ML20057D454
| ML20057D454 | |
| Person / Time | |
|---|---|
| Site: | Trojan File:Portland General Electric icon.png |
| Issue date: | 09/28/1993 |
| From: | Cross J, Quennoz S PORTLAND GENERAL ELECTRIC CO. |
| To: | NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM) |
| References | |
| NUDOCS 9310040237 | |
| Download: ML20057D454 (51) | |
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- e-Portland General Electric Company v {,_.
James E. Cross Vice President and Chief Nuclear Officer September 28,1993 Trojan Nuclear Plant Docket 50-344 License NPF-1 U.S. Nuclear Regulatory Commission Attn: Document Control Desk Washington DC 20555
Dear Sirs:
Response to NRC Comments Regarding Proposed Revision to the Troian Nuclear Oaality Assurance Program The purpose of this letter is to resubmit Portland General Electric Corporation's (PGE's) proposed revision to the Trojan Nuclear Quality Assurance (QA) Program (PGE-8010) with changes as requested by NRC letter, lated September 3,1993. NRC comments regarding PGE's proposed revision to the Trojan QA Program, which were conveyed during recent discussions between PGE and NRC, are also addressed by this letter.
Attachment I contains PGE's resubmittal, with changes indicated by revision bars in the right-hand margin. As requested in the NRC's September 3 letter, references to the Trojan long-term organization, including the Independent Review and Audit Committee (IRAC), have been removed. Wording has also been added to Section 3.2 to specifically address measures for the identification and control of design interfaces and for coordination among participating design organizations. These changes, as well as other minor editorial changes made to enhance clarity, do nct invalidate the conclusions of PGE's reviews of the previous submittal pursuant to 10 CFR 50.59 and 10 CFR 50.54.
During recent discussions with PGE, the NRC requested clarifying information to support the ongoin, ; view of PGE's proposed QA program. Attachment II, "PGE Response to NRC Comments Regarding Proposed Revision to QA Program," provides the requested information.
Sincerely,
,Jm e=u S. M. Quennoz for Attachments Od0CO 9310040237 930928 gY PDR ADDCK 05000344 1 SW Salmon Street. Portland. OR 97204
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Document Control Desk 1,.
September 28.- 1993 Pace 2 c:
Mr. Bobby H. Faulkenberry Regional Administrator, Region V U. S. Nuclear Regulatory Commission
- Mr. David Stewart-Smith l
State of Oregon Department of Energy i
Mr. James Melfi NRC Resident Inspector Trojan Nuclear Plant i
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Trojan Nuclear Plant Document Control Desk Docket 50-344 September 28,1993 License NPF-1 Attachment I 40 Pages.
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l PORTIAND GENERAL ELECTRIC (PGE)
NUCLEAR QUALITY ASSURANCE PROGRAM FOR TROJAN NUCLEAR PLANT a
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i l-l Portland General Electric Company 121 SW Salmon Street Portland, Oregon 97204
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PGE-8010-
.PGE NUCLEAR QUALITY ASSURANCE PROGRAM
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FOR i
TROJAN NUCLEAR PLANT i
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Approval.
General Manager, Nuclear Oversight Date
'l Approval:
Vice President and Chief Nuclear Officer Date P
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Portland General Electric Company
.i 121 SW Salmon Street Portland, Oregon 97204 Revision 4
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s TABLE OF CONTENIS Page TITLE PAGE.
1 APPROVAL PAGE 11 TABLE OF CONTENTS iii POLICY STATEMENT.
iv PROGRAM 1.0 ORGANIZATION 1 1--5 l-2.0 QUALITY ASSURANCE PROGRAM.
2 2-2 3.0 DESIGN CONTROL
.3 3-2 4.0 PROCUREMENT DOCUMENT CONTROL 4-1 5.0 INSTRUCTIONS, PROCEDURES, AND DRAWINGS 5-1 6.0 DOCUMENT CONTROL 6 6-2 7.0 CONTROL OF PURCHASED MATERIAL, EQUIPMENT AND SERVICES
.7 7-2 8.0 IDENTIFICATION AND CONTROL OF MATERIAL, PARTS, 8-1 AND COMPONENTS 9.0 CONTROL OF SPECIAL PROCESSES 9-1 I
10.0 INSPECTION 10-1 11.0 TEST CONTROL 11-1 12.0 CONTROL OF MEASURING AND TEST EQUIPMENT AND.
12 12-2 INSTALLED INSTRUMENTATION 13.0 HANDLING, STORAGE, AND SHIPPING.
13-1 14.0 INSPECTION, TEST, AND OPERATING STATUS 14-1 15.0 NONCONFORMING MATERIAL, PARTS,.0R COMPONENTS 15 15-2 16.0 CORRECTIVE ACTION.
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17.0 QUALITY ASSURANCE RECORDS.
17-1 18.0 AUDITS 18.......................
APPENDIX A - QUALITY ASSURANCE AND ADMINISTRATIVE.
A A-4 CONTROLS FOR PACKAGING RADI0 ACTIVE MATERIAL FOR TRANSPORT GLOSSARY.-.
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's PORTLAND GENERAL ELECTRIC COMPANY NUCLEAR QUALITY ASSURANCE PROGRAM
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POLICY STATEMENT Portland General Electric Company implements a Quality Assurance (QA) Program j
which directs quality-related activities at the Trojan Nuclear Plant.
l This QA Program complies with Title 10, Code of Federal Regulations, Part 50, Appendix B, " Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants" and 10 CFR 71, Subpart H. " Quality Assurance for Packaging and Transportation of Radioactive Material".
The approval of this document commits the Portland General Electric Company to the requirements of the QA Program described herein and its successful implementation. Portland General Electric Company personnel who perform quality-related functions are responsible for complying with the requirements i
of this QA Program.
Changes to the QA Program must be documented and approved by the General I.
Manager, Nuclear Oversight and the Vice President and Chief Nuclear Officer.
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Vice President and Chief Nuclear Officer Portland General Electric Company f
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a 1.0 ORGANIZATION l
L.1 PURPOSE
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The Portland General Electric Company (PGE or Company) executive management is.
responsible for the safety of the Trojan Nuclear Plant (TNP). The Nuclear i
Quality Assurance Program (hereafter referred to as the QA Program) deals l
specifically with management of quality-related activities pertaining to the operation, maintenance, design, modification, and decommissioning of the TNP.
This chapter describes the functions, authorities, responsibilities, and interfaces of the PGE management organizations involved with the TNP.
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lel__0RGANIZAIIDN The management organization for control of the TNP is shown in Figure 1.0-1.
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The Chairman of the Board is responsible to the Board of Directors for overall management of the Portland General Electric Company.
