ML19209A926
| ML19209A926 | |
| Person / Time | |
|---|---|
| Site: | 07100339 |
| Issue date: | 07/12/1979 |
| From: | Pender T WISCONSIN CENTRIFUGAL, INC. |
| To: | Macdonald C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML19209A927 | List: |
| References | |
| 13550, NUDOCS 7910050634 | |
| Download: ML19209A926 (1) | |
Text
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i W Wisconsi:gyentrifugn2, Ene.
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W pengC Mr. Charles E. Mactanald Transporation Branch D~ vision of Fuel Cycle and Material Safety U.S. Nuclear Regulatory Commission Washington, D.C.
20555
Dear Mr. MacDonald:
Attached is a copy of the Quality Assurance Program of Wisconsin Cen-tifugal, Inc. implemented for License Number 48-11641-01 in accordance with the requ'*ements of 10 CFR Part 71, Appendix E.
Please let me know if any other data is required for submittal for com-pliance with regulations for shipping radioisotopes designed within the li-cense number designated above.
Respect #gily submi* e,7
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J Radiation Safety Officer TP:ks Encis.
FEE EXEMPl' 1105 026 1C55D 79100so 6 2p p
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7-12-79 Quality Assurance Program
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db Wisconsin Centrifugal, Inc.
License No. 48-11641-01 For Compliance with 10 CFR Part 71, Appendix E 1.
Organi zation The final responsibility for the Quality Assurance (QA) Program for Part,
71 requirements rests with Wisconsin Centrifugal, Inc.
Design and fabrication shall not be conducted under this QA Program.
The QA Program is implemented as sh3wn on the attached organization chart.
The Radiation Safety Officer is responsible for overall adminstration of the program, training, and certification, document control, and audit-ing.
The radiographers are responsible for handling, storing, shipping, inspec-tion, test and operating status and record keeping.
2.
Quality Assurance Program The management of Wisconsin Centrifugal, Inc. establishes and implements this QA Program. Training, prior to engagements, for all QA functions is required according to written procedures.
QA Program revisions will be made according to written procedures with management sooroval. The QA Program will ensure that all defined QA procedures, engineerim pro-cedures, and specific provisions of the cackage design accrova'
.e satisfied.
The QA Program will emahasize control of the characteristics of the package which are critical to safety.
The Radiation Safety Officer shall assure that all radioactive material snipping packages are designed and manufactured under a GA Progran approv-ed by the N.R.C. for all packages designed or fabricated af ter July 1, 1973.
This requirement can be satisfied by receiving a certification to this effect from the manufacturer.
3.
Document Control All documents related to a specific shiccing package will be controlled through the use of writtan procedures. All document changes will be per-formed according to written procedures appr0ved by management.
The Radiation Safety Officer shall insure that all CA functions are con-ducted in accordance with the latest applicable changes to these documents, us53 1105 027
Quality Assurance Program Page 2 4.
Handlino, Storage, and Shipping Written safety procedures concerning the handling, storra, and shipping of packages for certain special form radioactive materials will be fol-lowed.
Shipments will not be made unless all tests, certifications, acceptances, and final inspections have '.een completed. Work instructions will be provided for handling, storage, ;nd shipping operations.
Radiography personnel shall perform tN critical handling, storage, and shipping operations.
5.
Insoection, Test and Ooerating Status Inspection test and operating status of packages for certain special form radioactive material will be indicated and controlled by written procedures.
Status will be indicated -by tag, label, marking or log entry. Status of non-conforming parts or packages will be positively maintained by written procedures.
Radiography personnel shall perform the regulatory required inspections and tests in accordance with written procedures.
The Radiotion Safety Officer shall ensure that these functions are perfomed.
6.
Quality Assurance Records Records of package approvals (including references and drawings), orocure-ment, inspections, tests, operating logs, audit results, personnel train-ing and qualifications and records of shipments will be maintained.
De-scriptions of equipment and written procedures will also be maintained.
These records will be maintained in accordance with written procedures.
The records will be identifiable and retrievable. A list of these records with their storage locations, will be maintained by the Radiation Safety Officer.
7.
Audits Established schedules of audits of the QA Program will be performed using wri tten check lists. Results of audits will be maintained and recorted to management. Audit reports will be evaluated and deficient areas cor-rected. The audits will be dependent on the safety significance of the activity being audited, but each activity will be addited at least once per year. Audit reports will be maintained as part of the cuality assur-ance records. Members of the audit team shall have no responsibuity in the activity being audited.
Date: ?'N"?
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Thomas L. Pender i105 028 Wisconsin Centrifugal, Inc.
905 E. St. Paul Avenue
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Waukesha, Wisconsin 53186 u -- ~
i Quality Assurance Program Organization Chart h5 5,,! '
For Wisconsin Centrifugal, Inc.
48-11641-01 For Compliance with 10 CFR Part 71, Appendix E
~
Robert Diper, President John !!einhardt, Director of Quality Control Radiation Safety Officer Thomas L. Pender Radiography Supervisor
'dilliam F. Orgas Sobert ! eyer Radiogr3cher Ip. Holloway Radic;racher l
.C. Linski Fadiceracher L'1553 1105 029
o Description of Responsibility 1.
President General management of the company 2.
Director of Quality Control Responsible of overall administration of all Quality Control and Assurance functions within the company.
3.
Radiation Safety Officer Responsible for overall adminstration of the radiation safety program (including Quality Assurance), personnel radiation safety training and certification, document control, and auditing of the radiation safety p rogram.
4 Radiographers Responsible for using, storing, shipping, inspection, testing, operating status, and record keeping of radioisotope sources and devices in accord with written procedures of the company as approved by the Radiation Safety Officer.
13550