ML20081H062
ML20081H062 | |
Person / Time | |
---|---|
Site: | Crystal River ![]() |
Issue date: | 03/20/1995 |
From: | FLORIDA POWER CORP. |
To: | |
Shared Package | |
ML20081H060 | List: |
References | |
NUDOCS 9503240083 | |
Download: ML20081H062 (103) | |
Text
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1.7 00ALITY PROGRAM (OPERATIONAL)
This Quality Program is revised and submitted to the NRC as required by 10 CFR 2
50.54(a). For later interim changes, contact the Nuclear Operations Quality Programs Department.
1.7. INTRODUCTION Florida Power Corporation (FPC) has implemented a comprehensive Quality Program in order to maintain the high quality of plant systems and equipment during operation, maintenance, repair, modification, and refueling. Sections 1.7.1, 1.7.2 (and Table 1-3),1.7.3 and 1.7.4 describe the FPC Quality Program during the operational phase which implements 10 CFR 50, Appendix B. This program and its implementation are available for audit by NRC personnel.
1.7.1.1 Oraanization FPC has established the functional responsibilities and authorities of positions / organizations involved in the Quality Program (Figures 1-26 and 1-26a through 1-26g). These figures, along with the functional departmental responsibilities described below, serve to document the relationships between operating organization positions. In certain instances, duties and authority to execute and audit the quality activities are delegated to other organizations.
In all cases, FPC retains responsibility for the Quality Program for Crystal River Unit 3.
Verification of conformance to established quality requirements on safety-related structures, systems, and components is accomplished by those individuals or groups who do not have direct responsibility for performing the work being verified.
Persons and organizations performing quality assurance functions have sufficient authority and organizational freedom to identify quality problems; initiate necessary action to provide for resolution of nonconformances through designated channels; verify implementation of solutions; and, control further processing, delivery, or installation of a nonconforming item until the proper disposition of the deficiency or the unsatisfactory condition has been approved.
The following summarizes the functional responsibilities and authorities of positions / organizations involved in directing and managing the FPC Quality Program:
. President _
Ultimate responsibility for the overall effectiveness of FPC's Quality Program rests with its President. He has assigned the responsibility for the implementation of the program to the Senior Vice President, Nuclear Operations.
1-71 (Rev. 20) 950324C083 950320 PDR ADDCK 05000302 P PDR l
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- 2. Senior Vice President, Nuclear Operations The Senior Vice President, Nuclear Operations shall have corporate.
responsibility for overall plant nuclear safety and shall take any measures needed to ensure acceptable performance of the staff in operating, maintaining, and providing technical support to the plant to ensure nuclear s&fety.
The Senior Vice President, Nuclear Operations is responsible for the implementation of the Quality Program. He has the authority and responsibility to resolve all problems related to the Quality Program when resolution cannot be obtained at subordinate levels of management. He has delegated the authority for administering the program to the Director, Quality Programs.
The Senior Vice President, Nuclear Operations is responsible for operations, engineering and quality program functions at Crystal River Unit 3. He has the authority and responsibility to administer the FPC Quality Program.
The Senior Vice President, Nuclear Operations is in charge of an organization consisting of the following elements:
- Nuclear Production
- Nuclear Engineering and Projects
- Nuclear Operations Materials and Controls
- Quality Programs The functions of each of these elements are defined below.
- a. Nuclear Production The Vice President, Nuclear Production, reporting to the Senior Vice President, Nuclear Operations, is responsible for the operations, site support, technical support, integrated scheduling and training functions of Crystal River Unit 3.
The Vice President, Nuclear Production is in charge of an organization consisting of the following elements:
- Nuclear Plant Operations
- Nuclear Operations Site Support
- Nuclear Plant Technical Support
- Production Management
- Nuclear Operations Training
- Outage Management The functions of each of these elements are defined below.
1-72 (Rev. 20)
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/$ /2 Nuclear Plant Doerations The Director, Nuclear Plant Operations (DNPO) is responsible for:
The safe, legal, and efficient on-site operation, maintenance, calibration of portable measuring and test equipment, chemistry, radiation protection, nuclear safety, and equipment and facility modification at the nuclear plant Planning and monitoring of all activities necessary to achieve and control optimum operations, maintenance and outage activities The development and implementation of an Inspection Planning Program for activities within his responsibility The CR-3 ALARA program Development, maintenance, and interpretation rf radiological effluent technical specifications and the environmental monitoring program Resolving disagreements with the PRC pursuant to Technical Specification 5.1.1 The DNPO directs the development and maintenance of an equipment list of portable measuring and test equipment. used to calibrate instrumentation and electrical equipment. The list and changes thereto are reviewed and approved.
Nuclear Operations Site Support The Director, Nuclear Operations Site Support is responsible for:
The coordination of all licensing requirements, regulations, reporting requirements and licensing commitments Radiological emergency preparedness CR-3 fire protection program Corporate Health Physics activities Coordination of the nuclear fuel management activities Monitoring and coordinating activities to ensure compliance with applicable regulatory, corporate, and safety requirements The CR-3 security program Interpretation of and evaluation of problems or issues, involving technical specification requirements The responsibility for the training and qualification of security force personnel 1-72a ( M 4) 1
ls lo Nuclear Plant Technical Support The Manager, Nuclear Plant Technical Support js responsible for:
Providing technical consulting to plot departments on activities or questions related to plant sptems to enhance safety and the overall capacity factor and reliability of CR-3 Monitoring component performance Performing inservice inspections Technical administration of surveillance procedures Coordinating preventative maintenance recommendations, predictive maintenance, and reliability centered maintenance evaluations Development of programs for NRC Maintenance and License Renewal Rules Production Manaaement The Production Manager is responsible for managing, directing, and supervising the activities of the day-to-day scheduling.
Outaae Manaaement The Outage Manager is responsible for managing, directing, and supervising the activities of the outage management groups.
He is also responsible for maintaining communications with owner's groups, other plants, and outside agencies to incorporate ideas to optimize outage schedules.
Nuclear Operations Trainino The Director, Nuclear Operations Training is responsible for nuclear training, including licensed and non-licensed operator, technician, engineer, general employee, nuclear emergency team, and mahtenance '
training, and specialized qualification / certification trotning, as required.
- b. Nuclear Enaineerino and Pro.iects The Director, Nuclear Engineering and Projects is responsible for:
Overall CR-3 design control activities The design, evaluation, and technical approval of plant modifications 1-72b (Rev. 22)
.i /o Development and implementation of an Inspection Planning Program for activities within his responsibility Engineering analyses, and evaluations The coordination of modification activities with the plant project management group Modification functional tests Technical review of plant procedures Management and direction of architect / engineer contracts Review of procurement documents to ensure inclusion of appropriate technical requirements Ensuring appropriate technical requirements are included in work authorizations Maintaining the configuration management program Providing input to Plant Organizations to enhance operability, maintainability, and reliability The development and control of procedures for engineering design and design related activities The coordination of Nuclear Engineering training on departmental operations and procedures Supporting the audit program activities, as requested by Quality Programs, for external engineering design organizations
- c. Nuclear Operations Materials and Controls The Director, Nuclear Operations Materials and Controls, is responsible for:
The management and acquisition of all quality related materials and services (including nuclear fuel fabrication)
Contract administration Supervision of the procurement quality group (reviews procurement documents for inspection planning, performs audits and surveys of suppliers, including access authorization programs, and conducts receipt inspections)
Supervision of the materials coordination group 1-72c (P= . 22) a
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c Supervision of material storage (except where material has been issued to, and remains in the custody of, the Plant).
Procedures related to these activities are covered principally in the Nuclear Procurement and Storage Manual.
Management of quality related records, drawings and manuals-Management and control of. software development A
1-72d (":e,22)
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- d. Quality Proarams l The Director, Quality Programs, reporting to the Senior Vice l l President, Nuclear Operations, has the responsibility to assure that i
the requirements of the Quality Program are implemented.
He has the authority and organizational freedom to:
Identify quality problems Initiate, recommend or provide possible solutions and Verify .
the implementation of solutions I
The Director, Quality Programs, has the authority to.
I Control further processing (including the authority to hold up work that is nonconforming), delivery, or installation of a l nonconforming item or conduct of a nonconforming activity, until the proper disposition of the deficiency or unsatisfactory condition has been approved. Nonconformances j are violations of the Quality Program requirements. The 1 Director, Quality Programs, has delegated this authority to ;
the Manager, Nuclear Quality Assessments, the Supervisor, I Quality Systems, and the Supervisor, Nuclear Quality Control. I I
Take decisions regarding work that is nonconforming directly ,
to other levels of FPC management. He is independent of l l
groups or functions directly responsible for performing j specific work activities affecting quality.
i l The Director, Quality Programs is responsible for assuring the l implementation of the Quality Programs Department training program.
The Director, Quality Programs, is in charge of an organization consisting of the following elements:
Nuclear Quality Assessments Quality Systems '
l Nuclear Quality Control l The functions of these elements are defined below:
l Nuclear Ouality Assessments The Manager, Nuclear Quality Assessments is responsible for:
Conducting quality assurance audits required by 10 CFR 50
- Appendix B, the responsibilities of the Nuclear General Review Committee as described in FSAR Section 12.8, and FPC's commitments to ANSI N18.7 as clarified in Table 1-3 l
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i Conducting external audits of FPC environmental monitoring contractors Acting as the FPC representative for the Cooperative I l Management Audit Program (CMAP), through nic.) FPC l periodically reviews the status and adequacy of its (uality i Program ,
l The development and implementation of a QA evaluation program I that encompasses all aspects of nuclear plant operations, j maintenance, modifications, and other related activities
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Quality Systems i l
The Supervisor, Quality Systems is responsible for: l Maintaining the interface with Nuclear Operations for all !
matters relating to the FPC Quality Program and related i commitments i Maintenance of the Quality Program, Departmental l l administrative procedures and programs j
Developing, analyzing and reporting trends of quality ;
activities t
The review of quality documents Modeling of processes of selected Nuclear Operations ;
activities l 1
Nuclear Ouality Control
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l i l The Supervisor, Nuclear Quality Control (NQC) is responsible for the l (NQC) inspection program, which includes the inspection of maintenance, modification, and test activities.
l 3. Nuclear General Review Committee l
l Refer to Section 12.8.2. l
- 4. Plant Review Committee Refer to Section 12.8.1. l
- 5. Supervisor, Material Technology ;
The Supervisor, Material Tect.nology, reporting through the Manager, Power Plant Support Services, to the Director, Fossil Operations Engineering and Technical Services, is responsible for providing engineering services for fossil, nuclear and other company I departments. This organization provides expertise involving i metallurgy, welding, coating, non-destructive examination, and other related technologies. i 1-74 (5 e. 22) !
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1.7.1.2 Ouality Proaram ;
6 This section (and the remainder of Section 1.7) describes the FPC Quality Program !
for Crystal River Unit 3 during the operational phase. The operational phase began with the commencement of fuel loading and ends with completion of plant decommissioning.
Section 1.7 of the CR-3 FSAR is management's summary of the quality requirements :
applicable to Crystal River Unit 3 during the operational phase.
The Quality Program complies with the requirements of 10 CFR 50, Appencix B.
This program requires that all persons performing quality activities associated with the operation of Crystal River Unit 3 comply with the program. FPC conducts or delegates the responsibility to conduct audits of the program activities.
t The Quality Program takes into account the need for special controls, processes, ,
tests, equipment, tools and skills to obtain the required quality. l t
Managers / Supervisors selecting personnel shall assure that the qualifications stated in the job description meet or exceed the ANSI N18.1 education and experience requirements identified in the job description. Managers / supervisors will ensure that an individual being selected meets the minimum education and ;
experience requirements of ANSI N18.1-1971 (as clarified in Table 1-3). l FPC has an indoctrination and training program for personnel performing quality activities to assure that they are knowledgeable of the Quality Program's procedures and requirements. The indoctrination and training program includes appropriate procedures and personnel records. Personnel responsible for l performing quality activities are instructed as to the purpose, scope and implementation of the quality-related manuals, instructions, and procedures.
Personnel performing quality activities are trained and qualified in the activity
- being performed.
j Quality activities such as inspection and test are done with appropriate
- equipment and under suitable conditicr.
- . Housekeeping and cleanliness controls i
are implemented through procedures. These controls meet the requirements of ANSI N18.7, Section 5.2.10, ANSI N45.2.1 and ANSI N45.2.3 as each is clarified in Table 1-3.
FPC's organizational structure and the functional responsibility assignments assure that:
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- 1. Attainment of program objectives is accomplished by those who have been assigned responsibility for performing work. This may include interim examinations, checks, and inspections of the work by the individual performing the work.
- 2. Verification of conformance to established program requirements is accomplished by a qualified person who does not have responsibility for performing or directly supervising the work. The method and extent of such verification shall be commensurate with the importance of the activity to plant safety and reliability as clarified by Table 1-3 (NRC Regulatory Guide 1.74, Item 4).
1-75 (k u. 22)
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- 3. In structuring the organization and assigning responsibility, '
quality assurance should be recognized as an interdisciplinary function involving many organizational components and, therefore, should not bc regarded as the sole domain of a single quality l l assurance group. Quality assurance encompasses many functions and 'i l activities and extends to various levels in all participating-l !
organizations, from the top executive to all workers whose activities may influence quality.
, The FPC Quality Program applies to structures, systems and components as defined i
in FSAR Section 1.6.4, equipment in the FPC " Safety Listing" and may be applied-to other equipment and activities at FPC management discretion.
FPC regularly reviews the status and adequacy of its Quality Progran through periodic reviews conducted at least once every two years. In addition responsible management reviews audit reports and corrective actions of that part 1 of the Quality Program which they are implementing.
Changes to the Quality Program which result in more stringent requirements will be entered in appropriate implementing procedures within 90 days of the Quality
, Program change unless otherwise specified in the commitment / requirement to change l the Quality Program or unless a longer period is evaluated and accepted by the l Director, Quality Programs. All other Quality Program changes will be reflected in appropriate implementing procedures at their next revision.
The FPC Quality Program meets the requirements of the Regulatory Guides and ANSI Standards as defined in Section 1.7.2 (and clarified in Table 1-3).
For activities where quality considerations are subject to interpretation, the management responsible for the activity shall also be responsible for assuring that programmatic controls are applied. This in.no way negates the need for clear management controls for all safety-related activities. Quality Programs Department personnel evaluate and verify that controls are' in place and effectively implemented through inspection, surveillance activities and audit activities.
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i i 1.7.1.3 Desian Control :
FPC's Nuclear Engineering Department verification engineer provides for an !
independent review of safety-related design changes. This review assures that i the design activities are in accordance with ANSI N45.2.11 as clarified in Table 1-3.
Maintenance or modifications which may affect safety-related structures, systems, or components are performed in a manner that ensures quality requirements, material specifications, and inspection requirements are met. Maintenance or j modifications of safety-related equipment are planned and performed in accordance with written procedures, documented instructions, or drawings appropriate to the circumstances which conform to applicable codes, standards, specifications, and criteria as clarified in Table 1-3.
1.7.1.4 Procurement Document Control Procurement documents are reviewed by qualified personnel, prior to purchase, to
- assure that quality requirements have been specified. Individuals reviewing i these procurement documents are not involved with the other phases of the procurement activity. These reviews are performed and documented in accordance
- with approved written procedures. ,
FPC's Quality Program contains provisions which require that: l i
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- 1. Procedures are established which clearly delineate the sequence of actions to be accomplished in the preparation, review, approval and control of J
procurement documents and which identify those positions or groups responsible for performing those functions.
2.
Reviewofandconcurrencewiththeprocurementdocumentsareperformedbyl independent procurement quality personnel to assure that the quality requirements are stated. This review is to determine that quality 3 requirements can be inspected and controlled, that there is adequate acceptance or rejection criteria, and that the procurement document has i been prepared in accordance with FPC Quality Program procedure requirements.
1 3. Documented evidence of the review and approval of procurement documents is
- provided and available for verification.
- 4. Procurement documents identify those 10 CFR 50 Appendix B requirements
, that must be complied with by the supplier's quality program. Details regarding evaluation and selection of suppliers are stated in the implementing documents of the Quality Program.
d l-77 (Rev. 20)
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- 5. Procurement documents contain or reference, as applicable, basic technical requirements such as regulatory requirements and design bases and identify the documentation to be prepared, nintained, submitted, and made available to FPC for review and/or ap ecol. FPC's procurement documents include provisions for control of nov- Jwances.
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- 6. Procurement documents contain the requirements for the retention, control, I and maintenance of records as appropriate.
- 7. Procurement documents contain the right of access to vendor's facilities-and records for source inspection and audit by FPC.
- 8. Changes and/or revisions to a procurement' document are subject to review i and approval requirements at least equivalent to those for the original-document.
1.7.1.5 Instructions. Procedures and Drawinos l !
FPC's Quality Program contains requirements to assure that each of the 18 ,
criteria within 10 CFR 50, Appendix B are delineated, accomplished, and-l controlled in accordance with approved written procedures.
i FPC's Quality Program contains provisions which require that instructions, procedures, or drawings include appropriate quantitative (such as dimensions, l tolerances,criteria acceptance and operating for . limits) or qualitative-(such determining that quality as workmanship activities samples) have been l
! satisfactorily accomplished.
Written procedures are adhered to in matters relating to nuclear safety. The program identifies when written procedures shall be followed step-by-step. In order to properly document that procedural steps are verified as required, each step of the procedure requiring verification is initialed or otherwise acknowledged when completed.
1.7.1.6 Document Control l FPC has a document control system for documents which prescribe activities affecting quality.
l FPC's Quality Program contains provisions which require that:
- 1. Measures are established to review documents, such as instructions, procedures, and drawings (and changes thereto) prior to release to assure that the quality requirements are sufficiently, clearly, and accurately stated.
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- 2. Changes to documents are reviewed and approved by the same organizations that performed the original review and approval unless delegated by the appropriate FPC organization to another qualified responsible organization.
- 3. The reviewing organization (s) has access to pertinent background I information upon which to base its approval and has an adequate !
understanding of the requirements and intent of the original document.
- 4. Approved changes are promptly included with instructions, procedures, drawings, and other appropriate documents.
- 5. Obsolete or superseded documents are controlled to prevent their use.
- 6. Documents are available at the start of the work for which they are needed. l
- 7. A method for identifying the current revision of instructions, procedures, and drawings is established and implemented. This information is updated ,
l and distributed as necessary to predetermined responsible personnel.
l As a minimum under this criteria, the controlled documents include:
, 1. Design specifications.
- 2. Design, manufacturing, construction, and installation drawings. ]
- 3. Quality Administrative Procedures and plant operating procedures, j
- 4. Manufacturer inspection and iesting instructions.
- 5. Procurement documents.
- 6. Maintenance, repair, and modification instructions.
- 7. Test surveillance instructions.
- 8. Refueling instructions.
l 9. In-service inspection instructions. ,
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Other procedures per Regulatory Guide 1.33, as clarified in Table 1-3.
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i 1.7.1.7 Control of Purchased Material. Eauipment and Services Vendor evaluation surveys to qualify potential suppliers in accordance with FPC approved written procedures and in compliance with ANSI N18.7, Section 5.2.13 and j ANSI N45.2.13 as each is clarified in Table 1-3, are conducted by FPC or through j qualified contractors. Suppliers' quality programs are reviewed and concurred ,
with prior to implementation of activities. l 1
Procurement of certain commercial grade commodities may be qualified for safety-related applications on the basis of current industrial controls which limit the possibility of variation among items. Commodity item suppliers are excluded from use for safety-related purchases upon evidence of poor Quality History; otherwise specific supplier approval is not required for commodity purchases, i FPC assures that quality requirements of the purchase document have-been met, !
l using source inspection, receipt inspection or document review, as appropriate. !
