ML20206E198
| ML20206E198 | |
| Person / Time | |
|---|---|
| Site: | 07100597 |
| Issue date: | 05/16/1986 |
| From: | WESTINGHOUSE ELECTRIC COMPANY, DIV OF CBS CORP. |
| To: | |
| Shared Package | |
| ML20206D888 | List: |
| References | |
| NUDOCS 8606230202 | |
| Download: ML20206E198 (73) | |
Text
Rev." O Date 5-16-86 TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabrication and Initital Testing of Radwaste Shipping Packages POLICY In order to use a U.S. Nuclear Regulatory Commission (NRC) certified package (hereafter simply referred to as package) for shipments of radioactive material in ;ccordance with the general license provided in 10 CFR Part 71.12, the user of the package must have a quality assurance (QA) program whose description has been submitted to and approved by the NRC as satisfying the provisions of Subpart H of 10 CFR Part 71.
This requirement notwithstanding, users may delegate to others, such as the Westinghouse Waste Technology. Services Division (WTSD), the work of establishing and executing the QA program, or any part thereof, but shall retain responsibility therefore. Westinghouse WTSD is a Division of the Westinghouse Electric Corporation.
WTSD recognizes the practical necessity for users of WTSD owned and certified packages to delegate most, if not all, of the work of establishing and executing the required QA program. WTSD has, therefore, developed a Quality Assurance Program description, the " Quality Assurance Program for the Engineering, Design, Procurement, Fabrication, and Initial Testing of Radwaste Shipping Packages" in recognition of WTSD's delegated responsibilities for assuring that its packages are designed, fabricated, and tested, in such a manner as to provide for the safety of the public..
The importance of QA in contributing to this safety is also reco'gnized.
In accordance with this philosophy this QA Program description has been f
prepared and by its issuance establishes the policies and practices for QA for the engineering, design, procurement, fabrication, and initial testing of WTSD packages.
The approval, issuance, and control of this Quality Assurance Program description shall be the responsibility of the Manager, Product Assurance, who has been assigned overall responsibility for its development and implementation. Day-to-day responsibilities for Quality Assurance, including preparation and review of additions, deletions, or modifications to this Quality Assurance Program description shall rest with the Product Assurance Systems-Manager who reports directly to the Manager, Product' Assurance.
I Disagreements or differences of opinion on Quality Assurance matters which originate with or are brought to the attention of the Quality Assurance Manager are expected to be resolved by him and the affected department l
manager or unit manager. Where such resolution is not achieved within a reasonable period of time., unresolved differences shall first be referred
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to the Manager,. Product Assurance, who shall then refer still unresolved matters to the General Manager.
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O Date 5-16-86 TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabricatign and Initital Testing of Radwaste Shipping Packagcc As directed by the General Manager through the issuance of this Quality Assurance Program description, the Manager, Product Assurance, is hereby assigned the responsibility for all matters related to quality with authority as established in this Quality Assurance Program.
All WTSD personnel with responsibility for activities related to WTSD package design, procurement, fabrication, and initial testing have the additional responsibility for being fully knowledgeable of policies and procedures described in this Quality Assurance Program description that are pertinent to their particular duties.
Conformance to the policies and practices described herein shall be required as of the date of approval and issue of this procedure.
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General Manager
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O Date 5-16-86 TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabrication and Initital Testing of Radwaste Shipping Packages TABLE OF CONTENTS SECTION TITLE Foreword Table of Contents 1
Organization 2
Quality Assurance Program 3
Design Control 4
Procurement Document Control 5
Instructions, Procedures, and Drawings 6
Document Control O
7 Control of Purchased Material, Equipment & Services 8
Identification and Control of Materials, Parts and Components 9
Control of Special Processes 10 Inspection 11 Test Control 12 Control of Measuring and Test Equipment 13 Handling, Storage and Shipping 14 Inspection, Test, and Operating Status 15 Nonconforming Materials, Parts, and Components 16 Corrective Action 17 Quality Assurance Records 18 Audits O
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TITLE: Quality Assurance Progrma for the Engineering, Design, Procurement, Fabrication and Initital Testing of Radwaste Shipping Packages SECTION 1 - ORGANIZATION 1.1 Scope and Apolicability 1.1.1 This section includes a description of the organizational responsibilities normally assumed by WTSD for the engineering, design, procurement, fabrication, and initial testing of radwaste shipping packages.
These responsibilities include both the performing functions involved in attaining quality objectives and the Quality Assurance functions.
The Quality Assurance functions are those of assuring that an appropriate Quality Assurance program is established and effectively executed for (a) performing the safety-related work functions and (b) verifying, e.g., by checking, auditing, and inspecting, that activities involving those safety-related functions have been correctly performed.
1.1.2 Terms, abbreviations, and definitions used in this Quality Assurance Program description are included in Table 1-1.
1.2 Organization and Responsibilities (3) 1.2.1 Figure 1-1 shows the organizational structure for WTSD.
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Individuals and groups having responsibility for activities falling within the scope of this Quality Assurance Program are clearly identified in the figure.
The authority and specific responsibilities of these individuals and groups for such quality related activities are described in the following sections.
1.2.2 General Manager 1.2.2.1 The General Manager of WTSD has ultimate responsibility for the Division's activities related to the engineering, design, procurement, fabrication, and initial testing of WTSD packages.
1.2.2.2 The General Manager's day-to-day responsibilities for implementing the Quality Assurance Program are delegated to the Manager, Product Assurance.
1.2.2.3 The General Manager shall retain responsibility for assuring the independence of the Manager, Product Assurance from schedules and costs and for providing the Manager, Product Assurance, the authority to direct and control the Quality Assurance Program and to ensure conformance to quality
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TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabrication and Initital Testing of Radwaste Shipping Packages 1.2.2.4 The General Manager is responsible for ensuring that the individual assigned the position of Manager, Product Assurance satisfies the qualification and experience requirements discussed in Section 1.4 of this procedure.
1.2.2.5 The General Manager reserves the right to conduct, or order, the auditing of any activity at any time to determine the effectiveness of the policies ~and requirements set forth in this Quality Assurance Program description and to determine compliance with the provisions of the Quality Assurance Program and implementing procedures.
1.2.3 Product Assurance 1.2.3.1 The Manager, Product Assurance reports to the General Manager, and is responsible for ensuring the implementation of the Quality Assurance Program.
1.2.3.2 The Manager, Product Assurance, is responsible for C,,)
conducting a formal review of the Quality A'ssurance Program on an annual basis and reporting the results to the General Manager.
1.2.3.3 The Manager, Product Assurance has been given the authority by the General Manager to identify quality problems and to initiate, recommend, or provide solutions to responsible individuals and groups. The Manager, Product Assurance, verifies implementation of these solutions.
1.2.3.4 The Manager, Product Assurance, has been given the authority by the General Manager to stop unsatisfactory work or further processing of t
unsatisfactory material that is not in conformance with specified quality requirements and/or the provisions of the Quality Assurance Program.
1.2.3.5 Specific duties of the Manager, Product Assurance, and his designated Product Assurance staff include
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the following:
(a)
Prepare and control the Quality Assurance Program description including revisions and its distribution.
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^ Date 5-16-86 TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabrication and Initital Testing of Radwaste Shipping Packages (b) Formulate Quality Assurance policies for use by WTSD.
(c) Review the Quality Assurance programs of suppliers and contractors as appropriate.
(d) Review specifications, drawings, and procedures for conformance to WTSD quality requirements, and, when appropriate, applicable industry I
standards and regulatory requirements.
(e) Manage the Product Assurance staff in the performance of their activities.
(f) Inform WTSD management of Product Assurance Department activities through distribution of
- reports, e.g.,
periodic audits, and other quality-related information.
.I (g) Monitor the performance of quality related activities and conduct periodic audits.of the Quality Assurance Program.
(h) Provide assistance as appropriate with the preparation of quality related procedures controlling the activities of WTSD personnel.
1.2.4 Purchasine Manager 1.2.4.1 The Purchasing Manager reports to the Controller.
1.2.4.2 The Purchasing Manager is responsible for material purchasing, expediting, internal material control and development and implementation of material control I
procedures and instructions.
l.2.5 Manager. Engineerina 1.2.5.1 The Manager, Engineering, reports directly to the General Manager and is responsible for managing the engineering department within WTSD and for the oversight of internal research and development.
1.2.5.2 The Manager, Engineering is responsible for managing Engineering Department activities related to d
preparation of package license applications and O-amendments thereto and is responsible for approving such applications.
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-TITLE: Quality Assurance Program.for the Engineering, Design, Procurement, Fabrication and Initital Testing of Radwaste Shipping Packages 1.2.6 Mananer. Desinn Ennineerinn 1.2.6.1 The Manager, Design Engineering reports to the Manager, Engineering.
a 1.2.6.2 Responsibilities of the Manager, Design Engineering include the following:
(a) management of engineering design and design drafting personnel; 7
(b) preparation,-review and approval of drawings, specifications, calculations, and test procedures; i'
(c) preparation of license documents including safety analysis reports, topical reports and amendments thereto; 1
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(d) coordination of engineering reviews and approvals of reports of nonconforming materials, parts, and components, including the disposition of those materials and items-1 j
(e) review and approval.of special test results; j
(f) development and implementation of engineering procedures and instructions, including design document control procedures; i
i (g) review and approval of technical vendor j
submittals, e.g.,
drawings, procedures, data
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sheets.
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1.2.7 Mananer. Nuclear Waste Proiects i,
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l.2.7.1 The Manager, Nuclear _ Waste Projects, reports to the General Manager.
I 1.2.7.2 The Manager, Nuclear Waste Projects, through his delegated Project Managers, has overall responsibility for coordinating the development of new WTSD package designs.
Day-to-day responsibility
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for these activities is delegated to the Manager, Package Projects.
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O Date 5-16-86 TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabrication and Initital Testing of Radwaste Shipping Packages 1.2.8 Manazer. Proieces 1.2.8.1' The Manager, Package Projects, reports to the Manager, Nuclear Waste Projects.
