ML20206C779
| ML20206C779 | |
| Person / Time | |
|---|---|
| Site: | 05000470 |
| Issue date: | 09/30/1988 |
| From: | ABB COMBUSTION ENGINEERING NUCLEAR FUEL (FORMERLY |
| To: | |
| Shared Package | |
| ML20206C776 | List: |
| References | |
| NUDOCS 8811160403 | |
| Download: ML20206C779 (43) | |
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1 NUCLIAR POWER SYSTEWS l l 1
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- 1 QUALITY !
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ASSURANCE l i
PROGRAM .
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- A Descrip"ion of the l l Nuclear Power Systems l r
Quality Assurance Program i l i l 0$kIIIOo0!OSoo0$70 l A PNU j ,
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O ABSTRACT This report describes the quality assurance program employed by the Nuclear Power Systems Divisien of Combustion Engineering, Inc., Power Systems for the supply of items and services subject to the requirements of 10CFR50, Appendix
- 8. The program is based on and responsive to the requirements of ANSI /ASME NQA-1, "Quality Assurance Program Requirements for Nurlear Facilities"; the ASME Boiler and Pressure Vessel Code Section !!!, Nuclear Power Plant Components; and the guidance in Regulatory Guide 1.28. "Quality Assurance Program Requirements (Design and Construction)" (Rev 03). .
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Table of Contents
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t Title WA f f
Cover Sheet i !
Abstract 11 i Table of Contents til I e
!. Introduction 1 l I
!!. Nuclear Power Systems' Quality Policy 2 L
!!!. Quality Assurance Criteria 4 !
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!!!.1 Organization 4 l
!!!.2 Quality Assurance Program 6 -
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!!!.3 Design Control 8
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!!!.4 Proevrement Document Control 16 j
!!!.5 Instructions Procedures and Drawings 18 l
< !!!.6 Document Control 19 l
!!!.7 Control of Purchased Items and Services 20
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!!!.8 Identification and Control of items 23 j
!!!.9 Control of Processes 23 l
!!!.10 Inspection 24 f
!!!.11 Test Control 25
!!!.12 Control of Hessuring and Test Equipment 26
!!!.13 Handling, Storage and Shipping 28
!!!.14 Inspection. Test and operating Status 29
!!!.15 Control ef Nonconforming Items 29 l
!!!.16 Corrective Action 30
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!!!.17 Quality Assurance Records 31 E
!!!.18 Audits 32
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Tabis of Contents (Continued)
Fioures Fleure No. Title Pase 40.
11-1 Organization Chart-Nuclear Quality Systems 35
!!-2 Organization Chart-Nuclear Power Systems 36 l Tables l
T3ble No1 Title Pane No.
!!!-1 Responsibilities of Nuclear Quality Systems 37
!!!-2 Responsibilities of Nuclear Power Systems 38 Business Units
!!!-3 Alternatives to NQA-1 and/or 39 D'1ulatory Guide 1.28 (Rev. 03)
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- 1. INTRODUCTION I1 purpose '
This report describes tae quality assurance progr? , employed by the Nuclear Power Systems Division of Combustion Engineering, Inc., Power Systems, for the supply of items and services subject to the requirements of 10CFR$0, Appendix B.
1.2 Scope This report includes a description of controls employed at the Nuclear Power Systems (NPS) facilities noted below. Section !!
presents the NPS commitment to quality and describes the NPS l quality assurance organization and responsibilities. Section
!!! describes the quality assurance controls employed to '
address each criterion of 10CFR50, Appendix B. The controls
- apply to all NPS facilities unless otherwise indicated.
