ML20247A226

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10CFR71 QA Program for Industrial Radiography & Sealed Sources
ML20247A226
Person / Time
Site: 07100669
Issue date: 03/13/1989
From: Hiersche R
COMO TECH INSPECTION SERVICE (FORMERLY COMO TECH
To:
References
NUDOCS 8903290072
Download: ML20247A226 (3)


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10 CFR PART 71 OA PROGRAM N

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SEALED SOURCES Tw I'

1.

Organization 71 The final responsibility for the Quality Assurance (QA) Program for Part 71 Requirements rests with COMO Tech Inspection.

Design and Fabrication shall not be conducted under this OA Program.

The.0A Program is implemented using the'following organization.

Note:

The organizational Chart as used in the-license application l

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should be presented for organizational. elements,s e.g.

(procurement l

quality assurance, radiation safety) functioning under the OA program including principal contractors should be identified.

1 The Radiation Safety Officer (RS0) is responsible for overall

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administration of the program, training and-certification, document control, and auditing.

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The Radiographer or the RSO assistants are responsible for handling, storing,-shipping, inspection, test and operating status and record-1 keeping.

i 2.

Quality. Assurance Program-The management'of COMO Tech Inspection establishes and implements this OA Program.

Training, prior to engagement, for all OA functions I

is required according to written procedures.

QA Program revisions will be made according to written procedures ~with management approval.

The QA Program will ensure'tha4 all defined QC procedures, engineering procedures, and specific provisions of the package design approval are satisfied.

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

i The Radiation Safety Officer (RS0) shall assure that all radio-1 active material shipping packages are designed and manufactured a

under a OA Program approved'by the Nuclear Regulatory Commision for all packages designed or fabricated after-January'1, 1979.

j This requirement will be satisfied by receiving a: certification to this effect from the manufacturer or supplier of the package.

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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 (RS0) shall insure that all OA functions are conducted in accordance with the latest applicable changes to these documents.

4.

Handling, Storage, and Shipping Written safety procedures concerning the handling, storage, and shipping of packages for radioactive material will be followed.

Shipments will not be made unless all tests, certifications,

' ' acceptances, and final inspections have been completed.

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

5.

Inspection, Test, and Operating Status Inspection, test, and operating status of packages for radioactive material will be indicatedsand controlled by written procedures.

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

Status of nonconforming parts ~or packages will be positively main-tained by written procedures.

Note:

10 CFR Part 34 identifies specific inspections and tests to be conducted during use and maintenance.

t 6.

Quality Assurance Records Records of package approvals (including references and drawings),

procurement, inspections, tests, operating logs, 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.

j The records will be identified and retrievable.

A list of these records, with their storagh loc'ations, will be maintained by the j

Radiation Safety Officer (RSO).

7.

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 deficient areas corrected.

The audits will be dependent on the safety significance of the activity being audited, but each activity will be audited at least once per year.

Audit reports will be maintained as part of the quality assurance records.

Members of the audit team shall have no responsibility in the activity being audited.

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Raymond E. Hiersche Sr.

Vice President 7/ 5/ SW-33PG

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