ML19332D155

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QA Program for Simon Lake
ML19332D155
Person / Time
Site: 07100261
Issue date: 11/16/1989
From:
NAVY, DEPT. OF, NAVAL SEA SYSTEMS COMMAND
To:
Shared Package
ML19332C325 List:
References
26094, NUDOCS 8911300092
Download: ML19332D155 (8)
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SIMONLAKEINST:9893.1B a- -Quality Assurance Program f 'i

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. Responsibility for the Quality Assurane (QA) A. ??ogram rests with Simon Lake. The QA Program is implemenwed l using the following organization: I COMMANDING OFFICER l REPAIR OFFICER hh QUALITY ASSURANCE OFFICER I;q-RADIATION SAFETY OFFICER (RS0) L RADIOLOGICAL CONTROLS OFFICER l L (SHIPPING) e i ASSISTANT RADIATION SAFETY OFFICER (ARS0) SENIOR RADIOGRAPHER RADIOGRAPHERS The QA Officer id responsibld for scheduling of audits by l parsonnel'not having direct responsibilities in the areas being l aud'ited-(Audit Branch Personnel) and training of NDT personnel. ,c The RSO is, responsible for overall administration.of the program, S certification, and document control. The. Radiological Controls Officer is responsible for Shipping. 2. -Program: SIMON LAKE QA Program will be guided by written . instruction' contained herein. This instruction will'be the basis oi Quality Assurance and the' guidance provided will be used -throughsut the period during which packaging is used. The components to be covered by this Quality Assurance Program 'includet (1) (2). Mode 660 uamma Ray Exposure Device Model 650 IR 192 Source Changer The Quality Assurance-Program requirements are based upon: .(1) The impact of malfunction or failure of the component upon. safety. (23-The need for special controls and surveillance over processes'and equipment. (3) The requirements for indoctrination and training of personne'1. \\ h1 DC 0 1 L c 1

r m + SIM0hLAKEINST 9893.~ 1B - 1 I 3. Procurement Documents. F Quality must be insured in documents for' procurement of . material,' equipment and services. Procurement o2 IR 192 aboard t, LSimon Lake will be guided by current directives outlined in SPCC ,4 instructionf 4235.108 series, and safety precautions in accordance .with le CFR Part 20. Documents for procurement will be controlled-through use of written procedures of: a. .NAVSUPINST 4000.34 SERIES b. SPCCINST 4235.108 SERIES E 4. Control and Identification: (a) Assurance must be maintained.that material, equipment l and services conform to specifications.of-the procurement. U ' Examination ofcthe products must be made upon delivery and will 'be controlled and documented in accordance with enclorure (a) of SIMONLAKESINST 9900.2 Series (NRMP No. 04697-AINP). (b) Identification and control measures will prevent use of incorrect or defective materials, parts, and components. -Model numbersiwill.be chetAod upon receipt and will be verified to be-authorized _by: Wavy haoiolactive Materials Permit. Devices revival numbers-will be logged in SIMON LAKE's NDT Lab

  • Receipt and Transfer Log
  • for accountability.

5. iNon-conforming Materials, Parts. Components: Written procedure established for control of materials, . parts. and ' components whi7h do not conf orm to permit provisions are in accordance with SIMON LAKE Navy Radioactive Materials Permit. 6. Handling. Shortage. and Shipping Control: Written procedure established for handling, storage and shipping are in accordance with SIMON LAKE Navy Radioactive ' Materials: Permit. 7. Corrective Actions .All personnel involved in the program are responsible for prompt reporting of conditions adverse to quality. Once identified, corrective action must be pursued as appropriate. Reporting will be in accordance with 10 CFR Part 21 i maintenance of records will be in accordance with 10 CFR 21.51. l.. + I l l'

G, ;i - e.'.. p SIMONLAXEINST 9803.1B t. i '8. Records -Records will be maintained to furnish evidence of Quality. _ Records must be identifiable and retrievable. The Record: Retention Program, will clearly identify the name of the record, responsibility,-location and. duration required to be L -maintained as shomm in Enclosure (3). - 9. Internal Inspections / Audits: Planned Audits will be conducted Semi-Annually to verify compliance with al aspects of-c the Quality Assurance Program. The audits will/ be conducted by trained personnel,not having direct responsibility in the area being audited. Audit personnel will be assigned by the Quality Assurance Officer.- Audit checklists and access to-T records / personnel will. be provided by the RSO/ARSO. Written-report of discrepancies noted.will be forwarded to'the Commanding Officer via the.RSO,-QA Officer-and Repair Officer. Completed = audits with annotated corrective action taken will be:kept=as record by the QA Officer-(NDT LAB) and copies maintained'by RSO. 9 + P'

y 4 10 SIMONLAXEINST 9893.1B Packaging 'QA* Record Retention Program Name Responsible Location Duration Radiographer .R-8 Division NDT Office File Training Officer Audit Schedule QA Office R-8 Office Indefinite and Results Shipping Container RSO/ARSO NDT Office File' Indefinite ' Certification Exposure Device RSO/ARSO NDT Office File Indefinite Certification Copy of License of RSO/ARSO NDT Office File Indefinite Material Receivers Reports of Defects RSO/ARSO NDT Office File Retain Non-compliance until' after delivery of components Leak Check Records RSO/ARSO/R-S NDT Office File 3 years ' Package Survey RSO/ARSO NDT Office File 3 years (Radiation) Package Survey RADCON Officer NDT Office File 3 years (Contamination) Source RADCON Officer NDT Office File / 3 years Accountability R-5 Files and Inventory Records Quarterly Source RSO/ARSO NDT Office File 3 years Inventory Receipt & Transfer RSO/ARSO NDT Office File-5 years . Log after transter Written Procedures RADCON Officer R-S Files / indefinite for Shipping NDT Office Files Enclosure (3) J

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Personne1' Training Shipping Document F11es ' RADCON Officer R-5,. Files
3. years NDT Office Files I

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.G. _ _. -y - a : ao: 4 5' SIMONLAXEINST 9893.lB g 'QA* Program Audit Checklist is f Pre-Req.- Auditor Review SIMONLAKEINST 9893.'1. -Pre-Req Auditor Review 10 CFR Part 71 Subport H. Pre-Requ Auditor Review SIMONLAXEINST 9900.2. Item Attribute Sat'Unsat Remarks 1. QA Audit perinrmed by person not having direct responsibility-in area being audited. 2. Current.QA Program approval by NRC. (NRC Form 31'1) Ref: le CFR 71.101 (C). 3. Current NRC approval (cert of compliance) for packages available for all components used. (NRC Form 018) Ref: 10 CFR 71.21 (A)-& (B). '4. NRC materials license available for package' receivers. (NRC Form 374) Re.t: 10CFR 71.12 (A) & (B). 5. SIMON LAKE Navy Radioactive Materials Permit current. (NRC Form 374) Ref: 10CFR 30.3 6. Procurement documents available and of good quality. p Ref:. 10CFR 71.109/21.31. '7. Control and identificat' ion of packages IAW encl (8) of NRMP. Ref: 10 CFR 71.11S and-117. 8. Review of procedures for handling, . storage, shipping control. 9. Non comformance of materials parts, components identified? Corrective action'and reporting adequate? Records? Ref: 10CFR 71.131/21.21/21.51. 1 k-10.. Record Retention Program in affect? Record identifiable and retrievable? Responsibility, location and duration established? Ref: 10 CFR 71.135. Enclosure (4)

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