1.2.8.2 Responsibilities of the Manager, Package Projects, include the following:
(a)
Initiating and/or approving Project Control Releases (PCRs) (See Figure 1-2) and purchase requisitions for the development, design, l
purchase, and fabrication of new WTSD packages.
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f (b) Reviewing and concurring with drawings, test
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procedures, specifications, and/or purchase requisitions and changes thereto, for documents resulting from 1.2.8.2(a).
t 1.2.8.3 The Manager, Package Projects, or his designee is i
also responsible for ensuring that procedures and instructions for package operation are prepared.
1.3 UTSD-User Interface Control 1.3.1 WTSD and the package user share responsibility for establishing and maintaining effective lines of communication between them.
In this regard the primary communication line between the customer and WTSD for matters related to the establishment and/or execution of-the Quality Assurance Program as applied to WTSD packages shall be between the customer's designated representative for such matters and WTSD's Manager, Product Assurance.
1.4 Manamer. Product Assurance Position Oualifications 1.4.1 The Manager, Product Assurance, is responsible-for. ensuring implementation of the Quality Assurance Program. The Manager, Product Assurance, shall satisfy the following minimum qualification requirements:
(a) Graduate of a four-year accredited college or university program in engineering or science; (b) Minimum of two (2) years experience in Quality Assurance, including testing or inspection (or both) of equivalent materials and structures; O
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TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabrication and Initital Testing of Radwaste Shipping Packages (c)
In lieu of a degree, a high school graduate plus five (5) years of experience in general Quality Assurance or engineering of equivalent materials and structures; (d)
Individuals without any prior experience with radwaste shipping packages shall have training sufficient to acquaint them with the safety aspects of WTSD packages.
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TITLE: Quality Assurance Program for the Engineering, Design, Procurement, t
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Fabrication and Initital Testing of Radwaste Shipping Packages TABLE l-1 DEFINITIONS OF TERMS certificate of compliance Form NRC-618 issued by the NRC for radioactive materials packages under 10 CFR Part 71, certificate of conformance A document signed or otherwise authenticated by an authorized individual certifying the degree to which items or services meet specified requirements.
package The packaging together with its 4
radioactive contents as presented for transport.
See 10 CFR 71.4 for additional definition.
package approval A license or certificate of compliance issued by the NRC for f-packaging of Type B, highway route controlled quantity, and fissile radioactive material under 10 CFR Part 71 user Each person or organization authorized by a specific license issued by the NRC to receive, possess, use, or transfer licensed materials to a carrier for transport or transports such material outside the confines of his plant or other place of use.
should A recommendation shall A requirement that must be complied with as part of the Quality Assurance program 10 CFR 71 Subpart H A subpart that describes-Quality Assurance requirements applying to the design, purchase, fabrication, handling, shipping, storing, cleaning, assembly, inspection, i
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TITLE: Quality Assurance Program for the Engineering, Design, Procurement, j
Fabrication and Initital Testing of Radwaste Shipping Packages testing, operation, maintenance, repair and modification of components of packaging which are important to safety.
will An indication of an intention to carry out a particular action even though that action is not a
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requirement of the Quality Assurance Program.
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O Date 5-16-86 TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabrication and-Initital Testing of Radwaste Shipping Packages WASTE TECHNOLOGY SERVICES DIVISION ORGANIZATION AND BASIC HEADOUARTERS OA PROGRAM RESPONSIBILITY CHART i
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TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabrication and Initital Testing of Radwaste Shipping Packages
~SECTION 2 - QUALITY ASSURANCE PROCRAM 2.1 Procram Obiectives 2.1.1 The quality objective of this Quality Assurance Program is to i
ensure that package approval applications and amendments thereto, for WTSD packages used for the sh*pment of l
radioactive materials, are prepared in acwordance with 10 CFR Part 71.31 and that fabricated packages conform to the terms and conditions set forth in each package approval.
1 2.2 Scope and Anolicability
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'2.2.1 This Quality Assurance Program satisfies the requirements of Subpart H of 10 CFR 71, as applied to the engineering, design, procurement, fabrication, and initial testing of WTSD packages.
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2.2.2 The structures, including appurtenances, components, parts, and design characteristics, controlled by this Quality Assurance Program are those described in the NRC package 7s approval, package approval application, and accompanying safety evaluation.
2.2.3 Activities that shall be controlled by this Quality Assurance Program include the following:
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i (a) Activities specifically required to be performed as a condition of the package approval (e.g., certain inspections, tests);
i (b) Activities that if performed improperly could cause the package to be designed, engineered or fabricated under i
conditions not in compliance with 10 CFR 71 or the package approval; (c) Activities in addition to those covered under (a) above that
.are determined nece,ssary by the Manager, Product Assurance, and/or other qualified WTSD personnel to verify that the package complies with the conditions of the package approval.
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TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabrication and Initital Testing of Radwaste Siiipping Packages 2.2.4 Not included within the scope of this Quality Assurance 4
Program established to implement the specific requirements of 10 CFR 71, Subpart H, are activities relating to the design, engineering, and procurement of motor carrier vehicles, parts, and components. regulated in accordance with 49 CFR dealing i
with transportation of hazardous materials, including tie-down systems, unless specifically referenced within 10 CFR 71 as a condition of the package approval or within the package approval.
2.2.5 The exclusions described in Article 2.2.4 notwithstanding, it is recognized by WTSD that the application of Quality Assurance principles and practices whenever practicable to the control of such activities is good policy. To the extent that WTSD is involved in such activities, this will be the case.
It is emphasized, however, that the provisions of this Quality Assurance Program affecting radwaste disposal activities are directed towards satisfying the specific requirements of 10 CFR 71, Subpart H, to insure that WTSD packages conform to the NRC approved design and specifica' cions for each individual package.
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2.2.6 Activities controlled by this Quality Assurance Program are accomplished under suitably controlled conditions such as the use-of appropriate equipment, suitable environmental conditions; adequate cleanliness. etc.
Special controls will be provided for processes, test equipment, tools and skills to attain the required quality.
2.2.7 The Manager, Product Assurance, shall be responsible for determining the specific activities to be controlled in accordance with the requirements of this Quality Assurance Program and informing individuals and groups responsible for those activities. The following considerations will form the bases for establishing the requirements and procedures for the Quality Assurance Program:
(a) The impact of malfqne, ion or failure of the item to safety; (b) The design and fabin ation complexity or uniqueness of the item; (c) The need for special controls and surveillance over processes and equipment; OG Page 2 of 9
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. TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabrication and Initital Testing of Radwaste Shipping Packages (d) The degree to which functional compliance can be demonstrated by inspection or test; and (e) The quality history and degree of standardization of the item.
2.2.8 WTSD personnel performing activities within the scope of this Quality Assurance Program shall adhere to the requirements of 1
the program.
2.3 Policy 2.3.1 This Quality Assurance Program has been developed by WTSD and
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establishes the policies and practices for Quality Assurance a
related to the engineering, design, procurement, fabrication, 2
and initial testing of WTSD packages.
These policies and
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practices are set forth in written procedures and instructions J
and shall be carried out in accordance with those procedures and instructions throughout the period of engineering, design, I
procurement, fabrication, and initial testing for these packages.
/N 2.3.2 k-The issuance and control of this Quality Assurance Program description shall be the responsibility of the WTSD Manager, s
Product Assurance. Additions, deletions, or modifications to this document shall require the approval of the General Manager before such change's may be incorporated.
2.3.3 Disagreements or differences of opinion on Quality Assurance matters which originate with or are brought to the attention j
of the Manager, Product Assurance,- are expected to be resolved jointly by him and the affected group or individual.
Where such resolution is not achieved within a reasonable-period of time, unresolved differences shall be referred to the-General Manager.
l 2.3.4 All WTSD QA/QC personnel are responsible for being fully l
j knowledgeable of all policies and practices described in this Quality Assurance Program description.
1 2.3.5 All WTSD personnel responsible'for and/or performing i
activities covered under this Quality Assurance Program are.
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responsible for knowing and implementing the portions of this l
program description pertinent to their respective
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responsibilities.
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Rev.
O Date 5-16-86 TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabrication and Initital Testing of Radwaste Shipping Packages 2.3.6 Conformance to the policies and practices described herein shall be required as of the date of approval and issue shown on the title page.
2.4 Procram Descriotion 2.4.1 This. Quality Assurance Program consists of (1) a formal, documented system of administrative controls over activities affecting quality, and (2) quality verification through independent review, surveillance, and audit of those activities.
2.4.2 The Quality Assurance Program requires the preparation of appropriate documents, including procedures, drawings, and specifications, which prescribe the measures which have been l
established to control activities affecting quality.
Compliance with this requirement is the responsibility of each and every organization or group with responsibility for activities controlled under this program. The measures which are established to control work must be detailed to the extent necessary to ensure that adequate controls have been q
incorporated.
2.4.3 Quality is verified and assured through a system of planned reviews, surveillances, and audits of quality affecting activities by the Product Assurance Department which is independent of other organizations responsible for performing such activities.
2.4.4 The Quality Assurance Program provides for control over activities affecting the quality of identified materials and components to an extent consistent with their importance to safety and as necessary to assure conformance to their design.
2.5 Resoonsibilities 2.5.1 WTSD's organization is described in Section 1.0.
l 2.5.2 UTSD has overall responsibility for this Quality Assurance Program.
Primary responsibility for establishing and implementing an integrated system of administrative controls over quality affecting activities rests with the Manager, Product Assurance, the Manager, Engineering, the Manager, Nuclear Waste Projects, and the Purchasing Manager.
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addition, WTSD may delegate the work of establishing, O
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/~')N TITLE: Quality Assurance Program for the Engineering, Design, Procurement,
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Fabrication and Initital Testing of Radwaste Shipping Packages executing, and implementing administrative controls over quality affecting activities to suppliers, especially fabrication and testing activities, but shall retain responsibility therefore.
These controls shall include provisions for quality verification appropriate to the activities being performed.
