ML20054G609
| ML20054G609 | |
| Person / Time | |
|---|---|
| Site: | 07100454 |
| Issue date: | 10/08/1981 |
| From: | Barrett H, Michael Brown ATOMIC ENERGY OF CANADA, LTD. |
| To: | |
| Shared Package | |
| ML20054G607 | List: |
| References | |
| 20798, NUDOCS 8206220133 | |
| Download: ML20054G609 (20) | |
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COM.V.EP.CIAL PRODUCTS OUALITY ASSURA' ICE PROGRAM
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VALIDATION ATOMIC ENERGY OF CANADA LIMITED - COMMERCIAL PRODUCTS i
l QUALITY ASSURANCE PROGRAM FOR THE
' DESIGN, TESTING AND FABRICATION OF RADIOACTIVE MATERIAL TRANSPORT PACKAGES 1
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Prepared by:
Manage Equipment Quality Assurance Date
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Approved by:
General Manager, Quality Assurance Date Accepted by:
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,___,i,_f, General Manager, Industrial Products Date b_'_b_YO_
Vice-President, Manufacturing and Date Distribution l
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Authorized by:
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Executive Vice-President Date Original Issue Date:
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4 TABLE OF CONTENTS AECL-CP Executive Organization Chart FIGURE 1 Quality Assurance Division FIGURE 2 Organization Chart l
SECTION PAGE 1
1.
Introduction 1
2.
Organization 1
)
3.
Quality Assurance Program 4
4.
Control of Materials, Parts, Components and Services 7
5.
Ins truc tions, Procedures and Drawings 8
6.
Document Control 8
7.
Identification of Materials, Parts - and j
Components 9
8.
Control of Special Processes 9
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9.
Inspection 10 10.
Test Control 11 11.
Control of Measuring and Test Equipment 11 12.
Handling, Storage and Shipping Requirements 12
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13.
Inspection, Test and Operation Status 12 14.
Non-conforming Material, Parts or Components 12 15.
Corrective Action 13 16.
Quality Assurance Records 13 17.
Audits 14 1
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""'2-PIGURE 1 ATOMIC ENERGY OF CANADA _ LIMITED - COMMERCI AL PRODUCTS EXECUTIVE ORGANilATION 1
1 1
l EXECUTIVE VICE-PRESIDENT J.M. BEDDOES LEGAL COUNSEL A.F. SCOTT VICE-PRESIDENT GENERAL M.4AGER VICE-PRESIDENT GENERAL MANAGER GENERAL MNAGER MNUFACTURING FINANCE IS0 TOPE GROUP INDUSTRIAL 6ROUP MEDICAL PRODUCTS
& DISTRIBUTION D.J.R. EVANS F.M.
FRASER R.A. HARROD H.M.F. WARLAND K.L. RICE GENERAL MNAGER GENERAL MAtlAGER HUMAN RESOURCES I)UALITY ASSURAtiCI:
R.L. WOLFF M.G. Brown
FIGURE 2 QUALITY ASSURANCE DIVISION ORGANIZATION l
GENERAL MANAGER, QUALITY ASSURANCli M.G.
HROWN I
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!!A!!AGER,
- MANAGER, MANAGER,
- MANAGER, MANAGER,
- MANAGER, PRODUCT EQUIPMENT ISOTOPE QUALITY REGULATORY RADIATION &
RADIATION INTEGRITY QUALITY ASSURANCE AFFAIRS INDUSTRIAL SAFETY MEASUREMENT ASSURANCE i
_A.
SiiEWCllENKO 11..l. liARRETT M.T. ANTONIADES I
E.F. RIDOllT
'W.L.
BRISSON B.J. JACKSON
- Quality Audits
- Inspection
- Licensing
- Non-Destructive Testing
- Metallurgical Services l
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1.
INTRODUCTION 1.1 Purpose 4
The purpose of this plan is to define the Atomic Energy of Canada Limited - Commercial Products (AECL-CP),
Quality Assurance Program, for the design, testing and fabrication of radioactive. material transport packages.
