ML20059G971
| ML20059G971 | |
| Person / Time | |
|---|---|
| Site: | Trojan File:Portland General Electric icon.png |
| Issue date: | 11/30/1993 |
| From: | Cross J PORTLAND GENERAL ELECTRIC CO. |
| To: | |
| Shared Package | |
| ML20059G954 | List: |
| References | |
| PGE-8010, NUDOCS 9311090223 | |
| Download: ML20059G971 (63) | |
Text
PGE-8010 O
PORTLAND GENERAL ELECTRIC (PGE)
NUCLEAR QUALITY ASSURANCE PROGRAM FOR TROJAN NUCLEAR PLANT O
Revision-16 November 1993 Portland General Electric Comprny 121 SW Salmon Street O
Portland, Oregon 97204 en 4
931109022 {3 344 IIji!.;
i i
PGE-8010 PGE NUCLEAR QUALITY ASSURANCE PROGRAM FOR TROJAN NUCLEAR PLANT l
// ~ / - D Approval:
' G nerhLganager, Nuclear Oversight Date
[
ffjyg Approval:
.# w e President and Chief Nuclear Officer Date l
i I
Portland General Electric Company 121 SW Salmon Street Portland, Oregon 97204
( Revision 16
TABLE OF CONTENTS I
Page TITLE PAGE.
i APPROVAL PAGE 11 i
TABLE OF CONTENTS iii POLICY STATEMENT.
iv PROGRAM 1
1.0 ORGANIZATION 1 1-5 I
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, Ph0CEDURES, 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 m
AND COMPONENTS g
9.0 CONTROL OF SPECIAL PROCESSES 9-1 l
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, OR COMPONENTS 15 15-2 16.0 CORRECTIVE ACTION.
16-1 17.0 QUALITY ASSURANCE RECORDS.
17-1 18.0 AUDITS 18-1 APPENDIX A - QUALITY ASSURANCE AND ADMINISTRATIVE.
A A-4 CONTROLS FOR PACKAGING RADI0 ACTIVE MATERIAL FOR TRANSPORT GLOSSARY.
G1 - G4
- lii -
Revision 16
l PORTLAND GENERAL ELECTRIC COMPANY NUCLEAR QUALITY ASSURANCE PROGRAM EQLIfY STATEMENT Portland General Electric Company implements a Quality Assurance (QA) Program i
which directs quality-related activities at the Trojan Nuclear Plant.
f This QA Program complies with. Title 10, Code of Federal Regulations. Part-50, l
l Appendix B, " Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants" and 10 CFR 71, Subpart H, " Quality Assurance for i
l Packaging and Transportation of Radioactive Material".
The approval of this document commits the Portland General Electric Company to j
the requirements of the QA Program described herein and its successful i
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 j
Manager, Nuclear Oversight and the Vice President and Chief Nuclear Of ficer.
O h M 1
VicAIPresident and Chief Nuclear Officer Portland General Electric Company j
/ / - / -- f T (Date) 1 i
i
)
O
- iv -
Revision 16 1
l l
1.0 ORGANIZATION 1.1 PURPOSE i
The Portland General Electric Company (FGE or Company) executive management is
]
responsible for the safety of the Trojan Nuclear Plant (TNP). The Nuclear Quality Assurance Program (hereafter referred to as the QA Program) deals specifically with management of quality-relcted activities pertaining to the operation, maintenance, design, modification, and decommissioning of the TNP.
i i
This chapter describes the functions, authorities, responsibilities, and interfaces of the PGE management organizations involved with the INP.
i 1.2 ORGANIZATION The management organization for control of the TNP is shown in Figure 1.0-1.
l The Chairman of the Board is responsible to the Board of Directors for overall s
\\
i management of the Portland General Electric Company. He delegates responsibility and authority for all aspects of the TNP to appropriate Senior Officers.
1.2.1 Chairman of 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 Officer and the President, PGE, the l
responsibility of assuring that management and staff implement the QA Program.
1.2.2 Vice Pigsident and Chief Nuclear Officer and Acting Vice President.
Nuclear The Vice President and Chief Nuclear Officer and Acting Vice President, Nuclear (hereafter referred to as Chief Nuclear Officer) reports to the CEO.
