ML19254E468

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Revision a to QA Program for Radioisotope Shipping & Receiving
ML19254E468
Person / Time
Site: 07100354
Issue date: 10/12/1979
From:
ADVANCED MEDICAL SYSTEMS, INC.
To:
Shared Package
ML19254E463 List:
References
14395, NUDOCS 7911010148
Download: ML19254E468 (12)
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Text

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QUALITY ASSURANCE PROCEDURE - RADIOISOTOPE SHIPPING & RECEIVING FOR COMPLlANCE WITH'jj g PART 71, APPEND X E 1.

Organization The final responsibility for the Quality Assurance (QA) Progrcm for Port 71 Requirements rests with ADVANCED MEDICAL SYSTEMS, INCORPORATED.

Design and Fabrication shcIl 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 overcil administration of the program, training and certification, document control, and cuditing.

The Persons named on the License (The Radiction Safety Officer, Source (A)

Fabrication & Service Menoger and personnel reporting to him) cre respon-isible for handling, storing, shipping, inspectien, test cnd operating stotus and record keeping.

2.

Quality Assurance Program The management of ADVANCED MEDICAL SYSTEMS, INCORPORATED, establishes and implements this QA Program. Training, prior to engagement, for all QA functions is required according to written procedures. QA Progrcm revisions will be made according to written procedures with Isotope Committee opproval. The QA Program will ensure that all defined QA procedures, engin-eering procedures, and specific provisions of the package design approval are satisfied. The QA Program will emphcsize control of the chorocteristics of the package which are critical to safet7 The Radiation Safety Officer shall assure that all radioactive meterial shipping packages are designed and manufactured under a QA Program opproved by Nuclear Regulatory Commission for all packages designed or fabriccted ofter

.luly 1,1978. This requirement can be satisfied 6.y receiving a certification to this effect from the manufacturer.

3.

Document Control All documents related to a specific shipping package will be controlled through the use of written procedures. All document changes will be performed accord-Ing to written procedures approved by the isotope Committee.

The Radiction Safety Officer shall insure that all QA functions are conducted in accordance with the latest cpplicable changes to these documents.

REVISION A -- 10-12-79 1281 14 ass 7 91101014 P -

QUALITY ASSURANCE PROCEDURE - RADIOISOTOPE SHIPPING & RECEIVING FOR COMPLIANCE WITH 10 CFR PART 71, APPENDIX E 4

Handling Storage and Shipping Written safety procedures concerning the handling, storage and shipping of packages containing radioactive meterial will be followed. Shipme.s., will not be mode unless all tests, certifications, acceptances, and final inspec-tions have been corapleted. Work instruction will be provided for handling, storage, and shipping operations. Persons named on the License shall super-vise the performance of the critical handling, storage and shipping operations.

5.

Inspection, Test and Operating Status Inspection, tsst and operating s+orus of packages containing radioactive material will be in6 coted and controlled by written procedures. Status will be indicated by tog: sabel merking or log entry. Status of non-conforming parts or packages will 'be positively maintained i / written procedures.

Persons named on the License shall perform the regulatory required inspections and tests in accordance with written procedures. The Radiation Safety Officer shall ensure that these functions are performed.

6.

Quality Assurance Records Reco-ds of package approvals (including references and drawings), procuremect, inspections, tests, operating logs, audit results, personnel training and quali-fications and records of shipments will be maintained. Descriptions of equip-

' ment and written procedures will also be maintained.

i These reebrds will be maintained in accordance with written procedures. The records will be identifiable and retrievable. These records will be maintained by the Radiation Safety Officer, e,

7.

Audits Established Schedules of oudits of the QA Program will be performed using written check lists. Results of audits will be maintained and reported to management.

Audit reports will be <svolu. ted and deficient areas corrected. The audits will be dependent on the safety significance of the ectivity being audited, but each act-ivity will be audited at least once per year. Audit reports will be maintained as part of the quality assurance records. Persons performing the audit shall have no responsibility in the activity being audited. The Engineering Manager will con-(A) duct the annual cudits.

REVISION A 10-12-79 128l i

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ORGANIZATION & FUNCTION CHART D *l D

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PRESIDENT j

Chief Executive Officer W

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Chainnan Isotope Comrnittee GENERAL MANAGER General Monocement of the Company Member of Isotoo Carronittee

. SOURCE RADIATION QUALITY FABRICATION &

SAFETY ASSURANCE SERVICE MANAGER STICH MANAGER Wmber Isotope Committee hmber of htope Committe.