The Program will assure that the required management i
efforts, equipment and procedures are directed towards satisfying the quality requirements of the Competent I
Authority
- for providing safe and reliable systems and components, to assure compliance with applicable codes i
and regulations.
i 1.2 Scope 1.2.1 This Quality Assurance Program is applicable to the
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control of all aspects of Type
'B' and certain aspects of Type
'A' radioactive material transport packages including design, processing, fabrication, assembly f
and testing.
1.2.2 The Plan is relevant to radioactive material transport packages for which design, construction and modification started af ter 1981 June.
I 1.2.3 This Program does not include controls over operational dependant facets such as use and maintenance of radioactive material transport packages.
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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.
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- Canada - Atomic Energy Control Board (AECB)
U.S.A. - United States Nuclear Regulatory Commission (USNRC) i 2
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2.1 Executive Vice-President The Executive Vice-President is responsible for establishing the Company's Quality Assurance Policy and ensuring that all Company operations are carried
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out in full compliance with that Policy; this f
responsibility includes the Quality Assurance Program described herein.
2.2 Vice-President, Manuf acturing and Dis tribution The Vice-President, Manufacturing and Distribution, reports directly to the Executive Vice-President.
He is responsible for the activities and facilities related to the manuf acture, procurement and processes involved in the production of transport packages.
He i
is responsible for ensuring that these activities are controlled to assure that the transport packages conform to the design certified by the Competent Authority.
4 2.3 General Manager, Quality Assurance The General Manager, Quality Assurance, reports to the Executive Vice-President, and is responsible for providing Quality Assurance Program Management i
for fabrication, assembly and testing of radioactive l
materials transport packages.
He is the final l
authority and represents AECL-CP on all quality ma tters.
His specific responsibilities with respect to transport packages include:
(a)
The administration of the Quality Assurance Program.
(b)
The promulgation and execution of Quality Assurance instructions, policies and procedures.
(c)
Inspection and Inspection Systems.
(d)
The authority to stop activities when the 3
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2.3 (d) seriousness of a condition may adversely af fect quality or safety.
(e)
The overall activities related to licensing of transport packages.
(f)
The performance of Quality Assurance Audits of operations and the reporting of non-compliance with established Quality Assurance Practices and Procedures.
Conducting audit follow-up and monitoring corrective action.
2.4 General Manager, Industrial Products The General Manager, Industrial Products, repor ts to the Executive Vice-President.
He is responsible for the preparation of new and modified designs of existing transport package models.
He is responsible for ensuring that these activities are carried out in compliance with the Quality Assurance Program and Procedures.
3.
QUALITY ASSURANCE PROGRAM 3.1 Management Review Review of the scope, status, implementation and ef fectiveness of the Quality Assurance Program is conducted by Management on that portion of the Program for which they have designated responsibility.
The reviews are conducted and documented a t leas t once every two years.
3.2 Quality Assurance Documents Technical specifications, drawings and documents relating to manufacture of transport packages are controlled through the use of written procedures.
All changes to documents are performed according to written procedures approved by Management.
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3.2 Quality Assurance ensures that all QA Manuals, including-revisions and relevant documents, are controlled and distributed in accordance with AECL-CP and other requirements.
Provisions are established for communication to all responsible organizations and individuals that Quality Policies, QA Manuals and Procedures are mandatory i
requirements which must be implemented and enforced.
3.3 Quality Assurance for Safety Related Systems, S tructures and Components 3.3.1 Quality Assurance interfaces with Regulatory Agencies I
on matters pertaining to licensing.
3.3.2 Quality Assurance reviews drawings and specifications of radioactive material transport packages to ensure compliance with labelling regulations, and to ensure that packages can be inspected and tested to specified quality and safety standards.
3.3.3 Disputes involving quality are resolved by a written non-conformance procedure with agreement for disposition involving QA/QC and other relevant Depar tments (Engineering, Manufacturing, Procurement, e tc. ).
3.4 Training i
An Indoctrination and Training Program, including i
periodic retraining, is established to assure tha t quality-affective activities in fabrication and i
testing are correctly carried out.
