APPENDIX D-TESTS FOR SPECIAL FORM LICENSED MATERIAL

1. Free Drop-A free drop through a distance of 30 feet onto a flat essentially unyielding horizontal surface, striking the surface 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. Heating--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]

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 § 71.4(1).

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.

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 activi ties 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 initiate, 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, including 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 organizations assigned the quality assurance functions have this required authority and organizational freedom. Irrespective of the orga nizational 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.

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 requirements 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 approval is issued.

ule for accomplishing the activities. a quality assurance program which complies with the requirements of this appendix. The quality assurance program shall be documented 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 organiza tions. The quality assurance program shall provide control over activities affecting the quality of the identified materials and components 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 activity. 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 program 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 surveillance over processes and equipment:

(4) The degree to which functional com pliance 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 as surance program at established intervals. Management of other organizations participating in the quality assurance program shall regularly review the status and adequacy of that part of the quality assurance program which they are executing.

3. DESIGN CONTROL

Measures shall be established to assure that applicable regulatory requirements and

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 suitable 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 following: 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 criteria 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.

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

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

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.

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

90-029 0-82--36

is maintained by heat number, part number, or other appropriate means, either on the item or on records traceable to the item, as required throughout fabrication, installation, and use of the item. These identification and control measures shall be designed to prevent the use of incorrect or defective materials, parts and components.

9. CONTROL OF SPECIAL PROCESSES

Measures shall be established to assure that special processes, including welding, heat treating, and nondestructive testing. are controlled and accomplished by qualified personnel using qualified procedures in accordance with applicable codes, standards, specifications, criteria, and other special requirements.

10. INSPECTION

A program for inspection of activities affecting quality shall be established and executed by or for the organization performing the activity to verify conformance with the documented instructions, procedures. and drawings for accomplishing the activity. Such inspection shall be performed by individuals other than those who performed the activity being inspected. Examination, measurements, or tests of material or products processed shall be performed for each work operation where necessary to assure quality. If inspection of processed material or products is impossible or disadvantageous, indirect control by monitoring processing methods, equipment, and personnel shall be provided. Both inspection and process monitoring shall be provided when quality control is inadequate without both. If mandatory inspection hold points, which require witnessing or inspecting by the licensee's designated representative and beyond which work shall not proceed without the consent of its designated representative, are required, the specific hold points shall be indicated in appropriate documents.

11. TEST CONTROL

A test program shall be established to assure that all testing required to demonstrate that the packaging components will perform satisfactorily in service is identified and performed in accordance with written test procedures which incorporate the requirements of this part and the requirements and acceptance limits contained in the package approval. The procedures shall include provisions for assuring that all prerequisites for the given test have been met. that adequate test instrumentation is available and used, and that the test is performed under suitable environmental conditions. Test results shall be documented and evaluated to assure that test requirements have been satisfied.

12. CONTROL OF MEASURING AND TEST

EQUIPMENT

Measures shall be established to assure that tools, gages, instruments, and other measuring and testing devices used in activi ties affecting quality are properly con trolled, calibrated, and adjusted at specified times to maintain accuracy within necessary limits.

13. HANDLING, STORAGE AND SHIPPING Measures shall be established to control the handling, storage, shipping. cleaning and preservation of materials and equipment to be used in packaging in accordance with instructions to prevent damage or deterioration. When necessary for particular products, special protective environments, such as inert gas atmosphere, specific moisture content levels and temperature levels shall be specified and provided.

14. INSPECTION. TEST AND OPERATING STATUS

Measures shall be established to indicate, by the use of markings such as stamps, tags. labels, routing cards, or other suitable means, the status of inspections and tests performed upon individual items of the packaging. These measures shall provide for the identification of items which have satisfactorily passed required inspections and tests, where necessary to preclude inadvertent by-passing of such inspections and

tests.

Measures shall also be established for indicating the operating status of components of the packaging, such as tagging valves and switches, to prevent inadvertent operation.

15. NONCONFORMING MATERIALS, PARTS, OR

COMPONENTS

Measures shall be established to control materials, parts, or components which do not conform to requirements in order to prevent their inadvertent use or installation. These measures shall include, as appropriate, procedures for identification, doc. umentation, segregation, disposition, and notification to affected organizations. Nonconforming items shall be reviewed and accepted, rejected, repaired or reworked in accordance with documented procedures.

16. CORRECTIVE ACTION

Measures shall be established to assure that conditions adverse to quality, such as deficiencies, deviations, defective material and equipment, and nonconformance, are promptly identified and corrected. In the case of a significant condition adverse to quality, the measures shall assure that the cause of the condition is determined and corrective action taken to preclude repetition. The identification of the significant

condition adverse to quality, the cause of the condition, and the corrective action taken shall be documented and reported to appropriate levels of management.

17. QUALITY ASSURANCE RECORDS Sufficient written records shall be maintained to furnish evidence of activities affecting quality. The records shall include the following: design records, records of use and the results of reviews, inspections, tests. audits, monitoring of work performance. and materials analyses. The records shall also include closely-related data such as qualifications of personnel procedures, and equipment. Inspection and test records shall, as a minimum, identify the inspector or data recorder, the type of observation. the results, the acceptability, and the action taken in connection with any deficiencies noted. Records shall be identifiable and retrievable. Consistent with applicable regulatory requirements, the licensee shall establish requirements concerning record retention, such as duration, location, and assigned responsibility.

18. AUDITS

A comprehensive system of planned and periodic audits shall be carried out to verify compliance with all aspects of the quality assurance program and to determine the effectiveness of the program. The audits shall be performed in accordance with the written procedures or check lists by appropriately trained personnel not having direct responsibilities in the areas being audited. Audit results shall be documented and reviewed by management having responsibility in the area audited. Followup action, including reaudit of deficient areas, shall be taken where indicated.

(Sec. 62, Pub. L. 83-703, 88-489: 68 Stat. 932. 78 Stat. 602 (42 U.S.C. 2092); sec. 201. Pub. L. 93-438, 88 Stat. 1242 (42 U.S.C. 5841)) [42 FR 39366. Aug. 4, 1977]

72.50 Safety analysis report updating. 72.51

Material balance, inventory and records requirements for stored materials. 72.52 Reports of accidental criticality or loss of special nuclear material.

72.53

72.54

Material status reports.

Nuclear material transfer reports.

72.55 Other records and reports.

72.56 Inspections and tests.

72.57 Violation.

72.61

Subpart E-Siting Evaluation Factors

General considerations.

72.62 Design basis external natural events. 72.63 Design basis external man-induced

events.

72.64 Identifying regions around an ISFSI site.