He delegates responsibility and authority for all aspects of the TNP to appropriate Senior Officers.
112d__ChairmanJzf the Board and Chief Executive Officer The Chairman of the Board and Chief Executive Officer (CEO) has delegated to the Vice President and Chief Nuclear Of ficer and the President, PGE, the responsibility of assuring that management and staff implement the QA Program.
I lt2.2 Vice PIesident and_ChiRf_Hacitar Officer and Acting Vice Prlsidenb l
Nuclear l
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The Vice President and Chief Nuclear Officer and Acting Vice President, l
Nuclear (hereafter referred to as Chief Nuclear Officer) reports to the CEO.
l He delegates to the General Manager, Trojan Plant, the responsibility for l
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nuclear power plant operations, maintenance, and radiation protection. ~The General Manager, Nuclear Oversight; the General Manager, Technical Functions; l
l the General Manager, Nuclear Plant Engineering / Decommissioning; and the l
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General Manager, Plant Support report to the Chief Nuclear Officer. The Chief l Nuclear Officer has delegated to the Nuclear Division managers responsibility for implementation of this QA Program.
r The Trojan Nuclear Operations Board reports to him, and he is responsible for l-evaluating recommendations of the Trojan Nuclear Operations Board and assuring l j
that responsible management acts on recommendations which are to be i
implemented, j
l 1.2.2.1 Trojan Nuclear Op.erations Board l
The Trojan Nuclear Operations Board performs review functions required by the l license.
The Trojan Nuclear Operations Board annually assesses the adequacy
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of the QA Program's implementation. Additionally, the Trojan Nuclear l
Operations Board is responsible for conducting a biennial audit of the Nuclear l Oversight Department.
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The results of the annual assessment of the QA Program's implementation, the j
biennial audit of the Nuclear Oversight Department, and audits of the Trojan l
Nuclear Operations Board, are forwarded to the Chief Nuclear Officer.
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l L2 2. 2 Nuclear Oversight Department.
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The Nuclear Oversight Department is under the direction of the General l
Manager, Nuclear Oversight. This department is independent of other
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departments performing quality-related activities.
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To control deviations from QA Program requirements, the Nuclear Oversight l
Department has the authority and responsibility to initiate stop work orders, j
as necessary, for any condition adverse to quality that has occurred or is
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developing.
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1,.2,2,2,1 General Manager. Nuclear Ovgraight l
The General Manager, Nuclear Oversight, together with the Chief Nuclear l
Officer, is. responsible for approving revisions to the QA Program. The General Manager, Nuclear Oversight, has the authority and independence to l
identify quality problems; initiate, recommend, or provide solutions to quality problems through designated channels; and verify implementation of solutions to quality problems. The General Manager, Nuclear Oversight, l
directs the Nuclear Oversight staff in the implementation of the overall QA l
Program, including contractor QA involvement 1.2.2.2.2 Oualification Requiraments for the General Manager. Nucle.ar l
QEcrsight l
The General Manager, Nuclear Oversight must be knowledge ble of the QA Program l' and 10 CFR 50, Appendix B, and maintain up-to-date knowledge of applicable regulatory guides, codes, and standards related to quality assurance.
The General Manager, Nuclear Oversight, must meet the following qualifications:l Eight years of experience in the field of quality assurance or equivalent number of years of nuclear plant experience in a supervisory position or a combination of the two.
Graduation from a four-year accredited engineering or science college or university may be substituted for four years of this experience. At least one year of this experience shall be nuclear power plant experience in the implementation of the quality assutance program.
112,2LGeneraLMan a g.er._Irolartl'lant l
l The General Manager, Trojan Plant, directs activities of the plant staff and.
l has overall authority and responsibility for the execution of this QA Program at the plant to ensure safety, 1-3 Revision
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.i LLL 3.1 Plant Staff.
The plant organization described in procedures details the functional areas and responsibilities, qualifications, and training required for personnel performing quality-related activities.
i 12222.4 General Manacer. Technical FunctinnE l
The General Manager, Technical Functions has been delegated responsibility for l 1
the direction and coordination of nuclear regulation and emergency planning.
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12222.5 General Manager. Nuclear Plant Engineering / Decommissioning l
The General Manager, Nuclear Plant Engineering / Decommissioning, has primary l
responsibility for direction and coordination of. decommissioning, design I
engineering, and for design control of the TNP to ensure safety and l
I reliability.
LLLIL__ General Manager. Plant _Euppari l
The General Manager, Plant Support, has been delegated responsibility for l
security, training, and the overall administration and maintenance of records.
12L3__fr_ealdenL_fGE The President, PGE, reports to the CEO and delegates responsibility for data and record control services and purchasing to the Vice President, Administration and for nonradiological environmental monitoring to the Vice President, Public Affairs.
LL11 Vice President. Public Aff aira The Vice President, Public Af fairs delegates to the Director of Environmental Policy the responsibility for nonradiological environmental monitoring.
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IIll FIGURE 1Al COMPANY ORGANIZATION FOR TROJAN NUCLEAR PLAhT l-5
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FIGURE 1.0-1 COMPANY ORGANIZATION FOR TROJAN NUCLEAR PLANT 1-5
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2.0 QUALITY ASSURANCE PROGRAM i
2.1 PURPOSE l
i This chapter describes the QA Program for the TFP, and C2 fines-the applicability of the QA Program including training necessary to assure its proper implementation and effectiveness.
I 2 d _ QUALITY ASSURANCE PROGRAM l
2.2.1 General t
This QA Program is applicable to quality-related items as defined in the i
Glossary of this program, j
i Safety-related structures, systems, and components are described in a j
controlled document.
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Generally, the action indicated in the text is applicable to safety-related items and activities and will be applied to the other quality-related areas, as necessary, to assure an appropriate level of quality, in relation to the complexity of work to be performed, the importance to safety and the environment, and the importance of an item's usage in the plant.
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.l The portions of this QA Program which are applicable to Packaging Radioactive j
Material for Transport are described in Appendix A of this program. The I
portions of this QA Program which are applicable to the remaining nonsafety-related, but quality-related areas, are described in a controlled
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document.
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The QA Program provides requirements for obtaining objective evidence that all quality-related components, systems, and structures are in conformance with the design specifications, test specifications, and criteria established for the plant and its components.
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1.2.2 Ouality-Related Procedunga Procedures cover quality-related aspects of administration and control.
The procedures document the policies and instructions necessary to fulfill the intent of the QA Program. They also include standard forms, lists, and checkoffs used in documenting the audits, surveillances, inspections, certifications, and reviews.
