ML19345C475
| ML19345C475 | |
| Person / Time | |
|---|---|
| Site: | 07100035 |
| Issue date: | 11/12/1980 |
| From: | Glass D, Mcdermott R, Remley M EMVROCIE, ROCKWELL INTERNATIONAL CORP. |
| To: | |
| Shared Package | |
| ML19345C474 | List: |
| References | |
| 17897, NUDOCS 8012050133 | |
| Download: ML19345C475 (31) | |
Text
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N001PP000002 PROGR AM TITLE QA Program for Packaging Licensed Radioactive Material for Shipment DOCUMENT TITLE QA Program Plan for Packaging Licensed Radioactive Ftterial for Shipment DOCUMENT TYPE KEY NOUNS QA Program Plan QA, Packeatng, Licensed Radioactive.% ttrial ORIGIN AL ISSUE DATE R EL. D ATE APPROV A: S DATE
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NAME M. T. A. Gentry KB07 10 CFR 71.51 requires each NRC licensee to
- D. M. Glass KB44 establish and maintain a QA program for the
- R. L. Jaseph KB44 design, fabricaticn, assembly, testing, use, R. J. McDermott KB44 and maintenance of packaging for licensed J. D. Miller JB02 radioactive material for shipment.
This M. E. Remley NB08 document describes the requirements which V. J. Schauber*
1810 apply to all activities affecting the ccm-R. J. Tuttle NB13 ponents of the packaging which are signifi-cantto safety, including designing, purchasing, fabrication, handling, shipping, storing, cleaning, assembling, inspecting, testing, operating, maintaining, repairing, and modi fying.
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1.0 INTRODUCTION
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Effective October 18, 1977, the Nuclear Regulatory Commission (NRC) amended its' regulations for packaging and transport of radioactive material. These amend-ments, published as changes to CFR Part 71, upgrade requirements for quality assurance in the design, fabrication, assembly, testing, use, and maintenance of packagings for shipping and transporting licensed radioactive material.
In general, the upgrading consists of applying the 18 criteria of 10 CFR 50 Appen-dix B to the packaging of radioactive material; the criteria cre published as 10 CFR 71 Appendix E.
2.0 SCOPE This QA program applies to all organizations and personnel who perform activities affecting the safety-related functions associated with designing, fabricating, maintaining, and using packages for licensed radioactive material.
It does not apply to packages used only for onsite shipments (i.e., where the vehicle never leaves ESG or Government-owned land), to license-exempt activities (e.g., where ESG has a G0C0 (Government owned-contractor operated) contract with Department of Energy (D0E), or to shipments in Government-owned, Government-escorted vehicles.
3.0 APPLICATION 1
In determining how to apply the requirements of this program to a particular 4
activity, responsible management shall consider:
1)
The importance of malfunction or failure of the item to safety, 2)
The design or fabrication complexity or uniqueness of the item, 3)
The need for special controls or surveillance over processes and equipment, 4)
The degree to which functional compliance can be demonstrated by inspection or test, and 5)
The quality history and degree of standardization of the item.
FORM 71M REV.180
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ockweH Intemational NO N001PP000002 Enerw Systeme Grog PAGE 3
Any change to design documents that changes conditions specified in the NRC approval of a package or container must also be approved by NRC.
When ESG purchases materials or services, measures to assure adequate quality shall be included in the procurement documents.
Subtier contractors shall be required to provide quality assurance programs to the extent necessary to assure adequate quality. The degree to which QA requirements are passed down to subtier suppliers shall specifically be considered by Engineering and QA personnel during P.O. initiation and review.
This program is implemented at ESG by the instructions and procedures listed in N0010FP810001.
4.0 QUALITY ASSURANCE PRCGRAM The subsections below describe ESG's quality assurance program for packaging licensed radioactive materials for shipment. The subsections are numbered as in N0.10FP810001, which describes the ESG procedures that implement this program.
4.1 ORGANIZATION 4.1.1 The responsibility for the QA program is retained and exercised by Energy Systems Group (ESG) of Rockwell International.
4.1.2 The QA/QC functions performed by ESG QA Project Managers, Inspection and Test, Instrumentation and Tech if cal Support, QA Audits and Controls, QA Engi-neering and Utility and Energy Programs Group, or delegated to other organiza-tions are identified and described in the ESG QA Manual and Standard Operating Procedures providing controls to assure all elements of Appendix E will be implemented.
(See QA organizational chart - Figure 1. )
4.1.3 Clear and effective lines of communication between the QA organization and principal contractors are established to assure proper direction of the QA program and resolution of QA problems.
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4.1.4 Organization charts identify the organizational elements which function under the control of the QA program (such as design engineering, procurement, manufacturing, construction, inspection (QC), testing, and QA) and demonstrate adequate control over quality aspects within and between organizations.
(See organizational chart - Figure 2.)
4.1.5 The interface relationships and QA responsibilities of each organizational element identified in Item 4.1.4 above are described and demonstrates assignment of responsibilities for requirements of Appendix E.
