ML19254D458
| ML19254D458 | |
| Person / Time | |
|---|---|
| Site: | 07100160 |
| Issue date: | 10/02/1979 |
| From: | OMAHA NONDESTRUCTIVE & METALLURGICAL TESTING, INC. |
| To: | |
| Shared Package | |
| ML19254D457 | List: |
| References | |
| NUDOCS 7910260004 | |
| Download: ML19254D458 (9) | |
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OMAHA NONDESTRUCTIVE AND METALLURCICAL TESTING, INC.
QA/QC SUB MANUAL - RECEIPT, HANDLING AND SHIPMENT OF RADIOACTIVE MATERIALS TABLE OF CONTENTS "The provisions of this quality assurance and controlsub manual treat the following criterion contained in Appendix E of 10CTR71.
h Paragraph Criterion Page I
Organizational Structure 11/100.01 II v ality Assurance Program 11/100.03 III Document Control 11/100.04 IV Handling, Storage and Shipping 11/100.05 V
Inspection, Test and Operating Status 11/100.06 VI Quality Assurance Records 11/100.07 VII Audits 11/100.08
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Page 11/100.01 I.
ORGANIZATION OF OMAHA NONDESTRUCTIVE AND METALLURGICAL TESTING, INC.
2917 Douglas Street, Omaha, Nebraska 681~;1 402-341-5181 CHAIRMAN OF THE BOARD and TECHNICAL CONSULTANT L. R. Mertz PRESIDENT R. D. Johnson VICE PRESIDENT L. G. Erickson, Jr.
VICE PRESIDENT AND SECRETARY T. J. Behrens RADIOGRAPHY PROGRAM RADIATION SAFETY OFFICER L. R. Mertz ASSISTANT RADIATION OFFICER R. D. Johnson ASS 7.STANT RADIATION SAFETY OFFICER L. G. Erickson, Jr.
ASSISTANT RADIATION SAFETY OFFICER W. C. Reynoldc ASSISTANT RADIATION SAFETY OFFICER D. R. Senner
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ASSISTANT RADIATION SAFETY OFFICER T. J. Behrens DIRECTOR OF QUALITY ASSURANCE S. D. Weidenham=er l
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QA/QC Manual Part 11 (Rev =1) 2 October 1979
Page 11/100.02 Organization:
L. R. Mertz, Radiation Safety Officer, is designated _ as the responsible individual for the overall administration of the program, training and certification document control and record keeping. He is also responsible for the Part 71 QA Requirements.
The listed Assistant Radi tion Safety Officers are responsible for handlin:g, storing, shipping, inspection, test and operating status.
The Director of Qu.tlity Assurance shall be responsible for performing annual audits and reporting to the management the results of the audits.
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l QA/Q CManual Part 11. (Rev = 1 )
2 October 1979
Page 11/100.03 i
II.
Quality Assurance Program:
All Radiation and Assistant Radiation Safety Officers who participate in this QA Program shall be properly trained in accordance to Omaha Non-destructive and Metallurgical Testing, Inc. written procedures in the "Eadiographer's Manual", Section ITT, pages 3.9 through 3.18.
The packages for shipment of radioactive material has been approved by the U. S. Nuclear Regulatory Commission and have received Certificate of Compliance Numbers 9032 and 9039, Revision No. 2.
Omaha Nondestructive and Metallurgical Testing, Inc. has been registered as users of these packages under the general license provisions of 10CFR71.12(b) or 40CFR173.393a.
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t QA/QC Manual Part 11 (Rev = 1) 2 October 1979
Page 11/100.04
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III. Document Control:
The Radiation Safety Officer shall be responsible for all documents related to a specific shipping package, and these documents will be
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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 QA functions are con-ducted in accordance with the latest applicable changes to these documeats.
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QA/QC Manual Part 11 (Rev = 1) 2 October 1979 r.:
Page 11/100.05 IV.
Handling, Storage and Shippiog:
The steps outlined in Procedures 1.1.04 and 11.05 for the receipt and transfer of radioactive sources shall be taken in order to assure safe handling and storage of sources.