- l The NPS facilities and the activities involved at each facility include:
Facility Activities l
NPS Headquarters. Engineering services and NSSS Windsor, CT (with design, procurement, testing, i offices also in inspection, repair, installation, Chattanooga,TN) and spare parts l
Nuclear Fuels Manufacture of nuclear fuel Manufacturing, pellets, fuel assemblies and Windsor, CT. and control element assemblies and t Hematite, MO associated activities l
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C-E Controls / Elect o- Design and manufacture of 1
i Mechanics, New instrumentation 4 control Britain, CT and systems and associated activities Windsor, CT C E Newington, Design and manufacture of
( Newington, 'JH mechanical systems and associated activities
!.3 Revision Control Revisions to this report will be in accordance with the standards specified in 10CFR$0.55 (f) (3). Specifically;
, T o within 90 days, NRC will be informed of changes to this l program that do not reduce previously accepted I comitments; l o changes that reduce comitments will be submitted for
- l NRC approval prior to implementation.
!!. NVCLEAR POWER $YSTEMS QUAL,lTY pot!CY
!!.1 Policy Statement The Executive Vice President, Nuclear Power $ystems, has authorized the following statement concerning quality assurance policy:
"A primary objective of Nuclear Power Systems is to deliver to l
our customers defect free, competitive products and services on time that fully comply with contract requirements.
The Vice President Nuclear Quality Systems has the responsibility for defining the NPS quality assurance progras Revision 5 L_
and shall bring to the attention of the Senior Vice President, Nuclear Power Systems any quality problem that cannot be res,1ved within the normal execution of tnis responsibility".
!!.2 Quality Assurance Or mantration ,
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The Quality Assurance (QA) organization in NPS is shown in !
Figure !!-1.
The Vice President, Nuclear Quality Systems (NQ1) is ;
responsible to assure that the QA policy, goals and objectives I l i are transmitted through levels of management and imposed on j quality functions. This is accomplished by distribution of l
. Quality Assurance Manuals which contain QA policy statements. I l
i t Responsibility for nuclear quality assurance rests with the l Executive Vice President, Nuclear Power Systems and is
} delegated to the Vice President, Nuclear Quality Systems, who i may further delegate specific activities to NQS personnel. -
Such delegation includes authority to stop work for i f
noncompliance to requirements. Stop work orders may be j originated at any organization level within NQS and executed at the level of a Manager, Director, or Vice President for action. In all cases where personnel perform quality i assurance functions, this delegation provides them authority j i and f.'eedom to initiate, reco m nd, or provide solutions to {
quality problems through management channels, i Compilance with quality requirements is measured through
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planned surveillance and/or audit activities and corrective :
Q,$ action follow-up by NQS personr.e1. NQS is independent of
,h other t'ganizations within NPS as shown in Figure !!-2. NQS l 1 interpre n quality related industry standards for intent and i guidance and is responsible for assuring that all quality !
assurance related procedures used in NPS comply with j established QA requirecents, f i
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!!I. QUALITY ASSURANCE CRITERIA ,
l gj This section describes each of the eighteen (18) elements of the Combustion Engineering, Inc., Power Systems, Nuclear Power Systems Division quality assurance program.
'.s !!I. 1 Organization ,
Combustion Engineering, Inc., (C-E) has corporate headquarters at Stamford, Connecticut, and is a diversified energy systems and services company. It contains several divisions, one of which is Nuclear Power Systems. The Executive Vice President, Nuclear Power Systems Division (NPS) is responsible for the supply of nuclear systems, nuclear fuel and nuclear services.
QA responsibilities originate within NPS as illustrated in Figures 11-1 and 11-2. NPS is headquartered at 1000 Prospect Hill Road, Windsor, Connecticut 06095.
Each project under contract at NPS is coordint.ted by a Project, Program, or Task Manager who is a member of either the Nuclear Systems, Nuclear Services or Nuclear Fuel organizations. The Project / Task Manager is responsible for coordinating and ocumenting all project work, assuring conformance with contract requirements and maintaining comunication channels among NPS, the customer, and all other participating organizations.
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The Vice President, Nuclear Quality Systems (NQS) reports at the same organizational level as other NPS Vice Presidents.
Responsibilities of NQS are listed in Table III-1. These responsibilities are carried out through the NQS staff (Figure 11-1) and by cooroinstion of all QA activities within NPS.
Details on responsibilities and interfaces among NQS 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. Responsibilities of the other NPS units are listed in Table III-2.