4.1.6 ESG's President is responsible for establishing QA policies, goals, and objectives and maintains a continuing involvement in QA matters. The Director of QA reports directly to the President.
4.1.7 ESG designates the position of Director, Quality Assurance, to be filled by a qualified individual, to retain overall authority and rpponsibility for the QA program.
4.1.8 The Director of Quality Assurance is responsible for the establishment of program / system requirements, QA policies and procedures, and provides administra-tive and technical direction in implementing them. He assigns responsibilities to subordinate managers and provides resources for accomplishing the assigned responsibilities.
He manages the QA program such that he can direct and control the organization's QA/QC program, can effectively assure the conformance to quality requirements, and is independent of undue influences and responsibilities for schedules and costs.
4.1.9 The QA Engineering group responsibilities are to: review and evaluate bid invitations and proposal requests from prospective customers and contribute proposal input regarding quality requirements; participate on Design Review and Change Control Boards; identify the need for special QA test equipment and facilities; provide QA tool requirements, review and approve tool orders, and prepare inspection instructions; prepare QA Acceptance Procedures; review and FORhe 1%F RSV. 3 0
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approve-shop travelers; administrate and participate in a material rev'iew system for nonconforming items; review and approve procurement documents; perform source inspections and surveillance cf procured items / services; prepare inspection plans for receiving and source inspectors; accumulate QA records for a program / contract and prepare data packages -for submittal to customers when required by contract;
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prepare Code Data Reports / Certificates of Compliance; implement and maintain a centralized filing system for,QA records.
4.1.10 The primary responsibilities of the Inspection and Test Unit are to:
perform receiving inspection of procured items and services, inspection and tests during in-house fabrication / assembly operations, final inspection, and inspection of tooling; perform or witness performance of acceptance or qualification tests of ESG fabricated items; verify conformance of items to design requirements and quality standards; perform nondestructive examination and acceptance of manufac-tured items; accept or reject items and withhold nonconforming items; verify acceptable packaging and shipping of items; keep and control code stamps issued by ASME; maintain a system for calibration control of linear measuring equipment; maintain a system for control of ESG identification stamps (planning, manu-facturing, and inspection).
4.1.11 'The QA Instrumentation and Technical Support is responsible for providing technical support to quality assurance in areas of nondestructive examination, performing all nonlinear instrumentation / calibration, operation of a QA laboratory for process control operations and product overchecks, and control and maintenance of weld procedures and the welder performance qualification system.
4.1.12 The QA responsibilities of the QA Audits and Controls group are as follows:
I provide management vi_sibility through audits into the performance of functions whose actions affect either the quality of the product or the security and control of special nuclear material; prepare, release, and control general operating procedures which outline and implement the quality assurance program at ESE; administer a corrective action system to assure prompt and effective correc-tion of condittens causing nonconformances to technical requirements / procedures; PORM 71M REV. SEO -
j RockwellInternettonal NO N001PP000002 Energy syuemme on**
PAGE 6
evaluate the plant / equipment capability of potential suppliers to furnish quality products / services; maintain a system for review / approval of potential suppliers' quality assurance / inspection capabilities and maintain a listing of approved suppliers; administer a system for tracking / followup of the material review process; and maintain a statistical evaluation capability.
4.1.13 The QA Project Manager is responsible for costs, schedule and technical performance for a selected program / project from a quality perspective, and for ensuring subcontractor performance and compliance to requirements.
4.1.14 The Audits and Controls Group, responsible for defining and controlling the contant of the QA pmgram and related manuals, and the cognizant manager responsible for final review and approval, have appropriate organizational position and authority.
4.1.15 The cognizant quality assurance engineer, responsible for furnishment and management of the ESG QA program at the contractor's site, has appropriate organi-zational position, responsibilities, and authority to exercise proper control over these functions. This indivielual is free of non-QA duties and can thus give full attention to assuring that tne QA program at the plant site is being effec-tively implemented.
4.1.16 The qualification requirements for the principal QA/QC managment positions demonstrate competence commensurate with the responsibilities of these positions.
The qualification requirements' are as follows:
Director, Quality Assurance - Bachelor of Science degree in Engineering, Science, or Technology; a minimum of 8 years experience in quality assurance, 1
engineering or advanced technology industry of which at least 2 years experience is in nuclear quality assurance; experienced in the direction of personnel, planning, and management resources regarding quality assurance; and possesses knowledge of industry and Government codes, standards, and regulations defining quality assurance.
POMM 71p REv. See
Rockwellintomational NO N00lPP000002 Eaersy syne orow PAGE 7
Quality Assurance Audits and Controls Manager, Quality Assurance Engineering Manager, and the Instrumentation and Technical Succort Unit Manager - Bachelor of Science degree in Engineering, Science, or Technology or equivalent training plus experience; 5 years of experience related to field of education major of which at least 2 years is in QA engineering or technology; and possess knowledge of at least two of the following:
statistical / reliability, non-destructive examination, physical / mechanical properties measurement, metal fabrication, measurement technology, instrument and control fabrication and testing, chemical processing and analysis, failure analysis, and quality program development and implementation.
