ML20079C964

Description of Nuclear QA Program

ML20079C964
Person / Time
Site:	05200002
Issue date:	06/13/1991
From:	ABB COMBUSTION ENGINEERING NUCLEAR FUEL (FORMERLY
To:
Shared Package
ML20079C962	List: LD-91-029, Forwards Rev 6 to Topical Rept CENPD-210, Description of Nuclear QA Program ML20079C964
References
CENPD-210, CENPD-210-R06, CENPD-210-R6, NUDOCS 9106260402
Download: ML20079C964 (48)

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i A ED D 7%Es p ASEA BROWN BOVERI ABB COMBUSTION ENGINEERING NUCLEAR POWER QUALITY ASSURANCE A DESCRIPTION OF THE NUCLEAR QUALITY ASSURANCE PROGRAM CENPD-210 REVISION 6 Asea Brown Boveriinc.

1000 Prospect Hill Road Windsor CT 06095 D $0$ibk cihbhibho2 P PDR

4 ABSTRACI' This report describes the quality assurance program employed by ABB Combustion Engineering Nuclear Power, a division of Combustion Engineering, Inc., for the supply of items and senices subject to the requirements of 10CFR50, Appendix B. The program is based on and is responsive to the requirements of ANSI /ASME NOA-1, "Ouality Assurance Program Requirements for Nuclear Facilities (1983 Edition with Addenda la (1983))"; the ASME Boiler and Pressure Vessel Code Section III, 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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_ Table of contents i

_Titic Page No.

Cover Sheet i Abstract ii Table of Contents iii I. Introduction 1 II. Quality Policy 3 III. Quality Assurance Criteria 4 III.1 Organization 4 III.2 Quality Assurance Program 6 III.3 Design Control 9 III.4 Procurement Document Control 18 III.5 Instructions Procedures and Drawings 20 III.6 Document Control 21 III.7 - Control of Purchased Items and Services 23 III.8 - Identification and Control of Items 25 III.9 Control of Processes 26 III.10 Inspection 27 III.Il Test Contral 28 III.12 Control of Measuring and Test Equipment 29 III.13 _ IIandling, Storage and Shipping 30 111.1 4 Inspection, Test and Operating Status 31 III.15 Control.of Nonconforming Items '32 III.16 Corrective Action 33 l III.17 Quality Assurance Records 34

l. 111.1 8 Audits 35 r

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l Table of Contents (Continued)

Eirures Figure No. _Titic Page No.

II-1 Organization Chart Nuclear Quality 38 l- II-2 Organization Chart-ABB Combustion 39 Engineering Nuclear Power Tables Table No. . Title Page No, III-1 Quality Assurance Responsibilities of 40 Nuclear Qualitj III-2 Responsibilities of Busines L'..hs 41

III-3 Clarifications to NQ,i-1 and/or 42

! Regulatory Guide 1.28 (Rev,03) l l

III-4 Typical List of Quality Assurance Procedures 43

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1. - INTRODUCTION 1.1 - Purnose This report describes the quality assurance program employed by ABB Combustion Engineering Nuclear Power (CENP) for the supply of items and services subject to the requirements of 10CFR50, Appendix B.

1.2 1 sops This report includes a description of controls employed at the facilities noted below. Section Il presents the commitment to quality and describes the l quality assurance organization and responsibilities.Section III describes the

. quality assurance controls employed to address each criterion of 10CFR50,

~ Appendix B. The controls apply to all facilities unless otherwise indicated.

The facilities and the activities involved at each facility include:

Facility Activities CENP Headquarters, Engineering services, nuclear Windsor, CF fuel design and NSSS design, p-L (with offices also in procurement, testing, inspection,

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L- Chattanooga, TN) repair, installation, and spare parts L

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l Nuclear Fuel Manufacture of nuclear fuel Manufacturing, pellets, fuel assemblies and Windsor, CT and control element assemblics and IIematite, MO associated activities ABB Electro. Design and manufacture of Mechanics, New instrumentation & control Britain, CT systems and associated activities ABB CENP Newington Design and manufacture of Operations, mechanical systems and Newington, NH associated activities I.3 Revision Control Revisions to this report will be in accordance with the standards specified in 10CFR50.55 (f) (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.

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11. OUAl.lTY POLICY 11.1 Policy Statement The President, ABB Combustion Engineering Nuclear Power has authorized the following statement concerning quality assurance policy:

"A primary objective of ABB Combustion Engineering Nuclear Power is to deliver to our clients defect free, competitive products and services on time that fully comply with contract requirements."

