ML20127E853

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Forwards QA Program for Radioactive Matl package:0754, for Review & Approval.Fee Paid
ML20127E853
Person / Time
Site: 07100754
Issue date: 11/03/1992
From: Stewart W
CODE SERVICES, INC.
To: Macdonald C
NRC
References
NUDOCS 9211060145
Download: ML20127E853 (22)
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Text

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3 Code Services, Inc.

Rt 1, Box 190-0 Madison, Alabama ?S758 205 340 1117 November 3,1992 United States NiiC US NRC 4E4 Washington, DC 20555 Attn:

Mr. Charles Mcdonald

Dear Mr. Mcdonald:

Submitted herewith please find Code Services.

Inc.'s Quality Assurance Program for your review and approval.

Also included, please find Code Services check for $250.00.

Thank you for your prompt attention in this matter.

Sincerely,

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Code Services, Inc.

Quality Assuranco Program for 10CFR Part 71 Sub Pert H

" Packaging and Transportation of Radioactive Material" l

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

Sub Part H 71.101 Quality Assurance Requirements i

71.103 QA Organization 2

71.105 QA Program 3

71.107 QA Package Design Control

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4 71.109 Procurement Document Control 5

71.111 Instructions, Procedures and Drawings 6

71.113 Document Control 7

71.115 Control of Purchased Material 8

71.117 Identification and Control of Mate' rials, Parts and Components 9

71.110 Control of Special Processes 10 71.121 Internal Incpection 11 71.123 Test Control 12 71.125 Control of Measuring and Test Eouipment 3

13 71.127 Handling Storage and Shipping Control 14 71.129 Inspection Test and Operating Status 15 71.131 Non-conforming Meterials, Parts and Components 16 71.133 Corrective Action s

17 71.135 Quality Assur ance Records 18 71.137 Audits

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1 Item 1 OA Organi4ation.

i A copy of the organizational structure is-included

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Item 2 Quality Assurance Program:

P This document establishes the quality assurance I

requirements for packaging and transportation of radioactive material.

It i s 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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Item 3 Quality Assuranca of Packago Design Control:

Codo Services, Inc. wil's not design Packagos.

Code Sorvices, Inc. will purchaso Packages only from suppliers who specifically design and manufacture Packages for t ransportation of radioactive materials.

Suppliers of these-Packegos shall have a quality assurance program approved by the Nuclear Regulatory Comtni ss ion.

A copy of the suppliers quality program approval shall be rnaintain9d by Code Services, Inc.

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Item 4 Procurement Document Control:

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The Quality Assurance Manager, Code Sorvices Inc.,

shall review purchase orders for transportation of-

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Packages (radioactive materials) and assure that purchase orders tare icsued only to those suppliers with an approved quality assuranco program.

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r Item 5 Instructions, Procedures and-Drawings:

1)

Packaging must be provided by a supplier with an approved program for the manufacture of packages in accordance with 10CFR Part 71 Subpart H.

2)

Packaging shall be. int..sected on a daily basis, when utilized, to check for wear and/or damage and.

correct function.

Records of these inspections shall be in accordance with Item 14 of this, manual.

3)

All items found worn, defective or inoperative shall be removed f rom service and identified with a red tag as a reject.

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Item 6 Document Control:

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All changes to thie Quality Assurance Program shall be reviewed and approved by the Quality Assuranco Manager.

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2)

All revisions and crianges shall be initialed, dated and issued by tho_ Quality Assuranco Manager.

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Item 7 Control of Purchased Material, Equipment and Services:

1)

All purchased mator1al, equipment or services shall be reviewed upon delivery to assure that the Quality Assurance Program Requirements are mot.

2)

Sourcos who provido Packages shall be considered acceptable provided they have a current cortificato of approval for their program.

3)

Packagos rocoived from approved rackaging sources shall be deemed acceptable proviuod they requiro no rowork or repair and are functional.

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i Item 8 Identification and Control of Hater;als Parts anu Components

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Codo Services, Inc. uses only the completed Package and does not engage in manufacture or assembly of components.

