ML20009E248
| ML20009E248 | |
| Person / Time | |
|---|---|
| Site: | 07100450 |
| Issue date: | 04/10/1981 |
| From: | Gorsira F GORISRA X-RAY, INC. |
| To: | |
| Shared Package | |
| ML20009E243 | List: |
| References | |
| GXI-11, NUDOCS 8107270298 | |
| Download: ML20009E248 (6) | |
Text
.
PROCEDURE:
QA PROGRAM FOR 10CFR, PART 71 b
C' GORSII X-Il Y, INC.
NUMBER: GXI-11 AT : 4/10/81 l
2403 OAD REV: Original PREl BY: F.
ors t r FARMINC 'O,7
, MI 48024 level 111 - Fred E. f ogra, Pres 4dep /'
tf
/
QA PROGRAM FOR 10 CFR PART 71 INDUSTRIAL RADIOGRAPHY LICENSE 21-19339-01 1.
Organization The final responsibility for ti,e Quality Assurance (QA) Program for Part 71 Requi rements rests wi th Gorsi ra X-Ray, Inc.
Design and Fabrication shall not be conducted under this QA Program. The QA Program is implemented using the Organizational Chart on Page 4.
The Radiation Safety Officer is the responsible Individual for the Part 71 QA requi rements and is also responsible for overall administration of the program, training and certi fication, document control and audi ting.
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The Radiographers are responsible for handling, storing, shipping, inspection, test, operating status and record keeping.
2.
Quality Assurance Program The management of Gorsi ra X-Ray, Inc. establishes and implements this QA Program. Training, prior to engagement, for all QA functions is required according to wri tten procedures. QA Program revisions will be made according F
to wrl tten procedures wi th 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 P~rogram will emphasize control of the characteristics of the package which are critical to safety.
The Radiation Safety Of ficer 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 (cameras and source cha'gers) designed or fabricated af ter January 1,1979 This requirement will be satisfied by receiving a certif! cation to this effect from the manufacturer.
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
SUBJECT:
QA PROGRAM FOR 10 CFR, PART 71 DATE ISSUED:
Ap ri 1 10, 1981 PAGE I
0F 5
FORM NO.
8107270298 810515
PDR m
PROCEDURE: QA PROGRAM FOR 10 CFR, PART 71 D (i) an0/8i O GORSI
\\
Y, INC.
wuwBER: Gxi-ii REV: Original -PRE ED BY: F E. orsi noa
- p OAD FARMINr i LL, MI 18024 Leve1 IIl - Fged-EfCorsTra, P(esTd'ent '
to written procedures approved by management.
The Radiation Safety Of ficer shall insure that all QA functions are conducted in accordance wt th the latest applicable changes to these documents.
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.
Radiography peismnel 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 writun 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.
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.
1.
6.
Quality Assurance Records Records of package approvals (including references and drawings), procurement, insper.clons, tes's, operating logs, audit results, personnel training and quallfications and records of shipments will Le maintained.
Descriptions of equipment and written procedures will also be nalntained.
These records will be maintained in accordance with written procedures.
The records will be identified and retrievable. A list of these records, with their storage locations, will be maintained by the Radiation Safety Officer.
l
SUBJECT:
QA PROGRAM FOR 10 CFR, PART 71 DATE ISSUED:
April 10, 1981 PAGE 2 0F_
5 pogg so, w
PROCEDURE: QA PROGRAM FOR 10 CFR, PART 71 f\\
GORSI Y, INC.
NWBER: GXI-11 4/10/8h DfA
-W f
(
)
3 gy p 939 REV: Original EREP BY: _F.a.Gdrs i ra i
3 93 FARMINC 1 LL, MI 48024 Level ll i - Fred E.jporM,-Pres tgent '
s 7
Audits Established schedules of audits of the QA Program will be performed using wri tten check lists.
Results of the audits will be maintained and reported to management. Auait 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
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reports will be maintained as part of the Quality Assuraice records. Membe rs of the audit team shall have no responsibility in the activity being audited.
a.
SUBJECT:
QA PROGRAM FOR 10 CFR, PART 71 DATE ISSUED:_ April 10, 1981 PAGE 3
OF 5
FORM No.
m
PROCEDURE: QA PROGRAtt FOR 10 CFR, PARTM Ip: 5/15/8h GORSI X Ik Y, INC.
M BER: GX I -M REV: Original PnM ED BY : F. E(.
orsira 2403 A,
OAD FAlth!!N
'O
,h!!48024
.h APPROVED BY:
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Level i I I - F red f[M 6rs ! rc,-Pre 5Taght
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LICENSE NUti3ER 21-19339-01 liANAGEllENT ORGANIZATIONAL STRUCTURE Gorsira X-Ray, Inc., was forrned and incorporated in the State of flichigan on October 31, 1979 9
The organizational structure is as follo.vs:
Fred E. Gorsi ra President Dr. Abelardo G. Contreras Vice-President Fred E. Gorsira General itanager f, Radiation Safety Officer Radiographers Assistant Radiographers
SUBJECT:
QA PROGRAft FOR 10 CFR, PART 71 DATE ISSUED:
itay 15, 1981 PACE 4
0F 5
FORM NO.
h
PROCEDURE: QA PROGRAM FOR 10 CFR, PART^ ( GORSI Y, INC. NUMBER: GXI-11 D 5/15/81 ,g g ggg m: M olnal d R' BU _ F.E. o s i ra 3 93 FAl(MINC 1 W 48024 Level t il - Fred E 6" I r2, P res i dep t / MANAGEMENT ORGANIZATIONAL STRUCTURE DESCRIPTION OF RESPONSIBILITY 1. President - General management of the company. 2. Vice-President - Assist the President in the general administration of the company. 3 General Manager and Radiation Safet3 Of ficer - Responsible for operations control, supervision of employees, job assignments, t rain ing. As R.S.O., responsib le for over- ~ all administration of the radiation safety program (including Quality Assurance), personnel radiation safety training and certi fication, document cont rol, and auditing of the radiation safety program. 4. Radiographers - Responsible for using, storing, shipping, inspection, testing, operating status, and record keeping of radioisotope sources and devices in accordance with written procedures of the company as approved by the General Manager and Radiation Safety Officer. 5. Assistant Radioaraphers - Responsible for assisting the radiographer in his duties. 19186
SUBJECT:
QA PROGRAM FOR 10 CFR, PART 71 DATE ISSUED: May 15. 1981 PACE c; oy q FORM NO. L'.}}