ML19211C183
| ML19211C183 | |
| Person / Time | |
|---|---|
| Site: | 07100160 |
| Issue date: | 12/07/1979 |
| From: | OMAHA NONDESTRUCTIVE & METALLURGICAL TESTING, INC. |
| To: | |
| Shared Package | |
| ML19211C180 | List: |
| References | |
| 14963, NUDOCS 8001110036 | |
| Download: ML19211C183 (14) | |
Text
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RECEIPT, HANDLING AND SHIPMENT CF RADI0 ACTIVE MATERIALS 1738 188 CMAHA NONDESTRUCTIVE AND METALLURGICAL TESTING, INC.
an malest Company 8001110o34
RECEIFT, HANDLING AND SHIPMENT OF RADIOACTIVE MATEllALS 1738 139 143E3
OMAHA NONDESTRUCTIVE AND METALLURGICAL TESTING, INC.
QA/QC SUB MANUAL - RECEIPT, HANDLING AND SHIPMENT OF RADI0 ACTIVE PE ERIALS TABLE OF CONTENTS The provisions of this quality assurance and control sub manual treat the following criterion contained in Appendix E of 10CFR71.
Paragraph Criterion Page I
Organizational Structure 11/100.01 II Quality Assurance Program 11/100.03 III Document Control 11/100.05 IV Handling, Storage and Shipping 11/100.06 V
Inspection, Test and Operating Status 11/100.08 VI Quality Assurance Records 11/100.10 VII Audits 11/100.11 1738 190
Page 11/100.01 I.
ORGANIZATION OF CMAHA NCNDESTRUCTIVE AND METALLURGICAL TESTING, INC.
2917 Douglas Street, Omaha, Nebraska 68131 402/341-5181 CORPORATE OFFICERS CHAIRMAN OF THE BOARD AND TECHNICAL CCNSULTANT L. R. Mertz PRESIDENT R. D. Johnson L. G. Erickson, Jr.
VICE PRESIDENT VICE FRESIDENT AND SECRETARY T. J. Behrens RADICGRAPHY PROGRAM RADIATION SAFETY CFFICER L. R. Mertz ASSISTANT RADIATION SAFETY OFFICER R. D. Johnson L. G. Erickson, Jr.
ASSISTANT RADIATION SAFETY OFFICER ASSISTANT RADIATICN SAFETY CFFICER D. R. Senner ASSISTANT RADIATION SAFETY CFFICER R. J. A11 mon DIRECTCR CF QUALITY ASSURANCE L. G. Erickson QA/QC Manual Part 11 (Rev. - 2) 7 December 1979 1738 191
Page 11/100.02 1.
ORGANIZATION:
(Continued)
The final responsibility for the Quality Assurance Program for Part 71 Require-ments rests with Omaha Nondestructive and Metallurgical Testing, Inc.
The Radiation Safety Officer is designated as the responsible individual for the overall administration of the program, training and certification, docu-ment control and record keeping. He is also responsible for the Part 71 QA Requirements.
The listed Assistant Radiation Safety Officers are responsible for handling, storing, shipping, inspection, test and operating status.
The Director of Quality Assurance shall be responsible for performing annual audits and reporting to the management of the results of the audits.
Transportation packages for radioactive =aterial shall not be designed or f ab-ricated by Omaha Nondestructive and Metallurgical Testing, Inc.
QA/QC Manual Part 11 (Rev. = 2) 7 December 1979 1738 192
Page 11/100.03 II.
QUALITY ASSURANCE PROGRAM This Quality Assurance Program is established and implemented by the Manage-ment of Omaha Nondestructive and Metallurgical Testing, Inc. to provide assurance that proper control of the Receipt, Handling and Shipment of Radio-active Materials is obtained.
All Radiation Safety and Assistant Radiation Saf ety Officers who participate in this Quality Assurance Program shall be properly trained in accordance with Omaha Nondestructive and Metallurgical Testing, Inc.'s written procedures as presented in the " Radiographer's Manual",Section III, pages 3.9 through 3.18.