The Vice-President, Nuclear Quality has the responsibility for defining the ABB Combustion 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, f II.2- Ouality Assurance Organization The Quality Assurance (OA) organization is shown in Figure 11-1.

' The Vice President, Nuclear Quality (NO) is responsible to assure that the .

OA . policy, goals and objectives are transmitted through levels of '

management and imposed on quality functions. This is accomplished by distribution of- Quality Assurance Manuals which contain. OA policy statements.

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x Responsibility for nuclear quality assurance rests with the President and is delegated to the Vice President, Nuclear Quality, who may further delegate specific activities to NO quality assurance personnel. Such delegation includes authority to stop work for noncompliance to requirements. Stop work orders are dispositioned by NO quality assurance personnel and may-be originated at any organization level and unit and executed at the level of a Manager, Director, Vice President or President for action. In all cases where personnel perform quality assurance functions, this delegation provides them authority and freedom to initiate, recommend or provide solutions to quality problems through management channels.

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Compliance with quality requirements b measured through planned l- surveillance and/or audit activities and corrective action follow-up by quality assurance personnel. NO is independent of c.aer organizations as shown in Figure 11-2.- NO interprets quality related industry standards for intent and

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guidance and is responsible for assuring that all quality assurance related procedures used comply with established QA requirements.

III. OUAUTY ASSURANCE CRITERIA This section describes each of the eighteen (18) elements of the ABB Combustion

' Engineering Nuclear Power quality assurance program.

III,1 Organization E

ABB Combustion Engineering Nuclear Power has headquarters at Windsor, Connecticut, and is a diversified energy systems and services unit of Page 4 Revision 6 p

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4 Combust:on Engineering, Inc. The President is responsible for the supply of nuclear systems, nuclear fuel and nuclear services. QA responsibilities are as illustrated in Figures 111 and 112.

Each project under contract is coordinated by a Project, Program, or Task hianager who is a member of either the Nuclear Systems, Nuclear Services or Nuclear Fuel organizations. The Project / Task hianager 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 orgamzations.

The Vice President, Nuclear Quality reports directly to the President and at the same organizational level as other Vice Presidents. Quality assurance responsibilities of NO are listed in Table 111-1. These responsibilities are carried out through the NQ staff (Figure 11-1) and by coordination of all QA activities. Details of responsibilities and interfaces among NQ and other organizations are contained in OA manuals and procedures. These interface relationships address items such as auditing, investigation of quality problems and implementation of corrective action. Responsibilities of the other units are listed in Table III-2.

NQ functions as an independent conununication channel between senior management and line management. This assures that senior management is appraised of quality matters and that the NQ staff receive and comply with directives from the President, v a the Vice President, Nuclear Quality.

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t The - Vice President _ Nuclear Quality meets regularly with the NO management staff to discuss quality issues, schedule quality efforts, establish goals and identify areas for improvements. These meetings are normally held monthly but may be at shorter or longer internals depending on the significance of quality ascurance activities and issues at that time. In addition, these meetings are supplemented by reports from the NO management staff to the Vice President, NO and from the Vice President, NO to the President.

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The detailed organizational structure of NO as well as the number of t personnel in NQ may change over time depending on quality needs as well as business needs. However, _NO will not become involved in activities i unrelated to OA that would prevent full attention to OA matters when necessary. NO personnel selection is based on knowledge of operationst GA regulations, practices and standards; past working experience in OA or related activities in nuclear power or a similar high technology industry and education considerations. I.' addition, NO management assignments are also based on evaluated management experience in similarly responsible positions.

III.2 Ouality Assurance Program

l. IIL2.1 Summary Description The OA program described herein is employed for the supply of items and services subject to the requirements of 10CFR50 Appendix B._ The progra.n is based on and responsive to the requirements of ANSI /ASME NOA L Page 6- Revision 6 L

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" Quality Assurance Program Requirements for Nuclear Facilities", the ASME Code, and the guidance in Regulatory Guide 1.28, " Quality Assurance

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Program Requirements (Design and Construction)". Alternatives to the explicit requirements and guidance given in NOA-1 and/or Regulatory Guide

_ i 1.28 are described in Table Ill 3.

In addition to the above, the appl! cable elements of ASME NOA 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 NOA-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.

l 111.2.2 Program Control The requirements of this program are implemented at each facility through OA manuals and procedures applicable to the activities conducted at each facility. All such documents are reviewed, approved and controlled by NO - ,

to assure compliance with program requirements.

