ML19296A577
| ML19296A577 | |
| Person / Time | |
|---|---|
| Site: | 07100315 |
| Issue date: | 04/09/1979 |
| From: | Ballard J RADIOGRAPHY INSPECTION, INC. |
| To: | |
| Shared Package | |
| ML19296A576 | List: |
| References | |
| NUDOCS 7906040104 | |
| Download: ML19296A577 (4) | |
Text
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QUALITY ASSURANCE PROGRAM ORGANIZATION CHART FOR A DlOG RA PfW lti)S26CTr 6 0 f MC.
(Name of Licensee) 99- /0 532 - o 9-TLicense Nu:r.ber)
F_0R COMPLIANCE WITH 10 CFR PART 71, APPENDIX E (NOTE TO LICENSEE) 1.
The Organizational Chart as used in the license application should be presented below the heading shown above.
It may be advisable to designate the Radiation Safety Officer as the responsible individual for the Part 71 QA Requirements.
2.
If you did not submit an Organizational Chart with your license application, Gamma Industries suggests that you use the chart format as attached for submission with Gamma Industries Form, #604-7001-001 2/79.
(00 NOT SUBMIT Th'0 JRGAliIZATIONAL CHARTS).
'b ra Iridus tries Form 4604-7001-001 2/79 790604Olby
QUALITY ASSURANCE PROGRAM 0F h/_\\JhocR,WHV lt0SPECTrod f NC.
TRame of"LTceiisiF 99-/0532-o3 (i_icense flumber)
FOR COMPLIANCE WITil 10 CFR PART 71, APPENDIX E 1.
Organization The final responsibility for the uality Assurance (QA) Program for Part 71 Requirements rests with _
toc RA P tf Y liarszen ed /rsc' Tflame of Licensee)
Design and Fabrication shall not be conducted under this QA Program.
The QA Program is implemented as shown on the attached organization chart.
The Radiation Safety Officer is responsible for overall administration of the program, training and certification, document control, and auditing.
The Radiographers are responsible for handling, storing, shipping, inspection, test and operating status and record keeping.
2.
Quality Assurance Program QLrfs R A p HLlmpcg3}:,o Itk.
The management of (Licensee fla m e establishes and implements this QA Program.
Training, prior to engagement, for all QA functions is required according to written procedures.
QA Program revisions will be made according to written procedures with manacement approval.
The QA Program will ensure that all defined QA procedures, engineering procedures, and specific provisions of the package design approval are satisfied.
The QA Program will emphasize control of the characteristics of the package which are critical to safety.
The Radiation Safety Officer shall assure that all radioactive raterial shipping packages are designed and manufactured undar a QA Program
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approved by fiuclear Regulatory Conmission for all packanes desinned or fabricated af ter July 1,1979.
This requirement can be satisfied by receiving a certification to this ef fect from the nanufactui er.
3.
Document. Control t
All documents related to a specific shipping packcon will be controlled i
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through the use of written procedures.
All dncument chances will be l
performed according to written procedures approved by nanagement.
The Rediation Safety Officer shall insure that all fp functions are
,i conducted in cccordance with the latest applicable changes to these I
documents.
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".:e. a I n,' r t r ' ", F., r m ; 50',-it191 --Onl 2/79 i
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4.
Handlina Storace and Shipping Uritten safety procedures concerning the handling, storage and shipping of packages for certain special form radioactive material will be foliowed.
Shipn 'nts will not be made unless all tests, certifications, acceptances, and final inspections have been comoleted. Work instruct-ions will ba rovided for handling, storage, and shipping operations.
Radiography personnel shall perform the critical handling, storage and shipping operations.
5.
Inspection, Test and Operating Status Inspection, test and operating status of packages for certain special form radioactive material will be indicated and controlled by written procedures.
Status will be indicated by tag, label, marking or log entry.
Status of nonconforming parts or packages will be positively mainta ned by wri tten procedures.
Radiography personnel shall perform the regulatory required inspections and tests in accordance with written procedures.
The Radiation Safety Officer shall ensure that these functions are performed.
_uality Assurance Records, Q
6.
Records of package approvals (including references and drawings),
procurnment, inspectiens, tests, operating logs, audit results, personnel training and qualifications and records of shipments will F maintained.
Descriptions of equipment and written procedures will alsc '" maintained.
These records will be maintained in accordance with written procedures.
The records will be identifiable and retrievable.
A list of these records, with their storage locations, will be maintained by the Radiation Safety Officer.
7.
Audits Established schedules of audits of the QA Program will be performed using uri tten check lists.
Results of audits will be maintained and reported to nanagement. Audit reports will be evaluated and deficieat areas corrected.
I The audits will be dependent on the safety significance of the activity f
being audited, but each activity will be audited at least nnce per year.
I Audit reports will be maintained as part of the quality assurance records.
I Moders of the audit team shall have no responsibility in the activity being audited.
Cligna ture and,k 0 EllA' C
OYb TEtie or Responsible Data Licensee Official 1
L E6 A
kRC QES i p aJT-i@I~nted f,are and litle of Responsible
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'1/0(_t!1S12!.utz b1_7 o.20731 t.icensee Address g
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Ga.' :a Industries Forn 1604-7001-001 2/79 3
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QUALITY ASSURAriCE PROGRAM ORGANIZATION CHART FOR DlOC,RR9H4 ItO5?. lCc.
l (flame of Licensee)
BR-10.732 - OD-(License fiumber)
LOR _
COMPLIAtlCE WIT-1 10 CFR PART 71, APPEf! DIX E_
d. f._CC QLIJ1F[p President t;ame Ope ra tions 1ia n a g e r Radiation Sa fety Of ficer (Afd. [267DE.
0.Tlt)ILLIAmS tla ne lla me h/0!!_.DALDEd Radiographer (1.0_.30AUh20 Radiographer L. Sc H Frjo Radiographer 4
L DESCRIPTI0tl 0F RESP 0t1SIBILITY l
President - General management of the company.
T..
Oyerations Manager -
Responsible for _ perations control of the o
company, supervision of employees, cost i
control, job assignme
's, personnel relations,
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trainin
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3.
Radiation Safety Officer - Responsible for overall administration g
g of the radiation safety progran (including Quality Assurance), personnel radiation sa f e ty tra in i ng a nd c'er ti fica tion,
document control, and auditing of the radiation safety program.
4.
Radiographers - Responsible for using, storing, shipping, inspection, testing, operating status, and record keeping of radroisotope sources and devices in a' cord with written procedures of the company as approved by the Opera tions Manager and Radiation Safety Officer.
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