Although the radioactive material shipping packages are designed and f abri-cated by others, the Radiation Safety Officer shall verify that these pack-ages are designed and f abricated in accordance with a Quality Assurance Pro-gram approved by the U. S. Nuclear Regulatory Commission. This verification shall be satisfied by receiving a manufacturer's certification of ccepliance with an approved Quality Assurance Program.
Packages currently being utilized for shipping radioactive materials have been approved by the U. S. Nuclear Regulatory Commission and Cc=pliance Certi-ficate Numbers 9032 and 9039, Revision No. 2, are on file. Omaha Ncndestruc-tive and Metallurgical Testing, Inc. has been registered as users of these packages under the general license provisions of 10CFR71.12(b) er 4CCFR173.393a.
All packages designed or fabricated for the ship =ent of radioactive materials af ter the effective date of this Quality Assurance Program shall be verified by manufacturer's certification as having been designed or fabricated in accordance with a Quality Assurance Program approved by the U. S. Nuclear Regulatory Commission.
QA/QC Manual Part 11 (Rev. - 2) 7 December 1979 1738 193
Page 11/100 04 II.
QUALITY ASSUR. alice PRCGRAM:
(Continued)
All receiving, handling and shipping procedures will emphasize definitive control of those package characteristics that are critical to safety.
All revisions to this Quality Assurance Program will be made in accordance with management approved written procedures.
1738 194 QA/QC Manual Part 11 (Rev. - 2) 7 December 1979
Page 11/100.05 III. DOCUMENT CONTROL The Radiation Saf ety Officer shall be responsible for all docu=ents related to a specific shipping package, and these documents will be controlled through the use of written procedures.
All document revisions will be made in accordance with procedures established for review and revision of programs, forms and procedures, as described in Parts I and IV of our " Quality Assurance Plan and Control System".
The Radiation Safety Officer will insure that all Quality Assurance functions are conducted in accordance with the latest applicable changes to these docu-ments.
1738 195 QA/QC Manual Part 11 (Rev. = 2) 7 December 1979
Page 11/100.06 IV.
HANLLING, STORAGE AND SHIPPING The steps outlined in Procedures 11.04 and 11.05 for the receipt, transfer and shipment of radioactive sources shall be taken in order to assure safe handling and storage of sources.
Inas=uch as all radioactive sources received and shipped from this Co=pany are the property of others, each shipment shall be made in only those con-tainers which, when provided by others, have certifications and/or approval for their use by the Nuclear Regulatory Commission. Upon receipt of equip-ment and source, the Radiation Safety Officer shall review Form 1190 to verify receipt of authorized radioactive materials and equipment and =ust maintain on file certifications of each item received or shipped. Only those containers authorized for use ar.d ootained from Technical Operations, Inc.
may be utilized for Ehipeent of sources frcm this Ccepany.
The provisions of Procedure 11.05 having been completed and any incidences of nonconformance having been corrected as described on Page 11/100.08 of this program, the inspection and preparation of radioactive materials and equip-ment may be deemed to be complete. Ecwever, it is necessary that final approval for shipment be made by the Radiation or Assistant Radiation S f ety Officer on Form 1191.
The' Radiation Safety Officer or an Assistant Radiation Safety Officer are solely responsible for ;rocure=ent of sources and equipment and will, upon notification of receipt of such sources and/or equipment, verify the receipt of the package and shall perform the handling and storage operations. Form 1190 shall be utilized by the responsible Safety Officer to docu=ent the proper receipt of sources and equip =ent.
Replacement and transfer operations shall be performed by the Radiation Safety Officer or an Assistant Radiation Safety Officer. Form 1121 shall be utilized by the responsible Safety Officer to document the proper replace-ment and transfer of radioactive sources.