III.2.3 Eypluation of Program Effectiveness t

l- The scope, status, implementation and adequacy of the OA program are i

j assessed by senior levels of management-in several ways. The President-l Page 7 Revision 6

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• l receives a monthly report from the Vica President, NQ covering major quality issues such as significant internal and client audit findings, industry quality-related developments and quality improvement needs. Quality issues and assessments are discussed during staff meetings with the Vice Presidents involved. An annual, independent assessment of the QA program is performed by personnel outside Nuclear Quality. This assessment is documented and any corrective actions are identified and tracked.

111.2.4 Personcil Indoctrination and Training 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 OA procedures. NQ is responsible for assuring that training requirements are met.

Indoctrination, training and qualification of personnel performing engineering, purchasing, fabricating, installing, handling, shipping and storing activities consists of at least:

o indoctrination in the purpose, scope and implementation of QA manuals, 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, Page 8 Revision 6

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.. - -l o maintenance of- proficiency by performance review, and/or reexamination, and/or retraining as determined by management. ,

-Indoctrination, training and qualification of NO personnel verifying quality affecting activities consists of the three items above and in addition the following:

o training and qualification in the principles, techniques and requiremcnts 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 qualification 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.

IIIJ- DESIGN CONTROL i

III3.1 General L Quality assurance procedures are used to assure that design activities are-carried out in a planned, controlled and timely manner and that applicable

, : sign requirements are established and correctly translated into design documents such as calculations, specifications and drawings.

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- These procedures provide specific instructions for accomplishment of design u activities by defining requirements for design inputs and outputs including:

o document format and content, o document identification, o review and approval, o design verification, o . issuance and distribution, o revision control, j- o- indication of document status, o record retention.  :

l The procedures apply to- design / engineering activities including such

- disciplines as reactor physics; stress, thermal, hydraulic and accident analyses; compatibility of materials; accessibility for inservice inspection, maintenance and repair; fuel design; instrumentation and controls design; and delineation of acceptance criteria 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 items)- essential to the safety-related functions of basic components are reviewed for suitability .of application and-compatibility with overall system design criteria; Page'10 Revision 6

o design interfaces among participating organizations (both internal and external) are identified and controlled; P'

o design work is verified or checked for adequacy; o design changes, including field changes, are subject to the same degree of control as applied to the original work.

Compliance to design control procedures is monitored by NQ internal compliance audits.

111.3.2 Design inputs Design work begins with the definition of the design requirements or design bases information. These requirements come from several sources. Typical sources include previously approved designs, those from engineering and product development efforts, contracts (e.g., equipment performance criteria, design life, regulatory requirements, codes and standards, interface requirements, etc.), Standard Safety Analysis Reports, topical report, and information from industry or government funded research activities.

A Projectfrask Manager (or equivalent) supplies the Cognizant Organization (s) (CO) with the design requirements or design bases and applicable quality requirements that are specified in contract documents, bid specifications, regultuons and industry standards as applicable to the respective efforts. Within the CO, specific tasks are established and assigned to cognizant engineers. The CO is responsible for selection and documentation of design inputs including the identification, substantiation and documentation of changes from previously approved designs.

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The CO assures that design inputs have been veified or annotated to clearly indimte data or assumptions that must be confirmed by later design efforts l or tests and that the design inputs are traceable by reference to the source l

of the data. Design documents containing input dm gre approved by the 1 author and verifier (s) of the documents. l i

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111.3.3 Design Calculations / Analyses The CO is responsible for selection of input data and analysis method, justification of assumptions, and preparation of design calculations.

Documentation of design calculations is detailed in purpose, method, assumptions, design input, references and units so that a person t:chnically qualified in the subject 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 identified, tested and verified to assure accuracy of method. Procedures are used to preclude use of unverified modifications. Sample problems used in the verification are retained as records and include unique identification of the version of the computer code and documentation of inputs and outputs.

Evidence of testing and verification of a given version of a computer code is documented and includes the signature of the author and verifier (s) of the code testing documentation. Dissemination ofinformation on computer code errors is provided via a computer program error notification system.

Computer source codes are protected to preclude uncontrolled modifications.

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I A qualified individual or group is assigned to verify th- design work (see 1113.7, Design Verification). When a standardized or previously proven design is used, the verification process is not duplicated; however, the applicability of the 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 verifier (s).

1113.4 Design Specifications The CO is responsinle for the preparation of design specifications. These specifications contain a complete basis for construction of items in accordance w'th the requirements of the ASMS Code, contractual documents, regulations, and other applicable information and, in conjunction with design drawings, contain all necessary information regarding materials and design. A design 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, o operability requirements as appropriate, o the effective ASME Code Edition, Addenda and Cases and other appropriate industry standards to be used for construction, o records required to be maintained, I

o special inspection, testing, and quality assurance requirements.