NQS functions as an independent communication channel between senior NPS management and line .nanagement. This assures that senior NPS management i*. appraised of quality matters and that the NQS staff receive and comply with directives from the Ex)ilscutiveVicePresident,NuclearPowerSystemsviatheVice President, Nuclear Quality Systems.
The Vice President. Nucle.:- Quality Systems meets as necessary and at least monthly with the NQS management staff to discuss quality issues, schedule quality efforts, establish goals and identify areas for improvements. These meetings are supplemented by reports frem the NQS management staff to the Vice Fresident, NQS and from the Vice President, Nuclear Quality Systems to the Executive Vice President, Nuclear Power Systems.
The detailed organizational structure of NQS as well as the number of personnel in NQS may change over time depending on p0.3 quality needs as well as business needs. However, NQS will not become involved in activities unrelated to QA that would prevent full attention to QA mattsrs.
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l NQS personnel selection is based on knowledge of NPS operations; QA regulations, practicer and standards; past working experience in QA or related activities in nuclear
((ph. power or a similar high technology industry and education considerations. In addition, NQS rinagement assignment; are also based on evaluated management experience in similarly responsible positions.
III.2 Quality Assurance program
!!!,2,1 %mmary Descrintion The QA program describtd herein is employed by NPS for the supply of items and sery;ces subject to the requirements of 10CFR50 Appendix B. The program is based on and responsive to the requirements of ANSI /ASME NQA-1 "Quality Assurance Program Requirements for Nuclear Facilities",
the ASME Code, and the guidance in Regulatory Guide 1.28, "Quality Assurance Program Requirements (Design and Construction)", Rev. 03. Alternatives to the explicit requirements and guidance given in NQA-1 and/or Regulatory Guide 1.28 are described in Table !!!-3.
!!!.2.2 Proaram Control The requirements of this program are implemented at each NPS facility through QA manuals and procedures applicable 3e0 to the activities conducted at each facility. All such documents are reviewed, approved and controlled by NQS to assure compliance with program requirements.
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!!!.2.3 Evaluation of proaram Effectiveness The scope, status, implementation and adequacy of the QA program are assessed by senior levels of management in several ways. The Executive Vice President, Nuclear Power Systems receives a monthly report from the Vice President, Nuclear Quality Syrstems covering major quality issues such as:
significant internal and customer audit findings, industry quality-related developments, and quality improvement needs.
Quality issues and assessments are discussed during regular
- t:ff r.setings with the Vice Presidents involved. The Vice
'f President, Nuclear Quality Systems is assessed, at least annually, for the performance of the QA program by the Executive Vice President, Nuclear Power Systems through a documented management appraisal system.
111.2.4 Personnel Indoctrination and Trainina The responsibility for assuring that personnel oerforming activities affecting quality are suitably trained rests with the organization performing those activities. Detailed personnel training requirements for each NPS facility are contained in QA procedures. NQS 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:
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o indoctrination in the purpose, srepe and implementation of QA manuals, and applicable .uctions and proceJures 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 NQS 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 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 qualification records and/or procedures delineate the specific functions personnel are qualified to perform as well as the basis for the qualification.
!!!.3 OESIGN CONTROL
!!!.3.1 General Quality assurance procedures are used to assure that design C
activities are carried out in a planned, controlled and timely g()' manner and that applicable design 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 activities by defining requirements for fesign 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, o indication of document status, o record retention.
. The procedures are applied to design / engineering activities as required by contract including such disciplines as reactor physics; stress, thermal, hydraulic and accident analyses; compatibility of materials; accessibility for inservice inspection, maintenance and a 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 l
standards are selected, specified, and included in the design; l
( o deviations from standards are controlled; o materials, parts, ecc;ipment, 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; o design interfaces among participating organizations internal and external to NpS ars identified and controlled; o design work is verified or checked fo* ad*quacy; o design changes, including field changes, are subject to the same degree of control as applied to the original work.