QA/QC Manual Part 11 (Rev. - 2) 7 December 1979 1738 196
Page 11/100.07 IV. HANDLING, STORAGE AND SHIPPING (Continued)
The return shipment operation of radioactive sources shall be performed by the Radiation Safety Of ficer or an Assistant Radiation Saf ety Officer. Form 1191 shall be utilized by the responsible Safety Officer to document the proper handling and final inspection of radioactive sources and equipment for shipment.
1738 197 QA/QC hanual Part 11 (Rev. = 2) 7 December 1979
Page 11/100.08 V.
INSPECTION, TEST AND OPERATING STAIVS The Radiation Safety Officer or an Assistant Radiation Safety Officer is solely responsible for performing the inspection and tests of the sources and equip-ment.
Procedure 11.05 prescribes steps to be taken should any item received not be accompanied by proper documentation or supplementary ite=s.
Should any item not be received which would cause cessation of further handling of the ship-ment, as noted in Procedure 11.05, the incidence of nonconformance must be docu=ented by the Radiation Safety Officer on Form 1190 and corrective action as prescribed in that Procedure shall be taken before further operations may resume.
During replacement or transfer of cources, should acts or items found to be not in compliance with established procedures, the corrective action prescribed in the license application and Operating Procedures of this Company shall be taken.
The final inspection, survey and preparation of equipment containing radioac-tive sourecs shall be completed, documented on Form 1191 by the individual responsible for such preparation, and submitted to the Radiation Safety Officer or, as assigned, to an Assistant Radiation Safety Officer prior to actual ship-ment and preparation of shipping papers for review. Should any item or instance of nonconformance exist, the Radiation Safety Officer or Assistant Radiation Safety Officer must docu=ent such r.onconformance on Form 1191 and take imme-diate corrective action to ensure proper completion of preparation for shipment.
Shipping papers may be prepared by the person who prepares the equipment and source for shipment, but the shipping papers must be submitted to the Radiation Safety Officer or Assistant Radiation Safety Officer for review prior to noti-fication of the carrier that a shipment of radioactive =aterial is to be picked up.
QA/QC Manual Part 11 (Rev. - 2) 7 December 1979 1738 198
Page 11/100.09 V.
INSPECTION, TEST AND OPERATING STAnJS:
(Continued)
Any items of nonconformance found to exist by others af ter delivery to a carrier is made must be documented on Form 1195 by the Radiation Safety Officer or Assistant Radiation Safety Officer. Any and all steps necessary to correct nonconformance must be immediately taken and docu=ented on Fcrm 1195. If the incident requires special steps for possible exposure of others monitored or not monitored, or should the isotope be lost, the provisions of Part I of the Operating Manual shall be followed.
1738 199 QA/QC Manual Part 11 (Rev. = 2) 7 Dece=ber 1979
Page 11/100.10 VI.
QUALITY ASSURANCE RECCRDS All records of package approvals (including references and drawings), procure-ment, inspection, tests, operating logs, audit results, persennel training and qualification, and records of shipments shall be maintained by the Radia-tion Safety Officer. Descriptions of equipment and written procedures will also be maintained.
Forms 1121, 1190, 1191 and 1195 and all other records shall be maintained in accordance with the written procedures in the Radiographer's Manual.
These records will be appropriately identified, maintained and rendered readily retrievable by the Radiation Saf ety Officer.
1738 200 QA/QC Manual Part 11 (Rev. - 2) 7 December 1979
Page 11/100.11 VII. AUDIT:
Audits of each activity of the Quality Assurance Program are performed at least once a year by the Director of Quality Assurance. The Director of Quality Assurance does not have any responsibility in the activity of receiving, handling, and shipping radioactive material. The audit will be performed by using written check lists, and the results of the audit will be maintained and reported to management. The audit reports will be evaluated and areas of nonconfor=ance will be documented and corrected.
The records of such audits shall be maintained by both the Radiation Safety Officer and the Director of Quality Assurance.
1738 20i QA/QC Manual Part 11 (Rev.
2) 7 December 1979 14963
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