LD-92-031, Marked-up Copy of QA Program Topical Rept
| ML20090K491 | |
| Person / Time | |
|---|---|
| Site: | 05200002 |
| Issue date: | 03/12/1992 |
| From: | ABB COMBUSTION ENGINEERING NUCLEAR FUEL (FORMERLY |
| To: | |
| Shared Package | |
| ML20090K482 | List: |
| References | |
| CENPD-210A, CENPD-210A-R06, CENPD-210A-R6, LD-92-031, LD-92-31, NUDOCS 9203190036 | |
| Download: ML20090K491 (45) | |
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Enclosure 11 to i
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. . LD 92 031 QUAIJIY ASSURANCE PROGRAM TOl'ICAl, REl' ORT CENPD 210A, REVISION 6 (Marked up Copy) i
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. . i ABSTRACT !
1 This report describes the quality assurance prograni employed by ABB Combustion 9
Engineering Nuclear Systems aml ADH Combustion Engineering Nuclear Fuel for the supply.-of items and services subject to the requirements; of 10CFR50,This-telut ,
descrite-the-qualit y-assumnee-prog r a m-employed-by-A B B- Comitust ion-Engineering Nuclear-Powerv-a-divishm-of-Combustion-Engineeringrinerr-for-the-wpply-of-items and-servin+-9ulieeHo-de-fequirement9-of-10GFR50; Appendix D. The program is based on and is responsive to the requirements of ANSI /ASME NQA-1,
- Quality Assurance Program Requirements for Nuclear Facilities (1983 FAition with Addenda la (1983))"; the ASME Boiler and Pressure Vessel Code Section 111, Nuclear Power Plant Components (1986 Edition), and the guidance in Regulatory Guide 1.28, " Quality Assurance Program Requirements (Design and Construction)" (Rev. 03).
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- 1. INTRODUCTLQN l
1.1 [htane i This report describes the quality assurance program employed by Allli Combastion Engineering Nuclear ~ Systems (NS) and ABB Combustion '
Engineering Nuclear Fuel (NF)-Power-(GENP) for the supply of items and f services subject to the requirements of 10CFR$0, Appendix B.
1.2 Empe -
This report includes a description of controls employed at the facilities noted below. Section 11 presents the commitment to quality a'id describes the quality assurance organization and responsibilities. Section 111 describes the quality assurance controls employed to address each criterion of 10CFR50, Appendix B, The controls apply to all facilities tmless otherwise indicated.
The facilitics and the activities involved at each facility include:
Eatility Aclirillo GENP-11eadquarters, Engineering services, nuclear Windsor, CT fuel design and NSSS design, (with offices also in procurement, te:; ting, inspection, Chattanooga TN) repair and installation -mimmtetarts Page1 Revision 7 :
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i Nuclear Fuel Manufacture of nuclear fuel Manufacturing, pellets, fuel assemblies and Windsor, CT and control element assemblies and Hematite, MO associated activities ABB Electro- Design and . manufacture of Mechanics, New instrumentation & control Britain CT systems and associated activities ABlFCENP-Newington Design and manufacture of Operations, mechanical systems and .
Newington, NH associated activities 1.3 Enision control Revisions to this report will be in accordance with the standards specified in 10CFR50.55 (0 (3). Specifically; o within 90 days, NRC will be informed of changes to this program that do not reduce previously accepted commitments; o changes that reduce commitments will be submitted for NRC approval prior to implementation. ,
Responsibility for'irnplementimg^the aboveLis_' assigned to AHil ' Combustion Engineeririg Nuclear Systems.
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- 11. GLMLITY POLICY i 11.1 LtlicLSlalement The Presidents of AllB Combustion Engineering Nuclear Systems and ABR Combustion Engineering Nuclear Fuel-Power have authorized the following statement concerning quality assurance policy:
"A primary objective of Aills Combustion Engineering Nuclear l Systems and Ailll' Combustion' Engineering Nuclear Fuel 42ewedis to deliver to our clients defect free, competitive products and services on time that fully comply with contract requirements."
Qulityf Assumnce= management within NSl and' NF Vice-President;-Nuclear Quality has the responsibility for de6ning their _ (mit's _' ABB-foncustion Engineering-Nuclear-Power quality assurance program and shall bring to the attention of the President any quality problem that cannot be resolved within the normal execution of this responsibility, 11,2 QualilylnutanctDrganizati.en The Nuclear Systems and Nuclear Fuel organizations'are shown in Figures 11-1 and 112.
TieQuality-Assurance (QANrganiettion-is-shown-in-Figure 41-h Regardless lof the . specific organizational'itruciure and organizational titles, Q;ality Assu~rancel(QA) management TheNice-PresidentrNuclear-QualityiNQ) is responsible to assure that the QA policy, goals and objectives are transmitted through levels of management and imposed on quality functions. This is Page 3 Revision 7
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accomplished by distribution of Qcahty Assurance Manuals which contain QA policy statements.
Responsibility for nuclear quality assurance rests with each unit's President and is delegated to QA management the-Vice-PresidentrNwlear-Quality; who may further delegate specific activities to their-NQ qualityussutanee persennel. Such delegation includes authority to stop work for noncompliance to requirements, Stop work orders are dispositioned by QA-NQ-quality essuranee-pernnel and may be originated at any organization level and unit and executed at the level of a Manager, Dire.. or, Vice President or President for action, in all cases where personnel perform quality assurance functions, this delegation provides them
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authority and freedom to initiate, recommend or provide solutions tc quality problems through management channels.
Compliance with quality requirements is measured through planned surveillance and/or audit activities and corrective action follow-up by quality assurance personnel. QA NQ is independent of other organizations as shown in Figures 11 1 and 11-2. QA NQ interprets quality related industry standards for intent and guidance and is responsible for assuring that all quality assurance related procedures used comply with established QA requirements. Each unit participates in an inter-unit audit program to verify that each is implementing its quality assurance program as necessaiy for items / services provided to eaeb c:her. When items / services are provided from one unit to another, management of the unit providing the item / service is responsible for the work.
111. 01MLLT_LMSILRMG CRITEP.JA This section describes each of the eighteen (18) elements of the ABB-Gw!mstion Engineering-Nuelear%wer quality assurance program.