Inspection and Test Unit Manaaer - Ten years experience in a manu-facturing industry of which five years will have been in quality control / assurance; general knowledge of manufacturing and inspection methods and techniques including dimension and electrical measurements, nondestructive examination, quality planning, and fabrication and assembly methods.
Quality Assurance Project Manager - Bachelor of Science degree in Science or Technology or equivalent training plus experience; 5 years experience related to design or manufacture of complex components of which at least 2 years was as a quality engineer involved in fabrication of nuclear components.
Exception to Cachelor's Degree Reouirement The Bachelor's degree requirements listed in Section 4.1.16 may be waived by those individuals responsible for review, approval and appointments to the QA positions.
In waiving the degree requirements, specific considera-tion will be given to a potential appointee's formal education, which must include college level courses in scientific areas applicable to the require-ments of the position, along with his on-the-job training, technical and administrative knowledge, work experience and demonstrated capability and performance in job assignments associated with and/or related to the particular position.
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Rockweilintemettonal NO N00lPP000002 Eaersy syn o,ou.
PAGE 8
4.1.17 Verification of conformance to establishec requirements is accomplished by individuals or groups who do not have direct responsibility for performing the work being verified.
4.1.18 Persons and organizations performing QA/QC functions have direct access to management levels which will assure accomplishment of quality-affecting activities. These personnel have sufficient authority and organizational freedom to perform the'ir QA/QC functions effectively and without reservation. They can:
1)
Identify quality problems 2)
Initiate, recommend, or provide solutions through designated channels 3)
Verify implementation of solutions.
4.1.19 Designated individuals in the Inspection and Test Group have the respon-sibility and authority, delineated in writing, to stop unsatisfactory work and control further processing delivery, or installation of nonconfoming material.
4.2 QUALITY ASSURANCE PROGRAM 4.2.1 Rockwell International's quality assurance program is developed to assure that ESG products (hardware, sof tware) and services meet all applicable quality requirements of the Company, customer contracts, and federal, state, and local government laws and regulations. This includes assuring that product and service quality requirements are clearly and properly identified and communicated, assuring that products / services are designed to meet quality requirements, and that products are produced (developed, procured, manufactured, constructed, and tested) and delivered as designed. These goals and objectives are incorporated in QA policies and procedures which a::sures their implementation.
4.2.2 Measures are provided by ESG and principal contractors, as appropriate, that demonstrate how their QA program meets 10 CFR 71, Appendix E, criteria.
4.2.3 The QA Director and Quality Engineering Manager regularly assess the scope, status, implementation, and effectiveness of the QA program to assure that the program is adequate and complies with 10 CFR 71, Appendix E, criteria.
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Rockwellintemetbnel NO N00lPP000002 Emory Syuemme Gr**
PAGE 9
4.2.4 Measures are provided by ESG to assure that trained. qualified personnel within his organization are assigned to determine that functions delegated to his principal contractors are being properly accomplished.
4.2.5 ESG's corporate QA policies, goals, and objectives are identified in the Standard Operating Procedures and Quality Assurance Manual, providing a trans-mittal channel through all levels of management to the implementation activities.
4.2.6 QA/QC responsibilities are designated for the implementation of the major activities contained in the QA manuals.
4.2.7 Provisions are established by the QA Audits and Control Group to control the distribution of the QA manuals and revisions thereto.
4.2.8 Provisions are established for communicating to all responsible organi:a-tions and individuals that quality policies, QA manuals, and procedures are mandatory requirements and are procedurally controlled.
4.2.9 A listing of the QA procedures plus a matrix of these procedures cross referenced to each criterion of Appendix E to 10 CFR 71 (N001QFP810001) demon-strates that Appendix E provisions are fully implemented by documented procedures.
4.2.10 The safety-related structures, systems, and components imposed by the QA program are identified, which consist of the methods and activities utilized in the packaging and transport of radioactive materials.
4.2.11 ESG reviews and documents agreement with the QA program provisions of its principal contractors to the extent that ESG can be assured that Appendix E will be implemented.
4.2.12 Provisions are established and identified in the QA Manual for the resolution of disputes involving quality, arising from a difference of opinion between QA/QC personnel and other department (engineering, procurement, manu-facturing, etc.) personnel.
PORM 71SP REV. See
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anos,svie o,oup PAGE 10 4.2.13 ' ESG is committed to quality products. This commitment originates with the President of ESG and is reflected throughout the organization by compre-hensive procedural coverage. The resolution of disputes between QA and other functions is resolved by management of the respective functions, however, disputes of ccnsiderable consequence may be carried to the President of ESG for final resolution.
4.2.14 An indoctrination and training program is established such that:
1)'
Personnel responsible for performing quality-affecting activ'ities are instructed as to the purpose, scope, and implementation of the quality-related manuals, instructions, and procedures.
21 Personnel performing quality-affecting activities are trained and qualified in the principles and techniques of the activity being performed.
