ML19260A464
| ML19260A464 | |
| Person / Time | |
|---|---|
| Site: | 07100026 |
| Issue date: | 10/29/1979 |
| From: | EASTERN TESTING & INSPECTION, INC. |
| To: | |
| Shared Package | |
| ML19260A463 | List: |
| References | |
| 14568, NUDOCS 7911210207 | |
| Download: ML19260A464 (16) | |
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l QUALITY ASSURANCE PROGRAM FOR I
EASTERN TESTING & INSPECTION, INC.
AS PER i
APPENDIX E TO 10 CER PART 71 l
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l TABLE OF CONTENTS SECTION TITLE PAGE #
STUEME:4T OF MANAGEMENT POLICY iii RECORD OF Q. A. PROGRAM REVISIONS iiii LETTER OF TRANSMITTAL iiiii i
1.
QUALITY ASSURANCE PROGRAM 1
2.
ORGANIZATION 5
l 3.
DOCUMENT CONTROL 6
4.
HANDLING STORAGE AND SHIPPING 7
5.
INSPECTION, TEST AND GPERATING STATUS 8
6.
QUALITY ASSURANCE RECORDS 9
7.
AUDITS 10 1382 I/9 i
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P QUALITY ASSURANCE PROGRAM STATEMENT OF MANAGEME"T POLICY The Quality Assurance Program described herein is applicable to the' i
services provided by Eastern Testing & Inspection for nondestructive l
examinations and related services. The scope of this program encompasses the applicable requirements of the United States Code of Federal Regulations (10CRF), Part 71, Appendix E; " Quality Assurance Criteria for shipping packages for Radioactive Materials".
l Quality Assurance is recognized by management as an inter-disciplinary function for which the Radiation Safety Of ficer is charged with the responsibility for establishing, imp. menting and maintaining a system to assure the conformance requirements.
All Eastern Testing & Inspection personnel assigned to operations subject to the requirements of this program shall be required to familiarize themselves with the policies and objectives set forth herein. They shall be responsible for executing those policies, explicit or implied, pertinent to their assignments.
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i QUALITY ASST'RANCE PROGRAM QUALITY ASSURANCE MANUAL RECORD OF REVISION i
l DATE SECTION NI'MBER REVISION NUMBER ENTERED BY REVIEWED BY APPROVED BY j
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l LETTER OF TRANSMITTAL j
Letter No.*
Date:
To:
From:
Reference:
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j We are sending you the following items:
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Drawing (s)
Procedure i
Copy of Document (s) i I
j Preliminary Report
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I Final Report i
Other i
l Copies Description Remarks and Reference l
These are transmitted as checked below:
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_ _ For your approval As you requested For review and comment Approved as noted l
For your information Acknowledge, date and return to sender i
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Remarks:
Cooy to:
Acknowledgement:
Sender:
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i Section L:
QUALITY ASSURANCE PROGRAM 1.1 Introduction The purpose of this Corporate Quality Assurance Manual is to delineate the means used by Eastern Testing 5 Inspection, Inc.,
(hereafter known as ETI.) for establishing and implementing a formal and comprehensive program which will assure " Quality Assurance Criteria for shipping packages for Radioactive Material."
Pursuant to Section 71.51, of 10 CRF Part 71, " Packaging of Radioactive Material for Transport and Transportation of Radio-active Material Under Certain Conditions," licensees must establish, execute and maintai*. a quality assudance program for shipping packages for transporting certain quantities of radioactive material, D.O.T. Regulations, this manual is in compliance with the above re-quirements.
This manual af fects all administrative and operating personnel employed by ETI.
The facilities and services provided by ETI, shall operate l
within the policies and requirements stated herein.
1.2 References I
l This manual has been developed by incorporating the applicable l
requirements or criteria of the following documents:
I I
Title 10, Code of Federal Regulations Part 71, Appendix E.
j II ETI Quality Control Procedures.
l III D.O.T. Specification packages i
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I QUALITY ASSURANCE PROG W1 I
1.3 De finit ions 1.3.1 Quality Assurance All those planned and systematic actions necessary to provide adequate confidence that item or facility an will perform satisfactorily in service.
1.3.2 Quality Control Those quality assurance actions which provide a means to measure the characteristics of an item, process or facility to established requirerents.
1.3.3 Soecial Form Radioactive Materials Material, if released from a package, might present some direct radiation hazard but, would present little hazard due to radictoxicity and little possibility of contamination.
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QUALITY ASSURANCE PROGRAM RV PAGE O
3 1.4 Control Resoonsibility i
The Radiation Safety Of ficcr is responsible for controlling i
the dis tribution of this manual.
