ML19320A824
| ML19320A824 | |
| Person / Time | |
|---|---|
| Site: | 07100381 |
| Issue date: | 06/04/1980 |
| From: | E.L. CONWELL & CO. |
| To: | |
| Shared Package | |
| ML19320A822 | List: |
| References | |
| 16544, NUDOCS 8007020652 | |
| Download: ML19320A824 (3) | |
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E. L. Co2twmLL Q Co.
10 CFR PART 71 QA PROGRAM RADIOACTIVE SHIPPING PACKAGES r0R INDUSTRIAL RADIOGRAPHY LICENSEES 1.
Organization The final responsibility for the Quality Assurance (QA) Program for Part 71 Requirements rests with E. L. Conwell Company. Design and Fabrication shall not be conducted under this QA Program. The QA Program is implemented using the following organization:
Radiation Safety Officer - per the attached organization chart.
The Radiation Safety Officer is responsible for overall administration of the program, training and certification, document control, and auditing.
The Radiographers are responsible for handling, storing, shipping, inspection, test'and operating status and rec:,rd keeping.
2 Quality Assurance Program The management of E. L. Conwell (, Company 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 acct.rding to written procedures with management approval. The QA Program will ensure that all defined QC 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 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.
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Document Control All documents related to a specific shipping package will be controlled th~ough the use of written procedures. All document changes will be r
performed according to written procedures approved by management.
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The Radiation Safety Officer shall insure that all QA functions are conducted in accordance with the' latest applicable changes to these documents.
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2-4 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'are provided for handling, storage, and shipping operations.
Radiography personnel shall perform the critical handling, storage and shipping operations.
5.
Inspection, Test, and operating 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 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), procure-ment, inspections, tests, operating logs, audit results, personnr.1 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 procadures. The records will be identifi'ed 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 Progran will be performed using
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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 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.
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