineering and Construction, who directs the activities of the Engineering, Construction and quality Assurance Departments, and the Senior Vice Presi-dent, Production and Transmission, who is responsible for directing the operation of the Company's generation and transmission facilities.
The Executive Vice President and General Manager is the corporate executive responsible for the Company's quality assurance program and is the highest level of management responsible for establishing Duke's quality assurance policies, goals and objectives. The basic policies, goals and objectives for quality assurance are stated by the following excerpt from the Duke Corporate Quality Assurance Program:
"The individuals who constitute Duke Power Company have full personal and corporate responsibility to assure that nuclear power plants are designed, constructed, tested and operated in a manner to protect the public health and safety.
The comprehensive program to assure this begins with initial design and continues throughout the life of the station. The Duke Power quality assurance program must assure that the necessary quality requirements for safety-related structures, systems, and components and materials are achieved."
Quality assurance policies, goals and objectives are addressed further in various corporate and departmental plans, procedures, manuals, etc.
In this manner, quality assurance philosophy and requirements are communicated to all levels of management.
Also Company management is committed to applicable quality assurance regulations, codes and standards as identified in Section 17 0.2.
17.2.1.2 Nuclear Safety Review Board The Executive Vice President and General Manager appoints a nuclear safety review board for each nuclear station to serve as a nuclear safety review j
and audit backup to the normal operating organization.
The membership of the nuclear safety review board for a particular station may, or may not, be l
unique from the membership of the boards for other stations. The organi-l zational structure, administrative requirements, responsibilities and i
authorities specific to each board are detailed in a written charter and in the Technical Specifications for the applicable station.
The nuclear safety review boards review proposed tests and experiments, pro-posed station modifications, and requests to the NRC for changes in a l
17.2-1 Amendment 2
station's license (s) or Technical Specifications, when such involve an un-reviewed safety question. Also, the boards review, on a selective basis, abnormal occurrences, unusual events and violations of a station's Technical Specifications, and make recommendations to prevent recurrence.
17.2.1.3 Steam Production Department 17.2.1.3.1 Vice President, Steam Production The Steam Production Department has direct line responsibility for all Duke Power Company nuclear station operations. The Steam Production Department is responsible for achieving quality results during preoperational testing, operation, testing and maintenance of the Company's nuclear stations and with complying with applicable codes, standards and NRC regulations. The functions of Steam Production are directed by the Vice President, Steam Product ion. The Vice President, Steam Production, formulates, recommends, and carries out plans, policies, and programs related to the generation of electric power; and reports to the Senior Vice President, Production and Transmission. The Vice President, Steam Production, is informed of significant problems or occurrences relating to safety and quality assurance through established administrative procedures, and participates directly in their resolution, where necessary.
17.2.1 3.2 Steam Production Department General Office The Steam Production Department General Office is divided into var ious sections as shown in Figure 17.2-1.
The activities of each section are directed by a manager who reports to the Vice President, Steam Production.
These sections are staffed with professional personnel experienced in all phase's of station operation who provide technical support to each nuclear station.
17 2.1.3 3 Station organization The station Managers report to the Vice President, Steam Production, through the Manager, Nuclear Production.
For each nuclear station, the assigned station Manager is directly responsible for the safe cperation of the fa c i l i ty.
The station Manager is also responsible for the administration and implementation of the quality assurance program as it applies to station operation. The qualification requirements for the static' Manager are in accordance with the provision of ANSI N18.1-1971 and are iresented in each station's PSAR and FSAR.
In the discharge of their responsibilities, the station Managers direct the activities of the station organizations. A typical station organization is shown in Figure 17.2-2.
17.2.1.4 Quality Assurance Department The Quality Assurance Department organizational structure is shown in Figure 17.1-8.
The Quality Assurance Department is responsible for verifying that plans, policies and procedures comply with NRC regulations; for verifying that procedures are properly implemented; and for performing quality control Inspections.
The activities of the Quality Assurance Department are directed by the Corporate Quality Assurance Manager, who reports to the Senior Vice 17.2-2 Entire Page Revised Amendment 2
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President, Engineering and Construction. The qualification requirements for the Corporate Quality Assurance Manager are given in Appendix A.
Resident at each operating nuclear station is a Senior Statlan Quality Assurance Engineer who reports to the Corporate quality Assurance Manager, through the Quality Assurance Manager, Operations. A Senior Station quality Assurance Engineer is responsible for all Quality Assurance Department activities at an operating station. He is supported by quality assurance engineers and technicians and by a quality control staff.
The quality Assurance Department has the authority and organizational function freedom to:
(a) Identify quality problems.
(b) Initiate, recommend or provide solutions to quality problems through designated channels.
(c) Verify the implementation of solutions to quality problems.
If sigolficant quality problems are identified by quality Assurance Department persannel, the Senior Station quality Assurance Engineer, or his designee, has the responsibility and authority to notify the station Manager, or his des 3gnee, to direct the affected work activity to cease pending satisfactory resolution of the identified problem.
Specific responsibilities of the Quality Assurance Department with regard to nuclear station operational activities are identified in subsequent sub-sections of this report.
In general, however, the Quality Assurance Depart-ment performs checking, auditing, and inspecting functions in order to verify that activities have been correctly performed. Therefore, due to the corporate organizational structure, the individuals performing such verifi-cations are distinctly independent of the personnel directly responsible for performlig the activities being checked, inspected or audit:3.
17.2.1.5 Department Interfaces With regard to the operational quality assurance program, activities af-fecting the quality of nuclear safety-related structures, systems and compcnents are performed by, or under the cognizance of, the Steam Pro-duction Department and the Quality Assurance Department.
If a disagreement arises between members of these departments, resolution is sought at successively higher levels of management, as necessary.
Such a disagreement may be resolved at any level of management up to and including the Executive Vice President and General tunager.
17.2-2a New Page Amendment 2
17.2.2 QUALITY ASSURANCE PROGRAM The Duke Power Ccmpany operational quality assurance program is described in various Company manuals. A summary of the topics addressed, and their relation-ship to the criteria of 10CFR50, Appendix B, is presented in Table 17.2-1.
Procedures and work instructions necessary to implement the requirements of the operational quality assurance program are developed by the organization responsible for the activity.
These procedures and instructions may be con-tained in manuals, station procedures and directives, administrative instructions i
and/or other documents. Onsite implementation of procedures and work instruc-tions is the responsibility of the station Manager, quality Assurance Depart-ment personnel verify that the procedures are followed by means of inspections, audits and other surveillance. Procedures for such inspections, audits and other surveillances are developed, approved and implemented by the Quality Assurance Department.
For each nuclear unit, those structures, systems and components which are con-sidered to be nuclear safety-related are identified. As design and construction of such structures, systems and components are completed, the responsibillry for the control of activities affecting the items is formally transferred to the Steam Production Department.
This transfer is documented and the affected structures, systems and components are identified by means of tags, labels, stamps or other suitable means as being under the control of the Steam Production Department. Applictble records such as vendor documentation packages and inspec-tion reports, piping Isometric drawings, welding records, etc. compiled during design and construction are transferred by the quality Assurance Department Construction Division to the Quality Assurance Department Operations Division concurrent with, or subsequent to, transfer of structures, systems and components to the Steam Production Department.