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A qualified individual or group is assigned to verify the specification (see

-III3.7, Design Verification). The document includes provisions for unigae identification and approvals of the author and verifier (s).

1113.5 Design Drawings The CO is responsible for the preparation of design drawings. These drawings include functional requirements for system / component interfaces, l

arrangement and layout, which are not direc4y used for producing an item.

Examples include: piping and instrument diagrams, layout drawings, general arrangement drawings, and elec:dcal diagrams. A drawing request system is ,

I used to define the scope and purpor for the drawing, the technical l l requirements to be incorporated and any t,9ecial features or notes to be included. The CO reviews the design drawing far technical content and_ i 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 1113.7, Design Verification).

1' III3.6 Other Design Documents I

L The CO is responsible for preparation of other design documents needed to

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define or describe cngineering requirements. These documents typically

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l include items such as: ' design bases or design data information; system descriptions; interface requirements; test requirements; guidelines for startup and operation; guidelines for installation; engineering studies; and software verification plans and results. A qualified individual or group is assigned to verify the design document (see III3.7, Design Verification). The document Page 14 Revision 6

includes provisions for unique identification and approvals by the author and verifier (s).

111.3.7 Design Verification Design output is reviewed to verify its adequacy. This verification provides assurance that the output meets the specified inputs and is correct and complete. Verification activities are performed by an individual or group other than those who performed the original work. In exceptional circumstances verification may be performed by the originator's supervisor, 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.

Audits by NQ cover the frequency and effectiveness of the use of supervisors as design verifiers to guard against abuse.

The CO determines the particular design verification method (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 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 Qualification Testing - suitable testing of a model, prototype or initial production unit,-

Qualification 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 verified. 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-

' des _ign work.

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Design Verification procedures address responsibilities of verifiers, items to

. be verified and documentation required.

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- Results of the verification are documented, including identification of the verifier (s). Design verification 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 Revision Control Design document revisions are subject to the same review, approval and distribution controh as those applied to the original work, llevision level notation is used to assure that obsolete or superseded documents are not used inadvertently. Quality assurance procedures include requirements for evaluation of reported changes resulting from items such as:

o qualification, preoperational, or operational test problems, o interference problems during con >truction, o disposition of nonconformances, o revised inputs (i.e., changes in regulatory or customer requirements),

and o operational experience.

Where changes to previously verified work have been made, veiification is repeated by the organization currently responsible for the work or by an equally qualified organization having access to the pectment information.

111.3,9 Jnterface Contro)

Quality assurance procedures contain the organizational structure within which the program is implemented 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 procedures.

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These proculures control the flow of design information by requiring the formal release of outputs involving interface information to other functional groups.- This is accomplished internally by documented correspondence or standmd document distribution forms and externally by letters or approved procurement documents. The transmittal identifies the verification status of the information or document and, where necessary, identifies incomplete items which require further verification. Where it is necessary to transmit design information orally or by other informal means, follow up by a controlled document is provided. Interface communications are trr.ccable from a request througn a related response to assure completeness and accuracy.

111.4 - PROCUREMENT DOCUMENT CONTROL Controlled procedures are used for the preparation, review and approval of procarement documents. Groups that prepare, review and approve procurement documents are identified in the procedures. These groups include design groups (CO's per Section 111.3), procurement groups, and NO. -!

Procurement documents include (either directly or by reference) the following requirements, as applicable:

o regulatory, ASME Code and industry standards; o tests and inspections, including acceptance criteria;-

o quality assurance program elements; ,

o quality assurance records retention times and disposition; o reporting, approving and dispositioning nonconformances; o righs of access by CENP and/or its representative (s);-

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o documentation submittal, review and approval; o extension of requirements to sub suppliers; o technical / design (including drawings and specifications);

o administrative; and o special processing, i

i It is the responsibility of the organization that prepares the procurement I document to assure that all required elements are addressed. Procurement documents are reviewed and approved by personnel tra!ned in OA procedures prior to issue. This approval is also applicable to supplements issued to chana . the requirements of the original procurement.

The procurement process for commercial grade' items and services uses the I same review and approval cycle. These are purchased to commercial standards where standards are available. Commercial items that become part of a system may be tested as part of the completed system. Procurement  !

' documents for standard commercial or previously approved items including spare or replacement parts essential to the safety functions of structuies, systems, and components, are reviewed and approved by personnel trained in OA procedures.

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Controls limited to those items and services to be subsequently dedicated as " basic components".

