ML20125E557
| ML20125E557 | |
| Person / Time | |
|---|---|
| Site: | 07100639 |
| Issue date: | 12/10/1992 |
| From: | Wos G WOS TESTING CO., INC. |
| To: | Macdonald C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| References | |
| NUDOCS 9212170117 | |
| Download: ML20125E557 (16) | |
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't, NUCLEAR REGULATORY COMMISSION Mr.E W ASWNO TON, D. C. 20555 9
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- pu c a 0 Y WOS' Testing, Inc.
CATTH:' Mr. Gerald W.
Wos
,,Y 1611 Nelson Drive
' J ',E, Eau'? Claire, WI 54703
Dear Mr. Wos:
Your Quality Assurance (QA) Program Approval for Radioactive Material Packages No. 0639 expires on January 31, 1993.
If you are a NRC licensee and conduct activities under the General Licenses of Subpart C of 10 CFR Part 71, or if you are an Agreement State licensee subject to the requirements of 10 CFR Part 71, you are required by 10 CFR S 150.20 to hold a QA program approved by the Commission as satisfying the pro-visions of Subpart 11 of 10 CFR Part 71.
You should request renewal of your QA program at least 30 days prior to the expi-ration date.
This will provide for continuation of your QA program to satisfy part of the provisions of Subpart C of 10 CFR Part 71 until a final determination has been taken on your application.
Unless an exemption is provided by 10 CFR S 170.11, an applica-tion fee of $250.00, as required by 10 CFR S 170.31, should
- be included with your request for renewal.
This notice of
@ G b expiration should not be construed that such notice will be hProvidedinthefuture.
If you do not desire to renew your
, d @A dQAtprogram,.please let me know.
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RADIDACTIVE MATERIAL LOG Shippers Declaration for Dangerous Gooda For Radioisotopes Departing From: WOS TESTING COMPANY 4821 London Road Eau Clair. Wisconsin To & From Temporary Job Sites. Primary Storage (Location Will Be Same As Dtpartu-r AcAra a) Date Time Out Projector Model # Projector SN Scurce SN Destination Time of Return i NATUE AND QUANTITY OF DANGEROUS GOODS Dangerous Goods identificaticn Class UN Quantity an Packing Authorization Subsi-type of packing Inst. or or Proper Shipping Name Divi-ID R sk sion No. Radioactive Radio-UN 1ridium-192 Material active 29 c11 w Type H Metal solid 7' ackage Special Form. Mater-Encapsulated 11 N.O.S. ial Cert. USA 1 Type B Tis 1.0 Packnge x Ci i Additional Handling Information I hereby declare that the contents of this consignment Name/ Title of Signatory accurately described above by proper shipping name and are classified, packed.. marked and labelled, and are in Place and Date all respects in the proper condition for transport by vehicle according to the applicabla International and Signature National Government Regulations. i 2%. 2
WOS TESTI!G QUALI'lY ASSUllNJCE PRCGIW4 Ibto tDTIQ' 'IO EMPlDYEPS Pursuant to 10 CFT1 Part 19...................... Paragraph 19.11........Eosting of notices to onployees...... Regulations Part 19; Regulatiens Part 20; License and Anundnents; Operating Procedures. All above Docunents nuy be found in X-ray files, and nny te examined by enployees wlo inve direct connection with licensed activities. ................ PD OWJ Et tr t DTICE........ tD I Kyr R1}DVE............. hwtfb ll 'b G. F. Nos Radiation Safety Officer 85 l
i j WOS TESTING QUALITY ASSURANCE PROGRAM i ] i STATEMENT OF POLICY FOR j QUALITY ASSURANCE PROGRAM i i I This company will make every effort to see that all shipments j are conducted safely and by qualified personnel. l The Radiation Safety Officer will have the authority and ]! responsibility to assure that this manual and all aspects of l 10 CFR Parts 19, 20, 30, 34, and 71 are implemented. The final responsibility for the quality assurance program for i Part 71 rests with the Wos Testing Corporation. { Any revision to this manual will be revised by entire page. 1 Revisions will take affect only after acceptance by the Nuclear Regulatory Commission. When acceptance has been granted,-the page will be initialed ] by the Radiation Safety Officer. 1 ij i } 1 2%rxtA 5 '1 % kba L. $ "11doj l Gerald F. Won Deborah K. Wos j Radiation Safety Officer President i i 1 i f 87 i s 4 y-. ,w ,,w s->,, -, a-n.,_--,-..-vmw. y ~-n.--
i } + !4 s J WOS TESTING QUALITY ASSURANCE PROGRAM q j i j-T l ORGANIZATIONAL CilART 4 i i l Vice-President Auditor President 1 i 4 Treasurer Radiation Safety Officer l i; j Secretary Radiographer t e 4 I l f l 4 i l I. d l d l 4 4 } 3 k 5 1-. i n .I 88 a e i+ d.............-,-._.._,__-......-,.._......-.-..-.m..--..
