ML20057A883
| ML20057A883 | |
| Person / Time | |
|---|---|
| Site: | 07100771 |
| Issue date: | 09/15/1993 |
| From: | Jankovich J NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Gray L LONGVIEW INSPECTION, INC. |
| References | |
| RTR-REGGD-07.010, RTR-REGGD-7.010 NUDOCS 9309160126 | |
| Download: ML20057A883 (4) | |
Text
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E UNITED STATES l'{
NUCLEAR REGULATORY COMMISSION
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WASHINGTON, D.C. 20555-0001 SEP 151993 i
SCDB: TOM 71-0771 Longview Inspection -
Gulf Coast Group, Inc.
ATTN: Mr. Lloyd A. Gray Corporate Radiation Safety Director 12421 East Freeway Houston, TX 77015
Dear Mr. Gray:
This is in response to your letter dated August 25, 1993, concerning packaging registration.
Please note,10 CFR s 71.12 requires an approved Quality Assurance (QA)
Program as a condition of general license. Accordingly, we are unable to register you for use of the packaging requested at this time.
It will be necessary for you to obtain an approved QA Program prior to the registration as a packaging user, or delivery'of licensed material to a carrier for transport, pursuant to 10 CFR Part 71.
Enclosed for your information is a copy of Regulatory Guide 7.10,
" Establishing Quality Assurance Programs for Packaging Used in the Transport or Radioactive Material." Annex 3 of the Regulatory Guide may be applicable to the activities you propose.
Also enclosed is a copy of a sample QA Program for radiography and sealed sources acceptable to the Commission for meeting the applicable quality requirements of 10 CFR Part 71, Subpart H.
Unless an exemption is provided by 10 CFR S 170.11 an application fee of
$370.00, as required by 10 CFR 9 170.31, should be included with your QA Program approval application.
If you have any questions concerning this matter, please contact Mr. Thomas Natula of my staff on (301) 504-2437.
Sincerely, 4[,
WU J n P. Jankovich, Section Leader Quality Assurance Section Source Containment and Devices Branch Division of Industrial and Medical Nuclear Safety, NMSS
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a 10 CFR PART 71 0A PROGRAM FOR INDUSTRIAL RADIOGRAPHY LICENSEES 1.
Organization The final responsibility for the Quality Assurance (QA) Program for Part 71 Requirements rests with (Company Name).
Design and fabrication shall not be conducted under this QA Program.
The QA Program is implemented using the following organization.
Note:
The Organizational Chart as used in the license application should be presented for organizational elements (e.g. procurement, quality assurance, radiation safety) functioning under the QA program.
Principal contractors should be identified.
The (
) is responsible for overall administration of the program, trair.ing and certification, document control, and auditing.
The (
) are responsible for handling, storing, shipping, inspection, test and operating status, and recordkeeping.
2.
Quality Assurance Program The management of (Company Name') establishes and implements this QA Program. Training, prior to engagement, for all QA functions is required
)
according to written procedures.
QA Program revisions will be made j
according to written procedures and with management approval.
The QA Program will ensure that all defined QA procedures, engineering procedures, and specific provisions of the packaging design approval are satisfied. The QA program will emphasize control of the characteristics of the package which are critical to safety.
The (
) shall assure that all radioactive material shipping packages are designed and manufactured under a QA Program approved by the Nuclear Regulatory Commission for all packages designed or fabricated after January 1, 1979. This requirement will be satisfied by receiving a certification to this effect from the manufacturer or supplier of the package.
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 and approved by management.
The (
) shall assure that all QA functions are conducted in accordance with the latest applicable changes to these documents.
Typically this responsibility is vested in the radiation safety officer (R50).
Typically this is the responsibility of the radiographers or the RSO assistant.
I
l 8
'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 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.
Note:
10 CFR Part 34 identifies specific inspections ar. tests to be conducted during use and maintenance.
6.
Quality Assurance Records Records of package approvals (including references and drawings),
procurement, inspections, tests, operating logs, audit results, and records of shipments will be mdintained.
Descriptions of equipment, written procedures, and records of personnel training and qualifications will be retained for three years beyond the date activity, for which this QA Program was developed, ends.
These records, will be maintained in accordance with written procedures.
The records will be identified and retrievable. A list of these records, with their storage locations, will be maintained by (
).
7.
Audits i
i 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 cach 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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