Such transfer of records is performed in accordance with established procedures.
TF operational quality assurance program is implemented as structures, systems and components are transferred. A preoperational test program is established and controlled to assure that all necessary inspection and testing on transferred structures, systems and components is performed and properly evaluated. The operational quality assurance program is gradually expanded as necessary until issuance of an operating license for the unit by the Nuclear Regulatory Commission at which time all nuclear safety-related activities for the unit are under the jurisdiction of the operational quality assurance program.
After the program has been fully implemented, it is continued throughout the operating life of the unit. The program receives on going review and is revised as necessary to assure its continued effectiveness.
J A training program is established for each nuclear station to develop and main-tain an organization qualified tq be respor.sible for operation, maintenance and other technical aspects of the nuclear station involved.
The program is formu-lated to provide the required training based on individual employee experience and intended position.
The program is in compliance with Nuclear Regulatory Com-mission licensing requirements, where applicable.
The training program is such that trained and qualified operating, naintenance, technical support and supervisory personnel are available in necessary numbers at the times required.
In all cases, the objectives of the training program shall be to assure safe and reliable operation of the station.
The training program is kept current to reficct station modifications and changes in procedures.
A continuing effort is used after a station goes into commercial operation for training of replacement personnel and -
17.2-3 Amendment 2
for periodic training necessary to assure that personnel remain proficient.
Station personnel receive formal orientation training in basic quality assurance policies and practices.
Special training of station personnel in quality assurance related matters, particularly new or revised requirements, i: conducted as necessary. Training records are maintained for each employee.
New quality Assurance Department personnel attend an indoctrination class concerning quality assurance authority, organization, policies, manuals and procedures. Personnel receive additional formal training, as appropriate, which addresses specific topics such as NRC regulations and guides, quality assurance procedures, auditing and applicable codes and standards. Retraining is performed as required. On-the-Job training is performed by an employee's supervisor in the specific procedures and requirements related to the employee's work activity. Training records are maintained for each employee.
Independent Levell audits, under the direction of the quality Assurance Manager,
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Operations, and Level 2 audits, under the direction of the Quality Assurance Manager, Audits and Training, provide assurance of compliance with the require-ments of the operational quality assurance program.
e 17.2-3a New Page Amendment 2 e
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.17.2 3 DESIGN CONTROL
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.in order to provide for the continued safe and reliable operation of a nuclear
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station's nuclear safety-related structures, systems and components, design control measures are implemented to assure that the quality of such structures, systems and components is not compromisad by modifications. These design l
control measures are commensurate with those applicable to the original design and assures that modifications are designed and implemented in accordance j
with applicable codes, bases, standards, specifications, etc.
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In order to assure proper interface control, the responsibilities of the l
various individuals / organizations involved in modifications are formally l
Identified.
The assignment of responsibility for the evaluation and design l
of a particular modification to a specific individual / organization is i
documented. Also, the written instructions addressing the control of modifi-cations address the communicacita of information between involved individuals /
organizations and, where appropriate, require documentation of such communi-
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cations.
1 Each request for a modification is reviewed by a cognizant, designated indi-vidual at the station to determine if the station is adequately qualified to perform the necessary evaluation and des!gn of the modification.
If it is determined that the station is adequately qualified, then an appropriate individual is assigned evaluation and design retponsibility for the proposed modification.
If it is determined that the stat!on is not adequately qualified, than the request for a modification is transmitted to the Steam Production Department General Office for assignment of evaluation and design responsi-bility to a qualified individual / organization.
4 For each proposed modification, the individual / organization assigned responsi-bility for evaluation and design of the modification considers the following in the design of the modification:
(a) Necessary design analyses, e.g., physics, stress, thermal, hydraulic, accident, etc.
I (b) Compatibility of materials.
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(c) Accessibility for operation, testing, maintenance, inservice inspection, etc.
I (d) Necessary installation and periodic inspections and tests, and acceptance i
criterla therefor.
(e) The suitability of application of materials, parts, ' components and pro -
cesses that are essential to the function.of the structure (s), system (s)
- and/or component (s) to-be modified.
The individual / organization assigned responsibility for evaluation and design 1
of a modification performs a safety evaluation of _the proposed modificar. ion.
l This evaluation provides the bases for the determination that the modification does' or does not involve' an unreviewed safety question. This evaluation is
'17.2-4'
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checked by an Individual / group other than the individual / group performing the safety evaluation, but who may be from the same organization as the individual /
group which performed the safety evaluation. This evaluation and the check thereof are documented.
Following completion of design and evaluation of a modification, the responsible individual / organization provides a summary of the design of the modification and information pertinent thereto. This summary addresses such items as:
(a) A description of the modification.
(b) References utilized in the evaluation and design of the modification, and necessary for the implementation of the modification.
(c) Special installation instructions.
(d) Operational, test, maintenance and inspection requirements.
(e) Materials, parts and components required in order to implement the modifi-j cation.
(f) Drawings revised and/or requiring revision.
(g) FSAR revision (s) and/or Technical Specifications amendment (s) necessary.
j (h) Whether or not the modification involves an unreviewed safety question.
i The design summary is checked by an individual / group other than the individual /
group preparing the summary, but who may be from the same organization as the Individual / group which prepared the summary. The design summary is approved by a cognizant, responsible individual within the organization which prepared the summary.
The design summary and the check and approval thereof are docu-mented.
Qualification testing of the design of a modification, including quali-fication testing of prototype units, is performed as necessary.
Proposed modifications are subsequently reviewed by the responsible Station Review Committee. The Quality Assurance Department reviews tre proposed modification, including applicable implementing procedures asseciated
- therewith, certifies that quality assurance requirements have been met and determines inspection requirements prior to implementation of the modifi-cation.
For modifications which are evaluated and designed by the station, the Steam Production Department Gen ^eral Office is forwarded a description of the modification prior to or concurrent with. implementation. Modifications which are determined to involve an unreviewed safety question are reviewed by the applicable nuclear safety revlea board and must be authorized by the Atomic Energy Commission prior to implementation.
l-Final approval of each station modification is the responsibility of the applicable station Manager. Modifications are then executed in accordance with approved checklists, instructions, procedures, drawings, ~ etc., appropriate Lto'the nature of the work to be performed. These checklists, instructions, procedures, drawings, etc. Include criteria for determining the acceptability of the modification.
17.2-4a New Page Amendment 2
Errors and deficiencies noted in the design of a modification are corrected by means of a revision to the modification. The control measures applied to each such modification revision are equivalent to the control measures applied to the modification originsily.
Each modification revision, and the review and approval thereof, is documented.
Adequate Identifiable and retrievable documentation of station modifications is retained for the life of the station.