The Product Assurance Department is primarily responsible for quality assurance reviews, surveillances, and audits, including audits and surveillances of WTSD suppliers, when appropriate.
2.6 Program Documentation 2.6.1 Quality Assurance Program policies and practices are contained in various WTSD procedures that comprise the Procedures Manual. A list of procedures that describe and implement this Quality Assurance Program is included in Table 2-1.
This list includes a cross-reference of these procedures to the requirements of 10 CFR 71, Subpart H.
2.6.2 The Manager, Product Assurance, has the authority to review and comment on all documents, including manuals, procedures, instructions, drawings, specifications, analyses,
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computations, and procurement documents that p,rescribe requirements for and controls over quality affecting activi?.ies related to the engineering, design, procurement, fabrication and initial testing of WTSD packages.
2.7 Personnel 2.7.1 It shall be the responsibility of the Manager, Product Assurance, to insure that WTSD personnel responsible for performing quality related activities are instructed as to the purpose, scope, and implementation of this Quality Assurance Program and implementing procedures.
2.7.2 The Manager, Product Assurance, or his designee shall periodically hold indoctrination and training meetings for new or newly reassigned WTSD personnel performing activities related to the engineering, design, procurement, fabrication or testing of packages.
Such personnel will usually be members of the Product Assurance, Engineering, Nuclear Waste Projects, and Purchasing Departments.
The frequency of these meetings shall be at the discretion of the Manager, Product Assurance, but shall not be less than once every twelve (12) months. The scope of these meetings should include the following:
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Fabrication and Initital Testing of Radwaste Shipping Packages (a) Review of sources of Quality Assurance requirements.
(b) Review of WTSD Quality Assurance program descriptions and associated manuals.
(c) Review of WTSD policies and operating procedures, e.g.,
procurement document control, engineering design control, highlighting as appropriate to the responsibilities of those personnel being trained.
The indoctrination and training meetings may be held with or by the appropriate departmental managers.
The written records of such meetings shall be forwarded to the Product Assurance and Human Resources Managers for their records.
2.7.3 The Manager, Product Assurance, or his designee shall periodically hold training meetings for WTSD personnel performing activities related to the engineering, design, procurement, fabrication, and initial testing of WTSD packages. The frequency of these meetings shall be at the ps discretion of the Manager, Product Assurance, but shall not be
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less frequent than once every 12 months.
The scope of these
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meetings should include the following:
(a) Review of audit results including any significant deficiencies or nonconformances.
(b) Review of significant changes to the following documents:
(1) Package certificates of compliance.
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(2) Quality Assurance Program policies and practices contained in procedures listed in Table 2-1.
(3) Rules and regulations related to package design.
The Product Assurance and Human Resources Managers shall maintain written records of all training meetings including the date held, subjects discussed, and attendance.
2.7.4 It shall be the responsibility of individual WTSD departmental managers to ensure that WTSD personnel responsible for performing quality related activities in each department are knowledgeable in the principles c:.d techniques of the activity being performed.
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TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabrication and Initital Testing of Radwaste Shipping Packages 4
2.7.5 The Manager, Product Assurance, shall be responsible for the selection and assignment of qualified auditors. The Manager, Product Assurance, whose minimum qualification requirements 3.
i are described in Section 1.4, shall establish the audit
-personnel qualifications apprcpriate to the nature and scope of the work to be performed and the importance of the activities being audited.
Personnel shall be selected for Quality Assurance auditing assignments based on experience or training which establishes that their qualifications are i
commensurate with the complexity or special nature of the 9
activities to be audited.
i 2.7.6 The supplementary and nonmandatory guidance on the qualification, education, and experience of audit personnel set forth in Supplement 2S-3 and Appendix 2A-3 respectively of ANSI /ASME NQA 1983, " Quality Assurance Program Requirements for Nuclear Power Plants", will be followed. The Manager, Product Assurance, will maintain auditor qualification records as recommended in ANSI /ASME NQA 1983.
4 2.7.7 The Manager, Product Assurance, shall also establish, O.
requirements for the qualification, maintenance, and i
certification of inspection and test personnel. Personnel shall be selected for inspection and test assignments based upon experience or training which establishes that their qualifications are commensurate with the complexity or special 1,
nature of the activities to be performed.
i 2.7.8 The Manager, Product Assurance, will maintain the qualification records of personnel performing inspection and test activities.
2.8 Management Reviews 2.8.1 The Manager, Product Assurance, shall review the status and adequacy of the Quality Assurance Program annually and report the results of that review to the General Managor.
2.8.2 The General Manager may require the Manager, Product i
Assurance, and other departmental managers to make formal recommendations with regard to the adequacy of Quality Assurance Program policies and practices and WTSD compliance with those policies and practices.
These' recommendations shall become part of the formal record of review of program effectiveness which shall be maintained by the Manager, Product Assurance.
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TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabrication and Initital Testing of Radwaste Shipping Packages 2.8.3 The purpose of the management review is to assess the scope, implementation, and effectiveness of the Quality Assurance Program to assure that the program is adequate and complies with the applicable requirements of 10 CFR 71, Subpart H.
2.9 WTSD Cenerated Certifications 2.9.1 Primary responsibility for the preparation and sign-off of certificates of conformance and/or compliance, issued by WTSD shall rest with the Manager, Product Assurance.
In his absence, the General Manager may assume this responsibility.
2.9.2 Other delegation of this responsibility may be made in writing by the Manager, Product Assurance.
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TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabrication and Initital Testing of Radwaste Shipping Packages
.lt TABLE 2-1 i
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E Matrix of Procedures that Implement All 3
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or Portions of 10 CFR 71, Subpart H
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Requirements for Quality Assurance g ! { ! {
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SUBPART H REQUIREMENTS g%
71.101 Quality Assurance Requirements l
l 71.103 Crganization e
71.105 Quality Assurance Program 71.107 Design Control e
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e 71.109 Procurement Document Control 71.111 Instructions, Procedures
+
and Drawings 71.113 Document Control 71.115 Control of Purchased Material, e
e Equipment & Services 71.117 Identification & Control of Materials, Parts &
Components 71.119 Control of Special Processes j
+
j 71.121 Inspection 71.123 Test Control
+
71.125 Control of Measuring and
'f Test Equipment 71.127 Handling, Storage & Shipping
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71.129 Inspection, Test & operating Status 71.131 Nonconforming Materials, e
Parts & Components I,
,71. 133 Corrective Action 71.135 Quality Assurance Records g,.,.
e g gj 71.137 Audits
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TITLE:. Quality Assurance Program for the Engineering, Design, Procurement, Fabrication and Initital Testing of Radwaste Shipping Packages SECTION 3 - DESIGN CONTROL 3.1 Scope 3.1.1 The requirements of this section shall apply to WTSD and, when appropriate, supplier activities relating to the design and fabrication of new WTSD packages.
3.1.2 This section establishes measures to insure that proposed designs of WTSD package structures, components and/or parts, and design changes thereto, are prepared and reviewed by qualified individuals, including Quality Assurance personnel, prior to fabrication or implementation to insure that-the proposed design meets the requirements of 10 CFR 71.
}
3.1.3 This section also establishes measures to insure that proposed applications for or amendments to the package approval are prepared, reviewed, and approved in accordance with the l
applicable requirements of Subpart H of 10 CFR 71.
r 3.2 Policy
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3.2.1 Design activities shall be controlled in accordance with documented procedures to ensure that applicable regulatory requirements and design bases are correctly translated into specifications, drawings, and, when appropriate, written procedures and instructions.
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3.2.2 Quality standards shall be specified in design documents and deviations and changes from these quality standards shall be l
controlled.
3.2.3 Design activities shall ensure the selection and review for suitability of application of materials, parts, equipment, and processes that are essential to the safety-related functions of the materials, parts, and components of the packaging.
3.2.4 Design verification and checking processes, such as design reviews, alternative calculations, or qualification testing shall be selected and accomplished as described in written procedures.
3.2.5 Verification of design shall be clearly documented, identifying the verification method used and the verifier.
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Fabrication and Initital Testing of Radwaste Shipping Packages 3.2.6 Verification of design shall be performed by individuals or groups other than those who performed the original design.
3.2.7 The Package Projects Manager shall be responsible for the overall identification and control of design interfaces for coordination among participating design organizations, and the establishment of written procedures among participating design organizations for the review, approval, release, distribution, and revision of documents involving design interfaces.
3.2.8 Design changes shall be reviewed and approved by the same individuals or organizations that performed the original design, review, and approval.
3.2.9 Design reviews, approvals, and releases, as well as the issuance of, distribution of, and revisions to drawings and specifications shall be performed as described in written procedures.
3.2.10 When a test program is used to verify the adequacy of a design, a qualification test of a prototype unit under design conditions should be used.
3.3 Resoonsibilities and Recuirements 3.3.1 A Project Control Release (PCR) (See Figure 1-2) form shall be used in accordance with the applicable procedures to initiate, document, and control the processing of all package designs, the subsequent preparation and changes to all design documents.
Changes to all approved design drawings will made via an Engineering Change Notice (ECN) (See Figure 3-1) issued i
by the Manager, Engineering Design, or his designee.
3.3.2 Design activities shall be documented in sufficient detail to permit adequate independent evaluation and checking.
3.3.3 Design control measures shall apply to: criticality physics, radiation shielding, stress, thermal, hydraulic, and accident analysis; compatibility of materials; accessibility for in-service inspection, maintenance and repair; features to facilitate decontamination; and delineation of acceptance criteria for inspection tests.
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TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabrication and Initital Testing of Radwaste Shipping Packages 3.3.4 Design verification activities shall be performed by individuals or groups other than those responsible for the original design and shall include ~one or more of the following, in accordance with Engineering Department procedures, taking into consideration the complexity of the design, the degree of standardization, the state of the art, the similarity of previously proven designs, and the importance of the design activity to safety:
(a) Checking and, when appropriate, alternate calculations by independent personnel; (b) Design reviews accomplished by design review team, chaired by the Manager, Engineering, or his designee.