He delegates to the General Manager, Trojan Plant, the responsibility for 1-1 Revision 16
nuclear power plant operations, maintenance, and radiation protection. The General Manager, Nuclear Oversight; the General Manager, Technical Functions; the General Manager, Nuclear Plant Engineering / Decommissioning; and the General Manager, Plant Support report to the Chief Nuclear Officer. The Chief Nuclear Officer has delegated to the Nuclear Division managers responsibility for implementation of this QA Program.
The Trojan Nuclear Operations Board reports to him, and he is responsible for evaluating recommendations of the Trojan Nuclear Operations Board and assuring that responsible management acts on recommendations which are to be implemented.
1.2.2.1 Trojan Nuclear Operations Board The Trojan Nuclear Operations Board performs review functions required by the license. The Trojan Nuclear Operations Board annually assesses the adequacy of the QA Program's implementation. Additionally, the Trojan Nuclear Operations Board is responsible for conducting a biennial audit of the Nuclear Oversight Department.
The results of the annual assessment of the QA Program's implementation, the biennial audit of the Nuclear Oversight Department, and audits of the Trojan Nuclear Operations Board, are forwarded to the Chief Nuclear Officer.
1.2.2.2 Nuclear Oversicht Department The Nuclear Oversight Department is under the direction of the General Manager, Nuclear Oversight. This department is independent of other departments performing quality-related activities.
To control deviations from QA Program requirements, the Nuclear Oversight Department has the authority and responsibility to initiate stop work orders, as necessary, for any condition adverse to quality that has occurred or is developing.
O l-2 Revision 16
1.2 1m2.1 General Manager. Nuclear Oversicht The General Manager, Nuclear Oversight, together with the Chief Nuclear Officer, is responsible for approving revisions to the QA Program. The General Manager, Nuclear Oversight, has the authority and independence to 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, directs the Nuclear Oversight staff in the implementation of the overall QA Program, including contractor QA involvement.
1.2.2.2.2 Oualification Reauirements for the General ManaggI2 Nuclear Oversight The General Manager, Nuclear Oversight must be knowledgeable of the QA Program 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:
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 assurance program.
1.2.2.3 General _Manacer. Trojan Plant The General Manager, Trojan Plant, directs activities of the plant staff and has overall authority and responsibility for the execution of this QA Program at the plant to ensure safety.
1-3 Revision 16
1.2.2.3.1 Plant Staff The plant organization described in procedures details the functional areas and responsibilities, qualifications, and training required for personnel performing quality-related activities.
1.2.2.4 General Manacer. Technical Functions The General Manager, Technical Functions has been delegated responsibility for the direction and coordination of nuclear regulation and emergency planning.
LL2.5 General Manager. Nuclear Plant Engineerinc/Decommissionine The General Manager, Nuclear Plant Engineering / Decommissioning, has primary responsibility for direction and coordination of decommissioning, design engineering, and for design control of the TNP to ensure safety and reliability.
LJ. 2. 6 General Manacer. Plant Support The General Manager, Plant Support, has been delegated responsibility for security, training, and the overall administration and maintenance of records, t
1.2.3 President. PGE 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.
LJ. 3.1 Vice President. Public Affairs The Vice President, Public Affairs delegates to the Director of Environmental Policy the responsibility for nonradiological environmental monitoring.
O 1-4 Revision 16
t muumasou l[
i l
>I 1
lnig lll11:
i si.
,'a O
lll1 ill-ii ill.
.lil i
iijil
'll
!;lli llll FIGURE 1.0-1 COMPANY ORGANIZATION FOR TROJAN NUCLEAR PLANT I-.5
2.0 QUALITY ASSURANCE PROGRAM j
2.1 PURPOSE This chapter describes the QA Program for the dip, and defines the applicability of the QA Program including training necessary to assure its proper implementation and effectiveness.
2.2 OliALITY ASSURANCE PROGRAM 2.2.1 General This QA Program is applicable to quality-related items as defined in the Glossary of this program.
Safety-related structures, systems, and components are described in a controlled document.
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.