3)
The scope, objective, and method of implementing the indoctrination and training program are documented.
4)
Proficiency of personnel performing quality-affecting activities is maintained by retraining, reexamining, and/or recertifying.
4.2.15 (Deleted.
Discussion of the PSAR is net applicable +4 ESG's activities under 10 CFR 71.)
4.2.16 Quality-related activities are performed with specified equipment and under suitable environmental conditions, and prerequisites have been satisfied prior to inspection and test.
4.2.17 ESG and its principal contractors, as appropriate, demonstrate that their QA orograms comply with 10 CFR 71, Appendix E, or describe acceptable alternatives in equivalent detail.
4.2.18 (Deleted. Applicable only to reactor plants.)
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Rockweilintomational NO N001PP000002 W SV " Cd***
PAGE 11 8
4.2.19 (Deleted. Discussion of the PSAR is not applicable to ESG's activities under 10 CFR 71.)
4.2.20 Provisions are made for keeping the QA program current.
4.2.21 (Deleted. Discussion of Regulation Guide 1.28 is not applicable to ESG's activities under 10 CFR 71.)
4.3 DESIGN CONTROL 4.3.1 Measures are established to carry out design activities in a planned, controlled, and orderly manner.
4.3.2 -Measures are established to correctly treslate the applicable regulatory requirements and design bases into specifications, drawings, written procedures, and instructions.
4.3.3 Quality standards are specified in the design documents, and changes to these quality standards are controlled.
4.3.4 Suitable design controls are applied to such activities as reactor physics; seismic, stress, thermal, hydraulic, radiation, and accident analyses; compati-bility of materials; and accessibility for inservice inspection, maintenance, and repair.
4.3.5 Designs are reviewed by QA Engineering personnel, as a member of the ESG Design Review Board, to assure that (1) design characteristics can be controlled, inspected, and tested and (2) inspection and test criteria are identified.
4.3.6 Internal and external design interface controls are established. These controls include the review, approval, release, distribution, and revision of documents involving design interfaces with participating design organizations.
FORM 719.P REV. 3 80
A Rockweilintomational NO N001PP000002 g) anergy syuamme Group PAGE 12 4.3.7 Proper selection and accomplishment of design verificaticn or checking processes such as by design reviews, alternate calculations, or qualification testing are performed. When a test program is used to verify the adequacy of a design, a qualification test of a prototype unit under adverse design conditions shall be used.
4.3.8 Individuals designated from the QA Engineering group and other functions are responsible for the review of the design prior to release and are other than the original designer and the designer's immediate suppervisor.
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4.3.9 Design and specification changes including field changes are subject to the same design controls and approvals that were applicable to the original design unless ESG designates another qualified responsible organization.
4.3.10 Errors and deficiencies in the design including the design process that could adversely affect safety-related structures, systems, and components are documented, and corrective action is taken to preclude repetition.
4.3.11 Materials, parts, and equipment which are standard, comercial (off the shelf), or which have been previously approved for a different application are reviewed for suitability prior to selection.
4.3.12 Selected individuals from the QA Engineering group participate in design reviews and other design verification activities and their authority and responsi-bility are identified and controlled by written procedures.
4.3.13 Measures are established for the selection of suitable materials, parts, equipment, and processes for safety-relateo structures, systems, and components which include the use of valid industry standards and specifications.
4.3.14 (Deleted. Discussion of Regulatory Guide 1.64 is not applicable to ESG's activities under 10 CFR 71.)
POnte 71SP MEv. 3 80
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- PAGE 13 4.4 PROCUREMENT DOCUMENT CONTROL 4.4.1 Procedures are established and incorporated in the Quality Assurance Manual that clearly delineate the sequence of actions to be accomplished in the prepara-tion, review, approval, and control of procurement documents by the Quality Assurance Engineering group.
4.4.2 A review and concurrence of the adequacy of quality requirements stated in procurement documents is performed 'uy qualified personnel in the Quality Assurance Engineering group. This review is to determine that quality requirements are correctly stated, inspectable, and controllable; there are adequate acceptance and rejection criteria; and the procurement deocument has been prepared, reviewed, and approved in accordance with QA program requirements.
4.4.3 The review and approval of procurement documents is signified by QA Engi-neering signature on the documents prior to rclease and are available for verification.
1 4.4.4 Procurement documents identify the applicable 10 CFR 71, Appendix E, requirements which must be complied with and described in the supplier's QA program. The QA program or portions thereof are reviewed and concurred with by qualified personnel in QA Engineering prior to initiation of activities affected by the program.
4.4.5 Procurement documents contain or reference the design basis technical requirements including the applicable regulatory requirements, material and component identification requirements, drawings, specifications, codes and
' ndustrial standards, test and inspection requirements, and special process i
instructions.
4.4.6 Procurement documents identify the documentation (e.g., drawings, specifi-cations, procedures, inspection and fabrication plans, inspection and test records, personnel and procedure qualifications, and chemical ~ and physical test results of material) to be prepared, maintained, and submitted to the purchaser for review and approval.