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l 1.7.1.8 Identification and Control of Materials. Parts and Components ,
FPC has established measures for the identification and control of materials, i j parts, and components. ;
I FPC's Quality Program contains provisions which require that:
! 1. Procedures are established which describe identification and control of j material, parts, and components, including partially fabricated ,
assemblies. l l
- 2. Identification requireinents are determined during the initial planning I
( stages (i.e., during generation of specification and design drawings). :
- 3. Identification is specified to the extent that the item identified can be j traced to the associated documentation, such as drawings, specifications, l purchase orders, manufacturing and inspection documents, and physical or l chemical mill test reports.
- 4. The degree of identification is specified on the design drawing or in referenced technical documents.
- 5. Measures are provided to assure that the location and method of identification do not affect the function or quality of the item being identified. J l
- 6. Measures are provided for the verification of correct identification of materials, parts, and components prior to release for manufacturing, shipping, construction and installation.
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l 1.7.1.9 Control of Special Processes 1 i
l Participating organizations provide written procedures for performance of special !
processes such as welding, heat treating, chemical cleaning, coating / painting, and non-destructive testing and include the requirements for qualification of personnel performing the work. i FPC's Quality Program contains provisions which require that:
- 1. Measures are established to assure adequate performance and control of i special processes such as welding, heat treating, chemical cleaning, coating / painting and non-destructive testing.
- 2. Measures are established to assure that procedures, equipment and personnel connected with special processes are qualified in accordance with the requirements of applicable codes, standards, and specifications.
- 3. Measures are established to assure that special processes are performed by l qualified personnel in accordance with approved written procedures. These !
j procedures provide for recording evidence of verification and, if
- applicable, inspection and process results.
- 4. An active file is maintained on qualification records of all special l process procedures and equipment, and personnel performing special l processes.
- 5. Special process procedures and the credentials of qualified personnel are regularly reviewed to assure they are of the latest revision and that personnel qualifications have not expired.
I 1.7.1.10 Inspections i Written procedures are required for the performance of in-process inspection.
- Inspection personnel are qualified in compliance with Regulatory Guides 1.8, l l 1.33,1.58, and 1.146 as each Regulatory Guide is clarified in Table 1-3.
1 FPC's Quality Program contains provisions which require that:
l 1. Inspection personnel are independent from the individual or group l physically performing the activity being inspected.
l 2. Inspection procedures, instructions and/or checklists are provided which document the date performed, by whom and/or by what equipment, the type of observation, the results, the data collected and its acceptability.
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- 3. Inspection procedures or instructions are available for use prior to '
performing the inspection operation.
- 4. Measures are provided for qualifying the inspectors and maintaining the current status of each inspector's qualifications.
- 5. Measures are established to assure that inspection equipment is within 1 calibration prior to performing an inspection operation. ]
- 6. Measures are provided for monitoring processing methods, equipment, and ;
personnel if inspection of processed material is impossible or l
, disadvantageous. Inspection and process monitoring are provided when i l control is inadequate without both. I l 7. Specific hold points are indicated in appropriate documents for mandatory j witnessing or inspection beyond which work shall not proceed without the i consent of FPC's designated representative.
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1.7.1.11 Test Control i l
Required tests are performed in accordance with approved written procedures to assure compliance with design documents. Testing activities are conducted during the operational phase to verify the compliance of components to design requirements.
FPC's Quality Program contains provisions which require that:
- 1. A test program is established to assure that all testing required to demonstrate that the item will perform satisfactorily in service ' is identified, documented, and accomplished in accordance with approved written procedures.
- 2. The test program covers the required tests, including, where appropriate, prototype qualification tests, proof tests prior 'to installation, i preoperational tests, and operational tests. '
- 3. Written test procedures are prepared which incorporate or reference the 1 requirements and acceptance limits contained in applicable design and procurement documents.
- 4. The written test procedures include, as appropriate, instructions for test method and identification of test prerequisites such as:
a) calibrated instrumentation;
! b) adequate and appropriate equipment; c) trained, qualified, licensed and/or certified personnel; d) preparation, condition, and completeness of item to be tested; and e) suitable and controlled environmental conditions. l 1-82 (Rev. 20) l
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- 5. Test results are documented and evaluated to assure that test requirements have been satisfied.
1.7.1.12 Control of Measurement and Test Eauioment FPC has established and implemented appropriate test and calibration procedures for test devices used to verify the acceptability of items within the Quality Program. Calibration records and controls are provided for measurement and test equipment in accordance with the requirements of ANSI N18.7, Section 5.2.16, ANSI l N45.2.4 and ANSI N45.2.8 as each ANSI Standard is clarified in Table 1-3.
FPC's Quality Program contains provisions which require that:
- 1. Procedures are established which describe the calibration technique, calibration frequency, maintenance and control of measuring and test instruments, tools, gauges, fixtures, reference standards, transfer standards, and non-destructive test equipment to be used in the measurement, inspection, and monitoring of safety-related components, systems, and structures.
- 2. Measurement and test equipment is uniquely identified and has traceability to the calibration test data.
- 3. Measurement and test instruments are calibrated and maintained at specified intervals, based on the required accuracy, purpose, the degree of usage stability characteristics, and other conditions affecting the measurement.
- 4. Measurement and test equipment is calibrated on or before the designated due date or before use.
- 5. When measurement and test equipment is found to be out of calibration, an investigation is conducted and documented to determine the validity of previous inspections performed and the acceptability of those items previously inspected.
- 6. Calibrating instruments have known valid relationships to a nationally recognized standard. If no national standard exists, the basis for calibration is documented,
- 7. Facilities used for calibrating sensitive or close tolerance measurement-and test equipment provide an environment that is sufficiently controlled to allow the measuring device to be evaluated and calibrated to its required accuracy.
1.7.1.13 Handlina. Storaae and Shiopina l FPC's Nuclear Operations Materials and Controls Department is responsible for material handling, storage, and shipping activities for plant spare parts and' operating supplies in accordance with approved written procedures and sound storage principles. These procedures meet the requirements of ANSI N18.7, Section 5.2.13.4 and ANSI N45.2.2 as they are clarified in Table 1-3.
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1.7.1.14 Inspection. Tests and Operatina Status l FPC has approved written procedures to assure the proper marking of equipment denoting its status.
FPC's Quality Program contains provisions which require that:
- 1. Measures are established and documented to identify the inspection, test, and operation status of structures, systems, and components, which provide means for assuring that required inspections and tests performed are known ,
throughout manufacturing, installation, and operation.
- 2. Measures are established to control the use of inspection and status indicators, including the authority for application and removal of tags, :
markings, and labels. !
- 3. Measures to preclude bypassing of required inspections, tests, and other critical operations are provided through approved written procedures.
- 4. The status of nonconforming, inoperative, or malfunctioning structures, systems, or components is clearly identified to prevent use.
1.7.1.15 Nonconformina Material. Parts. or Comoonents FPC has written requirements to be followed by persons performing quality activities, including contractors, to identify, document, segregate, disposition l and report to FPC, any nonconformance, deviation or other condition adversely j affecting quality. '
l FPC's Quality Program contains provisions which require that:
- 1. Measures and procedures are established to control the identification, documentation, segregation, review, disposition, and notification of the affected organization of nonconformances.
- 2. Documentation is provided which clearly identifies the nonconforming item, describes the nonconformance and disposition of the nonconformance, inspection requirements, and includes signature approval of the disposition.
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- 3. Measures are established and documented defining the responsibility and authority for determining the disposition of nonconforming items and approving the disposition.
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- 4. Nonconforming items are segregated from acceptable items (where feasible) and uniquely identified as nonconforming until properly 'dispositioned for use. ,
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- 5. Acceptability of " rework" or " repair" of materials, parts, components, !
systems, and structures are verified by reinspection and/or testing of the !
item in accordance with approved written procedures. !
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- 6. Nonconforming items which are dispositioned "use as is" or " repair" are formally controlled through approved procedures or design changes. ,
- 7. Nonconformance reports are made part of the quality assurance records.
1.7.1.16 Corrective Action ;
FPC has approved written procedures to be followed by persons performing quality l activities, including contractors, to assure that corrective action is taken to i preclude the recurrence of nonconformances, deviations or other discrepancies adversely affecting quality. ,
FPC's Quality Program contains provisions which require that:
- l. Conditions adverse to quality, such as failures, deficiencies, deviations, f defective material and equipment, and nonconformances are promptly t identified and corrected. ?
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- 2. Evaluation of nonconformance and determination of the need for corrective i action are in accordance with approved written procedures.
l 3. Measures are established to determine the cause of the nonconformance and j l institute corrective action to preclude the recurrence of those ;
l significant conditions adverse to quality.
- 4. Measures are established to follow up on corrective actions to assure L proper implementation and close out of the corrective action ;
documentation. '
l l S. Measures are established to document and report to appropriate levels of ^
l management significant conditions adverse to quality, cause of the conditions, and corrective action taken.
1.7.1.17 Ouality Assurance Records FPC has established and implemented a system for the collection, storage, and maintenance of quality assurance records as required by the design documents, procurement documents, and Regulatory Guide 1.88 as clarified in Table 1-3.
Records transmitted to the quality files are done so in accordance with approved l
written procedures.
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l FPC's Quality Program contains provisions which require that:
- 1. Quality assurance records are of two categories, lifetime and nonpermanent. (Nonpermanent records are required to show evidence that an activity was performed in accordance with applicable requirements but need not be retained for the life of the plant. Lifetime records are required to be maintained for the life of the plant while the particular item is installed in the plant or stored for future use).
- 2. Quality assurance records are those records that furnish documentary evidence of the quality of items and of activities affecting quality. (A l
document is considered a quality assurance record when the document has i been completed).
These records include the results of reviews, inspections, tests, audits, l monitoring of work performance and material analysis, the qualification of l personnel, procedures, and equipment, training records, design drawings i and subsequent modifications, specification reports, procurement documents, calibration procedures and reports, nonconformance and corrective action reports, and other records required by ANSI N18.7 as :
clarified in Table 1-3. The records are identifiable and retrievable per [
ANSI N45.2.9 as clarified in Table 1-3. :
- 3. The inspection and test records contain the following:
a) Description of the types of operation.
! b) Evidence of completion and/or verification of manufacturing I inspection or test operation.
1 1
- 4. Records are stamped, dated, initialed, signed, or otherwise authenticated by authorized personnel.
- 5. Storage facilities are constructed, located, and secured to prevent ,
destruction and minimize deterioration or loss of records. FPC maintains I
quality assurance records either in a vault for single copy records or as duplicate records in remote locations.
1.7.1.18 Audits Audits shall encompass, as a minimum, verification of compliance and l effectiveness of implementation of regulations and license provisions. Objective evidence shall be examined to determine if the audited program is effective in ;
performing its intended function. i l
The focus of the audits should be based on demonstrated performance. In this l way, the audit can be tailored to address areas most in need of improvement.
FPC and its contractors use approved written procedures for planned audits of l l FPC's quality activities. j l
1-86 (Rev. 22)
.c . ,
r These audits include provf sions for obtaining resolution of all deviations from written procedures used to perform the activities being audited. Audit procedures also include provisions for the dissemination of audit results to proper management levels for resolution of nonconformances and evaluation of the status of the Quality Program. FPC's Quality Programs Department will perform audits to assess the effectiveness of the FPC Quality Program as contained in this document. The results of these audits are reported to FPC management. The
. Quality Frograms Department maintains records of audit results.
FPL's Quality Program contains provisions which require that:
- 1. A comprehensive system of planned and documented audits is used to verify 1 i compliance with all aspects of the Quality Program. i
- 2. Audits are performed in accordance with approved written procedures or checklists and are conducted by appropriately trained personnel not having direct responsibilities in the areas being audited, i l 3. Audit results are documented. These results are then reviewed by -
l management having responsibility in the area audited.
l l 4. Deficient areas are reaudited when required based on the severity of I
discrepancies, extent of corrective action required and significance to safety, performance, and reliability.
- 5. Audits include an objective evaluation of quality-related practices, :
procedures, and instructions; the effectiveness of implementation; and the 4 conformance with policy directives. !
- 6. Audits include the evaluation of work areas, activities, processes, items, and the review of documents and records.
- 7. The following types of audits are performed: l l I a) Internal audits which provide a comprehensive independent l verification and evaluation of quality procedures and activities to ;
assure that they are meaningful and are effectively complying with !
the Quality Program requirements.
b) External audits of contractors, subcontractors, and vendors i performing activities under the Quality Program. These audits include verification and evaluation of their quality program, procedures, and activities to assure that they are meaningful and l are effectively complying with all aspects of the quality program i and procurement requirements.
- 8. Audits are scheduled consistent with FPC's commitments to ANSI N18.7 and Regulatory Guide 1.33 as clarified in Table 1-3.
1-87 (kv.22)
Audits shall encompass:
- a. The conformance of facility operation to provisions contained within the Technical Specification and applicable license conditions at least once per 12 months.
- b. The performance, training and qualifications of the entire facility staff at least once per 12 months.
- c. The results of actions taken to correct deficiencies occurring in the facility eauipment, structures, systems or method of operation that affect nuclear safety at least once per 6 months.
- d. The performance of activities required by the Quality Program Description to meet the criteria of 10 CFR 50, Appendix B, at least once per 24 months.
- e. The facility fire protection program and implementing procedures at least once per 12 months.
- f. The radiological environmental monitoring program and the results thereof at least once per 12 months.
- g. The Offsite Dose Calculation Manual and implementing procedures at least once per 24 months.
- h. The Process Control Program and implementing procedures for solidification of radioactive wastes at least once per 24 months.
- i. The performance activities required by the Quality Assurance Program for effluent and environmental monitoring at least once per 12 months.
- j. Any other area of facility operation considered appropriate by the NGRC or the Senior Vice President, Nuclear Operations.
- 9. Audit personnel qualifications meet the. requirements of Regulatory Guide i 1.146, as clarified in Table 1-3.
Audit reports encompassed by the section above, shall be forwarded to the Senior Vice President, Nuclear Operations and to management positions responsible for the areas audited within 30 days after completion of the audit.
1.7.2 PROGRAM COMMITMENT During the operation phase, FPC commits to comply with the requirements of the ANSI Standards listed in Table 1-3 and to implement the Regulatory Positions of the Regulatory Guides listed in Table 1-3, as clarified in that Table. Based i on this commitment, FPC considers and will refer to such Regulatory Positions as i requirements. When Regulatory Guides or ANSI Standards are superseded by an approved revision, that revision will not be implemented unless the FSAR is l modified accordingly.
l 1-88 (Rev. 22)
r I
1.7.3 QUALITY ASSURANCE STAFF Persons performing quality assurance functions, as defined in 10 CFR 50 Appendix B, conduct reviews and audits of FPC departments, suppliers and contnctors that perform safety-related functions in connection with the operation. - ofueling, testing, maintenance and modification of Crystal River Unit 3. These reviews and audits are performed in accordance with approved written procedures and in ,
compliance with approved minimum requirements for audit frequency. Persons ;
performing quality assurance functions are authorized to identify quality ,
problems and may recommend to FPC management that work be stopped under totally unacceptable conditions. Such persons have the organizational freedom to effectively perform the quality assurance functions.
1.7.4 GLOSSARY OF TERMS Terms used in the FPC Quality Program are defined below or in those Regulatory ,
Guides and ANSI Standards committed to by FPC, as clarified in Table 1-3.
l
- 1. Quality Activity :
The term " quality activity" is a general term used to describe activities within the total Quality Program. The purpose of using the term " quality :
activity" is to reserve the words " control" and " assurance" for those specific functions of the Quality Program defined as " quality control" and
" quality assurance."
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1-97 (Rev. 20)
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i 12.8 ADMINISTRATIVE CONTROL :
Admi;istrative controls are established to assure that operations, maintenance !
tests, and emergencies are handled in accordance with the written procedures !
which have been properly reviewed and approved. The Director, Nuclear Plant ;
l Operations has the responsibility and authority to operate the plant within the
- limits of the administrative controls. ,
A review of the operating logs, charts,.and other data are made by Operations, i Engineering, and other personnel.
l Non-routine operations are also closely reviewed. In addition to these reviews, l ;
l periodic plant staff meetings are held to keep operating personnel advised of ;
t current plant conditions.
12.8.1 PLANT REVIEW COMMITTEE (PRC) ;
A Pli.nt Review Committee (PRC) is established to review activities in accordance Section 12.8.1.5. The PRC recommends to the Director, Nuclear Plant Operations-approval or disapproval of the activities reviewed in Section 12.8.1.5.1.
12.8.1.1 Composition The PRC is composed of a minimum of five members and one chairman from Nuclear Operations personnel with cumulative expertise in the following areas: ,
operations, health physics, maintenance, modifications, engineering, nuclear safety, licensing, and quality. These positions will be designated by the DNP0 ]
in administrative procedures or policies.
12.8.1.2 Alternates Alternate members are appointed in writing by the PRC Chairman. l
! 12.8.1.3 Meetina Freauency ,
The PRC meets at least once per calendar month and as convened by the PRC l j Chairman or his designated alternate.
l 12.8.1.4 Ouorum l l
l A quorum of the PRC shall consist of the Chairman or his designated alternate and five members, including alternates. No more than two alternates shall participate as voting members in PRC activities at any one time. l l
12-15 (Rev. 22)
12.8.1.5 ResDonsibilities
- 1. The PRC shall be responsible to review .the description and evaluation of the following documents prior to their implementation, if a full evaluation is warranted in accordance with 10 CFR 50.59:
- a. modifications to plant systems or . equipment, tests and .
experiments, and test procedures associated with plant modifications,
- b. proposed changes to the Operating License, and Appendix "A" to the Operating License (Technical Specifications), and j
- c. Offsite Dose Calculation Manual (00CM). l
- 2. The PRC. shall be responsible to review:
i
- a. evaluations of procedures and changes thereto for those '
procedures required by Technical Specification 5.6.1.1.a (as. ..
further clarified in Table 1-3 with regard to Appendix "A" of !
Regulatory Guide 1.33), if a full evaluation is warranted in accordance with 10 CFR 50.59:
- b. Technical Specification Bases, and
- c. additional items as requested by the Chairman, Nuclear General l Review Committee (NGRC) or as requested by the Director, j Nuclear Plant Operations (DNP0). ;
i 12-16 ( ks. 22)
. ~. . - - - . _ ._ _ . . , _ -- . . . . . . _ . _ . - - .--
.o .' ,
12.8.1.6 Reco-ds l Written minutes of each PRC meeting are prepared. The meeting minutes contain a listing of activities of paragraph 12.8.1.5 that PRC recommended for approval or disapproval, including reasons for recommending disapproval. Minutes are distributed as described in administrative procedures or policies.
12.8.2 NUCLEAR GENERAL REVIEW COMMITTEE (NGRC)
The Nuclear General Review Committee conducts independent reviews of plant operations and reviews the audit program to assure that audits are being accomplished in accordance with the Quality Program Description. The NGRC shall, j as a minimum, advise the Senior Vice President, Nuclear Operations on matters j related to nuclear safety. The committee is appointed by the Sanior Vice i President, Nuclear Operations. NGRC members and alternates meet the requirements '
of ANSI /ANS-3.2-1988 " Corporate Safety Review Committee (CSRC)."
12.8.2.1 Composition ;
1 The NGRC is composed of the Chairman, Vice Chairman, and at least 5 members. No l )
more than a minority of the members shall have line responsibility for operation l of the facility.
- a. nuclear power plant operations,_ ,
l b. nuclear engineering,
- c. chemistry and radiochemistry,
- d. metallurgy, l e. nondestructive testing,
- f. instrumentation and control, l
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12-17 (Rev. 22) 1 l
- g. radiological safety,
- h. mechanical and electrical engineering,
- i. administrative controls, J. environmental, and
- k. quality assurance practices.
12.8.2.2 Function The Nuclear General Review Committee shall function to provide independent review and ' audit of designated activities in the areas of nuclear plant operations, maintenance, engineering, and plant support. l 12.8.2.3 Oualifications Qualifications of the NGRC Chairman and members shall be in accordance with the qualifications specified in section 4.7 of ANS 3.1-1993, " Independent Review Personnel".
12.8.2.4 Alternates NGRC alternate members shall be appointed in writing by the NGRC Chairman. l 12.8.2.5 Consultants Consultants may be utilized as determined by the NGRC Chairman to provide expert l advice to the NGRC.
