ML20133C256
| ML20133C256 | |
| Person / Time | |
|---|---|
| Site: | 07100544 |
| Issue date: | 06/18/1985 |
| From: | DELTECH, INC. |
| To: | |
| Shared Package | |
| ML20133C245 | List: |
| References | |
| NUDOCS 8508060418 | |
| Download: ML20133C256 (4) | |
Text
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i QUALITY ASSURANCE. PROGRAM i
ORGANIZATION CHART i-
- FOR DELTECH, INC.
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LICENSE NO. 50-23221-01-~
FOR
- r COMPLIANCE WITH-10 CFR PART.'71, APPENDIX-E-i i
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e J. K. DIETZ - PRESIDENT M. R. ENGBLOM - RADIATION SAFETY OFFICER RADIOGRAPHERS 1.
President - General management of company.
2.
Radiation Safety Officer Responsible for overall administration of the radiation safety program (including Quality Assurance),
personnel radiation safety training and certification, document control, and auditing of the radiation safety program.
3.
Radiographers Responsible for using,
- storing, shipping, i nspection, testing, operating status, and record keeping of radioisotope sources and devices in accordance with written procedrues of the company as approved by the Radiation Safety Officer.
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QUALITY ASSURANCE PROGRAM OF DELTECH, INC.
(Name of Licensee) 50-23221-01 (License Number)
FOR COMPLIANCE WITH 10 CFR PART 71, APPENDIX E 1.
Organization The final responsibility for the Quality Assurance (QA) Program for Part 71 Requirements rests with DELTECH. INC.
(Name of Licensee)
Design and Fabrication shall not be conducted under this QA Program.
The QA Program is implemented as shown on the attached organization chart.
The Radiation Safety Officer is responsible for overall administration of the program, training and certification, document control, and auditing.
j The Radiographers are responsible for handling, storing, shipping, inspection, test and operating status and record keeping.
2.
nuality Assurance Program The management of DELTECH. INC.
(Licensee Name)
Mtablishes and implersents this 44 Program. Training, prior to engagement, for all QA functions is required according to written procedures. QA program revisions will be made according to written procedures with management approval. The QA Program will ensure that all defined QA 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 Officer shall assure that all radioactive material shipping packages are designed and manufactured under a OA Program approved by Nuclear Regulatory Connission for all packanes desined or faLricated after July 1,1978. This requirement can be satisfied by receivinq a certification to this effect from the rianufacturer.
3.
Document Control All documents related to a specific shipping nackage will be controlled through the use of written procedures. All document chances will be performed according to written procedures approved by management.
The Radiation Safety Officer shall insure that all QA fu'ictions are conducted in accordance with the latest applicable changes to these documents.
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Han111ng Storage and Shipping 4
Written safety procedures concerning the handling, storage and shipping of packages for certain special form radioactive material will be followed. Shipments will not be made unless all testJ. certifications, acceptances, and final inspections have been completed. Work instruct-ions will be provided for handling, storage, and shipping operations.
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Radiography personnel shall-perform the critical handling, storage and shipping operations.
5.
Inspection Test and Operatina Status
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Inspection, test and operating status of packages for certain special 4
form radioactive material will be indicated and controlled by written procedures. Status will be indicated by tag, label, marking or log.
i entry. Status of nonconforming 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 Radiation Safety Officer shall ensure that these functions are perfonned.
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Quality Assurance Records Records of package approvals (including references and drawings),
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procurement. Inspections, tests, operating logs, audit results, personnel training and qualifications and records of shipments will be maintained, j
Descriptions of eq ipment and written procedures will also be maintained.
4 These records will be maintained in accordance with written ;;rocedures.
The records will be identifiable and retrievable. A list of these records, with their storage locations, will be maintained by the
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Radiation Safety Officer.
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Audits Established schedulas 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.
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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.
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Audit reports will be maintained as part of the quality assurance records.
Meleers of the audit team shall have no re ponsibility in the activity i
being audited.
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519ftature antp4(e of Responsible 4
Licensee Official MICHkEL R. 'ENGBIDM, RADIATION SAFETY OFF.
Printed Name and Title of Responsible Licensee Official P.O. Box 110638-
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Licensee Address
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