ML20210G921
| ML20210G921 | |
| Person / Time | |
|---|---|
| Site: | 07100609 |
| Issue date: | 09/04/1986 |
| From: | SCIENTIFIC MEASUREMENT SYSTEMS, INC. |
| To: | |
| Shared Package | |
| ML20210G911 | List: |
| References | |
| NUDOCS 8609260006 | |
| Download: ML20210G921 (3) | |
Text
_
4 QUALITY ASSURANCE PROGRAM 1.
Organization The final responsibility for the Quality Assurance (QA) Program for Part 71 Requirements rests with Scientific Measurement Systems, Inc. (SMS).
Design and
-Fabrication shall not be conducted under this QA Program.
The QA Program is implemented using the l
organization depicted in Fig.
l.
The Radiation Safety Officer is responsible for overall administration of the program, training and certification, document control, and auditing.
i The Radiographers/Tomographers are responsible for handling, storing, shipping, inspection, test and operating status and recordkeeping.
2.
Quality Assurance Program The management of the SMS Radiation Safety Program establishes and implements this QA Program.
- Training, j
prior to engagement, for all QA functions is required according to written procedures.
QA Program revisions will be made according to written procedures with i
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 pack' ages 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 i
effect from the manufacturer.
3.
Document Control l
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 management.
4 The Radiation Safety Officer shall insure that all QA functions are conducted in accordance with the latest applicable changes to these documents.
i i
8609260006 060904 PDR ADOCK 07100609 C
PDR I
i 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.'r4 Radiography / Tomography personnel shall perform the critical handling, storage, and shipping-cporations.
5.
Inspection, Test, and Operating Status' Inspection, test, and operating status of packages for i i
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 p'rocedures.
Radiography / Tomography 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), procurement, insp5ctions, tests opsrating logs, audit results, personnel training and qualifications and records cf shipments will be maintained.
Descriptions of equipment and written procedures will also be maintained _.
These records will be maintained-in Nccordance with written. procedures. -The reccrds will be identified 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 OA. 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.
Members of the audit tean shall have no responsibility in the activity being audited.
4 e.. e FRE51 DENT CEO RADIATION SATCTY OFFICER SECUntTY OFFICER QUALITY ASSURANCE MANAGER 1
t nMIUFACTURINC A!!D SALES AND RESEARCll AND ADH1111STRATIVE
[NCINEER1NC HARKCTINC DCVEl.orHCtlT SERVICES D2 sign Engineering Sales Orders contract Research Accounting Ptsduct Documentation Customer Liaison In. house Development Purchasing Hinufacturing Product Brochure Scanning Services Contract Administration Test Advertleing Application Studine Inventory Centre!
Trade Shous Figura 1.
Scientific Heesurement Systems Tunctional Organisation Chart k
e n