ML20004C776
| ML20004C776 | |
| Person / Time | |
|---|---|
| Site: | 07100454 |
| Issue date: | 05/25/1981 |
| From: | Beddoes J, Michael Brown, Ridout E ATOMIC ENERGY OF CANADA, LTD. |
| To: | |
| Shared Package | |
| ML20004C773 | List: |
| References | |
| 19136, NUDOCS 8106050219 | |
| Download: ML20004C776 (12) | |
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... 9 VALIDATION ATOMIC ENERGY OF CANADA LIMITED - COMMERCIAL PRODUCTS QUALITY ASSURANCE PROGRAM FOR DELIVERY OF A RADIOACTIVE MATERIAL PACKAGE TO A CARRIER FOR TRANSPORT f
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General Manager, Quality Date Assurance gnA - }, t *.
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Executi e Vice-President Date t
Original Issue Date 1981 May 25 1012C 81060502 1g
n 1981 May 25-ATOMIC ENERGY OF CANADA LIMITED - COMMERCIAL' PRODUCTS QUALITY ASSURANCE PROGRAM-FOR DELIVERY OF.A RADIOACTIVE MATERIAL PACKAGE TO A CARRIER'FOR TRANSPORT TABLE OF CONTENTS Page Validation, 1.
INTRODUCTION 1.1 Purpose 1.2-Scope 2.
ORGANIZATION 2.1 Executive Vice-President 2.2 General' Manager, Quality Assuranc0 3.
2.3 Manager, Regulatory Affairs-2.4 General Manager,. Industrial Products.
2.5 Genral Manager, Medical Products 2.6 Manager, Product Integrity 4.
QUALITY ASSURANCE PROGRAM FOR OPERATIONS 3.1 Quality Assurance' Program for Shipping e
3.2 Training 3.3 Personnel-Qualifications 3.4 Management Review 5.
3.5 Revision 3.6 Package Configuration DOCUMENT CONTROL CONTROL OF MEASURING AND TEST EQUIPMENT 6.
HANDLING, STORAGE AND SHIPPING 7.
INSPECTION,. TEST AND OPERATING STATUS 8.
QUALITY ASSURANCE RECORDS AUDITS
n 1981 MayH25
., 1.
INTRODUCTION 1.1-Purpose The purpose of this plan is to define Atomic Energy of Canada Limited - Commercial Products'-
(AECL-CP) quality assurance program for radio-active material psckages used to deliver radioactive material to a carrier for transport as required by 10 CFR71.12.
The program is limited to the company-operational dependent activities in the shipment of packages contain-ing radioactive materials; therefore, the package dependent elements of the quality assurance program as defined in 10 CFR71 -
Appendix E are not addressed.
1.2 Scope 1.2.1
.The scope of this program is-limited-to the operational elements for packages intended for use to ship Type B quantities of radioactive material.
1.2.2 As a general guideline, packages normally used by AECL-CP.which are under this quality program include, but are not limited to, those described in the following USNRC and Agreement State Licences:
54-00300-04 54-00300-09 54-00300-12 54-00300-13 12-18482-01 37-19318-01 5-2623 (Texas)
G. A'.
695-1 (Georgia)
Also specific package design models as follows:
F-J21 F-154 F-127 F-158 F-127X F-168 F-131 F-168X F-143 F-245 F-144 F-247 F-146 F-251 F-147 F-254
'981 M0y125 2-
- 1. 2. 3 '
This program applies to the integrity
.of:the; package as. achieved by-loading, closure, monitoring, and labelling-prior to delivery to a carrier.for-transport.
2.
ORGANIZATION AECL-CP organization is shown in Figure 1.-
The structure
.of the Quality Assurance Division.is~ illustrated in Figure 2.
. Specific responsibilities as they. relate to the program's activities are summarized below.
2.1 Executiv; Vice-President
'The Executive Vice-President is responsible'for establishing the company's-Quality Assurance Policy and ensuring that all company operations are carried'out in full compliance with that policy; this responsibility includes the quality assurance program described herein.
2.2 General Manager, Quality Assurance The General Manager, Quality Assurance, reports directly to the Executive Vice-President and is responsible for providing quality assurance program management for shipment of radioactive material packages.
He is the final authority and-represents AECL-CP on all quality matters.
His specific duties with respect to packages include:
(a)
The responsibility for the promulgation and execution of instructions, policies and procedures.
(b)
The administration of the quality assur-ance program.
(c)
The authority to stop activities when the seriousness of a condition may adversely affect quality or safety.
(d)
The overall activities related to licensing of packages.
(e)
The performance of quality' assurance audits of operations and the reporting of.non-conformances to established quality assurance practices and procedures.
(f)
Conducting audit-follow-up and monitoring corrective action.