If sufficient expertise is not available from within the owner organization, independent reviews shall be supplemented by use of outside consultants or other qualified organizations.
12.8.2.6 Meetina Freauency The NGRC shall meet at least once per six months.
12.8.2.7 Ouorum i
i A quorum of NGRC shall consist of the Chairman or his designated alternate ai;d five additional NGRC members, including alternates. No more than two alternates l shall participate as voting members in NGRC activities at any one time.
l 12-18 (Rev. 22) i
l 4
12.8.2.8 Review The NGRC shall review:
- a. Randomly selected evaluations of changes to the facility, changes to l procedures and changes to tests and experiments. '
l
- b. Any unreviewed safety question created as a result of a proposed change to the facility, proposed change in procedure, or proposed test or experiment.
- c. Proposed changes to the Operating License and Appendix A to the Operating License (Technical Specifications).
- d. Corrective actions associated with selected problem reports.
- e. Any other matter involving safe operation of the plant which an NGRC l member deems appropriate for consideration, or which is referred to the reviewers by members of Nuclear Operations staff or by other functional organizational units within FPC.
l f. Safety Limit violations,
- g. Quality Program audit reports and responses to the audit findings.
12.8.2.9 Audits Audits of facility activities shall be performed under the cognizance of the NGRC. Periodic review of the audit program shall be accomplished by assigning an NGRC member to be a liaison to selected audits.
12.8.2.10 Records Records of NGRC activities shall be prepared, approved and distributed. Meeting minutes should be disseminated promptly to appropriate members of management having responsibility in the area reviewed. 1 l
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12-19 (Rev. 22)
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12-20 (Rev. 22)
e Nuclear Operations Organization ;
Senior l
e Vice i President l President .;
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)
Supply i I Senior Vice Uf,*,*,'; '
President operations Nuclear Engineering &
Operations Technical Services l
I Nuclear Manager General l Power Plant .
Review l Support Cornmittee j Services ;
I I
I e Supervisor l Material Technology Director '
l Nuclear Director Vice Director j Operations Quality President Nuclear Nuclear Engineering l, Materiale Programs ,
& Controls Production and Projects j ;
L._._- _-.. ___ j Figwe 1-26b Figwe 1-2Sa Figure 1-26d I I I l l Director *"'U
Director Director Nuclear Production Outage Nuclear '
Operations "t Plant Manager Manager Operations
- o hm. cal g Operations Training g pp, Figwe 1-26e Figure 1-20e Figwe 1-26g Figwe 1-26f l Plant Review Committee i
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Nuclear Opet .+ ions Organization Figure 1-26 (RCv. 22) l l
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Nuclear Operations Site Support i Senior Vice {
Preeident i Nuclear ,
Operations
._____----- .- n Vice President Nuclear l Production f' ;
I i I !
Director i l Nuclear !
l Operatione l l Site l Support !
?
I I l Manager Manager Manager Nuclear Safety
[
Site Radiological Nuclear Concerne Nuclear Emergency Ucensing ' Program
- Servicoe Planning Representative E
l l
l l Superintendent Manager Nuclear Nucleer Fuel Secunty Management
& Safety Analysis i
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Nuclear Operations Site Support Organization Figure 1-26a l
(Rev. 20) r , , - - - - . , ,- - + ,,-n , <v- - r-n.w , c,- -
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Iluclear Operations Materials & Controls !
Senior Vice President '
Nuclear .;
Operations I i Director [
Nuclear i Operations i Materials &' l Controle j l
l 1 1 I I l i Nuclear Manager Meneger Manager l Information Nuclear Nuclear - Nuclear ,
Systems Operations . information Operatione Administration Financial Resources . Purchasing & .
Administration - Contracting i 1
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( Manager l Nuclear !
Operatione "**"'
Material Quality l j MaMal
^**"'*"*
Control i
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I Nuclear Operations l
. Materials & Controls Organization I Figure 1-26b i (Rev. 20)
e e Quality Programs Senior Vice President Nuclear Operations i
Director l Quality Programs i
I I l Supervisor Supervisor Manager l Quality Nuclear Nuclear l Systeme Quality Quality
! Control Assessmente l
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l Quality Programs Organization Figure 1-26c (Rev. 20)
.- . . _ .=
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.- s i
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Nuclear! Engineering & Projects l
l
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Senior l Vice j President I
IJuclear Operations f
Director j
' Nuclear ,
Engineering l
& Projects !
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Supervisor Manager Manager Manager l Nuclear Manager Nuclear Nuclear Nuclear }
Engineering Nuclear Procurement Configuration Projects .
(Engineering Engineering Engineering Management Support Design Services
! Services) t
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l Nuclear Engineering & Projects Figure 1-26d (Rev. 22) i il l
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l Nuclear Plant Operations l
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{ Vice :
( President Nuclear Production .
I Director !
Nuclear Plant - l Operations i i
I ;
I I I I l Manager Manager Nuclear Manager Nuclear Nuclear Shift Nuclear Plant Chemistry & Managere Plant j Maintenance Radiation Operatione Protection l
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l Nuclear Plant Operations Organization Figure 1-26e (Rev. 22)
L
i Nuclear Operations Training i
l l
Vice President l Nuclear .
Production l l
l l Director i Nuclear l Operations -
l Training ;
l i l l l l l l Manager Manager Nuclear Nuclear Nuclear Nuclear Operations Operatione Licensed Technical Training Training Operator Training - Controle Academic Training Supervisor - Specialist L
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l Nuclear Operations ,
Training Organization j Figure 1-26f i (Rev.18) i
i i
l Nuclear Plant Technical Support l
I l Vice President f Nuclear l Production l l
l Manager j Nuclear l Plent l Technical Support l l l l l l l l l ;
Senior l l Supervisor Supervisor Nuclear Reliebility !
Nuclear 3 Site Nuclear Site Nuclear Centered Results ~ l Engineering Engineering Maintenance Engineer Services Services Superintendent i
?
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l-I Nuclear Plant i Technical Support Organization Figure 1-26g (P.::. 22)
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TABLE l-3 I i !
Florida Power Corooration Ouality Procram Commitments i l
This table presents the Regulatory Guides and ANSI Standards endorsed by FPC as 4
part of its Quality Program.
In each of the ANSI Standards, other documents (i.e., other Standards, codes,- -
1 regulations, tables, or appendices) required to be included as part of the i Standard are either referenced or described in a special section of the Standard. i The specific applicability or acceptability of these referenced Standards, codes, i regulations, tables, or appendices is either covered in other specific areas in !
the FPC Quality Program description, including this Table, or such documents are
- not considered as Quality Program requirements, although they may be used as i i guidance. Whenever a standard endorsed in Table 1-3 invokes ANSI N45.2, FPC shall interpret the statement to mean a QA Program which meets the requirements !
j of 10 CFR 50, Appendix B. ,
When Sections of Standards are referenced within a clarification, it is understood that FPC shall comply with the referenced Sections as clarified. ;
Contents l
- Reaulatory Guide ANSI Standard Paae 1.8 (9/75)* N18.1 (71) 1-115 !
1.30 (8/72) N45.2.4 (72) 1-116 ;
1.33 (2/78) N18.7 (76)/ANS3.2 1-120 i 1.37 (3/73) N45.2.1 (73) 1-126 l 1.38 (5/77) N45.2.2 (72) 1-128 l
! 1.39 (9/77) N45.2.3 (73) 1-133 1.54 (6/73) N101.4 (72) 1-136 1.58 (9/80) N45.2.6 (78) 1-137 1.64 (6/76) N45.2.11 (74) 1-139 1.74 (2/74) N45.2.10 (73) 1-142 1.88 (10/76) N45.2.9 (74) 1-145 1.94 (4/76) N45.2.5 (74) 1-148 l.116 (6/76) N45.2.8 (75) 1-151 1.123 (7/77) N45.2.13 (76) 1-155 1.144 (9/80) N45.2.12 (77) 1-158 4 1.146 (8/80) N45.2.23 (78) 1-163 4
See Regulatory Guide clarifications for specific commitments to a more recent revision.
l l
l l-114 (Rev. 9)
.~ - - - .
NRC Reaulatory Guide 1.8 -
" Personnel Selection and Training" (Revision 1, ,
9/75) - Endorses ANSI N18.1-1971.
t The Quality Program complies with the requirements of this Guide with the '
following clarification: l
- 1) The experience requirements of the Director, Qcality Programs will meet l :
that specified in Section 4.4.5 of ANSI /ANS 3.1-78 (Endorsed by Regulatory l Guide 1.8 (Proposed Revision 2, 2/79). I i
- 2) During outages, FPC often uses additional non-CR-3 employees and contract 1 personnel to augment the facility staff. These personnel may or may not l report to the Director, Nuclear Plant Operations. These groups include, i but are not limited to, supplemental HP and I&C technicians, QC inspectors as well as FPC System Maintenance Crew (SMC) personnel. When used to perform safety-related activities, these personnel shall meet the education, training and experience requirements of ANSI N18.1-1971 for ,
equivalent positions or else they shall meet the requirements for j certification as inspection, examination or testing personnel as set forth .
in FPC's commitment to ANSI N45.2.6-1978 given elsewhere in this Table. i l 3) The education, experience, and certification requirement: of/for Shift
- l Supervisor will meet that specified in Section 4.3.1.1.b and 4.3.1.1.d of l ANSI /ANS 3.1-1981, as endorsed with clarification by Regulatory Guide 1.8, l
Rev. 2, 4/87. The training requirements will be specified in approved i procedures and programs which have been INP0 accredited.
- 4) The education, experience, and certification requirements of/for Senior l Operator will meet that specified in Section 4.3.1.2.b and 4.3.1.2.d of l ANSI /ANS 3.1-1981, as endorsed with clarification by Regulatory Guide 1.8, I Rev. 2, 4/87. The training requirements will be specified in approved procedures and programs which have been INP0 accredited.
- 5) The education, experience, and certification requirements of/for Licensed Operator will meet that specified in Section 4.5.1.2.a, 4.5.1.2.b and 4.5.1.2.d of ANSI /ANS 3.1-1981, as endorsed with clarification by Regulatory Guide 1.8, Rev. 2, 4/87. The training requirements will be
, specified in approved procedures and programs which have been INPO l l accredited. !
i l 6) The qualification requirement of/for Shift Technical Advisor (STA, OTA, l S0TA) will meet that specified in Section 4.4.8 of ANSI /ANS 3.1-1981, endorsed with clarification by Regulatory Guide 1.8, Rev. 2, 4/87, except effective 10/1/85 no degree equivalency will be considered in selecting STA l candidates. I i
l 4
1-115 (Rev. 18) l
NRC Reaulatory Guide 1.8 (Contirued)
- 7) With regard to section 4 of ANSI N18.1-1971, titled Oualifications:
Selection and qualification of personnel is based on the established !
requirements r# that posit'on through FPC hiring and Nuclear Operations l policies, thr ;0y meeths the intent of ANSI N18.1 The hiring policies are governed by the FPC Human Resources Department.
I
! 8) With regard to paragraph 5.5 of ANSI N18.1-1971, titled Retrainina and Replacement Trainino: FPC's retraining and replacement training program for .
the facility staff shall be maintained under the direction of the Senior l Vice President, Nuclear Operations and shall meet or exceed the- i
- requirements and recommendations of Section 5.5 of this standard and 10 CFR i l Part 55.
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NRC Reaulatory Guide 1.30 " Quality Assurance Requirements for the Installation, Inspection and Testing of Instrumentation and Electric Equipment" (8/72) -
Endorses ANSI N45.2.4 - 1972.
The Quality Program complies with the requirements of this Guide with the following clarifications: !
- 1) For operational phase maintenance and modification activities which are comparable in nature and extent to similar activities conducted auring the :
construction phase, FPC shall either control these activities under this Quality Program or under an NRC accepted Construction QA Program. When this Quality Program is used, FPC shall comply with the requirements of the Reaulatory Position documented in this Guide in that QA programmatic / administrative requirements included therein (subject to the clarifications below) shall apply to these maintenance and modification activities even though such requirements may not have been in effect originally. Technical requirements associated with the maintenance and modifications shall be the original requirements or better (e.g., code requirements, material properties, design margins, manufacturing processes, and inspection requirements).
The Scope of this Standard (Section 1.1) and the method of identifying calibration status (third sentence in Section 2.5.2) are defined in items 2 and l 3 below based on two classes of instruments.
l
- 2) Portable items of measuring and test equipment (M&TE) and reference l standards shall be tagged or labeled indicating the date of calibration !
- and/or the due date of recalibration as well as the identity of person l l performing calibration. These items are in a calibration program which requires recalibration on a specified frequency or, in certain cases, prior to use.
- 3) Instrumentation and electrical equipment which are (1) instruments l installed as listed in the Technical Specifications, (2) installed instrumentation used to verify Technical Specification parameters, and (3) installed safety-related instruments and electrical equipment that provide an active function during operation or shutdown (i.e., vice being designated safety-related solely because the instrument is an integral part of a pressure retaining boundary) shall be in a calibration program. This program provides, by the use of status cards, computer schedules, or tags, for the date that recalibration is due and indicates the status of calibration. In addition, each applicable instrument is identified with a unique number. This number is utilized in instrument maintenance records so that current calibration status, including data such as the date of calibration and identity of the person that performed the calibration, can be readily determined.
1-116 (Rev. 15)
NRC Reaulatory Guide 1.30 (Continued)
- 4) With regard to Section 1.4 of ANSI N45.2.4 - 1971 titled Definition:
Definitions in this Standard which are not included in ANSI N45.2.10 shall be used; all definitions which are included in ANSI N45.2.10 shall be used as clarified in FPC's commitment to Regulatory Guide 1.74.
- 5) With regard to Section 2.1 of ANSI N45.2.4 - 1971 titled Plannino:
Planning requirements, when necessary, shall be incorporated into maintenance and modification procedures.
- 6) With regard to Section 2.3 of ANSI N45.2.4 - 1971 titled Procedures and Instructions: Procedures and instructions shall be implemented as set forth in Sections 1.7.1.5,10 and 11 of the Quality Program Description and by compliance with the Crystal River Unit 3 Technical Specifications and ANSI N18.7 as set forth in Table 1-3 to that Program in lieu of the requirements set forth here.
- 7) With regard to Section 2.4 of ANSI N45.2.4 - 1971 titled Results: These requirements are met by implementing Sections 1.7.1.10, 11 and 17 of the Quality Program Description and by compliance with ANSI N18.7 as set forth
! in Table 1-3 of that Program in lieu of the requirements set forth here.
- 8) With regard to Section 3 of ANSI N45.2.4 - 1971 titled Preconstruction Verification: These requirements shall be implemented as follows: (1)
They are required only for major modifications. (2) They shall be implemented with the clarification that " approved instruction manuals" shall be interpreted to mean the manuals provided by the supplier as i required by the procurement order - these manuals are not necessarily l reviewed and approved, per se, by FPC.* (3) No special checks are required !
to be made by the person withdrawing a replacement part from the warehouse l j
-equivalent controls are assured by compliance with ANSI N45.2.2 as set i forth in Table 1-3 of the Quality Program Description. (4) They shall be complied with as stated, by individual technicians as part of the maintenance / modification process.
- See FPC's commitment to ANSI N18.7 in this Table for a description of how vendor manuals may be included in procedures.
l 9) With regard to Section 4 of ANSI N45.2.4 - 1971 titled Installation: These requirements shall be implemented by inclusion, as necessary in the !
I appropriate maintenance or modification procedure, where such procedures !
I are used. Standard FPC maintenance practices require that care be exercised in the six areas listed whether a procedure is required or not. l l
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l-117 (Rev. 5) l l
NRC Reaulatory Guide 1.30 (Continued)
- 10) With regard to Section 5.1 of ANSI N45.2.4 - 1971 titled Inspections: The requirements of Section 5.1, including Subsections 5.1.1, 5.1.2 and the first sentence of 5.1.3, shall be implemented as set forth in Section 1.7.1.10 of the Quality Program Description. The inspection program shall incorporate, as applicable, those items listed in these Subsections. The remaining sentence in 5.1.3 is covered in equivalent detail in FPC's commitment to ANSI N18.7, Section 5.2.6: The requirements as set forth in that commitment shall be implemented in lieu of the requirements stated here.
- 11) With regard to Section 5.2 of ANSI N45.2.4 - 1971 titled Tests: The requirements of Section 5.2, including Subsections 5.2.1 through 5.2.3 shall be implemented as set forth in Sections 1.7.1.3 and 11 of the Quality Program Description. The test program shall consider the elements outlined in this Section, where applicable, when developing test requirements for inclusion in maintenance and modification procedures. In some cases, testing requirements may be met by post-installation surveillance testing in lieu of a special post-installation test.
i 12) With regard to Section 6 of ANSI N45.2.4 - 1971 titled Post-Construction Verification: This activity is not generally considered applicable at operating facilities because of the scope of the work and the relatively short interval between installation and operation. Where considered l applicable, the elements described in this Section shall be considered in l the development and implementation of inspection and testing programs as described in Sections 1.7.1.3, 10 and 11 of the Quality Program Description.
- 13) With regard to Section 6.2.1 of ANSI N45.2.4 - 1972 titled fouioment Tests:
l The last paragraph of this Section deals with tagging and labeling items requiring calibration within post-construction verification equipment l tests. FPC shall meet the intent of this paragraph by complying with the provisions of Clarification 3 to this standard.
- 14) With regard to Section 7 of ANSI N45.2.4 - 1971 titled Data Analysis and Evaluation: These requirements shall be implemented as stated herein after adding the clarifying phrase "Where used" at the beginning of the paragraph.
t
- 15) With regard to Section 8 of the ANSI N45.2.4 - 1972 titled Records: FPC l shall maintain records in accordance with and to meet the requirements of j Section 1.7.1.17 of the Quality Program Description and ANSI N45.2.9 as
- specified in Table 1-3.
l 1-118 (Rev. 20)
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i 1-119 (Rev. 20) l
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NRC Reaulatory Guide 1.33 " Quality Assurance Requirements (Operation)" (Rev.
2, 2/78) - Endorses ANSI N18.7 - 1976/ANS-3.2, 1988 l The Quality Program complies with the requirements of this Guide with the following clarifications:
- 1) Paragraph C.3 of Regulatory Guide 1.33 (and Section 4.3.4 of ANSI N18.7 l
which it references) regarding subjects requiring independent review shall l be implemented as described in FSAR Section 12.8 by the Nuclear General t Review Committee. ANS-3.2, 1988 Section 4.4.2 shall be implemented by meeting the requirements of ANS-3.1, 1993, Section 4.7, not ANS-3.1, 1987 i as referenced. ,
- 2) Paragraph C.4 and subsections a through c of Regulatory Guide 1.33 (and Section 4.5 of ANSI N18.7 which they reference) shall be implemented as required by FSAR Section 12.8.2 which defines the " Audit Program" to be l conducted. The audit program is further defined and shall be implemented' as required by the commitment to ANSI N45.2.12 as stated in Table 1-3. ,
- 3) Paragraph C.S.a of Regulatory Guide 1.33 (and the second paragraph of Section 4.4 of ANSI N18.7 which it references) regarding review activities of the onsite operating organization shall be implemented by meeting the i requirements of FSAR Section 12.8.1. ;
- 4) Paragraph C.S.d of Regulatory Guide 1.33 (and Section 5.2.7.1 of ANSI N18.7 !
which it references) shall be implemented by adding the clarifying phrase '
l "Where applicable" in front of the fourth sentence of the fifth paragraph. ;
j The Regulatory Guide's changing of the two uses of the word "should" in !
i this sentence to "shall" unnecessarily restricts FPC's options on repair or l l replacement parts. It is not always practicable to test parts prior to r use. For modifications where these requirements are not considered i practicable, a review in accordance with the provisions of 10 CFR 50.59 :
shall be conducted and documented.
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- 5) Paragraph C.5.e of Regulatory Guide 1.33 (and Sections 5.2.13.4 of ANSI !
