ML19259A979
| ML19259A979 | |
| Person / Time | |
|---|---|
| Site: | 07100252 |
| Issue date: | 12/28/1978 |
| From: | Mckelvey E DAYTON X-RAY CO. |
| To: | |
| References | |
| LPR-1, NUDOCS 7901150153 | |
| Download: ML19259A979 (18) | |
Text
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Progr. me for 10 CFR Part 7 A
- p
)h Prepared by*E. W. McKelve s
y ate:
12-2e_78 D*F " L G"P*"f 7
Joor ated-Y 1150 W. Secofid Sh.
Re vision
-App,ov r
Dayton, OH 45407 y
<a<eWA i.
., o ot Revision date:
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Table of Contents ii 1.
Introduction 1.1 Purpose 1.2 Scope J
TH)S DOCUMENT CONTAINS 2
organization P00R QUAUTY PAGES i
i 2.1 Quality Assurance Personnel 2.2 Responsibilities 9
l.,
2.2.1 Manager e
x 2.2.2 Chief Radiographer 2.2.3 Inspectors 7
p s
go 3.
' Quality Assurance Program E
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Document Control
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Handling Storage and Shipping o, l g i
l 5.1 Receipt of Packaged Source 5.2 Inspection for shipping Damage t
l 5.3 Transfer of Source 5.3.1 Personnel Requirements 5.3.2 Transfer Procedure
, 5. 4 Shipping of Radiation Sources
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6.
Inspection Test and Operation 7
Quality Assurance Records 8.
Audits 1161S 790115oL5$
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QUALITY ASSURANCE PROGRAM 1.
Introduction 1.1 Purpose The purpose of this document is to present the requirements of 10 CFR Part 71 as they are implimented by the Dayton X-Ray Company.
The responsibilities of the perso.inel in the company will be defined and their method of implimentation established.
1.2 scope The extent of this company's use of shipping containers for commercial transportation is the receipt of a new isotope t
source from the supplier via commercial transportation, the transfer of the source from the shipping container to the operating container and the shipment of the old source back to the supplier.
The Dayton X-Ray Company uses only sealed sources of Iridium 192, Cobalt 60 and Cesium 137 for radio-graphic testing and instrument calibration.
The company uses only transportation packages supplied by the vendor.
The vendor will be required to provide a certification' that the shipping containers have met the requirements of 10 CFR Part 71 for its manufacturing and loading of the source.
2 Organization 2 '.1 Quality Assurance Personnel The licensee retains the responsibility for the Q. A. program for the receipt, transfercand shipment of sealed isctope inspection sources.
The responsible personnel at the Dayton
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QUALIT'Y ASSURANCE PROGRAM (con'd)
X-Rae Company'he re'af ter called the company, for the Q A is the President of the company who is the licensee and operations manager.
The Chief Radiographer is next in line of respon-sibility for the Q A Program.
Figure I shows the organizational chart of the company.
P resident and Operations Manager Technical Adviser 1
1 Chief Radiographer f
' Inspectors Figure I Organization Chart for Dayton X-Ray Company 2.2 Responsibilitie s 2.2.1 Manage r.
The responsibility of the manager is the overall control the laboratory facility personnel and operation as pre-sently defined in the Dayton X-Ray Co. Radiation Safety Manual.
The manager is responsible to develop a Quality Assurance Program and impliment it within t'he company.
The manager is responsible to appoint the Cnief Radio-grapher and other. personnel as necessary to accomplish the Q A Program.
The manager's fiscal responsibilities includes ordering new radiation sources and to assure that the purchase order requires a certificate that the transportation containers meet the requirements of 10 CFR 71.
QUALITY ASStJRANCE PROGRAM (con'd)
The manager.is responsible for the training personnel in the proper handling and transfer of sources in the facility.
2.2.2 Chief Radiographer The chief radiographer is responsible to operate and maintain the radiographic facility as defined in the company Radiation Safet'y Manual.
It is his respon-siblity to assure that the receipt of new sources, their transfer from the transport containers to the use con-
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tainer and shipment of the old source are accomplished in accordance with the Q A Program.
