ML19209C475
| ML19209C475 | |
| Person / Time | |
|---|---|
| Site: | 07100198 |
| Issue date: | 09/30/1979 |
| From: | NUCLEAR FUEL SERVICES, INC. |
| To: | |
| Shared Package | |
| ML19209C474 | List: |
| References | |
| 14026, NUDOCS 7910150625 | |
| Download: ML19209C475 (31) | |
Text
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DESCRIPTION OF QUALITY ASSURANCE PROGRAM FOR OPERATIONS NUCLEAR FUEL SERVICES, INC.
WEST VALLEY, NEW YORK SEPTEMBER 1979 iI43 332 7 910150 (2f 14026
QUALITY ASSURANCE PROGRAM DESCRIPTION TABLE OF CONTENTS 1.0 GENERAL CONSIDERATIONS 1.1 Organization for Quality Assurance 1.2 Safety and Quality Designations 1.2.1 Safety Class 1.2.2 Functional Classification 1.2.3 Quality Effort Classification 2.0 PROGRAM DESCRIPTION
2.1 Purpose and Scope
of Program 2.2 Organization, Responsibilities and Training 2.3 Operational Control 2.3.1 Planning for Activities 2.3.2 Technical Specifications 2.3.3 Operating Procedures 2.3.4 Transport Package Information 2.3.5 Surveillance Activities 2.3.6 Plant Safety Committee 2.3.7 Reporting of Incidents and Corrective Actions 2.3.8 Maintenance Program 2.4 Inspection and Testing 2.4.1 Testing Program 2.4.2 Inspection, Test and Operating Status 2.4.3 Measuring and Test Equipment 2.5 Purchased Materials, Equipment and Services 2.5.1 Procurement Document Control 2.5.2 Control of Purchased Items 2.5.3 Receiving Inspection 2.5.4 Non-Conforming Items 2.5.5 Corrective Action Pertaining to Purchased Items 2.5.6 Shipping 2.6 Documents, Records and Audit Inspections 2.6.1 Records 2.6.2 Document Control 2.6.3 Audits il43 33; 9/79
QUALITY ASSURANCE 1.0 GENERAL CONSIDERATIONS The purpose of this description is to describe the NFS quality assurance policies and procedures which are applicable to the radiological safety aspects of the testing and operation of components, systems and structures of the shut-down plant and related transport packaging, and to show how these comply with the quality assurance requirements defined in Title 10, Code of Federal Regu-lations, Paragraphs 50.34 and 71.51 The quality assurance program is designed to provide the appropriate control of quality for safety-related activities associated with the operation and maintenance of components, systems and structures that prevent or mitigate the consequences of postulated accidents that could cause undue risk to tae health and safety of the public.
1.1 0roanization for Quality Assurance The NFS quality assurance organization consists of the Quality Assur-ance and Licensing Manager at the corporate office level and a Quality Assur-ance Supervisor at the plant site.
The Quality Assurance and Licensing Manager has the authority to take direct action where necessary to enforce compliance with the established corporate quality assurance program and procedures. Specific functions assigned to the Quality Assurance and Licensing Manager relative to the West Valley site activities include:
Development of the policies, plans and procedures required by the corporate quality assurance programs.
Development of the corporate quality assurance programs as needed, assuring that all pertinent quality requirements are covered by these programs and that all personnel involved are cognizant of specific program requirements.
- Implementation of the required programs in a timely and orderly fashion.
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1-2 Establishment of procedures by which quality related documents are received, reviewed, appropriate actions taken and recorded and docu-ments filed.
Establishment of temporary and permanent filing and storage facili-ties for quality related documents.
Review and approval of the quality assurance programs established by NFS contractors when the quality assurance function has been included in the scope of work of such contractors. This includes the monitoring of such programs for conformance to the policies and procedures set forth in the NFS quality assurance manual.
Audits of NFS activities in a timely fashion, including the review of records and observation of procedures and practices t9 assure that the NFS quality assurance programs are being conducted accord-ing to approved procedures, are adequately documented, and are attaining their objective of assuring compliance with the NFS quality assurance policies and with applicable government require-ments and regulations.
Verification, through the Quality Assurance Supervisor at West Valley, that vendor supplied materials, components, and systeins meet the pertinent quality requirements as defined in appropriate purchase documents.
Preparation of reports to responsible personnel summarizing the status of quality related activities, including the disposition of non-conforming materials, components and systems.
The Quality Assurance and Licensing Manager reports directly to the President of NFS and informs him of the overall status of quality assurance activities and any problem areas requiring his attention and/or action. The Quality Assurance and Licensing Manager also reports his inspection and audit findings directly to the appropriate company management.
The NFS Quality Assurance Organization and its relationship to other activities covering current plant operations is shown in Figure 1-1.
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FIGURE l-1 NFS ORGANIZATION RELATIVE TO WEST VALLEY NFS PRESIDENT VICE PRESIDENT ENGIffEERING QUALITY ASSURANCE AND LICEf4 SING IW1.
