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Carbon (6) Cenum (58)
yielding horizontal surface, striking the surface in a position for which maximum damage is expected.
2. Puncture-A free drop through a dis. tance of 40 inches striking, in a position for which maximum damage is expected. the top end of a rertical cylindrical mild steel bar mounted on an essentially unyielding horizontal surface. The bar shall be 6 inches in diameter, with the top horizontal and its edge rounded to a radius of not more than one-quarter inch, and of such a length as to cause maximum damage to the package, but not less than 8 inches long. The long axis of the bar shall be perpendicular to the un. yielding horizontal surface.
3. Thermal-Exposure to a thermal test in which the heat input to the package is not less than that which would result from exposure of the whole package to a radiation environment of 1,475 F. for 30 minutes with an emissivity coefficient of 0.9. assuming the surfaces of the package have an absorp. tion coefficient of 0.8. The package shall not be cooled artificially until 3 hours after the test period unless it can be shown that the termperature on the inside of the package has begun to fall in less than 3 hours.
4. Water Immersion (fissile material packages only)-Immersion in water to the extent that all portions of the package to be tested are under at least 3 feet of water for a period of not less than 8 hours. (31 FR 9941, July 22, 1966, as amended at 33 FR 17623, Nov. 26, 1968)
APPENDIX C-TRANSPORT GROUPING OF
Astatine (85) Barium (56)
Hainium (72) Holmium (67) Hydrogen (1) Indium (49)
Berkelium (97) Beryllum (4) Bismuth (83)
See footnotes at end of table.
lodine (53) Continued | 125.
Fe 55 .....
Kr 85 m
Kr 87 (uncompressed)
Pb 212 ...... . ...
Lu 177.... . . ..
....... .... Mn 54......... .
Hg 197 m.
Hg 203..... .
Pu 238 (F)
K 43 Praseodymium (59) PI 112
Selenium (34) Silicon (14) Silver (47)
-----22222222222322522222ES5222=22522222222 23232322 23 =
Sulphur (16) Tantalum (73) Technetum (43)
Terbium (65) Thalhum (81)
See footnotes at end of table
APPENDIX C-TRANSPORT GROUPING OF
APPENDIX D-TESTS FOR SPECIAL FORM
Sn 117 m.
Sn 125 ... ..
nous paint, or absorbed
on sold material) Tungsten (74)
Xe 125 ...
Xe 135 (uncompressed)
Zn 69 m .......... . .. .
Zn 69....... ..... .
1. Free Drop-A free drop through a distance of 30 feet onto a flat essentially unyielding horizontal surface, striking the sur. face in such a position as to suffer maximum damage.
2. Percussion, Impact of the flat circular end of a 1 inch diameter steel rod weighing 3 pounds, dropped through a distance of 40 inches. The capsule or material shall be placed on a sheet of lead. of hardness number 3.5 to 4.5 on the Vickers scale, and not more than 1 inch thick. supported by a smooth essentially unyielding surface.
3. Hcating-Heating in air to a temperature of 1.475 F. and remaining at that temperature for a period of 10 minutes.
4. Immersion-Immersion for 24 hours in water at room temperature. The water shall be at pH 6-pH 8. with a maximum conductivity of 10 micromhos per centimeter. (Sec. 201. Pub. L. 93-438. 88 Stat. 1242 (42 U.S.C. 5841)) (31 FR 9941, July 22, 1966, as amended at 33 FR 17624. Nov. 26, 1968: 42 FR 25721, May 19. 1977)
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APPENDIX E-QUALITY ASSURANCE CRITERIA FOR SHIPPING PACKAGES FOR
RADIOACTIVE MATERIAL Introduction.-In accordance with $ 71.24. every applicant for an approval for use of a shipping package is required to describe his quality assurance program, and every licensee is required by $ 71.51 to establish and maintain a quality assurance program for the design. fabrication, assembly, testing, use', and maintenance of each packaging, as defined in $ 71.401).