(c) Qualification testing.
3.3.5 When applicable, the following shall be reviewed during design verification activities:
(a) That applicable regulatory requirements and design basis have been correctly incorporated into the design;
(
(b) That quality standards are specified; (c) That design characteristics can be controlled, inspected, and tested; (d) That inspection and test criteria are identified.
3.3.6 The Manager, Design Engineering, or his designee, shall review drawings, specifications, technical procedures, and safety analysis reports to verify that design criteria have been correctly and completely incorporated.
3.3.7 The Manager, Product Assurance, or his designee, shall review drawings, specifications, and technical procedures to verify that quality standards are specified.
3.3.8 Design and design document changes shall be controlled in I
accordance with Engineering Department procedures so as to insure the same design controls and approvals that were applicable to the original.
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Rev. O Date 5-16-86 TITLE: Quality Assurance Program for the Engineering, Design, Procurement,
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Fabrication and Initital Testing of Radwaste Shipping Packages 3.3.9 When applicable, suppliers furnishing WTSD packages or WTSD-purchased items or services for new packages shall be required in procurement documents to establish design control procedures appropriate to the activity being performed.
3.3.10 The Manager, Design Engineering, shall be responsible for specifying supplier design control requirements in procurement documents.
3.3.11 The Manager, Product Assurance, or his designee, shall review the adequacy of supplier design control requirements specified in procurement documents.
3.3.12 Engineering documents that include technical information related to the design and changes thereto, shall be maintained as a quality record in accordance with the requirements described in Section 17 of this procedure.
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.Date 5-16-86 TITLE: Quality Assurance Program for.the Engineering, Design, Procurement, Fabrication and Initital Testing of Radwaste Shipping Packages i
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O Date 5-16-86
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TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabrication and Initital Testing of Radwaste Shipping Packages SECTION 4 - PROCUREMENT DOCUMENT CONTROL 4.1 Scone and Applicability 4.1.1 This section delineates the sequence of actions to be accomplished in the preparation, review, approval and control of procurement documents used for the purchase of WTSD packages.
4.1.2 The requirements of this section also apply to the purchase by WTSD of items and services to be used for the design, fabrication, or testing of WTSD packages.
Purchased items may include steel plate or studs or nuts.
Services may include, for example, certain nondestructive examinations or painting.
In general, however, packages will be purchased as a unit.
' 4. 2 Procedure 4.2.1 Items and services shall be purchased in accordance with the requirements of this section and the applicable requirements of WTSD procurement procedures.
O) 4.2.2 The requisitioner shall be responsible for reviewing the q_
requirements of the package approval, including drawings and specifications, and identifying the specific requirements for the item and service to be procured.
4.2.3 The requisitioner shall be responsible for incorporating and/or referencing the following in a purchase requisiton:
(a) a statement of work to be performed by the supplier; (b) technical requirements including applicable regulatory requirements, material and component identification requirements, drawings, specifications, codes and industrial standards, test and inspection requirements, and special process instruction; (c) Applicable Quality Assurance requirements, e.g., the requirements of 10 CFR 71, Subpart H, appropriate to the items or services being procured; (d) the documentation (e.g., drawings, specification, procedures, inspection and fabrication plans, inspection and test records, personnel and procedure qualifications, material certifications, etc.) to be available for review or submitted to WTSD for information, review or approval; Page 1
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(e) a statement of WTSD's requirements for access to the supplier's facilities and records for source inspection and audit.
(f)
Instructions, when appropriate, for extending applicable requirements to lower tier subcontractors (may be included as part of 4.2.3(c).
4.2.4 The Manager, Product Assurance, or his designee shall review.
and approve purchase requisitions for items and services subject to the requirements of this Quality Assurance Program and add any quality requirements necessary to assure that the 3
iteas or services being procured meet quality program requirements.
4.2.5 For the purchase of items to be used in the fabrication of i
WTSD packages, the following procedures may be used:
(a) When the item's conformance to technical requirements can t
be verified upon receipt by inspection, test or other suitable means, the requirements of 4.2.3(c), (d), (e),
and (f) may be waived by the Manager, Product Assurance, i
or his designee, after reviewing the procedures to be used for such verification activities.
(b) When a Certificate of Conformance is used to accept an item or service the requirements of 4.2.3(c), (d), (e) and (f) may be waived by the Manager, Product Assurance, or his designee, after verifying and documenting that the supplier's certification system is acceptable. The
_ purchase requisition shall include the requirement that a i
Certificate of Conformance be submitted by the supplier.
1 j
4.2.6 The Manager, Engineering or his designee shall approve i
purchase requisitions for packages, items,-and services.
subject to the requirements of this Quality Assurance Program.
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4.2.7 Purchase requisitions, including attachments and purchase j
orders, requiring Quality Assurance approval are quality records and shall be controlled in accordance with the 1
requirements of Section 17 of this procedure.
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TITLE: Quality Assurance Program for the Engineering, Design, Procurement, (V
Fabrication and Initital Testing of Radwaste Shipping Packages SECTION 5 - INSTRUCTIONS, PROCEDURES, AND DRAtJINGS 5.1 Applicability 5.1.1 The requirements of this section apply to the activities of suppliers of IJTSD packages and, as appropriate, suppliers of WTSD purchased items and services for the fabrication and testing of new WTSD packages.
5.1.2 The requirements of this section also apply to WTSD activities for the engineering, design, procurement, fabrication, and initial testing of WTSD packages.
5.2 Policy 5.2.1 Activities subject to the requirements of this Quality Assurance Program shall be prescribed by documented instructions, procedures, or drawings of a type appropriate to the circumstances and accomplished in accordance with such documents.
5.2.2 These documents shall include, when necessary to ensure (g~j quality, appropriate quantitative and/or qualitative criteria for determining whether or not an activity has been satisfactorily accomplished.
5.2.3 Provisions shall be established to clearly delineate the sequence of actions to be accomplished in the preparation, review, and approval of these documents.
5.2.4 The appropriate Quality Assurance organization (WTSD or supplier / contractor) shall review and concur with inspection plans; test, calibration, and special process procedures; drawings and specifications; and changes thereto or acceptable alternatives thereto.
5.3 Reautrements and Responsibilities 5.3.1 A contractor or supplier responsible for activities subject to the requirements of this Quality Assurance Program shall be required in procurement documents to provide the instructions, procedures and drawings appropriate to the activity being n
Page 1 of 2
4 Rev. O Date 5-16-86 TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabrication and Initital Testing of Radwaste Shipping Packages accomplished. WTSD may require the submittal of such documents for review and acceptance prior to undertaking the activity.
Such a requirement will be identified in procurement documents.
5.3.2 The responsibility for specifying in procurement documents requirements for supplier or contractor instructions, procedures, and drawings shall rest with the requisitioner.
5.3.3 The Manager, Product Assurance, or his designee, shall be responsible for reviewing the adequacy of requirements for suppliers or contractor instructions, procedures, and drawings specified in procurement documents.
5.3.4 The requirements of Section 5.2.4 notwithstanding, supplier documents, including inspection plans, test and special j
process procedures, and drawings and specifications, submitted when required by WTSD procurement documents, shall only i
require approval of the Manager, Design Engineering or his designee.
UTSD individuals or groups responsible for performing 5.3.5
}
quality-related activities shall insure that written and approved instructions, procedures, and drawings appropriate to the circumstance are available prior to undertaking the j
activity.
4 l
5.3.6 The Manager, Product Assurance, or his designee, shall verify by audit that activities controlled by this Quality Assurance Program are prescribed by documented instructions, procedures, and drawings, as required by this section.
5.3.7 WTSD instructions, procedures, and drawings prescribing i
~
Assurance Program shall be reviewed and approved in accordance activities subject to the requirements of this Quality with requirements described in Section 6 of this procedure.
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SECTION 6 - DOCUMENT CONTROL j
6.1 Aeolicability
)
6.1.1 The requirements of this.section apply to suppliers of WTSD packages and, as appropriate, suppliers of WTSD-purchased 2
l items and services for the fabrication and-testing of new WTSD packages.
6.1.2 The requirements of this section also apply to WTSD documents
}
which prescribe activities subject to the requirements of this Quality Assurance Program.
+
6.2 Poliev 6.2.1 The review, approval, and issuance of documents, including changes thereto, which prescribe activities subject to the j
requirements of this Quality Assurance Program, including instructions, procedures, drawings, and specifications, shall be controlled in accordance with written procedures or
'f instructions.
6.2.2 Individuals or organizations responsible-for the pre'paration, review, approval, and issuance of documents shall be identified in document control procedures or instructions.
4
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6.2.3 Changes to documents subject to the requirements of this section shall be reviewed and approved by the same organizations that performed the original review and i
approval. At WTSD, this requirement may be waived in writing by the Manager, Product Assurance. The' written waiver'shall l
be maintained as part of the record of document revision.
i 6.2.4 Current issues of applicable documents subject to the requirements of this section will be available for use at the j
_ location where the prescribed activities are performed.
I 6.3 Recuirements and Resnonsibilities 6.3.1 A supplier responsible for activities subject to the I
requirements of this~ Quality Assurance Program shall be l
required in procurement documents to establish document j
control procedures appropriate to the activity being j
accomplished.
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O Date 5-16-86 TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabrication and Initital Testing of Radwaste Shipping Packages 6.3.2 The Manager, Product Assurance, shall be responsible for reviewing the adequacy of document control requirement specifications in procurement documents.
6.3.3. Quality-related documents and forms, including instructions, procedures, drawings and specifications, shall be controlled by written procedures to insure that such documents have been properly prepared and that appropriate revisions shall be available to personnel at the location where the work is to be performed.
These procedures, along with many of the documents and forms controlled by them, are incorporated into the WTSD Policies and Procedures Manual (DP&Ps) and the WTSD Product Assurance Manual (QAPs), as summarized in Table 2-2, Matrix of Procedures, Section 2.