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t Item 9 Control of Special Processes:

i Codo Services, Inc. does not engage in welding, heat treating or non-destructive testing on Packages.

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I tern 10 Internal Inspection:

Code Sorvices, Inc. is a user of Packages and internal inspection applios to the design and inanuf acture of Packages.

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Item 11 Test Control:

I Code Services, Inc. will execute no performance test on Packages.

Test control is a function of the packa00 manufacturer.

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Item 12 Control of Measuring and Test Equipment:

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In that Packages must be checked for containmont of radiation, survey motors are rQuired to measure t.he efficiency of the Package to shield-the radioactivo n.atorial.

2)

Radiction survoy motors are : calibrated overy three months.

Records of those calibrations are maintained by instrument model and serial numbers, t

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Only operable and calibrated survey motors-may be utilized for these tests.

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Item 13 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 and contamination from fouling operating mechanisms.

2)

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

Packages shall be stored 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-

'l 9 2, the curie strength and the transport index c)

The shipping document murt be properly filled out, i.e.:

PROPER SHIPPING NAME

" RADIOACTIVE MATERIAL, SPECIAL

FORM, N.O.S.,

RADIOACTIVE MATERIAL" 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 # USA /9036/B(U)

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 14 Inspection Test and Operating Status:

The following form is required to document the inspection, test and operating b.itus of Packages.

Additionally, the Package and over pack are to be visually checked for damage.

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APPENDIX Q DAILY UTILIZATION AND DOSIMETER LOG CUSTOMER LOCATIOtt city state CODE'S JOB NUMBER DATE day of week month day year EXPOSURE DEVICE:

model serial #

curies NUMBER OF EXPOSURES EXPOSURE TIME RADIOGRAPHER ASSISTANT I

FILM BADGE #

FILM BADGE #

DOSIMETER DOSIMETER RATE ALARM #

RATE ALARM #

MR/HR TO'AL MR/HR TOTAL SURVEY METER 8

MODEL #

S/N BATTERY CHK CAL DATE 1

2 RADIATION EQUIPMEN1 CHECK PROPER-CRANK DRIVE GUIDE CABLE DRIVE LABEL CABLE TUBE HOUSING GEAR RADIATION EQUIPMENT SURVEY l

REMOVAL TI(CODE)

TI(JOB)

RETURN AT SIX INCHES AT ONE METER EXTERNAL VEHICLE i

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Item 15 Non-conforming Materials, Partf-and Components:

Non-conforming Haterials, Par';s and Comporents shall be removed from service, red tagged as " Reject" and held separate from " Accept" items wnile disposition s

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T2 Item 16 Corrective Action:

1)

When a significant event or condition occurs which-is adverse to quality, the following steps shall be taken; a)

The event or condition shall be identified and documented, b)

Cause of the event or cond. tion shall be determined.

c)

Measures shall be-taken to prevent reoccurance of the event or condit t

t-s cause of-the event d)

The event or conditiren,

..ve action shall be or condition and cot recc.

a ano reperced to_the President and Board of Directors.

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Item 17 Quality Assurance Records:

1)

Written documer,tation of the Quality Program shall be maintained.

2)

Documentation shall include instructions, procedures and closely related specifications such I

as requited qualifications of personnel, procedures and equipment.

1 3)

Records ranerated for this procedure shall be maintained for two years on active file in 1310 quality manager's office.

a)

Records, procedures and instructions generated for this procedure shall be maintaitied on archive file for three years after-the date in' which Code Servics, Inc engages in activity.

for which the Quality Assurance Program was developed, b)

Superceded records, procedures and instructions shall be maintained for three years after it is superceded.

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1)

Planned and Periodic Audits shall be performed no 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 this program.

4)

A;dits shall be performed by trained personnel not having direct responsibilities iii the areas being audited.

5)

Audit results,shall be documented and reviewed with the managers of individual areas.

6)

Follow-up action and r:-audit of deficient areas shal'l-be taken.

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