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111.5 INSTILUCIIONSJ1LQE11U111!S /,ND DIL\ WINGS Quality affecting activitics such as engineering, manufacturing, inspection, terting, certification, handling, storage, shipping, etc., are prescribed by and performed in accordance with documented instructions, procedures, or drawings of a type appropriate to the circumstances. Quality assurance procedures require 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.

OL\.Suln11th(PIIKfthlres Itud.luilmfliQnS documents containing the systems and procedures that specify and describe the activities performed to provide adequate confidence that an item or service provided meets applicable requirements. A typical list of OA procedures is given in Table 1114.

Procurement Documents documents that specify requirements for purchase of an item or service including purchase requisitions, drawings, process or material specifications, procedures or instructions.

J'wrcu control Documenh - documents that are used to control oper9 ions on items. 'Wese operations include: forming. machining, assembling, welding, brazing, heat treatment, examination, inspection, testing, plating, etc.. These documents include:

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c  :?rocess Sheets / Travelers / Work Orders - contain steps and othe sequencing of operations performed to produce or install an item, r

o Manufacturing Drawings contain or reference item form and fit i requirements such as size, shape, materials, joining, finishing, torquing, etc., for directly producing an item and include specific acceptance criteria for these characteristics. Examples include assembly drawings and detail drawings.

o Process Instructions / Procedures - contain details on methodology, parameters, and acceptance criteria for operations performed in t manufacturing, repair, installation, inspection, testing, warehousing, dedication, etc.. Typleally, these documents are used to control operations such as nondestructive examination, inspection, elcuning, packaging, preservation, shipping, handling, welding, brazing, heat  ;

treatment, and similar special processes.

111.6 DOCUMENT CONTEDL Quality assurance procedures are used to assure current and appropriate 1 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 fer release, and distributed to and used at the location where the prescribed activity is performed.

These procedures address items such as:

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o identification of organizations responsible for preparing, reviewing, approving, issuing and revising documents. This includes design documents, Safety Analysis Reports, nonconformance reports, as built documents, and those documents identified N Section 111.5; 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 dacument number or any other relevant information that identify the document to be used; o ascertaining that proper documents are accessible and are being used.

This is accomplished by use of document lists and/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 obsoletc 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, i

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III,7 CONTROL OF PURCllASED ITl!MS AND SliitVICliS j ltems 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 service (by documentation  ;

e review, source surveillance, source and/or receiving inspection), control of I nonconforming conditions, supplier performance evaluations (assessments and l

audits), and qualification of audit, inspection and surveillance personnel.

i When specified in procurement documents, AllI3 Combustion Engineering i Nuclear Power performs surveillance of suppliers during fabrication, inspection, testing, and release of items and services. Quality procedures  !

provide guidance for surveillance activities. Where no established quality i standards exist for a specific supplier, the specif': technical requirements of t 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 NO, 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.

I 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 characteristics are met.

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r Initial supplier approval is via survey or evaluation that is conducted by NO.

The purpose of this is to verify that the new supp!!er is capable of complying with the quality requirements in the procurement documents. The results are  !

documented and any identified deficiencies are resolved prior to starting work, in accordance with IE Information Notice 86 21, suppliers that have received ASMii approval are considered " Approved Suppliers" on the basis ,

of the ASME approval.  !

t Supplier approval is maintained by tmnual evaluations and periodic audits.

The annual evaluations take into consideration items I.uch as supplier furnished documentationt results of prior surveillances, inspections, and auditst and item or service operating performance. The periodic audits  !

address the applicable criteria of 10CFR50, App. B and are normally 1 performed on a triennial basis. An alternative to the guidance in paragraph r C.3.2.1 of Regulatory Guide 1.28 (Rev. 3) is given in Table 1113.

For items shipped to a ABB Combustion Engineering Nuclear Power manufacturing or warehouse facility, receiving and/or source surveillance procedures are used to assure that the item and specified documentation ,

comply with the procurement document requirements. Measures are established to assure that items accepted and released are identified as to their inspection status in order to prevent the use or installation of non.

l accepted items and allow entry of only accepted items into the warehouse, -

The status is identified on the item or on documentation traceable to the Item.

For items procured by ABB Combustion Engineering Nuclear Power and i shipped to a nuclear power plant site, NQ issues a certification which indicates acceptance of the item. The certification includes specific L Page 24 Revision 6 L _ _

information identifying the item and the applicable procurement documents, and certifies that the item meets all applicable procurement requirements, including documentation requirements. The certification includes identification of any approved deviations from the procurement iequirements and is approved by authorized personnel. Procedures identify the actions necessary to initiate, authorize, issue, distribute, and revise certifications.