WEST VALLEY GENERAL MANAGER
- O r----
7 I
I ADMINISTRATIVE PLANT QUALITY SERVICES MANAGER
- ASSURAf4CE MANAGER SUPERVISOR
^
OPERATIONS TECHf4ICAL
& AEY u
MANAGER ifG R MANAGER u
LN R
- Ocal Assignment M
1-4 Quality Assurance and Licensing Manager supplemcnts his staff, as required, to provide specialized technical and other types of inspection support to assure that the quality assurance program is being implemented as established and that quality related problems are properly evaluated. As a general rule, such additional personnel are cognizant of but not directly involved in the quality related operation at hand.
1.2 Safety and Quality Designations The quality assurance program provides control over activities affect-ing the quality of the identified structures, systems and components to an extent consistent with their importance to safety. Safety Class (SC), Func-tional Classification (FC) and Quality Effort Classification (QEC) designations are provided to achieve the appropriate effort for consistency with the im-portance to safety.
1.2.1 Safety Class (SC)
The structures, systems and components of the plant which are currently used are categorized according to their specific function. The components of containers used for the transport of radioactive material will be classi-fled by NFS prior to use of such packages in accordance with the information required by 10 CFR 71.12a, b and c.
Three safety classes are designated and reference as SC I, SC II and SC III.
1.2.1.1 Safety Class I (SC I)
Safety Class I (SC I) structures, systems and components are those whose failures to function might cause or allow off-site concentrations of radicactive material approaching the guidelines of 10 CFR 100.ll(a) expanded to include other appropriate body organs.
Safety Class I structures, systems and components are referred to as safety-related. With the present and antici-pated near-term status of the West Valley site, no structures, systems or components are designated Safety Class I.
1.2.1.2 Safety Class II (SC II)
Safety Class II (SC II) structures, systems and components are those
)
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1-5 which are necessary for the radiological protection of plant personnel and/or the maintenance of the releases of radioactivity to below the Technical Speci-fication limits but whose failure to function would neither cause nor allow off-site concentration of radioactive material approaching the guidelines of 10CFR100.ll(a). The satisfaction of the function of SC II designations is assured by one or more of the following criteria:
- The provision of redundant components or alternates which will continue the function subsequent to failure or maloperation of the primary structure, system or component.
The ability to maintain the plant in a safe shutdown condition without the functioning of the Class II structure, system or component.
1.2.1.3 Safety Class III (SC III)
Safety Class III (SC III) structures, systems and components are those which are not required for either the radiological protection of plant personnel or the maintenance of the releases of radioactivity below the Technical Specification limits.
1.2.2 Functional Classification (FC)
In addition to the Safety Class designations, the structures, systems and components are given a Functional Classification in relation to their function or needed reliability.
Five different levels of Functional Classi-fication are provided and designated as FC-A, FC-B, FC-C, FC-D and FC-E.
The basis for selecting each level is as follows:
FC-A* structures, systems and components provide confinement of radio-active materials and/or essential supporting services which cannot be repaired in case of need within the time required to prevent an off-site concentration of radioactive material approaching the guide-lines of 10 CFR 100.ll(a) expanded to include other appropriate body organs.
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- With the present and anticipated near term status of the West Valley site, no plant structures, systems or components have this Functional Classification.
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1-6
- FC-B* structures, systems and components provide confinement of radioactive materials and/or essential supporting services which can be repaired in case of need within the time required to prevent and off-site concentration of radioactive material approaching the guidelines of 10 CFR 100.11(a) expanded to include other appropriate body organs.
- FC-C structures, systems and components are those whose failure to function will require immediate corrective action such as repair or replacement of failed items. The failure of Class C items will not cause or contribute to release of radioactivity resulting in off-site concentrations approaching the guidelines of 10 CFR 100.ll(a) expanded to include other appropriate body organs.
- FC-D structures, systems and components are those whose failure to function can be corrected by isolation of the failed item or by sub-stitution of alternate or backup equipment.
- FC-E structures, systems and components are those whose failure to function will not preclude continued normal activities.
1.2.3 Quality Effort Classification (QEC)
The extent of the quality assurance effort to be applied to the struc-tures, systems and components is to be consistent with their importance to safety and desired reliability.
Five QEC designations, identified by numerical designations 1 through 5, are provided to identify the extent of the quality assurance effort.
Structures and components are assigned an appropriate QEC.
Systems are composed of structures and components that will often entail more than one QEC designation. Thus, the QEC designations are generally applied to the parts of each system rather than the system in total.
A QEC-1 designation provides the greatest control and effort in assuring quali ty. This effort is to be provided for those structures, systems and
- With the present and anticipated near-term status of the West Valley site, no plant structures, systems or components have this Functional Classifica-tion.
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1-7 components or parts thereof that have a significant safety-related asper.t.
The quality effort is to be within the full scope of Appendix B of 10 CFR 50 or Appendix E of 10 CFR 71, as appropriate.
A QEC-2 designation is provided for those structures, systems or com-ponents of which only a portion has a significant safety-related aspect; the requirements of QEC -1 are to apply only to those designated portions of the structures, systems or components. The effort and control applied to the portions not designated QEC-1 are defined in the design documentation for the particular structure, system or component.