Where appropriate, the procedures assure that activities affecting quality are performed under suitably controlled conditions. Controlled conditions include.
the use of appropriate equipment, suitable anvironmental conditions for performing the activity, and adequate clean ess, handling, and storage to assure that required prerequisites for the given activity have been satisfied.
2Ja.3__ Training The training program provides for indoctrination and training of' personnel performing quality-related activities as necessary to assure that suitable proficiency is achieved and maintained.
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f 3.0 DESIGN CONTROL 3.1 PURPOSE This chapter describes controls to assure that design requirements af fecting quality-related items are correctly translated into design documents.
3.2 GENERAL The design control functions are defined in written and approved procedures
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that delineate euthority and responsibility of personnel involved in the preparation, review, and approval of design documents.
These procedures l
identify and control design interfaces and coordinate design activities among l
participating design organizations.
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L3_ DESIGN PR.QCLSS Quality standards are included or referenced in design documents. Any f
i exceptions and/or deviations from cpecified design quality standards are i
documented and controlled.
q Design documents are based upon the appropriate design bases, safety analysis, j
design regulations, codes and standards, and licensing documents.
The materials, parts, equipment, and processes selected and specified by I
design documents are reviewed to assure that they are suitable for the intended application.
3.4 DESJGN VERIFICAIION Design. control measures shall provide for verifying or checking the adequacy l
of design.
The verifying or checking process shall be performed by individuals or groups f
other than those who performed the original design, but who may be f rom the same organization.
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Where a test program is used to verify the adequacy of a specific design l
feature in lieu of other verifying or checking processes, it shall include suitable qualification testing of a prototype unit under the most adverse i
design conditions.
3.5 CHANGE CONTROL i
l Design changes, including field changes, shall be subject to design control l
measures commensurate with those applied to the original design and shall be i
approved by Engineering.
I Procedures provide for notification of personnel of desi n changes and/or E
modifications which may affect the performance of their duties.
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4.0 PROCUREMENT DOCUMENT CONTROL k,1 PURPOSE This chapter describes the preparation, review, approval, and control of procurement documents pertaining to quality-related items'and services to
.i assure the inclusion of applicable quality assurance requirements.
L;L_fRQCUBRENT DOCUMENT CONTROL PROGPR1 Applicable procurement requirements for quality-related items'and services are specified or referenced in procurement documents.
Procurement requisitions and supplements thereto are reviewed for adequacy by.
independent personnel knowledgeable of QA practices-and concepts.
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Procurement documents are reviewed and approved by a manager or his designee.
Approved procurement documents are submitted to the Vice President, Administration, or designee for procurement.
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I 5.0 INSTRUCTIONS, PROCEDURES, AND DRAWINGS-i 53]m PURPOSE
.i This chapter describes measures which will assure that activities affecting quality-related items and services are delineated, controlled, implemented, and accomplished through utilization of approved and documented instructions, l-procedures, or drawings.
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'i 5.2 INSTRUCIION
S. PROCEDURE
S. AND DRAWINGS 3
I Activities affecting quality shall be accomplished in accordance with approved
.t and documented instructions, procedures, or drawings.
Instructions and
-l-j procedures that describe activities affecting quality include the necessary.
limits and tolerances on material, equipment, processes, and specifications for activities associated with quality-related items and services.
Instructions and procedures also prescribe special controls, processes, test equipnen t, tools and skills to attain the required quality, and requirements l
for documentation and/or verification of quality by inspection and test. Also included are appropriate qualitative and quantitative acceptance criteria for determining that important activities have been satisfactorily accomplished.
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6.1 PURPOSE j
This chapter describes methods for review, approval, distribution, and control of documents and changes thereto which affect quality-related items.
l 62 _ DOCUMENT _CDHIROL PROGRAM i
Written procedures are available which provide for the preparation, review, and approval of documents requiring control.
These procedures identify the appropriate qualified individuals or groups responsible for determining that appropriate quantitative and qualitative criteria are included in documents describing quality-related activities and i
for verifying that these criteria have been satisfactorily met.
Procedures also require that documents are approved for implementation by appropriate levels of management and changes to the documents are reviewed and approved by I
i the same organizations as the original unless another responsible organization i
is designated by the governing procedure. Approved changes are included in controlled documents prior to implementation of the change.
Procedures shall ensure that documents are distributed in a timely manner to appropriate locations and are available for use by personnel performing prescribed activities.
Master lists or equivalent document control systems are established to identify the current revision of controlled documents. These lists are available for use by cognizant personnel to preclude the use of superseded documents.
Procedures dealing with corrective action shall be reviewed by the Nuclear l
Oversight Department. Other quality-related procedures, including contractor l procedures to be used onsite for quality-related work, are reviewed by personnel knowledgeable of QA practices and concepts.
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Temporary changes to quality-related documents may be made and implemented l
i if a procedural method has been established to control the review and approval of the temporary changes.
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7.0 CONTROL OF PURCHASED MATERIAL, EQUIPMENT, AND SERVICES -
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7.1 PURPOSE t
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This chapter describes the measures for selection and evaluation of
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procurement sources for quality-related items and services and for verifica-tion activities to assure that specified requirements are met.
I 7.2 OUALITY ASSURANCE PROGRAM EVALUATION
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PGE purchase orders / contracts for quality-related items or services are placed with contractors, suppliers, and service organizations who have been evaluated by the Nuclear Oversight Department for the applicable quality system level.
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Procedures govern the selection of procurement sources.
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j The effectiveness of the control of quality by contractors and suppliers shall be assessed at intervals consistent with the importance, complexity, and l
quantity of the product or service.
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Quality-related items and services procured from a contractor, supplier, or-l service organization for which a quality assurance program is required but has not been reviewed or accepted may be utilized'by PGE with the specific written approval of the Nuclear Oversight Department. Appropriate additional controls l such as source inspection, special receipt instructions, surveillance, and testing are imposed when this option is utilized.
141__Ecutte_lBapeAtlan. Survey. and Audit of Contractors and Suppliers of_ Quality-Related Items The Nuclear Oversight Department is responsible for assuring source l
inspections, surveys, or audits are performed as necessary.
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J.3 RECEIPT INSPECIIDH Receipt inspection of quality-related items is performed to assure that the requirements of the procurement documents have been met.
Accepted items are appropriately marked, removed from the inspection area, and located in a controlled storage area or issued for use.
Documentary evidence that items conform to the procurement document requirements shall be available at the plant prior to installation or use.
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8.0 IDENTIFICATION AND CONTROL OF MATERIAL, PARTS, AND COMPONENTS 8.1 PURPOSE
't This chapter describes measures for the identification and control of quality-related items to assure they can be traced to associated documents and to prevent the use of incorrect or defective material, parts, and components.
