ML19341A568
| ML19341A568 | |
| Person / Time | |
|---|---|
| Site: | 07100404 |
| Issue date: | 12/15/1980 |
| From: | CTI, INC. (FORMERLY ALASKA WELDING CENTER) |
| To: | |
| Shared Package | |
| ML19341A567 | List: |
| References | |
| 18154, NUDOCS 8101270126 | |
| Download: ML19341A568 (17) | |
Text
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_ h_s Authorized for Use Ef fective Date: 12/15/80 10 CFR, PART 71 QUALITY ASSURANCE PROGRAM FOR INDUSTRIAL RADIOGRAPHY LICENSEES i
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\\ f-10 CFR, PART 71
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QUALITY ASSURANCE PROGRAM REVISION SHEET
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12-15-80 All All Initial Release i
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REVISION SHEET FRCNT SECTION SECTION SECTION SECTION MATTER
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/h 10 CFR, PART 71 om 12/15/80 QUALITY ASSURANCE PROGPAM REVISION SHEET Appr. JW PAGE SECTION Subsection Revision Sheet i
List of Effective Pages 11 1
1.0 QUALITY PROGRAM 1.1 Introduction 1
1.2 Issuance and Control of the Manual 1
2 1.3 Program Review 2
1.4 QA Program Control and Revisions 2
1.5 Approval 2
1.6 NRC Access 1.7 Quality Assurance Indoctrination and Training 3
1.8 New and Transferred Employees 3
4 Figure 1 Transmittal Log 2.0 ORGANIZATION AND PLANNING 1
1 2.1 The Quality Organization 2.2 Quality Control Manual 2
Figure 2 Quality Organization Chart 5
3.0 DOCUMENT CONTROL 1
4.0 HANDLING, STORAGE AND SHIPPING 1
5.0 INSPECTION, TESTS AND OPERATING STATUS 1
1 6.0 QUALITY ASSURANCE RECORDS 1
7.0 AUDITS l
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ALASKA WELDING CENTER
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J 10 CFR, PART 71 Dei 12/15/80 QUALITY ASSURANCE PROGPAM A;pr. [W 1.0 QUALITY PROGRAM 1.1 Introduction Alaska Welding Center, hereinafter referred to as the Company, defines, establishes and implements by means of this Quality Assurance (QA) Program' a formal and comprehensive system to assure that the quality of the radiation safety for packaging of radioactive material for transport and transportation of radioactive material conforms to 10 CFR, Part 71 requirements.
The 10 CFR, Part 71 Quality Assurance Program of the Company is described by the policies and objectives set forth in this manual.
A Quality Control Manual shall be developed to identify, assign, and control the activities performed in accord-ance with 10 CFR, Part 71.
It shall include the duties, responsibilities, and organizational level of those persons charged with, the establishment and enforcement of the quality requirements.
The Radiation Safety Officer 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 designed or fab-ricated after January 1,1979.
1.2 Issuance and Control of the Manual 1.2.1 The Radiation Safety Officer is responsible for the preparation, issuance, maintenance and control of this Quality Assurance Program Manual.
He will determine those functions within the Company performing activities affecting radiation safety quality, and shall provide controlled copies of this manual to appropriate personnel.
1.2.2 All controlled copies of the manual will be individually numbered for control purposes.
A controlled record (Form 102, Figure 1) of each manual holder will be kept by the Manager of QA.
Should the holder's requirements for a manual cease, he shall promptly return this copy to the Manager of QA.
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12/15/80 09 10 CFR, PART 71 of, QUALITY ASSURANCE PRCGRAM Appr, J:4p-1.2.3 It is the responsibility of each holder of the manual to keep his copy current and to enter all revisions.
All revisions shall be distributed to all persons on the controlled distribution list.
Controlled copies of the Quality Assurance Manual may not be used by others out-side of the Company except with permission of the Radiation Safety Officer and with written agreenent that the manual will not be reproduced, copied or used in whole or in part except as permitted.
1.2.4 Copies for general information sha'l be issued as
" uncontrolled" copics.
The holder shall be responsibic for verifying that the contents of a reference copy is current prior to use.
1.3 Program Review 1.3.1 Review of the Quality Assurance Program will be conducted on an annual basis by management, the Radiation Safety Officer, the laboratory and project managers.
They shall verify the adequacy, completeness and effectiveness of the Program.
1.4 QA Program Control and Revisions 1.4.1 Revisions to this Quality Assurance Program are authorized when recommended by the Radiation Safety Officer and approved in writing by the P, resident.
A revision is defined as a permanent change to the QA Program Manual and which is d2otributed to all manual holders by the Radiation Safety Of ficer in the form of printed replace-ment pages.