This appendix establishes quality assurance requirements which apply to all activities affecting the components of the packaging which are significant to safety. These activities include designing. purchasing, fabricating, handling, shipping, storing, cleaning, assembling, inspecting, testing, operating, maintaining, repairing, and modifying.
As used in this appendix, "quality assurance" comprises all those planned and systematic actions necessary to provide adequate confidence that a system or component will perform satisfactorily in service. Quality assurance includes quality control, which comprises those quality assurance actions related to control of the physical characteristics and quality of the material or component to predetermined requirements.
* Atomic number shown in parentheses
Uncompressed means at a pressure not exceeding one atmosphere.
m-Metastable state. (F) Fissile material.
(31 FR 9941, July 22, 1966, as amended at 31 FR 10414, Aug. 3, 1966: 33 FR 17623. Nor, 26, 1968)
1. ORGANIZATION The licensee 'shall be responsible for the establishment and execution of the quality assurance program. The licensee may delegate to others, such as contractors, agents, or consultants, the work of establishing and executing the quality assurance program, or any part thereof, but shall retain responsibility therefor. The authority and duties of persons and organizations performing activities affecting the safety-related functions of structures. systems, and components shall be clearly established and delineated in writing. These activities include both the performing functions of attaining quality objectives and the quality assurance functions. The quality assurance functions are those of (a) assuring that an appropriate quality assurance program is established and effectively executed and (b) verifying. such as by checking, auditing, and inspection, that activities affecting the safety-related functions have been correctly performed. The persons and organizations performing quality assurance functions shall have sufficient authority and organizational freedom to identify quality problems; to ini. tiate, recommend or provide solutions; and to verify implementation of solutions. Such persons and organizations performing quality assurance functions shall report to a management level such that this required authority and organizational freedom, in cluding sufficient independence from cost and schedule when opposed to safety considerations, are provided. Because of the many variables involved, such as the number of personnel, the type of activity being performed, and the location or locations where activities are performed, the organizational structure for executing the quality assurance program may take various forms provided that the persons and organi zations assigned the quality assurance functions have this required authority and orga nizational freedom. Irrespective of the organizational structure, the individual(s) assigned the responsibility for assuring effective execution of any portion of the quality assurance program at any location where activities subject to this Appendix are being performed shall have direct access to such levels of management as may be necessary to perform this function.
ule for accomplishing the activities, a quality assurance program which complies with the requirements of this appendix. The quality assurance program shall be docu. mented by written procedures or instructions, and shall be carried out in accordance with those procedures throughout the period during which packaging is used. The licensee shall identify the material and components to be covered by the quality assur. ance program and the major organizations participating in the program, together with the designated function of these organizations. The quality assurance program shall provide control over activities affecting the quality of the identified materials and com ponents to an extent consistent with their importance to safety, and as necessary to assure conformance to the approved design of each individual package used for the shipment of radioactive material. Activities affecting quality shall be accomplished under suitably controlled conditions. Controlled conditions include the use of appropriate equipment; suitable environmental conditions for accomplishing the actil such as adequate cleanness; and assurance that all prerequisites for the given activity have been satisfied. The program shall take into account the need for special controls, processes, test equipment, tools and skills to attain the required quality, and the need for verification of quality by inspection and test.
The licensee shall base the requirements and procedures of his quality assurance pro. gram on the following considerations concerning the complexity and proposed use of the package and its components:
(1) The importance of malfunction or failure of the item to safety:
(2) The design and fabrication complexity or uniqueness of the item:
(3) The need for special controls and surleillance over processes and equipment:
(4) The degree to which functional compliance can be demonstrated by inspection or test; and
(5) The quality history and degree of standardization of the item.
The program shall provide for indoctrination and training of personnel performing activities affecting quality as necessary to assure that suitable proficiency is achieved and maintained. The licensee shall review the status and adequacy of the quality assurance program al established intervals. Management of other organizations participating in the quality assurance program shall regularly review the status and ade. quacy of that part of the quality assurance program which they are executing.
