ML20127L307

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QA Program for 10CFR71,Subpart H,Annex 3, Procurement,Use, Maint & Repair of Packages Designed to Transport Radiographic Exposure Devices
ML20127L307
Person / Time
Site: 07100754
Issue date: 01/15/1993
From:
CODE SERVICES, INC.
To:
Shared Package
ML20127L296 List:
References
NUDOCS 9301270086
Download: ML20127L307 (13)
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Text

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i CODE SERVICES, INC.

QUALITY ASSURANCE PROGRAM FOR 10CFR PART 71 SUB PART H ANNEX 3 "PROCUREHENT, USE, HAINTENANCE AND REPAIR OF PACKAGES DESIGNED TO TRANSPORT RADIOGRAP!!IC EXPOSURE DEVICES" i

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9 Index - Cross Reference to Sub Part H Requirement Item #

1 QA Organization CA Program 2

3 QA Package Design Control 4

Procurement Document Control l

5 Instructions, Procedures and Drawings 1

0 Document Control 7

Control of Purchased Material 8

Hancling Storage and Shipping Control 9

Inspection Test and Operating Status 10 Quality Assurance Records 11 Audits a

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l Item 1 QA Organization:

A copy of the organizational structure is included which definos responsibility by position.

v OltGANIZATIONAL CllAllT W.

11. STEWAllT PitESIDENT W.

11. STEWAltT ll.S.O.

t ODIE COUltVELL TilOHAS IIENDEllSON WANDA STEWAltT OPEl~ TAT 10NS QUALITY CONTitOL ADMINISTilATION MANAGEll MAN AG Ell MANAGEll a

TilOHAS IIENDEllSON COftP.

LEVEL III OFFICE Personnel i

I LEVEla Ill TECl!NICIANS

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i LEVEL II TECllNICIANS -----------l SUll-CONTitACT

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TECllNICIANS

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4 Item 2 Quality Assurance Program:

This document establishes the quality assurance re-quirements for packaging and transportation of radio-active material.

It is the policy of Code Services, Inc.

to perform all activities related to packaging and transportation of radioactive materials in a safe manner which meets the intent of 10CFR Part 71.

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Thomas R.

enderson,'Sr.

Radiation Safety Officor t

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Item 3 Quality Assurance of Package Design Control:

Code Services, Inc. will not design Packages.

Code

Services, Inc.

Will purchase- ' Packages only from suppliers who specifically design and manufacture Packages for transportation of radioactive materials.

Suppliers of these Packages shall have a quality assurance program approved by the Nuclear Regulatory Commission.

A copy of-the suppliers quality program approval shall be maintained by code Services, Inc.

1) Items controlled by the QA Program are designated in Code Services Operating and Emergency Procedures Manual.
2) Items, important to safety, which require periodic replacement because of limited operating life are identified ? and inspected daily per Code Services Operating and Emergency Manual.
3) Personnel indoctrination and training is governed l

by Code Services, Operating and Emergency Procedures Manual for individuals engaged in use and mainte-nance activities important to safety to assure that these personnel are knowledgeable before they engage in their activities.

4) Duties and responsibilities for the Quality Assurance Program are detailed in Code Services Operating and Emergency Procedures Manual.

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1 Item 4 Procurement Document Control:

The Quality Assurance Manager, code Services, Inc.,

shall review purchase orders for transportation of Packages (radioactive materials) and assure that purchase orders are issued only to those suppliers with an approved quality assurance program.

1) Code Services is a user of packages and not a designer of packages.

2)

Code Services, Inc.

will purchase packages only f rom manuf acturer's who certify - that packages are manuf actured under the control of an NRC approved QA program.

Certification of packages chall be specific to model and service numbers.

3) Code Services, Inc.'s operational and maintenance checks shall be in accordance with manuf acturer's specifications as incorporated in Code Services Operating and Emergency Procedure Manual.
4) Documentation for each package shall include but not be limited to the following:

a) certificate of compliance b) as built drawings c) use and maintenance manuals d) all documents referred to in the Certificate of-Compliart:0 1

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Item 5 Instructions, Procedurbs and Drawings:

1) Loading and unloading of radioactive materials shall be in accordance with manufacturer's recommended practices and code Services Operating and Emergency Procedures Manual.