PORM 71bP REV. SSG M
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RockwellIntemettonal NO N001PP000002 Enesgy Symmns Grog PAGE N
4.4.7 Procurement documents identify those records to be retained, controlled, and maintained by the supplier, and those delivered to the purchaser prior to use or installation of the hardware.
4.4.8 Procurement documents contain the procuring agency's right to access to supplier's facilities and records for source inspection and audit.
4.4.9 Changes and revisions to procurement documents are subject to at least the same review and approval by qualified personnel in QA Engineering as the original document.
4.4.10 Procurement documents for spare or replacement parts of safety-related structures, systems, and components are subject to controls at least equivalent to those used for the original equipment.
4.4.11 (Deleted. Discussion of procurement of nuclear power plaat items is not applicable to ESG's activities under 10 CFR 71.)
4.5 INSTRUCTIONS, PROCEDURES, AND ORAWINGS 4.5.1 Activities affecting quality are prescribed and accomplished in accordance
.with documented instructions, procedures, and drawings.
4.5.2 Provisions are established and described in ESG Standard Operating Pro-cedures and the Quality Assurance Manual which clearly delineate the sequence of actions to be acccmplished in the preparation, review, approval, and control of instruction, procedures, and drawings.
4.5.3 Methods for complying with each of the 18 criteria of 10 CFR 71, Appendix E, are specified in-instructions, procedures, and drawings.
4.5.4 Instructions, procedures, and drawings include quantitative (such as dimensions, tolerances, and operating limits) and qualitative (sut.h as workmanship samples) acceptance criteria to verify that important activities have been satisfactorily accomplished.
PORM 719 P REV. 2 30
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PAGE 15 i
4.5.5 The Quality Assurance Engineering group reviews inspection plans, test, special process procedures, and changes thereto.
4.6 DOCUMENT CONTROL 4.6.1 The review, approval, and issue of documents (such as those listed in Item 4.6.8 below) and changes thereto, prior to release, are procedurally con-
. trolled to assure they are adequate and the quality requirements are stated.
- l 4.6.2 The Engineering Release group issues documents after they are reviewed and approved by all affected organizations, including Quality Assurance Engineering.
4.6.3 Changes to documents are reviewed and approved by the same organizations that performed the original review and approval (QA Engineering) or by other qualified responsible organizations delegated by ESG.
4.6.4 Approved changes are included in instructions, procedures, drawings, and other documents prior to implementation of the change and of activities.
4.6.5 Obsolete or supersaded documents are controlled to prevent inadvertent use.
4.6.6 Documents are available at the location where the activity will be performed prior to commencing the work.
4.6.7 A master list or equivalent is established to identify the current revision number of instructions, procedures, specification, drawings, and procurement documents. This list is updated and distributed to predetermined, responsible
-personnel to preclude use of superseded documents.
4.6.8 The documents that are controlled under this subsection are identified including:
1)
Design specifications 2)
Design, manufacturing, construction, and installation drawings a
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PAGE 16 31 Procurement documents 4)
QA manuals 5)
(Del eted. PSAR's are not applicable.)
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Manufacturing, inspection, and testing instructions 7)
Test procedures 8)
Design change requests 9)
Nonconformance reports.
4.7 CONTROL 0F PURCHASED MATERIALS, EQUIPMENT, AND SERVICES 4.7.1 Qualified personnel in the QA Audits and Controls group evaluate the supplier's capability to provide acceptable quality services and products before the award of the procurement order or contract.
The QA Engineering group participate in the evaluation of those suppliers providing critical components.
4.7.2 The evaluation of suppliers is based on one or more of the following:
1)
The supplier's capability to comply with the elements of 10 CFR 71, Appendix E,-or 10 CFR 50, Appendix B, that are applicable to the type of material, equipment, or service being procured.
2)
A review of previous records and performance of suppliers who have provided similar articles of the type being procured.
3)
A survey of the supplier's facilities and QA program to determine his capability to supply a product which meets the design, manu-facturing, and quality requirements.
4.7.3 The results of supplier evaluations are documented by the Audits and Controls group and filed.
4.7.4 Surveillance of suppliers during. fabrication, inspection, testing, and shipment of materials, equipment, and components is planned and oerformed in accordance with written procedures to assure conformance to the purchase order requirements. These procedures provide for:
PORM 71SP REV. SSO
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h Rockwelllntemational NO N001PP000002 Ennw symm. Greue PAGE 17 11 Instructions that specify the characteristics or processes to be witnessed, inspected or verified, and accepted; the method of surveillance and the extent of documentation required; and those responsible for implementing these instructions.
2)
Audits and surveillance which :ssure that the supplier complies with the quality requirements. Surveillance is performed on those items where verification of procurement requirements cannot be determined upon receipt.
4.7.5 The supplier furnishes the following records as a minimum to the purchaser:
1)
Documentation that identifies the purchased material or equipment and the specific procurement requirements (e.g., codes, standards, and specifications) met by the items.