He is respor.sible to prepare all records prescribed by 10 CFR and the Q A Program for the receipt, transfer and shipment of sources.
He is respons'ible to train inspectors to assist in the receipt, transfer and shipment of sources and to desig-nate and train an assistant to receive, transfer and ship sources in accordance with the Q A Program when he is absent.
2.2.3 Inspectors only those personnel that have been trained and success-fully passed the Radiation Safety examination of the company can be classified as an inspector in the Q A Pro-The inspector is respcnsible to work in a safe gram.
manner in accordance with Q A Program and the Ccmpany Radiation Safety Manual.
QUAL 5TY ASSURANCE PROGRAM (con'd)
He shall* be capable of operating all radiation source-He shall be respon-control and handling equipment.
sible for the charging and wearing of a dosimeter and '
film badge when in the radiographic facility or other F
t.
radiation areas.
t to the chief The inspector designated as assistant i
radiographer shall assume the responsibilities and duties of the chief radiographer as defined in the company Radiation Safety Manual and the Q A Prografn.
3.
Quality Assurance Procram The quality assurance program shall be established and implimented by A training program shall be maintained to the manager of the company.
assure that all personnel involved in the program know and understand Revisions to the requirements and procedures of their specific duties.
the Q A Program shall be made in accordance with established procedures.
The handling of the shipping container and the transfer of the source the company Radiation shall include the requirements of this document, Safety Manual and documents which may be supplied by the source supplie special safety requirements that are peculiar to that that reflect Quality Assurance and Safety requirements provided specific container.
- ' with the source transport packages shall supercede the requirements of this document in case of a conflict.
4.
Document Control _
The purchase order for a new source shall be initiated by the manager for a certificate th at the shipping and shall include a requirement m
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QUALITY ASSURANCE PROGRAM (con'd) containers meet the suppliers Q A Program and request any special information for the proper handling and source transfer that is pec-uliar to the transport package.
Upon receipt of the source and prior to the signing of the shippers bill-of-lading the shipping container shall be checked by an area survey meter to assure that the mihimum requirement for shipping packages is not exceeded.
The nominal reading shall be recorded on the bill-of-lading and on the. source decav chart s'upplied with the source.
All bills of lading, shipping tags and caution labels shall be accom-plished in accordance with the Company Radiation Safety Manual and 49 CFR.
All records and shipping documents are the responsibility of the Chief Radiographer.
5.
Handling Storage and Shipping 5.1 Receipt of Packaged Source Assure that a properly calibrated fully operational area survey meter is used when surveying the transport shipping container in the shioners vehicle.
The shippers representative shall witness the indication of the meter.
CAUTICIF: DO NOT ACCEPT A SHIPPING CONTAINER FROM THE SHIPPER IF A READING OF MORE THAN 10 mr/hr.aC 1 METER IS OBTAINED FROM ANY DIRECTION AROUND THE CCNTAINER.
Record the reading from the container on the bill of lading and the source decay chart supplied with the source.
QUALITY ' ASSURANCE PROGRAM (con't) 5.2 Inspection for Shipping Damage The Chief Radiographer shall visually inspect the shipping container with the shipping representative to assure there is no physical damage to the container.
Any damage found shall be noted on the bill of lading.
NOTE: ANY DAMAGE TO THE LOCKS OR TRANSFER CONNECTEONS.THAT WOULD EFFECT THE GAFE TRANS-FER OF THE SOURCE IS CAUSE TO REJECT THE SHIPMENT.
5.3 Transfer of Source The source shall be transferred from the shipping container to the operating container as prescribed by the company Radiation Safety Manual and other instructions supplied by the source supplier that are peculiar to that source or shipping containers.
5.4 Shipping of Radiation Sources All shipping documents and labels shall be prepared in accordance with the company Radiation Safety Manual.
All established safety restrictions concerning the handling, storage and shipping of packages for encapsulated sources shall be followed.
Shipments shall not be made unless all tests, certifications, and final inspections have been completed.