A QEC-3 designation is provided for those structures, systems or com-ponents which because of design or fabrication complexity, accessibility for repair and maintenance, or other specific consideration, NFS elects to specify which parts of the quality assurance program apply.
A QEC-4 designation is provided for those structures, systems and com-ponents that require special features, testing and reliability greater than those available under normal commercial practices.
A QEC-5 designation is provided for structures, systems and components that have quality needs equivalent to conventional commercial practices.
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2-1 2.0 PROGRAM DESCRIPTION Section 1.0 of this chapter outlined general considerations relating to the quality assurance program for the West Valley plant and associated transport packaging and identified the responsiblities for various actions required under the plan.
Section 2.0 describes the quality assurance program for the facility which is entirely carried out within the NFS organization.
The NFS quality assurance program is compatible with the 18 requirements of both 10 CFR 50, Appendix B, and 10 CFR 71, Appendix E, and is described in greater detail in the Operations Manual for Quality Assurance, but is sum-marized here.
2.1 Purpose and Scope
of Program The quality assurance program established for control of the operations at the site is applied to those safety-related site activities, including the transport of radioactive material, which either have a direct or indirect effect on the safe functioning of those components, systems and structures whose failure or malfunction could lead to an accident cr could enhance the adverse affects of an accident resulting in undue radiological risk to the heath and safety of the public.
Such activities are referred to subsequently as " safety-related."
The relationship of the Operations Manual for Quality Assurance to other functions and operations is established in written procedures, instructions and controls.
By means of the quality assurance program, NFS intends to assure that the requisite controls are established and maintained and that the plant and its equipment are properly operated and maintained.
Full responsibility for the management of this program resides with NFS and activities connected with the administration of the program are carried out within the NFS organization.
Responsibility for the implementa-tion and auditing of the quality assurance program resides with the corporate Quality Assurance and Licensing Manager; responsibilities for the quality assurance functions at the plant are delegated to the Quality Assurance Supervisor.
Site functions covered by the quality assurance program are both the operation of the safety-related equipment and maintenance, repairs and 9/79
2-2 modifications of those components, systems and structures with radiological safety significance. All corollary activities related to these functions, such as design, purchase of materials and equipment, installation, test and operations assure an equivalent measure of control as exercised during the original design and construction of the plant and/or transport packages and their subsequent modifications and additions.
Safety-related operations are performed under such controls that it can be assured that approved equipment and environmental conditions appropriate to the test or operation are used, and the requirements of the quality plan are met.
Requirements are set fortn for the necessary special controls, pro-cesses, inspection and test equipment, and trained personnel.
Verification of the safety-related aspects of the activity, process or system can be made through inspection, testing or witnessing according to the provisions of the plan.
The quality assurance program for operations is documented in an Opera-tions Manual for Quality Assurance for the NFS West Valley plant which includes the following:
- NFS quality assurance policies and operational requirements, consistent with the requirements of 10 CFR 50, Appendix B, and 10 CFR 71, Appendix E;
- An outline of the administrative practices which have been establised to control the operations and related activities of the plant;
- A delineation of the assignments of operations and Quality Assurance responsibilities to individual func'tional pasitions and organizational groups within NFS;
- Classifications which define the quality assurance requirements to be met in safety-related activities; and
- A tabulation of the safety-related systems, components and operations which are subject to the quality assurance program requirements.
2.2 Organization, Responsibilities and Training NFS has established a quality assurance organization which is independ-ent of the line organizations for operations, maintenance and modification S'7' 1143 342
2-3 activities and whose identified functions are the implementation of the overall quality assurance program for the plant.
NFS Quality Assurance personnel report through the Quality Assurance and Licensing Manager directly tc the NFS President.
For the operation, maintenance and modification, NFS retains the responsi-bility for the entire program including routine applicable inspections.
The following sections delineate the NFS Quality Assurance organizations and opera-tions.
2.2.1 NFS Quality Assurance Organization for Operatf or.s The NFS corporate responsibility for quality assurance is delegated by the NFS Fresident to the Quality Assurance and Licensing Manager (Figure 1-1).
The Quality Assurance and Licensing Manager, located at the corporate office, is assisted by the Quality Assurance Supervisor, located at the site.
The site Quality Assurance Supervisor (with the aid of the corporate staff and other NFS technical personnel) perfonns audits; inspections; surveillance; verifies that the required inspections and tests have been made on the specific items, system or structure; confirms that the documentation is complete, traceable and certified, as appropriate; and perfonts vendor qualification inspections.
The identity, responsiblities and authorities of the Quality Assurance organization for operations are as follows:
Quality Assurance Manager (QAM)
The Quality Assurance and Licensing Manager is fully and independently responsible for the implementation and management of a quality assurance pro-gram related to the operation of the facility and associated packaging for the transport of radioactive material, and with respect to quality related matters, has the authority to take direct action. He reports directly to the President of NFS.
He has the responsibility for assuring that all quality related aspects have been carried out as stipulated; that quality assurance programs and procedures are developed and implemented in compliance with NFS quality policy, and that such programs and procedures are documented and ap-proved by the appropriate company officials.