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111.3.2 Desian inputs Design work begins with the definition of the design requirements or design bases information. These requirements come from several sources internal and external to NPS. The internal sources include requirements from previously approved designs and those from engineering and rtoduct development efforts. The e.tternal sources include requirements from con *racts (such as equipment performance criteria, design life, regulatory requirements, codes and standards, interface requirements, etc.) and information from industry or government funded research activities.
A project / Task 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, regulations and h
g' industry standards as applicable to the respective efforts.
Within the CO, specific tasks are established and assigned to-cognizant engineers. The C0 is responsible for selection and documentation of design inputs including the identification, substantiation, and documentation of changes from previously approved designs.
The CO assures that design inputs have been verified 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.
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111.3.3 Desian Calculations The C0 is responsible for selection of input data and analysis method, justification of assumptions, and preparation of design calculations.
Oo x. Atation of design c'.lculations is detailed in purpose, method, assumptions, design input, references and units so that a person technically 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 are uniquely identified. Coniputer cudes are 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 th; computer code and
, documentation of inputs and outputs. Evidence of testing and.
verification of a given version cf a computer code is documented and includes the signature of the author and verifier (s) of the code testing documentation. Dissemination of information on computer code errors is provided via a computer program error notification system. Computer source codes are protected by security methods to preclude unintentional, unplanned or unauthorized modifications.
A qualified individual or group is assigned to verify the design work (see !!!.3.7, 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.
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The cover sheet or revision page of the document includes provisions for unique identification and the signatures of the author (s) and verifier (s).
111.3.4 Desian Specifications The C0 is responsible for the preparation of design specifications. These specifications 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 i nformation regarding materials and design. A design specification includes:
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, o special inspection, testing, and quality assurance requirements.
A qualified individual or group is assigned to verify the specification (see !!!.3.7, Design Verification). The cover sheet or revision page of the document includes provisions for unique identification and approvals of the author and verifier (s).
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111.3.5 Design Drawinas The C0 is responsible for tne preparation of design drawings.
l These drawings include functional require.unts for system / component interfaces, arrangement and layout, which are not directly used for producing an item. Examples include:
i piping and instrument diagrams, layout drawings, general l arrangement drawings, and electrical diagrams. A drawing request system is used to define the scope and purpose for the l
0- drawing, tne technical requirements to be incorporated and any special features or notes to be included. The C0 reviews the design drawing for technical content and agreement with cniculations, analyses, or other apnlicable 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 Other Desian Documents The C0 is responsible for preparation of other design documents needed to define or describo engineering requirements. These documents typically 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 j (see 111.3.7, Design Verification). The cover sheet or revision page of the document includes provisions for unique identification and approvals by the author and verifier (s).
!!!.3.7 Desian Verification Design output is reviewed to verify its adequacy. This gQ.h verification provides assurance that the output meets the P specified inputs and is correct and complete.
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Verification activities are performed by an individual or group other than those who performed the original work. The verification may be performed by the originator's supervisor provided the supervisor is the only individual in the CO competent to perform the verification or provided:
o the supervisor did not specify the design approach, and o the supervisor did not rule out certain design considerations, o the supervisor did not establish the design input.
The C0 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 reviews, alternate calculations, and h qualification testing and are defined as follows:
JW o Design Reviews - independent review to assure that the information is correct and satisfactory. -
o Alternate Calculations - 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, j prototype or initial production unit.
l Qualification testing (as apposed to acceptance testing) is performed to test requirements established by the C0. 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 Revision 5
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requirements have been met. When tests are being performed on I models or mockups, scaling laws are established and verified and results are subject to error analysis when applictOle '
prior to use in final design work,
- g Results of the verification are documented and includes identification of the verifier (s). Design verification is h completed prior to relying upon the component, system, part or structure to perform its safety-related function.
III.3.8 R_evision C'ontrol Design document revisions a"e subject to the same review, approval and distribution controls as those applied to the original work. Revision level notation is used to assure that obselete 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 construction, 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, verification is repeated by the organization currently responsible for the work or by an equally qualified organization having access to the pertinent information.