Overall Administrotron of the Operate Hot Cell Overall Adninistration of the Quality Assurance Progran Isotope Equipment Maintenance Radiation Safety Program for Therapy Equipment being Isotope Shipptry & Receiving including Quality Assuranco Manufactured.

Field Service Requiring NRC License of Isotope Encapsulotten, incoming imp.ction-Therepy Eoutp.

Isotope Source Instoilation, Replace-Shipping, Receiving & Stc.oge Inprocess inspection-The cov Eauip.

ment & Removals Training of Radiation Safety and Final inspection-Therapy Eauipment irsto!!ction of Therapy Eaufpment c ificotton of Personnel Audit Good Mfg. Practices irnplernent G A Program-isotopes le.

- Document Control BRH Certifications Inventory Control-isotopes Moira,nence of NRC & DOT License.

Wmber Meterial Review Committee Scheduling-isotopes

& Certificates Liaison with HEW & BRH Scheduling-Field Service OFFICE ENGINEERING SALES MANAGER ENAGER MANAGER wmber Isotope Committee International Sales Inventory Control-Therapy Equip.

Sustaining Engineeing Domestic Sales Purchasing & Expediting i

Design Engineering Market Research Receiving-Therapy Materials Product Engineering Pricing Stockrooms industrial Engineering Quotetion Shipping-Therapy Envip.

Quality Assurance Pre edures Advertising Shipping Papers-Isotopes Quality Assurance Auc~.t-Sales Training Trsffic Control Therapy Eovipment 0 der Entry & Invoicing Good Manufoeturing Prectices Lrsal Notices & Reports bocedures Cost Accounting Document Control-Therapy Equip.

Member Material Review Cernm.

Mater ol Review Comm. Chairman Secretorial Pool Blueprint Reporduc.fon & Storage Reception MANUFACTURING MANAGER Control of the Therapy Equipnent Manufoeturing Functions Supeerision of Employees Manufoeturing Cost Control Personnel Relations Production Trelaing 1281 ::

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ORA NIZA TION CH A RT PRESIDENT S.S. Stein GENERAL MANAGER R.W. Arndt SOURCE FABRICATION RADIATION SAFETY OFFICER QUALITY ASSURANCE

& SERVICE MANAGER MANAGER D. Murray p;.D. Kelbley N.D. Kelbley OFFICE MANAGER ENGINEERING MANAGER SALES MANAGER M.H. Ames (open)

R.J. Skrtich MANUFACTURING MA_ NAGER 3

(open)

REVISION A 10-12-79 1281

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QUALITY ASSURANCE PROCEDURE - RADIOISOTOPE SHIPPING & RECEIVING RECEIVING RADIOSOTOPES All radioactive materials shipping containers, whether containing active materials or empty, will be surveyed in the following manner before acceptance and removal from the transporting vehicle:

f Using a Geiger meter (Victoreen Model 491 or similor) with beto shield open, survey the container to determine that the shielding is adequate to comply with current shipping regulations.

Record readings on "Redioisotopa Receiving Form" as shown on page 13e of this manual, if abnormal readings are detected the Radiction Safety Officer will be contocted to determine disposition.

Container is then to be removed from transporting vehicle (if applicable) and stored in a controlled creo.

A " Wet Smear" contamination check of the external surface will then be mode, using the Instrumentation de' scribed in Par. V, Section 1 of this manual. Any obnormalities will be immediately reported to the Radiction Safety Officer who will determine disposition and procedure. Containers used for various isotopes will be checked for a wide range of energies. Results will be recorded on the

" Radioisotope Receiving Form" (Page 13c)

PREPARING CONTAINERS FOR SHIPMENT Before loading with a radioisotope source (if applicable) the accessible internal surfaces will be given a wet smear con-tominction check and cleaned if necessary to meet current Regulatory Standards.

Container mechanisms (if any) will be checked for proper function and repaired if necessary.

The container and its mechanisms (if any) will be inspected for integrity and proper mechanical furttions in acco-dance with manufacturer's drawings, descriptions, certificates and check lists. Repairs will be made when necessary ofter consulting (A) with the Radiation Safety Officer for repair method opprovol.

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QUALITY ASSURANCE PROCEDURE RADIOISOTOPE SHIPPING & RECEIVING,

(continued)

Container may now be looded (if applicable).