8,2 GENERAL Quality-related items and subassemblies are identified (on the item or on records traceable to the item) in such a manner as to allow traceability to the appropriate quality documentation. The location and method of identification are selected to prevent affecting the function or quality of-the item.
When an item is subdivided, required identification markings will be transferred to each part or reflected in the records.
When several parts are joined in fabrication, a list of parts and corresponding identification documents will accompany the assembly, as necessary.
This documentation will include, as applicable, heat, lot, serial or part numbers, material certifications, weld or braze qualifications, test reports, NDE records, fabrication travelers, and other documentation to provide the bases for determining the acceptability of the assembly and its component parts.
Proper identification of materials, parts, and components is verified and documented at receipt inspection or prior to release for fabrication,.
assembly, shipping, or installation.
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-9.0 ~ CONTROL OF SPECIAL PROCESSES f
r 9.1 PUP 20SE.
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This chapter describes'the methods for the control of special processes relative to quality-related items.
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2,2 SPECIAL PAQCESS CONTROL PROGRAM q
Cognizant managers are responsible for ensuring:
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Procedures, equipment, and personnel connected with special processes are.
qualified in accorde.nce with applicable codes, standards, and specifications.
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Special processes are performed by qualified personnel and accomplished and documented in accordance with the approved procedure.
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Qualification records of procedures, equipment, and personnel associated with special processes are prepared and retained.
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10.0 ENSPECTION
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10.1 PURPOSE l
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i This chapter establishes and describes the methods for the inspection of
.i quality-related items and activities to assure-their_acesptability.
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10.2 GENERAL
.i Inspections are performed in accordance with written, approved inspection l
plans and/or inspection procedures, to verify that quality-related items and processes conform to predetermined quality requitements.
l Inspection programs are implemented through procedures which provide for i
preparation, review, and approval of inspection plans and procedures and provide for establishing mandatory hold points for witness by inspection.
l These procedures also define the minimum requirements for inspection plans.
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.I Inspection plans are approved by the responsible plant supervisor.
t Inspections shall be performed by individuals other than those who performed I
i or directly supervised the activity being inspected.
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i If direct inspection of items is impossible or disadvantageous, indirect control by monitoring processing methods, equipment,-and personnel shall be provided. Both inspection and process monitoring shall be provided when control is inadequate without both.
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11.0 TEST CONTROL
.i 11x1 PURPOSE i
This chapter describes the controls for testing required to demonstrate satisfactory performance of quality-related items. Tests within the scope of this chapter include periodic operational, instrumentation, and engineering i
tests, as well as tests required by modifications, maintenance, or significant l
changes in operating procedures. These tests are performed to verify that an j
item will perform satisfactorily in service.
f lL2_ JEST C0FTROL PROGE6B 112221 General i
l The work package for maintenance or modifications to quality-related items.
l identify those installation checks or tests necessary to demonstrate satisfactory performance of the affected equipment.
Installation checks are j
performed during the installation process to verify that items have been correctly installed and will function properly.
I Each test procedure is prepared and reviewed in accordance with applicable design documents, codes, and specifications.
The procedures shall include provisions for assuring that all prerequisites for the given test have been met, that adequate test instrumentation is i
available and used, and that the test is performed under suitable environmental conditions.
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Test results are documented, evaluated, and their acceptability determined by l
qualified personnel, i
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i 12.0 CONTROL OF MEASURING ~ AND TEST EQUIPMENT l
AND INSTALLED INSTRUMENTATION l
c 12.1 PURPOSE This chapter describes the provisions for the control of portable measuring i
and testing equipment and insta? led plant instrumentation utilized in the f
inspection, testing, and monitoring of quality-related items.
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12.2 MEASERlHG AND TEST EORIPMENT AND_ INSTALLED INSTRUMENTATION CONTROL f
PROGRAM 1%,1,1 General j
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The control of portable measuring and test equipment and installed instrumentation is implemented by specific procedures which describe accuracy requirements, calibration techniques, recall frequency requirements, and l
f calibration control.
Instruments, tools, gages, fixtures, and standards used in quantitative 1
measurement are uniquely identified, indicate calibration status, appear
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on a controlled list, are issued for use through a controlled issuance program, and are included in the calibration program.
j 12,2.2 Calibration Standards and Traceability i
Comparison standards used for calibrations and adjustment are traceable to f
nationally recognized standards wherever possible.
If not possible, the basis f
for calibration is documented.
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t Instruments used as standards are sent to approved calibration facilities for j
calibration at intervals consistent with the instrument manufacturer's j
guaranteed repeatability and the user's experience.
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12_,223__Lefective or Out-of-Calibration Meaggring and Test Equipment gud Installed Instrumentation i
When portable measuring or test equipment or installed instrumentation is l
found to be out of calibration or when its repair or replacement is required, an investigation is conducted and documented to determine the validity of previous inspection or test results and to determine the acceptability of those items previously inspected or tested.
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13.0 HANDLING, STORAGE, AND SHIPPING
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This chapter describes measures for the control of the handling, storage,
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shipping, cleaning, and preservation of quality-related items to preclude damage, loss, or deterioration.
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13J HANDLING. STORAGE. SHIEPING. CLEANING. AND PRESERVATION PROGR&J
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I RL1. General i
l On receipt of quality-related items, compliance with special requirements for protective environments is verified and documented by receipt inspection l
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personnel.
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Items are stored in a manner to protect against damage, degradation, or misuse.
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Quality-related items are handled, stored, preserved, or protected in accordance with specified codes and standards.
13 d d __llandling_nL_Qr Lty-Relaind_Ilems l.
Procedures or instructions will be used to ensure that handling equipment, cranes, and rigging are examined and tested prior to performing critical-lifts of quality-related items.
i 1LL3 Handling, Storagn_and_ Shipping of Radinac_tive MaisIlais Radiation protection personnel are responsible for establishing administrative controls and requirements for handling, storing, and shipping radioactive materials. These requirements are established in plant procedures.
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14.0 INSPECTION, TEST, AND OPERATING STATUS i
14.1 PURPOSE j
This chapter provides measures for the identification of the inspection, test, f
and operating status of quality-related items to preclude bypassing of j
regtvirements and inadvertent operation.
14_J d ESPECTION. TEST. AND OPERATING STATUS PROGRAM i
14.2.1 Insperilon_and Test Status Procedures are established to indicate the status of inspections and tests performed on quality-related items.
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Operations personnel are responsible for maintaining sufficient knowledge of tests or inspections in progress to control plant activities.
i If a required test, inspection, or other critical operation is to be bypassed, it is documented to provide appropriate controls in accordance with procedures.