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111.1 Diganizalien AI3B Combustion Engineering Nuclear Systems and A1313 Combustion F.ngineering Nuclear Fuel have-Powet4m* headquarters at Windsor, Connecticut, and-is a diversiGed energy +ystems eml*rvices-uniteffwnbustion-1;ngmeetinn lee;--The-Ptesident-is-fessmsiblefoHhe These units supply of nuclear systems, nuclear fuel and telate&imelear-services. -QA-responsibilities-are-as~iihtstratett in Figures 4M+md-lHh Each project under contract is coordinated by a Project, Program, or Task Manager who is a member of either the Nuclear SystemsrNuclear-Serviers-or Nuclear Fuel orga'1izations. The Project /Tast Manager is responsible for coordinating and documenting all project work, assuring conformance with contract requirements and maintaining communication channels with the client and all other participating organizations.
Quality Assurance management has direct access to the President of their ur.it (see Figures 11 1 and ll 2).-TheVice President;&wlear-Quidity reports-dirtetly4o the President-and-aHhe*me+rganiratioiml4evel-awther-Vice Presidents.-Quality avuranee Responsibilities of QA NQ are listed in Table !!!-1. These responsibilities are carried out through the QA NQ staff.4Figme-lH) and by coordination of all QA activities. Details of responsibilities and interfaces among QA NQ and other organizations are contained in QA manuals and procedures.
These interface relationships address items such as auditing, investigation of quality problems and implementation of corrective action. -Responsibilitiewf-the the Nuclear 4ystemsimd%elear-Fuel-other-smits-are-listed-in-Table-Ill4
' QA NQ functions as an independent communication channel between senior management and line management. This assures that senior management is Page5 Revision 7
appraised of quality matters and that the QA NQ staff receive and comply with directives from the President.r via-the-Vice-Presklentr-Melear-Quality 2
, QA management-The-VhwPresideny& clear-Quality meets regularly with the QA NQ-management staff to discuss quality issues, schedule quality efforts, establish goals and identify areas for improvements. These meetings ate normally held monthly but may be at shorter or longer internals depending on the significance of quality assurance activities and issues at that time. In addition, these meetings are supplemented by reports from the QA NQ management staff :
- to the respective President.-V4ce-Presidentr@NQ4md4nmHheNice-Presklent; '
QA-NQ-to-the-Presklent The detailed organizational structure of QA NQ as well as the number of personnel in QA NQ may change over time depending on quality needs as well as business needs. However, QA NQ will not become involved in activities unrelated to QA that would prevent full attention to QA matters when necessary.
QA NQ personnel selection is based on knowledge of operations; QA regulations, practices and standards; past working experience in QA or related activities in nuclear power or a similar high technology industry and education considerations.
In addition, QA NQ management assignments are also based on evaluated management experience in similarly responsible positions.
111.2 Quality Asstrance Program 111.2.1 Summary Description L The QA program' described herein is employed for the supply of items and services subject to the requirements of 10CFR50 Appendix 13. The program is i based on and responsive to the requirements of ANSI /ASME NQA-1 " Quality Assurance Program Requirements for Nuclear Facilities", the ASME Code, and Pap 6 Revision 7
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the guidance in Regulatory Guide 1.28, " Quality Assurance Program Requirements (Design and Construction)". Alternatives to the explicit I requirements and guidance given in NQA 1 and/or Regulatory Guide 1.28 are described in Table 111-24.
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In addition to the above, the applicable elements of ASME NQA 2, " Quality Assurance Requirements for Nuclear Facility Application" are applied to activities associated with the ABB Combustion Engineering Nuclear Power Standard Plant Design (" System 80+ Standard Design" as described in CESSAR DC). The application of NQA-2 requirements and/or those in ANSI N45.2 and its associated .
daughter standards for other than CESSAR DC activities is dependent on client contract requirements. ,
111. 2 .2 Program Cenac1 The requirements of this program are implemented at each facility through QA manuals and procedures applicable to the activities conducted at cach facility. All such documents are reviewed, approved and controlled by QA NQ to assure compilance with program requirements.
P 111. 2 . 3 Eygluation of_Emgram Effecibuns The scope, status, implementation and adequacy of the QA program are assessed by senior levels of management in several ways. The President receives a ,
monthly report from QA management-VkePresklent;-NQ covering major quality ,
issues such as signi0 cant internal and client audit fmdings, industry quality-related ,
developments and quality improvement needs. Quality issues and assessments are discussed during each President's staff meetings.-withahe-Vice-Presidents Page 7 Revision 7 v, ,m-.cww. ,w,-es ,e,.w-., ~m . , - - . - - 6 ++,e,.mm-.. ,y-w-.-, ;.-vev.,<e w v -,w.w - . . , . o..-,.. ,,,,-w~wm-,,e -
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involvah An annual, independent assessment of the QA program is performed by personnel outside the unit's QA organization-NuclearQmlity. This assessment is documented and any corrective actions are identified and tracked.
111.2.4 EcnonncUndsidaatimDLTraimng The responsibility for assuring that personnel performing activities affecting quality are suitably trained rests with the organization performing those activities.
Detailed personnel training requirements for each facility are contained in QA l
procedures. QA-NQ is responsible for assuring that training requirements are ;
met.
Indoctrination, training and quali0 cation of personnel performing engineering, t purchasing, fabricating, insta!!ing, handling, shipping ar.d storing activities consists of at least:
o indoctrination in the purimse, scope and implementation of QA manuah, and applicable instructions and procedures through self-study, o proficiency tests and/or performance reviews, and/or on-the job observations as determined by management, to determine adequacy of ,
training and qualification, o - maintenance of proficiency by performance review, and/or reexamination, and/or retraining as determined by management.
Indoctrination, training and qualification of QA NQ personnel verifying quality affecting activities consists of the three items above and in addition the following:
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o training and quali0 cation in the princip'es, techniques and requirements of the activity being performed. Documentation for these formal programs normally include the program objective, content, attendees, date(s) of the training or certification, and appropriate approvals.
For all of the above, training and quali0 cation is documented in certificates and/or procedures that delineate the specific functions personnel are qualified to perform as well as the basis for the qualification.
