package which meets the standards of subparts E and F of this part; however, the material must be contained in a Type A package. The Type A package must also meet the DOT requirements of 49 CFR 173.417(a). (b) The general license applies only to a licensee who has a quality assurance program approved by the Commission as satisfying the provisions of subpart H of this part. (c) The general license applies only when a packages contents: (1) Contain less than a Type A quantity of material; and (2) Contain less than 1000 g of plutonium, provided that: plutonium-239, plutonium-241, or any combination of radionuclides, constitutes less than 240 g of the total quantity of plutonium in the package. (d) The general license applies only to packages labeled with a CSI which:
C for those States which have users of Type B than Industrial **Note: 10 CFR Part 71.101 (g) indicates that QA programs for industrial radiography Type B Package users are covered by 10 CFR 34.31(b). It is also indicated that this section satisfies 71.12 (b) and thus would satisfy those sections referenced in this provision ( 71.101 through inspection, testing, operation, maintenance, repair, and modification of components of packaging that are important to safety. As used in this subpart, 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. The licensee, certificate holder, and applicant for a CoC are responsible for the quality assurance requirements as they apply to design, fabrication, testing, and modification of packaging. Each licensee is responsible for the quality assurance provision which applies to its use of a packaging for the shipment of licensed material subject to this subpart.
other 71.101 (g) Quality assurance requirements. C Amended Paragraph (g): (g) Radiography containers. A program for transport container inspection and maintenance limited to radiographic exposure devices, source changers, or packages transporting devices and meeting the requirements of 34.31(b) of this chapter or equivalent requirement, is deemed to satisfy the requirements of 71.17(b) and 71.101(b). 71.103 (a) Quality assurance organization. [C] for those States which have users of Type B than Industrial Radiography D otherwise **Note: 10 CFR Part 71.101 (g) indicates that QA programs for industrial Amended Paragraph (a): (a) The licensee2 , certificate holder, and applicant for a CoC shall be responsible for the establishment and execution of the quality assurance program. The licensee, certificate holder, and applicant for a CoC may delegate to others, such as contractors, agents, or consultants, the work of establishing and executing the quality assurance program, or any part of the quality assurance program, but shall retain responsibility for the
**Note: 10 CFR Part 71.101 (g) indicates that QA programs for industrial radiography Type B package are covered by 10 CFR 34.31 (b). It also indicated that this section satisfies 71.12 (b) and thus would satisfy those sections referenced in this provision (71.101 through 71.137.) through 71.137. The licensee, certificate holder, and applicant for a CoC shall document the quality assurance program by written procedures or instructions and shall carry out the program in accordance with those procedures throughout the period during which the packaging is used. The licensee, certificate holder, and applicant for a CoC shall identify the material and components to be covered by the quality assurance program, the major organizations participating in the program, and the designated functions of these organizations.(c) The licensee, certificate holder, and applicant for a CoC shall base the requirements and procedures of its quality assurance program on the following considerations concerning the complexity and proposed use of the package and its components: (1) The impact of malfunction or failure of the item to safety; (2) The design and fabrication
package users are covered by 10 CFR 34.31 (b). It also indicated that this section satisfies 71.12 (b) and thus would satisfy those sections referenced in this provision (71.101 through 71.137.) (b) The licensee shall establish measures to identify the operating status of components of the packaging, such as tagging valves and switches, to prevent inadvertent operation. 71.131 Nonconforming materials, parts, or components. [C]- for those States which have users of Type B than Industrial Radiography** D otherwise **Note: 10 CFR Part 71.101 (g) indicates that QA programs for industrial Amended Section: The licensee, certificate holder, and applicant for a CoC shall establish measures to control materials, parts, or components that do not conform to the licensees requirements to prevent their inadvertent use or installation. These measures must include, as appropriate, procedures for identification, documentation, segregation, disposition, and notification to affected organizations. Nonconforming items must be reviewed and accepted, rejected, repaired,
radiography Type B package are covered by 10 CFR 34.31 (b). It also indicated that this section satisfies 71.12 (b) and thus would satisfy those sections referenced in this provision (71.101 through 71.137.) or reworked in accordance with documented procedures. 71.133 Corrective action. C- for those States which have users of Type B than Industrial Radiography** D otherwise **Note: 10 CFR Part 71.101 (g) indicates that Amended Section: The licensee, certificate holder, and applicant for a CoC shall establish measures to assure that conditions adverse to quality, such as deficiencies, deviations, defective material and equipment, and nonconformances, are promptly identified and corrected. In the case of a significant condition adverse to quality, the measures must assure that the cause of the
QA programs for industrial radiography Type B package are covered by 10 CFR 34.31 (b). It also indicated that this section satisfies 71.12 (b) and thus would satisfy those sections referenced in this provision (71.101 through 71.137.) 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 must be documented and reported to appropriate levels of management. 71.135 Quality assurance records. C- for those States which have users of Type B than Industrial Radiography** D otherwise **Note: 10 CFR Part 71.101 (g) Amended Section: The licensee, certificate holder, and applicant for a CoC shall maintain sufficient written records to describe the activities affecting quality. The records must include the instructions, procedures, and drawings required by 71.111 to prescribe quality assurance activities and must include closely related specifications such as required qualifications
indicates that QA programs for industrial radiography Type B package users are covered by 10 CFR 34.31 (b). It also indicated that this section satisfies 71.12 (b) and thus would satisfy those sections referenced in this provision (71.101 through 71.137.) of personnel, procedures, and equipment. The records must include the instructions or procedures which establish a records retention program that is consistent with applicable regulations and designates factors such as duration, location, and assigned responsibility. The licensee, certificate holder, and applicant for a CoC shall retain these records for 3 years beyond the date when the licensee, certificate holder, and applicant for a CoC last engage in the activity for which the quality assurance program was developed. If any portion of the written procedures or instructions is superseded, the licensee, certificate holder, and applicant for a CoC shall retain the superseded material for 3 years after it is superseded. 71.137 Audits. C - for those States which have users of Type B Amended Section: The licensee, certificate holder, and applicant for a CoC carry out a comprehensive system of