He is required to perform periodic audits of quality assurance activities to insure continued adherence to approved procedures.
Specific functions assigned to the QAM for the operations quality assur-ance program include:
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2-4 Development of the policies, procedures and plans under which the quality assurance program is implemented; assurance that pertinent quality aspects are covered by the program and that necessary actions to implement the program are taken; Maintenance of a permanent filing system by which documents for safety-related actions are filed in a readily retrievable state; Direction of an experienced inspection staff assigned the responsi-bility of inspecting the NFS quality assurance activities fo.-
compliance with the requirements of the ove-il NFS plan; Review of major safety-related maintenance and plant modification plans te assure that the quality related aspects have been considered and are being implemented on a current basis; Verification that vendor-supplied safety-related materials meet the requirements of an approved quality plan; Preparation of reports for corporate level action surmarizing the status of quality related activities and the disposition of safety-related deficiencies, deviations, and non-conforming roaterials, components or systems; and Audit plant level quality assurance activities.
The QAM reports inspection findings to the General Manager, Vice President-Engineering and the NFS President. With espect to all quality-related matters, up to and including enforcing suspension of activities, the QAM has the authority to take direct action.
Such actions can be over-ruled only by the NFS President.
Quality Assurance Supervisor (QAS)
The QAS is located at the plant and is responsible far field activities l l 4 3 j 4 /j 9/79
2-5 related to the quality assurance program. All quality related activities, including inspection and verification of the NFS quality assurance program pertaining to the safety-related activities of the West Valley site are the responsibility of the QAS. The responsibilities include: assurance that quality problems are identified and reported to NFS management and surveil-lance of :alected activities.
Particular attention is directed to verifying the conformance of materials, items or systems with the specifications, material certifications, test data and vendor inspection on safety-related items. Audits of vendors as necessary are performed undar his direction and he reports the results of these directly to the Quality Assurance and Licensing Manager.
The QAS also has the responsibility of verifying that regulations and Technical Specifications are adhered to in day-to-day operations.
Supporting Staff Applicable to Quality Assurance The Quality Assurance and Licensing Manager will supplement his staff, as required, to provide technical and inspection support to assure that the quality assurance program is being implemented as established and the quality related problems are properly evaluater..
Program, policy and procedural changes are evaluated to verify that the change does not compromise the safety-related quality of the facility. To carry out tnis responsibility, the Quality Assurance Manager, through appropriate channels. obtains the services of the requisite engineering, scientific and clerical disciplines to implement special reviews and evaluations of safety-related activities.
The following management personnel have quality assurance responsi-bilities:
Vice President - Engineering The Vice President, Engineering is responsible for the activities at the site.
He provides an effective safety program which assures that activi-ties are in accordance with regulatory requirements and that the systems, components and structures are maintained, operated and reviewed to assure quality standards commensurate with their safety-related function.
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. 6 General Manaaer The General Manager has been delegated the responsibility for overall direction of the site activities.
The specific responsibilities include:
The management, througi. his departmental managers, of all activities carried on at the plant; Establishment of written and approved procedures for those areas of the plant which are being operated; Review of existing procedures and assuring that all procedures are up-to-date and in use; Investigation of abnormalities and maloperations and reporting of the circumstances and his recommendations to NFS corporate management; Recommendation of plant modifications or changes required for safety considerations; and Serve as Chairman of the Plant Safety Committee.
The General Manager is kept currently informed of the status and results of the quality assurance program including audits, inspection, deficiencies and non-conformances, and takes appropriate corrective action where necessary.
The General Manager may authorize his staff to undertake the following quality - and safety-related activities:
Carry out operations and maintenance required to keep the plant in a safe and high quality state; and Stop or change activities as required to protect the safety of plant personnel and the general public.
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2-7 2.3 Operational Control A number of operation controls are applied to:
Planning for activities; Acceptance of modified systems, structures, or components; Administration of technical specifications; Standard operating procedures; Surveillance of operations; Periodic review of operations; Incident reporting; Maintenance programs; and Special processes.
The manner in which such controls are applied and maintained is given in the following sections.
2.3.1 Planning for Activities Planning for maintenance and testirg includes documents (such as schedules, procedures, manuals, parts lists, and drawings) by which the safety-related activities are identified and controlled and the results o the activities are evaluated and reviewed.
Plans and documents for safety-related operaticnal and maintenance activities are submitted to the Plant Safety Committee for review and approval; quality-related aspects of safety-related items must be specifically approved by quality assurance personnel.
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2-8 2.3.2 Technical Specifications Proposed Technical Specifications are submitted to the USNRC for re-view and approval and then incorpirated into the Operating License.
These Technical Specifications define the operating restrictions and limits and d
delineate safety-related requirements of the plant, its systems and equipment.
Written procedures (See Section 2.3.3) approved by the Plant Safety Committee are established to implement these requirements and to assure that adequate operating margins of safety are being used. Quality assurance audits and in-spections are made to verify that the plant operatins, maintenance and modifi-cations are being done in conformance to the Technical Specifications. The Quality Assurance Supervisor verifies that these requirements are carried out and reports the results of his audits to plant management and the Quality Assurance and Licensing Manager.