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111.3.9 Interface Control Quality assurance procedures contain the organizational structure within which the program is implemented and delineate the authority and responsibility of the C0's involved. The organizational interfaces among contributing C0's, both internal and external to NPS, are controlled in accordance with these procedures.
Three procedures control the flow of design information by
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requiring the formal release of outputs involving interface (gh information to other functional groups. This is accomplished v:ithin NpS by documented correspondence or standard document distribtulon forms and external to NPS 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 verificatien. Where it is necessary to transmit der.ign information orally or by other informal means, follow-up by a -
controlled document is provided. Interface communications are traceable from a request through a related response to assure completeness and accuracy.
111.4 PROCUREMENT DOCUMENT CONTROL Controlled procedures are used for the preparation, review and approval of procurement documents. Groups that prepare, review and approve procurement documents are identified in the procedures.
Procurement documents include (either directly or by reference) the following requirements, as applicable:
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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 rignts of access by NPS and/or its representative (s);
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.
it is the responsibility of the NPS organization that prepares the procurement document to assure that all required elements are addressed. Procurement documents are 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 procuremont. .
The procurement process for comercial-gradeII) items and services uses the same review and approval cycle. These are bought to comercial standards where standards are available.
Comercial items that become part of a system may be tested as part of the completed system. Procurement documents for standard comercial 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.
(1) Controls limited to those items and services to be subsequently dedicated by NPS as "basic components".
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111.5 INSTRUCTION
S. PROCEDURE
S AND ORAWINGS Quality affecting activities such as engineering, manufacturing, inspection, testing, 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, anc drawings used to control quality affecting activities.
QA Manuals, procedures and Instructions - documents containing the systems and procedures that specify and describe the activities performed within NPS to provide adequate confidence-that an item or service provided meets applicable requirements, procurement Documents - documents that specify requirements for purchase of an item or service including purchase requisitions, drawings, process or material specifications, procedures or instructions, process Control Documents - 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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o Manufacturing Drawings - contain or reference item form and fit requirements, such as, size, shape, materials, joining, finishing. torquing, etc., for directly producing an item and include specific acceptance criteria for these characteristics. Examoles include assembly drawings and detail drawings, o Process Instructions / Procedures - contain details on methodology, parameters, and acceptance criteria for operations performed in manufacturing, repair, installation, inspection, testing, warehousing, dedication, etc..
Typically, these documents are used to control operations such as nondestructive examination, inspection, cleaning, packaging, preservation, shipping, handling, welding, brazing, heat treatment, and similar special processes.
I!!.6 00CUMENT CONTROL Quality assurance 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 2h *lh 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.
These procedures address items such as:
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 in Section !!!. 5; Revision 5
o use of distribution lists or equivalent to assure that the proper norsonnel 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 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. 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.
!!!.7 CONTROL OF PURCHASED ITEMS AND SERVICES Items and services are procured from approved suppliers. QA procedures specify requiree.ents for supplier evaluation and selection, control of supplier generated documents, acceptance of the item or service (by documentation review, source surveillance, source and/or receiving inspection), control of nonconforming conditions, supplier performance evaluations (assessments and audits), and qualification of NPS audit. .
inspection and surveillance personnel. I l
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- When specified in procurement documents, NpS performs l surveillance of suppliers during fabrication, inspection, l testing, and release of items and services. Quality procedures I 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 by NQS. 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 customer 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 requirements of the procurement document have been met.
g Initial supplier approval is via survey or evaluation that is conducted by NQS. The purpose of these are to verify that the new supplier 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.
Supplier approval is maintained by annual evaluations and periodic 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 address the applicable criteria of 10CFR50 Appendix B.
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Suppliers that have received ASME approval are approved on the basis of the ASME approval. ;
i For items shipped to a NPS mar.1facturing or warehouse facility, receiving and/or source surveillance procedures are used to assur6 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-accepted items and provide for the entry only of accepted items into the warehouse. The status is identified on the item or on documentation traceable to the item.