111.3 RESIDN CONTEDL 111.3. 1 GeAcral Quality assurance procedures are used to assure that design activities are carried out in a planned, controlled and tiracly manner and that applicable design requirements arc established and correctly translated into design documents such as calculations, specifications and drawings.
These procedures provide specific instructions for accomplishment of design
, actisities by defining requirements for design inputs and outputs includin;;;
o document format and content, o document identification, o review and approval, o design verification, o issuance and distribution, o revision control, L o. indication of document status, o record retention.
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l The procedures apply to design / engineering activities including such disciplines as scactor physics; stress, thermal, hydraulic and accident .malyses; compatibility :
of materials; accessibility for inservice inspection, maintenance and repair; fuel
- design; instrumentation and controls design; and delineation of acceptance criteria j for inspections and tests.
The procedures cover the total design process to assure that:
o appropriate design basis requirements including quality ;
standards are selected, specified, and included in the design; o deviations from standards are controlled; !
o materials, parts, equipment, and processes (including commercially
- obtained it:ms) essential to the safety related functions of basic I components are reviewed for suitability of application and compatibility l with overall system design criteria; o design interfaces among rarticipating organizations (both internal and :
external) are identified and controlled; o design work is verified or checked for adequacy; o design changes, including field changes, are subject to the same degree of l control as applied to the original . work. ;
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Compliance to design control procedures is monitored by QA NQ internal compliance audits.
111. 3 .2 Design inputs l
Design work begins with the definition of the design requirements or design bases _ r
- information. These requirements corne from several sources. Typical sources
- include previously approved designs,- those from - engineering and product development efforts, contracts (e.g., equipment performance criteria, design life, j regulatory requirements, codes and standards, interface requirements, etc.),
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Standard Safety Analysis Reports, topical report, and information from industry ;
or government funded research activities.
i A Project / Task Manager (or equivalent) supplies the Cognizant Organization (s) I (CO) with the design requirements or design bases and applicable quality requirements that are specified in contract documents, bid specifications, regulations and industry standards as applicable to the respective efforts. Within the LO, specific tasks are established and assigned to cognizant engineers. The CO is respotMble for selection and documentation of design inputs including the 4
i identification, substantiation and documentation of changes from previously 4 approved designs.
The CO assures that design inputs have been verined or annotated to clearly
- indicate data or assumptions that must be confirmed by later design efforts or tests and that the design inputs are traceable by reference to the source of the data. Design documents containing input data are approved by the author and verifier (s) of the documents. >
111.3.3 Ik3 ignfakulallons/Analysc
- The CO is responsible for selection of input data and analysis method, justincation of assumptions , and preparation of design calculations .
s Documentation of design calculations is detailed in purpose, method, assumptions, de'.ign input, references and units so that a person technically qualined in the sut, ject can review and understand the design and verify the results without ;
recourse to the originator.
- Computer codes (used in design analyses or supplied to clients) are uniquely identined, tested and verified to assure accuracy of method. procedures are used Pagei1 Revision 7 1
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l to preclude use of unverined snodi0 cations. Sample problems used in the a verification are retained as records and include unique identification of the version of the computer code and documentation of inputs amd outputs. Evidence of .
testing and verification of a given version of a computer code is documented and l includes the signature of the author and veriner(s) of the code testing l
documentation. Dissemination of information on cornputer code errors is !
i provided via a computer program error notification system. Computer source codes are protected to preclude uncontrolled modifications.
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A qualined individual or group is assigned to verify the design work (see 111,3.7, Design Verification). When a standardized or previously proven design is used, l the veri 0 cation process is not duplicated; however, the_ applicability of the t
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- standardized design is checked with respect to meeting pertinent inputs. The document includes provisions for unique identification and the signatures of the author (s) and veriner(s). j 111.3.4 Dnian3per.iGcaliens i The CO is responsible for the- preparation of design t.pecifications. These speci0eations contain a complete basis for construction of items in accordance with the requirements of the ASME Code, contractual documents, regulations, and other applicable information and, in conjunction with design drawings,
- contain all necessary information regarding materials and design. A design i specification includes, as applicable
-o functions and boundaries of the items covered, o the design requirements including all required overpressure protection requirements, o the environmental conditions including radiation, o the safety classification of the items covered, o material requirements including impact test requirements, Page 12 Revision _7
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i o olwrability requirements as appropriate, i o the effective ASMll Code Edition, Addenoa and Cases and other appropriate industry standards to be used for construction, o records required to be maintained, o special inslection, testing, and quality assurance requirements.
A qualified individual or group is assigned to verify the specincation (see 111.3.7 Design Verification). The document includes provisions for unique identification and approvals of the author and veri 0er(s).
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111. 3.5 Dutgn Drawings The CO is responsible for th'e preparation of design drawings. These drawings include functional requirements for system / component interfaces, arrangement and layout, which are not directly used for producing an item. Examples include:
piping and instrument diagrams, layout drawings, general arrangement drawings, and electrical diagrams. A drawing request system is used to define the scope and purpose for the drawing, the technical requirements to be incorporated and i
any special features or notes to be included. The CO reviews the design drawing for technical content and agreement with calculations, analyses, or other applicable design specification requirements. Additionally, a qualified individual or group is assigned to verify the contents of the drawing (see 111.3.7, Design Verification).
111.3, 6 OtheLDukn_Rontmenn The CO is responsible for preparation of other design documents needed to define or describe engineerinr, requirements. These documents typically include items such as: design bases or design data information; system descriptions; interface requirements; test requirements; guidelines for star up and operation; guidelines Page 13 Revision 7 l
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for installation; engineering studies; and software verification plans and results. ;
t A qualified individual or group is assigned to verify the design document (sec l 111.3.7, Design Veri 0 cation). The document includes provisions for unique 1 identillcation and approvals by the author and verifier (s).
111.3 .7 Ilesign Vedficatinn !
C Design output is reviewed to verify its adequacy. This veri 0 cation provides assurance that the output meets the specined inputs and is correct and complete.
Verification activities are performed by an individual or group other than those 1 who performed the original work. In exceptional circumstances verincation may ,
be performed by the originator's supenisor, provided: the supervisor is the only :
technically qualified individual in the CO; the need is individually documented ,
' and approved in advance by the supervisor's management; the supervisor did not !
specify the design approach, and did not rule out certain design considerations; the supervisor did not establish the design inputs used in the design. i Audits by QA NQ cover the frequency and effectiveness of the use of supervisors as design verifiers to guard against abuse.