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I A " check" is defined as a technical verification of accuracy by means of l
-partial or complete investigation, comparison, examination and/or independent l
determination of results.
l 17.2-4b
' Amendment 2 New Page
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i 17.2.4 PROCUREMENT DOCUMENT CONTROL l
Procurement of materials, parts and components associated with a station's nuclear safety-related structures, systems and components is controlled during the operational life of the station so as to assure that the safety and rella-bility of the station are not compromised. This control is commensurate with the controls utilized for procurement during the design and construction of i
the station.
j Each purchase requisition for materials, parts and components associated with nuclear safety-related structures, systems and components is identifiably designated as such. The level of control and protection applicable to each j
item is determined by a cognizant Individual designated by senior station management to perform such a function. This determination is checked by i
another cognizant individual designated to perform such a checking function by senior station management. Requisitions for items whose failure would cause the physical integrity of nuclear safety-related structures, systems or components to be violated include or reference detailed purchase specifications.
Subsequent to preparation, each purchase requisition is approved by the station Manager.
Purchass requisitions for nuclear safety-related materials, parts and compo-i nents are reviewed by the Quality Assurance Department to assure that quality 1
assurance requirements, including vendor documentation requirements and applicable j
10 CFR 50, Appendix B requirements, are adequately incorporated into the pur-chase document (s).
Significant changes to the content of such purchase requisitions are approved by the applicable purchase requisition originator and are reviewed by the quality Assurance Department.
l Where necessary, procurement documents require that nuclear safety-related mat-irials, parts and components be acquired from vendors determined to be j
acceptable by the Quality' Assurance Department - see Section 17 2.7 Determination of acceptability requires that a vendor provide Duke the j
right of access to the vendor's facilities and records for Inspection and audit.
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17.2-5 Entire Page Revised Amendment 2 I
17 2.5 lNSTRUCTIONS, PROCEDURES AND DRAWINGS The basic, written instructions and procedures for operational activities affecting quality are contained in the Steam Production Department's "Adminis-trative Policy Manual for Nuclear Stations."
It is required that personnel implement this manual as it pertains to the performance of their activities.
With regard to specific operational activities associated with nuclear safety-related structures, systems and components, it is required that such activi*.les be accomplished in accordance with procedares, instructions, drawings, check-lists, etc.
appropriate to the nature of the activities being performed. As necessary, such documents identify equipment necessary to perform an activity, specify conditions which must exist prior to and during performance of an activity, and include quantitative and/or qualitative acceptance criteria, com-patible with any applicable design specifications, for determining that the activity addressed is satisfactorily accomplished.
Examples of documents established concerning quality related operational activities are:
(a)
Preoperational Test Procedures (b) Periodic Test Procedures (c)
Operating Procedures (d)
Emergency Procedures (e)
Maintenance Procedures (f) instrument Procedures (g) Health Physics Procedures (h) Alarm Responses (i)
Chemistry Procedures in addition to the above, files of drawings and vendor documents applicable to the station's structures, systems and components are maintained at each nuclear station and are utilized, as appropriate, in the performance of quality related activities.
17.z-6 Amendment 2
17.2.6 DOCUMENT CONTROL The Steam Production Department's " Administrative policy Manual for Nuclear Stations" and the quality Assurance Department's " Operational Quality As-surance Manual" contain the basic written Instructions and procedures for operational quality assurance. The former document, and subsequent revisions thereto, are approved by the Vice President, Steam Production and certified to meet NRC quality assurance regulations by the Corporate Quality Assurance Ma na ge r.
It is considered a controlled document and numbered copies of the manual are distributed by cover letter from the Vice President, Steam Pro-duction. The latter manual is administered in the same manner, except that approval and distribution is by the Corporate Quality Assurance Manager.
Station procedures which address activities associated with nuclear safety-related structures, systems and components are subjected to a well-defined, established review and approval process. This process includes the require-ment that each procedure be reviewed by station personnel and the Station Review Committee. As appropriate, such procedures are also reviewed by personnel f rom the Steam Production Department General Office, by the Quality Assurance Department, by other departments within the Company, by the ap-plicable nuclear safety review board and by vendor personnel. Upon approval by the station Manager a procedure is issued for use. Major changes or revisions to approved procedures require final approval by senior station management and, as appropriate, are reviewed by the Station Review Committee.
In the case of station activities of a non-recurring nature, e.g.,
pre-operational tests, only an original copy of an approved procedure is available for use.
Such copies are controlled and are replaced whenever the procedure is superseded by a new issue.
For activities which are of a recurring nature, e.g.,
surveillance testing, current original copies of approved procedures are maintained in controlled, designated locations.
Copies of these original copies are then utilized in the performance of work activities. When such " working copies" involve the documentation of com-pliance with the procedure, the " working copy" of the procedure utilized is compared with the applicable original copy to assure validity. The signatu e of the individual responsible for the work activity, and the date the activity was performed, on the completed " working copy" of the procedure provides documentation of the fact that this ccmparison was made.
Such completed procedures are retained - see Section 17.2.17. When recurring work activities do not involve documentation of compliance with the procedure, e.g., certain operating activities, issuance of the applicable " working copies" is controlled to assure that only current copies are available for use.
Drawings and vendor documents, and changes thereto, are normally received from the Design Engineering Department for distribution and use by each nuclear station.
Distribution Indices are established and utilized for such documents within each station in order to assure their proper distribution and use. Working flies of drawings are periodically compared with the station master drawing file to assure their validity. Also, the master drawing file is periodically compared with appropriate reference sources, such as a Design Engineering Department drawing index, to assure its accuracy.
Original design and procurement documents are maintained and controlled by the Quality Assurance Department and are updated, as necessary,
.by the Design Engineering Department.
17.2-7 Amendment 2 o
17 2.7 CONTROL OF PUP. CHASED MATERIAL, EQUIPMENT AND SERVICES T
As stated in Section 17.2.4, the determination of vendor acceptability is the responsibility of the Quality Assurance Department. Where necessary, this i
determination of acceptability is based on an audit of the vendor by the quality Assurance Department. Such an audit is performed in accordance with a com-prehensive, written checklist to determine the ability of the vendor to comply with applicable criteria of 10 CFR 50, Appendix B.
The results of each such audit are summarized in a written audit report which identifies whether or not the subject vendor is qualified to provide specific items.
Each audit report is reviewed by the Quality Assurance Manager, Vendors, and if approved by the Quality Assurance Manager, Vendors, the subject supplier is placed on a list which identifies acceptable vendors. When the nature of an item is such that there is adequate experience and/or historical evidence to verify vendor capability, a supplier may be determined to be acceptable by the Quality Assurance Department without performance of a formal audit.
~~
Vendors are requalified by reaudit, or evaluation of previous excerlence or current performance, as appropriate.
As required by procurement criteria, in order to assure that material and equipment are fabricated in accordance with appilcable requirements, vendor review, audit and surveillance are performed by the quality Assurance Depart-ment, Vendors Division. This review, audit and surveillance includes witnessing of tests and fabrication checkpoints, and evaluation of overall vendor per-formance and is documented.
As required by the applicable purchase documents, suppliers furnish docu-mentation which identifies the material and equipment purchased and the specific procureeent requirements met by the items. Also,.as required by the applicable purchase documents, suppliers provide documentation which identifies any pro-curement requirements which have not been complied with, together with a description of any deviations and repair records.
Upon receipt at a station, the station organization is responsible for the control of nuclear safety-related materials, parts and components.
Such items are placed in a controlled, designated area and are subjected to a receipt inspection by station Quality Assurance Department personnel.
