ML19276H514
| ML19276H514 | |
| Person / Time | |
|---|---|
| Site: | 07100225 |
| Issue date: | 11/02/1979 |
| From: | NAVY, DEPT. OF, NAVAL RESEARCH LAB. |
| To: | |
| Shared Package | |
| ML19276H510 | List: |
| References | |
| NUDOCS 7911290042 | |
| Download: ML19276H514 (7) | |
Text
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10 CFR PART 71 QUALITY ASSURANCE PROGPAM FOR NAVAL RESEARCH LABORATORY 4555 OVERLOOK AVENUE, S.W.
WASHINGTON, D,C. 20375 1.
INTRODUCTICN The Naval Research Laboratory conducts a broadly-based multi-disciplinary program of scientific research and advanced technological development directed toward new and improved materials, equipment, techniques, systems, and related operational procedures for the Navy.
As an important part of this mission, the Laboratory performs scientific research and development for other Naval Comands and, where specifically qualified, for other agencies of the Department of Defense and, in defense related efforts, for other Government agencies.
Specifically, the Laboratory performs thermostructural materials research for the Navy, the Department of Energy, and the Nuclear Regulatory Comission which requires the packaging and periodic shipment of significant quantities of highly radioactive metallurgical specimens for disposal as waste.
In addition, the Laboratory possesses a number of sealed, Type B and Large Quantity sources which may ' e c
shipped for temporary use by Laboratory perscnnel at other locations or permanently transferred to other licensees.
Such activities require the following Quality Assurance Program.
2.
ORGANIZATION The Naval Research Laboratory, see Attachment I for organization chart, is contr.anded by a Navy Captain, who appoints a Radiological Cemittee and assigns it the responsibility for overseeing all matters of radiological safety. The Comittee consists of five civilian scientists, a Navy Officer, the Medical Officer, the Safety Officer, and the Radiological Safety Officer.
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$32 ENCLOSL'RE (1) to NR'. L7R 6070-49 7911290 gyZ
ine Radiological Safety Officer is responsible for conducting the Lcboratory's Radiological Safety Program, as well as for establishing and executing the Quality Assurance Program required by 10 CFR 71 -
Appendix E.
Administratively, he reports to the Associate Director of the Material and Radiation Scier.ce and Technology Directorate, but in matters pertaining to Radiological Safety or quality assurance, he reports directly to the Commanding Officer.
In administering the Quality Assurance Program, the Radiological Safety Officer must assure that all packaging is handled, : hipped, stored, cleaned, assembled, inspected, tested, maintained, and repaired in accordance with the specifications in Appendix E.
In addition, he shall assure that all packaging purchased for use in this program meets applicable specifications.
The Laboratory utilizes neither contractor nor consultant personnel in conducting this program and retains and exercises full responsibility for its successful execution.
3.
QUALITY ASSURANCE PROGRAM The Laboratory utilizes four Department of Transportation Specification 55 Casks to dispose of Type S quantities of radiological waste. These casks were registered by the Bureau of Explosives on 8 July 1969. There is no plan to purchase additional waste shipping containers unless the Soecification 55 container becomes obsolete.
If thic occurs, only NRC/ DOT-certified shipping containers will be purchased and used.
From time to time, the Laboratory also may be required to ship a sealed, Type B or Large Quantity source. Such shipments will be made in comercially available packaging which is certified by the manufacturer as confonning to applicable NRC/00T specifications, Any dispute involving the quality of these containers will be resolved by qualified, non-involved personnel appointed by the Commanding Officer.
In connection with the use of these shipping containers, the Radiological Safety Officer is responsible for establishing, executing, and revising & Quality Assurance Program in accordance with established procedures and, with management approval, ensuring that all applicable quality control procedures, engineering procedures, and specific provisions of container design approval are satisfied. The Program must emphasize control of the c'sracteristics of the container which are critical to safety and assure that quality-related activities are performed with specified equipment under suitable environmental conditions, and that all prerequisites have been satisifed prior to inspection and test.
It also must contain a training and indoctrination program which 2
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clearly defines its scope, objectives, and methods of implementation; instructs personnel performing quality-related activities as to the purpose, scope, and implementation of quality assurance procedures and instructions; trains and qualifies such personnel in the principles and techniques of the activity being pceformed; and provides for retraining, reexamining, and recertifying of these personnel to maintain proficiency.
The Quality Assurance Program is assessed regularly by management to assure that its scope, status, implementation, and effectiveness is adequate and that it complies with the criteria of Appendix E to 10 CFR 71.
4.
PROCUREMENT DOCUMENT CCNTROL The Quality Assurance Program clearly delineates the sequence of actions to be followed in the preparation, review, approval, and control of procurement documents and requires that:
a.
Procurement documents identify the requirements in Appendix E of 10 CFR 71 which must be complied with and described in the supplier's quality assurance program.
b.
Procurement documents must contain or reference the design basis technical requirements, including the applicable regulatory requirements, material and component identification requirements, drawing specifications, codes and industrial standards, test and inspection requirements and special process instructions, c.
