ML20141E854
| ML20141E854 | |
| Person / Time | |
|---|---|
| Site: | 07100587 |
| Issue date: | 04/07/1986 |
| From: | AIR FORCE, DEPT. OF |
| To: | |
| Shared Package | |
| ML20141E852 | List: |
| References | |
| NUDOCS 8604220406 | |
| Download: ML20141E854 (5) | |
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l U. S. AIR FORCE QUALITY ASSURANCE PROGRAMS APPLIED 'IO PROCUREENT, USE, MAINTENANCE, AND REPAIR OF PACKAGES DESIGNED 'It TRANSPORT SPECIAL FORM OR ENCAPSULATED SOURCES 3.1 Organization Organization charts identifying each organizational element (e.g.,
purchasing, engineering, quality assurance) functioning under the QA program, including principal contractors, will be established. Because limited staff may be devoted to QA/QC activities, certain individuals may be performing multiple duties.
If this is the case, measures will be established to ensure that designated individuals performing QA/QC functions hava written delegated authority to stop unsatisfactory work, unsatisf actory processing, or the installation of nonconforming material and that they have direct access to management levels that can ensure the accomplishment of activities important to safety.
Duties and qualifications will be identified for the positions with responsibility for (a) establishment of the QA program, (b) overall execution of the QA program, and (c) assessing the scope, status, and effectiveness of the QA program.
(Typically this responsibility is vested in the Radiation Safety Officer.) The duties and qualifications of other key personnel performing QA/QC functions will also be identified.
3.2 Quality Assurance Program Measures will be established to ensure that items designated to be controlled by the QA program are comatible with and emphasize the characteristics that are identified in the manufacturer's OA program.
Measures will be established to ensure that items igortant to safety requiring periodic replacement because of limited operating or shelf life are identified.
Measures will be established to provide for indoctrination and training to ensure that personnel engaged in use, maintenance, and repair activities important to safety are knowledgeable before they engage in such activities.
Measures will be established to ensure that procedures implementing QA/QC activities important to safety are contained in QA/QC manuals. A matrix of instructions and procedures will be established that cross-references each applicable QA program requirement of Appendix E of 10 CFR 71.
8604220406 860407 PDR ADOCK 07100587 C
3.3 Procurement Document Control 3.3.1 Package Procurement Measures will be established to ensure that procurement documentation (1) requires the manufacturers of packages to supply appropriate certifications verifying that the designated (model and serial number) package was manufactured under the control of an NRC-approved QA program, (2) identifies types of inspections and tests required during use and maintenance, and (3) designates cther pertinent documentation to be furnished with the package (e.g., certificate of compliance, as-built drawings, use and maintenance manuals, and all other documents referred to in the certificate of complaince).
3.3.2 Replacement Parts Procurement (If Applicable)
Measures will be established to require that purchase orders for spare or replacement parts be reviewed by QA personnel to ensure that appropriate technical and QA requirements are included in the purchase orders and that the orders are placed with suppliers previously qualified during fabrication of the package.
If replacement parts are purchased from suppliers not previously identified as qualified sources, the user must ensure that the replacement parts meet requirements at least as stringent as the original criteria.
3.4 Instructions, Procedures, and Drawings Measures will be established to ensure that loading radioactive material into or unloading radioactive materials from a package is controlled to protect the public health and safety and the environment.
3.5 Document Control Controls will be established to ensure that all documents and changes thereto are adequately reviewed and approved prior to their issuance.
Measures will be included to ensure that current issues of applicable documents are available at -the location where the activity is being performed to preclude use of obsolete or superceded documents.
All packages affected by design or manufacturing changes will be checked to verify that they are in accordance with the appropriate revision.
Documents under the control of the QA program will include at least the following:
1.
Operating Procedures, 2.
Maintenance Procedures,
E 3.
Inspection and Test Procedures, 4.
Loading and Unloading Procedures, 5.
Packaging for Transport Procedures, and 6.
Repair Procedures 3.6 Handling, Storage, and Shipping 3.6.1 Handling and Storage Measures will be established to ensure that procedures provide for any special handling required of the package while in storage or when moving from one station to another.
Particular attention will be given to precautions required for ensuring radiation safety of the package.
3.6.2 Preparation for Shipment Measures such as use of checklists will be established to ensure that all conditions have been met, including specified operations, inspections and tests, and NRC and DOT shipping requirements, and that all necessary shipping papers have been completed prior to delivery to a carrier.
3.7 Inspection, Test, and Operating Status Pa rt 34, Su bpa r t B, identifies specific inspections and certain tests to be conducted during use and maintenance of radiographic devices. Measures will be established to ensure that identification of the status of theses inspections and tests through use of tags, labels, markings, etc., is known by organizations resposnible for assurance of quality.
3.8 Quality Assurance Records A list of records to be controlled under the QA program and identification of retention times for each record will be established. These records will include, as a minimum, procurement documentation; inspection, test, and audit results; nonconformance and corrective reports; personnel training and certification; evidence of operational capability; and verification of repair, replacement, and maintenance.
Measures will be established to store records, provide for their safekeeping, and prevent their deterioration.
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l 3.9 Audit Elements of the QA audit program, including work areas, activities, and processes to be audited to ensure the objective evaluation of practices, procedures, and instructions important to safety and the effectiveness of i
their implementation will be established.
(If the organization is so small that independence of the auditing personnel is impractical, a checklist of the activities to be audited will be prepared.)
Frequencies for the audits listed in the paragraph above will be established, and will not b.e less than once a year.
Individuals or organizations responsible for performing external audits of the QA program to determine its overall_. effectiveness and compliance with management policies and procedtires will have no responsibility in the areas being audited.
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