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The operating status of systems, structures, and components undergoing maintenance, modification, or which have nonconformances, is identified using tags, if appropriate, under the direction of operations personnel to prevent inadvertent operation. Prior to the removal from service of operating equipment or systems, permission to change status is given and documented in accordance with procedures to assure that the removal will not have an adverse effect on plant safety.
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i 15.0 NONCONFORMING MATERIAL, PARTS, OR COMPONENTS-l t
15.1 PURPOSE i
i This chapter describes measures for documentation, control, and disposition of j
nonconforming quality-related items to prevent their inadvertent use or
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15.2 NONCONFORMING MATERIAL CONTROL PROGRAM i
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i Items that deviate from approved specifications, codes, drawings, or other applicable documents are considered as nonconforming.
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l control, disposition of nonconforming items, and notification of affected organizations.
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If this is not feasible, other I
methods are established to identify and control the nonconforming items.
.rJ 1512,2 Work Packagn A work package may be used in lieu of a nonconformance report in accordance with plant procedures when nonconforming items are identified which can be restored to the original design requirements under a " rework" disposition.
11t2a3_ RQnnonf.ormance Report i
Management reviews and approves nonconformance report dispositions.
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"Use as.is" or " modify" dispositions require the review and approval.of j
Engineering'.
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personnel.
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t 16.0 CORRECTIVE ACTION s
t 16.1 PUREQSE This chapter describes the corrective action measures to assure that conditions adverse to quality are identified, evaluated, and corrected. For' 1
significant conditions adverse to quality, corrective action is taken to preclude repetition.
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16.2 CORRECTIVE ACTION EROGRAM Procedures govern the use of nonconformance reports to assure that conditions adverse to quality are identified and corrected in a timely manner.
f Any individual has the authority and responsibility to report a condition adverse to quality to their manager or supervisor who will assure that it is I
or has been documented on a nonconformance report.
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Nonconformance reports documenting significant conditions adverse to quality require determination of cause and corrective actions taken to preclude repetition.
Copies of nonconformance reports which identify significant conditions adverse to quality are distributed to appropriate levels of management for information and review.
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17.0 QUALITY ASSURANCE RECORDS 17.1 PURPOSE This chapter describes measures for the identification, retention, and retrievability of records which furnish documentary evidence of the quality'of items or activities affecting quality.
17.2 OUALITY ASSURANCE RECORDS CONTROL PROGRAM Records should be identifiable to specific systems, structures, and components, when applicable.
Documents which are designated as quality assurance records shall be legible, accurate, and completed as appropriate for the work accomplished.
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Records are indexed, including as a minimum retention times and location of the records within the record system, to provide for retrieval without undue delay.
Quality assurance records are ultimately filed and maintained at a Permanent Records Storage Facility.
Prior to final transmittal of quality assurance records to permanent storage, the originating organization will be responsible for maintaining quality assurance record controls.
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18.0 AUDITS
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18.1 PURE 0SE l
This chapter describes the audit program utilized to verify the implementation, adequacy, and effectiveness of the QA Program.
l 1812J1TDlIl. SURVEILLANCE PROGIMM LH1211__ General The Nuclear Oversight ')epartment has overall responsibility for performing '
I planned and periodic intsrnal and external audits.
In addition, the Nuclear l.
Oversight Department performs surveillances of selected quality-related ll activities.
Audit schedules are established to meet applicable regulatory requirements and are based on the safety importance of the activities to be audited.
Audits shall be performed in accordance with written procedures using a check list or an annotated procedure which details the areas to be evaluated.
Audit results shall be documented. These results shall be reviewed by.
l management having responsibility in the area audited.
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Followup action, including reaudit of deficient areas, shall be taken where i
indicated.
IB_ 2,1__Andit_Eerssnnel
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Auditors are appropriately trained to assure competence for' performing the required audits. Audit team personnel shall be independent of the activities being audited.
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APPENDIX A QUALITY ASSURANCE AND ADMINISTRATIVE CONTROLS FOR PACKAGING RADIOACTIVE MATERIAL FOR TRANSPORT A-1 Revision l'
APPENDIX A QUALITY ASSURANCE AND ADMINISTRATIVE CONTROLS FOR PACKAGING RADIOACTIVE MATERIAL FOR TRANSPORT The Nuclear Quality Assurance Program (QA Program) assures that the requirements for packaging of_ radioactive material for transport as specified I
in 10 CFR 71 and the quality assurance criteria for shipping packages for radioactive material are satisfied.
The QA Program will assure that waste i
materials intended for disposal at a land disposal facility are properly classified, identified, and documented as required by 10 CFR 20 and 10 CFR 61.55, 61.56, and 61.57.
Activities involving the receipt and shipment of Type A packages under the requirements of 49 CFR 172-1.'3 are prescribed in written procedures, instructions, or drawings, i
Implementation of the QA Prcgram elements applicable to shipping radioactive material is under the management control of the General Manager, Trojan Plant. I Plant procedures implement the QA Program elements applicable to shipping i
radioactive material.
The chapters of the QA Program applicable to Packaging Radioactive Materials for Transport activities are described and modified beluw.
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1.0 and 2.0 Fully applies in addition to Section a. of this appendix.
3.0 Does not apply. PGE does not design NRC Type B packages.
i 4.0 Fully applies in addition to Section b. of this appendix.
5.0 Fully applies.
6.0 Fully applies.
7.0 Fully applies.
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' Chapter (s) l 8.0 Fully applies.
i 9.0 Does not apply. PGE does not fabricate NRC Type B q
. packages.
i 10.0 Fully _pplies.
11.0 Fully applies, i
12.0 Fully applies.
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14.0 Fully applies.
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i 16.0 Fully applies.
17.0 Fully applies in addition to Section c. of this appendix.
j 18.0 Fully applies, a.
QA_fragram Controls are established over activities affecting the quality of materials and components as necessary to ensure conformance to the approved design of each individual package used for the shipment of radioactive material. QA requirements and procedures are based on the following considerations concerning the complexity and proposed use of the 1
package and its components.
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(1)- The impact of malfunction or failure of the item to safety; A-3 Revision i
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1 (2) The need for_special controls and surveillance over processes and equipment; (3) The degree to which functional compliance can be demonstrated by inspection or test; and
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(4) The quality history and degree of standardization of the item.
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Ermsurement DocuntenLCan_tInl - Measures are established to assure that the applicable requirements of 10 CFR 71 are included or referenced in documents for procurement of materials, equipment, and services for shipping radioactive material, and that packages and procedures for use of these packages have been authorized by the NRC and documented in the NRC Certificate of Compliance.
c.
Q/LReccids In addition to the records required by the definition of Quality Assurance
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Records in the Glossary of this QA Program, the records must include the J
instructions, procedures, and drawings required by 10 CFR 71.111 and must include closely related records such as required qualifications of personnel, procedures, and equipment. The records must include the procedures which establish the records retentien program.