This inspection is intended to determine whether or not each item received conforms with applicable procurement requirements.
Such inspections and the subsequent determination of conformr e or nonconformance are documented by means of reports, which are retained on file by the quality Assurance Department, and, as appropriate, by tags attached to the items. Until a determination of conformance is made by the Quality Assurance Department, a nuclear safety-related material, part l
or component cannot be issued and installed.
Entire Page Revised' 17.2-8 Amendment 2
17.2.8 IDENTIFICATION AND CONTROL OF MATERIALS, PARTS AND COMPONENTS Following receipt inspection, materials, parts and components which are determined to be acceptable are assigned an Identifying designation (such as a serial number), as appropriate, in order to provide quality assurance traceability of each item, in the event that the identification of an item becomes lost or illegible, the item is considered nonconforming and not utilized until proper resolution of the nonconformance. When a designated item is subdivided, each subdivision is identified in accordance with the above requirements. Where physical identification of an item is impractical or Insufficient, physical separation, administrative controls or other appropriate means are utilized.
Conforming, nuclear safety-related materials, parts and components are stored in controlled, segregated areas designated for the storage of, such items. The issue of nuclear safety-related materials, parts and components is controlled and documented in such a manner that qualliy assurance traceability and inventory accountability is provided.
Nonconforming materials, parts and components are identified and segregated in such a manner as to preclude their inadvertent substitution for and use a's conforming materials, parts and components.
e 17.2-9 Amendment I
17.2.9 CONTROL OF SPECIAL PROCESSES The operational quality assurance program addresses the control of special processes such as welding, heat treating and non-destructive examination.
The program requires that approved, written procedures, qualified in ac-cordance with applicable codes and standards, be utilized when the performance of such processes affects the proper functioning of a station's nuclear safety-related structures, systems and components.
In addition, personnel performing such activities must be certified in accordance with applicable codes, and standards. Adequate documentation of personnel qualifications is required prior to performance of the applicable special process.
4 a
e 17 2-10 Amendment 2
17.2.10 INSPECTION in order to assure safe and reliable operation, a program of inspections for nuclear safety-related structures, systems and components is established at each nuclear station. The program addresses:
(a) Inservice inspections required by Section XI of the American Society of Mechanical Engineers Boiler and Pressure Vessel Code.
(b) Inspections to varify compliance with cleanliness criteria.
(c) inspections to verify compliance with certain station procedures for operation and maintenance.
(d) inspections to verify conformance of materials, parts and components received at a nuclear station with applicable specifications and require-ments.
(e) Inspections to verify the integrity of safety-related structures, systems and components during and/or af ter maintenance and modif' cation.
The performance of these inspections is the cespor.41o* d ity of the Quality Assurance Department. Therefore, the individuais performing such inspections are distinctly independent of the personnel directly responsible for performing the activities being inspected.
Personnel performing inspections are qualified, and the inspection activities performed, in accordance with appropriate quality control procedures. These procedures comply with the requirements of applicable codes and standards.
Modifications, repairs and replacements are inspected in accordance with the original design and inspection requirements, or acceptable alternatives.
Mandatory inspection hold points are included in the documents addressing the activities being performed, as necessary, and work does not proceed beyond such hold points until satisfactory completion of the required inspection by the Quality Assurance Department.
Inspection of vendor quality assurance programs and activities is performed by the Quality Assurance Department.
i 17.2-11 Amendment 2
17.2.11 TEST CONTROL The operational quality assurance program addresses both precperational and periodic (surveillance) testing. The program requires that such testing associated with nuclear safety-related structures, systems and components be accomplished in accordance with approved, written procedures and that schedules be provided and maintained in order to assure that all necessary testing is performed and properly evaluated on a timely basis.
Test controls include requirements on the review and approval of test proce-du.es,and on the review and approval of changes to such procedures, as discussed in Subsection 17.2.6 above. Also, specific criteria are established with regard to procedure cor. tent. Examples of items which must be considered in the preparation and review of procedures include:
(a)
References to material necessary in the preparation and performance of the procedure, including applicable design documents.
l (b) Tests which are required to be completed prior to, or concurrently with, the specified testing.
(c)
Special test equipment required to perform the specified testing.
(d)
Limits and precautions associated with the testing.
(e)
Station, unit and/or system status or conditions necessary to perform the specified testing.
(f)
Criteria for evaluating the acceptability of the results of the specified testing, compatible with any applicable design specifications.
l Requirements are also established for verification of test completion and for determining acceptability of tests results.
in the event that test results do not meet test acceptance criteria, a review of the test, test procedure and/or test results is conducted to determine the cause and the required corrective action.
In addition to the above, after maintenance to, or modification of, nuclear safety-related structures, systems and components certain proof tests, electrical tests, operational tests or other special tests are performed and documented as required to verify the satisfactory performance of the affected items.
17.2-12 Amendment 2
17 2.12 CONTROL OF MEASURING AND TEST EqulPMENT In order to assure the required accuracy of tools, gauges, instruments and other measuring and test devices affecting the proper functioning of nuclear safety-related structures, systems and components, a program of control and calibration for such devices is provided.
This program includes the following: l (a)
Devices are assigned permanent, identifying designations.
(b)
Devices are calibrated at prescribed intervals, and/or prior to use, against certified equipment having known, valid relationships to nation-ally recognized standards.
The calibration interval for a device is based on the applicable manufacturer's recommendations.
if experience dictates that the manufacturer's recommendatic..s are not appropriate, the calibration interval is changed as necessary.
(c)
Devices that have been acceptably calibrated are affixed with a tag, or tags, showing the date of calibration, the date the next calibration is due, an indication that the device is within calibration specifications and the identification of the Individual who was responsible for perform-ing the calibration.
(d)
Devices which fall to meet calibration specifications are affixed with a tag, or tags, showing the date of rejection, the reason for rejection and the identification of the Individual rejecting the device.
" Accepted" and " Rejected" calibration tags are sufficiently different to preclude confusion between them.
(e) ltems and processes determined to be acceptable based on measurements made with devices subsequently found to oe out of calibration are re-evaluated.
(f)
Devices are stored under conditions which are in accordance with, or more conservative than, the applicable manufacturer's recommendations.
(g)
Devices are issued under the control of responsible personnel so as to preclude unauthorized use.
(h)
Devices are shipped in a manner that is in accordance with, er more censer-vative than, the applicable manufacturer's recommendations.
(1)
Records are maintained on each device whish identifs such items as the device designation and the calibration frequency ar.d specifications.
These records also contain a history of device calibrations, repairs, restrictions on use, etc. and reflect the current status of the device.
i7.2-13 Amendment 2
17.2.13 HANDLING, STORAGE AND SHIPPING The operational quality assurance program requires that nuclear safety-related materials, parts and components be handled, stored and shipped in such a manner that the serviceability and quality assurance traceability of an item is not impaired. Handling, storage and shipping of an item is in accordance with any special requirements identified in documents per-tainin) to the item. Such requirements may include special handling tools and equipment, special protective coverings and/or special protective environments.
Conforming nuclear safety-related materials, parts and components are stored in controlled, segregated areas designated for the storage of such items.