The CD determines the particular design verification methcd(s) to be used and designates the individual or group responsible for the verification efforts. The acceptable verification methods include design review, alternate calculation, and i qualification testing and are defined as follows:
o- Design Review - independent critical review to assure that the information is correct and satisfactory.
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o Alternate Calculation - preparation of calculations or analyses using alternate methods to verify by comparison the correctness of the original work, o Quali0 cation Testing suitable testing of a model, prototype or initial production unit.
, Quali0 cation testing (as opposed to acceptance testing) is performed to test requirements established by the CO. The testing requirements include test conditions that simulate the most adverse design conditions (operating modes and environment) for the specific design feature (s) being verined. Test results are documented by the testing organization and evaluated by the CO to assure that test requirements have been met. When tests are being performed on models or-mockups, scaling laws are established and verified and results are subject to error analysis when applicable prior to use in final design work.
Design Veri 0 cation procedures address responsibilities of verifiers, items to be verified and documentation required.
Results of the verification are documented, including identification of the verifier (s). Design veri 0eation is completed prior to relying upon the component, system, part or structure to perform its safety-related function.
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111. 3. 8 ResintLCon11nl ,
Design document revisions are subject to the same review, approval and distribution controls as those applied to the original work. Revision les el notation is used to assure that obsolete or superseded documents are not used inadvertently. Quality assurance procedures include requirements for evaluation of repor1ed changes resulting from items such as:
o qualification, preoperational, or operational test problems, '
o interference problems during construction, o disposition of nonconformances, o resised inputs (i.e., changes in regulatory or customer requirements), -
and o operational experience.
Where changes to previously verified work have been inade, veriGeation is repeated by the organization currently responsib!c for the work or by an equally 4
qualified organization having access to th pertinent information.
111. 3. 9 inittfactCenirnl Quality assurance procedures contain the organizational structt. ' within which the pregram is implernented and delineate the authority and responsibility of the CO's involved. The organizational interfaces among contributing CO's, (both internal and external) are controlled in accordance with these proceduies.
These procedures control the Dow of design information by requiring the formal release of outputs involving . interface information to other funct:onal groups. This is accomplished internally by documented correspondence or standard document distribution forms and externally by letters or approved procurement documents.
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l The transmittal identifies the verification status of the information or document and, where necessary, identifies incomplete items which require further
, veri 0 cation. Where it is necessary to transmit design information orally or by other informal means, follow-up by a controlled document :s provided. Interface communications are traceable from a request through a related te ponse to assure completeness and accuracy.
l 111.4 PR_OCUREMENT DOCUMENT CONTEDL I Controlled procedures are used for the preparation, review and approval of l procurement documents, Groups that prepare, review and approve procurement documents are identined in the procedures. These groups include design groups (CO's per Section 111.3), procurement groups, and QA NQ. i Procurement documents include (either directly or by reference) the following ;
requirements, as appliccble:
o regulatary, ASME Code and industry standards; o tests and inspections, including acceptance criteria; o qua'ity assurance program elements; o quality assurance records retention times and disposition; o reporting, approving and dispositioning nonconformances; I o rights of access by NS and NF GENP and/or its representative (s);
o documentation submittal, review and approval; ,
o extension of requirements to sub-suppliers; o te&ical/ design (including drawings and specifications);
o administrative; and
- o special prccessing.
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i reviewed and approved by personnel trained in QA procedures prior to issue.
This approval .is also applicable to supplements issued to change the requirements of the original procurement.
l The procurement process for commercial-grade items and services uses the same review and approval cycle. These are purchased to commercial standards where standards are avaliable. Commercialitems that become part of a system may be tested as part of the completed system. Procurement documents for standard l l
l commercial or previously approved items including spare or replacement parts essential to the safety functions of structures, systems, and components, are
- reviewed and approved by personnel trained in QA procedures.
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'- Controls limited to those items and services to be subsequently dedicated as " basic components". ,
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. . i 111.5 MHRUCTIONS ]'BOCEDllRES AND DRA%1NGS Quality affecting activities such as engineering, manufacturing, inspection, f'
l testing, certification, handling, storage, shipping, etc., are pres:ribed by and performed in accordance with documented insuuctions, procedures, or drawir.gs l of a type appropriate to the circumstances. Quality assurance procedures require a that these documents include or reference quantitative or qualitative acceptance !
criteria for determining that the activity has been satisfactorily accomplished.
The following is a summary of the types of instructions, procedures, and drawings used to control quality affecting activities.
DA.MM#ahd't.ecchtteuDilnitngtiem - documents containing the systems and procedures that specify and describe the activities performed to provide adequate conSdence that an item or service provided meets applicable requirements. A typical list of QA procedures is given in Table 1113-4 hecurement Documcals - documents that specify requirements for purchase of an item or service including purchase requisitions, drawings, process or material specifications, procedures or instructions,
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hecruleniniDenLnlents n documents that are used to control operations on !
items. These operations include: forming, machining, assembling, welding, brazing, heat treatment, examination, inspection, testing, plating, etc.. These documents include; o -Process Sheets / Travelers / Work Orders - contain steps and the sequencing of operations performed to produce or install an item.
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1 o Manufacturing Drawings - contain or reference item form and fit requirements such as sire, shape, materials, joining, Onishing, torquing,
! etc., for directly producing an item and include specific acceptance criteria
- for these characteristics. Examples include assembly drawings and detail drawings.