The Chief Radiographer is responsible to assure that all records, shipping documents and safety precautions are complied with.
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QUALITY ASSURANCE PROGRAM (con't) 6.
Inspection, Test of Operation The shipping package data label shall be checked to assure that it was designed for the source size to be shipped.
Operation of sourc6s on and off the premises shall be performed in accordance with the company Radiation Safety Manual and the Combination Manual.
7.
Quality Assurance Records Operating logs, daily and weekly inspection reports and quarterly audits and surveys shall be maintained as prescribed by the Company Radiation Safety Manual.
Entries shall be made in the log and inspection reports when a new source is placed in operation.
Each time a source is used in the laboratory an entry shall be made in the log book.
Each time a source is removed from the facility an entry shall be made in the log book.
A complete package of documents including, trip report, mobile operations-check list, inspection report-Isotope equipment, Radiographers log sheet, Radiation area survey and state required note of possession of radiation materials. (see appendix I) shall be taken on each field inspection job.
The safety area survey sheet shall be made out for each job.
All trip reports shall be a portion of the custcmers inspection report which are filed in the customers contract file.
8.'
Audits Quarterly audits shall be made of records, instruments, equipment, area dose levels and operating procedures.
The audit reports shall be maintained in the audit file.
QUALITY ASSURANCE PROGRAM (con't)
The manager or a designated representative shall be repponsible for making the audits and preparing the reports.
Special nonscheduled audits shall be made at any time that the manager deems them to be necessary.
Reports of these audits will be filed in the audit file.
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President Md sWM and Radiogr-I manager apher i
Q A Functions:
1.
QA Program A, D B,
E
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2.
Training A, D B, D, E B
3.
Certifications D
4.
Testing D,
E E
5.
Document Change A
C B
6.
Shipping E
7.
Specifications A
D, E
8.
Audits D
D
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A-Establish
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B-Accept
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D-Initicte I
E-Perform
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Figure 2.
Example Responsibility Matrix 7.XX-8
APPENDIX I The attached sheets are the document package that the radiographer must take on each radiographic test job outside of the facility.
These forms are to be filled out and filed with the test report and purchase order in the customers fiie.
The reason that the document package is filed with each order is to assure that all pertinent data is available in case-of litigation with a customer on work accomplished or a suit by one of their employees alledging that he was exposed to radiation..
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Company Name Date Address Expense Job No.
P.O. No.
R?diographer is c is ta nt
'uchine Used
- s teria ls Used Leave Laboratory
.srrive Jcb Time out for meal End Job Arrive Laboratory Total Hiles Travel Time Job Time Total Time Overtime-Explain Fully Authorized by Scrap Jcb progress report Job Report No. LA I
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!!0BII.E OFr9A PIO?S CHECK L NT l
EQU?iMEft?
OK kkh EQUIMOR (CON'T)
OY i
.J 'Ar tu.CHU2 MAGNCTS l
_C SOtF.P.
RUBER STRAPS C"AnX_
MIIING PACDE detw E T m I
i
- unKInG FrNcn.
i S0_L'oCE CT FLASHLIGHT l
TUDE STAND PORTABE VIEWER RADIATION 11ARNING SIGp
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RQFE St,n'il MSTC l _ _ _
LEAD B*CCING ErSJfGRAP!GILOGk I
JCB PZPORT VEHICLE l
I I!!SECTION REPO3T Gy@9@)
FLARES rn.g FIRE EXTINGUSHER FILII HCIIEPS F UZL l
DEVEIcF R OIL WATE l
I FTE u)Tra unS l
i
- a. m. _ o m En cEDIT CARD t
FJT.M HANDES TRAVEL SHEET TBE3 P.M 3 TC'.21S l
NUlGER BOX 37IDE RULE e
TAE l
SHLNS i
2ENETRAMETERS l
rwt ENvEIorES T A P.t' _VEASURE ALL EEOU IMS MUST E CHECKED AND PROFER MEKING CONDITION HEFCRE IEAGT, LARI REMARKS:
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RADIOGRAPHER:
DATS:
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R ton X L Ucmpany
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140BTLE OFF'IATIONS
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CIGCK LIST l
EQU7FME!aT l OK p's -l kwMy EQUIFIENT (COIi'M OY O
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4 x g rgans MAG:sTS i
3 i
Sow.,cr.