The program includes training on quality related manuals, instructions, procedures, principles and techniques of activities being performed.
The scope, objective and method of implementing the Program are documented.
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3.5 Design Control 3.5.1 Industrial Product Engineering establish and implement procedures that assure all design activities are performed to the following requirements:
(a)
Translation of pertinent regulations, codes, standards and design bases into specifications, drawings, written procedures and instructions.
(b)
Design reviews to assure that purchasing, manufacturing and quality aspects have been adequately covered.
(c)
Provision of necessary Quality Program Standards in the design documents and specifications.
(d)
Deletions from and additions and changes to design documents, subsequent to approval for release are identified, documented, and controlled; and are subject to the same approvals as the original documents.
3.5.2 Industrial Products Engineering is responsible for demonstrating that the radioactive material transport package meets the regulatory requirements.
Verification of the adequacy of design will be demonstrated by calculation, test, modelling and/or reasoned argument.
3.5.3 Industrial Products Engineering provides technical j
specifications, tests and acceptance criteria for l
those items of the design necessary for safe and proper functioning of radioactive material transport packages.
They also review inspection and test plans prepared by Manufacturing and Quality Assurance to assure they are adequate.
3.5.4 Similar controls as the items in 3.5.1 to 3.5.3 above, are implemented for radioactive materials transport packages which are an integral part of a product or device, e.g. Gammacells, Therapy Heads, etc.
The overall Design Control responsibilities for products are as follows:
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. 1 3.5.4 (a)
New Medical Products - General Manager, i
Medical Products, (b)
Established New Medical Products (subsequent to 4
pilot production run) - Vice-President,
. Manufacturing and Distribution, (c )'
Industrial Products - General Manager, Industrial Products, j
(d)
Isotope Products - Vice-President Isotope Products.
Industrial Products Engineering is responsible for ensuring that designs meet regulations governing transport packages.
4.
CONTROL OF MATERIAL, PARTS, CCMPONENTS AND SERVICES 4.1 Procedures are established to control and maintain a system for selection, purchasing and surveillance of materials, parts, components and services which are I
required to meet the quality standards detailed in AECL-CP specifications.
They provide for:
4.1.1 Material used in the manufacture of the transport packages which is supplied through Stores.
Procedures provide for verification, certification and/or testing as appropriate for the safe and proper functioning of the transport packages, and for Cuality Assurance to accept or reject material based on criteria specified in drawings and specifications.
l 4.1.2 Material purchased specifically for transport packages.
These procedures provide for Quality Assurance to verify the basic technical recuirements contained in the l
purchase requisitions as follows:
(a)
Applicable regulatory requirements.
(b)
Material identification requirements.
(c)
Drawings.
(d)
Specifications.
(e)
Codes.
(f)
Industrial Standards.
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Test and Specification requirements.
(h)
Special Process Instructions.
4.2 Receiving inspection of material, equipment and I
services purchased for transport packages to assure, as appropriate:
(a)
The material, components and equipment are properly identified and correspond with the identification on the receiving documentation.
(b)
Material, components, equipments and acceptance records are inspected and approved according to i
Written instructions prior to release to Stores.
(c)
Inspection records or Certificates of Conformance l
attesting to the acceptance of material and components are available prior to release to a
Stores.
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(d)
Items accepted and released are identified as to their inspection status prior to forwarding them to a controlled storage area or releasing them for further work.
4.3 Where parts and services may affect the integrity of the product the supplier 's capability will be evaluated by survey conducted by representatives from Quality Assurance, Purchasing and Equipment Production.
The accessability to the suppliers' f acilities to be contractually arranged in the Purchase Order Terms and Conditions.
4.4 A record is maintained by Purchasing of approved vendors containing the following:
i (a)
Quality Level Certification Documents, (b)
Quality Assurance Manuals, (c)
S tatement from the vendor on his manuf acturing capability.
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- 4.5 There are procedures that identify records to be retained, controlled and maintained and for control of changes and revisions to purchase orders.