3
1981"May 25'
" 2.3 Manager, Regulatory Affairs The Manager,. Regulatory ' ffairs reports-to the A
General' Manager, Quality Assurance, and is1 responsible for the required activities for-the licensing and-provision of quality assur-ancel documents of packages.-
He,is a licensed source handler and. also serves as the ' Radiation.
Safety Officer for all field operations, and as such, assures that packages used'have been-approved by the Competent Authority'of Canada and re-validated by the U.S. Department of TransportationLfor use in transporting radio-active by-product material.
2.4 General Manager, Industrial-Products The General Manager, Industrial Products-reports to the Executive Vice-President.-
He is_respons-ible for the activities and facilities related to the use of packages incident to transport of radioactive materials for-use in. products:under his responsibility.
He is responsible for en-suring that these activities are carried out in compliance with the quality assurance program
-and procedures.
2.5 General Manager, Medical Products The General Manager, Medical Products reports to the Executive Vice-President.
He is responsible for the activities and facilities.
related to the use of packages used for.trans-port of radioactive materials to be installed in medical _ products.
He administers, through the Manager, Medical Installation and Service, and the Area Service Managers, the operations -
of the irea Offices.
He ensures that these activities-are carried out in compliance with-the quality assurance' program and procedares.
2.6 Manager, Product Integrity The Manager, Product Integrity reports to the:
General Manager, Quality Assurance'.
He is responsible for performing audits of those activities related to the program and reporting non-conformances to the responsible. managers.
L He also follows up audits, and requests and monitors corrective actions.
1981 May 25
' 3.
QUALITY ASSURANCE PROGRAM FOR OPERATIONS 3.1 The quality assurance. program for shipping packages is-implemented through.the use'of written procedures, instructions and training.
Also, it includes the document-ation of work ~done,1 checks, inspections, personnel'and procedure. qualifications.and:
audits.
To comply with the qualityL assur-ance-program requirements, procedures'and' instructions are available"and controlled for the following areas:
training of authnrized personnel, loading, closure, monitoring and labelling of' packages and licensing.
'3.2
~Trai'ning Personnel performing activities affecting quality and safety are formally trained in proper handling. techniques for the packages and also. receive indoctrination in (a)
Principles and practices of radiation protection.
(b)
Radioactivity measureme"t standardization, monitoring techniques aud instruments.
(c)
Mathematics and calculations basic to the-use and measurement of radioactivity, and (d)
Biological effects of radiation.
3.3 Personnel Qualifications Personnel handling or preparing shipping packages for delivery to a carrier for transport are'com-petent and duly. licensed source handlers, and are also appropriately trained and qualified.
3.4 Management Review Review of the scope, status, implementation and effectiveness of the quality assurance program-is conducted by management' on that portion of the program for which they have designated res-ponsibility.
The reviews are conducted ~and documented at least once every two years.
a.'
1981 May 25
-5'-
3.5 Revision-The General: Manager, Quality Assurance'is responsible for maintaining the currency of quality assurance program documents.
New or revised quality. assurance program req-uirements are implemented within 90 days following issue or as determined by the General Manager,' Quality Assurance.
Temporary deviations or additions to this document may be made with the approval of the General Manager, Quality Assurance and authorized by the Executive Vice-President and accepted by the responsible managers.
It is the responsibility of'the Manager, Regulatory Affairs to ensure that the re-visions to these documents are approved by the same signatories as the original document and.that, wher e necessary, it is lodged with the~ appropriate international-competent authorities.
3.6 Package Configuration The Radiation Safety Officer assures that modifications to packages are~ approved by the competent authority in Canada and are submitted to the U.S. Department of Trans-portation for re-validation.
4.
DOCUMENT CONTROL All documents related to shipping packages are con-trolled through the use of written procedures.
All changes to documents are performed according to written procedures app eved by management.
The Radiation Safety Office. ensures that all relevant quality assurance program procedures and. revisions are provided to each Area Office and that line responsibilities are conducted in accordance with those procedures.
Each of the Service Managers shall assure that the source handlers are aware of the latest procedures and are required to satisfy the RSO of same.
5.
CONTROL OF MEASURING AND TEST EQUIPMENT For package operations a portable radiation survey instrument is used to establish the radiation level-of the shippire package and to determine if the
1981 May 25' v.
6'-
package is contaminated with radioactive' material.
The procedures'used to control the. standard.of the measurin'g instrument provide ~ for:
5.1 Identification of the-instrument.'.
5.2
. Calibration of sources used.for calibrating
~ the : instruments in accordance with standards established by th6 National Research Council of Canada.-
I 5.31 Establishment of frequency;of calibration of the instrument.