The portions of this QA Program which are applicable to Packaging Radioactive Material for Transport are described in Appendix A of this program. The portions of this QA Program which are applicable to the remaining nonsafety-related, but quality-related areas, are described in a controlled document.
The QA Program provides requirements for obtaining objective evidence that all l
quality-related components, systems, and structures are in conformance with the design specifications, test specifications, and criteria established for I
the plant and its components.
O 2-1 Revision 16 l
1 2.2 Ouality-Related Procedures Procedures cover quality-related aspects of administration and control. The i
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 environmental conditions for performing the activity, and adequate cleanliness, handling, and storage to I
assure that required prerequisites for the given activity have been satisfied.
i LL3 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.
j O
i 2-2 Revision 16
i 3.0 DESIGN CONTROL l
3.1 PURPOSE l
l This chapter describes controls to assure that design requirements affecting quality-related items are correctly translated into design documents.
3.2 GENERAL The design control functions are defined in written and approved procedures that delineate authority and responsibility of personnel involved in the l
preparation, review, and approval of design documents. These procedures I
identify and control design interfaces and coordinate design activities among participating design organizations.
3.3 DESIGN PROCESS 1
Quality standards are included or referenced in design documents. Any exceptions and/or deviations from specified design quality standards are documented and controlled.
Design documents are based upon the appropriate design bases, safety analysis, design regulations, codes and standards, and licensing documents.
i The materials, parts, equipment, and processes selected and specified by design documents are reviewed to assure that they are suitable for the intended application.
L4 DESIGN VERIFICATION Design control measures shall provide for verifying or checking the adequacy i
of design.
l The verifying or checking process shall be performed by individuals or groups other than those who performed the original design, but who may be from the same organization.
3-1 Revision 16
Where a test program is used to verify the adequacy of a specific design feature in lieu of other verifying or checking processes, it shall include O-suitable qualification testing of a prototype unit under the most adverse design conditions.
3.5 CHANGE CONTRQL Design changes, including field changes, shall be subject to design control measures commensurate with those applied to the original design and shall be approved by Engineering.
Procedures provide for notification of personnel of design changes and/or modifications which may affect the performance of their duties.
l I
3-2 Revision 16
i i
l
\\
4.0 PROCUREMENT DOCUMENT CONTROL I
4.1 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.
4.2 PROCUREMENT DOCUMENT CONTROL PROGRAM 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.
Procurement documents are reviewed and approved by a manager or his designee.
Approved procurement documents are submitted to the Vice President, l
Administration, or designee for procurement.
1 1
s 4-1 Revision 16 i
J 5.0 INSTRUCTIONS, PROCEDURES, AND DRAWINGS 5.1 PUREQSE 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.
5.2 INSTRUCTION
S. PROCEDURE
S. AND DRAWINGS 1
Activities affecting quality shall be accomplished in accordance with approved and documented instructions, procedures, or drawings.
Instructions and l
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.
i Instructions and procedures also prescribe special controls, processes, test equipment, tools and skills to attain the required quality, and requirements for documentation and/or verification of quality by inspection and test. Also 1 sm I
i included are appropriate qualitative and quantitative acceptance criteria for determining that important activities have been satisfactorily accomplished.
l t
e O
5-1 Revision 16
6.0 DOCUMENT CONTROL 6.1 PURPOSE This chapter describes methods for review, approval, distribution, and control of documents and changes thereto which affect quality-related items.
l l
6.2 DOCUMENT CONTROL PROGRAM l
l Written procedures are available which provide for the preparation, review, and approval of documents requiring control.
j
)
?.tese procedures identify the appropriate qualified individuals or groups t
i 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 i
l levels of management and changes to the documents are reviewed and approved by i
l the same organizations as the original unless another responsible organization i
i is designated by the governing procedure. Approved changes are included in' controlled documents prior to implementation of the change.
j Procedures shall ensure that documents'are distributed in a timely manner to
)
appropriate locations and are available for use by personnel performing prescribed activities.
I I
l Master lists or equivalent document control systems are established to identify the current revision of controlled documents. These lists are I
available for use by cognizant personnel to preclude the use of superseded l
l documents.