Nonconforming items are stored such that they are segregated from con-forming items, in order to preclude their inadvertent substitution for and use as conforming materials parts and components, i
J-17.2-14 Amendment I
17.2.14 INSPECTION, TEST AND OPERATING STATUS In order to assure that equipment status is clearly evident, and to prevent Inadvertent operation, the operational quality assurance program requires nuclear safety-related structures, systems and components which are in an other than operable status to be identifiable as such. This identification may be means of tags, labels, stamps or other suitable methods. Where appropriate, an independent verification of the correct implementation of such identification measures is performed. When tags, labels or stamps are utilized for the iden-tification of equipment status, the issuance and removal thereof is documented in order to assure proper control of such identification measures. Also, pro-cedures require that the operability of an item removed from operation for maintenance or testing be verified prior to returning the item to normal service, inspections and tests required by the written approved procedures which address work activities are infrequently, temporarily deferred. When such a deferral does occur, a discrepancy is considered to exist and documentation of the acceptable completion of the affected work activity is not performed until the discrepancy is resolved.
Measures taken to identify equipment status by Steam Production Department personnel are controlled by the Steam Production Department. Measures taken by Quality Assurance Department personnel, during the performance of required inspections and quality control activities, to identify equipment status are controlled by the Quality Assurance Department.
f v
17.2-15 Amendment 2
17.2.15 NONCONFORMING MATERI ALS, PARTS AND COMPONENTS Nuclear safety-related materials, parts and components which are determined to be nonconforming are identified, segregated or otherwise controlled in such a manner as to prevent installation and/or use.
The determination of an item's nonconformance is documented by means of a report, which is retained on file by the Quality Assurance Department, and, as appropriate, by tags a ttached to the item.
Steam Production Department personnel are notified by Quality Assurance Department personnel of any nonconformances identified.
The Quality Assurance Department naintains a listing of the status of all nonconforming item reports. These reports, when complete, identify the nonconforming material, part or component; applicable inspection requirements; and the resolution, and approval thereof, of the nonconformance.
Provisions are established for identifying those quality Assurance Department personnel with the responsibility and authority for approving the resolution of non-conformances. Until a determination of conformance is made by the Quality Assurance Department, a nuclear safety-related material, part or component cannot be issued or installed. Tags which are placed on items to identify nonconformances are removed by the Quality Assurance Department upon resolution.
Information relating to nonconforming materials, parts and components is analyzed by the quality Assurance Department to determine if any discernible trends which might affect quality exist. When recurring nonconformances indicate possible vendor deficiencies, such information is considered in evaluation of vendor acceptability by the Quality Assurance Department.
17.2-16 Entire Page Revised Amendment 2
17.2.16 CORRECTIVE ACTION Station personnel are responsible for the implementation of the operational quality assurance program as it pertains to the performance of their activities.
Specific to this responsibility is the requirement for Informing the responsible supervisory personnel and/or for taking appropriate corrective action whenever any deficiency in the implementation of the requirements of the program is determined, i
l Discrepancies revealed during the performance of station operation, main-
{
tenance and testing activities must be resolved prior to verification of the completion of the activity being performed.
In the event of the failure of nuclear safety-related structures, systems and components, the cause. of the failure is evaluated, appropriate corrective action taken, and iters of the same type evaluated to determine whether or not they can be expected to continue to function in an appropriate manner.
Corrective action with regard to nonconforming materials, parts and components is discussed in f.ubsection 17.2.15 above.
Significant incidents occurring during operation which are, or coul1 be, related to the nuclear safety of the station are also the subject of special reports.
These reports:
(a)
Contain a summary description of the information relating to the subject
- incident, i
(b)
Contain an evaluation of the effects of the incident, g
I (c)
Describe corrective action taken or recommended as a result of the 1
incident, and (d) Describe, analyze ard ' valuate any significant nuclear safety-related 1
Implications of the lac; dent.
Each such report is reviewed by the subject station's Station Review Committee, and is transmitted by the responsible station Manager to the Vice-President, Steam Production, or his designee, and to the applicable nuclear safety review board.
Outstanding corrective action commitments made with regard to such incidents are identified and periodically reviewed to assure that the identified corrective-actions are properly completed and documented. An identified cor-rective action commitment is closed out upon written notification by a cognizant, i
responsible Individual of the satisfactory completion thereof.
Closure of l
corrective action commitments which specifically involve the Quality Assurance Department require written notification by the Quality Assurance Departnent of the satisfactory completion thereof.
J t
i 17.2-17 Amendment 2
17.2.17 OUALITY ASSURANCE RECORDS Each nuclear station is required to maintain adequate identifiable and retrievable quality assurance records.
Such records are managed in a con-trolled and systematic manner by means of a station Master File. Access to, and use of, this file is controlled.
Records required to be retained include:
(a)
Nuclear safety-related preoperational testing records.
(b)
Records of modifications to station nuclear safety-related structures, systems and components.
(c)
Radiation monitoring records.
(d)
Personnel radiation exposure records.
(e)
Records of radioactive releases and waste disposal.
(f)
Isotopic and physical inventory records of special nuclear materials.
(g)
Records of the qualifications, experience and training of appropriate station personnel.
(h)
Equipment histories for measuring and test devices.
(i)
Copies of approved purchase requisitions for items requiring quality assurance certification.
(J) Maintenance histories on nuclear safety-related instrumentation and electrical and mechanical equipment.
~
(k)
Records of special processes affecting nuclear safety-related structures, systems and components.
(1)
Records of Station Review Committee activities.
(m)
Operating records and logbooks.
(n)
Periodic testing records.
(c' Records of inspections.
(p)
Copies of approved and of completed station procedures.
(q)
Copies of audit reports received from the Quality Assurance Department, and responses thereto.
(r)
Copies of reports concerning station activities sent to the Nuclear Regulatory l Commission.
(s)
Copies of drawings and. vendor documents.
1 17.2-18 Amendment 2 l
r l
l (t)
Copies of minutes of meetings of the applicable nuclear safety review board.
(u)
Copies of station incident reports.
Records of activities within the pt.rview of the Quality Assurance Department are maintained by the Quality Assurance Department in a manner similar to that described above for station quality assurance records. These records include:
(a)
Records of inservice Inspections.
(b)
Records of quality control inspections.
~
(c)
Records such as vendor documentation packages and inspection reports, piping isometric drawings, welding records, etc. compiled during the design and construction of a nuclear station.
(d)
Records of audits performed by the quality Assurance Department of station activities.
(e)
Records of the qualifications of quality control and other appropriate Quality Assurance Department personnel.
Test records maintained by the station and inspection records maintained by the Quality Assurance Department contain the following:
(a)
A description of the activity performed.
(b)
The date and results of the activity.
(c)
Information relating to discrepancies identified with regard to the activity.
(d)
An identification of the data recorder (s) or inspector (s) involved in the activity.
(e)
Evidence of the completion, and verification thereof, of the activity.
(f)
An identification of the acceptability of the results of the activity.
The retention times for the various quality assurance records are in accordance with applicable requirements, including those of the Code of Federal Regulations, a station's Technical Specifications and established national codes and standards.