WOS TESTING QUALITY ASSURANCE PROGRAM e 11.1 ORGANIZATION Administration Authority and Responsibility Deborah K. Wos - President 1. Review the findings of internal inspections with the safety officer. 2. Take corrective action on all unsafe conditions. Gerald f. Wes - Radiation Safety Officer, Supervisor and Radiographer l. Is responsible for the overall administration of Title 10, Chapter 1 Part 71 of Federal Regulations. 2. Serve as liason officer with the Nuclear Regulatory Comn.ission, State Radiation and other agencies on matters relating to licensing and use of radiographic equipment. 3. Have direct supervisory responsibilities for the organization and [ operation of the WOS TESTING LABORATORY INC. 4. Maintain control of procurement and disposal of licensed by-product material. 5. Review, develop, and maintain up-to-date operating and emergency procedures co assure compliance with NRC regulations and our license requirements. 6. Investigate with the president cause of incidents to assure that necessary preventative action is taken. 7. Procure and maintain adequate radiation survey instrumerts and calibration services. 8. Establish and maintain adequate storage area. 9. Assume control and institute. corrective action in emergency situations. 10. Control survey instrument calibration, j 11. Establish and control personnel monitoring system. l 12. Establish and control Leak Test Program. 13. Establish and control record keeping system. { 14. Conduct inventories and maintain logs. { 15. Establish and control internal inspection system. j 16. Maintain exposure devices and associated equipment. p 17. Perform or request outside assistance for changing of' scaled sources. 18 Conduct training to prospective radiographer and radiographer's-assistants, prior to submitting to NRC their qualifications. I j 19. Examine and determine competency of personnel. 20. Responsible for distributien of exposure device keys to.the designated radiographers. L i j 89
i l WOS TESTING QUALITY ASSURA!1CE l'ROGRAM 1, I i 21. Will be responsible for all training and the documentation of that training, i 22. Will be responsible for all documents. 1 23. Will be responsibic for auditing, but will assign auditing duties I to someone knowledgeable, but not connected with implementation I of the safety program. 3 4 9 e 3 i i i 90 i
t i* WOS TESTING QUALITY ASSURANCE pHCORAM f I i 1 j 11.1 Radiographers - Responsibility Radiographers are responsibic for the following i j 1. The safe handling of radiographic projectors. i 2. Storage of radiographic projectors and the stored radiation material, l 3. Shipping of radioactive material and accompanying documents. 4. Inspection of radiographic projectors for proper operation. 5. Leak Tests to be performed over six months and necessary documentation. 6. Inspection of suevey instruments for proper operation. ? 7. Maintenance at three month intervals, unless needed on a higher frequency. 8. Daily Utilization Logs. j 9. Three month maintenance records. { 10. Reporting of any idiosyncrasies in operating status of projectors, j survey meters or accompanying _ documentation. i 4 i i 4 J ij i 4 f l t i 91