2. QUALITY ASSURANCE PROGRAM The licensee shall establish at the earliest practicable time, consistent with the sched
While the term "licensee" is used in this appendix, the quality assurance require ments are applicable to whatever design, fabrication, assembly and testing of the package is accomplished with respect to a package prior to the time a package approi'. al is issued.
3. DESIGN CONTROL Measures shall be established to assure that applicable regulatory requirements and
program consistent with the pertinent provisions of this part.
5. INSTRUCTIONS, PROCEDURES AND DRAWINGS
Activities affecting quality shall be prescribed by documented instructions, procedures, or drawings of a type appropriate to the circumstance and shall be accomplished in accordance with these instructions, procedures, or drawings. These shall include appropriate quantitative or qualitative acceptance criteria for determining that important activities have been satisfactorily accomplished.
6. DOCUMENT CONTROL
the package design, as specified in the license, for those materials and components to which this appendix applies, are correctly translated into specifications, drawings, procedures and instructions. These measures shall include provisions to assure that appropriate quality standards are specified and included in design documents and that deviations from such standards are controlled. Measures shall be established for the selection and review for suitability of application of materials, parts, equipment. and processes that are essential to the safety-related functions of the materials, parts, and components of the packaging.
Measures shall be established for the identification and control of design interfaces and for coordination among participating design organizations. These measures shall include the establishment of written procedures among participating design organizations for the review, approval, release, distribution, and revision of documents involving design interfaces. The design control measures shall provide for verifying or checking the adequacy of design, such as by the performance of design reviews, by the use of alternate or simplified calculational methods, or by the performance of a suit able testing program. The verifying or checking process shall be performed by individuals or groups other than those who performed the original design, but who may be from the same organization. Where a test program is used to verify the adequacy of a specific design feature in lieu of other verifying or checking processes, it shall include suitable qualification testing of a prototype or sample unit under the most adverse design conditions. Design control measures. shall be applied to items such as the follou's ing: criticality physics, radiation shielding. stress, thermal, hydraulic, and accident analyses; compatibility of materials; accessibility for inservice inspection, maintenance and repair: features to facilitate decontamination; and delineation of acceptance crite ria for inspections and tests.
Design changes, including field changes, shall be subject to design control measures commensurate with those applied to the original design. Changes in the conditions specified in the package approval require Commission approval.
Measures shall be established to control the issuance of documents, such as instructions, procedures, and drawings, including changes thereto, which prescribe all activities affecting quality. These measures shall assure that documents, including changes, are reviewed for adequacy and approved for release by authorized personnel and are distributed and used at the location where the prescribed activity is performed. Changes to documents shall be reviewed and approved by the same organizations that performed the original review and approval unless the applicant designates another organization.
7. CONTROL OF PURCHASED MATERIAL,
EQUIPMENT, AND SERVICES Measures shall be established to assure that purchased material, equipment, and services, whether purchased directly or through contractors and subcontractors, conform to the procurement documents. These measures shall include provisions, as appropriate, for source evaluation and selection, objective evidence of quality furnished by the contractor or subcontractor, inspection at the contractor or subcontractor source, and examination of products upon delivery. Documentary evidence that material and equipment conform to the procurement specifications shall be available prior to installation or use of such material and equipment. This documentary evidence shall be retained by or be available to the licensee and shall be sufficient to identify the specific requirements met by the purchased material and equipment. The effectiveness of the control of quality by contractors and subcontractors shall be assessed by the licensee or designee at intervals consistent with the importance, complexity and quantity of the product or services.
4. PROCUREMENT DOCUMENT CONTROL Measures shall be established to assure that applicable requirements of this part which are necessary to assure adequate quality are suitably included or referenced in the documents for procurement of material, equipment, and services, whether purchased by the licensee or by his contractors or subcontractors. To the extent necessary, the licensee shall require contractors or subcontractors to provide a quality assurance
8. IDENTIFICATION AND CONTROL OF MATERIALS,
PARTS AND COMPONENTS Measures shall be established for the identification and control of materials, parts, and components. These measures shall assure that identification of the item