To the maximum extent practicable, records are stored such that are protected from possible destruction by causes'such as fire, flooding, theft, insects and rodents and from possible deterioration due to a combination of extreme variations in temperature and humidity conditions.
Amendment 2 17.2-19 l
17.2.18 AUDITS Operational quality assurance activities are periodically audited by the quality Assurance Departsnent. The program for such audits is identical to that des-l cribed in Subsection 17.1.18, with Level I audits of operational activities being performed at each nuclear station under the direction of the responsible l
Station Senior Quality Assurance Engineer.
i I
i i
l 17.2-20 Amendment 2
Page 1 of 3 Table 17.2-1 Operational Quality Assurance Program 10 CFR 50 Appendix 8
- Section -
-Cri teria Reference-Scope Organization I, il Describes the Duke Power Company organi-zation applicable to operational quality assurance.
Administration of the Manual I, 11, V, VI, XVI Addresses the authority, implementation and revision of the " Administrative Policy Manual for Nuclear Stations."
Document Control 1,
ll, V, VI, XVil Establishes requirements for the handling and distribution of drawings, vendor docu-ments, station procedures, copies of the FSAR and copies of the " Administrative Policy Manual for Nuclear Stations."
Records Management 1, 11, V, VI, Vil, XVil Addresses the contents of the station's files and the record retention and manage-ment requirements for these files.
Centrol of Measuring and I,
ll, V, X11, XVil Describes the requirements for the identi-Test Equipment fication, calibration, storage, shipment and issue of measuring and test equipment.
Control of Materials, Parts I, ll, IV, V, VI, Vil, Addresses the procurement, receipt, receipt and Components Vill, Xill, XV,.XVil inspection, identification, handling, storage, shipping and issue of materials, parts and components.
Qualifications and Training I,
11, V, XVil Establishes requirements for the qualifi-of Personnel cations and training of applicable station personnel.
Amendment I i
Page 2 of 3 Table 17.2-1 (Cont'd)
Operational Quality Assurance Progran 10 CFR 50 Appendix B
- Section -
-Criteria Reference-Scope Review and Audit 1,
11, V, XVil, XVill Describes the responsibilities for review and audit of the nuclear safety review boards, the Station Review Committee and the Quality Assurance Department.
Control of Interfacing 1,
II, V, XVil Establishes requirements for controlling Individuals and Organi-the activities of Individuals and organi-zations zations which interface with a station operating organization.
Incident Reports I, 11, V, VI, XVI, Addresses the reporting of significant XVil station incidents and the content of such reports.
Opera tions I, ll, V, XIV, XVil Addresses the responsibilities of the operating organization, the content of Operating Procedures, the content of Emergency Procedures, the content of the Alarm Response Manual and the content of necessary operating records.
Testing 1, 11, V, XI, XIV, Establishes requirements for the content of XVII test procedures, the scheduling of testing and the performance of testing for both preoperational and periodic testing.
Maintenance 1, ll, V, X, XIV, XVI, Addresses the performance of maintenance, XVil the investigation of equipment failures, the evaluation of replacement parts, the scheduling of maintenance and the content of Maintenance Procedures and Instrument Procedures.
Amendment I i
Page 3 of 3 Table 17.2-1 (Cont'd)
Operational Quality Assurance Program 10 CFR 50 Appendix B
- Section -
-Criteria Reference-Scope Modifications I,
11, 111, V, XVil Establishes requirements for the initiation of a modification request, the review and approval of modification requests and the implementation of modifications.
Inspections I,
11, V, X, XVil Describes the responsibilities of personnel for inspections.
Special Processes I,
11, V, IX, XVil Addresses the responsibilities of personnel for the control of special nrocesses, the qualifications of personnel performing special processes and the requirements for procedures for special processes.
Administrative Instructions I, 11, V, VI, XI, Establishes requirements for the preparation, for Preoperational Test XVI, XVil review, approval and revision of Pre-Procedures operational Test Procedures and the conduct and documentation of preoperational tests.
Administrative instructions 1, 11, V, VI, XI, XVI, Addresses the preparation, review, approval, for Permanent Station XVII revision and use of permanent station pro-Procedures cedures.
Administrative Instructions I, 11, V, VI, XI, XVI, Addresses the preparation, review, approval, for Temporary Station XVil revision and use of temporary station Procedures procedures Administrative Instructions I, 11,.111, V, VI, XVil Establishes requirements for the initiation of for Podifications a modification request; the evaluation, design, review, approval and implementation of the modification; and the documentation thereof.
Amendment 2 i
i l
OPERATIONAL QUALITY ASSURANCE STEAH PRODUCTION DEPARTHENT ORGANIZATION l
Vice President Administrative Steam Services Production Staff Manager
]
Manager Manager Manager Technical t
System System
'".'"9 and 2
Operation Results and Environmental and Fuel Management Services M
Maintenance N
I I
y i
System System Technical Training Operation Results and Services and and Environmental Staff Maintenance Fuel Management Services Staff Staff Staff Hanager Manager
)m
- y,_
Nuclear Froduction Fossil Production fA l
l 52 Nuclear Fossil w%
Station Station Managers Superintendents n
E;-
E.
I
i l
OPERATIONAL QUALITY ASSURANCE TYPICAL NUCLEAR STATION ORGANIZATION Manager
_m, Operating Technical Maintenance Administrative Superintendent Services Superintendent Services 2
Superintendent Staff
~
k, r'>
Inst ument Operating Pe r fo rm,r.co Health Chemist Maintenance Engineer (s)
Eng ineer (;)
Physics Engineer Control l
l l
Supervisor Engineer I ns +.rument Shift Per forma nce Health Chemistry Maintenance g.
and g
Personnel Personnel Physics Personnel Personnel Control Personnel Personnel n
m i
9 W
O
_QZw A
i 1
I I
Appendix A qualification Requirements and Responsibilities
[
e 17A-1 i
i Amendment I
QUALIFICATIONS AND RESPONSIBILITIES CORPORATE QUALITY ASSURANCE MANAGER A.
Qua l i f i_cali ons Must meet the Company's general requirements and in addition:
1.
Have a Bachelor's degree in engineering or the equivalent in practical experience.
2.
Must have developed a high level of competence in the field of quality assurance or related technical areas associated with nuclear stations.
j 3
Must be innovative and have the ability to plan an ef fective overall quality assurance program for the Company.
4.
Must have the ability to effectively coordinate the implementation, monitoring and modification of quality assurance programs among the several departments of the Company.
3 Must exhibit qualities of leadership and communications ability, both oral and written.
B.
R_e_s pon s i_b i l i t i e s Under the general direction of the Senior Vice President, Engineering and Construction, the Corporate quality Assurance Manager is responsible for the overall direction of the Company's quality assurance program including technical supervision of quality assurance managers in the several divisions.
More specific responsibilities include:
1.
Development and maintenance of overall quality assurance policy complying l
i
'with the requirements of the Company and regulatory authorities.
17A-2 Amendment I
2.
Direct the implementation of the program within the several divisions of Quality Assurance with particular attention to interfaces.
3 Planning the training and development of quality assurance personnel in the company.
4.
Monitoring and surveillance of the effectiveness of quality assurance efforts in the company, including periodic reporting to the Senior Vice President, Engineering and Construction.