These procedures include provisions for review and acceptance of supplier furnished documentation (e.g., certificates of conformances, certified material test reports, non destructive examination reports) and for identifying and following up contingent conditions that require additional action aft,>r delivery to the power plant site. A contingent condition is any condition prohibiting the actual use of material or equipment for its specifi:d purpose.

Such items may be shipped to the clie to permit partial testing or preparation for use to proceed, but actui .c as intended will not be permitted until the contingent conditon is rs ed. Contingent conditions are monitored and their close-out is decumented.

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 IDIINTIFICATION AND CONTI(OI. 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 ser ice records or other appropriate means using a method which will not adversely affect the fit, or quality of the item supplied.

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Identification and control of items (including - consumables) is the responsibility of the organization responsible for the item, Identification of items is traceable to documents such as design documents, procurement documents, mill test reports or inspection records, Identification ofitems is verified and documented prior to release of the item for further use.

111,9 . CONTROL OF PROCESSES Special processes include those inspection or manufacturing activities that satisfy the following:  ;

o The results of which are highly dependent on the control of the process and/or skill of the operator; and b

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 OA procedures. These documents address items such as:-

o process procedure, personnel and equipment qualification requirements o process prerequisites Page 26 Revision 6 1

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o acceptance criteria o environmental conditions Process procedures and/or control documents are approved by NO.

Equipment and personnel associated with special processes are qualified in accordance with applicable codes, standards, QA procedures and/or contract requirements. Qualification records are reviewed by NO, and arc maintained and kept current by responsible organizations.

111.10 INSPECTION Inspections are performed in accordance with instructions, procedures and/or control documents which are reviewed by NO and approved by the responsible organization. These instructions / procedures provide criteria for determining accuracy requirements of inspection equipment, how and when 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 to the immediate supervisors who are responsible for the activity being inspected. The personnel performing inspections are trained, qualified and certified in accordance with procedures. The records of qualifications and certifications of inspectors are kept current by the responsible organization.

Instructions and procedures include, as appropriate, identification of characteristics and activities to be inspected, a description of the method of inspection, identification of the individuals or groups responsible for Page 27 Revision 6

1 performing the inspection, acceptance and/or rejection criteria, identification of required procedures, drawings and specifications including revisions, special inspection equipment and accuracy requirements, recording of the results of the inspection, and the inspector or data recorder.

The organization or individual performing the inspection is normally responsible 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 destructise examination testing (such as metallurgical, etc.) is performed using controlled procedures. The test procedures address the requirements as specified in test requests, specifications and/or codes and standards. Test procedures are submitted for review and approval prior to testing and the testing is witnessed by assigned and qualified personnel. Test procedures contain the following, as applicable:

o Provisions for assuring that prerequisites for the test h:ive been met;

o. Required instrumentation and accuracies: ,

o 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 emironmental conditions:

o. Acceptance and/or rejection criteria required to evaluate the test; o Recording the performance of the test; 0 - Use and identificatien of wii'uraicd uycipment; o Code and contract requirements; Page 28 Revision 6 r E-v e , ae. w- c m ,wme++.--e----*=. -N.,,.c - -

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o Test personnel qualification; o Method of recording test results; o Verification that the test procedures have been reviewed and approved.

l Test procedures and/or controlling documents are approved by NO. Test results, as a minimum, identify the item tested, date of the test, the '

procedure and revision level, the tester or data recorder, identification i

number of the equipment, test conditions, time, type of observation, results and acceptability, individual evaluating test results, and noted i nonconformances. The test results are evaluated and documented as specified in the test procedure. ,

111,12 CONTROL OF MEASURINO AND TEST EOUIPMENT 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 i requireme*,ts. Procedures contain the detailed requirements for the

! calibratic n (technique and frequency) and control, an'd describe orgar.zational responsibilities tor establishing, implementing, and assuring effectiveness of the calibration program.

L Standards used for calibration have known valid relationships to recognized ,

L national standards. These standards have an accuracy adequate to verify that measuring and test equipment being calibrated are within the tolerance  :

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 Page 29 Revision 6

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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 defined in procedures. These are based on the type of equipment, stability characteristics, required accuracy and other conditions affecting measurement control. Each item is identified to permit traceability to the calibration test data. This identification may be by either label, tag, or color coding, or I other means as provided for by procedure. This identification also indicates l 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 necesstry. l NO audits organizational units responsible for control of measuring and test equipment to assure compliance with applicable procedures.

111.13 liANDLING. STORAGE AND SillPPING q Procedures are used to control handling, storage and shipping of items to l ensure the meintenance 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 specifications, and instructions. The procedures specify or describe cleaning, handling, storage, packaging, shipping and preservation methods to preclude item damage, la:s, Page 30 - Revision 6 '

_= _ __ .._ _ . . .