RUBEER STRAPS l
l CEAnE MIXING PADDLE l
..ct5s Ttm NARKING PFNcn.
SOGCE E'.'
FLASHLIGHT l
TUFT, STAND PORTABLE VIEWER l
RADICION UARNI!!G SIG}S l
RCFE
'i Sut : Esin I
LEAD B.tCIING l
1.
R@hpAPKT3 LOG h
JCB REPORT VEHICLE l
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j 1.'!STE0 TION REPO3T ON @ 9b)
FLARES
,1 FIta FIRE EXTINGUSHE2 71Lij HCLCEPS FIEL L
DE'lELOFD.1 OIL l
WATIR l
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I WATE '.
EIS t
I T.E. P).0}SH..g CEDIT CARD I
FR M HANDERS TRAVEL SHEET TI?El PAPF. l TC'EIS
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NUl &~'R BOX SLIE RULE TAI 2 I
FII.!i ENVEIDPES TJiPE VEASl'RE ALL F.FOUIRED ITEMS ML'ST HE CHECKED AND PROFER MRKING CONDITICN N IEAIING LAB _.
F.E'JARKS :
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i R ADITRAPHER :
DATE:
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havton h Rey Go,npany INSFECTION REFCET ISCTCPE EQUIPMENT SCURCE TYFE CA' ERA NLMBER SOURCE NUMBER X
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X
, hfk P21'lRKS :
CHECKS FOR_ CAMERA oK ILCK FLUG SOURCE CABLE DISCCNFECT
,,_SCURCE TUBE PLUG N/ \\/
. CHECKS FCR SOURCE TUBE
/\\ b FLARES ALL CO' ECTIONS
, CRDiFS FRAYS OTHER DAMAGE i
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CHECKS FCR DRIVE CABLE
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FCOTAGE INDICATCR HANDLE CRANK l
THREADS I
STOFS g
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DO NCT [EE EQUIPMENT UNLESS ALL ITEMS ARE CHECKED AND CK.
ANY DISCFIFANCY MUST EE f REFCETED D2EDIATELY TO CHIEF RADICCRAPHER.
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.___ChhCEED BY: ( R A DIOGRAPH'-R )
DATE:
Oayton E bay bonipany
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RADIOCRAPERS LCG CC60 CUSTCMERS NAME & ADDRESS Rek$N h
$. h IR192 y
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a o
w Source #
$ s 5
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4 y
CAERA #
id y 5 9 FO#
lCCNTRACT#
METER #
METER READING CN VEHICLE PRICR TO LEAVING D '. J'CO S ::3 LAB.
DATE PLACE CF USE TIE OLT TD2 I'i wDm 9 h
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Dopo X Ray Company RADIATION AftEA SURVEY t
DIA GRAM READINGS I
A B
II A
B III A
B IV A
B ABOVE A
B BENEATH A
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..OAyfon X-3ay Company bSWlCL = kt*t*r4 AntlLA = buf 1150 W. SECOND STR EET, e ST A. B. P.O. 80X 7275 e DAYTON, OMIO 45407 e 513 / 228.4176 Radioactive Mat'l Carried Date Mat'l Source Curie Destination Class From In case of accident please call Dayton X-Ray Company (228-4176) between the hours of 8:00 AM to 4:30 PM.
on weekends and holidays please call Mr.
R'. W. Sammons (434-4748), if no answer there please call: NRC Regional Office (Daytime-312-858-2660, Nights' and Holidays 312-739-7711).
No unauthorized person shall remove source from truck.
Authorized Personnel:
John W. Gornes, Jr.
Mr. R. W. Sammons NRC Rep.
R. W. Sammons President MEDICAL e tMos*6TRi4L X.R AY ape *AR ATUS METALLURG6 CAL r.na f LAscRATony
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