Controlled lists (tables of contents, etc.) or master lists 6.3.4 shall be accessible to all personnel to verify the latest approved revision of the document. Where such lists are not appropriate, other written notice should be provided to document users to indicate the implementation date of a document revision, specific disposal or isolation n
requirements, or other appropriate instructions.
b 6.3.5 For documents on controlled distribution, instructions for the disposal of superseded documents shall be identified on the document transmittal / receipt acknowledgment form.
6.3.6 The Manager, Product Assurance, shall be responsible for the issuance and control of the manuals discussed below.
6.4 UTSD Ouality Assurance Program for Radwaste Shionine Packages 6.4.1 This WTSD Quality Assurance Program for Radwaste Shipping Packages is intended to ensure that WTSD personnel have ready access to a description of the Quality Assurance policies, procedures and practices related to the design, procurement, fabrication, and testing of WTSD packages. This manual references the implementing procedures in the two manuals described below as summarized in Table 2-2, Section 2.
6.5 WTSD Policies and Procedures Manual 6.5.l' The WTSD Policies and Procedures Manual contains a variety of technical and administrative procedures governing the operation of WTSD.
A number of these procedures describe O
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TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabrication and Initital Testing of Radwaste Shipping Packages measures for control over activities subject to the requirements of this Quality Assurance Program, including activities related to document control.
6.5.2 The Manager, Product Assurance has the resposibility to review and modify any procedures that include measures for the control of quality-related activities subject to the requirements of this Quality Assurance Program.
6.6 WTSD Product Assurance Manual l
6.6.1 The WTSD Product Assurance Manual is designed to moet the l
basic quality assurance systems and program requirements of those such as defined in 10CFR50, Appendix B; 10CFR71, Subpart H; 10CFR60, Subpart G; and ANSI /ASME NQA-1.
1 J
6.6.2 All of the procedures (QAPs) in the WTSD Product Assurance l
Manual are referenced as implementing procedures called out in
]
Table 2-2, Section 2, of this document, the WTSD " Quality Assurance Program for Radwaste Shipping Packages".
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Rev. O Date 5-16-86 OQ TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabrication and Initital Testing of Radwaste Shipping Packages SECTION 7 - CONTROL OF PURCHASED MATERIAL, EQUIPMENT, AND SERVICES 7.1 Scope 7.1.1 This section describes the measures that have been established to ensure that WTSD packages as well as items and components purchased for new WTSD packages conform to the procurement documents prepared in accordance with the requirements of Section 4.0.
7.1.2 The measures described in this section shall also apply to the acceptance of services, such as third party inspection, and engineering and consulting services, to the extent that such services involve activities subject to the requirements of this Quality Assurance Program.
7.2 Reauirements 7.2.1 The Manager, Product Assurance, or his designee, shall be responsible for evaluating on a case by-case basis, the need for supplementary measures to control purchased items and services, including evaluation and selection of procurement
)
sources prior to award of contract, evaluation and verification of suppliers' performance, including source surveillance and inspection, and testing after receipt.
These measures may be required when the quality of the item cannot be adequately verified through documentary evidence or inspections upon receipt (e.g., package procurement).
7.2.2 The supplementary requirements and nonmandatory guidance for control of purchased items and services set forth in Supplement 7S-1 and Appendix 7A-1 respectively of ANSI /ASME NQA 1983, " Quality Assurance Program Requirements for Nuclear Power Plants", will be followed.
7.2.3 The Manager, Product Assurance, or his designee, shall perform the evaluation described in Section 7.2.1 prior to approving quality related purchase requisitions for further processing.
7.2.4 Supplementary measures to control package components and material may ot be necessary if conformance to procurement requirements can be determined by receiving inspection and a supplier's Certificate of Conformance that specified requirements have been met.
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TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabrication and Initital Testing of Radwaste Shipping Packages 7.2.5 Verification of item or service conformance to procurement requirements solely by receiving inspection will only be considered when the items or services:
(a) are relatively simple or standard in design, manufacture, and test; (b) are adaptable to standard and easily verifiable inspections and/or tests of the end product to verify quality characteristics after delivery; and (c) are such that receiving inspection does not require operations which could affect the integrity, function, or cleanliness of the item.
7.2.6 Verification of item or service conformance to procurement requirements by a combination of receiving inspection and a supplier's Certificate of Conformance shall be satisfactory when the item or service is of simple design and involves standard materials, processes, and tests. However, specific supplemental documentation such as material certificates or f-~
test reports shall be required as appropriate by procurement
(_,)/
documents. The Manager, Product Assurance, or his designee, shall be responsible for specifying requirements for supplier Certificates of Conformance and supplementary documentation in purchase requisitions.
7.2.7 When a supplier's Certificate of Conformance is required by the purchase requisition:
(a) The requirements set forth in Section 8.2.1(a) through 8.2.1(e) of Supplement 7S-1 of ANSI /ASME NQA 1983 shall be communicated in writing to the supplier; or (b) A Certificate of Conformance form, requesting the applicable information set forth in (a), above will be supplied by WTSD.
7.2.8 Certificate of Conformance attesting to the acceptance of items or services shall be available prior to acceptance of the item or equipment.
7.2.9 The Manager, Product Assurance, or his designee, shall be responsible for verifying the validity of supplier Certificates of Conformance and evaluating the effectiveness of the supplier's certification system.
Such verifications v
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TITLE: Quality Assurance Program for the Engineering, Design, Procurement,
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Fabrication and Initital Testing of Radwaste Shipping Packages shall be conducted (e.g., during performance of audits of the supplier) at intervals commensurate with the supplier's past quality performance and the importance and complexity of the purchased items.
7.2.10 The Manager, Product Assurance, or his designee, shall be responsible for evaluating the scope and implementation of supplier quality assurance programs. Such evaluations shall be conducted at intervals commensurate with the supplier's past performance and the importance and complexity of the purchased items.
7.2.11 Evaluation and verification activities and results shall be documented, e.g., by written memoranda, and shall be maintained for the life of the package to which it applies in a file for the supplier.
7.2.12 The Manager, Product Assurance, or his designee, shall maintain a list of suppliers whose certification systems and/or quality assurance programs have been evaluated and determined to be effective.
This list will be reviewed at least annually by the Manager, Product Assurance, or his designee, and determinations made regarding the need to reevaluate each supplier or remove any supplier from the 2
l list.
Items may be purchased from suppliers on this list i
without reevaluation of their certification system or quality assurance program.
7.2.13 Receiving inspections shall be the responsibility of the Product Assurance Department.
7.2.14 Receiving inspections shall be coordinated with the review of supplier documentation when procurement documents require such documentation to be furnished.
7.2.15 Surveillance, if required, of suppliers during the fabrication, inspection, testing, and shipping of WTSD packages shall be performed in accordance with written inspection checklists. The Manager, Product Assurance, or his designee, shall be responsible for having written checklists prepared, for reviewing and approving those checklists, and for having those checklists available at the inspection location.
7.2.16 Surveillance, if required, of suppliers of package components or material may require written checklists when determined by the Manager, Product Assurance, or his desigm e, that special
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checklists are necessary to ensure the quality of inspection Page 3 of 4
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TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabrication and Initital Testing of Radwaste Shipping Packages
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activities. The need for written checklists will be determined as part of the Manager, Product Assurance's, or his designee's, review of purchase requisitions and prepared and controlled as described in Section 7.2.15.
7.2.17 Many package components or materials (e.g., steel plate) can be adequately receipt inspected by Product Assurance Department personnel without formal written inspection checklists.
The need for written checklists will be determined as part of the Manager, Product Assurance's, or his designee's, review of purchase requisitions and will be prepared and controlled as described in Section 7.2.15.
7.2.18 In certain cases involving procurement of services only, service may be accepted by any or all of the following methods:
(a) technical verification of the work performed and results; (b) surveillance and/or audit of the activity; (c) review of objective evidence for conformance to the (N) procurement document requirements.
7.2.19 Procurement documents shall include statements requiring suppliers to notify WTSD of any deviations from the requirements of the procurement documents that the supplier intends to incorporate in the item or service to be offered for acceptance by WTSD.
The documentation and disposition of such deviations shall be through the use of the VR form (See Figure 16-2) and shall be controlled in accordance with the requirements of Section 15 of this procedure.
7.2.20 Documentary evidence that material and equipment conform to the procurement specifications shall be available prior to installation or use of the material and equipment.
7.2.21 The Product Assurance Department shall assess the effectiveness of the quality assurance programs of its suppliers regularly through its pre-award supplier quality surveys (See Section 4), supplier source inspections (see Section 10) and quality program audits of the supplier activities (See Section 18).
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TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabrication and Initital Testing of Radwaste Shipping Packages SECTION 8 - IDENTIFICATION AND CONTROL OF MATERIALS, PARTS, AND COMPONENTS 8.1 Applicability 8.1.1 The requirements of this section apply to the identification and control by WTSD and its suppliers of WTSD purchased packages and components and materials, if required, for new packages.
8.2 Poliev 8.2.1 The identification of purchased materials, parts, and components shall be traceable to appropriate documentation such as drawings, specifications, purchase requisitions / orders, and manufacturing and inspection documents that establish requirements for the item and document how those requirements were satisfied.
8.2.2 The identification of purchased materials, parts, and components shall be maintained either on the item or on records traceable to the item to preclude use of incorrect or
()
defective items.
v 8.2.3 When parts marking is used, it must be clear, unambiguous, indelible and it must not affect the fit, function or quality of the item.
8.2.4 The correct identification of materials, parts, and components shall be verified and documented prior to release for fabrication, assembling, and installation.
8.3 Recuirements and Responsibilities 8.3.1 Suppliers furnishing packages or safety-related components and materials for new packages shall be required in procurement documents to establish procedures for the identification and control of materials, parts, and components.
8.3.2 The responsibility for specifying requirements in procurement documents for the identification and control of material, parts, and components by the supplier shall rest with the requisitioner, usually the Engineering Manager or his designee and shall be reviewed and approved by the Manager, Product Assurance, or his designee.