Procurement documents must identify the documentation (drawings, specifications, procedures, inspection and fabrication plans, inspectio' and test records, perso.nel and procedures qualifications, and chemical and physical test resuits of material) to be prepared, maintained,and submitted to the purchaser for review and approval.
d.
Procurement documents specify the procuring agency's right of access to the supplier's facilities and records and for source inspection and audit.
5.
INSTRUCTIONS, PROCEDURES, AND DRAWINGS Activities affecting quality shall be prescribed and accomplished in accordance with documented instructions, procedures, or drawings.
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6.
DOCUMENT CONTROL The review, approval and issue of documents, and changes thereto, are procedurally controll,ed, prior to release, to assure that they are adequate and that quality requirements are stated.
Changes to documents shall be reviewed and approved by the same organizations that performed the original review and approval, or by other equally qualified, responsible organizations, Approved changes shall be included in instructions, procedures, drawings, and other documents prior to implementation of the changes.
A master list, identifying the current revision number of instructions, procedures, specifications, drawings, and procurement documents, shall be established and maintained.
Applicable documents shall be avilable at the location where an activity is to be performed prior to commencing work.
7.
IDENTIFICATION AND CONTROL OF MATERIALS, PARTS, AND COMPONENTS If required, procedures will be established to identify and control materials, parts, and components, including partially fabricated sub-assemblies. Appropriate documentation, such as drawings, specifications, purchase orders, manufacturing and inspection documents, deviation reports, and physical and chemical mill test reports will be maintained to identify materials and parts important to the function of safety-related systems and components. Finally, identification of materials, parts, and components will be verified and documt:nted prior to their release for fabrication, assembly, and installation.
8.
CONTROL OF SPECIAL PROCESSES Where necessary, special processes such as welding, heat treating, nondestructive testing, and cleaning will be procedurally controlled, 9.
INSPECTION A program for the inspection of activities affecting quality shall be established to verify conformance with documented instructions, procedures, and drawings for accomplishing the activities. Sucn inspections shall be conduchd by personnel who are independent from the activity being inspet.,ed.
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- 10. CONTROL OF MCASURING AND TEST EQUIPMENT Measuring and test devices used in activities affecting quality shall be calibrated at specified intervals based upon required accuracy, purpose, degree of usage, stability requirements, and other conditions affecting measurements.
Reference and transfer standards used in calibration shall be based on nationally recognized standards.
When such standards do not exist, the basis for calibration shall be documented.
- 11. HANDLING, STORAGE, AND SHIPPIN Handling, preservation, storage, cleaning, packaging, and shipping shal be accomplished by qualified individuals in accordance with established procedures. They shall assbee that all conditions 'or NRC package approval and 00T shipping requirements are satisfied prior to shipment. They also shall assure that necessary shipping papers are prepared and that the departure, arrival, and destination of the package is established and monitored consistent with the safe transportation of the package.
12.
INSPECTION, TEST, AND OPERATING STATUS Procedures shall be established which will control the application and removal of inspection and welding stamps and other status indicators such as tags, labels, markings, and stamps to assure that required inspections, tests, and other critical operations are not bypassed and that the inspection, test, and operating status of packaging and components is known by affected organi::ations. The status of non-conforming, inoperative,or malfunctioning packages or ccmponents shall be diearly identified.
- 13. NONCONFCRMING MATERIAL, PARTS, OR COMPONENTS Procedures shall assure that affected organizations are made aware of nonconforming materials, parts, components, or services by means of identification, documentation, segregation, review disposition, and notification.
- 14. GUALITY ASSURANCE RECORDS Sufficient, identifiable,and retrievable quality assurance records
- hall be mintained to orovide documentary evicence of the quality and sa?ety of the items and activities affecting quality and safety. These O24 t
records shall include operating logs; results of reviews, inspections, tests, audits, and material analyses; qualification of personnel, procedures, and equipment and other documentation such as drawings, specifications, procurement documents, calibration procedures, and reports, as well as nonconfonnance and corrective actions reports. A list of these records and their storage locations shall be maintained.
Where applicable, inspection and test records shall contain the
, following:
a.
a description of the type of observation b.
evidence of completing and verifying a manufacturing, inspection, or test operation c.
date and results of the inspection or test d.
information on conditions adverse to quality e.
identification of inspector or data recorder f.
evidence as to the acceptabili cy of the results.
Design related records shall be maintained for the life of the shipping container while all other records shall be maintained for at least two years.
- 15. AUDITS Each activity covered by this Program shall be audited at least once per year by personnel having no direct responsibility in the areas being audited. Audits are performed in accordance with preestablished, written procedures and the resul ts are documented and reviewed with management responsible for the area audited. Responsible management shall take such actions as is necessary to correct reported deficiencies and a timely reaudit shall verify implementation of corrective actions to minimize recurrence of the deficiencies.
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ji ATTACHMENT 1
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