Make wet smear contamination check of extemot surface of container, and internal and extemot surfaces of overpack to be used (if applicable).

Load Container into Overpock (if applicable).

Fill out "Rodioactive Materials Shipping Record" and have approved by a person named on this license os o user.

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... _.. RADICACTIVE MATERIAL 5 HIPPING RECORD ~ ~ ~ '

CUSTOMER t.OC ATIO N CERTIFICATE OF COMPLIANCE NO.

CERTIFICATE OF COMPLIANCE HOLDER CERTIFICATE IN OUR FILE AMS REGISTERED USER DATE SHIPMENT MADE:

SOURCE INFORMATION-Isotope Mfg./ Cat. No.

Serial No.

Curies Curies Date Wipe Test Reading Wipe Test Date CONTAINER INFORMATION

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Model No. '

Serial No.

CONTAINER OA INSPECTION AND MAINTENANCE Check if OK Repair Notes * * * * * * * * * *

  • Internal Contamination External Contcrninction

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Preliminary Rodiation Survey Mechanical Functions Shutter or Drawer Locked Shutter or Container Sealed,

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Gaskets in good condition (if any)

Lifting Loops in good condition (if any)

Tie down Devices in good Condition and secured Casters in good condition Page I of 2 Container Identification Legible Radiation Warning Signs

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' GENERAL CONDITION:

_OVERPACK INFORMAT.lON Model No.

Serial No.

CVERPACK OA INSPECTION AND MAINTENANCE Check if OK Repair Notes * * * * * * * * * * *

  • Mechanical Functions Ai! Wood Joints Tight No Holes or Voids Lifting Loops in Good Condition Tie Down Devices in Good Condition and Secured Skid in Good Condition and Tight All Bolts Tight Overpack identification Legible Overpock Sealed Maximum Rodiation Level at 3 feet Maximum Rodiotion Level on Surface g

Transport index Labels Attached Opening Instrudtions Attached Shipping Togs Attached General Condition DATE INSPECTED:

INSPECTOR (initials)

APPROVAL OF LICENSED PERSON Repeir Notes"""""

Enter repairs mode to bring container or overpack into proper condition. include initials of Individust (s) making repairs and date of repairs.

Poge 2 of 2 1281

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TRANSPORTATION OF ISOTOPES SECTIGi IV Trar.. ferring or shipping of licensed quantities of isotopes outside the company itsalf, may be authorized only by the Radioisotope Cousittee.

Transportation of these isotopes froe the Isotope Operation to other areas, or from one area in the building to another, for the purpose of research or development work is pcruissible when such transportation procedures have been covered by the Radioisotope Committee in the initial programming of the work.

A.

General Transportation Proceduras 1.

All radioactive isotopes must be transported in containers that are suitably designed for use as temporary or permanent storage.

2.

If isotopes are in glass containers, transportation containers must be large enough to taka the volume of material, should the glass break. If gases are involved, containers must have a tight seal.

3.

Material must never be left unattended during such transports-tion between buildings.

4.

Whenevar practical, transport isotopes through buildings at periods of least congestion, and use the most direct route practicable.

5.

All licensed by-product material being transported must be labelled as prescribed by current regulations.

B.

Specific Transportation Procedures 4

1.

Receiving of Isotopes - Only personnel of the Isotope Operation

' are authorized to receive shipments of radioisotopes. Radiation monitoring of the article is required before removing from truck.

The form --

" Radioisotope Receiving Form" aust be prepared and delivered to the Isotope Operation Supervisor as soon as possible.

2.

Shipment of Isotopes - Only personnel of the Isotope Operation are authorized to supervise the handling of outgoing shipments of radioisotopes. All shipments must comply with current U.S.

N.R.C. and U.S. DOT regulations.

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RADIOISOTOPE RECEIVING FORM Corrier Nerne Troller No. Nome of Shipper City of Origin RADIATION SURVEY CONTAMINATION CHECK mR/ hour on surface Isq Ft wipe epm above background mR/ hour @ 3ft frcrn surface Transport index ISOTOPE RECORD isotope Nome Form Curies on RECORDS Container type Container Serial No. Permit No. Source Cat.No. Source Serial or Copsula numbers Lot nunber RECEIVED BY Date Received REMARKS: Note any cbnormalities. 9 1281 . 7 14335 13C

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