N18.7 which it references) shall be implemented subject to the same '
clarifications made for ANSI N45.2.2 elsewhere in Table 1-3.
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- 6) Paragraph C.5.f of Regulatory Guide 1.33 (and Section 5.2.19(2) of ANSI N18.7 which it references) shall be implemented with the substitution of the word " practical" for the word "possible" in the last sentence.
- 7) Paragraph C.S.g of Regulatory Guide 1.33 (and Section 5.2.19.1 of ANSI N18.7 which it references) shall be implemented with the addition of the modifier "normally" after each of the verbs (should) which the Regulatory Guide converts to "shall." lit is FPC's intent to fully comply with the requirements of this paragraph, and any conditions which do not fully comply shall be documented and approved by management personnel. In these ,
cases, the reason for the exception shall also be documented. The i documentation shall be retained for the same period of time as the related
- pre-operational test.
I 1-120 ( 5;. 22) l l )
NRC Reaulatory Guide 1.33 (Continued)
- 8) With regard to Section 3.4.2 of ANSI N18.7 - 1976 titled Reauirements for the Onsite Operatina Oraanization: Training Standards referenced in this Section shall be implemented if such Standards are included in Table 1-3 of the Quality Program Description or are otherwise part of the license of Crystal River Unit 3. FPC's method of documenting and otherwise meeting the remainder of the requirements of this Section are set forth in Section i 1.7.1.2 of the Quality Program Description and in other commitments for '
Crystal River Unit 3.
- 9) With regard to Section 4.1 of ANSI N18.7 - 1976 titled General: The FPC audit program shall be implemented in accordance with and to meet the requirements of ANSI N45.2.12 as endorsed in Table 1-3; Sections 1.7.1.16 and 18 of the Quality Program Description; and FSAR Section 12.8. The .
review aspects called out in this section are accomplished by FPC using the !
Nuclear General Review Committee, the Plant Review Committee, and the '
Quality Programs Department.
- 10) With regard to Section 4.2 of ANSI N18.7 - 1976 titled Proaram
Description:
Two aspects u e addressed in this Section: audits and i independent reviews. The independent review program is implemented as ;
described in FSAR Section 12.8. The FPC audit program shall be described !
l in accordance with and to meet the requirements of ANSI N45.2.12 as i
clarified in Table 1-3 and Sections 1.7.1.16 and 18 of the Quality Program Description.
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- 11) With regard to Section 4.3 of ANSI N18.7 - 1976 titled Independent Review Process: The requirements of this Section, including all of its subparts, shall be met by compliance with FSAR Section 12.8.2.
- 12) With regard to Section 4.4 of ANSI N18.7 - 1976 titled Review Activities of the Onsite Operatina Oraanization: The requirements of this section are met by compliance with FSAR Sections 12.8 and 12.8.1.
- 13) With regard to Section 4.5 of ANSI N18.7 - 1976 titled Audit Proaram: The 1 FPC audit program shall be implemented in accordance with and to meet the i
requirements of ANSI N45.2.12 as clarified in Table 1-3 and Sections l 1.7.1.16,17, and 18 of the Quality Program Description. l
- 14) With regard to Section 5.1 of ANSI N18.7 - 1976 titled Procram
Description:
l The fourth sentence in this Section required a " summary document"; FPC's Quality Program Description (Chapter 1.7 of the FSAR) is organized in ;
accordance with the 18 criteria of 10 CFR 50, Appendix B. FPC interprets I l
this FSAR description to fulfill the requirements for a " summary document." !
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1-121 (P= . 22) b
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NRC Reaulatory Guide 1.33 (Continued)-
- 15) With regard to Section' 5.2.2 ' of ANSI .N18.7 - 1976 titled Procedure Adherence: Temporary changes to procedures recommended in Regulatory Guide 1.33, Appendix A and others specified in Clarification 29, below, may- be made provided:.
- a. The intent of the existing proce' dure is not altered;.and [
- b. The change is approved by twa members of the plant management staff, at least one of whom holds a Senior Reactor Operator license;~ and
- c. The change is documented and subsequently reviewed and approved in accordance with Administrative procedures or policies.
- 16) With regard to Section 5.2.6 of ANSI N18.7 - 1976 titled Eauioment Control:
FPC shall comply with the " independent verification" requirements based on q the definition of this phrase as given under our commitment to . Regulatory Guide 1.74. l The . third sentence of the fourth' paragraph ~ requires- independent' verification "when appropriate." In the event of significant radiation :
levels is~ an area requiring independent verification, the' FPC . ALARA '
' Specialist makes recommendations regarding . access. However, the final i decision regarding access for independent verification will be made by ;
Operations. !
i Since FPC sometimes uses descriptive names to designate equipment, the i sixth paragraph, second sentence is replaced with: " Suitable means include j identification number or other descriptions which are traceable to records i' of the status of inspections and tests."
The first sentence in the seventh paragraph shall be complied with after 3 clarifying " operating personnel" to mean trained employees assigned to or l under the control of FPC management at Crystal River Unit 3. i
- 17) With regard to Section 5.2.7 of ANSI N18.7 - 1976 titled Maintenance and Modification: For other modifications, we are committed to the inspection requirements of Section 5.2.17 of ANSI N18.7 - 1976.
! Further with regard to Section 5.2.7 of ANSI N18.7 - 1976 titled Maintenance and Modification: Since some emergency situations could arise which might preclude preplanning of all activities, FPC shall comply with
! the following alternate to the first sentence in the second paragraph:
"Except in emergency or abnormal operating situations where immediate actions are required to protect the health and safety of the public, to protect' equipment or personnel, or to prevent the deterioration of plant conditions to a possibly unsafe or unstable level , maintenance or modification of equipment shall be preplanned and performed in accordance-with approved written procedures. _Where approved written procedures would be required and are not used, the activities that were accomplished shall L be documented after-the-fact and receive the same degree of review as if they had been preplanned.*
1-122 (hv. 22)
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.', j NRC Reaulatory Guide 1.33 (Continued)
- 18) With regard to .Section 5.2.7.1 of ANSI N18.7 - 1976 titled Maintenance l 1 Proarams: FPC shall comply with the requirements of the first sentence of I the fifth paragraph, where practical. This clarification is needed since it is not always possible to promptly determine cause of the malfunction.
In all cases, FPC shall initiate proceedings to determine the cause, and l
1 sha? make such determinations promptly, where practical.
- 19) With regard to Section 5.2.8 of ANSI 18.7 - 1976 titled Surveillance l Testina and Inspection Schedule: In lieu of a " master surveillance l schedule," the following requirement shall be complied with: "A l
surveillance testing schedule (s) shall be established reflecting the status of all in-plant surveillance tests and inspections."
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- 20) With regard to Section 5.2.9 of ANSI N18.7 - titled Plant Security andl Visitor Control: The requirements of the Crystal River Unit 3 Security Plan shall be implemented in lieu of these generd requirements.
l 21) With regard to Section 5.2.10 of ANSI N18.7 - 1976 titledHousekeepinaandl i Cleanliness Control: The requirements of this Section, beginning with the last sentence of the first paragraph and continuing through the end of the Section, shall be implemented as described in FPC's commitments to ANSI 1 i
N45.2.3 and N45.2.1 as set forth in Table 1-3 of the Quality Program l l
Description.
- 22) With regard to Section 5.2.13.1 of ANSI N18.7 - 1976 titled Procurement l Document Control: The words "the same" in the last sentence are replaced with the words "an equivalent."
- 23) With regard to Section 5,2.17 of ANSI N18.7 - 1976 titled Inspection: With l respect to the fourth paragraph, not all inspections may require generation l of a separate inspection procedure. Inspection requirements may be integrated into appropriate procedures or other documents with the procedure or document serving as the record. However, records of l inspections shall be identifiable and retrievable. I l
- 24) With regard to Section 5.2.19 of ANSI N18.7 - 1976 titled Test Control: l Item (1) of this Section is not considered applicable since the FPC Quality Program Description does not cover pre-operational testing.
l 25) With regard to Section 5.3.5(4) of ANSI N18.7 - 1976 titled Supportina Maintenance Documents: FPC may choose to include material from vendor manuals in any of three ways: (1) The applicable section of the manual may be duplicated, referenced in and attached to the procedure. (2) The procedure may simply state that the manual or a specific section is to be followed for performing a particular function; the manual must then be used )
i in conjunction with the procedure for performing the activity. (3) The pertinent material from the manual, either as originally written or as modified by the author / reviewers of the procedure, may be written into and become a part of the procedure. '
l-123 (Rev. 20) l i- _ _ _ _
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t NRC Reaulatory Guide 1.331 Continued)
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!' . In options (1) and (3) above, the material meets the' requirement to receive "the same level of review and approval as operating procedures" since the material' is reviewed as part'of the procedure review process. In option (2), the requirements shall be deemed to have been fulfilled by requiring
! a copy of the pertinent manual (manual sections)c to _be available to'and:
l considered by persons conducting the review of the procedure.
.Several procedures exist which establish the responsibilities for technical
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evaluation, distribution and -retention of vendor . manuals and. updates to vendor manuals.
l The existing practice is based on pertinent' vendor data being sent to the Nuclear Engineering Department either from 'the" ' vendor. or by
! inter-department transmittal. Nuclear Engineering reviews this information-j for technical content and applicability to CR-3. The relevant. information I
is then transmitted to Nuclear Document Control ' Nuclear Document Control controls'and distributes vendor manuals per administrative procedures.
The current practice is to use controlled vendor" manuals at the' job site or work area. (as a reference only) to reinforce the~ above options;. and to perform the work on . safety-related equipment. in : accordance : with the approved plant procedures and/or work instructions.
- 26) With regard to Section 5.3.9 of ANSI N18.7 - 1976 . titled Emeraency . l Procedures: As . directed by the ' NRC, FPC has developed : a ' format for-emergency procedures which is " symptom" based as opposed to " event" based as. stipulated in Section 5.3.9.1..
- 27) With regard to Section 5.3.9.2 of ANSI N18.7. - 1976-- titled Events 'of l l Potential Emeraency: NRC review of the FSAR. hasiidentified all natural L occurrences . which affect . Crystal River Unit 3. Therefore, 'FPC shall L interpret item (11) to mean the natural occurrences which have ?been evaluated in the FSAR for Crystal River Unit 3.
- 28) -With regard to Section 5.3.9.3 of ANSI N18.7 - 1976 titled Procedures for--
Imolementina Emeraency Plan: FPC's NRC. accepted Emergency Plan for Crystal River Unit 3 shall be implemented in lieu of the requirements :in this l Section.
- 29) Paragraph C.1 and Appendix A of Regulatory Guide 1.33 shall be implemented as required by the Crystal River Unit 3 Technical Specification 5.6.1.1.a,
" Procedures." In addition, FPC shall establish, implement, and maintain written procedures covering the activities referenced below:
- a. Refueling Operations
- b. Surveillance and test activities of safety related equipment l
- c. Process Control Program implementation 1-124 (Rev. 20) l l: - - . . , - . . , . . - .-.
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l NRC Reaulatory Guide 1.33 (Continued)
- 30) With regard to Section 3.4.2 of ANSI N18.7-1976 titled Reouirements for the Onsite Operatina Oraanhptions: Some of FPC's technical support ,
i organizations are physically !ccated at the CR-3 site. Therefore, the
! second sentence of this section shall be implemented as follows: " Initial
! incumbents or replacements fer members of the onsite operating organization l and onsite or offsite technical support organizations shall have l appropriato experience, training, and retraining to assure that necessary competence is maintained in accordance with the provisions of American l National Standard for Selection and Training of Nuclear Power Plant l Personnel, N18.1-1971."
For purposes of implementing Section 3.4.2 as clarified above, FPC also defines the FPC Relay Department Technicians who may perform safety-related l activities at CR-3 to be members of an offsite technical support l
organization.
l l 31) With regard to Section 5.2.19.1 of ANSI N18.7-1976 titled Pre-operational l Tests: This section will only apply in the event of major modification l activities which are similar in nature and extent to those activities that l occurred during initial construction of CR-3.
- 32) With regard to Section 5.2.19.2 of ANSI N18.7-1976 titled Tests Prior To And Durina Initial Plant Operation: This period of operation has already l passed and therefore this section is not applicable.
- 33) With regard to Section 2.2 of ANSI N18.7-1976 titled Glossary of Terms:
Definitions in this Standard which are not included in ANSI N45.2.10 shall-be used. All definitions which are included in ANSI N45.2.10 shall be used as clarified in FPC's commitment to Regulatory Guide 1.74. The term "onsite operating organization," defined in general terms in this Standard, shall be synonymous with "Facili' > Staff" which is defined in FPC's commitment to Regulatory Guide 1.74.
- 34) With regard to Section 5.2.15 of ANSI N18.7-1976 titled Review. Acoroval and Control of Procedures: FPC provides the following alternative guidance:
Each procedure described in FPC's commitment to Regulatory Guide 1.33 as clarified above, and changes thereto, shall be reviewed and approved. The review cycle shall consist of an intra-departmental review by a Qualified reviewer, and an interdisciplinary review by Qualified Reviewer (s) in interfacing departments, and approval by the responsible Interpretation Contact for the procedure as specified in administrative procedures.
1-125 (Rev. 22)
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j jfR.C Reaulatory Guide 1.33 (Continued)
The training and quali_fication of_ Qualified Reviewers shall be governed by i
, administrative procedures. Recertification will be' required on a periodic-basis.- As a minimum,- Qualified Reviewers shall meet the requirements of i ANSI N18.1 1971, Sections 4.2, 4.3, 4.4, or .4.6, or the equivalent.
- t l 'Non-routine procedures 'such. as Emergency Procedures. (EP), Abnormal;l ,
! Procedures (AP),.and Verification Procedures (VP) shall be reviewed no less l
- j. frequently than every two years to determine if changes are necessary.
- - Other procedures and programs (e.g., Process. Control- Program) shall be -
Revisions will generally .be. initiated through revised as necessary. .
reviews conducted by personnel during routine performance _of activities. !
evaluations of problems encountered during performance of- a procedure;- -)
evaluation of , corrective actions for self-identified deficiencies or. ,
events; evaluation of events occurring at other ' plants; evaluation of- i
- procedure changes necessary to implement modifications; . evaluation of ~'
i- procedure changes necessary to implement License, _ Technical Specification,
! or. FSAR revisions; as well as evaluations;of changes necessary to. resolve j Regulatory : Issues. Such ; changes Jshall be implemented as necessary. 'In some situations such implementation will. be completed prior to completion .
] of the in-process activity. Guidance on the need to revise procedures
, shall be provided in-plant administrative controls."
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j 1-125b (Rev. 18) i l
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NRC Reaulatorv Guide 1.37 " Quality Assurance Requirements for Cleaning of Fluid i Systems and Associated Components of Water-Cooled Nuclear Power Plants" (3/73)
- Endorses ANSI N45.2.1 - 1973.
The Quality Prograra Description complies with the requirements of this Guide with the following clarifications:
Throughout this Standard, references are made to cleanness associated with initial installation. For operations activities, qualified maintenance department personnel shall determine what items within a particular cleanness '
level are appropriate. As an example, the Reactor Internals are initially classified as Level B. Section 3.1.2 requires this cleanness level to have
" metal clean" surfaces and either a visual inspection or a dry white-cloth wipe.
After use in the Reactor Coolant System, FPC does not intend to clean components removed for maintenance or inspection until they have a bright " metal clean" surface, nor do we necessarily commit to performance of a dry white-cloth wipe.
The chemistry within the system is designed to obtain a tightly adhering metal oxide film (which reduces the luster of metal) and ALARA considerations may ,
preclude a dry white-cloth wipe.
Components which have been removed from a system shall be considered as being the l same cleanness level as the system from which they were removed. Such components need not be recleaned to meet initial installation cleanness levels prior to reinstallation. However, FPC shall assure that measures are taken to prevent degradation of the previously established or existing cleanness state of the system.
- 1) For operational phase maintenance and modification activities which are comparable in nature and extent to similar activities conducted during the construction phase, FPC shall either control these activities under this Quality Program Description or under an NRC accepted Construction QA Program. When this Quality Program Description is used, FPC shall comply .
with the requirements of the Reaulatory Position documented in this Guide in that QA programmatic / administrative requirements included therein (subject to the clarifications below) shall apply to these maintenance and modification activities even though such requirements may not have been in '
effect originally. Technical requirements associated with the maintenance and modifications shall be the original requirements or better (e.g., code l requirements, material properties, design margins, manufacturing processes, and inspection requirements).
- 2) This Guide and Standard are applicable to those areas of the Quality Assurance Program addressing on-site cleaning of materials and components, cleanliness control, and cleaning and layup of fluid systems during the i l operational phase. They do not cover off-site activities unless invoked in l l l procurement documents.
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l l-126 (Rev. 5)
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i NRC Reaulatory Guide 1.37 (Continued)
- 3) With regard to Paragraph C.3 of Regulatory Guide 1.37: The water quality !
for final flushing of fluid systems and associated components shall be at least equivalent to the quality of the operating system water for the oxygen and nitrogen content; but this does not infer that chromates or i other additives, normally in the system water, will be added to the flush water.
- 4) With regard to Paragraph C.4 of Regulatory Guide 1.37: Expendable materials, such as inks and related products; temperature indicating ,
sticks; tapes; gummed labels; wrapping materials (other than polyethylene); !
water soluble dam materials; lubricants; NDT penetrant materials, :
couplants, and desiccants, which contact stainless steel or nickel alloy l )
surfaces shall not contain lead, zinc, copper, mercury, cadmium and other low melting point metals, their. alloys or compounds as basic and essential chemical constituents. No more than 0.1 percent (1,000 ppm) halogens shall be allowed where such elements are leachable or where they could be i released by breakdown of the compounds under expected environmental '
conditions.
- 5) With regard to Section 1.4 of ANSI N45.2.1 - 1973 titled Definitions: ;
Definitions in this Standard which are not included in ANSI N45.2.10 shall '
be used; all definitions which are included in ANSI N45.1.10 shall be used !
as clarified in FPC's commitment to Regulatory Guide 1.74. '
- 6) With regard to Section 5 of ANSI N45.2.1 -
1973 titled Installation Cleanina: The recommendation that local rusting on corrosion resistant alloys be removed by mechanical methods is interpreted to mean that Iccal rusting may be removed mechanically, but the use of other removal means is not precluded.
- 7) With regard to Section 9 of ANSI N45.2.1 - 1973 titled Records: FPC shall l maintain records in accordance with and to meet the requirements of Section 1.7.1.17 of the Quality Program Description and ANSI N45.2.9 as specified l i in Table 1-3.
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1-127 (Rev. 5)
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l NRC Reaulatory Guide 1.38 " Quality Assurance Requirements for Packaging, j Shipping, Receiving, Storage, and Handling of Items for Water-Cooled Nuclear Power Plants" (Rev. 2, 5/77) Endorses ANSI N45.2.2 - 1972.
The Quality Program complies with the requirements of this cuide with the following clarifications:
- 1) With regard to Section 1.4 of ANSI N45.2.2 - 1972 titled Definitions:
Definitions in this Standard which are not included in ANSI N45.2.10 shall i be used; all definitions which are included in ANSI N45.2.10 shall be used l as clarified in FPC's commitment to Regulatory Guide 1.74.
- 2) With regard to Section 2.1 of ANSI N45.2.2 - 1972 titled Plannina: (First sentence) The specific items to be governed by the Standard shall be identified on the " Safety Listing". However, the Standard (as modified by clarifications in Table 1-3) is part of FPC's Quality Program Description and it shall therefore, be applied to those structures, systems, and components which are included in that Program.
- 3) With regard to Section 2.3 of ANSI N45.2.2 - 1972 titled Results: The specific methods for performing and documenting tests and inspections are given in Sections 1.7.1.10 and 11 of the Quality Program Description.
These requirements in these Sections shall be implemented in lieu of the general requirements here.
- 4) With regard to Section 2.4 of N45.2.2 -
1972 titled Personnel Oualifications: Specific requirements for personnel qualifications and training are set forth in Section 1.7.1.2 and in the commitments to l training standards in Table 1-3 of the Quality Program Description. These i requirements shall be implemented in lieu of the general requirements stated in this Section.