2.3.3 Operating Procedures A system of procedures and instructions pertaining to personnel control, equipment usage and control of operations ar a maintenance has been established.
The details of the operational management system takes the form of several different typ of procedures and instructions including Special Instruction Procedures (SIP.), Temporary Operating Procedures (T0Ps), Standard Operating Procedures (S0Ps), Letters of Authorization (LOAs), Run Plans and Instruction Logs.
2.3.3.1 Special Instruction Procedures Special Instruction Procedures (SIPS) are issued for tasks that are unique and/or must be performed in a carefully ordered sequence.
SIPS are separated into instructions and procedures for operations and maintenance on safety-related activities, and instructions and procedures to operate special equipment that is different from other equipment used for similar purposes which does not have safety significance.
There is no established fonnat for an EIP.
It contains special in-structions for special projects and is formatted accordingly. The purpose and scope are presented and step-by-step procedures are included. Responsi-bility for preparation of SIP lies with the Technical Services or Operatiuns l}43 348 9/79
2-9 Department. SIPS shall be reviewed and approved by the Safety Committee prior to each use. There is no authorization granted :o any individual to override the requirements of a safety-related SIP withot; approval of the Safety Com-mittee.
2.3.3.2 Temporary Operating Procedures Temporary Operating Procedures (T0Ps) are used in those situations where new equipment is to be put in use or where the operating procedure is to be used for only a short period of time. The TOP is automatically cancelled at the end of either the period for which it was used or three months, which-ever is longer.
If the provisions of the TOP are to be followed on a contin-uing basis, they are incorporated into a Standard Operating Procedure.
1.ike SIPS, TOPS are separated into categories with safety-related aspects and without safety significance.
The following description of requirements applies to all TOPS which have safety-related aspects.
Plant Safety Commitee review and approval is required prior to its implementation.
TOPS may be used in situations where frequent variations are expected.
Variations to the TOP which clearly do not change the intent of the approved procedures are authorized and can be made by a Shift Supervisor or other technical personnel involved in the implementation of the procedure.
Temporary changes which may involve a change in intent of the approved proced-ure must have the approval of the Operations Manager. There is no authorization granted to any individual to override the " Cautionary Notes" as specified in the TOP without Plant Safety Committee approval.
2.3.3.3 Standard Operating Procedures The Standard Ope oting Procedures are a detailed, step-by-step set of instructions which represent approved, preplanned methods to conduct opera-tions in a safe and orderly manner and which are intended to minimize arbitrary, unplanned actions and to preclude reliance on memory for procedural details.
Each S0P consists of a brief statement of the purpose for which it is to be used; the applicable area, location and description of equipment; a general outline of procedure in order to provide an understanding of the principles involved and how the equipment or system functions; a listing of special prt-cautions to be observed; and detailed, step-by-step instructions to permit the implemention of the procedure.
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2-10 Each S0P is reviewed and approved by the Plant Safety Committee prior to being issued and implemented initially, and is reviewed and approved at least annually thereafter even if no changes are required.
Sufficient flexibility is inherent in each S0P to cover the range of operating conditions as specified in the Run Plan. Special Precautions are stated for each S0P and the operators are never permitted to violate these "Special Precaution" provisions.
2.3.3.4 Letter of Authorization (LOA)
This document specifically authorizes either the receir' and storage of nuclear materials at the plant or the transport of nuclear materials from the plant. A separate LOA s issued for each lot of nuclear fuel materials received, stored or shipped.
Specific information included in the LOA describes the radio-active materials, defines the equipment to be used to carry out the LOA instruc-tions, and references the S0Ps (or TOPS) and/or transport packaging information required.
The LOA and all changes thereto are approved by the Plant Safety Commit-tee prior to being issued and implemented.
Safety-related deviations or varia-tions of the LOA conditions during its implementation are reported to the Operations Manager for corrective action and further instructions.
2.3.3.5 Run Plan Operational parameters and conditions are set forth in the " Shutdown Run Plan" which identifies the limits which are maintained during the present status of the site. All such limits (instrument settings, sampling frequency for each sampling point or station, and special precautions or conditions) are in conformance with the Technical Specifications, the operating license, and within limits prescribed by the approved operating procedures. The Technical Services Department in conjunction with the Operations Department prepared the
" Shutdown Run Plan" which was reviewed and approved by the Plant Safety Committee.
2.3.4 Transport Package Information The specific information required by 10 CFR 71.12 will be obtained by h?S, reviewed and incorporated, as appropriate, into the LOA prior to NFS' de-livary to a carrier of a transport package containing radioactive material sub-ject to 10 CFR 71.
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2-11 2.3.5 Surveillance.ctivities The operational quality assurance program includes surveillance activi-ties which are directed toward the detection and prevention of failures.
Rec-ords, data tabulations, instrument charts and logbooks are reviewed. The sur-veillance effort is c u ried out by the Technical Services Department to assure that specific characteristics of a system are examined.
The results of these surveillance activities are reported to the Plant Manager, Operations Manager, Quality Assurance Supervisor, and the Plant Safety Committee.