2)

Loading and unloading of radiographic materials shall be performed in a manner which protects _the-public health and safety and the environment.

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Item 6 Document Control:

1) All changes to this Quality Assurance Program shall be reviewed and approved by the Quality Assurance Manager.
2) All revisions and changes shall be initialed, dated and issued by the Quality Assurance Manager.
3) All packages affected by design or manufacturing changes shall be checked to verify that they are in accordance with the appropriate revision.
4) The following documents shall be governed by the QA Program:

a)

QA and QC Manuals b)

Operating Procedures c)

Maintenance Procedures d)

Inspection and Test Procedures e)

Loading and Unloading Procedures l

f)

Packaging for Transport Procedures g)

Repair Procedures i

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Item 7 Control of Purchased Haterial, Equipment and Services:

1) All purchased material, equipment or services shall be reviewed upon delivery to assure that the Quality Assurance Program Requirements are met.
2) Sources who provide Packages shall be considered acceptable provided they have a current certificate of approval for their program.
3) Packages received from approved packaging sources shall be deemed acceptable provided they require no rework or repair and are functional.

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Item 8 Handling Storage and Shipping Control:

1)

Packages and shipping materials shall be handled in such a manner as to prevent damage.

Packages and materials shall be maintained in such a manner as to prevent dirt ano contamination from fouling operating mechanisms.

I 2)

Packages and shipping containers shall be stored in a locked storage area.

Packages shall be ecored in the locked position.

3)

Shipping of Packages shall be in accordance with the following instructions:

a) Packages shall be placed in suitable over pack b)

Packages and over packs shall be identified with appropriate LEVEL I, II or III Radioactive Materials Labels.

These labels shall indicate the type of material, i.e.

IR 192, the cIrie strength and the transport-index c) The shipping document must be properly filled out, i.e.:

Ph0PER SHIPPING NAME

" RADIOACTIVE MATERIAL, SPECIAL

FORM, N.O.S.,

RADIOACTIVE MATEdIAL" UN #

UN2974 RQ*

QUANTITY AND TYPE OF IRIDIUM-192, TYPE B(U)

PACKAGING PACKAGE X CURIES PACKING INSTRUCTIONS TYPE I, II OR III STICKERS WITH TRANSPORT INDEX AUTHORIZATION TYPE B(U) PACKAGE CERTIFICATION Reportable quantity is 10 curies or more.

4) Proper tagging of this material and determination of transport index are mandatory.

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Item 9 Inspection Tect and Operating Status:

1) All radiographic exposure devices shall have-attached to it - by the user; a durable, legible, clearly visible label bearing the following data:

a) Chemical Symbol and Mass Number of the radio-nuclei in the device b)

Activity and data on which-this activity-was last measured c) Model number and serial number of the sealed source d)

Manufacturer of the Sealed Source e) Licensee's name, address and telephone. number

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Each package must display a label' which roads

" Danger - RADIOACTIVE"

3) Permissible radiation levels for packages shall be in accordance with Subpart B of Part-34 and Code Services Operating and Emergency Procedures Manual.
4) Each radiographic exposure device shall be tested for leakage at intervals not. to exceed six (6) months.

The leak test may not be.0.005 microcuries of radiation or higher.

A leak test result of 0.005 microcuries or higher dictates that the device be removed f rom service.

Code Services Operating and Emergency Procedure Manual specifies appropriate action in this event.

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Item 10 Quality Assurance records:

1) The Quality Assurance Program is contained in Code Services, Inc. 's Operating and Emergency Procedures Manual.
2) The Quality,' Assurance Program specifies records to be maintained and the retention requirements for these records.
3) Records retention shall be in accordance with Codo Services, Inc. 's Operating and Emergency Proceduros Manual and 10CFR Part 34.

Item 11 Audite:

1)

Planned and Periodic Audits shall be performed to verify compliance with all aspects of this Quality Assurance Program.

2) Audits shall determine the effectiveness of this program.
3) Audits shall be performed to a check list generated from th'is program.
4) Audits shall be performed by trained personnel not having direct responsibilities in the areas being audited.
5) Audit results shall be documented and reviewed with the managers of individual areas.

6)

Follow-up action and re-audit of deficient areas shall be taken.

7) Audit frequency and guidelines shall be in accor-dance with Code Services, Inc.'s Operating and Emergency Procedures Manual.

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