- 5) With regard to Section 2.7 of ANSI N45.2.2 - 1972 titled Classification of i
' Items: FPC may choose not to explicitly use the_ four level classification system. However, the specific requirements of the Standard that are appropriate to each class are generally applied to the items suggested in each classification and to similar items.
- 6) With regard to Section 3.2.1 of ANSI N45.2.2 - 1972 titled Level A Items:
As an alternate to the requirements for packaging and containerizing items in storage to control contaminants [ items (4) and (5)], FPC may choose a storage atmosphere which is free of harmful contaminants in concentrations i that could produce damage to stored items. Similarly [for item (7)], FPC may obviate the need for caps and plugs with an appropriate storage atmosphere, and may choose to protect weld-end preparations and threads by controlling the manner in which the items are stored. These clarifications apply whenever items (4), (5) or (7) are subsequently referenced and to l Section 3.5.1 titled Caos and Pluas and Section 3.4 titled Methods of i Preservation.
4 1-128 (Rev. 20)
i h egard o Se tio 3.2.2. of ANSI N45.2.2 - 1972 titled Level B Items:
As an alternate to the requirements for packaging of Level B items in containers or crates, particularly large items that may not be suitable for shipment in a fully enclosed van, (reference item (5) of Section 3.2.1), l FPC may choose to use an alternate means of packaging to ensure the item is j adequately protected during shipment. l
- 8) With regard to Section 3.3 of ANSI N45.2.2 - 1972 titled Cleanino: (Third l sentence) FPC interprets " documented cleaning methods" to allow generic cleaning procedures to be written which are implemented, as necessary, by i trained personnel. Each particular cleaning operation may not have an i individual cleaning procedure, or which type (s) or solvent (s) may be used i in a particular application. '
- 9) With regard to Section 3.4 of ANSI N45.2.2 - 1972 titled Methods of l Preservation: (First sentence) FPC shall comply with these requirements subject to the clarifications of Section 3.2.1 (4) and (5) above, and the definition of the phrase " deleterious corrosion" to mean that corrosion !
which cannot be subsequently removed and which adversely affects form, fit, 1 or function.
- 10) With regard to Section 3.6 of ANSI N45.2.2 - 1972 titled Barrier and Wrao l tLaterial and Desiccants: This section requires the use of nonhalogenated materials in contact with austenitic stainless steel. Refer to Regulatory Guide 1.37 for the FPC position.
- 11) With regard to Section 3.7.1 of ANSI N45.2.2 - 1972 titled Containers: l Cleated, sheathed boxes may be used up to 1000 lbs. rather than 500 lbs. as specified in 3.7.l(1). This type of box is safe for, and has been tested for, loads up to 1000 lbs. Other national standards allow this (see Federal Specification PPP-B-601). Special qualification testing may be required for loads above 1000 lbs.
1
- 12) With regard to Section 3.7.2 of ANSI N45.2.2 - 1972 titled Crates and l Skids: Crates and/or Skids shall normally be used for equipment in excess ,
of 500 lbs. Skids and runners shall normally be used on boxes with a gross l weight of 100 lbs. or more. Skids and runners are normally fabricated from four inch nominal lumber size and laid flat except where this is impractical because of the small dimensions of the container. If forklift handling is required, minimum floor clearance for forklift tines shall be provided.
- 13) With regard to Section 4.2.2 of ANSI N42.2.2 - 1972 titled Closed Carriers: l The use of fully enclosed furniture vans, as recommended in (2) of this Section, is not considered a requirement. FPC assures adequate protection from weather or other environmental conditions by a combination of vehicle enclosures and item packaging.
1-129 (Rev. 2.1)
l j NRC Reaulatory Guide 1.38 (Continued) l
- 14) With regard to Sections 4.3, 4.4 and 4.5 of ANSI N45.2.2 - 1972 titled, respectively, Precautions- Durino loadina and Transit, Identification and Markina, and Shioment from Countries Outside the United States: FPC shall l comply with the requirements of these Sections subject to the clarifications taken to other Sections which are referenced therein.
l l 15) With regard to Section 5.2.1 of ANSI N45.2.2 - 1972 titled Shiocina Damaae l l Inspection: Warehouse personnel normally visually scrutinize incoming l shipments for damage of the types listed in this Section; this activity is l not necessarily performed prior to unloading. Since all required items receive the Item Inspection of Section 5.2.2, separate documentation of the Shipping Damage Inspection is not necessary. Release of the transport agent after unloading and the signing for receipt of the shipment may be all of the action taken to document completion of the Shipping Damage Inspection. Any nonconformance noted shall be documented and dispositioned as required by Section 1.7.1.15 of the Quality Program Description. The person performing the visual scrutiny during unloading is not considered to be performing an inspection function as defined under Regulatory Guides 1.58 and 1.74; therefore, while he shall be trained to perform this function, he may not necessarily be certified (N45.2.6) as an Inspector.
- 16) With regard to Section 5.2.2 of ANSI N45.2.2 - 1972 titled Item Inspection: l
! The second division of this subsection requires six additional inspection
! activities if an item was not inspected or examined at the source. Nuclear j Engineering and Quality Programs Department shall determine and document the extent of receipt inspection based on consideration of Section 5.2.2.
- 17) With regard to Section 6.1.2 of ANSI N45.2.2 - 1972 titled Levels of l i Storaae: Subpart (2) is replaced with the following: i (2) Level B items shall be stored within a fire resistant, weathertight, and well ventilated building or equivalent enclosure. This building shall be situated and constructed so that it shall not normally be subject to flooding; the floor shall be paved or equal, and well drained. If any outside waters should come in contact with stored equipment, such equipment l shall be labeled or tagged nonconforming, and then the nonconformance document shall be processed and evaluated in accordance with Section 1.7.1.15. Items shall be placed on pallet for shoring or shelves to permit air circulation. The building shall be provided with heating and I temperature control or its equivalent to reduce condensation or corrosion. !
l Minimum temperature shall be 40'F and maximum temperature shall be 140*F or j less if so stipulated by a manufacturer. i
- 18) With regard to Section 6.2.1 of ANSI N45.2.2 - 1972 titled Access to l l
Storaae Areas: Items which fall within the Level D classification of the Standard may be stored in an area which is posted to limit access, but other controls such as fencing or guards are not considered to be required.
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- 19) With regard to Section 6.2.4 of ANSI N45.2.2 - 1972 titled Storaae of Food and Associated Items: This Section is replaced with 'ae following: "The use of food, drinks, and salt tablet dispensers in any storage area shall be controlled and shall be limited to designated areas where use or storage is not deleterious to stored items."
- 20) With regard to Section 6.2.5 of ANSI N45.2.2 - 1972 titled Measures to l Prevent Entrance of Animals: This Section is replaced with the following:
" Warehouse personnel shall be alert to detect evidence of rodents or small animals in indoor storage areas. If any evidence is detected, a survey or inspection shall be utilized to determine the extent of any possible damage or contamination. Exterminators, traps, poisons or other appropriate measures shall be used to control these animals to minimize possible '
undesirable effects on stored materials." i
- 21) With regard to Section 6.3.3 of ANSI N45.2.2. - 1972 titled Storaae of l j Hazardous Material: This Section is replaced with the following: (
" Hazardous chemicals, paints, solvents and similar materials shall be !
stored in approved cabinets which are not in close proximity to installed i plant systems which are required for safe shutdown or long term cooling of the plant."
- 22) Nith regard to Section 6.4.2 of ANSI N45.2 - 1972 titled Care of Items: l l Ine following alternates are provided for indicated subparts:
(5) " Space heaters in electrical equipment shall be energized unless a documented engineering evaluation determines that such space heaters are not required."
1 (6) "Large (greater than or equal to 50HP) rotating electrical equipment i shall be given insulation resistance tests on a scheduled basis unless a documented engineering evaluation determines that such tests are not i required." ;
(7) " Prior to being placed in storage, rotating equipment weighing over approximately 50 pounds shall be evaluated by engineering personnel to determine if shaft rotation in storage is required: The results of the evaluation shall be documented. If rotation is required, it shall be performed at specified intervals, be documented, and be conducted so that parts receive a coating of lubrication where applicable and so that the shaft does not come to rest in the same position occupied prior to rotation. For lcng shafts or heavy equipment subject to l undesirable bowing, shaft orientation after rotation shall be i specified and obtained." l 1
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- 23) With regard to Section 6.5 of ANSI N45.2.2 - 1972 titled Removal of Items !
From Storace: FPC does not consider the last sentence of this Section to normally apply to the operational phase due to the relatively short period 3 of time between installation and use. The first sentence of the Section is replaced with: "FPC shall develop, issue, and implement a procedure (s) which covers the removal of items from storage. The procedure (s) assures !
that the status of all material issued is know, controlled, and the !
appropriately dispositioned." l However, when the period of time between installation and use of ;
modifications is not short, then FPC must define the controls which are to l be implemented to assure that the quality of installed items is not I degreided prior to use. !
- 24) With regard to Section 6.6 of ANSI N45.2.2 - 1972 titled Storaae Records: l l FPC shall comply with the requirements of this Section with the :
clarification that, for record purposes, only the access of non-FPC 1 personnel into indoor storage areas shall be recorded. Unloading or pick-up of material shall not be considered access, nor shall inspection by ,
NRC or other regulatory agents, nor shall tours by non-FPC employees who I are accompanied by FPC employees.
- 25) With respect to Section 6.5 of ANSI N45.2.2 - 1972 titled Removal of Items l i from Storace: In addition to the clarification as stated in 22) above, FPC i defines in-process controls applied to material after removal of items from '
warehouse storage and prior to installation or use in the plant as follows: .
t a) During the period between issuance and installation, measures shall be taken to assure protection at least equivalent to that which exists at ;
the intended installation location. I b) Based upon the short in-process duration and on final acceptance I following inspection and testing, rotation of equipment, meggering, energizing of space heaters, periodic inspections, access controls, and similar items primarily associated with warehouse storage are not required during the in-process period.
Consistent with overall CR-3 planning objectives, safety-related material needed for maintenance and modifications should be staged (i.e. collected together as a discrete package) by warehouse personnel if practical. Such material should be maintained in the warehouse and under warehouse controls until needed for installation.
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i l NRC Reaulatory Guide 1.39 " Housekeeping Requirements for Water-Cooled Nuclear Power Plants" (Rev. 2, 9/77) - Endorses ANSI N45.2.3 - 1973 The Quality Program complies with the requirements of this Guide with the following clarifications:
- 1) For operational phase maintenance and modification activities which are comparable in nature and extent to similar activities conducted during the construction phase, FPC shall either control these activities under the Quality Program Description or under an NRC accepted Construction QA Program. When the Quality Program Description is used, FPC shall comply with the requirements of the fleaulatory Position documented in this Guide in that QA programmatic / administrative requirements included therein (subject to the clarifications below) shall apply to these maintenance and modification activities even though such requirements may not have been in effect originally. Technical requirements associated with the maintenance and modifications shall be the original requirements or better (e.g., code requirements, material properties, design margins, manufacturing processes, and in::pection requirements).
- 2) With regard to Section 1.4 of ANSI N45.2.3 - 1973 titled Definitions:
Definitions in this Standard which are not included in ANSI N45.2.10 shall be used. All definitions which are included in ANSI N45.2.10 shall be used as clarified in FPC's commitment to Regulatory Guide 1.74.
I 3) With regard to Section 2.1 of ANSI N45.2.3 - 1971 titled Plannina: FPC may i choose not to utilize the five-level zone designation system, but shall utilize standard janitorial and work practices to maintain a level of cleanliness commensurate with company policy in the areas of housekeeping, plant and personnel safety, and fire protection.
Cleanliness shall be maintained, consistent with the work being performed, so as to prevent the entry of foreign material into safety-related systems.
This shall include, as a minimum, documented cleanliness inspections which shall be performed prior to system closure. As necessary, (e.g., the opening is larger than the tools being used) control of personnel, tools, equipment, and supplies shall be established when major portions of the reactor system are opened for inspection, maintenance or repair.
Additional housekeeping requirements shall be implemented as required for control of radioactive contamination.
- 4) With regard to Section 2.2 of ANSI N45.2.3 - 1973 titled Procedures and Instructions: Procedures and instructions shall be implemented as set forth in Sections 1.7.1.5,10 and 11 of the Quality Program Description and by compliance with the Crystal River Unit 3 Technical Specifications and ANSI N18.7 as set forth in Table 1-3 of that Program in lieu of the requirements set forth here.
1-133 (Rev. 20)
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l l NRC Reaulatory Guide 1.39 (Continued) i
- 5) With regard to Section 3.1 of ANSI N45.2.3 ' 1973 titled Control of Site l Area: Not applicable tc the operational phase. ;
l 6) With regard to Section 3.2 of ANSI N45.2.3 - 1973 titled Control of Facilities including subsections 3.2.1 and 3.2.2: FPC may choose not to utilize the five-level zone designation system, but shall utilize standard '
janitorial and work practices to maintain a level of cleanliness commensurate with company policy in the areas of housekeeping, plant and personnel safety, and fire protection.
Cleanliness shall be maintained, consistent with the work being performed, i so as to prevent the entry of foreign material into safety-related systems.
This shall include, as a minimum, documented cleanliness inspections which shall be performed prior to system closure. As necessary, (e.g., the opening is larger than the tools being used) control of personnel, tools, equipment, and supplies shall be established when major portions of the i reactor system are opened for inspection, maintenance or repair.
Additional housekeeping requirements shall be implemented as required for l control of radioactive contamination.
l 7) With regard to Section 3.3 of ANSI N45.2.3 - 1973 titled Materials and Eauipment: The first paragraph in this Section is not applicable to the operational phase. Most of the items in this Section were written for construction activities. Maintenance and modification activities which are similar in nature and extent to construction activities shall be handled as set forth in Item 1 above.
- 8) With regard to Section 3.4 of ANSI N45.2.3 - 1973 titled Construction Tools. Supplies, and Eauipment: Most of the items in this Section were written for construction activities. Maintenance and modification l activities which are similar in nature and extent to construction activities shall be handled as set forth in Item 1 above. The portions of !
this Section which are considered applicable by responsible maintenance i
supervisory personnel shall be complied with as stated. Quality Programs .
Department personnel verify that appropriate controls are used through procedure reviews, audits and surveillance activities.
, 9) With regard to Section 3.5 of ANSI N45.2.3 - 1973 titled Surveillance.
I Inspection, and Examination: Subparagraph (1) is not applicable to the l
operational phase; (2), (3), and (4) shall be implemented.
- 10) With regard to Section 4 of ANSI N45.2.3 - 1973 titled Records: FPC shall maintain records in accordance with and to meet the requirements of Section 1.7.1.17 of the Quality Program Description and ANSI N45.2.9 as specified in Table 1-3.
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NRC Reaulatory Guide 1.39 (Continued) l
- 11) With regard to Section 2.3 of ANSI N45.23-1973 titled - Results: These requirements are met by implementing sections 1.7.1.10, 1.7.1.11 and 1.7.1.17 of the Quality Program Description and by compliance with ANSI N18.7 as set forth in Table 1-3 of that program in lieu of the requirements set forth here.
- 12) With regard to Section 2.4 of ANSI N45.2.3-1973 titled Personnel Qualifications: FPC will substitute the following paragraph for this section of the standard, "All personnel working in areas with special housekeeping controls shall be familiar with the necessities and requirements for cleanness control applicable to those areas. Training programs shall be utilized for this purpose where appropriate."
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1 NRC Reaulatory Guide 1.54 -
" Quality Assurance Requirements for Protective Coatings Applied to Water-Cooled Nuclear Power Plants" (Rev.- 0, 6/73) - Endorses ANSI N101.4-1972.
l The Quality Program meets the general intent of this guide. The program 1 concerning protective coatings is further delineated in the project specification i for Painting & Protective Coatings, R0-3147, and all appropriate plant !
procedures. '
ANSI N101.4-1972 was written to address the protective coating requirements for ,
the construction phase of nuclear power plants. It does not adequately address j the more frequently required small amount of painting that is necessary during !
the operational phase of a plant's life. '
R0-3147 meets the requirements of ANSI N101.4-1972 with the following clarifications.
- 1. REQUIREMENT: Section 1.2.2.1 " Class I Service Level applies to those systems and components of nuclear facilities. . .".
CLARIFICATION: FPC considers " Class I Service Level" to be those systems and components which may be exposed to a LOCA atmosphere l where failure of the protective coating could have a detrimental effect on plant safety. This applies to items in, or to be installed inside portions of the primary containment building. The portions of the primary containment where Class I service is necessary were identified in the " Evaluation Analysis of Potential Coatings Failures" (FSAR Section 1.11, Reference 2). This evaluation i established "near field" and "far field" locations within the containment where failure of the coatings could result i l in reactor building sump blockage and possibly affect sump operability post LOCA. The "near field" location is an area where failed protective coatings could fall directly into ,
the sump. "Far field" locations are areas where fluid I l velocities during LOCA recovery are adequate to transport l failed protective coatings to the sump and possibly result in sump blockage. R0-3147, Section 3:02 details the requirements for these items and is consistent with ANSI N101.2-1972.
- 2. REQUIREMENT: Section 2.3.3.4 "The coating manufacturer shall furnish application procedures . . . specification. This shall include the maximum and minimum ambient conditions at which application can be properly made."
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CLARIFICATION: The paint manufacturer for CR-3 has submitted technical !
bulletins which contain recommendations regarding 3 application of this manufacturer's coatings. These j recommendations have been factored into . the maintenance procedure for application of protective coatings inside the reactor building and will be attached to the procedure for reference. If a turnkey painting project is required, i R0-3147, Section 5:03.6 requires the contractor to submit for- FPC approval all fabrication, special processes, inspection, and test procedures for work to be performed !
on-site. R0-3147,' Section 3:02.2 also outlines precautions !
to be taken, such as not painting metal on concrete surfaces ;
when the surface temperature is below 50'F; and primer and i finish coatings shall not . be applied when the surface temperature of the item to be coated is within 5'F of wet bulb temperature.
- 3. REQUIREMENT: Section 2.5.2 "Before the start of the coating work in the ,
shop /or in the field, there shall be a shop meeting. . . . j CLARIFICATION: Approved plant procedures at Crystal River Unit 3 require pre-planning for all work requests, and personnel briefings are conducted before the start of all work. This i pre-planning activities and briefings cover such items as personnel safety, radiological exposure, and work practices for job involved. This approach to a task meets the intent of this section's requitement for a shop meeting. ,
- 4. REQUIREMENT: Section 3.4 "Each container shall be labeled with . . .
the date of manufacturer." l CLARIFICATION: R0-3147, Section 3:02.1 requires the paint manufacturer to ;
label the container with the batch number. Additional !
information for the batch such as the date of manufacturer ;
is available on-site in the certification provided by the manufacturer. i i
- 5. REQUIREMENT: Section 3.6.1 -
"The owner may require in the project i specification that a DBA exposure test . . . be performed on l specimens of each coating. . . .". j i !
! CLARIFICATION: Test data for the coatings and surface preparations used '
during construction are retained by the coating manufacturer I and may be obtained at any time. DBA test data for coatings and surface preparations used for maintenance coating work are maintained by FPC. The project specification states the '
coating systems that have been successfully DBA tested to requirements that. are equal to or greater than CR3 requirements may be used at CR-3.
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- 6. REQUIREMENT: Section 4.2.3 "The project specification shall include inspection methods to . . . temperature of substrates."
CLARIFICATION: R0-3147, Section 3:02.6 requires that inspections be performed by qualified personnel throughout the painting program. Inspection methods are provided.in the approved l plant procedures rather than the project specification. .
- 7. REQUIREMENT: Section 4.4 -
Removal of Contaminants. To avoid contamination of substrates, the project specification shall
. . . curing compounds." ,
CLARIFICATION: R0-3147, Section 3:02.3 addresses preparation of surfaces to l be painted including removal of weld splatter, degreasing, l use of solvents for cleaning, removal of grit and dust, etc.