5 Representing Company management at high level quality assurance meetings with regulatory agencies and industry groups.
6.
Maintaining a current file of quality assurance plans, programs and procedures in effect.
7 Reviewing the results of departmental audits through the reaudit stage and preparing a summary report for the Senior Vice President, Engineering and Construction.
8.
Directing such special audits as may be required from time to time.
r 17A-3 Amendment I
Appendix B Location of Responses to Requests for Additional In formation 178-1 Amendment I
)
LOCATION OF RESPONSES TO REQUESTS FOR ADDITIONAL INFORMATION Question 41.6 Identify the highest level of management, responsible for establishing DPC's Quality Assurance policies, goals, and objectives; (2) Provide a brief summary of these QA policies, goals, and objectives; (3) How are these policies, goals and objectives transmitted through -levels of manage-ment?; and (4) Describe the extent of continuing involvement of the highest corporate Manager in QA matters.
Answer 41.6 Question 41.6 is answered in revised text in 17.1.1.1.
Question 41.7 (1)
Identify the highest level of management, responsible for establishing the highest level company policies, goals, and objectives for Quality Assurance.
(2)
Identify those management levels between the Manager of QA and the highest level of management responsible for establishing the QA policies, goals and objectives.
Answer 41.7 Question 41.7 is answered in revised text in 17.1.1.1.
Question 41.8 Describe how disputes are resolved when there is a difference of decisions between QA/QC personnel and other departments. This includes such things as QA/QC personnel at department level disagreeing with personnel from Engineering, Procurement, Manu factu r i ng, Production relative to:
(a) the design content (b) purchase requisition and orders (c) instructions and procedures (d)
Review - Committee decisions (e) Manufacturing, inspection planning and inspection requirements (f) further processing of structures, systems and components t
(g) disposition of nonconformances (h) release of structures, systems, and components 17B-2 Amendment I
1 j
(i) corrective actions (J) audit results (k) stop work actions Answer 41.8 Question 41.8 is answered in revised text in 17.1.1.5 Question 41.9 Identify those areas in the QA Program where an activity is described, which includes QA/qC involvement.
If QA/QC has no involvement in these areas, then so state.
Answer 41.9 Question 41.9 is answered in Table 17.1-3 Question 41.10 The duties of the Principal Field Engineer, include supervision of the Senior Constructor Engineer and his staff.
Describe how the Principal Field Engineer can effectively supervise the Senior QC Engineer and in-spection staff since he is also responsible for the cost and schedule functions of field engineering personnel.
Answer 41.10 Question 41.10 is answered in revised text 17.1.1.3 Question 41.11 Table 17.0.2-1 does not list Regulatory Guide 1.54 nor does it include ANSI Standards N45.2.5, comments and supplementary Guidance on N45.2 series Standards listed in the AEC " Gray Booklet" WASH 1283 and " Green Booklet" WASH 1309 Will DPC connit to follow the above regulatory guides and ANSI Standards or commit to follow the guidance provided in WASH 1283 and 13097 Answer 41.11 Question 41.11 is answered in revised text in 17.0.2 and Table 17.0.2-1.
Question 41.12 Paragraph 17.1.2 states that the QA Manager issues, controls and audits the QA Manual.
It also states that the project QA Engineer reviews the Construction Department QA Manual and revisions thereto.
!n addition, it does not show participation by QA personnel relative to the Steam Production
-Quality Assurance Manual.
Describe the role of DPC's onsite and offsite QA/QC -
personnel in the review, concurrence, and approval process of these QA Manuals and changes thereto.
17B-3 Amendment I
Answer 41.12 Question 41.12 is answered in revised text in 17.1.2.
Question 41.13 Pa rag raph 17.1.11.2 states that tests are inspected by qualified persons.
Describe whether these inspectors are the QA/QC personnel or others?
Answer 41.13 Question 41.13 is answered in revised text in 17.1.11.2.
Question 41.14 (1)
Identify the organization responsible for the preparation, review and approval of inspection procedures and inspection hold and witness points.
(2)
Do inspection procedures, instructions, and/or check lists contain the following?
(a) Quality Characteristics to be inspected.
(b)
Individuals or groups responsible for performing the inspection.
(c) Acceptance and rejection criteria.
(d) A description of the method of Inspection.
(e)
Evidence of completion and certification of inspection.
(f)
Record of the results of the inspection.
2 (g)
Verification and all inspection operations are complete and acceptable.
(3) Are each inspector's qualifications / certifications kept current?
(4) is inspection of modifications, repairs, and replacements performed in accordance with the original design and inspection requirements or acceptable alternatives?
Answer 41.14 Question 41.14 is answered in revised text in 17.1.10.2.
Question 41.15 Describe how DPC assures that Standa/d "off-the-shel f" commerical or previously approved materials, parts, and components' are reviewed for suitability of application prior to selection.
Answer 41.15 l
Question 41.15 is answered in revised text in 17.1.3 i
178-4 Amendment l
Question 41.16 What are the bases for establishing intervals between calibrations of
~
measuring and test equipment?
Answer 41.16 Question 41.16 is answered in revised text in 17.1.12.2.
Question 41.17 How does DPC control the bypassing of required inspections, tests, and other critical operations when such bypassing is found necessary~
Answer 41.17 Question 41.17 is answered in revised text in 17.1.10.2.
Question 41.18 Describe controls which assure followup reviews are conducted to verify proper implementation of corrective actions and to close out the corrective' action documentation.
include a discussion of the role of DPC's QA/QC staf fs in corrective action.
Answer 41.18 1
Question 41.18 is answered in revised text in 17.1.16.
Question 41.19 Show how DPC assures that inspection and test records contain the following:
(a) a description of the type of observation.
(b) evidence of completing and/or verifying a manufacturing, inspection, or test operation.
(c) the results of the inspection or test.
(d)
Information related to nonconformances.
^
(e)
Inspector or data recorder.
(f) date.
(g) acceptability.
Answer'41.19 I
Question 41.19 is answered in revised text in 17.1.10.2.
17B-5 Amendment i
i Question 411.1 Section 17.0.2, 2nd and 3rd paragraphs, appear to be in contradiction with each other. Clarify that exceptions to ANSI Standards are only those listed in Table 17.0-1.
Also, reference to AEC Regulatory Guide 1.31 (in Table 17.0-1) should be deleted and covered elsewhere in the PSAR.
Answer 411.1 Question 411.1 is answered in revised text in 17.0.2 and Table 17.0-1.
Question 411.2 Table 17.0-1 should be revised to address ANSI N45.2.8 " Supplementary quality Assurance Requirements for Installation, inspection, and Testing of Mechanical Equipment and Systems for the Const'ruction Phase of Nuclear Power Plants. Ref:
WASH 1309 dated May 10, 1974, entitled, " Guidance on Quality Assurance Require-ments during the Construction Phase of Nuclear Power Plants."
Answer 411.2 Question 411.2 is answered in revised text in Table 17.0-1.
Question 411.3
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Revise Table 17.0-1 to include a description of DPC's exceptions to AEC Regulatory Guides 1.54 and 1.58.
Answer 411.3 Question 411.3 is' answered in revised text in Table 17.0-1.