4 WOS TESTING QUALITY ASSURANCE PROGRAM 11.2 Table of Contents Page Title and Approval 1 Radiographer Manual 2 Authorized Equipment to be used 3 Responsibility - Safety Officer 3-4 KEYS 4 l Summary of Notification Requiremtnts 5 R.S.O., Supervisor, Radiographer Qualifications 6 Radiographers - Responsibility 6 Assistant Radiographer - Description 7 Assistant Radiographer Trainee - Description 7 Training 8-9 Training Program 10-17 Isotope Radiography and Radiation Safety 18-30 Radiation Safety Test Trainee (Supplement E) 31-34 Supplement E answer sheet 35-36 Written Examination (Supplement C) 37-43 Supplement C answer sheet 44 Oral Examination (Supplement D) 45-46 Field Examination (Supplement E) 47-48 Individual Training and Experience 49-52 Facilities and Equipment 53A-53 Radiation Safety Program Personnel Monitoring Equipment 53 Radiation Detection Instruments 54 Survey Meter Calibration - Record 55 Radiographers Manual Personnel Dosimetry 56 Quarterly Internal Inspection Radiographer 59 Assistant Radiographer 60-61 Radiographer / Radiation SAFETY OFFICER 62-64. Index 65
WOS TESTING QUALITY ASSURANCE PROGRAM 4 1 Table of Contents (continued) Page Operating and Emergency Procedures 66-67 EMERGENCY (Wos - 6) 67-69A i lt Daily Utilization Log (Wos - 1) 70 j Monthly Utilization Log (Wos - 2) 71 Inspection. Tests, and operating status 72 J Audits 72 l Operating Procedures for source changers 72-75 Leak Testing 75-76 Leak Testing Record (Wos - 3) 77 Internal Inspection 78 4 l Internal Inspection Check List (Wos - 5 ) 79 Quarterly Maintenance 80-81 I Quarterly Maintenance Check List (Wos - 4) 82 1 j Posting and Restricting Radiation Areas-83 ] Movement - Radiographic Devices 83 { Transportation to Permitted Use Locations 84 1 l Radioactive Material Log (Wos - 8) 85 i Notice to Employees 86 f Statement of Policy for Quality Assurance Program 87 Organizational Chart '88 l Organization 1 j President - Responsibility 89 R.S.O., Supervisor, and Radiographer - Responsibility 89-90 1 Radiographers - Responsibility 91 Procurement Document Control j Drawings, Manufacturing, Certification Design Approval 92 j Document Control 92 j Handling, Storage, and Shipping-93' inspection, Tests, and Operating Statun 94 i Audits 94 i j , Records of Documents (Wos - 7) 95 5 i -i 4 1 1 j k..., ...__,_._.._._m......,_
_. -. _. - - ~. t WOS TESTING QUALITY ASSURANCE PROGRAM d j 11.3 PROCUREMENT DOCUMENT CONTROL { Drawings, Manufacturing. Certification. Design Approval 1 l It is the responsibility of the Radiation Safety Officer to review and approve drawings and manufacturing certifications in accordance with 10 CFR Part 71. .I i i The Radiation Safety Officer shall assure that all radioactive material j shipping packages are designed and manufactured under a Quality Assurance i Program approved by the Nuclear Regulatory Commission for all packages } designed or f abricated af ter January 1,1979. } This requirement will be satisfied by receiving a certification from 1 the projector manufacturer. The certification shall be kept on file at Wos Testing. 4 1 Document Control i All documents portaining to Radioactive Shipping Packages will be { gontrolled through Procedure Wos - 7. } The following documents shall fall under the scope of Wos - 7; Page 94: 1 j 1. Shipping papers 1 l 2. Receiving papers 3. Source decay curves i 4. Leak Test results t 5. Survey instrument calibration j 6. Periodic audit results - done at 3 month intervals l 7. Manufacturing certification and design approval l 8. Personnel training log 9. Film Badge Results 10. Dosimeter Records Wos - 2 11. Daily Utilization Log Wos - 1 4 1 4 l 1 a 92 4 1 l . _,.. _. _ _ _ _ _. _ _ _ = _ _.. _ _ _. _, , ~ _..._, -. _, _ _ _.
hva ALs11oo QUnL111 ewsUhrmLL l'hUblinH 11.6 llandling, Storage, and Shipping Sdpmt of udkrctim notelais will tot le nub udcss all ttsts, cetificatias, arqtates, ad fim1 inycthm Inn first hui coquetcd. 'Ilu mik;;;tqhr dull anty de ujcta cuitainiig de mlicrctim nattrial driig du folkuirn periods:
- 1. Wu takiq; pujceta mt of stmge catprtamt
- 2. Iticr to d11 pant ly comm carricr.