5.
INSTRUCTIONS, PROCEDURES AND DRAWINGS 5.1 The procurement, fabrication, assembly, inspection and testing of radioactive materials transport packages shall be performed in accordance with approved drawings, instructions, procedures or specifications.
5.2 Component assemblies and complete packages are inspected or tested in accordance with instructions or checklists written for the purpose of communicating quality requirements and inspection and test methods to QC Inspection and Test personnel.
6.
DOCUMENT CONTROL 6.1 Each part of the organization listed in Section 2 generates documents in the course of performing its assigned tasks.
Procedures shall be established describing the Document Control System in each organization.
The Document Control System will be designed to assure review, approval, distribution and revision.
6.2 Master records for fabrication and testing of radioactive material transport packages are prepared and maintained by Industrial Products Engineering.
They establish and identify the current revision number of instructions, procedures, specifications, drawings and procurement procedures.
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7.
IDENTIFICATION OF MATERIAL, PARTS AND COMPONENTS 7.1 Procedures are established to identify materials, parts and components including partial fabrications.
7.2 Identification procedures assure that identity is maintained either on the item, or on records traceable to the item, to preclude use of incorrect or defective items.
7.3 Identification of materials and parts specifically identified as important to the function of safety-related systems and components will be stamped, etched, etc., in appropriate places.
This identification can be traced to documentation such as drawings, specifications, purchase orders, manufacturing and inspection documents, deviation reports, and physical and chemical mill test reports.
8.
CONTROL OF SPECIAL PROCESSES 8.1 Special processes such as welding, heat trea tmen t,
lead pouring, cleaning and passivation are procedurally controlled.
8.2 These special processes are accomplished in accordance with applicable codes, standards and specifications.
8.3 Manufacturing and Quality Assurance personnel, procedures and equipment, involved or utilized in the execution of control of special processes, are qualified to meet the requirements of applicable codes and standards.
8.4 Documented evidence of the validity of such qualifications is maintained for all such personnel, procedures, and equipment, in accordance with applicable codes and standards.
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8.5 Quality Assurance has the responsibility of periodically surveying these records to assure the continued validity of all such qualifications.
9.
INSPECTION 9.1 Inspection and test checklists verify conformance of quality-affective activities with established requirements.
They are documented in accordance with written and controlled procedures.
9.2 Inspection personnel are independent from the individuals performing the particular activity requiring inspection.
9.3 Inspection personnel are qualified in accordance with applicable codes, standards and AECL-CP training programs.
Their qualifications and certifications are kept current.
9.4 Inspection of all modifications, repair and replacement activities are conducted in accordance with the original design and inspection requirements.
9.5 The radioactive material transport packages inspection and test checklist identify mandatory witness and hold points for quality surveillance.
9.6 All quality-related activities are perf ormed with specific equipment under suitable environmental conditions.
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10.
TEST CONTROL 10.1 Industrial Products Engineering will specify tests, when required, to demonstrate that completed transport packages will perform satisfactorily in service.
10.2 Industrial Products Engineering will identify repairs to packages in service that require testing in accordance with the original specifications.
10,3 Cuality Assurance reviews test plans prepared by Manuf acturing to ensure they meet the requirements of the Technical Specifications prepared by Industrial Products Engineering.
They also verify that test results are documented by Manufacturing.
11.
CONTROL OF MEASURING AND TEST EQUIPMENT 11.1 Quality Assurance calibrate all measuring and test instruments relating to Inspection and Manuf acturing at specified intervals, based on the required accuracy, purpose, frequency of usage, stability characteristics, and other conditions aff ecting measurement.
Written procedures ensure that measuring and test equipment, both in Inspection and Manuf acturing areas, are identified and traceable to calibration test data, 11.2 Procedures indicate that measures are taken to determine the validity of previous inspections performed when measuring and test equipment is found to be out of calibration.
Repairs and re-calibration are recorded, 11.3 Calibration procedures refer to transfer standards which are traceable to recognized National Standards.
Where National Standards do not exist, provisions are established to document the basis for calibration.