4-or deterioration by environmental conditions. These activities are accomplished by trained personnel.

l The application of quality considerations to handling, storage, and shipping l 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 containets, 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, j provided, and verified when required. These special tools or handling .

- 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 NO, Eqtdpment and personnel qualification records are audited by NO, 111,14 INSPECTION. TEST AND OPERATING STATUS Documents, such as travelers, I,rocess shcets, 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 whec a given operation, test, inspection, or examination was completed. Quality a surance procedures control the use of travelers, process sheets and work orders including methods for making sequence changes and identification of nonconforming items. No sequence change is allowed if it compromises the safety function of the item. Any change to travelers, etc.

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i are subject to the same controls as the original. These documents accompany items throughout processing.

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 for the use that it was intended. When such indicators are used, only NO is authorized to affix and remove inspection status indicators. This assures control of any possible inadvertent bypassing of required inspections, tests, and operations. NO may waive certain check points, etc. at its discretion.

111.15 CONTI(OL OF NONCONFolullNG 1l'liMS 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 er groups, including NO, 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 ne aconformance and its dispa sition including re inspection requirements, and documented approval of this disposition. When Page 32 Revision 6

l l.

l noncomorming items are repaired or otherwise made suitable for their intended use, they are inspected or tested 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 requirements. These individuals have access to necessary background information.

Nonconformances are periodically evaluated by NO for quality trends.

Findings considered significant are reported to management for review and assessment.

111.16 CORIUiCFIVE AcrION Conditions adverse to quality, such as nonconformances, failures, malfunctions, deficiencies, deviations, or defective materials and equipment, are identified, documented and reported to appropriate levels of management These conditions may be identified by suppliers, surveillance, inspection or audit activities at suppliers, internal audits / inspections, client audits, agency audits / inspections or by independent investigations conducted by N O.

OA procedures 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 identified, accepted and implemented in a timely manner.

Page 33 Revision 6

These procedures require identification of cause (as deemed necessary),

corrective action to prevent recurrence, verification of implementation, and follow up and close out ofinternal audit and supplier audit / surveillance audit findings. Followp action is taken by NO to verify corrective action. NO concurrence with the action is documented.

Trend analyses are periodically performed on surveillance and audit activities.

Results of such analyses are reported to appropriate levels of management.

111.17 OUAllTY ASS.UR6EG RI.CQRDS 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 modified in accordance with individual contract requirements. The system includes provisions for records such as design, manufacturing, procurement, installation, inspection, and qualification. NQ is responsible for the maintenance of permanent quality record files. Files are indexed to facilitate storage and retrieval. The records are reviewed for cmnpleteness, 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 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 Page 34 Revision 6

9

+

reviewed and evaluated for adequacy, as necessary, during surveillance visits to supplier's facilities.

111.18 AUDITS Internal compliance audits are performed by NO on applicable organization units at least once per calendar year. External audits of suppliers are performed by NO at a frequency commensurate with the supplier scope of supply and status and importance of the supplier aethity.

An annual audit schedule is established indicating the frequency and organization (s) to be audited. The audits include review of activities affecting quality. Since all elements of the OA Program do not apply to all activities, only the applicable elements are monitored during audits. Audit frequencies and areas to be audited may be modified based on previous audit findings and conditions such as organization changes, major procedure revisions, deficiencies and nonconformances, and verification of corrective action. The audit schedule may be revised if necessary.

NO personnel assigned to perform audits are qualified and certified prior to performing audits. All audits performed by NO are led by a lead auditor.

Qualification'is based on training, educatloa, experience, and successful completion of examination. Auditors have no direct responsibility in the areas audited. NO may employ qualified auditors from other organizations to perform audits and/or NO may use the sesults of supplier audits performed by other organizations. Ilawever, NO retains responsibility for the audits in such cases.

Page 35 Revision 6

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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 notified in advance of scheduled audits.

An audit report is issued and signed by the Ixad 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 sununary 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.

The audit report is transmitted to the audited organization cognizant management.

If deficiencies 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.