The Quality As-surance Department audits the surveillance activity program carried out by the Technical Services and Maintenance Departments and submits its findings to the plant and corporate management.
2.3.6 Plant Safety Committee The Plant Safety Comittee is required by the Technical Specifications ar'
,s responsible for the review and approval of:
(1) Special Instruction Procedures with significant safety aspects (SIPS), Temporary Operating Procedures (TOPS), Standard Operating Procedures (S0Ps), Run Plans and Letters of Autharization (LOAs),
and Emergency Procedures; (2) changes in process equipment design other than those permitted by a Safety Comittee-approved procedure; and (3) investigation of all abnormal occurrences relative to nuclear criticality safety or radiological safety.
The Committee 4
--de up of personnel assigned to functional positions as follows:
Committee Member General Manager (Chairman)
Operations Manager Technical Services Manager Health and Safety Manager Quality Assurance Supervisor (Secretary)
The procedures which govern the actions and responsibilities of the Committee are set forth in the Plant Administration Procedures and in the Opera-tions Manual for Quality Assurance.
These procedures provide for reporting I143 351
- 2-12 format, notification of meetings, preparation of agenda, submittal of review, distribution ci documents, conduct of investigations, and recommendations concerning corrective actions by the appropriate management organization.
2.3.7 Reperting of Incidents and Corrective Actions Incident reports required by the provisions of Federal Regulations include a description of the occurrence, a statement of the then prevailing conditions, an analysis of the probable cause, and a summary of the corrective actions taken.
Sufficient information is included to pemit the safety impli-cations of the incident to be evaluated by appropriate responsible management personnel.
These reports are prepared by the responsible department and submitted to the General Manager.
If required, these incidents are reported to the cog-nizant NRC office as stipulated in the Commission's Regulations 10 CFR Parts 20, 21, 50, 70, 71 and 73, or the Department of Transporation's Regulation 49 CFR Part 173.
2.3.8 Maintenance Program The maintenance of safety-related items is performed through proced-ures which are established and implemented for identifying and authorizing the kinds of maintenance, replacement, adjustment, or repair that can be carried out routinely in contrast with those modifications which require review and safety analysis. The program includes praventive maintenance, repair, replace-ment and calibration of items, equipment and systems.
Each of these is discussed in the following subsections.
2.3.8.1 Preventive Maintenance The preventive maintenance program is intended to detect and repair or replace worn or failing items before failure occurs, thereby assuring reli-able operation of all safety-related systems.
Use is made of two categories for identification and control of items requiring preventive maintenance actions; namely, Tickle File and the Lubrication Chart.
Items within each category are scheduled to be examined at least annually.
Maintenance personnel are regularly assigned to complete specific tasks; satisfactory completion is indicated by Ii43 352 9/79
2-13 sign-off; follow-up requirements or difficulties are noted and reported to the Operations Panager who initiates corrective action.
Generally, preventive maintenance is routine and procedures are used without individual approval being required prior to the actions being taken.
However, the maintenance performed on equipment in high radiation areas or where criticality considerations may present a concern, special work proced-ures and permits are used.
Records are kept for equipment maintenance on safety-related items to provide a historical documentation of tne frequency of repair compared to preventive maintenance attention.
In this way, more frequent maintenance can be easily directed toward trouble-producing items and system weaknesses are identified.
Two Tickle Card Files are used to assure that the maintenance of safety-related items is not inadvertently overlookea and that the items are maintained as required on the astablished frequency.
The Operations Tickle File refers to items maintained by the Operations Department; other items are maintained through the Maintenane. Tickle File.
In each Tickle File system, the card contains the items to be maintained along with the frequency and specific instructions or references by which the work is carried out.
Upon completion of the work defined on the Tickle File Card, the card is dated and initialed.
Suggestions, deficiencies or defects concerning the assigned item are reported to the Operations Manager for corrective action.
Safety-related plant equipment items requiring lubrication services are listed on and lubricated according to the Maintenance Lubrication Schedule.
This master chart of lubriaction requirements designates the specific location and requirements of each item; upon completion of the lubrication, the schedule is dated and initialed.
2.3.8.2 Repair and Replacement If a safety-related item fails, the failure is recorded in the equip-ment file and in the Maintenance Log and procedures for repair or replacement are initiated.
Replacement of "like-kind"; i.e., replacement with another item of identical specifications, is authorized without additional specific IM3 353 9m
2-14 approvals by the Plant Safety Committee.
Replacement of a failed item with one whose specifications differ from those of the failed item requires a safety and design review.
Modifications to safety-related items must meet the same or more stringent specifications than the item which was replaced or must receive approval by the Plant Safety Comittee prior to such changes being made.
If the requirements and specifications are changed from those stipu-lated for the replaced item, a design review and evaluation mur be made to verify that the individual and overall safety margins are not degraded or compromised.
In situations wherein a Technical Specification or Certificate of Compliance condition is involved, a formal approval is required from the NRC before the change is made.
