ML19284B690
| ML19284B690 | |
| Person / Time | |
|---|---|
| Site: | 07100382 |
| Issue date: | 10/20/1980 |
| From: | INTERIOR, DEPT. OF, GEOLOGICAL SURVEY |
| To: | |
| Shared Package | |
| ML19284B688 | List: |
| References | |
| 17707, NUDOCS 8011120661 | |
| Download: ML19284B690 (12) | |
Text
.
O THE UNITED STATES GEOLOGICAL SURVEY TRIGA REACTOR FACILITY QUALITY ASSURANCE PROGRAM FOR 10 CFR 71 SHIPMENTS OF RADIOACTIVE MATERIALS October 20. 1980 Date om A
i 8011120 ggj
Table of Contents Title P2ge Table of Contents i
1.
Introduction 1-1 2.
Quality Assurance 2-1 2.1 Organization 2-1 2.2 Scope 2-2 2.3 Design Control 2-2 2.4 Procurement Documents 2-3 2.5 Instruction, Procedures, and Drawings 2-4 2.6 Document Control 2-4 2.7 Control of Purchased Material, Equipment, and Services 2-5 2.8 Identification and Control of Materials, Parts and 2-6 Components 2.9 Control of Special Processes 2-6 2.10 Inspection 2-6 2.11 Control of Measurement and Test Equipment 2-7 2.12 Handling, Storage, and Shipping 2-7 2.13 Inspection, Test, and Operating Status 2-8 2.14 Nonconforming Material, Parts, or Components 2-8 2.15 Corrective Action 2-8 2.16 Quality Assurance Records 2-9 2.17 Audits 2-9 i
1.
INTRODUCTION Licensees authorized to package radioactive material for transport or transfer such materials to a carrier for transport are required to maintain and follow a NRC approved Quality Assurance (QA) Program. This QA program has been developed to meet the NRC requirements imposed by 10 CFR 71 and upon approval will be followed by the U.S. Geological Survey TRIGA Reactor (GSTR) facility.
The program is applicable to any GSTR activity involving the design, manufacture, maintenance, or use of NRC licensed shipping packages or the packaging and shipment of radioactive materials pursuant to 10 CFR 71.
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2.
QUALITY ASSURANCE 2.1 Organization Responsibility for the development and implementation of the quality assurance progran is assigned to the Reactor Supervisor.
Responsibility for execution of parts of this program may be delegated to individuals either within or outside the Reactor Group.
The Reactor Supervisor, or in his absence, the Senior Reactor Operator-in-Charge, has the responsibility and authority to stop unsar 'sfactory work and to control further processing, delivery, or installation c.
nonconforming material.
Under the direction of the Reactor Supervisor, the Reactor Group provides for the shipping of all spent fuel and fissile material and other by product material. Since no separate Quality Assurance group exists, these individuals, as necessary, provide for inspection or other verification by a second indivi-dual or by test, utilizing, if necessary, personnel outside the Reactor Group in order to assure a high degree of confidence that the shipping packages will perform satisfactorily in service. Experience and/or training for all QA functions will be required and accomplished in accordance with established procedures.
Where special qualifications or facilities are required, such as welders' certifications, personnel or organizations outside the Reactor Group may be assigned responsibility for the performance of specific qutlity assurance activities. Responsibility for acceptance, however, remains with the Reactor Group.
Distribution of QA documents and revisions the eto will be controlled by the Reactor Supervisor.
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2.2 Scope The quality assurance program includes those design, construction, maintenance, and coeration activities associated with the procurement, testing, use, maintenance, and repair of the shipping packages of 10 CFR 71 licensed material.
Any activity which could af fect the ability of such a structure, system, or component to perform safely and as specified falls within the scope of this quality assurance program. These activities include designing, purchasing, handling, shipping, storing, cleaning, inspecting, testing, maintaining, repairing, loading, and modifying. Where appropriate, these activities are carried out in accordance with written procedures, instructions, and drawings, as described in the following subsections. The QA progr'am will be applied in a graded approach, i.e., applied to an extent consistent with the importan~=
of safety.
The shipping packages within the scope of the program included are all shipping packages covered under 10 CFR 71.
In order to facilitate the preparation and revision of documents, to assure the appropriate reviews acd approvals, and to document operation of the quality assurance program, an approval requirements and document revision checklist will be used as required for specifying and recording required actions and QA approvals. The checklist will be used as necessary for the activities described in the following subsections.