For items procured by NPS and shipped to a nuclear power plant site, NQS issues a certification which indicates acceptance of the item. The certification includes specific 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 NPS approved deviations from the procurement requirements 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.
he certificates of 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 on-site for its specified purpose. Such items may be shipped to the site to permit partial testing or preparation for use to proceed, but actual use as intended will not be permitted until the contingent conditon is resolved.
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Contingent conditions are monitored and their close-out is documented.
The measures established for item acceptance and supplier auditing provide the means for evaluating the supplier's certificates of conformance to ensure that they are valid.
!!!. 8 IDENTIFICATION AND CONTROL 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 records or other appropriate means using a method which will not adversely affect the fit, function or quality of the item supplied. Identification and control of items (including consumables), is the sosponsibility 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 of items is verified and documented prior to release of the item for further use.
!!!.9 CONTROL OF PROCESSES r
Special processes include those inspection or manufacturing ,
activities that satisfy the following:
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- g o The results of which are highly dependent on the control of ,
g((p the process and/or skill of the operator; and L
o The quality of the activity can neither be determined by inspection, nor it is considered advantageous to perform destructive examinations or tests.
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Special processes include activities such as welding, heat treating, non-destructive examination, and cleaning.
. These type of processes are controlled by documents such as f process sheet travelers and special processing procedures which are generated in accordance with QA procedures. These y documents address items such as:
o process procedure, personnel and equipment qualification requirements o process prerequisites
- o acceptance criteria o environmental conditions Process procedures and/or control documents are approved by l NQS. Equipment and personnel associated with special processes l are qualified in accordance with applicable codes, standards, *
', QA procedures and/or contract requirements. Qualification l records are reviewed by NQS, and are maintained and kept current ey responsible organizations.
!!!.10 INSPECTION a
Inspections are performed in accordance with instructions f
procedures and/or control documents which are reviewed by NQS 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.
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Inspections are performed by personnel other than thcse 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 i
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, j)) identification of the individuals or groups responsible for jPh' 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 inspSctor 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.
!!!. 11 TEST CONTROL Acceptance testing (such as hydrostatic, pre-operational, ,
i etc.), and destructive 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, fest procedures are submitted for review and approval prior to testing and, if necessary, testing is witnessed by assigned and qualified personnel. Test procedures contain tne following, as applicable:
o Provisions for assuring that prerequisites for the test have been met; o Required instrumentation and accuracies; Revision 5
e 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 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 requirements; o Test personnel qualification; o Method of recording test results; o Verification that the test procedures ha<a been reviewed and approved.
Test procedures and/or controlling documents are approved by NQS.
Test results, as a minimum, identify the item tested, date of the test, the procedure and revision level, the tester or data' recorder, identification number of the equipment, test conditions, time, type of observation, results and acceptability, individual evaluating test results, and noted nonconformances. The test results are evaluated and documented as specified in the test procedure.
111.12 CONTROL OF MEASURING AND TEST EQUIPMENT 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 cetailed requirements for the calibration (technique and frequency) and control, and describe organizational responsibilities for establishing, implementing, and assuring effectiveness of too calibration program.
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Standards used for calibration have known valid relationships to recognized 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 tee required accuracy of the equipment being calibrated. Greater uncertainty may be acceptable when limited b)
"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 1.em 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 other means as provided for by procedure. This identification 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.
NQS audits organizational units responsible for control of measuring and test equipment to assure compliance with applicable procedures.
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!!! 13 HANDLING. STORAGE AND SHipp!NG Procedures are used to control handling, storage and shipping of items to ensure the maintenance of quality from source through delivery to the customer. 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 l to preclude item damage, loss, or deterioration by enviianmental conditions. Where required, these activities are ,
accomplished by appropriately trained personnel.
l The application of quality considerations to handling, storage, and shipping is based upon considerations such as the level of a 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
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j containers, shock absorbers, accelerometers and special tools l or handling devices) and special protective environments (such as inert gas atmosphere, specific moisture content levels, and tenperature levels) are specified, 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, i Handling, storage, and shipping procedures and/or controlling d documents are approved by NQS. Equipment and personnel qualification records are audited by NQS.