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Section 4.5 "The coating applicator shall report daily on
- 8. REQUIREMENT: :
surface preparation conditions encountered during each shift CLARIFICATION: The precautions and surface preparations stated in R0-3147, ;
Sections 3:02.2 and 3:02.3, respectively, provide assurance that adequate surface preparation is performed prior to ,
j applying protective coatings. In addition, R0-3147, Section l 3:02.6 provides the requirements for quality control documentation of surface preparation. This documentation requirement meets the intent of ANSI N101.4-1972, Section 4.5. ,
- 9. REQUIREMENT: Section 5.2.2 - "These application procedures . shall be approved by the coating applicator, the coating l minufacturer, and'the owner or his representative."
CLARIFICATION: Manufacturer recommendations- presented in the form of technical bulletins are reviewed by FPC for applicability and inclusion into specific plant procedures used by the coating applicator. Application procedures other than those recommended by the coating manufacturer may be used if they l are supported by DBA test data applicable to CR-3. When painting is to be done by an outside contractor, he nay use FPC generated painting procedures or his procedures which must be approved by FPC in accordance with R0-3147, Section 3:05.
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'10. REQUIREMENT: Section 5.4.3 on the application work for-each area of work . . .". j
- CLARIFICATION
- FPC meets the intent of the. controls described in Section-5.4.3 through' requirements- detailed . in ' R0-3147, Section l 3:02.6 for documentation of activities _ performed ~and ?
i . inspection of those activities. The paint application l procedure requires quality control inspection of painting at_ i specific points in the procedure. This approach meets the j intent of the_ daily reporting requirements. 1
- 11. REQUIREMENT: Section 6.2.3 - " Inspection agencies shall' provide 'the services of one or more qualified inspectors. . .".
1 CLARIFICATION: FPC QC Inspectors or approved contractor personnel _who are trained to perform coatings inspection _in accordance with !
the FPC approved Quality Program and are certified in 1 accordance with ANSI ' N45.2.6-1978, - as addressed in FSAR ;
commitments, will perform the required inspections at CR-3. 'i Because of the relatively small amount .of protective. (
coatings application performed at CR-3, FPC's QC Inspectors !
may also perform other types of inspections. However, when i protective coating application .is taking place, an !
appropriately certified QC Inspector (s) will be available to l perform the prescribed inspections as specified by program i
, requirements. j
- 12. REQUIREMENT: Section 6.2.4 -
" Inspection shall conform to all- the l applicable requirements of Section 7, Inspection, of ANSI l N5.9. . .". !
i CLARIFICATION: FSAR Section 1.7.1.10 provides FPC_'s overall requirements !
for. inspections. R0-3147, Section l3:02.6 further details j specific inspection requirements. -
- 13. REQUIREMENT: Section 6.3.2 . "The project specification shall state whether this training is required."
CLARIFICATION: All inspections are performed by Quality Control' inspectors who are qualified to ANSI N45.2.6-1978. Inspectors are also trained on coating requirements, procedures, and inspection techniques. Further inspection program requirements are described in FSAR Section 1.7.1.10.
1-136c (Rev. 14)
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- 14. REQUIREMENT: Section 6.4 " Scope of Inspections . . . all aspects of the coating work."
CLARIFICATION: As stated in the clarification for Section 4.2.3, inspection methods are described in the approved plant procedures and l occur at specified points in the painting program. . R0-3147, Section 3:02.1 subitem 5 requires the services of the paint i manufacturer shall be made available for field consultation. '
His advice and recommendations are subject to FPC approval l before use, j i
! 15. REQUIREMENT: Section 6.5 "The maximum thickness may 'also be critical !
and . . . the coating manufacturer." ,
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a CLARIFICATION: R0-3147, Section 3:02.6 limits the maximum thickness of ,
paint sags and runs to 18 mil dry film thickness (DFT) at !
its thickest point. This value has been agreed to by FPC 1 and its paint manufacturer. The paint schedule, R0-3147,- 2 Section 3:04.1 provides a range' (min to max) of dry film ,
thickness-(DFT) for coatings'used inside containment.
, 16. REQUIREMENT: Section 6.6 " Coating inspection equipment . . .". !
CLARIFICATION: FPC utilizes calibrated and approved equipment and gauge indicators. No wet film thickness (WFT) equipment is used )
since WFT is only a guide during application. FPC considers l the measurement of dry film thickness sufficient to meet the intent of Section 6.6.7 of ANSI N101.4-1972.- Paint industry practice is to specify dry film thickness for protective coatings. R0-3147, Sections 3:02.4, 3:04, and 3:02.6 discuss the dry film thickness requirements.
- 17. REQUIREMENT: Section 6.8.1 "A written daily coating inspection record shall be submitted by the coating inspection agency." j CLARIFICATION: Approved plant procedures require quality assurance documentation to meet record requirements for specific
, inspections. Further, detailed inspections are conducted to ensure requirements in accordance with FSAR Section 1.7.1.10.
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- 18. REQUIREMENT: Section 7' " Quality Assurance Documentation . . .". j CLARIFICATION: R0-3147, Sections 3:02.6 and 5:03 address Quality Assurance documentation deemed necessary for painting at CR-3. These 2 are in accordance with ANSI N45.2.9-1974. FPC utilizes
-forms which are. developed to meet the painting program.
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- 19. REQUIREMENT: . Section 4.2.1 - "The surface preparation of substrates or previously primed...of the project specification." !
CLARIFICATION: R0-3147 requires that surfaces be prepared in accordance !
with the manufacturers recommendation.but also allows i surface preparation other than those recommended by the i manufacturer if DBA test data is available to support the !
use of the alternate surface preparation. l l
The painting program delineated in R0-3147 will ensure that all protective !
coatings used inside the primary containment will be proper coatings, applied by j qualified perso_nnel and in accordance with manufacturers' instructions, and will be inspected and have proper documentation. This program will meet the intent 4 of Regulatory Guide 1.54, Revision 0. i i
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NRC Reaulatory Guide 1.58 -
" Qualification of Nuclear Power Plant Inspection, i Examination and Testing Personnel" (Rev. 1, 9/80) - Endorses ANSI N45.2.6 - !
1978.
l The Quality Program complies with the requirements of this Guide with the following clarifications-
- 1) With regard to Regulatory Position C.1 (and Section 1.2 of ANSI N45.2.6 - '
1978 which it references), the qualifications of each member of the j facility staff shall be as set forth in Technical Specifications or in j Items 2 or 8 below.
- 2) With regard to Regulatory Positions C.2, C.3 and C.6 (and Sections 1.2 and l
3.5 of ANSI N45.2.6 - 1978 which they reference), personnel performing i inspections, examinations or tests which are NOT covered by Item 1 above or i Items 8, 9 or 12 below shall be qualified as follows-l
- a. (1) Personnel performing nondestructive examinations shall be !
qualified in accordance with the revision of SNT-TC-1A referenced I by the Edition and Addenda of Section XI of the ASME Boiler and l Pressure Vessel (B&PV) Code to which FPC is committed in the ]
Repair and Replacement Program. i l (2) Personnel performing nondestructive examinations of new systems, which are not within the scope of the Repair and Replacement l Program, shall be qualified in accordance with the revision of l SNT-TC-1A referenced by the Edition and Addenda of Section III of l ASME B&PV Code identified within the modification design package.
l (3) An examiner qualified under the 1975 Edition of SNT-TC-1A shall l not require requalification under the 1980 Edition until such time as the examiner is subject to requalification, as provided for in the response to ASNT Inquiry 80-14.
(4) ASME Section XI Certified 1.evel III NDE Personnel, Division 1, 2, and 3 shall have a period of certification of five years as justified by ASME Code Case N-356 which has subsequently been approved by the NRC.
- b. QC personnel performing inspection, examination, and test activities at CR-3, whether FPC or contract personnel, shall be qualified in accordance with ANSI N45.2.6-1978. Where the ASME Boiler and Pressure l Vessel Code specified the qualifications for inspectors performing
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l such activities to be in accordance with ANSI N45.2.6-1973, the l qualifications shall still be in accordance with ANSI N45.2.6-1978 as !
justified by Code Case N-424 and subsequent acceptance by the NRC.
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NRC Reaulatory Guide 1.58 (Continued) i
- 3) With regard to Regulatory Position .C . 4 (and Section 1.5 of ANSI i N45.2.6-1978 which it references), FPC's generic clarification at the l beginning of Table 1-3 is consistent with this NRC Position. l
- 4) With regard to Regulatory Position C.5 (and Section 3.4 of ANSI !
N45.2.6-1978 which it references), and ANSI N45.2.6-1978 Sections 3.2 and i' 3.3, FPC reserves the right to specify activities which may be conducted by use of documented position descriptions rather than using the specific Level I, 11 and III designation used in the Standard. However, the qualifications of personnel performing similar activities shall be ;
consistent with the qualification requirements of the Standard except as ;
noted in Items- 1 and 2 above and Item 8 below. l ;
- 5) With regard to Regulatory Position C.8, FPC has an ALARA program which is applicable to all personnel performing activities at Crystal River Unit 3 as described in the Regulatory Position.
- 6) Regulatory Position C.9 is not applicable to Crystal River Unit 3.
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NRC Reaulatory Guide 1.58 (Continued)
- 7) With regard to Regulatory Position C.10 (and Section 2.2 of ANSI N45.2.6 - !
, 1978 which it references), FPC shall document exceptions to the !
l qualifications requirements as set forth in the clarification of Section ;
! 3.5. Initial and subsequent evaluation of other personnel shall be i performed and documented either in required TPC personnel evaluations or l other suitable records. l 1
- 8) QA persennel performing inspections, examinations and testing as cart of i their routine assignment as auditors or lead auditors shall be qualified as set forth in commitments to ANSI N45.2.23 elsewhere in this Table.
- 9) With regard to Section 1.2' of ANSI N45.2.6 - 1978 titled Apolicability- I The third paragraph requires that the Standard be used in conjunction with i ANSI ProgramN45.2; FPC no The Description. longer specifically fourth paragraphcommits requiresto ANSI that N45.2 in the the Standard be Quality l ;
imposed on personnel other than FPC employees; the applicability of the '
Standard to suppliers shall be documented and applied, as appropriate, in the procurement documents for such suppliers.
- 10) With regard to Section 1.4 of ANSI N45.2.6 - 1978 titled Definitions:
Definitions in this Standard which are not included in ANSI N45.2.10 shall !
be used; all definitions which are included in ANSI N45.2.10 shall be used I as clarified in FPC's commitment to Regulatory Guide 1.74. .
- 11) With regard to Section 2.5 of ANSI N45.2.6 - 1978 titled Physical: FPC !
shall implement the requirements of this Section with the stipulation that, !
! where no special physical characteristics are required, none shall be i specified. The converse is also true: If no special physical requirements ,
are stipulated by FPC, none are considered necessary. l
- 12) With regard to Section 3.5 of ANSI N45.2.6 - 1978 titled Education' and !
Exoerience - Recommendations: FPC reserves the right to use personnel who l do not meet all the educational and experience requirements of this Section !
provided: The use of personnel who do not meet these requirements shall be the exception rather than the rule and each such case shall receive a documented management evaluation and justification for the exception. An example of a documented management evaluation and justification would be one which includes objective criteria (examination, review of actual work performed) to demonstrate that equivalent competence is possessed by such an individual.
l l-138 (Rev. 5) l
NRC Reaulatory Guide 1.64 " Quality Assurance Requirements for the Design of Nuclear Power Plants" (Rev. 2, 6/76) - Endorses ANSI N45.2.ll - 1974.
The Quality Program complies with the requirements of this Guide with the l following clarifications: l
- 1) For operational phase maintenance and modification activities which are l comparable in nature and extent to similar activities conducted during the l construction phase, FPC shall either control these activities under this {
Quality Program Description or under an NRC accepted Construction QA i Program. When this Quality Program Description is used, FPC shall comply j with the requirements of the Reaulatory Position documented in this Guide i in that QA programmatic / administrative requirements included therein I (subject to the clarification below) shall apply to these maintenance and l modification activities even though such requirements may not have been in .
effect originally. Technical requirements associated with the maintenance j and modifications shall be the original requirements or better (e.g., code ;
requirements, material properties, design margins, manufacturing processes, i and inspection requirements). j
- 2) With regard to Paragraph C.2(1) of Regulatory Guide 1.64: If in an I exceptional circumstance the designer's immediate Supervisor is the only technically qualified individual available, this review can be conducted by !
the Supervisor, providing that: (a) the other requirements of- the Regulatory Position are satisfied, (b) the justification is individually documented and approved by the Supervisor's management, and (c) quality assurance audits cover frequency and effectiveness of use of Supervisors as :
design verifiers to guard against abuse. ,
l 3) With regard to Section 1.4 of ANSI N45.2.11 - 1974 titled Definitions-Definitions in this Standard which are not included in ANSI N45.2.10 shall be used; all definitions which are included in ANSI N45.2.10 shall be used i as clarified in FPC's commitment to Regulatory Guide 1.74.
- 4) With regard to Sections 2.1 and 2.2 of ANSI N45.2.11 - 1974 titled, respectively, Establishment and Documentation and Procram Procedures:
Sections 1.7.1.16 and 1.7.1.18 of the Quality Program Description and commitments to ANSI N45.2.12 as set forth in Table 1-3 of that Program l
shall be met in lieu of the last paragraph of Section 2.1 and items 6,12 and 13 in Section 2.2.
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- 5) With regard to Section 5.2.4 of ANSI N45.2.ll - 1974 titled Documentation:
For the documentation of interdisciplinary design reviews, there must be
- documented evidence of the acceptability of design documents or portions l
thereof, prior to release (material, stress, physics, mechanical, electrical, concrete, etc.). The signature or initials of those who determine the acceptability of the design relative to their_ respective disciplinary area of concern shall be on the document or on a separate form traceable to the document. A document that indicates the reviewer's comments need not be retained.
i 1-139 (Rev. 20) l
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l NRC Reaulatory Guide 1.64 (Continued) 1
- 6) With regard to Section 6.1 of ANSI N45.2.11 - 1974 titled General: The third paragraph in this Section stipulates certain requirements relative to "the results of design verification." FPC may comply with these requirements by having the reviewer (s) sign and date an appropriate document providing the following conditions are also met:
a) Documented engineering / design procedures are established which cover the extent of design review.
b) The procedures identify the duties of the reviewer and the extent of his responsibility for which he attests with his signature.
c) The procedures specify the extent of documentation necessary for the type of design verification applicable to the complexity of the design. ;
d) The signature and date is affixed in accordance with the procedures.
FPC shall also permit initials to be used in lieu of the signature required above if a file is maintained to correlate characteristic initials versus individuals such that each set of characteristic initials can be traced to an individual. This correlation must be readily available to NRC inspectors whenever the document is being used.
- 7) The timing of design verification is not mentioned in the Standard. FPC shall perform verification in a timely manner. If other than by l qualification testing of a prototype or lead production unit, verification ;
should be completed prior to release for procurement, manufacturing or construction or release to another organization for use in other design activities. In those cases where this timing cannot be met, the design verification may be deferred, provided that the justification for this action is documented and the unverified portion of the design output document and all design output documents, based on the unverified data, are appropriately identified and controlled. Site activities associated with a design or design change shall not proceed without verification past the point where the installation would become irreversible without extensive demolition and rework. In all cases, the design verification shall be completed prior to relying upon the component, system, or structure to I perform its safety-related function. I 1
- 8) With regard to Section 10 of ANSI N45.2.11 - 1974 titled Records: FPC !
shall maintain records in accordance with and to meet the requirements of '
Section 1.7.1.17 of the Quality Program Description and ANSI N45.2.9 as i i specified in Table 1-3. The additional requirements of the first sentence !'
of the second paragraph in this Section shall also be met.
l 1-140 (Rev. 20) l
1 1
NRC Reoulatory Guide 1.64 (Continued) 9). With regard to Section 11 (including Subsections 11.1 through-11.7) of ANSI N45.2.11 - 1974, titled Audits: The FPC's Audit Program shall be implemented in accordance with and to meet the requirements of: ANSI N18.7 and ANSI N45.2.12 as endorsed in Table 1-3 and Sections 1.7.1.16 and 18 of !
the Quality Program Description. f
FSAR contains any design or design input that has not been previously l documented, reviewed and approved in accordance with the requirements ;
contained in the Quality Program Description or another approved design !
control QA program and if the FSAR is used as a design document during the design process, that specific information must be controlled and verified in accordance with the commitments here and Section 1.7.1.3 of the Quality Program Description. ;
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NRC Reaulatory Guide 1.74 " Quality Assurance Terms and Definition" (2/74) -
, Endorses ANSI N45.2.10 - 1973 The Quality Program complies with the requirements of this Guide with the following clarifications:
- 1) FPC reserves the right to define additional words or phrases which are not included in this Standard. Such additional definitions shall be documented ,
in appropriate procedures and/or in attachments / appendices to quality j assurance procedures / manuals, or in Sections of the Quality Program !
Description.
- 2) In addition to the Standard's definition of " Inspection," FPC shall use the l following: " Inspection (when used to refer to activities that are NOT l performed by quality organization personnel) - Examining, viewing closely, l scrutinizing, looking over or otherwise checking activities. Personnel l performing these functions are not necessarily certified to ANSI N45.2.6." <
l When FPC intends for inspections to be performed in accordance with the Quality Program Description by personnel certified as required by that Program and for activities defined by " Inspection" in ANSI N45.2.10, appropriate references to the plant quality organization which shall perform the activity or to Quality Procedures to be used for performing the activity shall be made. If such references are NOT made, inspections are to be considered under the additional definition given above.
- 3) In addition to the Standard's definition of " procurement documents," FPC shall utilize the definitions given in ANSI N45.2.13 and in Regulatory Guide 1.74. The composite definition is given as follows: Procurement documents - Contractually binding documents that identify and define the l requirements which items or services must meet in order to be considered
~
acceptable by the purchaser. They include documents which authorize the seller to perform services or supply equipment, material or facilities on j 4 behalf of the purchaser (e.g., Engineering Service Agreements (agreements .
j for engineering, construction, or consulting services)), contracts, letters
- of intent, work authorization (in some cases), purchase requisitions, purchase orders, or proposals and their acceptance, drawings,
- specifications, or instructions which define requirements for purchase. j
- 4) " Independent Verification" - Verification by an individual other than the person who performed the operation or activity being verified that required actions have been completed.
Such verification shall not require i
! confirmation of the identical action when other indications provide assurance or indication that the prescribed activity is in fact complete.
4 Examples include, but are not limited to: verification of a breaker opening by observing the actuation of status or indicating lights at the required panel-meter indicated value; verification that a valve has been positioned by observing the starting or stopping of flow on meter indications or by remote valve positions indicating lights.
1-142 (Rev. 20) l
NRC Reaulatory Guide 1.74 (Continued)
- 5) "Must" . (Not defined in any ANSI ' Standard) -- An ' internally auditable requirement imposed by FPC management upon its employees, contractors, and agents - above and in excess of the legally binding requirements of the appropriate regulatory body. Such items are . internally required but not externally enforceable. _ .
- 6) "NRC accepted Construction - QA. Program"? - (1) a program for design or construction which was reviewed by the QA organization 'of the NRC and accepted for use; (2) the revision of that NRC accepted program which is in effect at .the time that FPC authorizes commencement: of work;- and . (3) a program which the FPC QA organization reviews and concurs that the QA.
Program controls are acceptable for the activity.to be performed..
- 7) " Program Deficiencies" (Not defined in ANSI N45.2.10, but used and defined differently in ANSI N45.2.12) - Failure to develop, . document or implement-effectively any applicable element of the Quality Program Description.
- 8) " Quality Assurance Program Requirements" (Not defined in ANSI N45.2.10 but used and defined differently in ANSI N45.2.13) -
Those individual requirements of the Quality Program Description which, when invoked in, total or in part, establish the requirements of the Quality Program.for the activity being controlled. Although not specifically used in the' Quality Program Description, ANSI N45.2 may be imposed upon FPC's suppliers.
