ML19256F044
| ML19256F044 | |
| Person / Time | |
|---|---|
| Site: | 07100350 |
| Issue date: | 09/28/1979 |
| From: | Pengov C, Stickney J PICKER INTERNATIONAL, INC. |
| To: | |
| Shared Package | |
| ML19256F037 | List: |
| References | |
| QAB-1199, QAB-1199-1, NUDOCS 7911210032 | |
| Download: ML19256F044 (4) | |
Text
NUMBER
+
CORPORATE POLICY FOR PICKER CORPORATION SilIPPING AND RECE1VING RADIOISOTOPES Q AB-1199 O AT E 155U ED Operosing Practie.
Test O th.,
September 28, 1979 PAGE 1
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 priot to July 1,1978.
In accordance with 10 CFR part 71.51 this po!!cy deals only with maintaince and use of all shipping containers and does not concern itself with fabrication or design.
1.1 Organization 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 OA 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 trainLig and certification, document control and auditing.
The Persons named on the license (Safety Officer, Supervisor of the Isotope Facility and the personnel reporting to him and the licensed service engineers g in the Service Organization) are responsible for handling, storing, shipping, v
inspection test and operating status and record keeping.
1.2 Quality Assurance Program The Management of Picker Corporation establishes and implenwnts 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 OA Program will ensure that all defined QA Procedures, engineering procedures, and specific provisions of the package design approvals are satisfied. The QA Program will emphasize control of the characteristics of the package which are critical to safety.
15 / b M./
7911210 O'7'>,'
2, PG 131 2 M-370 f/,R RED BY AP ROVAL CATA LOG #
REVISICN
<,,,y A 10/5/79
- )
C; / Pengov U
QAB-1199 Page 2-
- 1. 3
, Document Control All documents related to a 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 Safety Officers (Safety Officer and Industry Relations Mgr.) shall insure that all QA functions are conducted in accordance with the latest h
applicable changes to these documents.
~
- 1. 4 Handling Storage 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 finalinspections have been completed. Work instruction 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 op rations.
- 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 indicated by tag, label, marking or log entry. Status of non-conforming 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 shipments will be maintained. Descriptions of equipment and written procedures will also be maintained.
These records will be maintained in accordance with written procedures. The Q
records will be identifiable and retrievable. These records will be maintained by the Safety Officer and/or Mgr. Isotope Operations.
- 1. 7 Au di'a 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 defincient areas corrected.
1 3/S
!38
Q AB-1199 Page 3
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.
PROGRAM RESPONSIBILIITES Q. A. Manager Special Systems Division is responsible for the total administration of Q. A Program at the factory.
Industry Relations Manager is responsible for the administration of the field Q.A. Program.
The Safety Officer is re ponsible for the administration of the factory Q. A. Program h
Annual adits per 1.7 of the policy will be conducted by the Q. A. Manager @
Q. A. Inspections 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 g
engineers in the service organization 13/S
?39
Q A B-1199 Page 4
PRESIDENT K. J. CARLSON C'J edid Group V.P.
V.P. North American Industry Relations CD Diagnostic Equipment Sales & Service MGR 7
H. F. KELLER C. R. IIULLIHEN W. D. ASilBY
>O I
N.
l n
e V. P. Teahnical Director I
8 Special Systems Division of Advanced Dev. Group 8
GENERAL MGR Isotope Committee 8
R.IDCKER Chairman J. B. STICKNEY SERVICE ORGANIZ ATION MFG. MGR.
Q.A.
MGR W. MOG D. J. CHURCIIILL MGR. Isotope Operations MFG TEST Supervisor /Eng. Therapy R. W. ARNDT SAFETY OFFICER MFG ENG.
INSPECTION C. A. PENGOV Supervisor Isotope FP'ility b P. C.
Q. A. ENG.
D. MURRAY PURCHASING ENG. SERVICES I
Licensing and Q. A. Program Direction TIIERAPY ENGINEERING September 25, 1979