1.4.2 The Nuclear Regulatory Commission shall be notified of all revisions and a copy submitted to them for approval.
1.5 Approval 1.5.1 All Quality Assurance Program changes shall receive the approval of the NRC prior to their implementation.
1.6 NRC Access.
- 1. 6.1 The MRC shall have access to Company operations and docu-mentation as required to assure conformance to all 10 CFR, Part 71 requirements.
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jb 10 CFR, PART 71 om 12/15/80 QUALITY ASSURANCE PROGRAM Am..J_ v 1.7 Quality Assurance Indoctrination and Training 1.7.1 Tne Radiation Safety Officer shall be responsible for developing and implementing indoctrination und training programs for employees whose function will be subject to the requirements stated in this manual.
1.8 New and Transferred Radiographers 1.8.1 The purpose of the QA indoctrination and training pro-gram is to familiarize radiographers with the Quality Assurance Program, stressing the import 7.ce and meaning of Q';ality Assurance as it applies to 10 CFR, Part 71.
1.8.2 The Quality Assurance indoctrination and training will be conducted by the Radiation Safety Officer or a desig-nated representative.
The indoctrination may be accomplished either as a group lecture or personnel interview.
During the lecture or interview, the follow-ing items will be covered:
a) Objectives of the Quality Assurance Program.
b) Quality Assurance organization and how it affects the duties and responsibilities of radiographers.
c) Contents of the Quality Assurance Program and appli--
cable Quality Control procedures with specific emphasis placed on those sections which most directly affect the Radiographers' safety duties.
d) Control of the characteristics of the package which are critical to safety.
ALSKA WELDING CENTER
A1ASKA VELDING CENTER QUALITY ASSURANCE ffANUAL TRANSMITTAL LOC
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DATE DELIVERED TO/DATE ACKNOWLEDGED BY/DATi Form 102 Figure 1 q <a,4
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2.0 ALASKA WELDING CENTER l,'71 s
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Date QUALITY ASSURANCE PROGRAM ORGANIZATION AND PLANNING gfy 2.0 ORGANIZATION AND PLANNING 2.1 The Quality Organization 2.1.1 The General Manager is the chief operating officer.
Each project and the laboratory is charged by the General Manager with the responsibility for assuring that all radiation safety tests, inspections, examinations, ser-vices and operations performed will conform to 10 CFR, Part 71, reauirements.
The final responsibility for the Quality Assurance (QA)
Program for Part 71 requirements rests with Alaska Welding Canter.
Design and fabrication shall not be conducted under this QA Program.
The Rcdiation Safety Officer is responsible for overall administration of the program, training and certifica-
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tion, docunent control and auditing.
The Radiographers are responsible for handling, storing, shipping, inspection test and operating status and recordkeeping.
2.1.2 The Radiation Safety Officer is appointed by the General Manager and is responsible for directing the development and implementation of the Quality Assurance Program and the survaillance and auditing of the QA Program and Quality Control procedures.
He reports to the General t
l Manager for managecent and administrative guidance.
He is also responsible specifically for:
a) Directing the preparation and Lnplementation of QC procedures for the laboratory and projects.
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b) Directing the preparation of Quality Control pro-l cedures for all activities.
l c) Directing the preparation of test and inspection l
procedures, l
l d) Performing and directing scheduled monitoring and surveillance of the quality program at the laboratory i
and all projects.
e) Determining and issuing of stop-work / resume work orders.
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f) Revieuing the QA Program and reporting the status to the General Manager.
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ik e-10 CFR, PART 71 12/15/80 Dae QUALITY ASSURANCE PROGRAM ORGANIZATION AND PLANNING 4Pr. IV 2.1.3 A Manager of Technical Services is directed by the Radia-tion Safety Officer for the purpose of implementing the Quality Assurance and Quality Control procedures.
The Manager of Technical Services is responsible for the implementation and surveillance of the Quality Control procedures for the laboratory and projects.
He reports directly to the Radiation Safety Officer on matters relating to the radiation safety program. *He is also responsible specifically for:
a)
Development, implementation and control of receiving, packaging and inspection procedures.
b)
Directing and monitoring of personnel qualifications and certifications.
c)
Directing and monitoring of personnel training.
d)
Providing assistance to the Radiation Safety Officer in the auditing and inspection of the laboratory and proj e cts'.
e)
Functional relationship between the Radiation Safety Officer and radiography personnel.
2.1.4 The General _ Manager has established the quality program so its functions are not influenced by operations or produc-tion, ~ and that the management and direction of the Radia-tion Safety ' Officer is his responsibility. The Radiation
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Safety Officer'shall report directly to the General Manager and interface with laboratory and project managers and other management and supervisory personnel.