2.3 Design Control The GSTR facility does not intend to be involved in the design of pack-ages.
Hcwever, in case of modifications of or additiens to those packages 2-2
within the scope of this quality assurance program, the Reactor Supervisor provides for a design review by the appropriate individuals whom he may des-ignate. The reviews are performed by individuals or groups other than those who performed the original design. The review assures that applicable regu-latory requirements and also the design basis as specified in the license or other approval applications are incorporated in the specifications, drawings, procedures, and instructions.
Documentation for the design verification reviews is provided in the form of approvals containing the signatures of at least two individuals who are familiar with the safety-related functions of the affected structures, systems, and components.
Assurance that the approved design is correctly implemented is accomplished by requiring that documents which fall within the scope of the quality assurance progr am shall be checked by a knowledgeable individual other than the one who prepared the documents and they shall be sigr.ed or initiai3d by both individuals.
2.4 Procurement Documents This facility will use shipping packages which have been licensed and manufactured by others for use by general licensees. Under such circumstances, we will have provided to us containers which have been manufactured pursuant to such licenses, Under these situations, certification will be provided for use wi th the authorized content.
The procurement documents shall identify the applicable 10 CFR Part 71, Appendix E requirements which must be complied with and described in the supplier's QA program. The documents shall also require that quality-related 2-3
activities be performed with specified ecalpment and under suitable environ-mental conditions and that prerequisites have been satisfied prior to inspection and testing.
The Geological Survey's right of access to supplier's. facilities and records for source inspection and aud t *,qall be specified in the procurement documents.
The Reactor Supervisor, or his designee, shall review and approve the specifications, drawings, procedures, or other documents which are part of purchase orders and contracts subject to the quality assurance program.
The Reactor Supervisor shall specify for which materials, equipment, and services the procurement documents will be reviewed.
2.5 Instructions, Procedures and Drawings Activities afft ting quality shall be prescribed where accropriate by documents which shall be prepared, approved, and retained on file.
2.6 Document Control Documents relating to a particular type of activity are, in general, prepared under the direction of the supervisor who is delegated the responsi-bility for maintaining a file of such documents, revising them to reflect approved design changes and as-built conditions, and clearly identifying the document as originally approved, and all civisions.
Distribution of docu-ments is subject to the approval of the Reactor Supervisor or other designated Individual, All approved changes will be included in instructions, procedures, drawings, and other documents.
Changes to documents shall be reviewed and approved by the same Reactor Group, person or group, or the same organization that performed the original review and approval, unless the Reactor Supersisor specifically designate 2 another responsible group or organization.
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Applicable documents will be available at the locations where the activity will be performed.
2.7 Control of Purchased Material, Eauionent and Services in general, all materials, equipment, and services are subject to inspec-tion and approval of both quality and quantity prior to acceptance.
Respon-sibility for these functions rest with the Reactor Superviser or his designee.
Inspection generally is performed after receipt of the material, equipment, or service at the reactor site.
The documentation (e.g., drawings, specifications, procedures, inspection and fabrication plans, inspection and test records, personnel and procedure qualifications, and chemical and physical test results of material) to be prepared, maintained, and submi tted to the Geological Survey for review and approval will be identified in the procurement documents.
Procurement documents will identify those records to be retained, controlled, and maintainea by the supplier, and those to be delivered to the Geological Survey prior to use or Installation of the hardware.
When considered necessary to assure quality, and particularly for non-standard items, only bids submitted by vendors deemed qualified and acceptable to the Reactor Supervisor, or his designated representative will be considered.
Contractors and suppliers are selected on the basis of references, past per-formance to the Geological Survey, reputation, and other investigation, Appropriate credentials, licenses if required by law, code, or regulation, will be furnished and retained on file. No deviations f rcn procurement documents are allowed without written request by the vendor and approval by the Reactor Supervisor or his designated representative.
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2.8 Identification and Control of Materials, Parts and Comoonents identification and control is required for materials, parts, or compon-ents where it is necessary to identify items through stages of fabrication, delivery, utilization, repair and/or modification.
2.9 Control of Soecial Processes The Reactor Supervisor may delegate the responsibility for incorporating into instruction, procedures, and drawings, used either for procurements or for control of internal activities within the scope of the quality assurance program, the applicable portions of codes and standards in order to assure that special processes, including welding and non-destructive testing, are accomplished by qualified personnel using qualified procedures.
