ML19259A987
| ML19259A987 | |
| Person / Time | |
|---|---|
| Site: | 07100253 |
| Issue date: | 12/28/1978 |
| From: | TWIN PORTS TESTING, INC. |
| To: | NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| References | |
| NUDOCS 7901150172 | |
| Download: ML19259A987 (11) | |
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'0 TWIN PORTS TESTING, INC.
- -d13 1816 North Road 1I Duluth, Minnesota 55811 (218) 722-2173 December 28, 1978 Director, Office of Nuclear Material Safety and Safeguards
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Nuclear Regulatory Commission Washington, D.C.
20555 Gentlemen:
This letter is in regard to the development of a quality essurance pro-gram as required by 10 CFR Part 71, " Packaging of Radioactive Material for Transport, 71.51."
Seven (7) copies of the program description accompany this letter as requested.
Our company is an industrial radiography installation.
We do not menu-facture, sell, or distribute radioactive source material, source ex-changers, exposure devices or shipping containers.
Therefore, we have de-veloped our program as such.
Please address all pertinent information to our company address, attention:
Mr. Richard D. McKeever, R.P.O.
Sincerely, D'251l bRd(cecy Richard D. McKeever Radiation Protection Officer RLD:md y' \\ SI'Q,5 XSN vs n,f. &
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TWIN PORTS T ESTING, INC.
1816 North Road Duluth, Minnesota 55811 (218) 722-2173 DESCPIP'~ ON OF QUALITV ASSURANCE PROGRAM FOR PACriAGING OF RADI0 ACTIVE MATERIAL FOR TRANEP0itT AND TRANSPORTATION OF RADI0 ACTIVE MATERI AL UNDER CERTAIN CONDITIONS QA-001-70 December 15, 1970 TidIN PORTS TESTING, Inc.
1816 North Road D u lu t.h, Minnesota 55811 By-Product Material License No. 2;
- ~. 32 -01
N TWIN PORTS TESTING, IN 1816 North Road Duluth, Minnesota 55811 (218) 722-2173 QA-001-78 December 15, 1T/8 REVISIONS R. vision fjo.
Date g Revision Date of Approval Approved By O
TWIN PORTS TESTING, INC.
1816 North Road Duluth, Minnesota 55811 (218) 722-2173 QA-001-78 December 15, 1978 TABLE OF CONTENTS Intratfut r. ion page 1 Description of' Quality Assurance Program
- 1. Organizatlun 2
- 2. Quality Assurance Program 3
- 3. Document Control 4
- 4. Handling, Storage, and Shipping 4
- 5. Inspection, Tests and Operating Status 4
- 6. Quality Assurance Records 5
- 7. Audits 5
Appendicles A.
Organizai,ional Chart 7
TWIN PORTS TiiSTING, INC.
1816 bhrth Road Duluth, Minnesota 55811
(:218) 722-:2173 QA-001-78 December 15, 1978 This Quality Assurance Program description is developed in accordance with 10 CFR Part 71, "Packnqing of Radioactive Material for Transport and Trans-portation of Radioactive Material Under C rtain Conditions," paragraph 71.51.
The purpose of the development of this prcgram is to ensure that approved package designs are uned, trained personnal are available, safety is en-sured, complete records are maintained, laner company communications are accomplished, and all regulatory requirements are met in regard to the pack-aging and shipping of special form radioactive material.
The scope of the entire program is developed from seven main topics which are:
Organization Quality Assurance Program Document Control Handling, Storage and Shipping Inspection, Test. and Operating Status Quality Assurance Records Audits Each of these areas in being developed to best suit the needs of our com-pany in compliance with regulatory requirements.
Twin Ports Testing, Inc.
is an industrial radingraphy installation which uses subcontractors to supply sources, source exchangers, exposure devices, '3nd shippino containers.
The following Quality Assurance Program has been developed to take these facts into consideration.
(1)
TWIN PORTS T dSTING, INC.
1816 North Road Duluth, Minnesota 55811 (218) 722-:2173 QA-001-78 December 15, 1978 QUALITY ASSURANCE PROGRAM for the use, maintenance and repair of shipping packages for certain special form radioactive material.
