ML19209A665

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QA Program for Administration of Radiotherapy Program
ML19209A665
Person / Time
Site: 07100029
Issue date: 09/17/1979
From:
MSI NUCLEAR
To:
Shared Package
ML19209A663 List:
References
NUDOCS 7910050149
Download: ML19209A665 (5)


Text

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TEL (801) 484-8803*TWX 910-925-5613 QUALITY ASSURANCE PROGRAM FOR THE ADMINISTRATION OF THE RADIOGRAPHY PROGRAM SEPTEMBER 1979 REVISION 1 1

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TEL (801) 484-8803*TWX 910-925-5613 oc, QUALITY ASSURANCE PROG 3AM FOR THE ADMINISTFATION OF THE RADIOGRAPHY PROGRAM TABLE OF CONTENTS 1.

ORGANIZATION 2.

QUALITY ASSURANCE PROGRA*i 3

DOCUMENT CONTROL 4 ~.

HANDLING STORAGE AND SHIPPING 5

INSPECTION, TEST AND OPERATING STATUS 6.

QUALITY ASSURANCE RECORDS 7

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ORGANIZATION I

The final responsibility for 'the. Quality Assurance (QA) Program for Part 71, requirements rests with MSI Testing, Inc.

Design and Fabrication shall not be conducted under'this QA Program.

The QA

. Program is implemented using the Crganizational Chart on the attached page.

The Radiation Safety Officer is responsible for overall administra-tion of the program, training and certification, document control, and auditing.

The Radiographers are responsible for handling, storing, shipping, inspection, test and operating status and record keeping.

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QUALITY ASSURANCE PROGRAM The management of MSI Testing, Inc. establishes and implements this QA Program.

Training, prior to engagement, for all QA functions is. required according to written procedures with management approval.

The QA' Program will ensure that all defined QC Procedures, engineering procedures, and specific provisions of the package design approval are satisfied.

The QA Program will emphasize control of the characteristics of the package which are critical to safety.

The Radiation Safety 0fficer shall assure that all' radioactive

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material shipping packages are designed and manufactur.ed under a QA Program approved by Nuclear Regulatory Commission for all packages designed or fabricated aft'r the effective date of the QA Program.

e This requirement can'be satisfied by 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 according to written procedures approved by management.

The Radiation Safety Officer shall ensure that all QA functions are conducted in accordance with the latest applicable changes to these docenents.

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HANDLING STORAGE AND SHIPPING Written safety procedures concerning the handling, storage and shipping of packages for certain'special form radioactive material will be followed.- Shipment will not be made unless all tests, certifications, acceptances and final inspections have been completed.

Work instructions will 'ce provided for handling, storage and shipping operations.

Radiography personnel shall perform the critical handling, storage and shipping operations.

5 INSPECTION, TEST AND OPERATING STATUS Inspection, test and operating status of packages for certain special form radioactive material Nill be indicated and controlled by written procedures.

Status will be indicated by. tag, label, marking or log entry.

Status of nonconforming parts or packages will be positively maintained by written procedures.

Radi,sraphy personnel shall perform the regulatory required inspections and tests in accordance with written procedures.

The Radiation Safety Officer shall ensure that these functions are performed.

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QUALITY ASSURANCE RECORDS Records of package approvals (including referances and drawings),

procurement, inspections, tests, operatirig lors, audit ~ results,

personnel training and qualifications and records of shipments will be maintained.

Descriptions of equipment.and written procedures will also be maintained.

These records will be maintained in accordance with written procedures, and the records will be identifiable-and retrievable.

A list of t.hese records, with their storage locations, will be maintained by the Radiation Safety Officer.

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AUDITS Established schedules of audits 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 evaluated and deficim't areas corrected.

The audits will be dependent on the safety significance of the activity being audited, but each activity will be audited by the Radiation Safety Officer or his

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designee at least once per year.

Audit reports will be maintained as part of the quality assurance records, i110 096 mone-

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