Procedures dealing with corrective action shall be reviewed by the Nuclear Oversight Department. Other quality-related procedures, including contractor procedures to be used onsite for quality-related work. are reviewed by personnel knowledgeable of QA practices and concepts.
6-1 Revision-16
- - _. _ _._. _._ _ __,,_ _ _.,_ ___._ _.,_. l
Temporary changes to quality-related documents may be made and implemented if a procedural method has been established to control the review and approval of the temporary changes.
1 O
l l
l 1
O 6-2 Revision 16
l
\\
7.0 CONTROL OF PURCHASED MATERIAL, EQUIPMENT, AND SERVICES O
7.1 PURPOSE This chapter describes the measures for selection and evaluation of procurement sources for quality-related items and services and for verifica-tion activities to assure that specified requirements are met.
)
7.2 OUALITY ASSURANCE PROGRAM EVALUATION 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.
Procedures govern the selection of procurement sources.
i e
l The effectiveness of the control of quality by contractors and suppliers shall be assessed at intervals consistent with the importance, complexity, and quantity of the product or service.
j Quality-related item.1 and services procured from a contractor, supplier, or i
i 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 such as source inspection, special receipt instructions, surveillance, and testing are imposed when this option is utilized.
7.2.1 Source Inspection. Survev. and Audit of Contractors and Suppligra of Ouality-Related Items The Nucim r Oversight Department is responsible for assuring source inspections, surveys, or audits are performed as necessary.
O 7-1 Revision 16
7.3 RECEIPT INSPECTION i
Receipt inspection of quality-related items is performed to assure that the j
requirements of the procurement documents have been met.
I 1
Accepted items are appropriately marked, removed from the inspection area, and located in a controlled storage area or issued for use.
i Documentary evidence that items conform to the procurement document requiramarts shall be available at the plant prior to installation or use.
t l
l 1
i 7-2 Revision 16
8.0 IDENTIFICATION AND CONTROL OF MATERIAL, PARTS, AND COMPONENTS 8.1 PURPOSE 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.
i i
l When an item is subdivided, required identification markings will be l
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 neces'sary. 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.
)
O 8-1 Revision 16 l
9.0 CONTROL OF SPECIAL PROCESSES
(
9.1 PURPOSE This chapter de.ieribes the methods for the control of special processes relative to quality-related items.
9.2 SPECIAL PROCESS CONTROL PROGRAM l
Cognizant managers are responsible for ensuring:
Procedures, equipment, and personnel connected with special processes are a.
I qualified in accordance with applicable codes, standards, and specifications.
l l
b.
Special processes are performed by qualified personnel and accomplished and documented in accordance with the approved procedure.
I c.
Qualification records of procedures, equipment, and personnel associated
()
with special processes are prepared and retained.
l l
l t
P t
l 9-1 Revision 16 i
(
l 10.0 INSPECTION 10.1 PURPOSE This chapter establishes and describes the methods for the inspection of quality-related items and activities to a..ure their acc atability.
10.2 GENERAL Inspections are performed in accordance with written, approved inspection plans and/or inspection procedures, to verify that quality-related items and processes conform to predetermined quality requirements.
Inspection programs are implemented through procedures which provide for preparation, review, and approval of inspection plans and procedures and provide for establishing mandatory hold points for witness by inspection.
These procedures also define the minimum requirements for inspection plans.
Inspection plans are approved by the responsible plant supervisor.
Inspections shall be performed by individuals other than those who performed or directly supervised the activity being inspected.
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.
O 10-1 Revision 16
11.0 TEST CONTROL O
11.1 PURPOSE This chapter describes the controls for testing required to demonstrate satisfactory perfortnance of quality-related items. Tests within the scope of this chapter include periodic operational, instrumentation, and engineering tests, as well as tests required by modifications, maintenance, or significant changes in operating procedures. These tests are performed to verify that an item will perform satisfactorily in service.
11.2 TEST CONTROL PROGBAM 11.2.1 General 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 performed during the installation process to verify that items have been v
correctly installed and will function properly.
l Each test precedure 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 in available and used, and that the test is performed under suitable environmental conditions.
11.2.2 Test Documentation Test results are documented, evaluated, and their acceptability determined by qualified personnel.
