ML19249E764
| ML19249E764 | |
| Person / Time | |
|---|---|
| Site: | 07100260 |
| Issue date: | 09/10/1979 |
| From: | Mykyta L ASTROTECH, INC. |
| To: | |
| References | |
| NUDOCS 7910020380 | |
| Download: ML19249E764 (12) | |
Text
Ra>% 73-2.4o E N]W ASTROTECil INC.
7801 Allentown Boulevard 7
P. O. Box 6159 11arr is bur g, Pe nnsylva nia 17112 17, LY 10 23
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I QUALITY ASSURANCE PROGRAM FOR SHIPPING PACFACES OF RADIOACTIVE FnTERIAL 9
19lOt)'O 14073 Ap rov' d by; ri Prepared by:
l L. Mykyta, R.S.O.
p, gw Se ptember 10, 1979 6
1078 141
TABLE OF CONTENTS r
Subject IIcading Pa ge RE VI S I ON S IIE ET......................................................
1 IN TR ODU C TI ON........................................................
2 I.
OR G\\NIZATIONA L S TRUCIURE......................................
3 II.
DU TIES AND RE S P0NSIBILITIES...................................
4 III. QUALITY AS SURANCE PR0 GRAM.....................................
5 IV.
D OCUMENT C O NTR 0 L..............................................
6 V.
IIAND LING, STORAGE AND SHIPPING................................
7 VI.
INS PECTION, TEST AND OPERATING STATUS.........................
8 VII. QUA LITY A S SURANCE RE C 0RD S.....................................
9 VI I I. AUD IT S........................................................
10 107B I42
REVISION SHEET Nevision #
Page Seetion Para gra ph Date Signature
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1078 i4';
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INTRODUCTION This procedure is to be followed whenever approved radiographic cameras or source changers are to be transported outside the confines of ASTR0 TECH INC.
fa c ilities. These procedures are for transportation of only radiographic caceras and source changers containing encapsulated sealed ganma emitters which the manufacturers have assured compliance and approval under Title 10, Chapter 1, Part 71 Transportation of radioactive materials under these procedures shall be only by trained and qualified personnel and of compliance with these procedures each time transportation of radioactive materials outside our facilities occurs. It is the purpose of these procedures to assure gg safety in transporting of radioactive materials and to retain a record of compliance with them.
Design and fabrication shall not be conducted under this Quality Assurance Pro gra m.
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i 1078 i44 (2)
I.
ORCANIZATIONAL STRUCTURE FP.ESIDENT VICE PRESIDENT I
RADIATION SAFETY OFFICER l
ASSISTANT RADIATION SAFETY OFFICER I
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RADIOGRAPIIERS l
ASSISTANT RADIOGRAP11ERS g
EAINEES OTHER APPROVED TRANSPORTERS 1078 145
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DUTIES AND RESPONSIBILITIES Ihe final responsibility for the Quality Assurance Program for Part 71 requirements res ts with ASTR0 TECH INC., Division of CERTIFIED TESTING IABORATORIES, INC.
i Design and Fabrication shall not be conducted under this Quality Assurance Pro gra m.
PRESIDENT:
Overall Control of Corporate Operations.
VICE PRESIDENT:
Responsible for General Operations. Re por ts to Pres ident.
RADIATION SAFETY OFFICER:
Responsible for Overall Administration of the Program, Training a nd Certification, Document Control and Auditing.
RADIOGRAPHERS :
Responsible for Ha ndling, S toring, Shipping (Tra nsporta tion), Inspection, Tes t a nd Operating Status and Record Keeping. Reports to Radiation Safety Officer concerning Radiation Safety and Quality Assurance Program.
ASSISTANT RADIOGRAPHER:
Perform Radiography under Direction of Radiogra pher. Reports to Radiographer.
Reports to Radiation Safety Officer concerning Radiation Safety.
OTHER APPROVED TRANSPORTERS:
Responsible to his own Supervisor for Quality Assurance Program and to Astratech's Radiation Safety Officer.
ASIR0 TECH INC. as licensee retains Responsibility for the Quality Assurance Program.
1078 146 (4)
QUALITY ASSURANCE PROGRAM The Management of ASTROTECH INC. establishes and implements the Quality Assurance Program.
Training ard experience for all Quality Assurance functions is required according to established procedures.
Quality Assurance Program revisions will be made according to established procedures with Management approval.
The Quality Assurance Program will ensure that all defined Quality Control Procedures, Engineering Procedures and Specific Provisions of the package design approval are satisfied.
The Quality Assurance Program will emphasize control of the characteristics of the package which are critical to safety.
The Radiation Safety Officer shall assure that all radioactive material shipping packages are designed and manufactured under the Quality Assurance Program approved by Nuclear Regulatory Commission for all packages designed or fabricated af ter the effective date of the Quality Assurance Program.
1078 147 (5)
DOCUMENT CONTROL
- All documents related to a specific shipping package will be controlled through the use of established procedures.
All document changes will be performed according to established procedures approved by the Management.
The Radiation Safety Officer shall ensure that all Quality Assurance functions are conducted in accordance with the latest applicable changes to these documents.
ye 1078 148 (6)
IMNDLING, STORACE AND SHIPPING Established safety procedures concerning the handling, storage and shipping of packages for certain special form radioactive material will be followed.
Shipnents will not be made unless all tests, certifications, acceptances,
and final inspections have been completed.
Work instructions will be provided for handling, storage and shipping o pera t ions..
Radiography personnel shall perform the critical handling, storage and shipping opera tions.
107(f 149
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(7)
INSFECTION, TEST AND OPERATING STATUS Inspection, test and operating status of packages for certain special form of radioactive material will be indicated and controlled by established procedures.
Status will be indicated by tag, label, marking or log antry.
Status of nonconforming parts or packages will be positively maintained by established procedures.
Radiography personnel shall perform the Regulatory required inspections and tests in accordance with established procedures.
The Radiation Safety Officer shall ensure that these functions are performed.
1078 150 (8)
QUALITY ASSURANCE RECORDS Records of inspections, tests, operating logs, audit results, personnel training and qualifications and records of shipments will be maintained.
These records will be maintained in accordance with established procedures.
A list of such records will be maintained by the Radiation Safety Officer.
T 1078 151 (9)
AUDITS Established schedules of audits of the Quality Assurance Program will be performed using a written check list.
Results of audits will be maintained and reported to Management. Aud it reports will be evaluated and corrected.
The audits will be dependent on the safety significance of the activity being audited, but each activity will be audited at least once a year.
Audit reports will be maintained as part of the Quality Assurance records.
The auditor shall have no responsibility in the activity being audited.
9 (10)