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TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabrication and Initital Testing of Radwaste Shipping Packages SECTION 9 - CONTROL OF SPECIAL PROCESSES 9.1 Aeolicability 9.1.1 The requirements of this section apply to special processes performed by suppliers of WTSD packages and, as appropriate,
' suppliers of WTSD purchased items and services for the fabrication and testing of new packages.
i 9.2 Poliev
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9.2.1 Special processes, such as welding, heat treating, and nondestructive testing, shall be procedurally controlled.
9.2.2 Procedures, equipment, and personnel associated with these j
processes shall be qualified in accordance with applicable codes, standards and/or specifications.
9.2.3 Records of procedures, including qualification records of
'i procedures, equipment and personnel associated with special processes shall be established, filed, and kept current.
2 9.3 Recuirements and Resoonsibilities i
f 9.3.1 Suppliers furnishing WTSD packages or WTSD purchased j
components for new packages shall be required in procurement documents to establish procedures for the control of special 4
l processes.
9.3.2 The Manager, Design Engineering, or his designee, shall be responsible for identifying in procurement documents j
applicable codes and standards, as specified in the package certificate of Co:apliance, for the control of special processes as well as documentation to be submitted to WTSD for information, review or approval.
i 9.3.3 The Manager, Product Assurance shall be responsible for reviewing the adequacy of requirements for the control of special processes as specified in procurement documents.
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O Date 5-16-86 TITLE: Quality Assurance Program for the Engineering, Design, Procurement,
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Fabrication and Initital Testing of Radwaste Shipping Packages SECTION 10 - INSPECTION 10.1 Scone and Applicability 10.1.1 The requirements of this section apply to the inspection activities of suppliers of WTSD packages and, as appropriate, suppliers of WTSD purchased items and services for the fabrication and testing of new WTSD packages.
10.1.2 The requirements of this section shall also apply to WTSD inspection and surveillance or monitoring activities, including in-process and final inspection activities during the manufacture and/or at the completion of fabrication of packages or package components.
,10.2 Poliev 10.2.1 An inspection program which verifies conformance of quality-affecting activities with appropriate requirements shall be established, documented, and accomplished in accordance with written and controlled procedures.
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10.2.2 Personnel assigned to perform inspection activities shall be other than those who are performing or directly supervising the activity being verified.
These individuals shall not report to the immediate supervisors who are responsible for the activity being inspected.
10.2.3 Inspection personnel shall be qualified in accordance with applicable codes, standards, and company training programs, as appropriate. Qualifications and certifications shall be kept current.
10.2.4 Repairs, replacements, and modifications during fabrication shall be inspected in accordance with the original design and inspection requirements or acceptable alternatives.
10.2.5 Provisions shall be established that identify, as applicable, mandatory inspection hold points for witness by an inspector.
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TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabrication and Initital Testing of Radwaste Shipping Packages 10.3 Reauirements and Responsibilities 10.3.1 Suppliers furnishing WTSD packages and, when appropriate, WTSD purchased items and services for new packages, shall be required in procurement documents to establish an inspection program in accordance with the requirements of this section.
10.3.2 The Manager, Design Engineering, or his designee, shall assist in the identification of WTSD witness points for the performance of quality verification activities.
10.3.3 The Manager, Product Assurance, or his designee, shall be responsible for identifying in procurement documents, the adequacy of supplier inspection program requirements and for identifying WTSD witness points therein.
10.3.4 The Manager, Product Assurance, or his designee, shall also be responsible for identifying in procurement documents supplier inspection personnel training and qualification requirements, as applicable.
10.3.5 WTSD quality verification may include, as appropriate, y
measurements and inspections, surveillance or monitoring of processing methods, equipment, and personnel, and reviews of the records or performance of activities.
10.3.6 Responsibility for quality verification activities rests with the Manager, Product Assurance.
10.3.7 Based upon witness points specified in procurement documents, the Manager, Product Assurance, or his designee, shall determine the requirements for verification, the method (s) to be used, the schedule, the personnel to be assigned, and the need for supplemental verification activities.
10.3.8 Personnel assigned to perform quality verification activities shall be other than those who are performing or directly supervising the activity being verified. These individuals shall not report directly to the immediate supervisors who are responsible for the activity being inspected.
In general, individuals performing quality verification activities will be members of the Product Assurance Department.
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TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabric _alion.and Initital Testing of Radwaste Shinping Packages 10.3.9 Tn'e Manager, Product Assurance, or his' designee, shall, by Inspection Instruction and Data Sheets"(IIDS - See Figure 10-1) and Testing / Verification Procedures (TVPs - See Figure 10-2), assign responsibility for performance of specific quality verifications. The forms should include, to the exte.nt necessary, the following information:
(a) identification of characteristics and activities to be verified; (b) a description of the method of verification; (c) identification of, or qualification requirements for, the individual (s) responsible for performing the verification; (d) acceptance and rejection, criteria, as appropriate; (e) identification of required procedures, drawings, and specifications and revision; (f) description of necessary measuring and test equipment O
including accuracy requirements.
10.3.10 Individuals assigned quality verification duties shall document the results of the verification, including the identification of nonconformances on the forms or on specified data sheets, and return,to the Manager; Product Assuranca, or his designee.
10.3.11 The Manager, Product Assurance, or his designee, shall maintain a file of all quality verification documents as a record of implementation of the quitlity verffication program. A copy of the documents will also be filed in the Quality Assurance purchaso order file.
10.3.12 During final inspection activities, a review will be made of all previous quality verification documents to verify that all nonconformances have been satisfactorily corrected.
This review will be documented.
10.3.13 The Manager, Product Assurance, or his designee, shall ensure that individuals assigned quality verification duties are knowledgeable in the activities to be verified and clearly understand the requirements of the quality verification memo.
The Manager, Product Assurance, may satisfy this responsibility by discussing the planned
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veriC1 cation with the individual (s) to be assigned.
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Page 3 of 6 1
Figure 10-1(a)
Rev.
O Date 5-16-86 TITLE: Quality Assurance Program for the Engineering, Design, Procurement.,
Fabrication and Initital Testing of Radwaste Shipping Packages
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O Date 5-16-86 T
TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabrication and Initital Testing of Radwaste, Shipping Packages
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Figure 10-2 i
Rev.
O Date 5-16-86 TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabrication and Initital Testing of Radwaste Shipping Packages 4
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j TESTING / VERIFICATION PROCEDURE yyp go, p,.
waste Technolow Services Dms.on Effectwe Date West.nghouse Electre Corporation Supersedes:
P.O. Som 288, Meshion. Pennsylvenia 15883 No.
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Rev. O Date 5-16-86 TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabricatipn and Initital Testing of Radwaste Shipping Packages SECTION 11 - TEST CONTROL 11.1 Scope and Anolicability 11.1.1 Preoperational tests conducted during or upon completion of WTSD package fabrication shall be subject to the requirements of this section, 11.2 Recuirements 11.2.1 Testing required to demonstrate that items will perform satisfactorily in service shall be performed in accordance with written test procedures which incorporate the requirements and acceptance limits contained in applicable design an/ licensing documents.
11.2.2 Test procedures may be prepared by WTSD or by a supplier.
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Procurement documents will specify those procedures required to be submitted to WTSD for review, approval, or information.
r-11.2.3 Test procedures shall include provisions for assuring that
(,,g) all prerequisites for the given test have been met, that adequate test instrumentation and equipment is available and used, and that the test is monitored and is performed under suitable anvironmental conditions by competent personnel.
Test procedures shall also identify, based upon the accuracy desired, the need for the calibration and control of measuring and test equipment if normal commercial equipment does not provide adequate accuracy.
11.2.4 Test results shall be documented and evaluated to assure that test requirements have been satisfied.
11.2.5 The WTSD Engineering Department is respot.sible for preparation of test procedures and the review of test results (if acceptance criteria are not contained in test procedures or referenced documents and/or standards, e.g.,
drawings, codes), and supplier submitted procedures.
11.2.6 When modifications or repairs are made or replacements added to preoperational packages, testing will be performed in accordance with the original design and testing requirements, or acceptable alternatives.
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TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabrication and Initital Testing of Radwaste Shipping Packages SECTION 12 - CONTROL OF MEASURING AND TEST EOUIPMEMI I
12.1 Scope and ADolicability 12.1.1 The requirements of this section apply to the fabrication and initial testing of WTSD packages.
12.2 Poliev 12.2.1 Tools, gages, instruments, and other measuring and_ testing i
devices used in activities affecting quality shall be properly controlled and calibrated and adjusted to maintain accuracy within necessary limits.
12.2.2 Controlled measuring _and test equipment may be calibrated either at specified intervals or on a prior-to-use basis.
12.3 Resoonsibilities and Reauirements 12.3.1 Procurement documents shall include, as appropriate, requirements for the control of measuring and test equipment used in quality-related activities during the fabrication O
and testing of WTSD packages.
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12.3.2 The Manager, Product Assurance,- or his designee, shall be responsible for reviewing the adequacy of requirements, 1
specified in procurement documents, to control the accuracy-of measuring and test equipment.
12.3.3 Measuring and test equipment, controlled by this section, shall be identified and traceable to the appropriate calibration records.
12.3.4 The calibration status and the planned date of its next calibration shall be marked on the equipment.
12.3.5 The method and interval of calibration of controlled measuring and test equipment should be based on the. type of equipment, its stability characteristics, the required accuracy and'other conditions affecting measurement control.
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TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabrication and Initital Testing of Radwaste Shipping Packages 12.3.6 Controlled measuring and test equipment shall be calibrated, adjusted, and maintained against certified equipment having known valid relationships to nationally. recognized standards.
If no national standard exists, the basis for calibration shall be documented.
If normal commercial practices provide adequate accuracy, special calibration and control measures are not required.
r 12.3.7 When controlled measuring and test equipment, calibrated at specified intervals, are found to be out of calibration,' an 1
evaluation may be made and documented of the validity of 4
previous measurements or tests performed with that
{
equipment.
Such evaluations shall be required when the verification of the acceptability of items previously measured, inspected or tested with that equipment is i
required to. ensure that a WTSD package conforms to its approval requirements.