11-1 Revision 16
l l
12.0 CONTROL OF MEASURING AND TEST EQUIPMENT AND INSTALLED INSTRUMENTATION O
12.1 PURPOSE This chapter describes the provisions for the control of portable measuring and testing equipment and installed plant instrumentation utilized in the inspection, testing, and monitoring of quality-related items.
j 12.2 MEASURING AND TEST EOUIPMENT AND INSTAT. fin INSTRUMENTATION CONTROL IRQGEld I
12.2.1 General 1
The control of portable measuring and test equipment and installed I
instrumentation is implemented by specific procedures which describe accuracy requirements, calibration techniques, recall frequency requirements, and l
calibration control.
j i
Instruments, tools, gages, fixtures, and standards used in quantitative measurement are uniquely identified, indicate calibration status, appear on a controlled list, are issued for use through a controlled issuance i
l l
program, and are included in the calibration program.
)
12.2.2 Calibration Standards and Traceability i
l Comparison standards used for calibrations and adjustment are traceable to nationally recognized standards wherever possible.
If not possible, the basis for calibration is documented.
Instruments used as standards are sent to approved calibration facilities for calibration at intervals consistent with the instrument manufacturer's guaranteed repeatability and the user's experience.
l 1
O l
12-1 Revision 16
12.2.3 Defective or Out-of-Calibration _ Measuring 'and Test Equipment f'
and Installed Instrumentation When portable measuring or test equipment or installed instrumentation is 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.
l i
l l
I l
1 4
O l
12-2 Revision 16
13.0 HANDLING, STORAGE, AND SHIPPING 13.1 PURPOSE r
This chapter describes measures for the control of the handling, storage, shipping, cleaning, and preservation of quality-related items to preclude damage, loss, or deterioration.
13.2 HANDLING. STORAGE. SHIPPING. CLEANING. AND PRESERVATIDN PROGRAM 13.2.1 General On receipt of quality-related items, compliance with special requirements for protective environments is verified and documented by receipt inspection personnel.
Items are stored in a manner to protect against damage, degradation, or misuse.
Quality-related items are handled, stored, preserved, or protected in accordance with specified codes and standards.
13.2.2 Randline of Oualitv-Related Items 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.
13.2.3 Handling. Storage. and Shipping of Radioactive Mattrials l
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.
O 13-1 Revision 16 l
i 14.0 INSPECTION, TEST, AND OPERATING STATUS 14.1 PURPOSE 1
l This chapter provides measures for the identification of the inspection, test, and operating status of quality-related items to preclude bypassing of requirements and inadvertent operation.
l 14.2 INSPECTION. TEST. AND OPERATING STATUS PROGRAM 14.2.1 Inspection and Test Status Procedures are established to indicate the status of inspections and tests performed on quality-related items.
Operations personnel are responsible for maintaining suf ficient knowledge of tests or inspections in progress to contrcl 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.
14.2.2_ QpM Ating_SfAtus t
l The operating status of systems, structurr.s. and components undergoing j
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 vill not have an adverse effect on plant safety.
l O
14-1 Revision 16 1
1
15.0 NONCONFORMING MATERIAL, PARTS, OR COMPONENTS 15.1 PURPOSE l
This chapter describes measures for documentation, control, and disposition of nonconforming quality-related items to prevent their inadvertent use or installation.
15.2 NONCONFORMING MATERIAL CONTROL PROGRAM 15.2.1 General 1
Items that deviate from approved specifications, codes, drawings, or other applicable documents are considered as nonconforming.
Procedures govern the use of nonconforman:e reports for identification, control, disposition of nonconforming items, and notification of affected organizations.
()
Unless such controls are not feasible, nonconforming items are identified with l
appropriate tags and segregated to indicate their unacceptable status until the nonconformance is properly dispositioned.
If this is not feasible, other methods are established to identify and control the nonconforming items.
15.2.2 Work Packagg j
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 f
restored to the original design requirements under a " rework" disposition-l l
i l
15 2.3 Noncsnformance Report Management reviews and approves nonconformance report dispositions.
I 1
15-1 Revision 16 l
l m
"Use as is" or " modify" dispositions require the review and approval of Engineering.