- 9) " Quality assurance- records"-- (Not defined in' ANSI N45.2.10 and defined without " expansion" in ANSI N45.2.9.- 1974) - The definition of " quality assurance records" which is given in Section 1.4 of ANSI N45.2.9 - 1974 shall be used with the clarification that " quality assurance records" are-the Lifetime Quality Assurance Records defined in Section 2.2.1 and the Nonpermanent Quality 4ssurance Records defined in Section 2.2.2. of the
' the applicable portions of the Code of Federal Regulations, Title-10. Standard
- 10) "Will" - (Not defined in any ANSI standard) - Means the same as "shall" except when context shows that it is simply being used to. indicate events which are to take place in the future. In the latter case, "will" is normally followed by "be".
- 11) " Facility staff" - (Not defined in any ANSI standard) - Means those ,
personnel who report to the CR-3 Director, Nuclear Plant Operations. This j term shall' also be synonymous with the "On site Operating Organization" described (but not defined) in ANSI N18.7-1976, Section 3.4.2; the " Unit Staff described in the Technical Specifications Section .5.2.2; and the ;
" facility staff" as used in FSAR Section 12.8.2.8.b.
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1-144 (Rev. 20)-
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NRC Reaulatory Guide 1.88 " Collection, Storage and Maintenance of Nuclear Power l Plant Quality Assurance Records" (Rev. 2, 10/76) - Endorses ANSI N45.2.9 - 1974 l i
The Quality Program complies with the requirements of this guide with the '
following clarifier 11ons .
- 1) With regard to Section 1.4 of ANSI N45.2.9 -.1974 titled Definitions: The only definitiun given in this Standard is not included in ANSI N45.2.10. ]
The Standard's definition of " quality assurance records" shall be used with ,
the clarification that " quality assurance records" are the Lifetime Quality l Assurance Records defined in Section 2.2.1 and the Nonpermanent Quality !
Assurance Records defined in Section 2.2.2 as well as those records i specifically required to be retained by the applicable portions of the Code '
of Federal Regulations, Title 10. This clarification is also given in this l -
Table under Regulatory Guide 1.74.
- 2) With regard to Section 3.2.1 of ANSI N45.2.9 - 1974 titled Generation of Quality Assurance Records: The phrase " completely filled out" is clarified !
to mean that sufficient information is recorded to fulfill the intended purpose of the record.
l
- 3) With regard to Section 3.2.2 of ANSI N45.2.9 - 1974 titled index: The !
phrase "an index" is clarified to mean a collection of documents or indices !
which, when taken together, supply the information attributed to "an index" {
in the Standard. :
1 The specification location of a record "within a storage area" may not i always be delineated (e.g. The specific location within a computer record :
file may not be constant. Further, FPC may utilize a computer assisted I random access filing system where such a " location" could not be readily j documented, nor would such a location be meaningful). The storage location i shall be delineated, but where file locations change with time, the specific location of a record within that file may not always be documented.
- 4) With regard to Section 3.2.7 of ANSI N45.2.9 - 1974 titled Retention of Records: FPC generally maintains that Lifetime QA Records as defined above in Clarification 1, are those records required to be maintained by or for Florida Power Corporation for the life of the particular item while it is installed in the plant or stored for future use. Likewise, Non-Permanent QA Records need not be retained for the life of the item. In lieu of Appendix A to ANSI N45.2.9, FPC has established a listing of types of records that have been assigned specific retention periods.
The following records shall be retained for at least five years:
- a. Records and logs of facility operation covering time intervals at each power level.
- b. Records and logs of principal maintenance activities, inspections, repair and replacement of. principal items of equipment related to nuclear safety.
1-145 (Rev. 20) i
- - - _ - . _ = _ .-
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1 l 5 l NRC Reaulatory Guide 1.88 (Continued) l I
- c. All Reportable Events submitted to the Commission. j d, Records of surveillance activities, inspections and calibrations :
required by Technical Specifications. l
- e. Records of reactor tests and experiments. j
! i l f. Records of changes made to Operating Procedures.
1
- g. Records of radioactive shipments. i l h. Records of sealed source and fission detector leak tests. and i l
results. l t
- 1. Records of annual physical inventory of all sealed source -l j material of record.
- The following records shall be retained for the duration of the Facility Operating License: !
- a. Records and drawing - changes reflecting facility design !
modifications made to systems and equipment described in the FSAR. i
- b. Records of new and irradiated fuel inventory, fuel transfers and j assembly burnup histories. !
l c. Records of facility radiation and contamination surveys. ;
- d. Records of radiation exposure for all individuals entering {
radiation control areas. j
- e. Records of gaseous and liquid radioactive material released to the environs.
- f. Records of transient or operational cycles for those facility components identified in FSAR Table 4.8.
- g. Records of training and qualification for current members of the l plant staff.
- h. Records of inservice inspection performed pursuant to lechnical Specifications.
' 1. Records of Quality Assurance activities required by the Quality Program Description,
- j. Records of reviews performed for changes made to procedures or equipment or reviews of tests and experiments pursuart to 10 CFR l 50.59.
1-146 (Rev. 20)
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NRC Reaulatory Guide 1.88 (Continued) !
- k. Records of meetings of the PRC and NGRC. .
t
- 1. Records for Environmental Qualification.
- m. Records of analytical results required by the Operational Radiological Environmental Monitoring Program. j
- n. Records of reviews performed for changes made to the Offsite Dose Calculation Manual. ;
j o. Records of reviews and changes to the Process Control Program. ,
This documentation shall contain 1) sufficient information to i
l support the change together with the appropriate analyses or l evaluations justifying the change (s), and 2) a determination that l
the change will maintain the overall conformance of the ,
solidified waste product to existing requirements of Federal, I State, or other applicable regulations. ;
- 5) With regard to Section 4.2 of ANSI N45.2.9 - 1974 titled Timeliness: FPC's contractual agreement with its vendors, A/E, constructors, and suppliers shall constitute fulfillment of the requirements of this Section.
, 6) With regard to Section 5.3 of ANSI N45.2.9 - 1974 titled Storace: The first sentence is clarified by stating that an individual or group 'of individuals or a classification of employee shall be designated and assigned the authority to enforce written storage procedures. The term '
" custodian" may or may not be used as part of that designation.
- 7) With regard to Section 5.4 of ANSI N45.2.9 - 1974 titled Preservation: The ,
following clarification is substituted for the current Subsection 5.4.2 '
" Records shall not be stored loosely. They shall be secured for storage.in file cabinets or on shelving in containers". Although not a verbatim quote, this is the position taken in the latest consensus Standard (ANSI /ASME NQA-lb-1981, Supplement 17S-1, Section 4.2(b)).
- 8) With regard to Subsection 5.4.3 of ANSI N45.2.9 - 1974 titled Special Processed Records: The following clarification is substituted for the current Subsection 5.4.3: " Provisions shall be made for special processed records (such as radiographs, photographs, negatives, microfilm and magnetic media) to prevent damage from excessive light, stacking, electromagnetic fields, temperature and humidity as appropriate to the record type." This is the position taken in the latest consensus Standard (ANSI /ASME NQA-lb-1981, Supplement 17S-1, Section 4.2(c)).
- 9) With regard to Section 5.5 of ANSI N45.2.9 - 1974 titled Safekeepina:
Routine general office and nuclear site security systems and access controls are provided. No special security systems are required to be established for record storage areas.
1-147 (Rev. 20)
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NRC Reaulatory Guide 1.88 (Continued)
- 10) With regard to Section 5.6 of ANSI N45.2.9 - 1974 titled Facility: This Section provides no distinction between temporary and permanent facilities.
To cover temporary storage, the following clarification is added: Active records (those completed but not yet duplicated or placed on microform) may i be temporarily stored in one-hour fire rated file cabinets. In general, l records shall not be maintained in such temporary storage for more than three months after completion without being duplicated (for dual storage) or being placed on microfilm. Any exceptions to this three month storage shall be evaluated and approved by the Director, Quality Programs; a list of all such excepted records shall be maintained and available for NRC review. Open-ended documents (those revised or updated on a more-or-less continuing basis over an extended period of time (e.g. persennel qualification and training documents, equipment history cards, audit or surveillance schedules)) and those which are cumulative in nature (e.g.,
nonconforming item logs, control room log books, night order books) are not :
considered as QA records since they are not " complete". These documents are controlled by the department procedures. These types of documents shall become QA records: when they are issued as a specific revision (e.g., the audit schedule); when they are filled-up or discontinued (e.g.,
log books or equipment history cards); on a predefined periodic basis when l the completed portion of the on-going document shall be transferred to the l records storage facility as a " record" (e.g., training and qualification i records). The applicable provisien of Section 5.3 shall be met by QA l records in temporary storage.
l Where duplicate storage is employed as permitted by the second paragraph of ,
Section 5.6, no special construction requirements are applicable. However, I the record storage locations shall be sufficiently separated from one another that they are not generally susceptible to simultaneous destruction by the same natural disaster (e.g., fire, flooding) . Aldough not a verbatim quote, this is the position taken in the latest cou:: casus Standard (ANSI /ASME NQA-lb-1981, Supplement 17S-1, Section 4.4.2). ;
The fourth paragraph of Section 5.6, item 3 is modified to require a two-hour minimum fire rating to be conshtent with the 1979 version of the l Standard, NQA-lb-1981, and NRC Criteria for Record Storace Facilities !
- (Guidance-ANSI N45.2.9, Section 5.6) issued 7/1/80.
The fourth paragraph of Section 5.6, item 9 is clarified to read: "No i pipes or penetrations except those used exclusively for fire protection, I l lighting, temperature / humidity control, or communications are to be located !
l within the facility. All such penetrations shall be sealed or dampened to '
l comply with a minimum two-hour fire protection rating." This is the l position taken in the latest consensus Standard (ANSI /ASME NQA-lb-1981, l Supplement 17S-1, Section 4.4.1(j)).
With regard to Section 6.2 of ANSI N45.2.9 - 1974 titled Accessibility:
The second paragraph of this Section is clarified to mean that persons authorized access shall be designated. That designation will be: 1) all Records Management Department personnel; and 2) the specific names of personnel outside that department who have been authorized to have access.
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1-147b (Rev. 20) ;
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i NRC Reaulatory Guide 1.94 " Quality Assurance Requirements for Installation, Inspection, and Testing of Structural Concrete and Structural Steel during the Construction Phase of Nuclear Power Plants" (Rev. 1, 4/76) - Endorses ANSI '
N45.2.5 - 1974.
The Quality Program complies with the requirements of this Guide with the following clarifications: ,
l
- 1) For operational phase maintenance and modification activities which are comparable in nature and extent to similar activities conducted during the construction phase, FPC shall either control these at.tivities under this Quality Program Description or under an NRC accepted Construction QA Program. When this Quality Program Description is used, FPC shall comply with the requirements of the Reaulatory Position documented in this Guide in that QA programmatic / administrative requirements included therein (subject to the clarifications below) shall apply to these maintenance and j modification activities even though such requirements may not have been in effect originally. Technical requirements associated with the maintenance and modifications shall be the original requirements or better (e.g., code l requirements, material properties, design margins, manufacturing processes, i and inspection requirements).
l 2) With regard to Section 1.1 of ANSI N45.2.5 - 1974 titled Scope: The last paragraph of this Section is not applicable to the operational phase.
- 3) With regard to Section 1.2 of ANSI N45.2.5 - 1974 titled Applicability:
The first sentence in this Section is not applicable to the operational phase. FPC shall comply with the second sentence in this Section with the clarifications that "importance of the item or service involved" is interpreted to mean those to which the Quality Program Description applies,
- and the extent of coverage shall be defined by supervisory maintenance i
personnel by the way in which they implement the other requirements of this l Standard.
In the second paragraph of this Section, FPC shall substitute the words
" maintenance and modification" for the word " construction" as the modifier of " procedures".
- 4) With regard to Section 1.3 of ANSI N45.2.5 - 1974 titled Responsibility:
This Section's requirements are met by the definitions for positions and the organizational responsibilities outlined in Section 1.7.1.1 of the l Quality Program Description, and the position descriptions for plant personnel.
- 5) With regard to Section 1.4 of ANSI N45.2.5 - 1974 titled Definitions:
Definitions in this Standard which are not included in ANSI N45.2.10 shall be used. All definitions which are included in ANSI N45.2.10 shall be used j as clarified in FPC's commitment to Regulatory Guide 1.74.
1-148 (Rev. 20) l
NRC Reaulatory Guide 1.94 (Continued)
- 6) With regard to Section 2.1 of ANSI N45.2.5 - 1974 titled Plannina:
Planning requirements, when necessary, shall be incorporated into !
maintenance and modification procedures. {
- 7) With regard to Section 2.2 of ANSI N45.2.5 - 1974 titled Procedures and .I Instructions: Procedures and instructions shall be implemented as set
- forth in Sections 1.7.1.5,10, and 11 of the Quality Program Description i
and by compliance with ANSI N18.7 as set forth in Table 1-3 of that Program l in lieu of the requirements set forth here.
- 8) With regard to Section 2.3 of ANSI N45.2.5 - 1974 titled Results: These requirements are met by implementing Sections 1.7.1.10,11, and 17 of the Quality Program Description and by compliance with ANSI N18.7 as set forth in Table 1-3 of that Program in lieu of the requirements set forth here.
- 9) With regard to Section 2.5.2 of ANSI N45.2.5 - 1974 titled Calibration and i Control: The first paragraph of this Section shall be met as set forth in Item 2 of FPC's commitment to Regulatory Guide 1.30 elsewhere in this Table.
- 10) With regard to Section 4.8 of ANSI N45.2.5 - 1974 titled In-Process Tests-on Concrete and Reinforcina Steel: The seventh sentence specifies the i location for taking pumped concrete samples. There may be instances when the pump line discharge is inaccessible for sampling and there may be other instances when, although samples could be taken, the technician would be in such a position that he could not satisfactorily conduct the tests. In j these instances, FPC shall sample the concrete at the truck just before it enters the pump inlet hopper. When this technique is used, a correlation shall be established between truck discharge test results and pump line discharge test results.
- 11) With regard to Section 5.4 of ANSI N45.2.5 - 1974 titled Hiah Strenath Boltina: Item 1 of the second paragraph of this Section requires at least ,
two threads to extend beyond the nut.
^
FPC shall normally meet this l criterion but may accept installations which have the point of the bolt l
- flush with or outside of the face of the nut when completely installed if }
a direct-tension indicator is used to tighten the bolt.
- 12) With regard to Section 7 of ANSI N45.2.5 - 1974 titled Records: FPC shall ,
maintain records in accordance with and to meet the requirements of Section
- 1.7.1.17 of the Quality Program Description and ANSI N45.2.9 as specified
^
in Table 1-3.
- 13) With regard to Section 6.1 of ANSI N45.2.5 -
1974 titled General:
Inspection and test requirements shall be implemented as defined in Sections 1.7.1.3,10 and 11 of the Quality Program Description and FPC's commitment to Section 5.2.7 of ANSI N18.7 as described in Table 1-3 of that Program in lieu of the requirements set forth here.
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NRC Reaulatory Guide 1.Us " Quality Assurance Requirements for Installation, l Inspection and Testing of Mechanical Equipment and Systems" (Rev. 0-R, 6/76) -
Endorses ANSI N45.2.8 - 1975 The Quality Program complies with the requirements of this Guide with the following clarifications:
- 1) For operational phase maintenance and modification activities which are j comparable in nature and extent to similar activities conducted during the I construction phase, FPC shall either control these activities under this Quality Program Description or under an NRC accepted Construction QA Program. When this Quality Program Description is used, FPC shall comply with the requirements of the Reaulatory Position documented in this Guide in that QA programmatic / administrative requirements included therein (subject to the clarifications below) shall apply to these maintenance and modification activities even though such requirements may not have been in effect originally. Technical requirements associated with the maintenance and modifications shall be the original requirements or better (e.g., code requirements, material properties, design margins, manufacturing processes, and inspection requirements).
- 2) With regard to Section 1.1 of ANSI N45.2.8 - 1975 titled Scope: The last paragraph of this Section is not applicable to the operational phase. The applicable portions of the requirements of this Standard shall also be ,
applied after fuel load; therefore, the last twenty-two words in the last !
sentence of the second paragraph under this Section are also not l appropriate to the operational phase.
- 3) With regard to Section 1.2 of ANSI N45.2.8 - 1975 titled Applicability:
The first sentence in this Section is not applicable to the operational phase. FPC shall comply with the third sentence in this Section with the clarifications that "important mechanical items to be covered" is interpreted to mean those to which the Quality Program Description applies, ,
and "the extent of coverage" shall be defined by supervisory maintenance l personnel by the way in which they implement the other requirements of this '
Standard.
- 4) With regard to Section 1.3 of ANSI N45.2.8 - 1975 titled Responsibility: ,
This Section's requirements are met by the definitions for positions and the organizational responsibilities outlined in Section 1.7.1.1 of the l Quality Program Description, and the position descriptions for plant i personnel.
4 l 1-151 (Rev. 20)
NRC Reaulatory Guide 1.116 (Continued)
- 5) With regard to Section 1.4 of ANSI N45.2.8 - 1975 titled Definitions:
Definitions in this Standard which are not included in ANSI N45.2.10 shall ,
be used. All definitions which are included in ANSI N45.2.10 shall be used as clarified in FPC's commitment to Regulatory Guide 1.74.
- 6) With regard to Section 2.1 of ANSI N45.2.8 -
1975 titled Plannina: f Planning requirements, when necessary, shall be incorporated into maintenance and modification procedures. l
- 7) With regard to Section 2.2_of ANSI N45.2.8 - 1975 titled Procedures and '
Instructions: Procedures and instructions shall be implemented as set forth in Section 1.7.1.5,10 and 11 of the Quality Program Description and l '
by compliance with ANSI N18.7 as set forth in Table 1-3 of that Program in lieu of the requirements set ferth here. ,
- 8) With regard to Section 2.3 of ANSI N45.2.8 - 1975 titled Results: These requirements are met by implementing Sections 1.7.1.10,11 and 17 of the Quality Program Description and by compliance with ANSI N18.7 as set forth in Table 1-3 of that Program in lieu of the requirements set forth here.
- 9) With regard to Section 2.8.2 of ANSI N45.2.8 - 1975 titled Calibration and i Control: The first paragraph of this Section shall be met as set forth in
- Item 2 of FPC's commitment to Regulatory Guide 1.30 elsewhere in this Table.
- 10) With regard to Section 2.9 of ANSI N45.2.8 - 1975 titled Prereouisites: -
i Most of the items in this Section were written for construction activities.
l Maintenance and modification activities which are similar in nature and .
extent to construction activities shall be handled as set forth in Item 1 I above. The portions of this Section which are considered applicable by responsible maintenance supervisory personnel shall be complied with as !
stated. -
- 11) With regard to Section 3.1 of ANSI N45.2.8 - 1975 titled Pre-Installation Verification: (Including Subsections 3.1, 3.2, 3.3, 3.4 and 3.5) Most of the items in this Section (and its Subsections) were written for construction activities. Maintenance and modification activities which are similar in nature and extent to construction activities shall be handled as set forth in Item 1 above. the portions of this Section (and its Subsections) which are considered applicable by responsible maintenance supervisory personnel shall be complied with as stated. Quality Programs Department personnel verify that appropriate controls are used through procedure reviews, audits, and surveillance activities.
1-152 (Rev. 20) i 1
i NRC Reaulatory Guide 1.116 (Continued)
- 12) With regard to Sections 4.1 and 4.2 of ANSI N45.2.8 -
1975 titled, l '
respectively, General and Process and Procedure Control: FPC meets these requirements by commitments to ANSI N18.7 as set forth elsewhere in this Table.
- 13) With regard to Section 4.4 of ANSI N45.2.8 - 1975 titled Inspections: The requirements of Section 4.4 shall be implemented as set forth in Section l 1.7.1.10 of the Quality Program Description. The inspection program shall l incorporate, as applicable, those items listed in Section 4.4.