These records shall be retained for three years beyond the date when PGE last engages in packaging and shipping radioactive materials controlled by this appendix.
If any portion of the written procedures or instructions is superseded.
PGE shall retain the superseded material for three years after it is t
superseded.
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GLOSSARY' Audit: An activity which determines through investigation, review, and l
objective evidence, the adequacy,of, and adherence to,' established procedures, instructions, specifications, codes, standards, or other applicable contractuni and licensing requirements, and the effectiveness of 1
implementation.
I falibration: The process by which measuring or test equipment is checked against standards of equal or higher accuracy and adjusted as necessary to
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assure its compliance with designated specifications.
fen 11111ons_MYerse to Ouality: Departures from specified requirements.,such l
as failures, malfunctions, deficiencies, deviations, defective material or equipment, and ronconformances.
CRIrective Aclinn: Action taken to correct conditions adverse to quality and to preclude repetition of significant conditions adverse to quality.
Reaign: The technical and management processes which commence with the' identification of design inputs and which lead to and include the issuance of design output documents such as drawings, specifications, and other documents defining the technical and physical requirements of systems,. structures, and components.
i DSaign Change: A change or alteration to the technical or physical requirements of an item.
Design Documenta: Specifications, drawings, calculations, and analyses associated with design changes and modifications that define technical requirements.
J Desien Verification: The process of reviewing, confirming, or substantiating the design by one or more methods to provide assurance that the design meets the specified design requirements. This may be accomplished by the performance of design reviews, use of alternate or simplified calculational methods, or by performance of a suitable testing program.
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Documents Reauiring Control: Documents requiring control contain written or
.l pictorial information describing, defining, specifying, reporting, or j
certifying activities, requirements, procedures, or results. As a minimum, j
these include design specifications; procurement documents; drawings; QA Program; procedures; Defueled Safety Analysis Report; manufacturing, inspection, maintenance, modification, design change and testing instructions; nonconformance reports; as-built packages; and other documentation affecting quality-related items.
Examinalian: An element of inspection consisting of investigation of i
materials, components, supplies, and services to determine conformance to those specified requirements which can be determined by such investigation.
Examination is usually nondestructive and includes simple physical manipulation, gauging, and measurement.
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ldentification: A'means by which material, equipment, or parts can be traced to their associated quality documentation through the use of heat number, lot number, serial number, part number.. purchase order number, or other appropriate means.
t inspection: An element of quality control which by means of examination, I
observation, or measurement determines the conformance of materials, supplies, f
components, parts, appurtenances, systems, processes, or structures to predetermined quality requirements.
Installation Checks: Those measurements,_ verifications, and comparisons performed following maintenance or modification to determine satisfactory condition, accuracy, safety, or performance.
Installation checks do not include tests or NDE inspections.
Installation checks include but are not limited to a.
Pipe hangers, seismic anchors, and restraints are properly installed; b.
Pump seals and packing are properly installed; c.
Valve glands and packing are installed; d.
Valve stroking, actuation, and settings are proper; e.
Rotation of prime movers is correct; f.
Electrical circuits, controls, and relay settings are correct; g.
Phasing of electrical buses is correct; h.
Instrumentation is calibrated and in service as required; i.
Limit switches, interlocks, and stops are properly adjusted and set.
Measuring and Test Equipment: Devices or systems used to calibrate, measure, gauge, test, or inspect in order to control or acquire data to verify conformance to specified requirements. Measuring and Test Equipment does not include permanently installed plant instrumentation nor does it include test equipment used for preliminary checks where data obtained will not be used to determine acceptability or verify conformance to established criteria.
McIlllitation: A planned change in plant design or operation accomplished in accordance with the requirements and limitations of applicable codes, standards, procedures, specifications, licenses, and predetermined safety restrictions.
Mndify_(lermed "repitir" in ANSLN_41L10): The disposition applied to nonconforming itemi which are restored to a condition such that the capability of an item to function reliably and safely is unimpaired, even though that item still may not conform to the original requirement.
Nonconformanre: A deficiency in characteristic, dccumentation, or procedure which renders the quality of an item or activity unacceptable or indeterminate.
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farmanent Records Storage Facility:
'A Permanent Records Storage Facility is l
an environmentally controlled room or vault with controlled access which l
provides protection of quality assurance records from fire, theft, flood, and deterioration.
Erntedure: A document that specifies or describes how an activity is to be performed.
It may include methods to be employed, equipment or materials to be used, and sequence of operation.
frocutement Documents: Those purchase requisitions, stock purchase repeating requisitions, term purchase order renewals, release letters, letters of intent, bid specifications, contracts, purchase orders, specifications, or other documents which provide contractual basis for procurement actions.
They identify and define the requirements which items or servicen must meet in order to be acceptable to the Purchaser.
Eurnhased Servicea: Purchased services are services procured by PGE to support quality-related items. Examples include design analysis, evaluations, reviews, audits, calibration, and data reduction.
Quality Assurance (OA): All those planned and systematic actions necessary to provide adequate confidence that an item or a facility will perform satisfactorily in service.
Quality Assurance Records:
Those records which provide documentary evidence of the quality of items and/or activities affecting quality. A document is considered a QA record when the document is complete, valid, legible, and adequately identifiable to the item or activity involved. Documents shall be I
considered valid records only if stamped, initialed, signed, or otherwise authenticated and dated by authorized personnel. A record is completed when the final review signature or other authentication is placed on the document or on a documentation package containing multiple documents. QA records include operating logs and the results of reviews, inspections, tests, audits, monitoring of work performance, and material analyses. QA records also include closely related data such as qualifications of personnel, procedures, l
and equipment. Decommissioning records will be dispositioned in accordance with 10 CFR 50.75.
Quality-RelatEd: The tem " quality-related" encompasses those items and activities which are safety-related or are associated with:
- Environmental and Effluent Monitoring.
- Monitoring equipment used to determine operability (as required by Trojan Technical Specifications) of safety-related equipment.
- Fire Protection equipment protecting areas containing safety-related equipment.
- Radiation Protection.
- Packaging Radioactive Material for Transport.
- Radioactive Waste Management Systems.
Quality _Re_quirements: Quality requirements include, but are not limited to,
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such items as test, inspection, and acceptance criteria and any special instructions and prerequisites for such activities as designing,
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identification, fabrication, cleaning, erecting, packaging, handling, shipping, and extended storage.
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a-Radiat. ion _.PIntactinn: Radiological controls applied to radiation areas, radiation services, or radiation-producing machines consistent with the requirements of 10 CFR 19, 10 CFR 20,-and 10 CFR 50, Appendix I.