Question 411.4 Clarify the introduction to Table 17.1-3 " quality Assurance Functions",to indicate whether these functions apply solely to vendors and shops or to DPC as well.
Answer 411.4 Question 411.4 is answered in revised text in. Table 17.1-3 Question 411.5 j
Provide a summary description of advanced planning for the control of i
management and technical interfaces between DPC's Construction Department, DPC's Engineering Department, the NSSS, and DPC's Steam Production Department during the phasecut of design and construction, and during preoperational testing and plant turnover.
l Answer 411.5 i
l Question 411.5 is answered in revised text in 17.1.2,.
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Question 411.6 Section 17.1.2 briefly discusses DPC's training program. The discussion should be expanded to provide further information on the scope and depth of this program.
Include a discussion of (1) the topics covered and (2) the types of management, engineering, QA, QC and other line and staff personnel required to attend DPC's Indoctrinatior and training program.
Answer 411.6 Question 411.6 is answered in revised text in 17.1.2 Question 411.7 Identify whether procurement documents for spare or replacement parts for safety-related structures, systems, and components are subject to controls at least equivalent to those used for the original equipment.
Answer 411.7 Question 411.7 is answered in revised text in 17.1.4.
Question 411.8 Section 17.0 of the Topical Report states that both Sections 17.1 and 17.2 I
are applicable to FSAR's.
However, the contents of the Topical Report do not have this appilcability. Section 17.0 of the Standard Format states that the "FSAR should describe the QA Program to be established and executed during operation of the nuclear power plant." Since Section 17.2 of the Topical Report covers QA during station operation, including maintenance and modification, Section 17.0 should be revised to state that Section 17.1 applies to PSAR's and Section 17.2 applies to FSAR's.
Answer 411.8 Question 411.8 is answered in revised text in 17.0.
Question 411.9 Describe whether QA individuals have the delegated responsibility and authority, delineated in writing, to stop unsatisfactory work and stop further processing of unsatisfactory material; or include reference to 17.1.1.4 and 17.1.1.5 Answer 411.9 Question 411.9 is answered in revised text in 17.2.1.4.
Question 411.10 i
Describe the provisions that control the transfer of QA related activities l
and. records from the principal contractors to the applicant during the i
178-7 Amendment 2 l
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Question 411.10 (continued) preoperational testing phase up to fuel loading. This description should Include:
(a) The identification of those significant QA-related activities required by the appilcant.
(b) - The means of tagging and identifying structures, systems, and com-ponents in a manner that denotes the inspection and test status.
(c) The procedures established to assure the effective transfer, storage, and control of records.
Answer 411.10 Question 411.10 is answered in revised text in 17.2.2 Question 411.11 Section 17.2.2 does not address the DPC indoctrination and training program during the operational phase. Describe the DPC indoctrination and training program for those personnel performing quality related activities to assure that suitable proficiency is achieved and maintained.
Describe the extent to which-the program assures that:
(a)
Personnel responsible for performing quality activities are instructed as to the purpose, scope, and implementation of the quality-related manuals, instructions, and procedures.
(b)
Personnel performing quality-related activities are trained and qualified in the principles and techniques of the activity being performed.
(c) Appropriate training procedures are established.
Answer 411.11 Question 411.11 is answered in revised text in 17.2.2.
Question 411.12 Describe the provisions which assure that' quality-related activities, such as inspection and test, are performed with appropriate equipment and under suitable environmental conditions.
Answer 411.12 Question 411.12 is answered in revised text in 17.2.10, 17.2.11, and 17.2.12.
Question 411.13 Describe the provisions for proper selection of design verification method i
such as design reviews, alternate calculations, or qualification testing for 178-8 Amendment 2 New Page
Question 411.13 (continued) redesign effort during major modification and major maintenance.
Answer 411.13 Question 411.13 is answered in revised text in 17.2 3 Question 411.14 Describe the types of design changes which are initiated and approved at the plant, both with and without concurrence from the "offsite" office.
Answer 411.14 Question 411.14 is answered in revised text in 17.2.3 Question 411.15 Describe the QA provisions co' tained in procurement documents.
Include a discussion of the extent to which procurement documents contain:
(a) Applicable requirements of Appendix B to 10 CFR 50.
(b)
Identification of documentation to be prepared, maintained, submitted, and retained.
(c) Purchaser's right of access to supplier's facilities and records for source inspection and audit.
Answer 411.15 Question 411.15 is answered in revised text in 17.2.4.
Question 411.16 Discuss the extent to which procurements for spare or replacement parts of safety related items are subject to controls equivalent to those'used for the original equipment.
Answer 411.16 Question 411.16 is answered in revised text in 17.2.4.
Question 411.17 Describe how obsolete and superseded documents are controlled to prevent inadvertent use.
Answer 411.17
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Question 411.17 is answered in revised text in 17.2.6.
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1 Question 411.18 Describe whether provisions are established for identifying purchased items as being under the control of either the "onsite" or "offsite" organizations.
Answer 411.18 Question 411.18 is answered in revised text in 17.2.7 Question 411.19 Describe those provisions which assure that written test procedures include or reference the requirements and acceptance limits contained in applicable design documents.
Answer 411.19 Question 411.19 is answered in revised text in 17.2.11.
Question 411.20 Describe the bases for establishing the calibration frequency of measuring and test equipment.
Answer 411.20 i
Question 411.20 is answered in revised text in 17.2.12.
Question 411.21
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Describe the provisions for traceability of reference and transfer standards to nationally recognized standards; or include reference to 17.1.12.2.
Answer 411.21 Question 411.21 is answered in revised text in 17.2.12.
Question 411.22 Describe hav DPC controls the bypassing of required inspections, tests, and other critical operations.
Answer 411.22 Question 411.22 is answered in revised text in 17.2.14.
Question 411.23 Describe how the application and removal of tags, stamps, markings, and labels are controlled.
Answer 411.23 l
Question 411.23 is answered in revised text in 17.2.14.
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f" Question 411.24 Identify those Individuals or groups delegated the responsibility and authority for dispositioning and approving conformances.
Answer 411.24 Question 411.24 is answered in revised text in 17.2.15 Question 411.25 Describe whether nonconformance reports are periodically analyzed for quality trends and the results forwarded to manacement.
Answer 411.25 Question 411.25 is answered in revised text in 17.2.15 Question 411.26 Describe whether follow-up reviews are conducted to verify proper implemen-tation of corrective actions and to close out the corrective action documentation.
Answer 411.26 Quastion 411.26 is answered in revised text in 17.2.16.
Question 411.27 4
Describe the content of inspection and test records.
Discuss whether inspec-tion and test records contain the following:
(a)- A description of the type of observation.
(b)
Evidence of completing and verifying a manufacturing,. inspection, or test operation.
(c) The date and results of the inspection or test.
(d)
Information related to nonconformances.
-(e)
Inspector or data recorder. identification.
(f) A statement as to the acceptability of the results.
. Answer 411.27 Question 411.27 is answered in revised text in 17.2.17 Question 411.28
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Describe -the bases for establishing the frequency of audits.
g Answer 411.28 Question. 411.28 is answered ini revised text in~17.2.18.
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