2)
Cocumentation that identifies any procurement requirements which have not been met together with a description of those nonconform-ances dispositioned " accent as is" or " repair."
The review and acceptance of these documents is described in the ESG's QA program and as a minimum shall be undertaken by a responsible individual in the QA Engineering group.
4.7.6 Supplier's certificates of conformance are periodically evaluated through audits conducted by the Audits and Controls group, independent inspections by the Inspection and Test group, or tests by the appropriate QA group to assure they are valid.
4.7.7 Receiving inspection (by the Inspection and Test group) of the supplier-furnished material, equipment, and services is performed to assure conformance to purchase order requirements; typical activities include:
1)
The material, component, or equipment is properly identified and corresponds with t'
'dentification on receiving documentation.
PORM 719 P REV. SAO
NO.
N001PP000002 j Rockwellintemononal sases, s, mens armo PAGE 18 2)
Material, components, equipments, and acceptance records are inspected and judged acceptable in accordance with predetermined inspection instructions, prior to installation or use.
3)
Inspection records or certificates of conformance attesting to the acceptance of material, components, and equipment are available prior to installation or use.
4)
Items accepted and eleased are identified as to their inspection status prior to forwarding 'them to a controlled storage area or releasing them for installation or further work.
4.7.8 The effectiveness of the control of quality by suppliers is assessed through audits, surveillance, and the reporting of nonconforming supplied material at intervals consistent with the importance, complexity, and quantity of the item.
4.7.9 Spare or replacement par ts of safety-related items are subject to controls at least equivalent to those used for the original equipment.
4.7.10 (Celeted. Discussion of procurements for nuclear power plants does not apply to ESG's activities under 10 CFR 71.)
4.8 IDENT 9ICATION AND CONTROL 0F MATERIALS, PARTS, AND COMPONENTS 4.8.1 Procedures are established to identify and control materials, parts, and components including partially fabricated subassemblies.
4.8.2 Identification requirements are determined during generation of speci-fications and design drawings.
4.8.3 Process control and inspection procedures assure that identification ia maintained either on the item or on records traceable to the item to preclude use of incorrect or defective items.
POAM 74P REV. 500
' g/ 7 NO N001PP000002 Rockweilintemenonal Eaway s, semi ome PAGE 19 4.8.4 Identification of materials and parts important to the function of safety-related structures, systems, and components can be traced to the appropriate documentation such as drawings, specifications, purci;ase orderc, manufacturing and inspection documents, deviation reports, and physical and chemical mill test reports.
4.8.5 The location and the method of identification do not affect the fit, function, or quality of the item being identified.
6 4.8.6 Correct identification of material, parts, and components is verified and documented by designated Inspection and Test personnel prior to release for fabrication, assembling, shipping, and installation.
4.9 CONTROL OF SPECIAL PROCESSES 4.9.1 Special processes such as welding, heat treating, nondestructive testing, and cleaning are proc =& ally controlled.
4.9.2 Procedures, equipment, and personnel connected with special processes are qualified in accordance with applicable codes, standards, and specifications.
4.9.3 Special processes are performed by qualified personnel and accomplished in accordance with written process sheets or equivalent with recorded evidence of verification.
4.9.4 Qualification records of procedures, equipment, and personnel associated with special processes are established, filed, and kept current and maintained by Quality Assurance. The Instrumentation and Technical Support group mainta
..a records of all weld and welder qualifications, and the Training Department main-tains-the records associated with NDE examiners. Other special processes and operators are provided, trained, and certified on a special as-needed basis.
4.9.5 (Deleted. NA to ESG's activities under 10 CFR 71.)
"'ORM 719.P REV. See
Rockwelllnternational NO N00lPP000002 En.,,y sr.t.
foup PAGE 20
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4.10 INSPECTION 4.10.1 An inspection program which verifies conformance of quality-affecting activities with requirements is established, documented, and accomplished in accordance with written controlled procedures and as identified in the Quality Assurance Manual and Standard Operating Procedures.
4.10.2 Inspection personnel are independent from the individuals performing the activity being inspected.
4.10.3 Inspection procedures, instructions, and checklists provide for the following:
1)
Identification of characteristics and activities to be inspected.
2)
Identification of the individuals or groups responsible for per-forming the inspection operation.
3)
Acceptance and rejection criteria.
4)
A description of the method of inspection.
5)
Recording evidence of completing and verifying a manufacturing, inspection, or test operation.
6)
Recording inspector or data recorder and the results of the inspection operation.
4.10.4 Inspection procedures or instructions are used with necessary drawings and specifications when performing inspection operations.
4.10.5 Inspectors are qualified in accordance with applicable codes, standards, and company training programs, and their qualifications and certifications are kept current.
4.10.6 Modifications, repairs, and replacement are inspected in accordance with the original design and inspection requirements or acceptable alternatives.
PORM 719 P R EV. 2-80
(&) Rockwellintemenmal NO N001PP000002 sases, svens=e Grous PAGE 21 4.10.7 Provisions are established that identify mandatory inspection hold points for witness by an inspector.