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12.3.8 Special calibrations shall be performed when accuracy of I
controlled measuring and test equipment is suspect.
Measuring and test equipment consistently found to be out of j
calibration will be repaired or replaced.
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TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabrication and Initital Testing of Radwaste Shipping Packages SECTION 13 - HANDLING. STORAGE AND SHIPPING 13.1 Applicability 13.1.1 The requirements of this section apply to the purchase of WTSD packages and purchased components and materials for the fabrication and testing of new WTSD packages.
13.2 Reauirements and Responsibilities 13.2.1 WTSD procurement documents shall include, as appropriate, requirements for handling, storage, shipping, cleaning, and preservation of WTSD packages during fabrication.
13.2.2 The Manager, Design Engineering, or his designee, shall be 4
responsible for specifying, in procurement documents, supplier handling, storage, and shipping requirements.
13.2.3 The Manager, Product Assurance, or his designee, shall be responsible for reviewing the adequacy of handling, storage and shipping requirements specified in procurement documents.
13.2.4 Prior to the first use of a newly fabricated WTSD package, a quality assurance review shall be performed to verify the following information:
(a) That supplier deviations have been properly processed and, where necessary, incorporated into the package approval; (b) That operating instructions and procedures have been prepared; (c) That the package has been inspected by supplier and/or WTSD personnel (see Section 10) to ascertain that there are no cracks, pinholes, uncontrolled voids, or other defects that could significantly reduce the effectiveness of the package; (d) That preoperational tests of packages, as specified in the package approval, have been performed; and (e) That the package is properly identified.
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TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabrication and Initital Testing of Radwaste Shipping Packages SECTION 14 - INSPECTION. TEST AND OPERATING STATUS 14.1 Aeolicability 14.1.1 The requirements of this section apply to the suppliers of WTSD packages and, as appropriate, WTSD purchased components and materials used for the fabrication and testing of WTSD packages.
14.2 Poliev
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14.2.1 The acceptability of package fabrications, components, and materials with regard to inspections and tests performed shall be known by affected organizations.
14.2.2 The application and removal of inspection and. welding stamps, when utilized, and status indicators such as tags, markings, labels, and stamps shall be procedurally controlled.
14.2.3 The bypassing of required inspections, tests, and other critical operations shall be procedurally controlled.
14.2.4 The status of nonconforming package fabrications, i
components, and materials shall be identified to prevent inadvertent use.
14.3 Reauirements and Resoonsibilities l
14.3.1 Suppliers furnishing packages or, as appropriate, WTSD i.
purchased components or materials, shall be required in procurement documents to establish procedures, including the i
use of markings such as stamps, tags, labels, routing cards or other suitable means, for the maintenance of the l
inspection, test, and status of these items in accordance with the requirements of this section.
14.3.2 The responsibility for specific supplier. inspection,_ test, and operating status requirements in procurement dccuments shall rest with the Manager, Product Assurance, or his i
designee.
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TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabrication and Initital Testing of Radwaste Shipping Packages m-SECTION 15 - NONCONFORMING MATERIAL. PARTS OR COMPONENTS 15.1 Scope and Apolicability 15.1.1 The requirements of this section apply to the suppliers of UTSD packages and, as appropriate, suppliers of WTSD purchased items and services for the fabrication and testing of new packages.
15.1.2 Nonconformances identified by WTSD personnel during quality verification activities shall be controlled in accordance with the requirements of Section 10.
15.1.3 Procedural or programmatic nonconformances and other conditions adverse to quality that are not directly related to package materials, parts, or components shall be controlled in accordance with the requirements of Section 16.
15.2 Policy 15.2.1 The identification, documentation, segregation, review, f-*)x disposition, and notification to affected organizations of
^
t nonconforming materials, parts, components, or services shall be procedurally controlled.
15.2.2 Nonconformance disposition documentation shall identify the nonconforming item and describe the nonconformance, the disposition of the nonconformance, inspection requirements,
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if appropriate, and shall include signature approval of the disposition.
15.2.3 Nonconforming items chall be segregated from acceptable items and identified as discrepant until properly dispositioned. When segregation is impractical or impossible due to physical conditions, such as size, weight, or access limitations, other precautions shall be employed to preclude inadvertent use of a nonconforming item.
15.2.4 Repaired and reworked items shall be reinspected and retested as originally inspected or tested, or by a method which is at least equal to the original inspection and testing method.
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Quality Assurance Program for the Engineering, Design, Procurement, d
TITLE:
Fabrication and Initital Testing of Radwaste Shipping Packages 15.3 Reauirements and Responsibilities 15.3.1 Suppliers furnishing WTSD packages and, when appropriate, purchased items and services for use in packages, shall be required in procurement documents to establish procedures for the control of nonconforming items in accordance with the requirements of this section.
15.3.2 The responsibility for specifying in procurement documents supplier requirements for the control of nonconforming material, parts, or components shall rest with the Manager, Product Assurance.
15.3.3 When appropriate, suppliers and contractors shall be required in procurement documents to submit a description of deviations from procurement documents which involve accept-as-is or repair dispositions to WTSD using a Variation Request (VR) form (l! Form WTSD 0006) shown in Figure 16-2.
15.3.4 The Variation Request (VR) form shall be processed as follows:
m (a) VRs shall be forwarded initially to the Manager, Product Assurance, or his designee, to assign a control number to the VR and to enter the number and date in the VR log for control purposes.
(b) The VR shall then be forwarded to the Engineering Department for disposition.
(c) The VR disposition shall be approved by Engineering and Product Assurance.
(d) Upon completion of the VR, the-Manager, Product Assurance, shall enter the close-out date in the VR log and forward the VR to the Purchasing Manager.
(NOTE: The WTSD Engineering follow-up is not necessarily required for this close-out, as it is primarily for internal Engineering Department usage.)
O 2
of 3 Page
. _ =. _
Rev.
O Date 5-16-86 TITLE: Quality Assurance Program for ttt3 Engineering, Design, Procurement, Fabrication and initital Testing of Radwaste Shipping Packages (e) The Purchasing Manager, or his designee, shall transmit the dispositioned VR to the supplier or contractor and be responsible for legal / financial negotiations as required.
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15.3.5 The VR form may be generated for a supplier by WTSD personnel, based upon information furnished by the supplier in another form.
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O Date 5-16-86 TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabrication and Initital Testing of Radwaste Shipping Packages SECTION 16 - CORRECTIVE ACTION 16.1 Poliev 16.1.1 This Quality Assurance Program has been established to provide adequate confidence that WTSD packages will be designed, fabricated, and tested in accordance with the requirements of 10 CFR Part 71 and the resulting package approval. Notwithstanding the program as instituted, conditions will occasionally occur which could cause a degradation of quality.
Such conditions as failures, malfunctions, deficiencies (including design deficiencies and procedural deficiencies), deviations, defective material and equipment, and nonconformances shall be promptly identified and corrected in accordance with established measures.
16.1.2 In the case of significant conditions adverse to quality, the cause of the condition will be determined if possible and corrective action taken to preclude repetition.
In general, such special corrective action will be. required
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where:
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(a) nonconformance reports indicate trends due to inadequate procedural controls; (b) existing procedures controlling important activities related to engineering design, fabrication, and testing are not being properly implemented; (c) recurring problems with nonconforming materials, parts or components are encountered; (d) conditions adverse to quality identified during audits or surveillance are not resolved to a satisfactory conclusion within a reasonable time.
J 16.1.3 The proper implementation of corrective actions shall be verified by the performance of followup reviews.
16.2 Procedure 16.2.1 Inspection and Material Disposition Report (IMDR)
(a) The Inspection and Material Disposition Report (IMDR)
(Figure 16-1) is used to document nonconformances requiring Preliminary Review Board (PRB), Engineering
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Review Board (ERB) and/or Material Review Board (MRB) disposition.
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of 10
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O Date 5-16-86
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TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabrication and Initital Testing of Radwaste Shipping Packages (b) The descriptions of these uses of the IMDR are given in Section 15.
For WTSD-caused defects, a statement of cause and corrective action must be entered on each IMDR by the cognizant Management representative.
16.2.2 Variation Request (VR)
(a) The Variation Request (VR) (Figure 16-2) is used by suppliers to submit nonconformances (Ref: Section 15) to WTSD.
The supplier enters an appropriate corrective action statement on each VR.
(b)
It is the responsibility of the WTSD Product Assurance Engineer who dispositions the VR to verify that the corrective action statement adequately addresses resolution of the nonconforming condition.
16.2.3 Request for Corrective Action (RCA)
(a) The Request for Corrective Action (RCA) (Figure 16-3) is used by Product Assurance to notify suppliers of a s
significant condition adverse to quality (Ref:
Section 15).
(b) The RCA is transmitted by a Purchasing Department letter to the supplier who is required to complete the RCA and identify the scheduled completion date of the proposed corrective action.
(c) The " Follow-up Comments" space on the RCA is completed by the initiating WTSD Product Assurance representative and/or the Product Assurance Systems Manager to document satisfactory closeout of the RCA.
16.2.4 Audit Action Reports (AAR)
(a) Audit Action Reports (AAR) (Figure 16-4) are initiated by the Manager, Product Assurance to obtain corrective actions required as a result of internal audits of WTSD. A description of the use of the AAR is given in Section 18.
(b) The Corrective Action Plan and scheduled completion date for the implementation of the accion are entered on the form by the cognizant Manager.
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TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabrication and Initital Testing of Radwaste Shipping Packages 1
-l (c) The Manager, Product Assurance is responsible for evaluating the acceptability of the proposed corrective action and the scheduled completion date, returning i
those which are not acceptable for revision, and insuring that. acceptable corrective action: are properly completed.
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Figura 16-1(a)
Rev.