Reject: The disposition applied to nonconforming items which are unsuitable for their intended purpose but which may be feasible to return to the supplier l
as salvage for replacement or credit, or feasible to scrap.
Rework: The disposition applied to nonconforming items which are made to conform to a prior specified requirement by completion, remachining, j
reassembly, or other corrective means.
'i Significant_ Condition Adverse to Ouality: A departure from specified j
requirements is considered to be a significant condition adverse to quality if-l the condition appears to be an event (1) which requires reporting in 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> or less in accordance with the Plant License, 10 CFR 20, or 10 CFR 50.72; (2) which requires reporting in accordance with 10 CFR 21; or (3) which j
involves a significant breakdown in the QA Program implementation.
Spatial _fracasa: A process or operation performed on an item in such a manner that conformance to specified requirements and verification of all essential characteristics may not be determined solely by inspection, test, or examination; assurance that all steps of the process were properly carried out depends in part on the skill of the operator, use of specified equipment, and adherence to the qualified process procedures and control. Special processes include, but are not limited to: welding, heat treating, metal spraying, and nondestructive testing.
Etap_ Work: The authority that permits immediate stoppage of quality-relate'd activities such as design, procurement, fabrication, inspcction, testing, or
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Surv_gillance: A documented observation or review of an activity for the l
purpose of verifying conformance with specified requirements or evaluating.
l their adequacy and effectiveness.
IeSMDg: The determination or verification of the capability of an item to meet specified requirements by subjecting the item to a set of physical, j
chemical, environmental, or operating conditions.
Umr_As_Is : A disposition applied to nonconforming items which do not meet all l
specified requirements but do safely and reliably meet their intended purpose.
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Trojan Nuclear Plant Document Control Desk Docket 50-344 Septembcr 28,1993 j
License NPF-1 Attachment II Page 1 of 8 PGE RESPONSE TO NRC COMMENTS REGARDING PROPOSED REVISION TO QA PROGRAM t
CIIAPTER 1 1a Change wording in last sentence of first Ia Use of term " operation" is for operation paragraph of Section 1.1 to clarify the of equipment and systems necessary to term " operation."
support safe storage ofirradiated spent fuel. No change required.
CHAPTER 2 l
2a Justify removing fire protection from the 2a Fire Protection is still covered by the QA QA Program document (and moving it to Program (see Glossary definition for PGE-1012).
" Quality Related"). Appendices were i
removed from the QA Program (except for 10 CFR 71 Radiation Material Packaging which requires NRC approval per 71.101). Per Section 2.2.1, paragraph 4, the portions of the QA Program which are applicable to each category of Quality-Related are described in other controlled documents. The Appendix on QA and Administrative Control for FP fits best in the FP Topical Report PGE-1012.
I 2b Justify removing specific reference to a 2b As a Defueled Plant, the number of safety-related list.
safety-related SSC's are minimal and will be identified in a controlled document (although not necessarily in the form of a list).
2c Justify removing definition of position 2c This is stated in Section 1.2.1.
having overall authority / responsibility for j
implementation of QA Program.
2d PGE support organizations not identified.
2d Although not specifically called " support organizations" in new QA Program, they
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are covered in Chapter 1 and include offsite Departments specified in Section 1.2.3 and 1.2.3.1 and shown in Figure 1.0-1.
2e Section 2.2.3 doesn't address training of 2e The wording " personnel performing contractors, suppliers, and service Quality-Related activities" is intended to organizations.
include PGE personnel & contractor
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1 Trojan Nuclear Plant Document Control Desk Docket 50-344 September 28,1993
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License NPF-1 Attachment II Page 2 of 8 2e Continued 2e Continued personnel. Other chapters in the manual also require training or qualifications to i
perform work (e.g., Chapters 9,11, and 18) and the wording used is broad enough to encompass contractors.
l 2f Justify deleting the following sections (of 2f See Below j
the old plan):
2.5 - Fire Protection 2.5 See response to Item 2a.
I 2.6 - Packaging Radiation Material 2.6 See new Appendix A and Section 2.2.1, 2.7 - Radwaste Management Systems paragraph 4.
I 2.8 - Technical Specification Monitoring 2.7 & 2.8 l
2.9 - Security Still covered by QA Program: See i
2.10- Emergency Planning Section 2.2.1, paragraph 4 and Glossary definition for " Quality-Related" 2.9 In conjunction with the new Defueled Security Plan which is expected to be formally approved by 9/30/93, Security will no longer be addressed under the 10 CFR 50, Appendix B, QA Program.
l As stated in the Defueled Security Plan, an act of radiological sabotage under the bounding sabotage events could not result in a radiological release in excess of 10 CFR 100 limits or the EPA PAG limits. Therefore, Security events will not result in " undue dsk to the hea th and i
safety of the public" as specified in the Introduction Section 10 CFR 50, Appendix B.
Security activities continue to be governed by the NRC approved Security Plan, Technical Specifications, and 10 CFR 73 requirements. These include requirements for implementing procedures, training, records, maintenance and testing, and annual audits.
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Trojan Nuclear Plant Document Control Desk o
Docket 50-344 September 28,1993 License NPF-1 Attachment II Page 3 of 8 2f Continued 2f Continued 2.10 In conjunction with the Defueled Emergency Plan (EP), which is expected to be formally approved by 9/30/93, EP will no longer be addressed under the 10 CFR 50, Appendix B, QA Program.
Based on the new defueled Trojan accident analyses and calculation of potential ingestion doses for the " worst case" fire in the Radwaste Storage Building, the calculated offsite plume and ingestion doses are less than EPA PAG limits. As a result, the preplanned response measures in the Emergency Plan are generally limited to the Industrial Area and there is no " undue risk to the health and safety of the public" EP activities continue to be governed by the NRC approved Emergency Plan, Technical Specifications, and 10 CFR 50, Appendix E requirements. These include requirements for implementing procedures, training, facilities and equipment, and annual audits.
2g Chapter 2 does not include Criterion II 2g This is covered by TNOB and is covered requirement to ".. regularly review the in Section 1.2.2.1. This is also covered by status and adequacy of the quality Chapter 18 via QA audits &
assurance program."
su veillances.
2h Justify removing reference to Section 3.2 2h Section 2.2.1 paragraph 2 of the new of the FSAR that provided guidelines for program states " Safety-related stmetures, determination of safety-related structures, systems, and components are described in systems, and components (SSC).
a controlled document."
Chapter 6 and the Glossary definition of i
" Documents Requiring Control" provide requirements pertaining to controlled documents. This definition also specifies a list of documents which require control.
