ML19207B280
| ML19207B280 | |
| Person / Time | |
|---|---|
| Site: | 07100067 |
| Issue date: | 07/18/1979 |
| From: | Rudley W MEDI-PHYSICS, INC. (SUBS. OF HOFFMAN-LA ROCHE, INC.) |
| To: | |
| Shared Package | |
| ML19207B279 | List: |
| References | |
| NUDOCS 7908240286 | |
| Download: ML19207B280 (3) | |
Text
Page 1 of 3 pages Prepared byW/,4L Approved by:/s4./M4 Date approved: 7/18/79/
APPLICATION FOR COMPLIANCE WITH 10 CFR-71 QUALITY ASSURANCE PROGRAM FOR INDUSTRIAL LICENSES 1.
Organization The final responsibility for the Quality Assurance (QA) Program for 10 CFR, Part 71 requirements rests with Medi-Physics, Inc. Design and fabrication shall not be conducted under this QA program. The QA program is implemented using the following organization:
President Vice President of Operations Eastern Regional Operations Manager Responsible for QA Program Assistant Geht Distribution Manager The Eastern Operations Manager is responsible for the MPI reactor group personnel and radiation safety as well as the administration of the program training, and certification, document control, and auditing.
The Chemist and Assistant Distribution Manager are responsible for handling, storing, shipping, inspecting, testing, record keeping, and maintaining operational status of the containers.
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Page 2 of 3
pages Prepared by:A h4s Approved by: 3mz/ LL4., _
6 Date approved: 7/18/79' 2.
Quality Assurance Program The management of Aledi-Physics, Inc. establishes and implements the QA Program. Training prior to engagement for all QA functions is required according to written procedures. Quality assurance revisions will be made according to written procedures with management approval.
This QA Program will insure that all defined quality control procedures and engineering procedures are in compliance with NRC regulations and that specific provisions of the package design meet NRC requirements.
The Radiation Safety Officer (Easte. n Regional Operations AIanager) will assure that all radicactive material shipping packages are designed and manufactured under the QA Program approved by the Nuclear Regulatory Commission after the effective date of the QA Program. Certification to this effect will be documented by the manufacturer's independent certification facility.
3.
Document Control All documents related to a specific package will be controlled through the use of written procedur
. All document revisions will require manage-ment approval.
The Radiation Safety Off:cer (Eastern Regional Operations 11anager) will issure 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 special form radioactive material will be followed.
Shipments will not be made unless all tests, certifications, acceptances, and final inspections have been ecmpleted. Work instructions will be provided for handling, storage, and shipping operations.
The AIPI Chemist and Distribution personnel shall perform the critical handling, storage, and shipping cperations.
5.
Inspection, Testing, and Operating Status Inspection, testing, and operat!ng status of packages for 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 maintained by written procedures.
DlO4.1,
Page 3 of 3 pages Prepared by: # dQ(.A Approved by:_ hp/go.
Date approved: 7/1q/70 /
The AIPI Chemist and Distribution personnel shall perform the regulatory required inspections and tests in accordance with written procedures.
The Radiation Safety Officer (Eastern Regional Operations 11anager) shall insure that these functions are performed.
6.
Quality Assur mce Records Complete and accurate.*ecords will be maintained regarding: package approvals (including references and drawings), procurement, inspections and tests, operating logs, audit results, personnel training and qualifications; and shipments. A description of all equipment will also be maintained.
These records will be identifiable and retrievable. A list of these records with their storage locations will be maintained by the Radiation Safety Officer (Eastern Regional Operations Slanager).
7.
Audits Established schedules of audits of this QA Program will be performed using ;ritten check lists. Results of these audits will be maintained and reported to management. Audit reports will be evaluated and deficient areas corrected. The scheduling of audits will be dependent on the safety significance of the activity being audited, but each activity will be audited at least once a year. Audit reports will be maintained as part of the quality assurance records. 11 embers of the audit team shall have no responsibility for the activity being audited.
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