1.
Organization 1.01 The quality assurance program will be supervised by the Radia-tion Protection Officer.
It will be his responsibility to see that all items of the quality assurance program are followed to train and ascertain the qualifications of personnel working un-der him; to verify inspections on all shipments to be delivered to common carriers; to maintain all records pertaining to the quality assurance program; perform audits of subcontractors supplying radioactive sources, exposure devices, source exchangers and shipping containers and maintain all records for those audits.
1.02 The Chief Radiographer will be responsible to see that packaging is in accordanne with specifications set forth in Twin Ports Testing, Inc. procedures.
The other Radiographers and Assistant Radiographers shall be responsible to the Chief Radiographer and will take orders from him concerning shipping, receiving, and packaging of radio-active sourcen, exposure devices, and source exchangers.
The Chief Radiographer will be responsible to see that all logs and check lists for the~ shipment and reception of radioactive sources, exposure de-vices and source exchangers are maintained and made available to the Radiation Protection Officer.
1.03 The Radiographers will be responsible for packaging and opening of packages of radioactive material shipments, for assisting in the maintenance of required logs, for performing required tests as in-structed, and giving instruction to Assistant Radiographers con-cerning the packaging and shipping of radioactive material.
1.04 The Assistant Radiographers will be directly responsible to the Radiographer with whom they are working and will i_n_ rg instance perform either packaging or opering of packages of radioactive material without the direct supervision of a qualified Radiographer.,
1.05 The Helper-Trainees will not package or open packages of radio-active materials.
They may participate only in viewing the process performed fur instructional purposes.
(2)
4,001-78 luin Ports Testing, Inc.
December 15, 1978 Duluth, Minnesota a
e 1.06 The Laboratory Manager and the Vice President of the corpora-tion will be responsible for performing audits of the QA pro-gram, maintaining records of those audits and making known to the QA personnel the results of those audits.
1.07 See Appendix A (Organizational Chart) 2.
Quality Assurance Program 2.01 The management of Twin Ports Testing, Inc. establishes and imple-ments thic quality assurance program.
2.02 The quality assurance program will ensure that all defined Quality Control procedures, engineering procedures, and specific package design approval are satisfied both within the company structure and ur those subcontracting companies supplying related services.
r 2.03 All engineerinq design, engineering procedures, Quality Control procedures, and manufacturing specifications related to radioactive sources, source exchangers, exposure devices and shipping containers supplied to Twin Ports Testing, Inc. by another organization will be the responsibility of that organization.
The activities of those organizations so involved will be audited.
2.04 Personnel will be trained in respect to procedure requirement for shipping, recoiving, maintenance, labeling, storage, handling, safety, and regulatory requirements regarding packaging prior to the implementation of the program.
In addition they will receive instruction concerning proper form completion and equipment familiar-ity.
All instruction and training will be performed by the Radia-tion Protection Officer in accordance with written procedures.
2.05 Shipping, receiving, and packaging of radioactive materials will be performed in accordance with Twin Ports Testiig, Inc. uritten pro-cedures and all regulatory requirements.
2.06 Radioactive material shipments by common carriers uill be logged and records maintained as per written procedures.
2.07 Radioactive material shipments by company vehicle will be logged and records maintained as per written procedures.
2.08 A data sheet with a procedure check list will be completed for each package of iodinnctive material either shipped or received and this sheet will he maintained as a portion of the Quality Assurance records.
2.09 Records will he completed and maintained for all shipping, receiving, tests, inspections, and defective equipment on specific forms in accordance with established procedures.
(3)
,QA 1)O?-78 Twin Ports Testing, Inc.
Dgcember 15, 1978 Duluth, Minnesota 2.1b The required rompleted forms will be reviewed and approved by the Radiation Protection Officer prior to shipping and after receiving radioactive packages.
2.11 No radioactive material package shipments will be dolivered to a common carrier or leave the laboratory confines of the company without the final approval of either the Radiation Protection Officer or the Chief Radiographer.
3.
Document Control 3.01 The documentation required for each specific shipment of a package of radioactive material uill be as set forth in Twin Ports Testing, Inc. written procedures.