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l 0 Process Instructions / Procedures - contain details on rnethodology, parameters, and acceptance criteria for operations performed in 1
manufacturing, repair, installation, inspection, testing, warehousmg, dedication, etc.. Typically, these documents are used to control l
! operations such as nondestructive examination, inspection, cleaning, packaging, preservation, shipping, handling, welding, brazing, heat ,
treatment, and similar special processes. i
- 111.6 DOCUh1EECONTROL Quality apurance procedures are used to assure current and appropriate documents are used. These procedures control issuance of instructions, procedures, and drawings that specify quality requirements or that prescribe activities affecting quality. The procedures specify how documents are reviewed for adequacy, approved for release, and distributed to and used at the location where the prescribed activity is performed, l These procedures address items such as
o identification of organizations responsible for preparing, reviewing, 7 approving, issuing and revising cocuments. This includes design documents, Safety Analysis Reports, nonconformance reports, as built ,
documents, and those documents identified in Section 111.5;
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o- use of distribution lists or equivalent to assure that the proper personnel or organizations are provided the required documents to perform the work; o document identification to assure that the proper document is used in performing a particular activity The identification includes the document number or any other relevant information that identify the document to be ,
used; o ascertaining that proper documents are accessible and ne being used, This is accomplished by use of dxuraent list u1d/or files showing the latest applicable revision or use of receipt control systems or marking documents as obsolete. This assures that the latest applicable documents have been received and obsolete revisions recalled or discarded, where appropriate.
Changes to documents are reviewed, approved, and released by the organizations responsible for the work unless other organizations are specifically designated.
In all cases, the reviewing organization (s) has access to pertinent information or background data upon which to base approval, page 21 Revision 7
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111.7 CONMOL OF PUEG6SD11It!MSL1ND SERVICliS Jtems and services are procured from approved suppliers. QA procedures specify requirements for supplier evaluation and selection, control of supplier generated documents, acceptance of the item or senice (by documentation review, source suneillance, source and/or receiving inspection), control of nonconforming >
conditions, supplier performance evaluations (assessments and audits), and qualification of audit, inspection and surveillance personnel.
When specified in procurement documents,--ABibGombuMion-Engineering Nuelm-Power-performs-surveillance-of-supplien surveillances are performed during fabrication, inspection. testing, and release of items and services. Quality procedures provide guidance for surveillance activities, Where no established
- quality standards exist for a specific supplier, the specific technical requirements of the procurement documents are used as the basis for surveillance. The degree of surveillance varies with the degree of importance of equipment, supplier ,
performance, and complexity of items. The degree of surveillance is determined by the organization that prepared the order and QA NQ. This surveillance is performed using instructions which define the operation or process to be witnessed and the verifications to be made.
The procurement of spare or replacements parts and components are governed by
- client order requirements.
For commercial-grade items which are supplied as safety-related, but where specific QA control cannot be imposed in a practical manner, specific provisions are made during receiving inspection or source surveillance to verify that critical L characteristics are met.
Initial supplier approval is via *,urvey or evaluation that is conducted by QA NQ.
The purpose of this is to verify that the new supplier is capable of complying with the quality requirements in the procurement documents. The results are Page 22 Revision 7 f..
1 documented and any identined denciencies are resolved prior to starting work.
In accordance with IE Information Notice 8641, suppliers that have received ASME approval are considered " Approved Supplien" on the basis of the ASME approval, f
Supplier approval is maintained by annual evaluations and periodie audits. The annual evaluations take into consideration items such as supplier furnished ,
documentation; results of prior surveillances, inspections, and audits; and item ,
or service operating performance. The periodic audits t.ddress the applicable ,
l criteria of 10CFR50, App. B and are normally performed on a triennial basis.
1 alternative to the guidance in paragraph C.3.2.1 of Regulatory Guide 1.28 .
/. 3) is given in Table 111-2-3.
t items shipped to a ABB-Gembustim-Engineering--Nedear-Power _NS/NF -
rnanufacturing or warehouse facility., nceiving and/or source surveillance procedures are used to assure that the -item and specified-documentation comply with the procurement document requiremcats. Measures are established to assure that items accepted ano 4eleased are identined as to their inspection status in order [
to prevent the use or installation of non-accepted items and allow entry of only accepted items into the warehouse. The status is identified on the item or on docunientation traceable to the item.
For items procured-by-A BBfembusbon-Engineering-Nudear-Power and shipped to a nuclear power plant site, QA NQ issues a certification which indicates
!- acceptance of the item. The certification includes specific information identifying the item and the applicable procuremen. documents, and certifies that the item meets all applicable procurement requirements, including documenution requirements. The certiGestion includes identification of any approved deviations from the procurement requirements and is ,:pproved by authorized l
personnel. . Procedures identify the actions necessary to initiate, authorize, issue, l distribute, and revise certifications. These procedures include provisions for review and acceptance of supplie; furnished documentation (e.g., certincates of I l Page 23 Revision 7 L -, -. , -
conformances, certified material test reports, non-destructive examination reports) and for identifying and following-up contingent conditions that require additional action after delivery to the power plant site. A contingent condition is any condition prohibiting the actual use of material or equipment for its specified purpose. Such items may be shipped to the client to permit partial testing or preparation for use to proceed, but actual use as intended will not be permitted until the contmgent conditon is resolved. Contingent conditions are monitored and their close-out is documented. +
The measures established for item acceptance and supplier auditing provide the means for evaluating supplier certificates of conformance to ensure that they are valid.
111.8 lllbETIFICATION ANRf0EGOI. OF ITEMS Identification requirements are controlled by procedures and are specified in the procurement and process control documents for quality related products and services.
Item identification may be by heat number, part number, equipment or service l records or other appropriate means using a method which will not adversely affect l the fit, function or quality of the item supplied. Identification and control of l items (including consumables)is the responsibility of the o ganization responsible t
j' for the item.
L l
- l. Identification of items is traceable to documents such as design documents, l procurement documents, mill test ieports or inspection records. Identification of items is verified and documented prior to release of the item for further use.
III.9 CDXfROL QElBOCESSES Special processes include those inspection or manufacturing activities that satisfy the following:
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4 4
o The results of which are highly dependent on the control of the process and/or skill of the operator; and
- o The quality of the activity can neither be determined by inspection, nor it is considered advantageous to perform destructive examinations or tests.
Special processes include activities such as welding, heat treating, non-destructive examination, and cleaning. These type of processes are controlled by documents such as process sheets, travelers and special processing procedures which are generated in accordance with QA procedures. These documents address iten.s such as:
3 o process procedure, personnel and equipment qualification requirements o process prerequisites o acceptance criteria f o environmental conditions Process procedures and/or control documents are approved by QA NQ.