Tags associated with a nonconformance report are removed only by authorized personnel.
l
}
l l
l l
c l
i M
l J
\\
\\
15-2 Revision 16 i
l
I i
16.0 CORRECTIVE ACTION
()
16.1 PURPOSE i
This chapter describes the corrective action measures to assure that j
conditions adverse to quality are identified, evaluated, and corrected. For
{
significant conditions adverse to quality, corrective action is taken to preclude repetition.
l 16.2 CORRECTIVE ACTION PROGEAM Procedures govern the use of nonconformance reports to assure that conditions adverse to quality are identified and corrected in a timely manner.
t Any individual has the authority and responsibility to report a condition I
I adverse to quality to their manager or supervisor who will assure that it is or has been documented on a nonconformance report.
Nonconformance reports documenting significant conditions adverse to quality
()
require determination of cause and corrective actions taken to preclude repetition.
t l
l l
Copies of nonconformance reports which identify significant conditions adverse to quality are distributed to appropriate levels of management for information l
and review.
l l
I l
16-1 Revision 16
i 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 CUALITY ASSURANCE RECORDS CONTROL PROGRAM
[
I Records should be identifiable to specific systems, structures, and components, when applicable.
Documents which are designated as quality assurance records shall be legible, l
accurate, and completed as appropriate for the work accomplished.
i Records are indexed, including as a minimum retention times and location of the records within the record system, to provide for retrieval without undue l
delay.
Quality assurance records are ultimately filed and maintained at a Permanent Records Storage Facility.
l Prior to final transmittal of quality assurance records to permanent storage, the originating organization will be responsible for maintaining quality assurance record controls.
17-1 Revision 16
18.0 AUDITS
()
18.1 PURPOSE l
This chapter describes the audit program utilized to verify the j
implementation, adequacy, and effectiveness of the QA Program.
i i
l 18.2 AUDIT / SURVEILLANCE PROGRAM i
11.2 1 General The Nuclear Oversight Department has overall responsibility for performing planned and periodic internal and external audits.
In addition, the Nuclear Oversight Department performs surveillances of selected quality-related activities.
j 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.
i i
l Audit results shall be documented. These results shall be reviewed by management having responsibility in the area audited.
Followup action, including reaudit of deficient areas, shall be taken where indicated.
18.2.2 Audit Personnel j
Auditors are appropriately trained to assure competence for performing the required audits. Audit team personnel shall be independent of the activities being audited.
O 18-1 Revision 16
.~.
O APPENDIX A QUALITY ASSURANCE AND ADMINISTRATIVE CONTROLS FOR PACKAGING RADI0 ACTIVE MATERIAL FOR TRANSI' ORT O
O A-1 Revision 16
1 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 in 10 CFR 71 and the quality assurance criteria for shipping packages for radioactive material are satisfied. The QA Program will assure that waste materials intended for disposal at a land disposal facility are properly classified, 3dentified, 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 172-173 are prescribed in written procedures, instructions, or drawings.
Implementation of the QA Program elements applicable to shipping radioactive material is under the management control of the General Manager, Trojan Plant.
Plant procedures implement the QA Program elements applicable to shipping radioactive material.
O The chapters of the QA Program applicable to Packaging Radioactive Materials for Transport activities are described and modified below.
Chapter (s) 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.
4.0 Fully applies in addition to Section b. of this appendix.
5.0 Fully applies.
6.0 Fully applies.
7.0 Fully applies.
u A Revision 16
Chapter (s) 8.0 Fully applies.
9.0 Does not apply. PGE does not f abricate NRC Type B 1
packages.
j i
10.0 Fully applies.
j 11.0, Fully applies.
12.0 Fully applies.
i 13.0 Fully applies.
14.0 Fully applies.
15.0 Fully applies.
j 16.0 Fully applies.
17.0 Fully applies in addition to Section c. of this appendix.
18.0 Fully applies, a.
0A Program
)
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 package and its components.
(1) The impact of malfunction or failure of the item to safety; A-3 Revision 16
(2) The need for special controls and surveillance over processes and equipment; O
(3) The degree to which functional compliance can be demonstrated by inspection or test; and l
)
(4) The quality history and degree of standardization of the item.
b.
