ML19296A567

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QA Program,For License 8-2370
ML19296A567
Person / Time
Site: 07100317
Issue date: 04/16/1979
From: Benefield W
HUDSON PRODUCTS CORP.
To:
Shared Package
ML19296A566 List:
References
NUDOCS 7905240210
Download: ML19296A567 (4)


Text

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h OUALITY ASSURA';CE PROGRAM ORGAtlIZATIC" Cut.RT FOR lhid s o n Products Carnora tion

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8-2370

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FOR COMPLIAfiCE HITH 10 CFR PART 71, APPEi; DIX E (t:0TE TO LICEf;SEE) 1.

The Organizational Chart as used in the license apolication should be presented below the heading sho',in 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, Camma Industries suggests that you use the chart format as att2ched for submission with Garma Industries Forn, *601-7001-001 2/79.

(D0 tiOT SUBMIT TWO ORGY 1IZATIO';4L CHARTS).

Gamma Indus tries Forn *601-7001-001 2/79 7905240 A/o

OURITY ASSUN N~E PRO ^> RAM OF pu,hmn ~Proects Corpora: ion

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8-2370

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FOR COMPLIANCE UITH 10 CFR P/AT 71, APPENDIX E 1.

Organization The final responsibilit, for the Quality Assurdrice (QA) Program for Part 71 Requirenents rests with Ilud-on Productr, corporation

~ ~~~-(Name o f Li'censeef Design and Fabrication shall not be conducted under this QA Program.

The QA Program is ic.plemented 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 handlinq, storing, shipping, inspection, test and operating status and record keeping.

2.

Quality Assurance Progran lhe nanagement of iludson Produc ts Corporation

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establishes and implements this QA Program Training, prior to engagement, for all QA functions is required according to written procedures.

QA Progran revisions will b 2 mde accordino to written procedures with nanagenent approval.

The QA Progrem will ensure that all defined QA procedures, engineering procedures, and specific provisions of the package design approval are satisfied.

The DA Program will emphasize control of the characteristics of the package which are cri tical to safety.

The Radiation Safety Of ficer shall assure that all radioactive material shippino packages are designed and nnnufactured under a OA Progran approved by Nuclear Regul;'ory Cor nission for all pa 'kaces desiened or fabricated after July 1, 1973.

This requirment can be satisfiesi by receiving a certification to this ef fect from th^ rinuf acturer.

3.

Docur'ent Control All documerits related to a specific shipping nackaoe ill be controlled through the use of written procedures.

All docur ?nt channe will Le performod according to written procedures approved by rananarient.

The Radia tion Sa fety Of ficer shall in:,ure that all QA fimctions are j

conducted in accordance with th" latest aanlicable chinox o hoso

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4.

Ra nil _in,q S to_rige a nd Shippi rg Written safety procedures concerning the handling, storage and shipping of packages for certain special forn radioactive material will be follo.wd.

Shipments will not be made unless all tests, certificatioris, acceptances, and final inspections inve been ce pleted.

Work instruct-ions vill be provided for handling, storage, and ship,oing operations.

Radiography personnel shall perform the critical handling, storage end shipping operations.

5.

.Insfec tion, Test and _0perating Sta tus Inspection, test and operating status of packages for certain special form radioactive naterial will be indicated and controlled by written procedures.

Status will be indicated by tag, label, narking or log entry.

Status of nonconforming parts or packages will be positively maintained by written procedures.

Radiography personnel shall perform the regulatory required inspections and tts's in accordance with written procedures.

The Radiation Safety Of ficer shall ensure that these functions are perforned.

6.

Quality Assuranc_e Records Records of package approvals (including references and drawings),

procurement, inspections, tests, operating logs, audit results, personnel training and qualifications and records of hipments will be maintained.

Descriptions of equipment and written procedures will also be maintained.

These rccords 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 written check lists.

Results of audits will be mintained and reported to management. Audit reports will be evaluated and deficient areas corrected.

The audits will be dependent on the safety significance of th9 activity being audited, but each activity will be audited at least once per year Audit reports will be maintained as part of the quality assurance records.

fierhers of the audit team shall have no responsibility in the activity j

being audited.

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-Q1!ALITY ASSUdCE PROGRAM ORCA iIZATIC.'l CHART FOR s

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8-2370

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FOR COMPLIANCF WITH 10 CFP PART 71, APPENDIX E E. C. Snith President Nane Operations Manager Radiation Safety Officer E. M. Davidson

11. E. Benefield fla me Nane L. Sralla P a dl o g ra p h e r A. Mata Radiographer J. Shofner

_ Radiographer 11. L. IIall

~ Rad i.sgrapher-

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Beneficid 1

-tdioggpher DESCRIPTION OF RESPONSIBILITY 1.

President - General management of the company 2.

Op rations Manager -

Responsible for opera tions control of the i

E company, supervision of employees, cost control, job assignments, personnel relations, I

training.

3.

Radiation S a f e ty~ O f f i c e r - Responsible for overall administration

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of the radiation safety program (including Quality Assurance), personnel radiation i

safety training and certification, document control, and auditing of the radiation safety program.

4.

R a d i o g~r a p h e rs - Responsible for using, storing, shipping, inspection,

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testing, operating status, and record keeping 04 r a d i'o i s o t o p e sources and devices in accord with uritten procedure" of th9 cc,pany as approved by the Operation, Manager and Radiation Sa.~ety Officer.

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