- 14) With regard to Section 4.5 of ANSI N45.2.8 - 1975 titled Installation Checks: (Including Subsections 4.5.1 and 4.5.2.) The portions of this Section (and its Subsections) which are considered applicable by responsible maintenance supervisory personnel shall be complied with as stated. Such items shall be specified in appropriate maintenance or modification procedures.
- 15) With regard to Section 4.6 of ANSI N45.2.8 - 1975 titled Care of Items:
FPC does not consider most of this Section to be applicable to the I operational phase due to the relatively short period of time between l installation and use. Consistent with commitments to ANSI N45.2.3 and ANSI l N18.7 as given elsewhere in this Table, FPC shall implement appropriate J housekeeping and preventive maintenance procedures to assure that all ;
material which has been installed is appropriately protected and l maintained. j
- 16) With regard to Section 5.1 of ANSI N45.2.8 - 1975 titled General: The !
requirements of this Section shall be implemented as set forth in Sections i 1.7.1.3 and 11 of the Quality Program Description. The test program shall consider the elements outlined in this Section, where applicable, when developing test requirements for inclusion in maintenance and modification '
procedures. In some cases, testing requirements may be met by post- ;
installation surveillance testing in lieu of a special post-installation test.
- 17) With regard to Sections 5.2, 5.3 and 5.4 of ANSI N45.2.8 - 1975 titled, respectively, Pre-operational Testina, Cold Functional Tests, and Hot Functional Tests: Except for maintenance and modification activities which are similar in nature and extent to similar construction activities (which are handled as set forth in Item 1 above), the extensive testing program described in these Sections would not be applicable to operational phasi Activities. Where certain items are applicable, as determined by supervisory maintenance personnel, they shall be included in appropriate procedures or handled as described under Item 7 above. Quality Programs Department personnel verify that appropriate controls are used through procedure reviews, audits, and surveillance activities. i 1-153 (Rev. 9)
i NRC Reaulatory Guide 1.116 (Continued) '
I ,
'18) With regard to Section 6 of ANSI N45.2.8:- 1975 titled Data Analysis and i Evaluation: FPC shall process and analyze inspection and test data as. set !
.forth in Sections 11.7.1.10,11, and 17 of the Quality Program Description i and our commitment.to Sections 5.2.7 and 5.2.17 of ANSI N18.7 as described i in Table 1-3 of the Program. .j i 19) With regard to Section 7 of ANSI N45.2.8 - 1975 titled Records: FPC shall !
I maintain records in accordance with and to meet the requirements of Section !
1.7.1.17 of the Quality Program Description and ANSI N45.2.9 as.specified i in Table 1-3. j
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., .. j NRC Reaulatory Guide 1.123 " Quality Assurance Requirements for Control of Procurement of Items and Services for Nuclear Power Plants" (Rev. 1, 7/77) -
Endorses ANSI N45.2.13 - 1976.
The Quality Program complies with the requirements of this Guide with the following clarifications:
- 1) Paragraph C.6.c of Regulatory Guide 1.123 (and Sections 10.2.a through f of ANSI N45.2.13 which it references) shall be implemented as originally l written (i.e., with the verb "should" instead of the verb "shall"). '
- 2) Paragraph C.6.e of Regulatory Guide 1.123 (and Section 10.3.4 of ANSI N45.2.13 which it references) shall be implemented as originally written (i.e., with the verb "should" instead of the verb "shall ") . This flexibility is necessary because FPC may not always be able to obtain agreement with a supplier. Since FPC retains the ultimate responsibility for performance of purchased equipment and .since FPC maintains its own Nuclear Engineering Department, FPC should be allowed to exercise this management / engineering prerogative with respect to the final decision on post installation test requirements.
- 3) With regard to Section 1.3 of ANSI N45.2.13 - 1976 titled Definitions:
With two exceptions (Procurement Document and Quality Assurance Program Requirements) definitions in_ this Standard which are not included in ANSI N45.2.10 shall be used; all definitions which are included in ANSI N45.2.10 shall be used as clarified in FPC's commitment to Regulatory Guide 1.74.
The two exceptions are defined in Table 1-3 under Regulatory Guide 1.74.
- 4) With regard to Section 1.2.2 of ANSI N45.2.13 - 1976 titled Purchaser's i Responsibilities: Item c is one of the options which may be used by FPC to assure quality; however, any of the options given in 10 CFR 50, Appendix B, Criterion VII as implemented by Sections 1.7.1.4 and 7 of the Quality i Program Description may also be used. I
- 5) With regard to Section 3.1 of ANSI N45.2.13 - 1976 titled Procurement Document PreDaration. Review and Chanae Control: The phrase "the same .
degree of control" is stipulated to mean " equivalent level of review and l approval." The changed document may not always be reviewed by the originator; however, at least an equivalent level of supervision shall review and approve any changes.
- 6) With regard to Section 3.4 of ANSI N45.2.13 - 1976 titled Procurement l )
Document Control: FPC shall meet the requirements of Sections 1.7.1.4 and 7 of the Quality Program Description in lieu of the requirements specified !
in this Section. ;
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- l NRC Reculatory Guide 1.123 (Continued)
- 7) With regard to Section 5.3 of ANSI N45.2.13 -
1976 titled Pre-award Evaluation: FPC shall comply with an alternate paragraph which reads:
"Except in unusual circumstances (e.g., replacement parts are needed to preclude the development of some unsafe or undesirable condition.at Crystal River Unit 3), a pre-award evaluation of the Supplier shall be performed as required by the Quality Program Description."
- 8) With regard to Section 6.4 of' ANSI. N45.2.13 - 1976 titled Control of Chanaes in Items or Services: The phrase "the Quality Program" shall be inserted in lieu of " ANSI N45.2, Section 7."
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- 9) With regard to Section 8.2 of ANSI N45.2.13 - 1976 titled Disposition: The third sentence of item b is revised to read: Nonconformances to the contractual procurement requirements or purchaser approved documents and 1 which consist of one or more of the following shall be submitted to the purchaser for approval of the. recommended disposition prior to shipment '
when the nonconformance could adversely affect the end use of a module or shippable component
- relative to safety, interchangeability, operability, .
J reliability, integrity, or maintainability:
a) Technical or material requirement is violated; I b) Requirement in supplier documents, which have been approved by the .
purchaser, is violated; l c) Nonconformance cannot be corrected by continuation of the original j manufacturing process or by rework; and/or d) The item does not conform to the original requirement even though the item can be restored to a condition such that the capability of the item to function is unimpaired.
- A module is an " assembled device, instrument, or piece of equipment identified by serial number or other identification code, having been evaluated by inspection and/or test for conformance to procurement requirements regarding end use." A shippable component is a "part of a device, instrument, or piece of equipment which is shipped as an individual item and which has been evaluated by inspection and/or test
- for conformance to procurement requirements regarding end use."
- 10) With regard to Section 11 of ANSI N45.2.13 - 1976 titled Quality Assurance Records: FPC shall maintain records in accordance with and to meet the
! requirements of Section 1.7.1.17 of the Quality Program Description and ANSI N45.2.9 as specified in Table 1-3.
- 11) With regard to Section 12 of ANSI N45.2.13 -
1976 titled Audit of Procurement Prooram: The FPC audit program shall be implemented in accordance with and to meet the requirements of ANSI N45.2.12 as clarified in Table 1-3 and Sections 1.7.1.16 and 18 of the Quality Program Description.
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! NRC Reaulatory Guide 1.144' " Auditing of Quality Assurance Programs for Nuclear. l 4 Power Plants" (Rev. 1, 9/80) - Endorses ANSI N45.2.12 -.1977. :
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The Quality Program complies with the requirements of this Guide with the l' following clarifications:
- 1) Paragraph: C.3.a of Regulatory Guide 1.144 (and Section 3.5.2 of' ANSI -l
- N45.2.12 which it references) shall be implemented by meeting the audit -l 3
frequency requirements described in FSAR Section 1.7.1.18 for audits under l l C.3.a(1). Audits under C.3.a(2) are not covered by this Quality Program i Description. >
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- 2) Paragraph C.3.b of Regulatory Guide 1.144 (and Section 3.5.2 of ANSI N45.2.12 which it references) shall be implemented as follows:
j C.3.b(1) shall. include items- designated ' commercial . grade which are determined to be acceptable b.v receipt or ' source inspection. j
! 3) Paragraph- C.4.a of Regulatory Guide 1.144 (and Section 3.5.3.3 of ANSI 4
N45.2.12 which it references), shall be implemented with the clarification 4' that the Director,- Quality Progracs or nis designee shall determine which reorganizations.or procedure revisions are "significant."
- 4) Paragraph C.7 of Regulatory Guide'l.144 (and Section 5.2 of ANSI N45.2.12 .i which it references) shall be implemented by - maintaining records in !
accordance with and to meet the requirements of Section 1.7.1.17 of the' ;
Quality Program Description and ANSI N45.2.9 as specified in Table 1-3. ,
With respect to the. additional audit records recommended in C.7, FPC may retain such records, but their retention shall not be considered mandatory. !
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- 5) With regard to Section 1.4 of ANSI N45.2.12 - .1977 titled Definitions: l With one exception (Program Deficiencies) the definitions in this Standard !
which are not included in ANSI N45.2.10 shall be used as clarified in FPC's !
commitment to' Regulatory Guide 1.74. ~ A clarified definition of the exception is defined in Table 1-3 under Regulatory Guide 1.74. !
- 6) With regard to Section 2.2 of ANSI N45.2.12 - 1977 titled Personnel !
Qualifications: FPC audit personnel shall be qualified to meet the ;
requirements of ANSI N45.2.23 as endorsed in Table 1-3 and Sections 1.7.1.2 :
and 18 of the Quality Program Description.
- 7) With regard to Section 2.3 and Subsections 2.3.1 through 2.3.3 of ANSI N45.2.12.-1977 titled Trainina: FPC ' audit personnel shall be trained as necessary to meet the requirements of ANSI N45.2.23 as endorsed in Table L
,- 1-3 and Sections 1.7.1.2 and 18 of the Quality Program Description.
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., .g NRC Reculatory Guide 1.144 (Continued)
- 8) With regard to Section 2.4 of ANSI N45.2.12 - 1977 titled Maintenance of Proficiency: FPC audit personnel shall maintain their proficiency by meeting the requirements of ANSI N45.2.23 as endorsed in Table 1-3 and Sections 1.7.1.2 and 18 of the Quality Program Description.
- 9) With regard to Section 3.3 of ANSI N45.2.12 - 1977 titled Essential Elements of the Audit System: FPC shall comply with Subsection 3.3.5 as it was originally written (Subsection 3.2.5 in ANSI N45.2.12, Draft 3, Revision 4): " Provisions for reporting on the effectiveness of the quality assurance program to the responsible management." For auditing and audited organizations within FPC, " effectiveness of the quality assurance program" is reported to responsible management by meeting the requirements of FSAR Section 12.8.2.10, Sections 1.7.1.1, 2,16 and 18 of the Quality Program Description and ANSI N18.7 Section 4.5 as clarified in Table 1-3. For audited organizations outside (e.g., vendors, suppliers) of FPC, transmittal of the audit report shall be deemed to meet the requirements of Subsection 3.3.5 "for reporting on the effectiveness of the quality assurance program to the responsible management".
Subsection 3.3.6 requirements are considered to be fulfilled by compliance with the organization 3 d reporting measures outlined in the Quality Program Description. l Subsection 3.3.7 requires verification of effective corrective action on a
" timely basis." Timely basis is interpreted to mean within the framework or period of time for completion of corrective action that is accepted by the quality organization. Each finding requires response and a corrective action completion date; these dates are subject to revision (with the approval of the quality organization) and must be escalated to higher authority when there is a disagreement between the audited and the auditing organization on what constitutes " timely corrective action."
- 10) With regard to Section 3.5 of ANSI N45.2.12 - 1977 titled Schedulino:
Subsection 3.5.3.1 is interpreted to mean that FPC may procedurally control qualification of a contractor's or supplier's quality assurance program prior to awarding a contract or purchase order by means other than audit.
- 11) With regard to Section 4.3.1 of ANSI N45.2.12 - 1977 titled Pre-Audit Conference: FPC shall comply with requirements of this Section by inserting the word "Normally" at the beginning of the first sentence. This clarification is required because, in the case of certain unannounced audits or audits of a particular operation or work activity, a pre-audit conference might interfere with the activity or with the spontaneity of the operation or activity being audited. In other cases, persons who should be present at a pre-audit conference may not always be available. Such lack of availability should not be an impediment to beginning an audit. Even in the above examples, which are not intended to be all inclusive, the material set forth in Section 4.3.1 is normally covered during the course of the audit.
1-159 (Rev. 20)
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, >g NRC Reaulatory Guide 1.144 (Continued)
- 12) With regard to Section 4.3.2 of ANSI N45.2.12 - 1977 titled Audit Process:
a) Subsection 4.3.2.2 could be. interpreted to limit audits to the review ~i l of only objective evidence; sometimes and for some program elements, ;
no objective evidence may be available. FPC shall comply with an l l alternate sentence which reads: "When available, objective evidence shall be examined for compliance with Quality Program requirements.
If subjective evidence is used (e.g., personal interviews, direct i observations by the auditor), then the audit report must indicate how the evidence was obtained."
b) Subsection 4.3.2.4 is modified as follows to take into account the fact that some nonconformances are virtually " obvious" with respect to i
I the needed corrective action: "When a nonconformance or Quality '
Program deficiency is identified as a result of an audit, unless the !
apparent cause, extent, and corrective action are readily evident, further investigation shall be conducted by the audited organization in an effort to identify the cause and to determine the extent of the corrective action required."
c) Subsection 4.3.2.5 contains a recommendation which is clarified with !
the definition of " acknowledged by a member of the audited organization" to mean that "a member of the audited organization has been informed of the findings." Agreement or disagreement with a finding may be expressed in the response from the audited l organization.
! 13) With regard to Section 4.3.3. of ANSI N45.2.12 - 1977 titled Post-Audit l Conference: FPC shall substitute and comply with the following paragraph: l "For all external audits, a post-audit conference shall be held with i management of the audited organization to present audit findings and !
clarify misunderstandings; where no adverse findings exist, this conference :
may be waived by management of the audited organization. Such waiver shall ;
be documented in the audit report. Unless unusual operating or maintenance l
, conditions preclude attendance by appropriate managers / supervisors, a l
post-audit conference shall be held with managers / supervisors for all ,
internal audits for the same reasons as above. Again, if there are no .
adverse findings, the management of the internal audited organization may I waive the post-audit conference. Such waiver shall be documented in the l audit report."
l l l-160 (Rev. 20) l l
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t NRC Reaulatory Guide 1.144 (Continued)
- 14) With regard to Section 4.4 of ANSI N45.2.12 - 1977 titled Reportina:
l a) This Section states that the audit report shall be signed by the audit i team leader; this is not always the most expeditious route to take to j l
assure that the audit report is issued as soon as practical. FPC ;
shall comply with Section 4.4 as clarified in the opening: "An audit ;
report, which shall be signed by the audit team leader, or his I supervisor in his absence, shall provide:" In cases where the audit l report is not signed by the Lead Auditor due to his absence, one :
record copy of the report must be signed by the Lead Auditor upon his !
return. The report shall not require .the Lead Auditor's :
review / concurrence / signature if the Lead Auditor is no longer employed !
by FPC at the time the audit report is issued.
b) FPC shall comply with Subsection 4.4.3 clarified to read: l
" Supervisory level personnel with whom significant discussions were !
held during the course of pre-audit (where conducted), audit, and ,
post-audit (where conducted) activities." !
i c) Audit reports may not necessarily contain an evaluation statement '
regarding the effectiveness of the quality assurarice program elements l l
which were audited, as required by Subsection 4.4.4, but they shall !
i provide a summary of the audited areas and the results.
l l d) Subsection 4.4.6 requires audit reports to include recommendations for ,
l corrective actions; FPC may choose not to comply with this l l requirement. Instead, FPC auditors / lead auditors are required to !
l document all adverse findings. The procedure for processing Audit l Findings allows the auditor / lead auditor to document actions which are l l considered necessary to correct the finding; the auditor / lead auditor !
may also document actions which are reconsidered unacceptable for !
correcting the finding. The Audit Finding with these " Auditor :
Recommendations" is then transmitted to the audited organization. In !
addition, the auditor / lead auditor is required to review the response !
to the Audit Finding and determine if it is acceptable. Any :
disagreements must be escalated to higher management' for resolution via the Nonconformance Report (NCR) process.
e) The last paragraph in Section 4.4 deals with distribution of audit reports. FPC shall comply with these requirements after substituting the following for the last sentence: "The audit report shall be issued within thirty days after the last day of the audit".
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NRC Reaulatory Guide 1.144 (Continued)-
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- 15) With regard to Section 4.5.1 of ANSI N45.2.12 - 1977 titled By Audited Oraanization: FPC shall comply with the following clarification of this Section: " Management of the audited organization or activity shall review and investigate all adverse audit findings, as necessary, (e.g., where the cause is not already known or another organization has not already investigated and found the cause, etc.) to determine and schedule appropriate corrective action (which includes action to prevent-recurrence). They shall respond, in writing, within thirty working days after the date of issuance of the audit report. The response shall clearly state the corrective action taken or planned to prevent recurrence and the results of the investigation, if conducted. In the event that corrective action is not completed by the time the response is submitted, the audited organization's response shall include a scheduled date for completion of planned corrective action. A follow-up response shall be provided. stating the corrective action taken and the date that the action was completed. If corrective actions are verified as satisfactorily completed by the quality organization prior to the scheduled completion date, no follow-up response is required. The audited organization shall take appropriate action to assure that corrective action is accomplished as scheduled. Either the Director, Quality Programs or the Manager, Quality Assessments may waive the requirement for a supplementary response.
- 16) With regard to Section 5.1 of ANSI N45.2.12 - 1977 titled General: FPC shall maintain records in accordance with and to meet the requirements of i Section 1.7.1.17 of the Quality Program Description and ANSI N45.2.9 'as -
specified in Table 1-3. (See also Item 4 above).
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I 1-162 (Rev. 20)
g NRC Reaulatory Guide 1.146 " Qualification of Quality Assurance Program Audit Personnel for Nuclear Power Plants" (Rev. O, 8/80) - Endorses ANSI N45.2.23 -
1978 The Quality Program complies with the requirements of this Guide with the following clarifications:
- 1) With regard to Section 1.4 of ANSI N45.2.3 - 1978 titled Definitions" Definitions in this Standard which are not included in ANSI N45.2.10 shall l be used.
- 2) With regard to Section 2.2 of ANSI N45.2.23 - 1978 titled Qualification of
- Auditors
- Subsection 2.2.1 references an ANSI B45.2 (presumed to be ANSI l N45.2); therefore, FPC shall comply with an alternate Subsection 2.2.1 l which reads: " Orientation to provide a working knowledge and understanding l of the Quality Program Description, including the ANSI Standards and Regulatory Guides included in Table 1-3 of that Program, and FPC's procedures for conducting audits and reporting results."
- 3) With regard to Section 4.1 of ANSI N45.2.23 - 1978 titled Oraanizational Responsibility: FPC shall comply with this Section with the substitution l of the follcwing sentence in place of the last sentence in the Section.
l "The Director, Quality Programs or the Director Nuclear Operations l
! Materials and Controls, or his designee shall, prior to commencing the l audit, assign personnel who collectively have experience or training
- commensurate with the scope, complexity, or special nature of the l activities to be audited."
l l 4) With regard to Section 5.3 of ANSI N45.2.23 - 1978 titled Updatina of Lead Auditor's Records: FPC shall substitute the following sentence for this Section: " Records for each Lead Auditor shall be maintained and updated during the period of the annual management assessment as defined in Section l
3.2 (as clarified)."
l 5) With regard to Section 5.4 of ANSI N45.2.23 -
1978 titled Records i Retention: FPC shall substitute the following sentence for this Section:
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" Qualification records shall be generated and maintained as required by Sections 1.7.1.2,17, and 18 of the Quality Program Description and by commitment to ANSI N45.2.9 as set forth in Table 1-3 of that Program."
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