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The Radiation Sa'!ety Officer or a designated Assistaat Radiation Saf ety Officer is solaly responsible for the procurement of sources and equipment and must, upon notification of receipt of such sources and/or equipment, take steps to insure the proper receipt and handling of them. Form 1190 shall be utilized l
by the responsible Safety Officer to document the proper receipt of equipment and sources, while replacement and transfer operations require the use of Form 1121 to document the radiographic operations necessary to complete re-placement and transfer to sources. All document flow for radiographic op-erations is directly from the operator to the Radiation Safety Officer.
' Inasmuch as all radioactive sources received and shipped from this Company are the property of others, each shipment shall be cade in only those con-1 I
tainers which, when provided by others, have certifications and/or approvsl l
for their use by the Nuclear Regulatory Co= mission. Upon receipt _ of equip-ment and' source, the Radiation Safety Officer shall review Form li90 to verify receipt of authorized rcdioactive materials and equipment and must maintain on file certifications of each item received or shipped. Only those containers authorized for use and obtained from Technical Operations, Inc. may be utilized for shipment of sources from this company.
The provisions of Procedure 11.05 having been completed and any incidences of nonconformance having been corrected as described on Page 11/100.06 of this prog ram, the inspection and preparation of radioactive materials and equipment may be deemed to be complete. However, it is necessary that final approval for ship-ment be made by the Radiation or Assistant Radiation Safety Officer on Form 1191.
QA/QC Manual Part 11 (Rev = l) 2 October 1979
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I Page 11/100.06 V.
Inspection, Test and Operating Status i
Procedure 11.05 prescribes steps to be taken should any item received not be l
accompanied by proper documentation or supplemsntary items. Should any item i
j i-not be received which would cause cessation of further handling of the ship-3 ment, as noted in Procedure 11.05, the incidence of nonconformance must be documented by the Radiation Safety Officer on Form 1190 and corrective action i
as prescribed in that Procedure shall be taken before further operations may i
resume.
3 During replacement or transfer of sources, 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.
i The final inspection, survey and preparation of equipment containing radio-active sources 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 i
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Safety Officer must document such nonconformance on Form 1191 and take i= mediate corrective action to ensure proper completion of preparation for shipment.
I Shipping papers may be prepared by the person uho prepares the equi; cent and I
s'ource for shipment, but the shipping papers must be submitted to the Technical Director or Assistant Radiation Safety Officer for review prior to notification I
of the carrier that a shipment of radioactive material is to be picked up.
Any items of nonconformance found to exist by others af ter delivery to a carrier I
is made must be documented on Form 1195 by the Radiation Safety Officer or Assistant Radiation St.=2ty Officer. Any and all steps necessary to correct non-conformance must be immediately taken and documented on Form 1195.
If the in-1 cident 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 Op-I ersting Manual shall be followed.
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i QA/QC Manual Part 11 (Rev = 1) 2 October 1979 l
Page 11/100.07 VI.
Quality Assurance Records:
All records of package approvals (including references and drawings), pro-curement, inspections, tests, operating logs, audit results, Dersonnel train-t ing and qualification, and records of shipments shall be maintained by the Radiation Safety Officer. Descriptions of equipment and writtten procedures will also be maintained.
Forms 1121, 1190, 1191, and 1195 and all other records shall be maintained i
in accordance with the written procedures in the Radiographer's Manual. A list of these records, with their storage location, se.ll be maintained by the Radiation Safety Officer.
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QA/QC Manual Part 11 (Rev = 1) 2 October 1979
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Page 11/100.08 VII. Audit:
Audits of the QA Program are scheduled for at least once a year by the i
Director of Quality Assurance. The Director of Quality Assurance does l
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noc have any responsibility in the activity of receiving, handling, and
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shipping radioactive material. The audit will be perfor=ed 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
~f of nonconformance will be documented and corrected. The records of such i
audits shall be maintai ed by both the Radiation Safety Officer and the j
Director of Quality Assurance.
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l QA/QC Manual Part 11 (Rev = 1) 2 October 1979 i
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