Equipment and personnel associated with special processes are qualified in accordance with applicable codes, standards, _QA procedures and/or contract I
requirements. Qualification records are reviewed by QA NQ, and are maintained and kept current by responsible organizations.
l 111.10 ISSPECTION i
~
L Inspections are performed in accordance with instructions, procedures and/or j control documents which are reviewed by QA NQ and approved by the responsible organization. These instructions / procedures provide criteria for
[ determining accuracy requirements of inspection equipment, how and when o - Page 25 Revision 7 c - . .. - . . . . - - . - ..
3
,
- i i
inspections are performed, and mandatory inspection hold points beyond which work may not proceed until inspected by a designated inspector.
Inspections are performed by personnel other than those who performed or directly supervised the activity being inspected and who do not report directly :o the immediate supervisors who are responsible for the activity being inspected.
The personnel performing inspections are trained, qualified and certined in accordance with procedures. The records of quali6 cations and certifications of inspectors are kept current by the responsible organization.
1 Instructions and procedures include, as appropriate, identification of characteilstics and activities to be inspected, a description of the method of inspection, identification of the individuals or groups responsible for performing the inspection, acceptance and/c,r rejection criteria, identification of required.
procedures, drawings and specifications including revisions, special inspcetion equipment and accuracy requirements, recording of the results of the inspection, l and the inspector or data recorder. ,
l The organization or individual performing the inspection is normally responsible l
l for evaluating the results and determining the acceptability of the inspected item.
l-111.11 TEST CONTROL ,
Acceptance testing (such as hydrostatic, pre-operational, etc.), and destructive examination testirg (such as metallurgical, etc.) is performed using controlled procedures. The test procedu'res address the requirements as specified in test requests, speciGcations and/or codes and standards. Test procedures are submitted for resiew and approval pdor to testing and the testing is witnessed by assigned and quali0ed personnel. Test procedures contain the following, as _
applicable:
e Provisions for assuring that prerequisites for the test have been met; Page 26 - Revision 7
, . , ~_ __ _ _
o Required instrumentation and accuracies; e Instructions for conducting the test and for acquiring and recording the data necessary for evaluation; o Witnessing of the testing by qualified personnel; o Required environmental conditions; o Acceptance and/or rejection criteria required to evaluate the test; o Recording the performance of the test; o Use and identification of calibrated equipment; o Code and contract requ;rements; o Test personnel qualification; o Method of recording test results; o Verification that the test precedures have been reviewed and approved.
Test procedures and/or controllirig documents are approved by QA NQ. Test results, as a minimum, identify the item tested, date of the test, the pmcedure and revision level the tester or data recorder, identification number of the equipment, f
g test conditions, time, type of observation, results and acceptability, individual evaluating rest results, and noted nonconformances. The test results are evaluated and documented as specified in the test procedure.
111.12 ff0XmOL OEA1EASL31NO AND TEST EQl)lEhgiN_I Gages, instruments, and other inspection, measuring and testing equipment and devices used in activities affecting quality are required to be of the proper range, type and accuracy in order to verify conformance to established requirements.
Procedures contain the detailed requirements for the calibration (technique and frequency) and control. and describe organizational responsibilities for establishing, implementing, and assuring effectiveness of the calibraion program.
Standards used for calibration have known valid relationships to recognized national standards. These standards have an acceracy adequate to verify that measuring and test equipment being calibrated are within the tolerance Page 27 Revision 7
1 I
, e a
requirements for which they are being used, When possible and practical, measuring and test equipment are calibrated against standards that have an accuracy of at least four times the required accuracy of the equipment being calibrated. - Greater uncertainty may be acceptable when limited by " state-of-the-art" . Where national standards do not exist for reference standards, the basis of the calibration is documented.
The method and interval of calibration for each item is denned in procedures.
These are based on the type of equipment, stability characteristics, required accuracy and other conditions affecting measurement control. Each item i:,
identified to permit traceability to the calibration test data. This identi0 cation may be by either label, tag, or mlor coding, or other means as provided for by procedure. This identincation also indicates the date of the next required calibration.
When an instrument is found to be out of calibration, an investigation to determine the validity of previous inspections performed with the instrument and the acceptability of items inspected or tested since the last calibration is conducted, inspections or tests are repeated on affected items as necessary.
QA NQ audits organizational units responsible for control of measuring and test equipment to assure compliance with applicable procedures.
111.13 HANDLING. STORAGE AND SHIPPING Procedures are used to control handling, storage and shipping of items to ensure the maintenance of quality from source through delivery to the client. These
. procedures may be in various formats such as process sheets, travelers, work' orders, drawings, shipping instructions, process specincations, and instructions.
The procedures specify or describe cleaning, handling, storage, packaging, shipping and preservation methods to preclude item damage, loss, or deterioration
- Page 28 Revision 7
by environmental conditions, These activities are accomplished by trained personne).
The application of quality considerations to handling, storage, and shipping is based upon considerations such as the level of sensitivity of the item to environmental conditions, its resistance to physical forces, and its relative replaceability. When required for particular items, special equipment (such as containers, shock absorbers, accelerometers and special tools or handling devices) and special protective environments (such as inert gas atmosphere, specific >
moisture content levels, and temperature levels) are specified, provided, and verified when required. Tiicse special tools or nandling devices are inspected, tested, and controlled in accordance with procedures. Only experienced or trained personnel are used to work with these devices.
Handling, storage, and shipping procedures and/or controlling documents are approved by QA NQ. Equipment and personnel qualific otion records are audited
, by QA NQ.
111.14 EPECrlON. TEST AND OPERATING STATUS r
Documents, such as travelers, process sheets, and work orders are used for identifying required inspections, tests, examinations, and processing status of items. The documents indicate the status of the operation (s) being performed, the required signatures (or other similar means), and the date indicating when a given operation, test, inspection, or examination was completed. Quality assurance
_ procedures control the use of travelers, process sheets and work orders including methods for making sequence citanges and identification of nonconforming items.
No sequence change is allowed if it compromises the safety function of the item.
Any change to travelers, etc. are subject to the same controls as the original.
These documents accompany items throughout processing.