4.10.8 Inspection and Test personnel who perform receiving and process verifica-tion inspections are identified and shown to have sufficient independence and qualifications.
4.10.9 Provisions are established for indirect control by monitoring processinc methods, equipment, and personnel if direct inspection is not possible.
4.10.10 (Deleted. NA to ESG's activities under 10 CFR 71.)
4.11 TEST CONTROL 4.11.1 A test program, when required, to demonstrate that the item will perform satisfactorily in service is established, documented, and accomplished in accord-ance with written controlled procedures.
4.11.2 Modifications, repairs, and replacements are tested in accordance with the original design and testing requirements or acceptable alternatives.
4.11.3 Written test procedures incorporate or reference:
1)
The requirements and acceptance limits contained in applicable design and procurement documents.
2)
Instructions for performing the test.
3)
Test prerequisities such as:
a)
Calibrated instrumentation b)
Adequate and appropriate equipment c)
Trained, qualified, and licensed or certified personnel d)
Completenes:: of item to be tested e)
Suitable and controlled environmental conditions 4
?
POmu 7tp may. See -
x..-
WIintwnedonal NO' N001PP000002 energy srecome Group PAGE f)
Provisions for data collection and storage.
4)
Mandatory inspection hold points for witness by owner, contractor, or inspector.
5)
Acceptance and rejection criteria.
6)-
Methods of documenting or recording test data and results.
4.11.4 Test results are documented, evaluated, and the#r acceptability determined
~
by a qualified, responsible individual of.the Inspection and Test group.
4.11.5 (Deleted.
FA to ESG's activities under 10 CFR 71.)
4.12 CONTROL OF MEASURING AND TEST EQUIPMENT 4.12.1 Provisions, contained in procedures, describe the calibration technique and frequency, maintenance, and control of the measuring and test equipment (instruments, tools, gages, fixtures, reference and transfer standards, and nondestructive test equipment) which is used in the measurement, inspectior., and monitoring of safety-related components, systems and structures.
4.12.2 Measuring and test equipment is identified and traceable to the calibration test data.
4.12.3 Measuring and test equipment is labeled or tagged to indicated data of the next calibration.
4.12.4 Measaring and test instruments are calibrated at specified intervals based on the required accuracy, purpose, degree of usage, stability characteristics, and other conditions affecting the measurement.
4.12.5 Measures are taken and documented to determine the validity of previous inspections performed when measuring and test equipment is found to be out of calibration.
t ponM 71Se nsv. See
r (m
WllW NO N001PP000002.
Eneser Systems Group PAGE 23 4.12.6 Calibrating standards have an uncer* ..y (error) requirement of no more than 1/4th of the-tolerance of the equipment Deing calibrated. A greater uncertainty may be acceptable when limited by the " state of the art."
4.12.7 The complete status of all items under the calibration system is recerded and maintained.
4.12.8 Reference and transfer standards are traceable to nationally recognized I
standards; or, where' national standards do not exist, provisions are established to document the basis for calibration.
4.13 HANDLING, STORAGE, AND SHIPPING 4.13.1 Special handling, preservation, storage, cleaning, packagin,. and ship-ping requirements are established and accomplished by qualified individuals in accordance with predetermined work and verified by QA Inspection and Test personnel in
- cordance with inspection instructions.
4.13.2 Procedures are prepared which control the cleaning,- handling, storage, packaging, shipping, and preservation of materials, components, and systems in accordance with design and specification requirements to preclude damage, loss, or deterioration by enviconmental conditions such as temperature or humidity.
4.13.3 (Deleted. NA to ESG's activities' under 10 CFR 71.)
4.14 INSPECTION, TEST, AND OPERATING STATUS 4.14.1 Identification of the inspection, test, and operating status of structures, systems, and components is known throughcut manufacturing and installation.
4.14.2 The application and removal of inspection and weldiag stamps and status indicators such as tags, markings, labels, and stamps are procedurally controlled.
T ponu nSenav.ies n
Rockwelllntematbnal NO N001PP000002 Enerw Systems Grote PAGE 24 4.14.3 Bypassing of required inspections, tests, and other critical operations is procedurally controlled under the cognizance of the QA organization.
4.14.4 The status of nonconforming, inoperative, or malfunctioning structures, systems, or components is identified to prevent inadvertent use by attaching
" hold tags" to the items.
4.15 NONCONFORMING MATERIALS, PARTS, OR CCMPONENTS 4.15.1 The identification, documentation, segregation, review, disposition, and notification to affected organizations of nonconforming materials, parts, components, er services are procedurally controlled.
4.15.2 Documentation identifies the nonconforming item, describes the non-conformance, the disposition of the nonconformance, and the inspection require-ments, and includes signature approval of the disposition by members of the Material Review Board 1.hich includes Quality Assurance.
4.15.3 Those irdividuals from the Procurement, Manufacturing, and Quality Assurance depart. tents who make up the Material Review Board are delegated the responsibility and authority for the disposition and approval of c.onconforming items.
Provisions are cstablished and identified in the Quality Assurance Manual and ESG Standard Operating Procedures.