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111.14 INSPECTION. TEST AND OPERATING STATUS 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 changes and identification of nonconforming items. These documents accompany items throughout processing.
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, Status indicators such as tags, forms, labels, etc. may also be useo tu iuentify status of items. These indicators indicate ine 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 NQS
! is authorized to affix and remove inspection status indicators.
This assures control of any possible inadvertent bypassing of required inspections, tests, and operations. NQS may waive certain check points, etc. at its discretion.
!!!.15 CONTROL OF NONCONFORMING ITEMS 1
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[) ,f,k A nonconforming item is defined as that which does not meet specified reentrements.
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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 NQS, authorized to disposition and approve nonconformances, verification requirements, and l descrite the segregation and/or control of nonconforming items to prevent inadvertent use.
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 tested in accordance with the original inspection j and test requirements or acceptable alternatives.
Individuals dispositioning nonconformances are selected based - I 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 NQS for quality I trends. Findings considered significant are reported to l management for review and assessment.
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CORRECTIVE ACT!0fi t
Conditions a6erss to quality, sue', as a nonconformances, failures, malfunctions, deficiencies, deviations, or defective i materials and equipment, are identified, documented and 0, reported to appropriate levels of management. These l conditions may be identified by suppliers, surveillance, l inspection or audit activities at suppliers, internal audits / inspections, customer audits, agency audits / inspections '
or by independant investigations conducted by NQS.
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QA procedures specify how conditions adverse to quality are
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documented and reported to cognizant parties, including appropriate levels of management, for action and for assuring that corrective action is suitably identified, accepted and imp 1tmented.
V These procedures require identification of cause (as deemed necessary), corrective action to prevent recurrence, I verification of implementation; and follow-up and close-out of internal audit, and supplier audit / surveillance audit findings. Follow-up action is taken by NQS to verify corrective ac* ion.
Trend analyses are periodically performed on surveillance and audit activities. Results of such analyses are reported to appropriate levels of management.
I !!1.17 00At.!TY ASSURANCE RECOROS j .
1 Quality Assurance records are preplanned, generated, stored.
l and maintained so as to provide objective evidence that
- quality assurance requi.tments have been met. The records program is planned for a s*andard system out may be expanded
. or specifically modified in accordance with individual
! contract requirements. The system includes provisions for records such as: design, marufacturing, procurement, j installation, inspection, and qualification.
i j NQS is responsible for the maintenance of quality record files. Files are indexed to facilitate storage and retrieval.
The records are reviewed for :ompleteness, per procedure requirements, prior to retention and are available for review by customers, for those records applicable to thAt customer's j contrut(s). Quality records are maintained in accordaNe with contract requirements, i
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e Unless otherwise authnrized, suppliers are required to submit a copy of designated quality records to NPS for transmittal to the f customer (s) before the procurement order is concluded. Prior to i 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 reviewed and evasuated for adequacy, as necessary, during surveillance visits to supplier's facilities. '
t Ill.18 AVOITS i Internal compliance audits are performed on applicable NPS !
, organization units at leas' ice oe . alendar year. Extnrnal audits of suppliers are pe.' arm c it a frequency comensurate ;
with the suppliers scope of supp.; and status and importance of l
the suppliers' activity.
An annual audit schedule is estab,ished it;dicating the frequency
- and organization (s) to be audited. The audits include review of activities affecting quality. Since all elements of the QA 1 Program do not apply to all activities, only the applicable ,
elements are monitored during audits. Audit frequencies and i areas to be audited may be modified based on previous audit l
t findings and conditions such as organization changes, major !
precedure revisions, deficiencies and nonconformances, and verification of corrective action. The wudit schedule may be revised if necessary.
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PiQS personnel assigned to perform audits are qualified and !
certifid r *ior to their performing audii:s. Qualification is based on training, education, experience, and successful l completion of examination. Auditors have no direct responsibility in the areas audited. l i
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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) risponsible for the activity or '
area being audited is notified 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),
c 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.
The audit report is transmitted to the audited organization (s)' I eognizant management. !