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h Status indicators such as tags, forms, labels, etc. may also be used to identify status of items. These indicators indicate the current status such as:
a) acceptability or approval of the item, b) a hold situation where a nonconformance exists, and c) rejection where an item is unacceptable foi the use that it was intended. When such indicators are used, only QA NQ is authorized to affix and remove inspection status indicators. This assutes control of any possible inadvertent bypassing of required inspections, tests, and operations. QA' NQ may i waive certain check points, etc. at its discretion.
111.15 CANTROL OF NONCONFORMING ITlihjS A nonconforming item is defined as that which does not meet specified ,
requirements.
Procedures are used to control the identification, documentation, segregation (when practical), review and disposition of nonconforming items (including computer codes), and include notification to affected organizations if disposition is other than scrap. These procedures identify individuals or groups, including OA NQ, authorized to disposition and approve nonconformances, verification requirements, and describe the segregation and/or control of nonconforming items to prevent inadvertent use. Nonconformances are resolved prior to shipment of an item.
Documentation ~contains the identification -of the nonconforming items, a
^
description of the nonconformance and its disposition including re-inspection requirements, and documented approval of this disposition. When nonconforming items are repaired or otherwise made suitable for their intended use, they are inspected or testext in accordance with the original inspection and test requirements or acceptable alternatives.
Individuals dispositioning nonconformances are selected based on experience and competence related to the item being evaluated, and an understanding of the Page 30 Revision 7
requirements. These individuals have access to necessary background information.
Nonconformances are periodically evaluated by QANQ for quality trends.
Findings considered significant are reponed to management for' review and assessment.
III.16 CORRECTIVE ACTION ,
Conditions adverse to quality, such as nonconformances, failures, malfunctions, denciencies, deviations, or defective materials and equipment, are identined, documented and reported to appropriate levels of managemem. These conditions may be identined by suppliers, surveillance, inspection or audit activities at l
suppliers, internal audits / inspections, client audits, agency audits / inspections or by independent investigations conducted by QANQ.
QA precedures specify how conditions adverse to quality are documented and reported to cognizant parties, including appropriate levels of management, for action and for assuring that corrective action is suitably identiDed, accepted and implemented in a timely manner.
These procedures require identincation of cause (as deemed necessary), corrective I
action to prevent recurrence, verincation of implementation, and follow-up and close-out ofintemal audit and supplier audit / surveillance audit Gndings_ Follow-up action is taken by QANQ to verify corrective action. QANQ concurrence with the action is documented.
l Trend analyses are periodically performed on surveillance and audit activities.
L Results of such analyses are reported to appropriate levels of management.
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111.17 QilM,lTX b.S1URANCE RECORDS Quality Assurance records are preplanned, generated, stored, and maintained so as to provide objective evidence that quality assurance requirements have been met. The records program is planned for a standard system but may be expanded or specifically modined in accordance with individual contract requirements. The system includes provisions for records such as design, manufacturing, procurement, installation, inspection, and qualincation. _QANQ is responsible for the maintenance of permanent quality record files. Files are indexed to facilitate storage an:1 retrieval. The records are reviewed for completeness, per procedure requirements, prior to retention and are available for review by clients, for those records applicable to that client's contract. Unless otherwise authorized, suppliers are required to submit a copy of designated quality records for transmittal to the client (s) before the procurement order is concluded. Prior to shipment of a l-
=
purchased item, the quality records compiled by the supplier are reviewed for completeness and acceptability. The results of these reviews are recorded. Test results are reviewed and evaluated for adequacy, as necessary, during surveillance visits to supplier's facilities.
111.18 AUDITS Internal compliance audits are performed by Q'ANQ on applicable organization units at ! cast once per calendar year. External audits of suppliers are performed by QANQ at a frequency commensurate with the supplier scope of supply and status and importance of the supplier activity, o An annual audit schedule is established indicating the frequency and -
1-l~ organimtion(s) to be audited. The audits include review of activities affe: ting quality. Since all elements of the QA Program do not apply to all activities, only the applicable elements are monitored during audits. Audit frequencies and areas Page 32 Revision 7
to be audited may be modified based on previous audit fmdings and conditions such as organizr. tion changes, major procedure revisions, deficiencies and nonconformances, and verification of corrective action. The audit schedule may be revised if necessary.
QANQ personnel assigned to perform audits are qualified and certified prior to performing audits. All audits performed by QANQ are led by a lead auditor.
Qualification is based on training, education, experience, and successful completion of examination. Auditors have no direct responsibility in the areas audited. QANQ may employ qualified auditors from other organizatioris to perform audits and/or QANQ may use the results of supplier audits performed by other organizations. However, QANQ retains responsibility for the audits in such cases.
An audit plan identifies the area to be audited, audit scope, requirements, audit personnel, organizations to be notified, applicable documents, schedule, and procedures or checklists to be used. The organization (s) responsible for the activity or area being audited is noti 6ed in advance of scheduled audits.
An audit report is issued and signed by the . Lead Auditor and includes the following information, as appropriate:
o- description of the audit scope, o identification of the auditor (s),
o identification of persons contacted during the audit, o summary of audit results, including a statement on the effectiveness of the quality assurance program elements which were audited, o description of each reported adverse audit finding in sufficient detail to enable corrective action to be taken by the audited organization, Page 33 Revision 7
,~.
The audit report is transmitted to the audited organization cognizant management.
If de6ciencies are found during the audit the following actions are performed:
o The auditor documents the deficiencies in the audit report with a required response date, o - The audited organization documents corrective action and returns the response to the auditor within the required response time.
o Auditors assure that deficiencies are answered in the allotted time and that adequate corrective action has been implemented or scheduled; verify the ,
adequacy and completeness of corrective action; close out the denciency when the reported condition has been resolved; and assure that relevant audit documents are retained as records including the plan, report and corrective action completion, o Incomplete corrective action responses are brought to the attention of the applicable business unit management for resolution and if necessary to the Vice-Presidentr--NQ--of-President. Follow-up action is taken until corrective action is completed.
o l
p Page 34 Revision 7-l I'
V
.~ . . . - .
NuckatSyltcau
_ffssid;nt 6HILCombustion Engincedog Nuclear Systems Yice President. Nuclear Systems EngineeriDE Mice PresidInt.Eucleatlyitems Developinent Director. Quality Assurance L
Vice Presidculand General Manager. Newington Ooeratioqs hianaccL_Qualjly_An.urance i
Yir. ePresident and General Manager. Electro-Mechanics Man 3ggr. Quality Assurance ContIQ1ktaud_Q1her Administrative Positions l.