- 3. Innaliately tpn tu:eipt frun carrm carricr.
- 4. Innallately qui ticeipt fran autfrr milq;rghr.
- 5. Wuntr ujceta is in qcratim. Sunty ntst tu talullefore ad afttr de smtce is emlini in ad mt.
- 6. Itix to a irrk ttst.
- 7. Prix to phnirg pujcctcr in stcm;e cnynrtnmt.
- 8. Aytine safe sttnge of smtce in poj tcr is supct.
- 9. Drirg a sante duge.
Projcctats dull le stmd in 1ttd limi stmge luxos wickd ly un 'Rstirg. Stcuge cmtaimes dull in 1cchd dui smtce ad ujccta are witidn de cmfirrs of du stmge cmtaimr. In ddgmt, tin (f0, 900, (120 or 2-T (Iridhm 192) ad (f0 ('llullun 1X)) pujcntcr x ttrb16K),fe4, cr 741 (Cdn1t (0) pojccta utst tu krini with tiu stmge phg imerttd ad Itclui with a tagrr prof seal. Wul diinni with du cnitahul Irkliun 192, Qinit (0, cr 'Ilulitm 170, tiu milcretim vellm 111 lain 1 ntst le kbitificd with " Iridiun 192 ", h " Cdalt (0 ", cr "'Ilullun 170, de ruhr of arim cmtahrd, ad du tmtgrrtatim irrbx, Odch is tiu nnxinun tidiatim Ic.el nmsutui at a distare of 3 fmt fran tin arfire of du cmtalmr. Wul tie ttibi (f0, 900, 920, or 2-T " Iridlun 192 " cr (f0 "Ilullun 1Xf' pujccta x ttib1680, f&, or 741 " Cdn1t (O " pujcctcr is nrehul as a ddpmt, uptk tin systan ady with a pyrrly calittutcd anty nettr. If titre is chnga to du pojceta, mtify tiu Itdiatim Safety Offica innr111ately. If milaticn laels e>mi du apuul lauls, follw Iirrrgrry Prtcabrs Ws - 6, pgm 67-GA When the radioactive material decays to such a degree which renders the source inefficient-for use it will be exchanged for a new source from Source Production and Equipment Co. or Amersham Amertest, or RTS Technology. t 9b
~. _ _ _. _ _ - _ _ _ _. _ _. _ _ _ _ _ _.. _ _ _ _. _. _ _ _ _ _, _ _, a 1 i WOS TESTING QUALITY ASSURANCE PROGRAM 1 11.7 Inspection. Tests, and Operating Status q 1 i The radiographer will perform a daily inspection pertaining to the operating status of the projector and all accessories included with or in any way effecting the safe operation of the sealed source.. Non-comformance will be noted by a written description on the daily utili-I r.ation log. Wos - 1 Page 70. Nonconformances will also be reported verbally to the Radiation Safety Officer. The Radiation Safety Officer j shall take immediate steps to resolve the noncomformances, i i Leak tests will be performed on a sealed source at six (6) month f intervals. Leak tests will be performed by the radiographer in accordance with Procedure Wos -3, Page 77. i l Quarterly maintenance on projectors will be performed at three (3) month intervals. A quarterly inventory of the equipment and sealed source ) will be taken during the quarterly maintenance and logged on the quarterly maintenance form. Quarterly maintenance will be performed ? j by the radiographers and recorded on quarterly maintenance forms. j Quarterly maintenance will be performed by Procedure Wos - 4 Page 82. 1 l 11.8 Audits 4 i j Periodic three (3) month audits of the Quality Assurance Program will be performed using written check lists. Results of the audits will be i maintained and reported to management. Audit reports will be evaluated j and deficient arcas corrected. The audits will be dependent on the j safety significance of the activity being audited, but each activity j will be audited at least once per year. Audit reports will be maintained j as part of the quality assurance records. Hembers of the audtt team i shall have no responsibility in the-activity being audited. k2-k I i i i. 1 f 94 -.-...--e i, r,,. .-,...J.,n,-,,ny.,,-.,,.w,,.,,_r. ,_-,,,.,_.,w.,r.-,,-m,,,,,_. ,,_,.,,,,w gwm,,99,.
