ML19282A097
| ML19282A097 | |
| Person / Time | |
|---|---|
| Site: | 07100305 |
| Issue date: | 03/01/1979 |
| From: | Grashaw T AMERICAN X-RAY & INSPECTION, INC. |
| To: | |
| Shared Package | |
| ML19282A096 | List: |
| References | |
| NUDOCS 7905100365 | |
| Download: ML19282A097 (5) | |
Text
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QUALITY ASSURANCE PROGRAM OF AMERICAN X-RAY & INSPECTION, INC.
FOR COMPLIANCE WITH 10 CFR PART 71, APPENDIX E 1.
O rgan i zat ion The final responsibility for the quali ty Assurance (QA) Program for Part 71 Requi rements rests with American X-Ray s inspection, Inc.
Design and Fabrication shall not be conducted under this QA P rog ram. The QA Program is implemented as shown on the attached organization chart.
The Radiation Safety Officer is responsible for overall admin-istration of the program, training and certi fication, document control, and auditing.
The Radiographers are responsible for handling, storing, shipping, inspection, test and operating status and record keeping.
2.
Quali ty Assurance Program The management of American X-Ray s inspection, Inc, 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 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 r..onufactured under a QA Program approved by Nuclear Regulatory Commission for all packages designed or fabricated af ter July 1,1978.
This requirement can be satisfied by receiving a certi fication to this ef fect from the manufacturer.
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3 Document Control i
All documents related to a speci fic 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 shall insure that all QA 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 certain special form 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.
Radiography personnel shall perform the critical handling, storage and shipping operations.
5.
Insoection, Test and operating Status inspection, test and operating status of packages for certain special form radioactive material will be indicated and controlled by wri tten 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.
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 performed.
6.
Quality Assurance Records Records of package approvals (including references and drawings),
prccurement, inspections, tests, operating logs, audit res ul ts,
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 pro-cedures. The records will be identi fiable and retrievable. A list of these records, with their storage locations, will be maintained by the Radiation Safety Officer.
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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 of 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.
March 1, 1979 Date Thomas D. Grashaw Radiation Safety Of ficer 24030 Haggerty Road Farmington Hills, Michigan 48024 Page 3
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QUALITY ASSURANCE PROGRAM ORGANIZATION CHART FOR AMERI CAN X-RAY s INSPECTION, INC.
LICENSE HUMBER 21-154550-1 FOR COMPLIANCE WITH 10 CFR PART 71, APPENDIX E Andrew C. Struzyk President James Malleis Vice President Andrew C. S truzyk General Manager Radi og raphe rs Thomas D. Grashaw Radiation Safety Officer Lab Su rrvisor i
Randell D. Wells Radiation Safety Moni tor Page 4
DESCRIPTION OF RESPONSIBillTY 1.
President - General management of the company.
2.
General Manager - Responsible for operations control of the company, supervision of enployees, cost control, Job assignments, personnel relations, training.
3.
Radiation Safety Officer - Responsible for overall administration of the radiation safety program (including quality Assurance), personnel radiation safety training and certi fication, document control, and auditing of the radiation safety program.
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 Operations Manager and Radiation Safety Of ficer.
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