5.4 Maintenance of calibration records.
5.5 The' removal from service and repair of' damaged or inaccurate instrumentation.
6.
HANDLING, STORAGE AND SHIPPING-For-package operations, written procedures provide.for:
6.1 Work instructions for handling, preservation, storage, cleaning, packaging, labelling, monitoring and shipping requirements to be completed.by duly licensed source handlers.
6.2 Verification by the source handler that the activities in Item 6.1 have been completed and that the USNRC and U.S.
Department of Transportation shipping. requirements are properly-satisfied prior to consignment to a carrier for transport.
6.3 All shipping documentation (certification, acceptances, etc.) to be prepared prior to shipment by AECL-CP at the Ottawa Head Office of AECL-CP.
6.4 The assurance that a duly licensed source handler performs all the critical handling, monitoring, storage and preparation for.
transport operations.
6.5 Emergency procedures by both AECL-CP (the consignor) and the commercial carrier.
1981 Mny 25 7'-
7.
INSPECTION, TEST AND OPERATING. STATUS 7.1 Inspection, test and operating status of the package are indicated and controlled by written procedures in conjunction with the handling, storage, monitoring, labelling and shipping operations.
7.2 A check list' is prepared and signed by the source handler and maintained both at the U.S.
Office and at AECL-CP, Ottawa, for each ship ment.
The check list identifies the regulatory required inspections and tests as in the written procedures.
7.3 Each Area Service Manager ensuresithat'these functions are performed.
The Radiation Safety Officer, by verification of documentation, and periodic inspection, assures that these functions have been performed.
7.4 If the package is not suitable for shipment because of damage or non-conformance the status-and disposition of the package is maintained-by written procedure.
8.
QUALITY ASSURANCE RECORDS 8.1 Sufficient records are prepared and maintained in. accordance with the written procedures of the quality assurance program to furnish objective evidence of the integrity and safety of the shipping package.
These records are identif-iable to written procedures ;and traceable to the package and its movements.
8.2 Records attesting to.the personnel training and qualifications are maintained at each Area Office and at AECL-CP.
8.3 Records are stored at AECL-CP Central Records and at the applicable Area Office for use as working records.
Record retention times are based on established procedures. consistent with commitments to the competent authority.
9.
AUDITS 9.1 Planned Quality Assurance audits are performed by personnel who are appropriately trained and have no direct responsibilities in the areas
- 1981 May.25:
- n. audited.
.The audits are performed'in accord-ance with. written procedures and established:
quality audit' techniques.
9.2 The audits determine-the degree of conformance to. approved procedures and quality assurance
. documents and provide objective evidence to evaluate-the effectiveness of the program.
9.3 Corrective action for non-conformance is're-quested from;the. responsible manager.and
. completion of'the corrective action is verified.
Uncorrected non-conformances are carried-as Open Audit Items until corrected.
9.4 Audit frequency.is based on the status, safety, importance or problems.
At least one activity.
is audited each year.
9.5 Copies of'acdit reports are provided to res-ponsible managers and senior management. ' Audit reports and related corrective action are main-tained in Central Records atithe. Ottawa Head Office of AECL-CP.
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FIGURE 1 e
ATOMIC tdERGY OF CANADA LIMITED - C0ffERCIAL PRODUCTS EXECUTIVE ORGANIZATION EXECUTIVE VICE-PRESIDENT-J.M. BEDDOES LEGAL COUNSEL l
A.F. SCOTT VICE-PRESIDENT
' GENERAL MANAGER GENERAL MANAGER GENERAL MANAGER A TUR NG ISOTOPE GROUP INDUSTRIAL GROUP PEDICAL PRODUCTS FINANCE d
& DISTRIBUTION D.J.R. EVANS F.M. FRASER R.A. HARROD H.M.F. WARLAND K.L. RICE GENERAL MANAGER CENERAL MAtIAGER HlMAN RESOURCES QUALITY ASSURA!;Cl; R.L. WOLFF M.G. Brown J.M. BEnn0ES-1981 APRIL
FIGURE 2 ATOMIC l ENERGY OF CANADA LTD.
QUALITY ASSURANCE DIVISION COM'M ERCI AL PRODUCTS ORG AN IZATIO N BR DEVELOPMENT OFFICER SECRETARY E G. RICE E. GOLDING 4
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EQUIPMENT QUALITY RADIAMN 8 INONAL ISOM WALITY PRODUCT INTEGRITY RADIATION MEASUREENT REGULATORY AFFAIRS ASSURANCE SAFETY ASSURANCE MANAGER MANAGER MANAGER MANAGER MANAGER MANAGER H.J. BARRETT A.SHEWCHENKO B.J. JACKSON W.L BRISSON M.T. ANTONI ADES E.F. RIDOUT
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