O Date 5-16-86
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TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabricatign and Initital Testing of Radwaste Shipping Packages 1r GUAlfiY ASSURANCE e
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TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabrication and Initital Testing of Radwaste Shipping Packages VAA4AT504 AE0 VEST WORK $NEET waste TECn40t0GV SERVICES Olvell0B (11 Q ASIff Code Q thee-A38BE Code WESTINGHOUSE ELECTRIC CORPORATIOS (2) VR h P O BOI 296.18A01504. PA.19863 C0elaBENTS DISP 0 sits 04 138 del 465 Dese Ceedmeesde Apposed Sensposes Lassed one Osg. Casese. ECO he to Des Chases 144 0UAllTV A38uRASCE Date Aprosed Ceedesesse Asureved r
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O Date 5-16-86 TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabrication and Initital Testing of Radwaste Shipping Packages I
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O Date 5-16-86 TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabrication and Initital Testing of Radwaste Shipping Packages i
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Figure 16-4 Rev.
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('~hI TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Q
Fabrication and Initital Testing of Radwaste Shipping Packages wa:Ti Tacunotosy sanvices ommon AUDIT ACT10ft REPORT AAR 88*-
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O Date 5-16-86
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TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabrication and Initital Testing of Radwaste Shipping Packages SECTION 17 - OUALITY ASSURANCE RECORDS 17.1 Scope 17.1.1 The requirements of this section apply to records that furnish evidence of the quality of materials, parts, and components used in the fabrication of WTSD packages and of the quality of activities that fall within the scope of this Quality Assurance Program.
17.1.2 Records subject to the requirements of this section include at least the following:
(a) NRC Certificate of Compliance for WTSD packages and all changes thereto including applications for license amendments.
(b) Copies of drawings, specifications, procedures, safety analyses and other documents referenced in each packages license.
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(c)
Procurement records including purchase requisitions,
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purchase orders, and specifications.
(d) Supplier documentation including certificates of conformance, material certifications, test reports, special process procedures, personnel certification records, etc.
(e) Personnel training and qualification records, for WTSD personnel performing activities within the scope of this Quality Assurance Program.
(f) Records of management reviews of Quality Assurance Program effectiveness.
(g) Records of reviews of procedures, instructions and other documents as required by this Quality Assurance Program.
(h) Records of quality verification activities performed by Product Assurance Department personnel, including witness and hold point inspections or waivers thereof.
(i) Measuring and test equipment calibration records.
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TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabrication and Initital Testing of Radwaste Shipping Packages i
(j) Records of the identification and processing and disposition of nonconformances and other conditions adverse to quality including completed IMDRs, VRs, l
RCAs, and AARs (see Section 16) and. supporting documentation.
(k) Records of Product Assurance Department audits.
17.2 Reauirements and Resoonsibilities 17.2.1 WTSD procurement documents shall specify supplier documentation (e.g., drawings, specifications, procedures, inspection and fabrication plans, inspection and test records, personnel and procedure qualifications, material certifications, etc.) to be submitted to WTSD as well as other appropriate quality assurance record requirements.
.i 17.2.2 Inspection and test records should contain the following l
information, when applicable:
(a) A description of the observation; O
(b)
Evidence of completing and verifying manufacturing, inspection, and testing operations; (c) Results of inspections and tests, with appropriate dates; (d) Conditions detrimental to quality; l
(e) Names of inspectors / testers or data recorders; (f)
Evidence of acceptability; and, (g) Actions taken in connection with any deficiencies noted.
i 17.2.3 The Manager, Product Assurance, or his designee, shall be responsible for preparation cnd maintenanca of a Records Index for WTSD records foe each project.
17.2.4 The Records Index shall consist of a listing of document or record types (e.g., IMDRs, VRs, AARs, purchase orders, certificates of conformance, etc.) that contain information related to the quality of items and activities in each project controlled by this Quality Assurance Program.
Page 2 of 3
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Rev.
O Date 5-16-86 TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabrication and Initital Testing of Padwaste Shipping Packages 17.2.5 The Records Index shall include the following information:
(a) Record name and/or designation; (b)
Filing or storage location (s);
(c) Retention time requirements; (d) Records custodian, i.e., the name of the individual responsible for the file; (e) Description of access control provisions, if any.
17.2.6 When access control provisions (see 17.2.5(e)) are identified on the Records Index, removal of records from files and from the immediate storage area shall be documented with record OUT cards.
These cards shall be placed in the storage location of the removed record.'.nd shall contain the following:
e (a)
Identification of the record; 4
(b) Name of individual removing the record; (c) Date of removal.
17.2.7 Records that document the condition of the package (e.g.,
design records, material test reports, fabrication test reports, etc.) shall be retained for at least the lifetime of the package.
17.2.8 Records that show evidence that an activity was performed in accordance with the applicable requirements (e.g., personnel qualification records, audit reports, etc.) will be maintained for at least two years and may be disposed of by the Manager, Product Assurance only after determination that they do not contain information directly pertinent to the condition of the package.
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Rev. O Date 5-16-86 TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabrication and Initital Testing of Radwaste Shipping Packages SECTION 18 - AUDITS 18.1 Policy 18.1.1 Audits of this Quality Assurance Program shall be performed:
(a) To evaluate compliance with the Quality Assurance Program requirements, methods, and procedures (b) To assess progress in assigned tasks (c) To determine adequacy of performance (d) To verify implementation of recommended corrective action 18.1.2 Audits shall include evaluation of work areas, activities, processes, and items and a review of documents and records.
18.1.3 Audits shall be performed by competent individuals having no direct responsibility in the area being audited.
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18.1.4 Audits shall be performed in accordance with pre-established written procedures or checklists.
18.1.5 Audit results shall be documented and reviewed with management having responsibility in the area audited.
18.1.6 Conditions adverse to quality revealed by the audit shall be documented and resolved in accordance with the requirements of Section 16 of this procedure.
18.1.7 Deficient areas will be reaudited on a timely basis to verify implementation of corrective actions.
18.1.8 All quality-related functions are to be audited annually or more frequently if appropriate. Documented customer and interdivisional Westinghouse audits may be counted in the implementation of this requirement.
18.2 Procedure 18.2.1 The Manager, Product Assurance, or his designee, is responsible for planning, scheduling, conducting, evaluating, and documenting audits.
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O Date 5-16-86 TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabricatign and Initital Testing of Radwaste Shipping Packages 18.2.2 Product Assurance and non-Product Assurance Department personnel may assist the Manager, Product Assurance, with planning and implementing the audit program.
These functions will be performed, however, under the direction of the Manager, Product Assurance.
18.2.3 The Manager, Product Assurance, shall prepare and maintain an audit schedule.
The schedule shall include the following information:
(a) A description or listing of the major elements of the Quality Assurance Program that must be audited at least annually (b) The date and audit log nun.ber for the last audit conducted for each element (c) The planned date for the next audit for each program element.
18.2.4 The audit schedule shall be periodically reviewed and 3
revised by the Manager, Product Assurance, as necessary to assure that coverage and schedule reflect current activities.
18.2.5 Unscheduled audits may be conducted by Product Assurance for one or more of the following conditions:
(a) When it is necessary to determine the capability of a supplier's Quality Assurance Program prior to awarding of a contract or purchase order.
(b) When significant changes are made in functional areas of the Quality Assurance Program such as a significant reorganization or procedure change.
(c) When there is evidence that the performance or reliability or package materials or parts are in jeopardy di-to deficiencies in this Quality Assurance Program.
(d) When a systematic, independent assessment of program effectiveness or item quality, or both, is necessary.
(e) When it is necessary to verify implementation of required corrective actions.
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TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabrication and Initital Testing of Radwaste Shipping Packages 18.2.6 Scheduled or unscheduled audits shall be conducted by using appropriately prepared audit checklists.
The standard Internal Audit Checklist form (WTSD-0020) shown in Figure 18-1 may be used to prepare audit checklists.
18.2.7 The auditor should review applicable portions of the Quality Assurance Program description and other related documents such as the package license, AARs, IMDRs, VRs, RCAs, previous audit checklists, procedures, specifications, codes, and standards to develop an audit checklist.
The checklist is intended for use as a guide and should not restrict the audit investigation when findings raise further questions that are not specifically included in the checklist.
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18.2.8 One or more individuals comprise an audit team.
The Manager, Product Assurance, shall select a leader for each audit team.
The team leader shall assure that the audit team is prepared prior to initiation of the audit.
fr3 18.2.9 Involved organizations shall be notified by the Manager,
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Product Assurance, of a scheduled audit reasonably in advance of the audit date.
This notification should be in writing and should include general information on the scope of the audit, schedule of meetings and method of audit.
Unannounced audits may be performed.
18.2.10 A brief pre-audit conference should be scheduled with the cognizant organization management.
18.2.11 When any deficiency is found by an audit, further investigation shall be conducted in an effort to identify the basic cause of the deficiency.
Elements found to be deficient should be acknowledged by a member of the audited organization.
18.2.12 Deficiencies determined by the audit team leader to represent conditions adverse to quality must be documented on an AAR in accordance with the requirements of Section 16.
18.2.13 At the conclusion of the audit, an exit interview should be held with management of the audited organization. An effort should be made to clarify misunderstandings and reach agreement on findings that constitute Quality Assurance Program deficiencies. An effort should also be made to establish a tentative schedule for corrective action for
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each deficiency.
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TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabricatiop. and Initital Testing of Radwaste Shipping Packages 18.2.14 The audit team leader shall prepare an audit report listing the audit findings, items of understanding, and dates when corrective action is to be accomplished and when response to th'e audit report is required. The audit report shall be transmitted to the audited organization with a cover letter i
er memo signed by the Manager, Product Assurance.
18.2.15 The General Manager shall receive a copy of all audit F
reports.
18.2.16 The Manager, Product Assurance, or his designee, shall maintain an audit log to record entries of audits that were conducted.
The audit log number shall be assigned to audit-checklists used during-the audit.
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TITLE: Quality Assurance Program for the Engineering, Design, Procurement, Fabrication and Initital Testing of Radwaste Shipping Packages waste TECH 4010GY SERVICES OlvlS104 INTERNAL AUDIT CHECKLIST Audit Oste (s):
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