Page 36 llevision 6

o- Auditors assure that deficiencies are answered in the allotted time and that adequate corrective action has been implemented or scheduled; 1

verify the adequacy and completeness of corrective action; close out the deficiency when the reported condition has been resolved; and assure that relevant audit documents are retained as records i including the phm, report and corrective action completion.

i o incomplete corrective action responses are brought to the attention of the applicable business unit management for resolution and if

, necessary to the Vice President, NO or President. Follow up action- l Is taken until corrective action is completed.

t L

i h

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Nuclear Ouality 1

I President. AHR Combustion Engineering Nuclear Power Vice President. Nuclear Ouality  ;

Director. Ouality Onerations Manager. Ouality Progr:UnS Manager. Training and Administration Lhianager. Quality Assurance (NFM. Windsor)

Manager. Quality Assurance (NFM. Hematite)-

Manager. Quality Assurance (Newington Operatiom) t Manager. Ouality Assurance (E-M)

,.J TLicensing Managers Note: NFM = Nuclear Fuel Manufacturing.

E M = Electro Mechanics Figure 111 Page 38 Revision 6

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Allil Combustion Engineering Nuclear Power President. AHH Combustion EngineeringEttclear Powet Vice President. Nuclear Quality, Vice President. Nuclear Synenf Vice President. Nuclear Fuel $

Vice President. Nuclear Services U

i Controller and Otlief Administrab Positions (1) includes Electro-Mechanics and Newington Operations facilities.

(2) includes Nuclear Fuel Manufacturing facilities.

Figure 112 Page 39 llevision 6

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Table 1111 j Ouality Assurance Responsibilities of Nuclear Ouality.

1 o Interface with all CENP organizations in the solution of day to day quality problems. '!

i 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 CENP OA program.

L ,

l 0 Cond At the OA internal audit program. j i

o Provide interpretations for OA Standards, o Interface with the U.S. Nuclear Regulatory Commission on quality policies, procedures and requirements. .

i o Perform quality data collection and trend analysis, o Maintain NO personnel training and qualification records, o Perform supplier evaluations.

L o - Perform audits at supplier facilities.

l o Review resolution of deviations / nonconforming conditions.

o Review procurement orders.

o Establish and execute witness and hold points (surveillance and/or inspection),

o Monitor conformance to procurement requirements.

Page 40 Revision 6 L

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Table 1112 Responsibilities of llusiness Units Nuclear Systems:

1. Design, procurement and fabrication of Nuclear Steam Supply System (NSSS) components, systems and structures for NSSS contracts.

2. Design and fabrication of instrumentation and control systems.

Nuclear Services:

1. Engineering, examination, installation, repair and maintenance services to operating nuclear power plants.

2. Nuclear power plant spare parts.

3. Design, procurement, and fabrication of components, systems and structures to operating nuclear power plants.

Nuclear Fuel:

1. Design, pre arement and fabrication of nuclear fuel (both initial and reload cores) and related products and services.

. Controller And Others:

1. Administrative management duties, such as accounting.

Page 41 Revision 6

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d Table 1113 Clarifications and Alternatives to NOA 1 and/or Regulatory Guide 1.28 (Itev. 03)

Ergulatorv Guide 1.28 Paragraph C.1 Training procedures are used to ensure that individuals are Clarification qualified in a m: inner commensurate with the requirements of ,

their job description. Operating piocedures ensure that l activities are accomplished at the correct inspection / organization level. This W.y be used in lieu 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: auditing will resume when work resumes); or ii) documentation reviews and surveillance and/or inspections and/or independent 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 verified by documentation review and one or more of the following depending upon procurement scope and complexity:

a) audit h) surveillance c) inspection d) independent test.

XOA 1 Suoplement 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 Clarification other records are classified as " working" files). " Working" files are controlled to assure adequate preservation and safe keeping while awaiting transfer to permanent storage, or the client, or expiration of retention requirements.

Page 42 Revision f i

o Table 1114 Typical List of Quality Assurance Procedures o Preparation and Control of Quality Plans o Stop Work Order o Indoctrination & Trainiing 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 D-sign Analysis o Design Interface Control o Design Verification o Preparation, Control & Retention of Drawings 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 Procedures I

Page 43 Revision 6 l

,. X Table 111-4 (continued) o Preparation & Control of Operating Procedures o Preparation .x C:r'rol of Technical Operating Procedures o Preparation & Conco ' A Specifications o Control of Quality Assurance ' 4n" :.: .

o Preparation and Control of Fich . e. t o Preparation & Control of Wehlin! hoc 8;re Specifications o Supplier Evaluation & Approval ( A) proved Suppliers lit) o Control of Supplier Document St.bi tittals o Control of Supplier Nonconformances o Source Surveillance o Certification of Satisfactory Completion of Work o inspection o Control of Measuring & Test Equipment o Contro: of Nonconforming items o Corrective Action Report o Quality Trend Anaiysis o Records Retention o Owner's Records Package (Purchased items) o Control of N Symbol Stamping o Internal Compliance Audits o Supplier Audits Page 44 Revision 6 ,

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