ML19256E135
| ML19256E135 | |
| Person / Time | |
|---|---|
| Site: | 07100350 |
| Issue date: | 09/28/1979 |
| From: | PICKER INTERNATIONAL, INC. |
| To: | |
| Shared Package | |
| ML19256E134 | List: |
| References | |
| 14317, QAB-1199, NUDOCS 7910290238 | |
| Download: ML19256E135 (4) | |
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'4UM B ER PICKER CORPOfIATION ORPORAE NLICY FOR QA&l199 SIIIPPING AND RECEIVING RADIOISOTOPES DATE 155UED operating Practice Test Other SCptember 28, 1979 PAGE I
OF 4
- 1. 0 PURPOSE:
This policy outlines the requirements for compliance with 10 CFR part 71 appendix E as it concerns shipping and receiving radioisotopes.
Design and Fabrication of all Picker Containers was prior to July 1,1978.
In accordance with 10 CFR part 71.51 this policy deals only with maintaince and use of all shipping containers and does not concern itself with fabricaaon or design.
1.1 Or.11zation The final responsibility for the Quality Assurance (QA) Program for Part 71 requirements as it pertains to Picker shipments rests with The Picker Corporation.
Design and Fabrication shall not be conducted under this QA Program. The QA Program is implemented as shown on the attached organization chart.
The Isotope Committee Chairman, Industry Relations Manager and Special Systems Divisional Manager are responsible for overall administration of the program training and certification, document control and auditing.
The 7ersons named on the license are responsible for handling, storing, sh:pping, inspection test and operating status and record keeping.
1.2 Quality Assurance Program The Management of Picker Corporation establishes and implements the Q.A Program. Training prior to engagement for all QA functions is required according to written job descriptions. QA Program revisions will be made according to written procedures with Isotope Committee approval.
The QA Program will ensure that all defined Q A Procedures, engineering proccdures, and specific provisions of the package design approvals are satisfied. The Q A. Program will emphasize control of the characteristics of the package which are critical to safety.
1 " 6 350 7 9102 90 2 3 F P31312M 370
/R RED BY APPROVAL CATALOG #
REVISIONS C.
P gov
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QA B-1199 Page 2
1.3 Docu ment Control All documents related tc specific shipping package will be controlled through the use of written procedures. All document changes will be performed according to written procedures approved by the Isotope Committee.
The Radiation SafetyOfficers shall insure that all QA functions are conducted in accordince with the latest applicable changes to these documents.
1.4 Handling Storftge and Shipping Written safety procedures concerning the handling, storage and shipping of packages containing radioactive material will be followed. Shipments will not be made unless all tests, certifications, acceptance, and final inspections have been completed. Work instructions will be provided for handling, storage, and shipping operations. Persons named on the Licenses shall supervise the performance of the critical handling, storage and shipping operations.
- 1. 5 Inspection Test and Operating Status Inspection, test and operating status of packages containing radioactive material will be indicated and controlled by written procedures. Status will be ir 'cated by tag, label, marking or log entry. Status of non-conforn
.g parts or packages will be positively maintained by written procedures.
Persons named on the Licenses shall perform the regulatory required inspections and tests in accordance with written procedures. The Radiation Safety Officers shall ensure that these functions are performed.
- 1. 6 Quality Assurance Records Records of package approvals (including references and drawings) procurement, inspections, tests, operating logs, audit results, personnel training and qualifi-cations and records of su.,..sents will be maintained. Descriptions 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. These records will be maintained by the Radiation Safety Officer and/or Mgr Isotope Operationc.
1.7 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 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. The individual performing the audit shall have no direct responsibility in the activity being audited.
1,',' 6 3 5 1
QAB-1190 Page 3
PROGRAM RESPONSIBILITIES Q. A. Manager Special systems Division is responsible for the total administration of Q. A. Program at the factory.
Industry Relations Manager la responsible for the administration of the field Q. A. Program Audit and other Q. A. related activities will be conducted at the factory by the Special Systems Division Safety Officer.
Q. A. Ir.spections of shipments will be done by the Isotope Facility personnel under the direction of the Supervisor, Isotope Facility.
Q A. Inspections in the field will be performed by the licensed service engineers.
IU6 352
QAB-1199 Page 4
PRESIDENT p
K. J. CARLSON dto Group V.P.
V.P. North American Inuustry Relations d
Diagnostic Equipment Sales & Service MGR H. F. KELLER C. R. HULLHIEN W. D. ASHBY i
l s,
un V. P. Technical Director I
3n Special Systems Division of Advanced Dev. Group GENERAL MGR Isotope Committee C
C R. LOCKER Chairman J. B. STICKNEY l
SERVICE ORGANIZATION
____________i MFG. MGR.
Q.A.
MGR W.MOG D. J. CHURCHILL MGR. Isotope Operations MFG TEST Supervisor /Eng. Therapy
.ARET SAFETY OFFICER MFG ENG.
INSPECT ~ON C. A. PENGOV Supervisor Isotope D. MURRAY P. C.
Q. A. ENG.
PURCHASING ENG. SERVICES THERAPY ENGINEERING September 25, 1979