2.3.8.3 Instrument Calibration Plant instruments which are being used are calibrated and maintained in accordance with routine, prepared procedures and schedules. A master list of the plant instrumentation stipulated the frequency of calibration and main-tenance requirements for each instrument. Completion of a calibration is noted by the initials of the instrument shop employee making the calibration; any repairs or calibration adjustments made are also recorded in the instru-ment file for the particular instrument.
2.4 Inspection and Testing Inspections of activities that affect safety-related activities are routinely performed to assure continuing conformance to documented instruc-tions, procedures and drawings.
Secondary measurement methods, including recording devices and monitoring instruments are used when direct inspection is not desirable because of radiation levels, concentrations of radioactive materials, criticality considerations or because shielding and the structures themselves prevent a direct inspection.
The routine use of the inspection and testing equipment is the re-sponsibility of the Operations or Maintanance Department, as applicable.
The Technical Services verifies that the appropriate inspection and testing 9/79 II43 354
2-15 capabilities are used as specified and directed; Quality Assurance conduc';s an overall audit of the entire program.
2.4.1 Testing Program Testing programs including qualification tests, acceptance tests, and performance tests are carried out.
For such programs the following assur-ances are obtained and verified:
Instrumente are adequately calibrated; Personnel are trained and qualified; cffluent release, confinement and contamination controls are operable and adequate; Appropriate environmental controls for components, systems and personnel are available and in use; Emergency procedures and programs are up to date and implemented; and Requirements and specifications of the licenses and the regulations are observed and operations are within proper compliance.
Results of the test programs are documented and evaluated to assure that the test requirements are met. Deviations and apparent nonconformances are sub-mitted to the appropriate management for consideration and disposition and the Plant Safety Committee if corrective actions involving safety-related equipment are required.
s 2.4.2 Inspection, Test and Operating Status The current status of each test and inspection item is clearly deline-ated by the use of dated and approved tages, stickers, reports, labels, cards, or other suitable means to assure that the required inspections and tests have been and are being performed, that the status of each inspection and/or test is always identified and readily determinable, and that a formal, prescribed system is used to identify the status and current adequacy of gauges and test equipment.
Items that are deficient, defective or othemise do not conform to the specifications and requirements are uniquely identified and whenever possible are quarantined or segregated pending decision to repair or replace.
Items to be discarded are inactivated so that they cannot be inadvertently used.
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2-16 2.4.3 Measuring and Test Equipment Procedures, instructions and schedules are established to assure that the gauges, instruments and measuring and testing equipment are calibrated and adjusted and are used in such a way that results obtained correctly and accurately represent the then current condition of the item being examined. Calibration and measurement standards are certified and traceable to accepted references (such as National Bureau of Standards).
The records for calibrations are com-plete and available for review and updating.
2.5 Purchased Materials, Equipment and Services Controls are established to assure that purchased materials, equipment and services used in plant or transport activities are subjected to equivalent reviews, evaluations and restrictions that were applicable in the initial de-sign and construction of the plant or transport package, and that the overall quality and safety of the plant or transport package are not degraded or com-promised by use of replacement materials or equipment of lesser quality. These controls comprise procurement documents, item identification and traceability of purchased items when received, receiving inspection, identification of non-conforming material, and corrective actions.
2.5.1 Procurement Document Control Documents for procurement of materials, equipment and services which involve safety-related activities or items either contain or reference the ap-plicable regulatory criteria, codes, standards or other requirements which are necessary to stipulate and establish the requisite level of quality.
Procure-ment documents include provisions for the following, as applicable:
Primary technical requirements including drawings, test and specifications requirements, special instructions, applicable codes and industrial standards; Quality assurance program requirements wSich are applicable to the contract or order; Ii43 356 9"9
2-17 Surveillance and inspection at the manufacturer's plant, including access by NFS or its agents to the manufacturer's plant and records as required for quality assurance purposes; and Documentation, to be provided by the manufacturer, including records which are to be prepared, maintained, submitted, or made available for review (drawings; specifications; procedures; procurement documents; inspection and test records; personnel, process, and equipment qualifications; and physical and chemical test results). Provisions are included to establish the schedule and manner for retention or ultimate disposition of the records.
The Purchasing Department, in conjunction with originating department is responsible for assuring that all applicable information, restrictions, and requirements are included in the purchase request.
Quality assurance audits the NFS procurement documents to verify that the requisite controls are being applied.
2.5.2 Control of Purchased Items Controls are applied to safety-related materials, new and replacement parts, equipment, systems, and services involving these items.
The items to be controlled in this matter are identified.
Quality Assurance audits the purchasing records to verify that identified items are being controlled as specified.
When necessary, Quality Assurance inspects and audits the suppliers and reviews the test reports, inspection records, and certifications.
Corrective actions are taken as required in accordance with the provisions of the purchase order and the established quality program.
2.5.3 Receiving Inspection Receiving inspection activities are coordinated with the surveillance and inspection activities performed at the vendor's facility. This includes assuring that items have not been damaged in shipment and are stored and preserved satisfactorily.
Sampling methods for inspection of items may involve destructive
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2-18 measurement or analytical techniques.
In such cases a sample size and a method of analysis are established which will verify the quality is in accordance with the purchase documents.