M 1.4.1 Each manual will be individually numbered for control purposes.
1.4.2 A record of each manual holder will be kept by the '
I Radiation Safety Of ficer.
Holders address, issue c3 date, company (if applicable), and manual number shall cc:3 be recorded.
Should the holder's requirement for the manual cease, he shall promptly return this copy to the Radiation Safety Of ficer.
1.4.3 All employees of the ETI laboratories will receive applicable sections of the manual which pertain to their work assignment.
i 1.4.4 It is the responsibility of each holder of the manual to keep his copy current and to enter all revisions.
1.4.5 Form 4 ETI-QAC-101 " Letter of Transmittal" will be used to document the issuance & revisions of quality assurance program manuals.
1.5 Radiation Safety officer's Responsibilities I
lias overall responsibility for the implementation of the l
l QA/QC program.
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i II Aids laboratory in establishing quality control procedures t
in accordance with this manual.
r III Updates quality control procedures and implements quality l
assurance policies and programs.
Verifies, by periodic reviews, the adequacy and completeness of the QA/QC programs and procedures. Determines revision needs as appropriate.
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IV The Radiation Safety Officer or his represent.ttive shall be i
responsible for training programs for employees whose
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functions will be subject to the requirements set forth in i
this manual.
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It is the duty of Radiation Safety Of ficer or his repre-sentative to explain:
I (a) the contents and objectives of the quality assurance j
program to all employees, and determine indoctrination requirements for new employees.
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(b) The QA/QC or;pnic.,t ion and how it af fects the duties and responsibilities of the employees.
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EASTERN TESTING & INSPECTION, INC.
QUALITY ASSURA 'CE/0UALITY CONTROL ORGANIZATION CHART PRESIDENT H. J. SONI
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QA/QC SECRETARY
= RESPONSIBILITY l
HELEN RULBEWSKY
= COMMUNICATION I
J. BADIALI l
VICE PRESIDENT R.S.O.
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D. RULBEWSKY SUPERVISOR 1382 187 RADIOGRAPHER RADIOGRAPHER S110P STTE/ PROJECT I
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i Section 2: ORGANIZATION l
t 2.1 The ETI Quality Organization The Radiation Safety Of ficer of ETI, is responsible for Quality Aasurance (QA) and is responsible for directing the development and implementation of the quality assurance program, the surveillance and auditing of the QA program, and quality control procedures.
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2.2 The Radiation Safety Of ficer or his representative shall audit site projects as well as the shop and laboratory to determine compliance to QA/QC manuals and procedures, and shall report nonconformances to the Radiation Safety Of ficer for corrective action.
The Shop Supervisor (laboratory) and Site Supervisor (projects)
I shall immediately report all nonconformances to the Radiation Safety Officer.
i 2.3 The Radiation Safety Officer shall assure that all radioactive material shipping packages are designed and manufactured-under Q.A.
l Program approved by N.R.C. for all packages designed or fabricated af ter ef fective date of the Q. A. Program.
This requirement can be satisfied by receiving a certification to this ef fect from the i
manufacturer.
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QUALITY ASSURA"CE PROGR.Ut l
Section 3.
Document Control 3.1 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.
3.2 The Radiation Safety Of ficer shall insure that all QA func-tions are conducted in accordance with the latest applicable changes to these documents.
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l Section 5.
Ins pec t io n, Test and Ooeratine Status 5.1 Inspection, test and operating status of packages for i
certain special form radioactive material will be in-dicated and controlled by written procedures.
Status i
will be indicated by tag, label, marking or log entry.
Status of nonconforming parts or packages will be posi-tively maintained by written procedures.
5.2 tadiography personnel shall perform the regulatory re-quired inspections and tests in accordance with written j
procedures.
The Radiation Safety Officer shall ensure that these functions are performed.
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I Section 6.
Quality Assurance Records 6.1 Records of package approvals (including references and, drawings), procurement, inspections, tests, operating logs, audit results, personnel training and qualifications I
and records of shipments will be maintained. Descriptions of equipment and written procedures will also be maintained.
6.2 These records will be maintained in accordance with written procedures. The records will be identifiable and retrievable. A list of these records, with their storage locations, will be maintained by the Radiation Safec/
Officer.
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Section 7.
Audits 7.1 Established schedules of audits of the QA Program will*
be performed using written check lists.
7.2 Results of audits will be maintained and reported to management.
7.3 Audit reports will be evaluated and deficient areas l
l corrected.
The audits will be dependent on the safety I
significance of the activity being audited, but each l
l activity will be audited at least once per year.
7.4 Audit reports will be maintained as part of the quality l
i assurance records. Members of the audit team shall have l
l no responsibility in the activity being audited.
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