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12.
HANDLING, STORAGE AND SHIPPING REQUIREMENTS 12.1 Industrial Products Engineering specifies special handling and storage requirements to maintain product integrity.
12.2 Manufacturing prepares written procedures for cleaning, handling, storage and preservation of fabrication materials.
12.3 Quality Assurance prepares procedures and instructions to verify that activities are monitored and documented for record purposes.
13.
INSPECTION, TEST AND OPERATION STATUS 13.1 Quality Assurance provides written procedures to define the inspection, test and operation status.
These will be indicated by the use of markings such as stamps, tags, labels, routing cards, etc.
13.2 Quality Assurance verifies that the application and removal of inspection welding stamps and status indicators such as tags, markings, labels and stamps are procedurally controlled.
14.
NON-CONFORMING MATERIAL, PARTS OR COMPONENTS 14.1 Any raw material, part or assembly, which has been found to deviate from the Engineering definition provided by drawings and specifications, or any deviation from an approved procedure, will require the initiation of a Deviation Report.
14.2 The Non-Conformance Report will identify and describe the non-conforming items, and will indicate the disposition of the non-conformance and the l
inspection requirements together with the approval of the disposition by Industrial Products Engineering.
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14.3 Quality Assurance Procedures are prepared and ensure that non-conforming items are segregated from acceptable items, identified, and put into a special quarantine area until properly dispositioned.
These procedures ensure that acceptability of re-work or repair of materials, components, and systems are verified by re-inspecting and re-testing.
14.4 Where arbitration of non-conformance disposition is required, the Quality Assurance Procedures refer to a Materials Review Board made up of a Senior Manager from Design Engineering (relevant products group),
Production Engineering and Quality Assurance.
Where the non-conformance involves another Department, e.g.
Purchasing, Materials Planning, then a representative from that Department will serve on the MRB in an advisory capacity.
15.
CORRECTIVE ACTION 15.1 Necessary corrective actions shall be identified, documented, and implemented in a manner appropriate to the cause and importance of the deficient condition.
Documentation may be by formal letters, audit reports, or special forms such as the Customer Complaint Form or Corrective Action Request Form.
The cause and corrective action for adverse quality conditions shall be reported to appropriate Management and when warranted, to Regulatory Agencies.
16.
QUALITY ASSURANCE RECORDS 16.1 Records are maintained which contain documentary evidence of activities and data relevant to the quality of a component or package.
These records 14
16.1 testify directly or indirectly that the component or package can perform in compliance with jurisdictional and specified requirements.
16.2 All documentary records are identifiable and retrievable for the following time periods; Quality Assurance Records 5 years Design Engineering Records indefinitely Purchasing Records 5 years Manufacturing Records 5 years j
16.3 The radioactive materials transport package master record maintains listings of current documents which outline, but are not limited to, the design, calculations, drawings, tes ts, inspections, and material analysis.
16.4 Where applicable, inspection and test records will contain the following:
(a) description of the type of observation, (b) evidence of completing and verifying a manuf acturing inspection or test operation, (c) the date and results of the inspection and test checklist, (d) information relating to conditions adverse to quality, (e)
Inspector or data record identification, (f) evidence as to acceptability of results.
17.
AUDITS 17.1 Planned Quality Assurance audits are performed by personnel who are appropriately trained and have no direct responsibilities in the areas audited.
The audits are performed in accordance with written procedures and established quality audit techniques.
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17.2 The audits determine the degree of conformance to approved procedures and Quality Assurance documents.
They provide objective evidence to evaluate the e
ef f ectiveness of the Program.
17.3 Corrective action for non-conformance is requested from the responsible Manager and completion of the corrective action is verified.
Uncorrected non-j conformances are carried as Open Audit items until corrected.
i 17.4 Audit frequency is based on the status, safety and importance of problems.
At least one activity is audited each year.
17.5 Copies of audit reports are provided to responsible Managers and Senior Management.
17.6 Audit reports and related corrective action are maintained in Central Records at the Kanata site of AECL-CP.
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