Procurement Document Control - 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.
0A Rerords I
In addition to the records required by the definition of Quality Assurance Records in the Glossary of this QA Program, the records must include the 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 retention 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 superseded.
4 O
A-4 Revision 16
GLOSSARY i
Audit: An activity which determines through investigation, review, and j
objective evidence, the adequacy of, and adherence: to, established procedures, instructions, specifications, codes, standards, or other applicable contractual and licensing requirements, and the effectiveness of implementation.
l Calibration: The process by which measuring or test equipment is checked j
against standards of equal or higher accuracy and adjusted as necessary to assure its compliance with designated specifications, j
Conditions Adverse to Ouality: Departures from specified requirements, such as failures, malfunctions, deficiencies, deviations, defective material or equipment, and nonconformances.
Correclive Action: Action taken to correct conditions adverse to quality and l
to preclude repetition of significant conditions adverse to quality.
Derdgn: 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.
Desien Chance: A change or alteration to the technical or physical requirements of an item.
Design Documents:
Specifications, drawings, calculations, and analyses associated with design changes and modifications that define technical requirements.
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 mathods, or by performance of a suitable testing program.
Dacuments Requir_ine Control: Documents requiring control contain written or pictorial information describing, defining, specifying, reporting, or l
certifying activities, requirements, procedures, or results. As a minimum, 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.
Esamination: An element of inspection consisting of investigation of 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 l
manipulation, gauging, and measurement.
Gl-1 Revision 16 l
Identification: 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.
Inspection: An element of quality control which by means of examination, observation, or measurement determines the conformance of materials, supplies, 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:
I'ipe hangers, seismic anchors, and restraints are properly installed; a.
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.
Liectrical 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 Equi EEnt: Devices or systems used to calibrate, measure, P
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.
Modification: 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.
Modify (termed " repair" in ANSI N45.2.10): The disposition applied to nonconforming items 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.
Ernconf ormac.e: A deficiency in characteristic, d'ocumentation, or procedure which renders the quality of an item or activity unacceptable or indeterminate.
O G1-2 Revision 16
Permanent Records Sforage Facility: A Permanent Records Storage Facility is an environmentally controlled room or vault with controlled access which provides protection of quality assurance records from fire, theft, flood, and
()
deterioration.
Procedure: 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.
Procurement 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 services must meet in order te be acceptable to the Purchaser.
Purchased Services: 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 considered valid records only if stamped, initialed, signed, or otherwise e'()
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, and equipment. Decommissioning records will be dispositioned in accordance with 10 CFR 50.75.
)
Qua.lity-Related: The term " 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 Requiremsn1E: Quality requirements include, but are not limited to, such items as test, inspection, and acceptance criteria and any special instructions and prerequisites for such activities as designing.
identification, fabrication, cleaning, erecting, packaging, handling,
/' 'h shipping, and extended storage.
O Gl-3 Revision 16
Radiation Protection: Radiological controls applied to radiation areas, radiation services, or radiation-producing machines consistent with the g
requirements of 10 CFR 19,10 CFR 20, and 10 CFR 50, Appendix I.
Reject: The disposition applied to noncon2orming items which are unsuitable for their intended purpose but which may be feasible to return to the supplier 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, reassembly, or other corrective means.
Sienificant condition Adverse to Ouality: A departure from specified requirements is considered to be a significant condition adverse to quality if 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 involves a significant breakdown in the QA Program implementation.
Egecial Process: 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.
O Stop Work: The authority that permits immediate stoppage of quality-related activities such as design, procurement, fabrication, inspection, testing, or removal.
Surveillance: A documented observation or review of an activity for the purpose of verifying conformance with specified requirements or evaluating their adequacy and effectiveness.
Testing: The determination or verification of the capability of an item to meet specified requirements by subjecting the item to a set of physical, chemical, environmental, or operating conditions.
l Ese As Is: A disposition applied to nonconforming items which do not meet all specified requirements but do safely and reliably meet their intended purpose.
]
l
()
ZTOP.40 Gl-4 Revision 16 1
.- -