Vendors will be required to furnish documented evidence of qualifica-tions, when applicable, including individual as well as company licenser or other proof of competence.
The Reactor Staf f, as appropriate, is responsible for surveillance of both vendor and in-house special processes when needed and for certifying to the Reactor Supervisor in written form that the work has been accomplished as specified.
The Reactor Supervisor may at times involve expert counsel on special problems. The written recommendation of the consultant shall be obtained and shall be part of the quality assurance file, but responsibili ty for acceptance of the work shall renair with the Reactor Supervisor or his designated alter-nate.
2.10 Insoection The inspection program includes examinations, measurenents. and tests to assure that materials, equipment, and services conform to the requirements 2-6
of applicable instructions, procedures, and drawings.
Quality in structures, systems, and components, affected by the above activities is assured thrcugh inspection and/or testing on cumpletion of a job or prior to use.
General require-ments for the inspection of purchased material, equipment, and services were stated in Section 2.7.
Packages which fail to meet the requirements of inspections or tests will be repaired and retested prior to use.
2.11 Control of Measurement and Test Equipment Measuring and test instruments shall be calibrated at specified intervals based on the required accuracy, purpose, degree of usage, stablility, character-istics, and other conditions affecting the measurement.
When measuring and test equipment is found to be out of calibration, measures shall be taken and documented to determine the validity of previous inspections pe r fo rmed.
Reference and transfer standards shall be traceable to nationally recoginzed standards; or, where national standards do not exist, the basis for calibration must be documented.
2.12 Handling, Storage, and Shicoing The handling, storage, and moving of casks and all parts of casks will be controlled to assure safety, prevent degredation, prevent damage, and prevent loss.
The package shall not be released for shipment until the QA program is canpleted including tests, inspections, and documentation.
Hand l ing, prese rvat ion, storage, cleaning, packaging, and shipping require-me.its are established and accomplished by qualified individuals in accordance with predetermined work and inspection instructions.
All necessary shipping papers will be prepared, and all conditions of the NRC package approval and the U.S. Department of Transportation shipping requirements will be satisfied prior to shipment.
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Identification of shipping cask will be traceable to the appropriate documentation; and departure time, arrival time, and destination of a package will be established and monitored to a degree consistent with the safe trans-portation of the package.
2.13 Insocction, Test and coerating status The status of shipping containers will be indicated by a tag, label, marking, a log entry, or other documentation.
The records will indicate when periodic surveillance tests have been performed.
2.14 Nonconforming Material, Parts, or Comoonents items found to be nonconforming in operation or in surveillance tests are recorded by identification number, if any, in appropriate documents and removed from service until repai red.
The identi fication, documentation, segregation, review, disposition, and notification to affected organizations of nonconforming materials, parts, components, or services will be in accordance with established procedures. -
The repair, transfer to other use, disposal, or other ultimate disposi-tion will be recorded. The repaired items must still comply with the original speci fications or approved modifications.
2.15 corrective Action Because of the relative small number of packages, most conditions adverse to safe operation are easily and quickly communicated.
Depending upon the i
importance of the deficiency, the information and corrective action may be transmitted to the Reactor Supervisor for a decision on appropriate corrective ac t i on.
Decisions as to corrective action are nade en a case by case basis, depending upon the nature, severity, and frequency of the deficiency.
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2.16 Quality Assurance Records Activities within the scope of the quality assurance program will be documented. Sufficient records will be maintained to provide documentary evidence of the quality of items and the activities affecting quality.
The QA records include operating logs; results of inspections, tests, and audits; and qualification of personnel, procedures, and equipment.
QA records will be identifiable and retrievable.
"he Reactor Supervisor will maintain a file of these records, and will be responsible for their maintenance.
Records will be retained a minimum of one year af ter shipment has been completed.
2.17 Audits Audits of the QA program will be performed by the Reactor Operations Committee which audits all operations of the Geological Survey TRIGA Reactor (GSTR) facility. These audits will be performed annually.
The results of the audits will be documented and reviewed with management having responsibility for the QA program. Management will take the necessary action to correct any deficiencies revealed by the audit.
Deficient areas will be reaudited on a timely basis to verify corrective actions have been implemented.
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