Figure 11-1 l
Page 35 Revision 7 4
i
_Nnslear Fuel Errsidg&ABB Combustion Engineering Nuc]sar_B!cl Director. Fuel Encinsering (PWR)-
.o Director. Fuelfnglepinent (PWRJ_ -
Vice-President. BIgulatory Affairs Vice-President. BWR Technology andjingintcring w
Man _agir._ Ouality_Assuraine Vice President. Fuel Manufacturine Operations L'l;Lnt Manager. Windsor Plant Manager. Hematite 1
MaDager. Ouality Assurance Contro]ler and Other Administrative Positions Figure II-2 y Page 36 Revision 7
-l
Table 111-1 Ouelity-Awurance-Responsibilities of Ouality Assurance-Nuclear Guainy o Interface with all NS or NF-GENP-organizations in the solution of day to day quality problems.
o Provide the necessary direction for quality through approval and distribution of quality policies, manuals and procedures.
o Provide an assessment of the scope, status, implementation and adequacy of the GENP QA program, o Conduct the QA internal audit program, o Provide interpretations for QA Standards.
o Interface with the U.S. Nuclear Regulatory Commission on quality policies, procedures and requirements, o Perform quality data collection and trend analysis, o Maintain QANQ personnel training and qualification records.
o Perform supplier evaluations.
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=, ..
o- Perform audits at supplier facilities.
o Review re' solution of dcviations/nonconforniing conditions.
o- Review procurement orders, o' - Establish and; execute witness and hold points (surveillance and/or inspection), ,
- o. Monitor conformance to procurement requirements.
1 F
Page 38 Revision 7
. ._ ~ _ . _ .
Talk-Ill4 Responsibilities cf-Business-Units
. Huelear Systemn 4r- Design ,--procurement-and-fabricat km-ef-N tKMNir-Steam, Supply-4 system-(N SS R) componentsrs ystemsstnd-structureefor-NSShmtraen:
- 2. Desiga-nnd-fatnicatkin-of-instrumentatkmsmdemtrol-systems--
Nuclear Scr< ices;
- 1. Engineer %examinationr-installathm:-fepair+nd-main tenarvee-services-to-operating miclear-power-plantw 2, Nuelear-power-planl+paretartw I
l
- 3. - Designr procurenwntrami-fabrication-ofennponents-systemsekstructures4oeperating nuelear-power-plants- <
- l. Nacht Fueh L
t I-L 1. DesignMnceurement-and-fabricatkm-of-neelear-fuel-4butirinitial-ami-relood-cores) .
L and-related-praluets and services:
- Fontroller-Aed-Gthere Page 39 Revision 7 l
i
- 4. Administrative-management-duties,-sth+awnug 1
s e
I J
1 1
Page 40 Revision 7 -
..- 4
- i.
Table 111-24 Clarifications and Alternatives to NQA 1 and/or Regulatory Guide 1.28 (Rev. 03)
Regulatorv Guide 1.28 Paragraph C.1 Training procedures are used to ensure timt individuals are ClariGeation quali6cd in a manner commensurate with the requirements of their job description. Operating procedures ensure that activities are accomplished at the correct inspection / organization level. This may be used in ileu of personnel level ratings.
Paragraph C.3.2.1 An audit of approved suppliers' quality assurance program is Alternative conducted on a triennial basis unless:
i) there is no active work in progress (note: auduing will resume when work resumes); or li) documentation reviews and surveillance and/or inspections and/or indeoendent tests show acceptable quality assurance program implementation; or lii) the procurement is for ASME Code items from suppliers that hold valid ASME Certificates of Authorization or Quality Systems Certificates. In this case acceptable quality assurance program implementation will be veri 6ed by documentation review and one or more of the following depending upon procurement scope and complexity:
a) audit b) surveillance c) inspection d) independent test.
J N_Q6-1 Supphrnent 17S-1 Paragraph 2.3 Record validation / authentication is by identification in Clarification procedures and logging.
Paragraph 4.0 Applies only to records transferred to permanent storage (all Cladfication other records are classi6ed as " working" files). " Working" Gles are controlled to assure adequate preservation and safe keeping while awaiting transfer to permanent storage, or the client, or expiration of retention requirements.
Page 41 Revision 7 .
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Table 111-34 Typical List of Quality Assurance Procedures o Preparation and Control of Quality Plans o Stop Work Order ,
, o _ Indoctrination & Training of Personnel o Certification Program for Inspection, Examination and Testing Personnel o Certification Program for Audit Personnel o Certification Program for Nondestructive Examination Personnel o Qualification of Registered Professional Engineers for ASME Code Certifying Activities '
o- Determination of Quality Class o Design input .
-o Design Analysis o Design Interface Control o - Design Verification o Preparation, Control & Retention of Drawings L o Specifications
- o. Design Change, Field Change, Corrective Action o- Safety Analysis Reports (SAR) and SAR Changes o- Design Reports o Control of Supplier Technical Change Requests
- o. Preparation, Review & Approval of Purchase Orders o Dedication of Commercial Grade Items o .- Preparation & Control of. Quality Assurance Pncedures 4
J
,; . Page 42 - Revision 7
+
Table ill-4 (continued) -
.o Preparation & Control of Operating Procedures o- Preparation & Control of Technical Operating Procedures '
o Preparation & Control of QA Specifications
-o Control of Quality Assurance Manuals
-o. Preparation and Control of Field Work o - Preparation & Control of _ Welding Procedure Specifications o Supplier Evaluation & Approval (Approved Suppliers List) o Control of Supplier Document Submittals o Control of Supplier Nonconformances o Source Surveillance o Certification of Satisfactory Completion of Work o inspection o Control of Measuring & Test Equipment o - Control of Nonconforming Items i o- Corrective Action Report '
o Quality Trend Analysis
~
~o ' Records Retention -
o' Owner's Records Package (Purchased items)
>o- - Control of N Symbol Stamping o- Internal Compliance Audits o Supplier Audits 6
Page 43 Revision 7
_ . . .