If deficiencies are found during the audit the following '
actions are performed:
o The auditor (s) documents the deficiencies in the audit l report with a required response dat6.
t o The audited orgcnization documents corrective action and returns the response to the auditor within the required response time.
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li, o Auditors assure that deficiencies are answered in the allotted time and that adequate corrective action has been isolemented or scheduled; verify the adequacy and completeness of corrective action; close out the deficiency when the reported condition has been resolved; and assure that relevant dudit documents are retained as records including the plan, report and corrective action completion.
o incomplete corrective action responses are brought to the attention of management for resolution and if necessary to the Vice President. Nuclear Quality Systems. Follow-up action is taken until correcs te ,ction is completed.
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- Nuclear Quality Systems Executive Vice President. Nuclear Power Systems Vice President. Nuclear Quality Systems Director. Quality Coerations Manager. Quality Programs Manager. Training and Administration I Manager. Quality Assurance (NFM. Windsor)
I Manager. Quality Asturance (NFM Hematite)
! Manager. Quality Assurance (Newington) l Manager. Quality Assurance (E-M/C-E Controls) -
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Figure !!-1
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Nuclear Power Systems '
L ExetcwtNe 0;n';. Vice President. Nuclear Power Systems Vice President. Nuclear Quality Systems Vice President. Nuclear Systems (l}
Vice President. Nuclear Fue1 II Vice President. Nuclear Services Controller (1) includes C-E Controls / Electro-Mechanics and C-E Newington facilities.
(2) includes Nuclear Fuels Manufacturing facilities. ,
Figure !!-2 Revision 5
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Table !!!-1 Responsibilities of Nuclear Quality Systems Interface with all NPS organizations in the solution of day to day quality problems.
Provide for NPS the necessary direction for quality through approval and distribution of quality policies, manuals and procedures.
Provide an assessment of the scope, status, implementation and adequacy of the NPS QA program.
Conduct the QA internal audit program.
Provide interpretations for QA Standards.
Peform quality data collection and trend analysis. .
Maintain NQS personnel training and qualification records.
80" Perform supplier evaluations.
l Perform systems audits at supplier facilities.
Review resolution of deviations.
Review procurement orders. ;
Establish and execute witness and hold points (surveillance and/or !
inspection),
l l Monitor conformance to procurement requirements.
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r-e a Table III-2 ;
I Responsibilities of Nuclear Power Systems Business Units Nuclear Systems: i
- 1. Design, procurement and fabrication of Nuclear Steam Supply System (NSSS) l components, systems and structures for NSSS contracts. [
- 2. NSSS Licensing t
- 3. Design and fabrication of instrumentation and control systems.
Nuclear Services:
- 1. Engineering, examination incta11ation, repair and maintenance services to !
I operating nuclear power plants.
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- 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, procurement and fabrication of nuclear fuel (both initial and l reload cores) and related products and services. .
I Controller: [
, 1. Administrative management duties, such as accounting.
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e o e Table !!!-3 Alternatives to NQA-1 and/or Regulatory Guide 1.28 (Rev. 03)
Section Alternative NQA-1, Supplements 25-1 and 2S-2, and Not applicable to personnel who Regulatory Guide 1.28 paragraph C.1 do not do inspection, testing or non-destructive examination (NDE).
The training program ensures that individuals are qualified in a manner comensurate with the requirements of their job description, operating procedures ensure that activities are accomplished at the correct inspection / organization level; this is in lieu of personnel level ratings.
Regulatory Guide 1.28 The frequency of auditing a Paragraph C.3.2.1 supplier is based on:
i) if active work is in progress under a purchase order, ~
ii) results of quality trend evaluations, iii) quality classification of item or service, iv) processes being employed, v) item or service complexity or uniqueness, vi) number of planned surveillances, vii) number of current orders.
NQA-1 Supplement 175-1 Record validation is controlled paragraph 2.3 by procedure in lieu of stamping, initialing or signing, paragraph 2.8 Record retention period is as required by contract and controlled by procedure in lieu of marking, paragraph 4.0 Applies only to records transferred to permanent storage (all other records are classified as "working" file:i).
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