During vendor inspection and prior to acceptance of safety-related items, quality assurance inspectors review the vendor documents, drawings, certifications, test results and the vendor-inspection data for completeness, acceptability and conformance to purchase order requirements.
2.5.4 Non-Conforming Items Items that do not meet the specification requirements are identified, controlled and subjected to special handling.
The responsibilities for the control of non-conforming items are NFS' during the present status of site activities; non-conforming items are quarantined and separated from conforming, acceptable items when practical.
2.5.5 Corrective Action Pertaining to Purchased Items Purchased items received at the site which do not conform to the terms of the purchase order and specifications are segregated when practical to prevent the use of defective items which could cause quality degradation.
The program provides a mechanism for taking action to correct or otherwise dispese of non-conforming items. Special attention is given to measures for preventing a recurrence of the non-conformance including, where necessary, removal of a vendor from the bidders list.
Corrective Action Requests are used to identify those deficient items which were intended to be used for operations and maintenance activities.
The Corrective Action Request is distributed to the department which requisitioned the item and also to quality assurance.
These reports are evaluated by appro-priate personnel who make recommendations for actions to correct and prevent the recurrence of the deficient conditions.
The implementation of the recommendations for corrective acticns is audited by quality assurance; the.Tractiveness thereof is routinely reported to management.
Continued submittal of non-conforming items will require that a vendor either be formally requalified or removed from the qualified list.
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2-19 2.5.6 Shipping and Handling As required, vendors provide inspection and handling control of items shipped to the plant to assure that:
The items to be shipped have been irspected and have passed the required inspections and tests; Proper packaging, preservative measures and handling precautions have been used; and Proper identification has been placed on items and packages.
Repe1ted non-conformance of received items caused by poor shipping practices will be a reason for removing a vendor from the bidders list.
2.6 Documents, Records, and Audit-Inspections A continuing function of quality assurance is to assure that documents and records are maintained as useable for the NFS management to evaluate the adequacy of the quality assurance program.
Audits and the records thereof constitute a primary check-and-balance on the conformance of the activities to the quality assurance program requirements.
2.6.1 Records Records maintained include the applicable regulatory and NFS quclity assurance documents and records developed during the course of operation, maintenance, shutdown and cleanout, and modification of the plant.
Such records and documents include but are not limited to the following:
Operating, inspection, and maintenance logs; Results of analyses, tests, inspections, reviews, and audits; Training, certification and qualification of personnel; Radiation exposures and radioactive effluent releases; lJ43 "<S9 9/79
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2-20 Shipment and receipt of radioactive materials including packaging tests; Procedures (SOP,10P, SIP);
Run Plans and Letters of Authorization; Surveillance records and operational reviews; Maintenance procedures and records; Modifications to the plant or transport packaging and authorizations therefor; Incident reports and corrective actions taken; and Quality Assurance inspection, audit and evaluation records.
NFS has established for each set of documents a retention period con-sistent with the importance of the quality-related records; the assigned storage location and the responsibility therefor are also stipulated.
2.6.2 Document Control NFS has established a system to control the issuance of and changes to all procedures, specifications and drawings. Quality Assurance periodically audits the working files, logs and documents, as appropriate, to assure that only approved versions are available and in use.
2.6.3 Audits NFS performs periodic audits which are described in the Operations Manual for Quality Assurance to determine the effectiveness of the quality assurance program, and to assure that the quality assurance program and safety-related activities of operation, maintenance and modification confonn to the applicable codes, standards, license conditions and the regulatory and NFS requirements pertaining to quality. Through these audits NFS verifies that:
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2-21 The quality assurance program is adequate to assure that the operations, maintenance, and modification activities are being conducted in conformance to the proper procedures and instructions; Deficiencies, corrective actions required, and quality-related activities are being reported to the appropriate management; Documentation is being prepared in a manner such as to assure complete retention of the quality-related information and to facilitate retrieval of such information; and That the applicable corrective actions are being implemented.
At the plant level, a program has been established to provide regular audits.
Regulatory or license requirements are identified by a specific audit task.
Each task identifies the requirement, the plant procedures to comply with the requirement, and the frequency of the audit (monthly, quarterly, or annual), based on the importance of the requirc ant to radiological or nuclear safety.
On a timely basis, each task is audited by the Quality Assurance Supervisor who reviews plant records to assure compliance to the require-ment and that proper documentation is available.
The Quality Assurance Supervisor issues a regular report to the General Manager which details the status of the audit program. The report includes identification of the audit tasks performed, and any quality related problems noted.
For each quality problem identified, subsequent reports detail corrective action and follow-up investigations until the problem is resolved.
On an annual basis, the Corporate Quality Assurance Manager is responsible for an audit of the plant level quality assurance program.
He may conduct the audit personally or appoint an audit team independent cf the site acti vii.ies.
Tne corporate audit reviews the plant level program for completeness and reviews quality assurance records to verify implementation of the procedures documented within the program.
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2-22 Technical specifications also require that plant management shall provide for periodic audits of the operations throughout the entire f;cility with regard to radiological and nuclear safety. These audits shall be performed by competent company or other technical personnel not directly responsible for the operation audited, 1l43 362 Elb's6