Figure 2 is a chart of the quality organization.
2.2 Quality Control Manual The purpose of the Quality Control Manual is to outline the methods to be used in administering those elements of the Quality Assurance Program applicable to 10 CFR,'the Part 71 projects and to the laboratory.
For projects, Quality Control Manual shall contain all of the specific procedures applicable to any field project.
For labor-atories, the Quality Control Manual shall describe the operations and specific safety quality requirements for the laboratory; it shall also include how these elements n..se.
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nn 0 10 CFR, PART 71 12/15/80 QUALITY ASSURANCE PROGRAM Am. [V ORGANIZATION AND PLANNING are implemented by detailed procedures.
The Radiation Safety Officer is responsible for directing the develop-ment of the Quality Control Manual.
2.2.2 The laboratory and project manager is responsible to the Technical Services Manager for the planning, administra-tion and performance of receiving, packaging and inspection of radioactive materials.
2. "_. 2.1 Procedures for the required radiation transport operations are found in the Quality Control Manual for laboratories and for projects.
The Manual will include directions, work instructions, drawings, forms and controls to assure that activities and operations performed conform to the required quality level.
2.2.2.2 The receiving, packaging, shipping and inspection pro-cedures include:
a)
Type of operations to be performed.
b)
Equipment to be used.
c)
Procedures for directing and controlling operations.
d)
Work instructions.
e)
Identification of items on which the operation is to be performed.
f)
Results.
g)
Documentation of work performed.
2.2.3 The Quality Control Manual will consist of four sections and include the subjects listed below:
a)
Section 1.0 Organization - This section will contain an organization chart for the facility, the functions and responsibilities of the key positions, and the management control system.
b)
Section 2.0 Administration - This sect 1on will contain or reference the correspondence and filing system, 4*,*qz
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Dee QUALITY ASSURANCE PROGRAM ORGANIZATION AND PLANNING Apr.r. M W document control system, procurement system, and any other administrative functions affecting radi-ation safety materiuls.
c)
Section 3.0-Operations Quality Control Procedures -
This section will contain or reference procedures for:
1) operations 2) material receiving 3) handling and storage 4) identification and control of processed materials and items 5) nonconformance and corrective action 6) calibration of measuring and test equipment 7) quality control inspections and records 8) other quality related items as may be necessary d)
Section 5.0 Audits - This section shall contain the procedure to be used.
This procedure will identify audit fre quen cy.,
items to be audited, and include the audit form to be used.
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Alaska Welding Center General Manager Radiation Safety Officer Manager.
Technical Services 4
Laboratory Field ' Proj ects Laboratory Manager
' Project Manager (.s)
Radiographers Radiographers-Level II Level II Figure 2-QUALITY ORGANIZATION CHART 1
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QUALITY ASSURANCE PROGRAM DOCUMENT CONTROL Appr. 1 2: 7 3.0 DOCUMENT CONTROL 3.1 All laboratory and project documents related to a specific shipping package will be controlled through the use of written procedures.
All document changes will be per-formed according to written procedures approved by management.
The Radiation Safety Officer shall insure that all QA.
functions are conducted in accordance with the latest applicable changes to these documents.
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10 CFR, PART 71 12/15/80 Date QUALITY ASSURANCE PROGRAM HANDLING, STORAGE AND SHIPPING Appr. #kV_
4.0 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 personnel shall perform the critical handling, storage, and shipping operations.
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s 10 CFR, PART 1 2/15/80 D33 INSPECTION, TEST & OPERATING STATUS bW Appt.
5.0 INSPECTION, TEST, AND OPERATING STATUS and operating status of packages for 5.1 Inspection, test 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 procedures.
Radiography personnel shall perform the reg,ulatory-required inspections and tests in accordance with written pro-cedures.
The Radiation Safety Officer shall ensure that these functions are perfc.rmed.
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N-10 CFR, PART 1 12/15/80 Date QUALITY ASSURANCE PROGRAM RECORDS App,,
Fu 6.0 QUALITY ASSURANCE RECORDS Records of package approvals (including references and drawings), procurement, inspections, tests, opera ting logs, audit results, personnel training and qualifica-tions 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 records will be identified and retrievable.
A list of these records, with their storage locations, will be maintained by the Radiation Safety Officer.
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12 /15 / 8_0 QUALITY ASS 6RANCE PROGRAM AUDITS Appr. M 7.0 AUDITS 7.1 Established schedules of audits of the QA Program will be pecformed 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
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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 team shall have no responsibility in the activity being audited.
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