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Trojan Nuclear Plant Document Control Desk Docket 50-344 Septemter 28,1993 License NPF-1 Attachment II Page 4 of 8 2h Continued 2h Continued These QA Program commitments provide adequate controls on the Trojan controlled document (s) that contain the guidelines for determination of safety-related SSCs and that describe safety-related SSCs.
2i Describe how thelast sentence of 2i Trojan's new QA Program continues to 4
10 CFR 50 Appendix B, Criterion II, meet this requirement of Appendix B in related tc management regularly the same way it was met in the existing reviewing the status and adequacy of the QA Program.
QA Program, is met.
-l Chapter 1 of the new QA Program requires management to implement the i
QA Program. Part of this responsibility includes regular reviews of activities under their areas of responsibility for adequacy and conformance with procedures, which implement the QA Program. Many of these procedures contain specific management review and approval steps which are an integral part of Trojan's administrative controls.
Examples of these management reviews (which are required in the new QA Program) are: procurement document review / approval, procedure j
review / approval, inspection plan approval, nonconformance report disposition review / approval, and review of audit results for their areas of responsibility.
Additionally, Section 1.2.2.1 of the new QA Program requires the TNOB to annually assess the adequacy of the QA Program's implementation. There were no significant changes made to the wording in Section 1.2.2.1 from the old to the new QA Program.
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Docket 50-344 -
' September 28,1993 License NPF-1 Attachment II l
Page 5 of 8 CIIAPTER 3 i
i 3a Justify removing compatibility of materials 3a This is covered in Section 3.3, para 3, and suitability of application and wording meets Appendix B.
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considerations.
3b Justify removing design interfaces and 3b Section 3.2 of the new program requires design organization description, which
".. written and approved procedures that must be included to comply with delineate authority and responsibility of Criterion III.
personnel involved in the preparation, review, and approval of design documents."
Section 1.2.2.4 assigns responsibility to the General Manager, Technical Functions "..for the direction and coordination of... engineering."
These two sections address this portion l
of Appendix B, Criterion III. To clarify Section 3.2 words have been added to specifically address measures for the idemification and control of design interfaces and for coordination among participating design organizations.
CIIAPTER 4 4a Justify removing statement for 4a Section 4.2 of the new program requires procurement documents to require that " Applicable procurement contractors or subcontractors to provide requirements for quality-related items and an Appendix B QA program.
services are specified or referenced in procurement documents." and Section 7.2 requires that " purchase orders / contracts...are placed with i
contractors, suppliers, and service organizations who have been evaluated by the Quality Department for the i
applicable quality system level." These two Sections together meet the requirements of Appendix B, Criterion IV.
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Docket 50-344 September 28,1993 License hTF-1 Attachment II Page 6 of 8 j
l CIIAPTER 5 1
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Sa Justify removing Section 5.2.2.
Sa Under the old QA Program, Section 5.2.2 is specific to " Support Organization" 4
procedures and complements Section 5.2.1 which is specific to plant procedures. Under the new QA Program, Appendix B, Criterion V, i
requirements are described for all quality rehted insuuctions, procedures and drawings in Sections 5.1 and 5.2.
CIIAPTER 12 i
12a Justify removing Section 12.2.3 regarding 12a This old Section covered portable M&TE maintenance of portable measurement and maintained in protected test equipment.
locations / environments and used by knowledgeable people. This is procedure level detail and is not addressed in Appendix B.
12bJustify removing Section 12.2.4 regarding 12b This old Section covered specific details calibration records.
that were required to be included in calibration documentation. This is procedure level detail and is not addressed in Appendix B.
12c Justify removing description of personnel 12c Section 12.2.1 covered Nuclear responsibilities from Chapter 12 (Sections Oversight reviews, audits & surveillance 12.2.1 and 12.3).
ofM&TE. This is covered by Chapter 18.
Also, Section 12.2.1 covered cognizant Managers / Supervisors to assure calibration controls. This is procedure level detail. Chapter I covers organizational responsibilities.
Section 12.3 covered control ofM&TE by Contractors & Suppliers and Nuclear Oversight audits /surveillances. Chapters 4,7, and 18 in the new program cover these areas.
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Docket 50-344 September 28,1993 License NPF-1 Attachment II Page 7 of 8 CIIAPTER 14 14a Justify removing description of personnel 14a Section 14.3.1 covered specific managers responsibilities from Chapter 14 (Sections (by title) and Planning and Control 14.3.1 and 14.4.1).
Depanment actions. Thi-3 procedure level detail and is not addressed in Appendix B._ Chapter I covers organizational responsibilities.
Section 14.4.1 covered Nuclear Oversight audits / surveillance of suppliers.
This is covered by Chapters 7 & 18.
CIIAPTER 15 15a Justify removing information regarding 15a The discussion of10 CFR 21 evaluation CFR 50.59 Reviews & nonconformance and reponing is procedure level detail tracking (Section 15.2.3) and 10 CFR 21 and is not specifically addressed in evaluation / reporting (Section 15.2.4).
Appendix B. However, the Glossary definition for "Significant Condition Adverse to Quality" does retain the linkage to 10 CFR 21. There is no specific Appendix B requirement for a 10 CFR 50.59 review of nonconformance reports. Corrective actions which may i
require changes to the facility or procedures described in the Safety Analysis Report (SAR) or which involve tests or experiments not described in the SAR would still require a 10 CFR 50.59 review as required by the regulation and technical specifications.
CIIAPTER 16 i
16a Justify removing Nuclear Oversight 16a This is procedure level detail and is not re::ponsibuities from Section 16.2.2, addressed in Appendix B. Present plans paragraphs 1 and 4 of old program.
are to have the Quality Department retain ownership of the Corrective Action Program which tracks nonconformances through closure.
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'4 Docket 50-344 September 28,1993 License NPF-1 Attachment II Page 8 of 8 CIIAPTER 17 17aJustify removing Sections 17.3.3,17.3.5, 17a This is procedure level detail and is not 17.3.6, and 17.4.
addressed in Appendix B. (see Glossary definition for " Quality Assurance Records"). In addition, the QA audit program assesses adequacy of the QA Records Program.
Requirements for control of QA Records (both onsite and offsite) are now contained in Sections 17.1 and 17.2 of the new program.
CIIAPTER 18 18a Justify removing Auditor training and 18a This is procedure level detail and is not proficiency requirements of Section addressed in Appendix B. The new 18.2.2.
Section 18.2.2 meets Appendix B.
18bJustify removing discussion of audit 18b The discussion of audit schedules has program schedules of Section 18.3.3.
been reduced in detail and is now included in Section 18.2.1. The new wording adequately addresses Appendix B requirements. Details on audit schedules are covered in appropriate QA procedures.