4.15.4' Nonconforming items are segregated from acceptable items and identified as discrepant by Inspection and Test personnel until properly dispositioned.
4.15.5 Acceptability of rework or repair of materials, parts, components, systems, and structures is verified by reinspecting and retesting the item as originally inspected and tested or by a method which is at least equal to the original inspection and testing method.
Inspection, testing, rework, and repair procedures are documented.
PORM 71SP MEV. 2-90
N001PP000002-RockwellInternadonal NO energy syseeme Group PAGE l
4.15.6 Nonconformance reports dispositioned " accept as is"~ or " repair" are made
-part of the inspection _ records and forwarded with the hardware to the purchaser for review and assessment.
4 4.15.7 Nonconformance reports are periodically analyzed to show quality trends, and the results are reported to' management for review and assessment.
+.16 CORRECTIVE ACTION 4.16.1 Evaluation of conditions adverse to quality (such as nonconformances, failures, malfunctions, deficiencies, deviations, and defective material and equipment) is conducted to determine the need for corrective action in accordance with established procedures.
4.16.2 Corrective action is initiated following the determination of a condition adverse to quality to preclude recurrence.
i
]
4.16.3 Follow-up reviews are conducted to verify proper implementation of corrective actions and to close out the corrective action documentation.
4.16.4 Significant conditions adverse to quality, the cause of the conditions, and the corrective action taken are reported to cognizant levels of management for review and assessment.
4.17 QUALITY ASSURANCE RECOR05 j
4.17.1 Sufficient records are maintained to provide documentary evidence of the quality of items and the activities affecting quality.
i 4.17.2 QA records include operating logs; results.of reviews, inspections, tests, audits, and material analyses; monitoring of work performance; qualification of personnel, procedures, and equipment; and other documentation such as drawings, specifications, procurement documents, calibration procedures and reports; nonconformance' reports; and corrective action reports.
POMM 71SP MEv, SSO
RockwellIntemational NO N001PP000002 en w syst.m. croup PAGE 26 d.17.3 Records are identifiable and retrievable.
4.17.4 Requirements and responsibilities for record transmittals, retention (such as duration, location, fire protection, and assigned responsibilities) and maintenance subsequent to completion of work are consistent with applicable codes, standards, and procurement documents.
4.17.5 Inspection and test records contain tre following where applicable:
1)
A description of the type of observation.
2)
Evidence of completing and verif"ing a manufacturing, inspection, or test operation.
3)
The date and results of the inspection or test.
4)
Information related to conditions adverse to quality.
5)
Inspector or data recorder identification.
6)
Evidence as to the acceptability of the results.
4.17.5 Record storage facilities are constructed, located, and secured to prevent destruction of the records by fire, flooding, theft, and deterioration oy environmental conditions such as temperature or humidity.
4.17.7 (Deleted.
NA to ESG's activities under 10 CFR 71.)
4.18 AUDITS 4.18.1 Audits are performed in accordance with preestablished written procedures or check lists and conducted by trained personnel in the QA Audits and Controls group u.' by other personnel not having direct responsibilities in the areas being audited.
4.18.2 Audit results are documented and then reviewed with management having responsibility in the area audited.
POMM 719# REV. 2-80
(t. $j) Rockwellintomational NO N001PP000002 Energy Syuemme Group PAGE 27 4.18.3 Responsible management takes the necessary action to correct the deficien-cies revealed by the audit.
4.18.4 Deficient areas are reaudited on a timely basis to verify implementation of corrective Mtions which minimize recurrence of deficiencies.
4.18.5 Audits include an objective evaluation of quality-related practices, procedures, and' instructions and the effectiveness of implementation.
4.18.6 Audits include the objective evaluation of work areas, activities, processes, and items, and the review of documents and records.
4.18.7 Audits to assure that procedures and activities are me:ningful and comply with the overali QA program are performed by:
1)
The Audits and Controls group, to provide a comprehensive inde '
pendent verification and evaluation of quality-related procedures and activities.
4.18.8 Provisions are established requiring that audits be performed in those areas where the requirements of Appendix E to 10 CFR Part 71 are being implemented.
Areas of primary concern include those activities associated with:
1)
(Deleted.
NA to ESG's activities under 10 CFR 71.)
2)
The preparation, review, approval, and control of early procurements.
3)
Indoctrination and training programs.
41 Interface control an,ang ESG and principal subcontractors.
4.18.9 Audits are regularly scheduled on the basis of the status and safety importance of the activities being performed and are initiated early enough to assure effective quality assurance during the design, procurement, and contracting activi ties.
1783?
PORM 719 P REV. 500
.o WilW NO N001PP000002 Eneser syneses Group PAGE 28 4.18.10 Audit data are analyzed and the. reports, which indicated quality
- trends and the effectiveness of the QA program, are reported to management for review and assessment.
4.18.11 The requirements and guidelines of ANSI N45.2.12 are complied with or acceptable alternatives are provided.
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i PORM 71&P MEV. 500 i
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