-. _..--..~.-.-.- - - - -.. - _.. - - -. = - _ -.. - - -....... -. -. - -.... 4 1 l WOS TESTING QUALITY ASSURANCE PROGRAM l i a i i i i 11.8 Procedure Wos - Records of Documents a { Obtaining and filing of records will be the responsibility of the i Radiation Safety Officer. 1 j-When ordering material from the manufacturer, it will be requested that all certification records shall accompany the material. Upon receipt ) ] of the material, the documents will be filed. l If the documentation is not received with the material, a written request for the documentation will be sent out promptly. l When documentation is initiated by Wos Testing, copies of that documentation will be filed. I j The Radiation Safety Officer shall insure that all quality assurance functions are conducted in accordance with the latest applicable changea to these documents. 3 f These records will be readily retrievable, identifiable, and available } to management and Nuclear Reulatory inspection Personnel. J The Radiation Safety Officer will be responsibic for the continued maintenance of the documents at Wos Testing. I i t l i-f i l-i- i 1 i i 95 i .i. ,,e- .m -..... ---,~., _..-,,..,-,.,-m,--._.~.., w, .---.....,_.,_,.~.___~__._,_,.,.,-,,m.,,-
_~. - -. - -. - __ - ~_ 1 I 15.0 CONTROL OF NONCONFORMING MATERIALS, PARTS OR COMPONENTS 4 15.1 Nonc forming materials, parts or components are those items tested or inspected by WTI at the request of the purchaser which are found to be in noncompliance with applicable specifications. 15.2 WTI, in its operations, shall identify and/or eegregate where possible, those items failing to conform with applicable specifications. 15.3 The disposition and resolution of nonconforming items shall be the responsibility of the purchaser. 15.4 The identification and disposition of internal items which do not conform to the requirements of this manual will be 4 resolved in accordance with Section 10 (Inspection), Section 16 (Corrective Action) and Section 18 (Audits) of this manual. 15.5 WTI when required by contract shall provide a-program which assures measures to prevent inadvertent use or installation of safety-related materials, parts and components which are not in compliance with the require-meats of applicable codes, standards, drawings, specific-cations and other procurement documents. The program requires identification, classification, resolution and follow-up of material nonconformances. Measures provided by the program includes a. Procedures to control the identification, docu-mentation, segregation, review, disposition and notification to designated organizations of the nonconformance of materials, parts, or components. b. Documentation which clearly identifies the noncon-forming items, describes the nonconformance, the disposition of the nonconforming items, the inspec-tion requirements, and includes signature approval of the disposition. c. Documentation and definition of the responsibility and authority for determining the disposition of nonconforming items. d. Degregation, if practicable, of nonconforming items from acceptable items and identification as dis-crepant until properly dispositioned for use. Access to the items will be controlled. .a
7.- - j 1 4 Verification of acceptability of rework or repair e. 4 of materials, parts, components, systems and structures by reinspecting the item as originally inspected or by a method which is at least equal 2 to the original inspection method and documentation of inspection rework and repair procedures. Rein-i spections are performed in accordance with written j work instructions and are documented. i f. Perform and forward periodic analysis of material nonconformance reports to responsible management to j show quality trends. g. Incorporation of nonconformance reports disposi-l tioned "use-as-is" or " repair" as part of the reports covering nonconforming items identified at 4 supplier locations and at the site, j Nonconforming items that can be restored to drawing and specification requirements may be reworked to drawing and i j specification. j oocumented approval is provided to WTI prior to releasing any nonconforming item for installation or construction 3 j when it has been repaired or designated "use-as-is". i 15.6 Reporting of Defects and Noncompliance (10CFR21) i 15.6.1 Deviations identified in nuclear materials, parts, or components through test inspection operations of WTI shall be reported to the purchaser or licensee for evaluation. l 15.6.2 The report of deviations shall be acknowledged by the signature of the recipient. i 15.6.3 A copy of the completed report shall be forwarded l to the President, WTI. } l 15.6.4 The disposition of the deviation shall be completed i by the purchaser or licensee and WTI notified if re-examination is required. i i 15.6.5 WTI maintains the right to report any deviation 4 - directly to the Commission (NRC). 4 4 5 i 4 _,. -..}}