3.02 All of the forms listed in the procedure must be completed and accompany the shipment.
A copy of these forms will be kept on file by the Radiation Protection Officer until such time as they are released by the regulatory agency.
3.03 Any change in documentation must be performed in a written ammend-ment to the procedure, be approved by the management, and must meet requirements of the regulatory agencies.
3.04 It will be the responsibility of the Radiation Protection Officer to maintain these records and ensure that all Quality Assurance functions are performed in accordance with the latest changes to the procedures.
4.
Handling, Storage, and Shipping 4.01 Handling, storage, and shipping will be performed in accordance with specifications set forth in Twin Ports Testing, Inc. written procedures.
4.02 These proceduren set forth all requirements necessary to meet all safety requirements, minimize equipment deterioration, and mini-mize public health hazards.
5.
Inspection, Test, and Operating Status 5.01 Inspection, test, and operating status of packages for certain special form radioactive material will be controlled by Twin Ports Testing, Inc. written procedures.
5.02 The results of tests shall be recorded and operating status logged.
Defective parts or packages shall be " red tagged" until corrective measures are taken or repairs are made.
(4)
(4-001-78 Twin Ports Testinr, Inc.
oecember 15, 197a ouluth, Minnesota 5.03 It shall be the duty of either the Radiographer or Assistant
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Radiographer under the direction of the Radiographer to perform these tests and inspections in accordance with the written procedures.
5.04 The Radiation Protection Officer shall have the responsibility to ensure that all functions are carried out and that records are maintained.
E.
Quality Assurance Records 6.01 Records of shipping and receiving, package approvals, procurement, inspections, tests, operating legs, audit results, personnel training and qualifications shall be maintained.
6.02 Descriptions of equipment and written procedures shall be main-tained.
6.03 All records shall be maintained in accordance with wrt. ten procedures.
6.04 All records shall be available and identifiable until such time as they are released by the regulatory agency.
6.05 The Radiation Protection Officer shall be responsible for storing and maintaining all records for the quality assurance program.
6.06 The Radiation Protection Officer shall be responsible for making the records availaole and identifying all records on file if so re-quested by the regulatory agency.
7.
Audits 7.01 Established schedules of audits of the quality assurance program shall be performed using written check lists.
7.02 Audits will be performed hy the Vice President and the Laboratory Manager or ruin Ports Testing, Inc.
7.03 Audits of suhcontracting companies who supply radioactive sources, scurce exchangers, exposure devices, and shipping containers to Twin Ports Testing, Inc. shall be performed by the Radiation Protection Officer of Tuin Ports Testing, Inc.
7.04 The results of audits shall be maintained and reported to all per-sonnel within the quality assurance program.
7.05 Audit report, shall be evaluated and all deficient areas shall be corrected and re-audited.
(5)
.QA-01)1-78 Twin Furts Testing, Inc.
3acember 15, 1978 Duluth, Minnesota 7.06 The frequency nf audits shall be dependent upon the safety sig-nificance of the activity being audited, but each activity shall be audited a minimum of once a year.
7.07 Audit reporto shall be maintained as a part of the quality assur-ance recordn.
7.08 The management personnel as listed in 7.02 will have no direct re-sponsibility in the activities audited.
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APPLI s1X A I ioi n i o r t,n i e a t,ing, Int..
Decembe" 15, 1970 Organizational Chart PRESIDENT Richard L. DeBolt VICE PRESIDENT T111 dred M. DeDolt SECRETARY-TREASURER Mildred M. DeBolt ACCOUNTING LABORATORY MANAGER Eikill R Schi i linrj Rictord L. DeBolt PURCHASING AGEfJ TS RAgATIONPROTECTIONOFF-IC R. McKeever, M. DeBolt Richard D. McKeever OPERATIONS SUPERVISOR Richard D. McKeever CHIEF RADIOGRAPHER Thomes Walk FUTURE RADIOGRAPHER RA[IOG APIER Jerry Russell ASS'T. RADIOGRAPHER ASS'T. RADIOGRAPHER p, w ge WW m 39
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.M..W.A HELPER-TRAINEE HELPER - TRAINEE Uarbara Uonson (7)